CA2475178A1 - Vessel sealing system - Google Patents
Vessel sealing system Download PDFInfo
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- CA2475178A1 CA2475178A1 CA002475178A CA2475178A CA2475178A1 CA 2475178 A1 CA2475178 A1 CA 2475178A1 CA 002475178 A CA002475178 A CA 002475178A CA 2475178 A CA2475178 A CA 2475178A CA 2475178 A1 CA2475178 A1 CA 2475178A1
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- pulse
- tissue
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- electrosurgical
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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
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
- A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
-
- 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
-
- 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
- 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
- A61B18/14—Probes or electrodes therefor
- A61B18/1442—Probes having pivoting end effectors, e.g. forceps
-
- 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
- A61B18/14—Probes or electrodes therefor
- A61B18/1482—Probes or electrodes therefor having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
-
- 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
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B2017/2926—Details of heads or jaws
- A61B2017/2945—Curved jaws
-
- 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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
-
- 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
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00404—Blood vessels other than those in or around the heart
- A61B2018/00428—Severing
-
- 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
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00589—Coagulation
-
- 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
- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/00601—Cutting
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- A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
- A61B2018/0063—Sealing
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- A61B2018/00684—Sensing and controlling the application of energy using lookup tables
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- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00702—Power or energy
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- A61B2018/00696—Controlled or regulated parameters
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- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00773—Sensed parameters
- A61B2018/00791—Temperature
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- 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
- A61B2018/00827—Current
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- 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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- 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
- A61B2018/1246—Generators therefor characterised by the output polarity
- A61B2018/126—Generators therefor characterised by the output polarity bipolar
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61B18/14—Probes or electrodes therefor
- A61B2018/1405—Electrodes having a specific shape
- A61B2018/1425—Needle
- A61B2018/1432—Needle curved
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- 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
- A61B18/14—Probes or electrodes therefor
- A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
Abstract
A method for electrosurgically sealing a tissue includes steps of: (A) applying a first pulse of RF
energy to the tissue; and (B) applying at least one subsequent RF energy pulse to the tissue and keeping constant or varying RF energy parameters of individual pulses of subsequent RF energy pulses in accordance with at least one characteristic of an electrical transient that occurs during the individual RF energy pulses. The method terminates the generation of the at least one subsequent RF pulse upon a determination that the electrical transient is absent.
energy to the tissue; and (B) applying at least one subsequent RF energy pulse to the tissue and keeping constant or varying RF energy parameters of individual pulses of subsequent RF energy pulses in accordance with at least one characteristic of an electrical transient that occurs during the individual RF energy pulses. The method terminates the generation of the at least one subsequent RF pulse upon a determination that the electrical transient is absent.
Description
VESSEL SEALING SYSTEM
FIELD:
This invention relates generally to medical instruments and, in particular, to generators IS that provide radio frequency (R'F~ energy useful in sealing tissue and vessels during electrosurgical and other procedures.
BACKGROUND:
20 Electrosurgical generators are employed by surgeons to cut and coagulate the tissue of a patient. High frequency electrical power, which may be also referred to as radio frequency (RF) power or energy, is produced by the electrosurgical generator and appli8d to the tissue by an .electrosurgical tool. Hoth monopolar and bipolar conf~.gurations are comsnanly used during electrosurgical procedures.
Electrosurgica~. techniques can be used to. seal small diameter . blood vessels and~vascular bundles. Anvther~app'lication of electrosurgical techniques is in tissue fusion wherein two ~ ..
layers.of tissue are grasped and clamped together by a , ~~ .
suitable electrosurgical tool while the electrosurgical RF
energy is applied. The two layers of. tissue are then fused together. ~ ' . ~ ' At this point it is significant to note tha~~'thev.process of coagulating small ~vessels~ is fundamenta7.ly different than vessel sealing or tissue fusion. for the parposes herein the term coagulation ran be defined as a process. of desiccating tissue wherein the tis~ue.cells are ruptured and dried.
Vessel se~.ling or tigsue.fuai4n can both be defined as . C..I
desiccating tissue by the pxocess of liquefying the collagen in the tissue so that it crosslinks and reforms into a fused mass. Thus, the Coagulation of small vessels if generally sufficient to close them, however, larger vessels normally need to be sealed to assure permanent closure.
However, and as employed herein, the tear "electrosurgical desiccation" is intended to encompass any tissue desiccation 30, procedure, including electroeurgical coagulation, desiccation, vessel scaling, and tissue fusion.
' s One of the problems that can arise from electrosurgical desiccation is undesirable tissue damage due to thermal effects, wherein otherwise healthy tissue surrounding the tissue to which the electrosurgical energy is being applied is thermally damaged by an affect kno~rn in the art as "thermal spread". During the occurrence of thermal spread excess heat from the operative site can be directly conducted to the adjacent tissue, and/or the release of Steam from the tissue being tr~ated at the operative site can result in damage to the surrounding tissue.
It can be appreciated that it would be desirable to provide an electrosurgical generator that limited the possibility of i5 the occurrence of thermal spread.
Another problem that can arise with conventional electrosurgical techniques is a buildup of eschar on the electrosurgical tool or instrument. Eschar is a deposit that ~0 forms on working surfacets) of the tool, and results from tissue that is eleetrosurgically desiccated and then charred.
One result of the buildup of esGhar is a~ reduction in the effectiveness of the surgical tool. The buildup of eschar on the electrosurgical tool can be reduced if less heat is 25 developed at the operative site. .
i It has been well established that a measurement of the electrical impedance of tissue provides an indication of the state of desiccation of the tissue, and this observation has 30 been utilized in some electrosurgical generators to automatically terminate the generation of electrosurgical power based on a measurement of tissue impedance.
At least two techniques for determining an optimal amount of desiccation are known by those skilled in this art. One technique sets a threshold impedance, and terminates eleetrosurgical power when the measured tissue impedance crosses the threshold. A second technique terminates the generation of electrosurgical power based on dynamic variations in the tissue impedance.
A discussion of the dynamic variations of tissue impedance can be found in a publication entitled "Automatically Controlled Bipolar Electrocoagulation", Ncuro~uraical Review, 7:2-3, pp. 187-190, 1984, by vallfors and Bergdahl. Figure 2 of this publication depicts the impedance as a function of time duta.ng the heating of a tissue, and the authors raported that the impedance value of tissue was observed to be near to a minimum value at the moment of coagulation. Based on this observation, the authors suggest a micro-camnputer technique for monitoring the minimum impedance and subseguently terminating the output power to avoid charring the tissue.
Another publication by the same authors, "Studies on Coagulation and the Development of an Automatic Computerized Bipolar Coagulator", Journal of Neurosurqery, 75:1, pp. 148-151, July 1992, discusses the impedance behavior of tissue .
and its application to electrosurgical vessel sealing, and reports that the impedance has a minimum value at the rnament of coagulation.
The following U.S. Patents are alsn.of interest in this area.
U.S. Patent No.: 5,540,684, Hassler. Jr. addresses the problem associated with turning off the RF energy output automatically after the tissue impedance has fallen from a 5 predetermined maximum, subsequently risen from a predetermined ~.nimum and then reached a particular threshold. A storage device records maximum and minimum impedance values, and a circuit determines the threshold.
U.S. Patent No.: 5,472,'443, Cordis et al., discusses a t0 variation of tissue impedance with temperature, wherein the impedance is shown to fall, and then to xise, as the temperature is increased. Figure 2 of this patent shows a relatively lower temperature Region A where salts contained in body fluids are believed to dissociate, thereby decreasing the electrical impedance. A relatively next higher temperature Region B is where the water in the tissue boils . away, causing the impedance to rise. The~rtext relatively higher temperature Region C is where the tissue becomes charred, which results in a slight J.owering of the electrical impedance. U.B. Patent No.: 4,191,188, Helt et a3.., discloses the use of two timers whose duty cycles dre simultaneously and proportionately adjusted so that high frequency signal bursts are constantly centered about the peak power paint, regardless of duty cycle variations.
Also of interest is U.S. Patent 130.: 5,827,271, Buysse et al., "Energy Delivery System for Vessel Sealing°, which employs a surgical tool capable of grasping a tissue and applying an appropriate amount of closure force to the tissue, and for then conducting electrosurgical energy to the tissue concurrently with the application of the closure force. Figure 2 of this patent, sk~own herein as figure 1 for depicting the prior art, illustrates a set of power curves Which represent the electrosurgical power delivered to the tissue as a Function of the tissue impedance. At iow impadances, the electrosurgical power is increased by rapidly increasing the output current. The i»crease in electrosurgical power is terminated when a first impedance breakpoint, labeled as 1, is reached (e. g. <20 ohms). Next, the electrosurgical power is held approximately constant until proteins in the vessels and other tissues have melted.
The itnpesdaace at which this sec,~aent ends varies in accordance with the magnitude of the RMS polder. For example, where the maximum RMS power is approximately 12S Watts,'tha segment (B) ends at about 12B ohms. When a lower power is used (e.g.~ 75 Watts), the segment (C) may end at an impedance value of 256 ohms. Next, the output power is lowered to less than one half the ma~cimum valua, and the lower power delivery is terminated when a second impedance breakpoint is reached (2.048 x 108 ohms)_ Alternatives to using the impedance for determining the second brdakpoint are the use of I-V phase angle, or the magnitude of the output current.
Based on the foregoing it should be evident that electrosurgery requires the controlled application of AF
energy to an operative tissue site. To achieve successful clinical resuita during surgery, the elactrosurgical generator should produce a aantrolled output RF signal having an amplitude and wave shape that is applied to the tissue within predetermined operating levels. however, problems can arise during electrosurgery when rapid desiccation of tisSUe occurs resulting in excess RF'levels being applied to the tissue. These excess levels produce less than desirable tissue effects, which can increase thermal spread, or can cause tissue charring and may shred and disintegrate tissue.
It would be desirable to provide a systeza with more controlled output to improve vessel sealing and reduce damage to surrounding tissue. The factors that affect ves3el sealing include the surgical instrument utilized, as well as the generator for applying RF energy to the instrument jaws.
It has been recognized that the gap between the instrument ~,0 jaws and the picessure of the haws against the tissue affect tissue scaling because o~ their impact on current flow. For example, insufficient pressure or an excessive gap will not supply sufficient energy to the tissue and could result in an inadequate seal.
However, it has also bean recognized that the application of RF energy also affects the seal. Far example, pulsing of RF
energy will improve the seal. This is because the tissue loses moisture as it desiccates and by stopping yr siqnificantiy lowering the output the generator between pulses. this allows aome moisture to return to the tissue for the application of next RF pulse. It has also been recognized by the inventors that'varying each pulse dependent on certain parameters is also advantageous in providing an improved seal. Thus, it would be advantageous to provide a ve$ael sealing system which better controls RF energy and which can be varied at the outset of the procedure to acccomomodate different tissue structures, and which can further be varied during the procedure itself to accor~wdate changes in the tissue as it desiccates.
FIELD:
This invention relates generally to medical instruments and, in particular, to generators IS that provide radio frequency (R'F~ energy useful in sealing tissue and vessels during electrosurgical and other procedures.
BACKGROUND:
20 Electrosurgical generators are employed by surgeons to cut and coagulate the tissue of a patient. High frequency electrical power, which may be also referred to as radio frequency (RF) power or energy, is produced by the electrosurgical generator and appli8d to the tissue by an .electrosurgical tool. Hoth monopolar and bipolar conf~.gurations are comsnanly used during electrosurgical procedures.
Electrosurgica~. techniques can be used to. seal small diameter . blood vessels and~vascular bundles. Anvther~app'lication of electrosurgical techniques is in tissue fusion wherein two ~ ..
layers.of tissue are grasped and clamped together by a , ~~ .
suitable electrosurgical tool while the electrosurgical RF
energy is applied. The two layers of. tissue are then fused together. ~ ' . ~ ' At this point it is significant to note tha~~'thev.process of coagulating small ~vessels~ is fundamenta7.ly different than vessel sealing or tissue fusion. for the parposes herein the term coagulation ran be defined as a process. of desiccating tissue wherein the tis~ue.cells are ruptured and dried.
Vessel se~.ling or tigsue.fuai4n can both be defined as . C..I
desiccating tissue by the pxocess of liquefying the collagen in the tissue so that it crosslinks and reforms into a fused mass. Thus, the Coagulation of small vessels if generally sufficient to close them, however, larger vessels normally need to be sealed to assure permanent closure.
However, and as employed herein, the tear "electrosurgical desiccation" is intended to encompass any tissue desiccation 30, procedure, including electroeurgical coagulation, desiccation, vessel scaling, and tissue fusion.
' s One of the problems that can arise from electrosurgical desiccation is undesirable tissue damage due to thermal effects, wherein otherwise healthy tissue surrounding the tissue to which the electrosurgical energy is being applied is thermally damaged by an affect kno~rn in the art as "thermal spread". During the occurrence of thermal spread excess heat from the operative site can be directly conducted to the adjacent tissue, and/or the release of Steam from the tissue being tr~ated at the operative site can result in damage to the surrounding tissue.
It can be appreciated that it would be desirable to provide an electrosurgical generator that limited the possibility of i5 the occurrence of thermal spread.
Another problem that can arise with conventional electrosurgical techniques is a buildup of eschar on the electrosurgical tool or instrument. Eschar is a deposit that ~0 forms on working surfacets) of the tool, and results from tissue that is eleetrosurgically desiccated and then charred.
One result of the buildup of esGhar is a~ reduction in the effectiveness of the surgical tool. The buildup of eschar on the electrosurgical tool can be reduced if less heat is 25 developed at the operative site. .
i It has been well established that a measurement of the electrical impedance of tissue provides an indication of the state of desiccation of the tissue, and this observation has 30 been utilized in some electrosurgical generators to automatically terminate the generation of electrosurgical power based on a measurement of tissue impedance.
At least two techniques for determining an optimal amount of desiccation are known by those skilled in this art. One technique sets a threshold impedance, and terminates eleetrosurgical power when the measured tissue impedance crosses the threshold. A second technique terminates the generation of electrosurgical power based on dynamic variations in the tissue impedance.
A discussion of the dynamic variations of tissue impedance can be found in a publication entitled "Automatically Controlled Bipolar Electrocoagulation", Ncuro~uraical Review, 7:2-3, pp. 187-190, 1984, by vallfors and Bergdahl. Figure 2 of this publication depicts the impedance as a function of time duta.ng the heating of a tissue, and the authors raported that the impedance value of tissue was observed to be near to a minimum value at the moment of coagulation. Based on this observation, the authors suggest a micro-camnputer technique for monitoring the minimum impedance and subseguently terminating the output power to avoid charring the tissue.
Another publication by the same authors, "Studies on Coagulation and the Development of an Automatic Computerized Bipolar Coagulator", Journal of Neurosurqery, 75:1, pp. 148-151, July 1992, discusses the impedance behavior of tissue .
and its application to electrosurgical vessel sealing, and reports that the impedance has a minimum value at the rnament of coagulation.
The following U.S. Patents are alsn.of interest in this area.
U.S. Patent No.: 5,540,684, Hassler. Jr. addresses the problem associated with turning off the RF energy output automatically after the tissue impedance has fallen from a 5 predetermined maximum, subsequently risen from a predetermined ~.nimum and then reached a particular threshold. A storage device records maximum and minimum impedance values, and a circuit determines the threshold.
U.S. Patent No.: 5,472,'443, Cordis et al., discusses a t0 variation of tissue impedance with temperature, wherein the impedance is shown to fall, and then to xise, as the temperature is increased. Figure 2 of this patent shows a relatively lower temperature Region A where salts contained in body fluids are believed to dissociate, thereby decreasing the electrical impedance. A relatively next higher temperature Region B is where the water in the tissue boils . away, causing the impedance to rise. The~rtext relatively higher temperature Region C is where the tissue becomes charred, which results in a slight J.owering of the electrical impedance. U.B. Patent No.: 4,191,188, Helt et a3.., discloses the use of two timers whose duty cycles dre simultaneously and proportionately adjusted so that high frequency signal bursts are constantly centered about the peak power paint, regardless of duty cycle variations.
Also of interest is U.S. Patent 130.: 5,827,271, Buysse et al., "Energy Delivery System for Vessel Sealing°, which employs a surgical tool capable of grasping a tissue and applying an appropriate amount of closure force to the tissue, and for then conducting electrosurgical energy to the tissue concurrently with the application of the closure force. Figure 2 of this patent, sk~own herein as figure 1 for depicting the prior art, illustrates a set of power curves Which represent the electrosurgical power delivered to the tissue as a Function of the tissue impedance. At iow impadances, the electrosurgical power is increased by rapidly increasing the output current. The i»crease in electrosurgical power is terminated when a first impedance breakpoint, labeled as 1, is reached (e. g. <20 ohms). Next, the electrosurgical power is held approximately constant until proteins in the vessels and other tissues have melted.
The itnpesdaace at which this sec,~aent ends varies in accordance with the magnitude of the RMS polder. For example, where the maximum RMS power is approximately 12S Watts,'tha segment (B) ends at about 12B ohms. When a lower power is used (e.g.~ 75 Watts), the segment (C) may end at an impedance value of 256 ohms. Next, the output power is lowered to less than one half the ma~cimum valua, and the lower power delivery is terminated when a second impedance breakpoint is reached (2.048 x 108 ohms)_ Alternatives to using the impedance for determining the second brdakpoint are the use of I-V phase angle, or the magnitude of the output current.
Based on the foregoing it should be evident that electrosurgery requires the controlled application of AF
energy to an operative tissue site. To achieve successful clinical resuita during surgery, the elactrosurgical generator should produce a aantrolled output RF signal having an amplitude and wave shape that is applied to the tissue within predetermined operating levels. however, problems can arise during electrosurgery when rapid desiccation of tisSUe occurs resulting in excess RF'levels being applied to the tissue. These excess levels produce less than desirable tissue effects, which can increase thermal spread, or can cause tissue charring and may shred and disintegrate tissue.
It would be desirable to provide a systeza with more controlled output to improve vessel sealing and reduce damage to surrounding tissue. The factors that affect ves3el sealing include the surgical instrument utilized, as well as the generator for applying RF energy to the instrument jaws.
It has been recognized that the gap between the instrument ~,0 jaws and the picessure of the haws against the tissue affect tissue scaling because o~ their impact on current flow. For example, insufficient pressure or an excessive gap will not supply sufficient energy to the tissue and could result in an inadequate seal.
However, it has also bean recognized that the application of RF energy also affects the seal. Far example, pulsing of RF
energy will improve the seal. This is because the tissue loses moisture as it desiccates and by stopping yr siqnificantiy lowering the output the generator between pulses. this allows aome moisture to return to the tissue for the application of next RF pulse. It has also been recognized by the inventors that'varying each pulse dependent on certain parameters is also advantageous in providing an improved seal. Thus, it would be advantageous to provide a ve$ael sealing system which better controls RF energy and which can be varied at the outset of the procedure to acccomomodate different tissue structures, and which can further be varied during the procedure itself to accor~wdate changes in the tissue as it desiccates.
An accom~ttodation for overvoltage dlamping is also desirable.
In this regard, conventional overvaltage techniques use a means of clamping or clipping the excess overvoltage using avalanche devices such as diodes, zener diodes and transorbs, so as to limit the operating levels. In these techniques the excess energy, as well as the forward conduction energy, is absorbed by the protection device and inefficiently dissipated in the form of heat. Moxe advanced prior art techniciues actively clamp only the excess energy using a predetermined comparator reference va~.ue, but still absorb and dissipate the excess energy in the fo~an of heat.
U.S. Patent No.: 5,594,636 discloses a system for AC to AC
power conversion using switched citation. This system addresses overvoltage conditions which occur during switched cv~autation by incorporating ari active output voltage sensing end clamping using an active clamp voltage regulator which energizes to limit the output. The active clamp switches in a resistive load to dissipate the excess energy caused by the overvoltage condition.
Other patents in this area include U.S. Patent No.:
5,500,616, which discloses an overvoltage clamp circuit, and D.S. Patent No.: 5,596,966, which discloses an isolated half-bridge power module. Both of these patents identify output overvoltage limiting for all power devices, and overvoitage limit protection is provided for power devices by using proportionately scaled zeners to monitor a~xld track the output off voltage of each device to prevent power device failure.
The zener device is circuit configured such that it provides feedback to the gate of the power device, When zener . . 9 avalanche occurs the polder device partially turns an, absorbing the excess overvoltage energy in conjunction with the connective load.
Reference can also be had to U.S. Patent No.: 9,546,222 for disclosing an Inverter incorporating overvoltage clamping.
Dvervoltage clamping is provided by using diode clamping devices referenced to DC power sources. The DC power sources provide a predetermined reference voltage to clamp the overvoltage condition, absorbing the excess energy through clamp diodes which dissipate the excess voltage in the form of heat.
It would be advantageous as to provide an electrosurgical generator having improved overvoltage limit and transient energy suppression.
The foregoing and other problems are overcome by methods and apparatus in accordance with embodiments disclosed herein.
An electrosurgical generator includes a controlling data processor that executes software algorithms providing a number of new and useful features. These features preferably include the generation of an initial pulse, thSt is a lvw power pulse of RF energy that is used to sense at least one electrical characteristic of the tissue prior tv starting an electrosurgical desiccation cycle, such as a tissue sealing 3Q cycle. The sensed electrical characteristic is then used as an input into the deterad.natian of initial sealing parametersr thereby tasking the selling procedure adaptive to the characteristics of the tissue to be sealed. Another feature preferably provided measures the time required for the tissue to begin desiccating, preferably by observa,nq an electricah transient at the beginning of an RF energy pulse, to determine and/or modify further seal parameters. Another preferable feature performs a tissue temperature control function by adjusting the duty cycle of the RF energy pulses applied to the tissue, thereby avoiding the problems that can result frown excessive tissue heating. A further preferable feature controllably decreases the RF pulse voltage With each pulse of RF energy so that as the tissue desiccates and shrinks (thereby reducing the spacing between the surgical tool electrodesl, arcing between the electrodes is avoided, as is the tissue destruction that may result from uncontrolled arcing. Preferably a Seal Intensity operator control is provided that enables the operator to control the sealing of tissue by varying parameters other than simply the RF power.
The system disclosed herein preferably further provides a unique method for overvoltage limiting and transient energy suppression. An electrosurgical system uses dynamic, real-time automatic detuning of the RF energy delivered to the tissue of interest. More specifically, this technique automatically limits excess output RF voltages by dynamically changing the tuning in a resonant source of RF .
electrosurgical energy, and by altering the shape of the RF
source signal used to develop the output AF signal. The inventive technique limits the excess output transient RF
energy by a resonant detuning of the generator. This occurs 1~
in a manner which does not clip or significantly distort the generated RF output signal used in a clinical environment for electrosurgical applications.
A method for electrosurgically sealing a tissue, in accordance with this disclosure, preferably includes the steps of (A) applying an initial pulse of RF energy to the tissue, the pulse having characteristics selected so as not to appreciably heat the tissue; (B) measuring a value of at least one electrical characteristic of the tissue in response to the applied first pulse; (C) in accordance with the measured at least one electrical characteristic, determining an initial set of pulse parameters for use during the next RF energy pulse that is applied to the tissue; and (D) varying the pulse parameters of subsequent RF energy pulses individually in accordance with at least one characteristic of an electrical transient that occurs during each individual subsequent RF energy pulse. The method terminates the generation of subsequent RF energy pulses based upon a reduction in the output voltage or upon a determination that the electrical transient is absent.
The at least one characteristic that controls the variation of the pulse parameters is preferably a width of the electrical transient that occurs at the beginning of each subsequent RF energy pulse. The initial set of pulse parameters include a magnitude of a starting current and voltage, and the pulse parameters that are varied include a pulse duty cycle and a pulse amplitude. Preferably, the subsequent RF energy pulses are each reduced or modified in amplitude by a controlled amount from a previous RF energy pulse, thereby compensating for a decrees a in the spacing between the surgical.tool~electrodes due to desiccation of the tissue between the electrodes.
The step of determining an initial set of pulse parameters preferably includes a step of using the measured value 'of at least one electrical characteristic of the tissue to'readout the initial set of pulse parameters from an entry in a lookup table .
. - . .
The step of. determining an initial set of pulse parameters may also preferably include a step of reading out the initial :' set of pulse para~aeters from an entry in one of a plurality of lookup tables, where'the looitup table is selected either 7.5 manually or automatically, based on the electrosurgical instrument or tool. that is beingwused. ~ .
The method also preferably includes a step of modifying predetermined ones of the pulse parameters in accordance With a control input from an operator. The predetermined . ones of the pulse parameters that are modified include a pulse power, a pulse starting current and voltage level, a pulse voltage decay scale factor, and a pulse dwell time.
Preferably.a circuit is coupled to:the output of the electro$u~rgical generator for protecting the output against , .
an~overPoltage.aondition~ and includes.a suppressor that detunea a tuned resonant circuit at the output for reducing a . magnitude of a voltage appearing at the output'. In accordance .30 with this aspect of the disclosure, the circuit has a ' capacitance network in parallel with an inductance that forms a portion of the output stage of the generator. A vo7.tage actuated switch, such as a transorb, couples an additional capacitance across the network upon an occurrence of an overvoltage condition, thereby detuning the resonant network and reducing the raagaitude of the voltage output, no~scx~~r=opt os ~ Dc~s The above set forth and other features of the invention are made more apparent in the ensuing Detailed Description when read in con3unction with the attached Drawings, wherein:
Fig. lA is a graph that plots output power versus tissue impedance (Z) in ohms, in accordance Nith the operative of a prior art electrosurgical generator:
Fig. 18 is a graph that plots output power versus impedance in ohms, in accordance with the operation of an electrosurgical generator that is an aspect of this disclosure;
Fig. 2 is a simplified block diagram of an electrosurgical System that can be used to practice the teachings of this disclosure:
Fig. 3 is a perspective view of one embodiment of a surgical instrument having bipolar forceps that are suitable for practicing this disclosure Fig. 4 is an enlarged, perspective view o~ a distal end of the bipolar forceps shown in Fig. 3;
~ . . .
' za ~~
Fig. 5 is a.perspective view of an embediment'o~ a surgical instrument having forceps that are suitable for use in an~ , endoscopic surgical procedure utilizing the electrosurgical .system disclosed herein:
Fig. 6A is a simplified block diagram of a presently , preferred embodiment:of the power control circuit of the eleetrosurgiGal generator of Fig. 2:
~,p . -Fig. 6B depicts the organization of a seal parameter lookup table tZLTT~ shown in F3c~. 6A=~
Fig. 7A and 7B illustrates a presently preferred electrosurgical generator output waveform of RM5 current vs. time for .
' implementing at least the first pulse of the pulsed operat~:on .
made that is an aspect of this disclosure; ' .
Fig. 8 depicts a fu7,l set of elsctxoaurg3.cal RF pulses in ' accordance with this disclosure, and illustrates the voltage, .
current and.poWer characteristics of the pulses, as Hell as 'the response of the tissue impedance to the applied RF
pulses; ~ ~ ' z5 Fig. 9A illustrates a Seal Tntensity control that forma a ' part of this disclosure, while Figs. 9B and 9C show a preferred variation in certain parameter-s from the seal parameter LUT based on different Seal..Intensity settings;
Fig. 10 is a simplified block diagram of a circuit for achieving an overvoltage limiting r and transient energy suppression energy function;
Fig. 11 is a waveform diagram illustrating the effect of the operation of the circuit in Fig.
5 10;
Fig. 12 is a logic flow diagram that illustrates a method in accordance with the system disclosed herein;
10 Fig. 13 is a more detailed logic flow diagram that illustrates a method in accordance with the system disclosed herein;
Fig. 14 is a chart illustrating a fixed number of pulses determined from the measured impedance and the RMS current pulse width;
Fig. 15 illustrates a Seal Intensity control that forms a part of this disclosure; and Fig. 16 is a logic flow diagram that illustrates another method in accordance with the system disclosed herein.
DETAILED DESCRIPTION OF THE IyREFERRED EMBODIMENT
An electrosurgical system 1, which can be used to practice this invention, is shown in Fig. 2. The system 1 can be used for sealing vessels 3 and other tissues of a patient, including ducts, veins, arteries and vascular tissue. The system 1 includes an electro-surgical generator 2 and a surgical tool, also referred to herein as a surgical instrument 4.
The surgical instrument 4 is illustrated by way of example, and as will become apparent from the discussion below, other instruments can be utilized. The electrosurgical generator 2, which is of most interest to the teachings herein, includes several interconnected sub-units, including an RF drive circuit 2A, a power control circuit 2B, a variable D.C. power supply 2C and an output amplifier 2D. The surgical instrument 4 is electrically connected to the electrosurgical generator 2 using a plug 5 for receiving 1.6 ..
i controlled electrosurgical power therefrom. The surgical instrument A has some type of end effector member 6, such as a forceps or hemostat, capable of grasping and holding the vessels and tissues of the patient. The member 6, also referred to simply as end effector 6, is assumed, in this embodiment, to be capable of applying and maintaining a relatively constant level of pressure on the vessel 3.
The member 6 is provided in the form of bipolar electrosurgiaal forasps using two generally opposing electrodes disposed on inner opposing surfaces of the member 6, and which are both electrically coupled to the output of the electrosurgical generator 2. Durinq use, different electric potentials are applied to each electrode. In that tissue is an electrical conductor, when the forceps are utilised to clamp or grasp the vessel 3 therebetween, the electrical energy output from the electrosurgical generator 2 is transferred through the intervening tissue. Hoth open surgical procedures and endoscopic surgical procedures can be performed with suitably adapted .surgi.cal inst~uaents 9. It should also be noted that the member 6 could be monopolar forceps that utilize one active electrode, with the other (return) electroda'ox pad being attached externally to the patient, or a combination of bipolar and monopalar forceps.
By way of further explanation, Fig. 3 is a perspective view of one embodiment of the surgical instrument 4 having a bipolar end effector implemented as forceps 6A while Fig. 4 is an enlarged, perspective view of a distal end of the bipolar forceps 6A shown in Fig. 3.
Referring now to Figs. 3 and 9, a~bipolar surgical instrument 9 for use with open surgical procedures includes s mechanical forceps 20 and an electrode assembly 21. In the drawings and in the description which follows, the term "proximal", as is traditional, refers to the end of the instrument 4 which is closer to the user, while the term "distal~ refers to the end Nhich is fuxthex from the user.
Mechanical forceps 20 includes first and second members 9 and 11 which each have an elongated shaft 12 and 14, respectively. Shafts 12 and Z4 each include a proximal end and a distal end. Each proxi~aal end of each shaft portion 12, 14 includes a handle member 16 and 18 attached thereto to allow a user to effect movement of the two shaft portions 7.2 and 14 relative to one another. Extending from the distal end of each shaft portion 12 and 14 are end effactors 22 and 24, respectively. The end effectors 22 and 29 are movable relative to one another in response to movement of handle members 16 and 18. These end effectors members 6A can be referred to collectively as bipolar forceps.
Preferably, shaft portions 12 and 14 are affixed to one another at a point proximate the end effectors 22 and 24 about a pivot 25. As such, movement of the handles 16 and I8 imparts movement of the end effectors 22 and 24 from an open position, wherein the end ef~ectors 22 and 24 are disposed in spaced relat~.on relative to one another, to a clamping or closed position, wherein the end effectors 22 and 24 cooperate to grasp the tubular vessel 3 therebetween. Either one or both of the end effectors 22, 24 can be u~ovabls.
As is best seen in Fig. 4, end ei~fector 24 includes an upper or first jaw member 44 which has an inner facing surface and a plurality of mechanical interfaces disposed thereon which are dimensioned to releasable engage a portion of an electrode assembly 21, which may be disposable. Preferably, the mechanical interfaces include sockets 41 which are disposed at least partia7.ly through the inner facing surface of jaw member 44 and which are dimensioned to receive a complimentary detent attached to an upper electrode 21A of the disposable electrode assembly 21. The upp~r eleetxode 21A
is disposed across from a corxespoading lower electrode 218.
The and effectvr 22 includes a second or lower jaw member 42 which has an inner facing surface which opposes the inner facing surface of the first jaw member 44.
Preferably, shaft members 12 and 14 of the mechanical forceps are designed to transmit a particular desired force to the opposing inner facing surfaces of the jaw members 22 and 24 when clamped. In paxticular, since the shaft members 12 and 20 14 effectively act together in a spring~like manner (i.~., bending that behaqee like a~ spring), the length, width, height and deflection of the shaft members 12 and 19 directly iu~aCts the overall transmitted force imposed on opposing jaw members 42 and 94. Preferably, jaw members 22 and 24 are more rigid than the shaft members 12 and 14 and the strain energy stored i.n the shaft members 12 and 14 provides a constant closure force between the jaw members 42 and 49.
Each shaft member 12 and l4 also includes a ratchet portion 32 and 34. Preferably, each ratchet, e.g., 32, extends from the pxoxirnal end of its respective shaft member 12 towards the other ratchet 34 in a generally vertically aligned manner such that the inner facing surfaces of each ratchet 32 and 34 abut one another when the end effectors 22 and.24 are moved from the open position to the closed position. Each ratchet 32 and 34 includes a plurality of flanges which project from the Inner facing surface of each ratchet 32 and 34 such that the ratchets 32 and 34 can interlock in at least one position. In the embodiment shown in Eig, 3, the ratchets 32 and 34 interlock at several different positions. Preferably, each ratchet position ho~.ds a specific, i.e., constant.
strain energy in the shaft members 12 and 14 which, in turn, transmits a specific force to the end effectors 22 and 24 and, thus, to the electrodes 21A and 21B. Also, preferably a stop is provided on one or both of the end effectors 22, 24 to maintain a lareferred gap between the ~ aws . .
In some cases it may be preferable to include other mechanisms to control and/or limit the movement of the jaw members 42 and 44 relative to one another. For example, a 24 ratchet and pawl system could be~utilized to~segment the movement of the two handles into discrete units which, in turn, impart discrete movexaent to the jaw members 42 and 44 relative to one another.
Fig. 5 is a perspective view of an embodiment of the surgical instrument 4 having end eftector members or forceps 6B that are suitable for an endoscopic surgical procedure. The end effeetor member 6B is depicted as sealing the tubular vessel 3 through a cannula assembly 130, 132.
The surgical instrument 4 fvr use With endosscopic surgical procedures includes a drive rod assembly 50 which is coupled to a handle assembly 54. The drive rod assembly 50 includes an elongated hollow shaft portion 52 having a proximal end 5 and a distal end. An end effector assembly 68 is attached to the distal end of shaft 52 and includes a pair of opposing jaw members. Preferably, handle assembly 54 is attached to the proximal end of sh~att 52 and includes an activator 56 for imparting movement of the forceps jaw members of end effect:or 10 ~nober 6B from an open position, wherein the jaw members area disposed in spaced relation relative to one another, to a clamping or closed position, wherein the jaw members cooperate to grasp tissue tharebetween.
Z5 Activatar 56 includes a movable handle 58 having an aperture 60 defined therein for receiving at least one of the operator's fingers and a fixed handle 62 having an aperture 64 defined therein for receiving an operator's thumb.
Movable handle 58 is selectiqely moveable from a first 20 position relative to fined handle 62 to a second position in the fixed handle 62 to close the jaw a~abexs. preferably, fixed handle 62 includes a ehannnl 66 which extends proximally for receiving a ratchet 66 which i9 coupled to movable handle 58. This structure allows for progressive closure of the end effector assembly, as well as a locking engagement of the opposing jaw members. In some cases it may be preferable to include other mechanisms to control and/or limit the movement of handle 58 relative to handle 62 such as, e.g., hydraulic, semi-hydraulic and/or gearing systems.
As with instrument 4, a stop can also be prov~,ded to caaintain a preferred.gap between the jaw members.
The handle 62 i.nciudes handle sectians~62a and 62b, and is generally hollow such that a cavity is formed therein for housing various internal caatt~onents. For example, the cavity can house a PC board which connects the electrosuzgical energy being transmitted from'the electrosurgical generator 2 to each haw member, via connector 5. More particularly, electrosurgical energy generated from the electrosurgical . generator 2 is transmitted to the handle PC board by a cable 5A. The PC.board diverts the electrosurgicai energy from ' the generator into two different electrical potentials which are transmitted to each jaw member by a separate terminal clip. The handle 62 may also~house circuitry that .
conmnunicate8 With~the generator 2, far example, identifying characteristics of the electrosuxqical tool 4 for use by the - electrosurgical generator 2, whe=e the electrosurg~.cal generator 2 may select a particrilar seal parameter lookup w table based on those characteristics (as described below).
Preferably, a lost motion mechanism 3.s positioned between each of the handle sections 62a and 62b'for maintaining a .~ predetermined or maxi~aum clamping force for' sealing'"tis~ua between the jaw members.
Having thus described two exemplary and non~limiting embodiments of surgical instruments 4 that can be employed , with the eleatrosurgical generator.2, a description will noW
be provided of various aspects of the inventive electrosurgical generator 2.
22~
Fig. 6A~is a block diagram that~iLlustrates the power control circuit 2B of Fig. Z in greater detail. The power control . . circuit ZB includes a suitably prograasued data processor.?Q .~ , ' . that is preferai~ly implemented, as one or more~microcontroiler devices. In a most preferred embodiment there are two pr3.ncipal mi.crocontrollers, referred to as a main ~miarocoatroller ?OA and a feedback microcontroller 709. These . twQ u4icrocontrolhrs are. capable of comcsxnicating. using .
shared data that is scored and retrieved fro~a a shared .
. 10 .vread/write memory ?Z. A control program fox the data . processor 70~'is stored in a program memory 74, and includes . ~ ., ' ' software 'routines-and algorithms for ~eontxolling the overall 'operation of the eleatrosuiQical ge~xator 2. xn general, the ~~~~feedback microcontroller ?0B has a digital. output bus Coupled . .15 to an input of a digital to analog converter (DAC) block '?6 .. . . ' ~xhich outputs aa' ana3.og siguai: This, ~s a system control _ . ~ ~ ,... _ voltage ~SCv),;~which is applied to the variable DC power ..supply 2C to'oontrcl the magnitude of the voltage and current y ~ . of output RF poises . ~ ' . .
.. -. .~ An~an$Zog to digital converter (ADC) block ?8 reaeivea analog inputs and sources a digital, input bus of the feedback microoontroller ?0B. using the ADC block,?B the microcontroller ?0B is apprised of the value of the actual output voltage and the actual butput current, thereby closing, .
the feedback loop with the 8CY signal. The values of th$
output voltage and carte»t,~n be_used for determining tissue ' wimpedance, power and energy delivery for the overall, . , .
;general control of the applied RF energy waveform.. .
It should be noted that at least the ADC block 78'can be an internal block of the feedback microcontroller .
' 7oB, and need not be a separate, external .
cobc~panent. It should be further dated that the same analog signals can be digitized and read into the master microcontroller 70A, thereby providing redundancy. The.ma$ ter mierocontrolJ.er 70A controls the state ton/off) of the high voltage (e. g., 190V mar) pow~r supply as a safety precaution, controls the front panel display(s), such as a Seai Intensity display, described below and shown in Fig. 9A, and also receives various input switch closures, such as a Seal Intensity selected by an operator.
.10 It is noted that in a preferred embod~.ment of the electrosurgical generator 2 a third (waveform) rnicrocontroller 74C is employed to generate the desired 970 kHz sinusoidal waveform tihat forms the basis of the RF pulses applied to the tissue to ba sealed, such as the vessel 3 (Fig. 2). The waveform microcontroller 70C is controlled by the feedback microcontroller 708 and is progranQaed thereby.
An output signal line from the feedback microcontroller 70B
is coupled to a Reset input of the waveform mi.croeontroller~
70C to easeritially turn the wavefor~a microcontrollsr 70C on and off to provide the pulsed RF signnl in accordance with an aspect of this disclosure. This particular arrangement is, of course, not to be viewed in a limiting sense upon the ' . practice of this system, as those skilled in the art may derive a number of methods and circuits for generating the desired RF pulses in accordance with the teachings found herein.
As an overview, the software algorithm$ executed by the data processor 70 provide the following features. First, and referring now also to the preferred waveform depicted in Fig.
.
?, a low power initial pulse of RF~energy is used to sense at .
least one electrical characteristic of the tissue prior to starti.ng~ the seal cycle. Second. the sensed electrical characteristic of the tissue is used as an input into tha~
5~ deteratination of the initial sealing parameters, thereby making the sealing procedure adaptive to the characteristics . , of the tissue to be sealed. Thixd, the technique measures the time required for the tissue to begin desiccating, preferably by observing as electrical transient , to determine and/or modify further seal parameters..Fourth, the technique performs a tissue tes~perature~ control function' by adjusting the duty cycle of RF pulses applied to the tissue, thereby . ..
avoiding excessive tissue heating and the.pxoblems that arise .
fr~a excessive tissue heating. This ie preferably .
~15 accomplished by~usi.ng at least one calculated seal parameter related to the time required tar the tissue to begin , desiccating. Fifth, the technique controllably changes the RF pulse voltage with each pulse of RF energy DEL as the tissue desiccates and shrinks tthercby' reducing .the spacing, between the surgical instru~aent.electrodes~; arcing between the instrument electrodes (e.g. 2IA,and 218. of Fig. 4) is avoided, as is the tissue 'destruct~:oii that may re$ult from .
such uncontrolled arc~.ng. This is also preferably accomplished by using at least one calculated seal parameter that is related to the time required for the tissue to begin desiccating. Sixth, the above-mentioned Seal Intensity front panel control (Fig. 9A1 enables the operator to control the sealing of tissue by varying parameters other than simply the RF power. These various aspects of this disclosure are now described in further detail.
v ~ ~~ a . ~ 25 ~ . . . .
Referring now also to the logic flow diagram of Fig. 13, the impedance sensing feature is imphemented~at the beginning of ' . the seal cycle, wherein the eiectrosurgical generator 2 , ..
senses at least one ~e7.eetric~tl characteristic of the tissue, .5 for example, impedance, I y phase rotation, or the output ' Current, by using n short burst of RF energy (Fig, 13, Steps A and 8). The electrical characteristic of the tissue may be measured at any freguent~ or power level, but preferably is per~for~ned at the sa~ae fregvency as the . intended working ' ~ ~ . .
14.~ frequency.(e.Q., 470 kEZz). In a most preferred case the short .
burst of RF.energy (prefBrably less than about'2ti0 millisecond, at~d more pret~rably about 100 ~ millisecond) . is a .
~- 470 kHz else wave pith approximaxely 5i1 of power. The initial pulse RF power is made low, and the pulse time is made. as 15 short as possible, to~~enable an~~.nitial tissue electrical .
characteristic maasuremdcnt to be made .t~~.thout excessively heating the tissue.
.~ .
In a most preferred embodiment the electr~.cal characteristic 20 .serised'is the tissue impedance Which is employed to determine an initial set of parameters that are input ~o the sealing algorithm, and which are used to control the selection of sealing parameters, including the starting power, current ~
. aad~voltage (Fig. Z3, Step C). Other sealing parameters may 2~ i include duty cycle and pulse width: Generally, if the sensed impedance is in the lower ranges, then the initial power and :. starting voltage are made relatively lower, the assumption being that the tissue will desiccate faster and require less energy. Tf the sensed impedance is in the higher ranges, the ~a initial pawer and starting voltage are made relatively higher, the assumption being that the tissue will desiccate slower and require more energy.
i In other embodiments at least one of~any'other tissue electrical characteristic, for example, the voltage or current, can be used to set the parameters.,Thesa initial parameters are prefgiably modified in accordance With the setting of the Seal intensity control input (Fig. 13, Step D), as will be described in further detail .below.
.Referring again to Fig. 13, Step C, the sensed i~npedance~ is ~10 employed to determine ~rh3ch set of values axe used from~a seal parameter lookup table (LUT) 80 (eee Figs. 6A and 6H). ' The seal parameter look up table iaay one of a~plurality that' .
are stored in~the generator or accessible to'the generator.
. Furthermore, the seal parameter table may be~seleetec~ , 15~ manually or automatically, based on, for~exartple, the electrosurgical tool or ~r~strumant be~5.ng ~aplnyed. The, specific values read from the heal parameter LtTT 80 Fig. 68) .
. are then adjusted based on the Seal Intensity front panel setting 82' (Fig. Z3, Step D) , as 'is ~ shown sabre clearly in .
20 Figa. 9A and 9H. xn a preferred, but sot limiting embodiment, the values read fro~a the seal parameter'hDT 80 comprise the power, the maximum voltage'; starting voltage, minimum voltage, voltage decay, voltage ramp, maximum RF on time, maximum cool scale factor, pulse minimum, pulse dwell time, pulse off time, . 25.~ current and the desired pulse width. In a preferred, but not ' limiting embodiment, the seal parameter values adjusted by the Seal Intensity front panel setting 82 (Figs. 9A and 9B) comprise the power, starting voltage, voltage decay, and pulse dwell time.
SO
~ , . . , ~ 2?
Figure 1B is a graph that plots autput power versus_fmpeda=ice in ohms for the disclosed electrosurgieal,generator. The . ~ plot labeled "Intensity Bar 1" shows the electrosurgical .
.generator por~er output versus impedance when the "VLOW"
. 5 setting 82A (Fig. 9A} of the Seal Intensity.front~panel.
setting 82 is selected. The plot labeled intensity Bar 2 .
shows the power output of the electrosurgical generator when the "LOW" settin~i 82B of the Seai Intensity front panel setting 92 is Selected. The,plot labeled,Intensity Bars~3', ~~ , . XO 4, 5,_sho'tvs the power output of the electxosurgical venerator - . ~ ~ when the "1~D" 82C, ~ "IiIGH"' $2D or YEixGHa 82E Seal , Intensit:y ' ' .~ .front panel settings 82 are selected: The 8ea1 Intensity ~ - , . .
front ,.panel , settings .82 ad just the sea~.~.paraineter values as . , . ;;
. shown in Fig. 9B. These values may be adjusted depending on 15 instrument used, tissue characteristics or surgical intent.
r . .
. Discussing this aspect of the disclosure now in further . ' ' ' detail, and ~sferri~g as well to Fig's: T ~ and ~8, the selected Seal Parameter Table, adjusted by'the Seal Intensity .front .pa~e3...settings is then utilized by the RF energy geaer~tion ~systera and'.an initial RF.sealing pulse is then staxted. v '~ Asweachwpulse i~WRF -energy is ~-applied to the tissue, the current initially rises tc~ a ma~ci~aum (Pulse Peak), end .t#~en, as the tissue desiccates and the impedance rises due to loss of moisture in the tissue, the current falls. Reference in th~.s xegard can be had to the circled areas designated as "A'~s . : in the Ice, waveform of F~.g. 8 , The actual width of the resulting electrical transient, preferably a current . transient "A", is an important factor in determining what type and amount'of tissue is between the jaws (electrodes).~f the surgical instrument 4 (measur~d from "Full Power RF
Start" to "Poise Low and Stable~.)~The actual current ., . ' transient or pulse width is also. employed to detarcnine the changes to, ar the values of, the parameters of the poise duty cycle ~"Ih~tell.Time") and tc the change of the pulse .
voltage, as well as other parameters. This parameter can also~be used to determine whether the tissue aeal~has been . completed, or if the surgical instrument 4 has shorted.
As an alternative to directly measuring the pulse width, the rate of change of an electrical characteristic (for.exanipie . current, voltage, ~impedanoe,~ete.) of the transient aA"
(shown in Fig:~~7B) may be measured periodically (indicated by the reference number 90 shown in Fi.g. 7H) over the tune the transient occurs. The~rate of change of the .electrical ~ ..
characteristic may be proportional.to the width Ot 95 of the , tzansieat '"A", defined by the relationship:
At cc deldt ZO where de/dt is the change in the electrical charaeteri9tic over time: .This rate of change may then be used to provide an indication of the Width of the transient "A" in detexzaining.the type and amount of tissue that is between the haws (electrodes) of th~ surgical instrument 4,~as Well as ' the $ubsecluent pulse duty cycle ("Dwell Time"), the amount of subsequent pulse volt~.ge reduction, as well as other parameters.
~efe~ring to-E'ig. 13.~Step E, a subsequent RF enexgy pulse is applied to the~tissue, and the pulse width of the leading edge current transient'is,.m~asured'(Fig. 13, Step F). A
determination'is made if the current transient is present.. If it is, control passes via connector "a" to Step H, otherwise control passes via connector "b" to Step K.
Assuming that the current transient i.s present, and referring to Fig. 13, Step A, if the current transient pule a . .
is wide, for example, approximately in the range of 500-1000 ms, th~n one can assume the presence of a large amount of tissue, or tissue that requires mare RF energy to desiccate.
Thus, the Dwell Time is increased, and an increase or small reduction is made in the amplitude of the next RF pulse (see the Vrms waveform in Fig. 8, and Fig. 13, Step I). If the current transient pulse is narrow, for example, about 250 ms or less (indicating that the tissue impedance rapidly rose), then one can assume a small amount of tissue, of a tissue type that requires little RF energy to desiccate is present_ Other ranges of current transient pulse widths can also be used.
The relationship between the current transient pulse width and the tissue characteristics may be empirically derived. In this case the Dwell Time can be made shorter, and a larger reduction in the amplitude of the next RF pulse can be made as well (Fig. 13, Step J).
Zf a current pulse is not observed at Fig. 13, Step G, it may _25 be assumed that either the instrument 4 has shorted, the tissue has not yet begun to desiccate,~or that the tissue has been fully desiccated and, thus, the seal cycle is comp3ete.
The determ~.nation of which of the above has occurred is preferably made by observing the tissue impedance at fig.~l3, Steps K and M. If the impedance is less than a low~threshold value (THREBHL), then a shorted instrument 9 is assumed (Fig.
13, Step L), while if the impedance~is greater than a high threshold value (THRESHH), then a complete tissue seal is assumed (Fig. 13, Step N).
5 If the tissue impedance is otherwise found to be between the high and low threshold values, a determination is made as to whether the Max RF On Time has been exceeded. If the Max RF
On Time has been exceeded, it is assumed that the seal cannot be successfully completed for some reason and the sealing 10 procedure is terminated. If the Max RF On Time has not been exceeded then it is assumed that the tissue has not yet received enough RF energy to start desiccation, and the seal cycle continues (connector "c").
15 After the actual pulse width measurement has been completed, the Dwell Time is determined based on the actual pulse Width and on the Dwell Time field in the seal parameter LUT 80(see Fig. 6B.) The RF pulse is continued until the Dwell Time has elapsed, effectively determining the total time that RF
20 energy is delivered for that pulse. The RF pulse is then turned off or reduced to a very low Level for an amount of time specified by the Pulse Off field. This low level allows some moisture to return to the tissue.
25 Based on the initial Desired Pulse Width field of the seal parameter LUT 80 for the first pulse, or, for subsequent pulses, the actual pulse width of the previous pulse, the desired voltage limit kept constant or adjusted based on the Voltage Decay and Voltage Ramp fields. The desired voltage limit Is kept constant or raised during. the pulse if the actual pulse width is greater than the Desired Pulse Width field (or last actual) pulse width), and is kept constaht or lowered if the actual pulse width is less than the Desired Pulse Width field <or the ' last actual pulse width).
When the Desired Voltage has'been reduced to the Minimum ,Voltage field, then the~RF energy pulsing is terminated and the electrosurgicai generator 2 enters a cool-down period having a duration that is set by the Maximum Cool SF field end the actual pulse w~.dth of the first pulse.
xo~
Several of the ~oragoing and other terms are defined with greater specificity as follows (see also Fig. 7).
The Actual Pulse width is the t~rne from pulse. start to pulse 1~5 low. The Pulse Peak is the point where the current reaches ~a maximum value, and does not exceed this value for some predeteriai:ned period of tine (measured in mil7.isecoads) . The ' peak value of the ~u3.se, Peak eaa be reached until the Pulse Peak-X% value is reached, which is the point.whera the 20 ' current bas~decrea$ed to souse predetermined determi»ed percentage, X,of the value of Pulse Peak. Pulse 3~ow is the .~ ~ ' point where the current reaches a low point, and 'does not go.
.lower for another predetermined period of time. The value of the. Maximum RF On Time or~MAX Pulsa Time is preferably 25 ~ preprogranened to some value that cannot be readily changed.
The RF pulse is terminated automatically if the Pulse Peak is .
' reached but tha Pulse Peak-X% value is not obtained with-the~
duration set by the Maximum RF On Time field of the seal para~oneter LUT 80.
30' ' 32 ' Referring to Fig. 68, the seal par~uaeter hUT.80 is employed by the feedback microcontroller 70H in determining how to set the various outputs that impact the RF output of the ..
electxoaurgical generator 2. The seal parameter Zv'r 80 is .
partitioned into a plurality of storage regions, each being associated with a particular measured initial impedance.
More particularly, the Impedance Range defines a plurality of impedance breakpoints (in ohms) Which are employed to determine which net of variables are to be used for a particular sealing cyche. The particular Impedance Range that ~.s selected ie.basatl on the above described dance Sense State (Fig. 7) that is executed at the start of the aeah cycle. The individual data fields of the'seal parameter LDT
84 are defined as foliaws.
The actual values for the Impedanco Ranges of Low, Med how, . Med High, or High, are preferably contained.in one of a ' plurality of. tables stored in the generator 2, o~ othexwise~.~
.. . accessible tQ the generator 2.. A speci'fis table may be "
selected automatically, for example, based on signals received from the electroaurgical tool 4 being used, ar by the operator indicating what electrosurgical tool is iri.'use. ' ' ..
Power is the RF power setting to be ussd (in Watts~~:..Max .. ,. 25 . Voltage is the greatest value that the output, voltage can achieve (e.g., range 0 - about~190Yy. Start Voltage is the .
greatest valu~a that the first pulse voltage can adhieve (e.c~.,,.x~nge 0 - about 190V). Subsequent pulse voltage values. -are typically modified downwards from this value. The SO Minimum Voltage is the voltage endpoint, and the seal ' cycle can be assumed to be complete when the RF pulse . voltage has been reduced to this value. The Voltage Decay scale factor is the rate (in volts) at which the desired voltage is lowered if the ct~rre~nt Actual E~ulse Width is less than the Desired Pulse Width. The.
Voltage Ramp scale factor is the rate at which the desired voltage will be ineroaaed if the Actual Pulse l~idth is greater than the Desired Pulse Width. The Maximum RF On Time is the maximum amount of time (e. g., about 5-20 seconds!) that the RF power can be delivered, as desoribed above. The Msxiawm Cool Down Time det~rminem the generator oool down time, also as described above. Pulse Minimum establishes the minimum Desired Pulse ~iidth value. It c~ be noted that for eaoh RF pulse, the Dssirad, Pulse Width is. equal to the Actual Pulse Width from the previous pulse, or the Desired Pulse field if the first pulse. Tha Dwell Time scale factor was also discussed previously, and is the Lime (iri milliseconds) that the RF pulse is continued after the current drops to the Pulse Low and Stable point (see Fig. 7). Pulse Ott is the off time (in milliseconds) between RF pulses. Desired Pulse Width is a targeted pulse Width and determines when the Desired Voltage (Vast) is raised, lowered or kept constant. If the~Actual Pulse Width is less'fihan th~a Desired Pulse Width, then Vset is decreased, while if the Actual Pulse Width is gxeater than the Desired Pulse Width, then Vset is increased. If the Actual Pulse Width ie equal to the Desired Pulse Width, ~25 then Vset ie kept constant. The Desired Pulse Width is used ae the Desired Pul$e'T~idth for each sequential pulse.
.In general, a new Desired Pulse Width cannot be greater than a previous Desired Pulse width, and cannot be less than Pulse Minimum.
Hy applying the series of RF pulses to the tissue, the surgical generator 2 effectively raises the tissue 34 .
temperature to a certain level, and than maintains the teiaperature relatively constant. If the RF pulse width is too long, then the tissu~ may be excessively heated and may stick to the electrodes 21A, 218 of the surgical instrument 4, and/or an explosive vaporization of tissue fluid may damage the tissue, such as the vessel 3. If the RF pulse width is too narrow, then the tissue will not reach a temperature that is high enough t4 properly seal. As such, it cetn be appreciated that a proper balance of duty cycle to tissue .type is important.
During the pulse off cycle that is made possible in accordance with the teachings herein, the tissue relaxes, thereby allowing the steam to exit without tissue destruction. They tissue responds by rehydrating, which in turn i.owers the tissue impedance. The lower impedance allows the delivery of more current in the next pulse. This type of pulsed operation thus tends to regulate the tissue temperature so that the temperature does not rise to nn undesirable level, while still performing the desired electrosurgical procedure, and may also allow more energy to be delivered, and thus achieving better desiccation.
As each RF pulse is delivered to the tissue., the tissue desiccates and shrinks due to pressure being applied by the jaws of the surgical instrument 4. The inventors have realized that if the voltage applied to the tissue is not reduced, then as the spacing between the haws Qf the surgical instrument 9 is gradually reduced due to shrinking of the tissue, an undesirable arcing can develop which may vapor~.ze the tissue, resulting in bleeding.
r As is made evident in the V~ trace of Fig. 8, and as was described above, the voltage of each successive RF pulse can be controllably decreased, thereby compensating for the 5 desiccation-induced narrowing of the gap between the surgica 1 instrument electrodes 21A and 218. That is, the difference in electric potential between the electrodes is decreased as the gap between the electrodes decreases., thereby avoiding arcing. ~ .
As was noted'previous7.y, the Seal Intensity front panel adjustment is.not a simple RF power control. The adjustment .' of the seal intensity is acco~aplished.by adjusting the power of the electrosurgical generator 2, as.weZl as the generator . .y voltage, the duty cycle of the RF pulses, the length of time of the seal cycle (e.g.y number of RF pulses), and the rata .of voltage reduetion for suceessive RF pulses. Figs. 9H and 9C
. illustrate an exemplary set of~parameters (Power, Start Voltage, Voltage Decay and Dwell Time) ,' and 'how they modify.. ~ . ... .
the contents of the seal parameter LUT 80 depending on the ~~
setting.of the Seal Intensity control B2 shown in Fig. 9A.
Generally, high~r~settings of the Seal Intensity control 82.
increase the seal time. and the energy delivered while lower settings decrease the seal~time and the energy delivered.
In the Fig. 9B embodiment, it is instinctive to note that for the Medium, High and Very High Seal Intensity settings the RF Power remains unchanged, while variations are made w instead in the Start Voltage, Voltage Decay and Dwell Time ' 30' Parameters.
Based on the foregoing it can be appreciated that ari aspect of this disclosure is a method far eleatroaurgically sealing a tissue. Referring to Fig. 12, the method includes steps of:
(A) applying an initial pulse of RF energy to the tiasue,~the pulse having characteristics ealeeted so as not to ex~Pssively'heat the tissue: (9) measuring at least one electrical characteristic of the tissue in response to the 'applied pulse: (C) in accordance with the measured electrical characteristic , determining an initial set of pulse parameters for use during a first RF energy pulse that is applied to .the tissue: and (D) varying the. pulse par~neters .of individual ones of subsequent RF energy pulses in accordance with tit least one aharaoteristic of an electric current transient that occurs at the beginning of each individual one (pulses) of the subsequent RF energy pulses.
The method can terminate the generation of subsequent RF
energy pulses upon a determination that the current transient is absent yr that the voltage has been reduced to a predefined'level. In another embodiment of the present invention, the initial pulse may be combined with at least the first subsequent pulse..
Reference is now made to Figs. 10 and 11 for a description of a novel over-voltage limit and transient energy suppression '25 aspect of the system disclosed herein.
. A bi-directional transorb T91 normally is non-operational.
As long as the operating RF output levels stay below the turn-on threshaid of TS1, eleatrosurgical energy is provided at a controlled~rate of tissue desiaoation. However, in the event that rapid biasue desiccation oaaurs, or that arcing is present in the surgical tissue field, the RF output may exhibit operating voltage levels in excess of the normal RF
levels used to achieve the contxolled rate of tissue desiccation. rf the excess voltage present is left unrestrained, the tissue 3 racy begin to exhibit undesirable clinical effects contrary to the desired clinical outcome.
The TS1 is a strategic threshold that is set to turn on above normal operating levels, but below and just prior to the RF
output reaching an excess voltage Level where undesirable tissue effects begin to occur. The voltage applied across TS1 is proportionately scaled to follow the RF output voltage delivered to the tissue 3. The transorb TSl is selected such that its turn on response is faster than the generator source RF signal. This allows the transorb TSl to automatically track and respond quickly in the first cycle of an excess RF
output overvoltaqe condition.
z~
Note should be made in Fig. 10 of the capacitor components or network C2, C3, arid C4 that parallel the magnetic dxive network (MDNl) which has an inductive characteristic and is contained within the eleatrosurgical generator 2. The comdbination of the inductive MON1 and the cspacitive networks forms a resonant tuned network which yields the waveshape canfiguration of the RF source signal shown in Fig. 11:
A turn on of tranaorb device TS1, which functions as a voltage controlled switch, instantaneously connects the serial capacitance C1 across the capacitor netwoxk C2, C3, and Gg. Rn immediate change then appears in the tuning of the resonant network iasntioned above, which then instantaneously sltezs the waveshape of the RF source signal shown in Fig. 11. The time base T1 of the nominally half-sine signal shown increases incrementally in width out to time T2, which automatically lowers the peak voltage of the AF output signal. The peak voltage decreases because the Voltage-Time product of the signal shown in Fig. ll~is constant for a given operating quiescence. The concept of a Voltage-Time product is well known to those skilled in the art, and is not further discussed h4rein.
As the peak voltage decreases, the excess overvoltage is automatically limited and is restricted to operating levels below that which cause negative clinical effects. trace the excess RF output voltage level falls below the tranaorb threshold, the TSl device turns off and the electrosurgical generator 2 returns to a controlled rate of tissue desiccation.
In the event that arcing is present in the surgical tissue field, undesirable excess transient RF energy may exist and may be reflected in the RF output of the electrosurgiCal generator 2. This in turn may generate a cozreaponding excess RF output voltage that creates sufficient transient overvaltage to turn on the transorb TS1. In this condition the cycle repeats as described above, Where T81 turns on, alters the resonant tuned network comprised of the magnetic and capacitive components, and thus also alters the RF source signal waveshape. This automatically reduces the excess overvoltage.
In accordance with this aspect of the disclosure, the excess RF transient en~rgy is suppressed and the overvoltage is limf.ted by the dynamic, real-time automatic datuning of the RF energy delivered to the tissue being treated.
_ . .39 2t should be noted that the embodiment of Figs. 10 and 11 can be used to improve the operation of conventional electrosurgical generators, as well as with the novel pulsed output electrosurgical generator 2 that was described previously. ' ,~ .
~~In an additional embodiment the measured electrical characteristic of the tissue,. preferably the. impedance (Zi), and the RMS cuz~rent pulse width (P") may be used to detertaine a fixed voltage reduction factor (V~) to be. used for' .
Su~SeQueIlt pulses, and to determine a.fixed number of pulses ~(Pa) to be delivered for the sealing procedure. The , , . .
relationship among ire voltage reduction factor, the measured ~..
1S impedance ~nd.the liMS current pulse width may be defined as ' ' V~ = F (Z=, P") , and the relationship , among the number of ' purses, the measured impedance arid the RMS curirent pulse .
. width may be defined' as Pf s F~ (Z=. P") ~ . Zn Fig. 14 ~s fixed number of pulses. P~~ 100 -determined fra~a the'maasured impedance and the RMS.~urrent pulse width are shown,' Each subsequent pulse may be reduced by the fixed voltage reduction factor (vae~) 110, also determined from the . ' measured impedance and the RMS current'pulse width.
In a further additional embodiment, tissue sealing is accomplished by the electrosurgical system described above by continuously monitoring or sensing the current or tissue impedance rate of change. If the rate of change increases above a predetermined limit, then 1:ZF
pulsing is automatically terminated by controlling the electrosurgical generator 2 accordingly and any previously changed pulse parameters (e.g., power, voltage and current increments) are reset to the original default values. In this embodiment, the ending current or tissue impedance, i.e., the current or tissue impedance at the end of each RF pulse, is also continuously monitored or sensed. The ending values are then used to determine the pulse parameters for the subsequent RF
pulse; to determine if the seal cycle should end (based on the ending values of the last few RF
pulses which did not change by more than a predetermined amount); and to determine the duty cycle of the subsequent 1:ZF pulse.
Further, in this embodiment,1',tF power, pulse width, current andlor voltage levels of subsequent RF pulses can be kept constant or modified on a pulse-by-pulse basis depending on whether the tissue has responded to the previously applied RF energy or pulse (i.e., if the tissue impedance has begun to rise). For example, if the tissue has not responded to a previously applied RF pulse, the 1ZF power output, pulse width, current and/or voltage levels are increased for the subsequent RF pulse.
Hence, since these RF pulse parameters can subsequently be modified following the initial RF
pulse, the initial set of RF pulse parameters, i.e., a magnitude of a starting RF power level, a magnitude of a starting voltage level, a magnitude of the starting pulse width, and a magnitude of a starting current level, are selected accordingly such that the fast or initial RF pulse does not excessively heat the tissue. One or more of these starting levels are modified during subsequent RF pulses to account for varying tissue properties, if the tissue has not responded to the previously applied RF pulse which includes the initial 1tF pulse.
The above functions are implemented by a seal intensity algorithm represented as a set of programmable instructions configured for being executed by at least one processing unit of a 3o vessel sealing system. The vessel sealing system includes a Seal Intensity control panel for manually adjusting the starting voltage level, in a similar fashion as described above with reference to Figs. 9A and 9B.
As shown in Fig. 15, a preferred Seal Intensity control panel of the present inventive embodiment includes six settings, i.e., "Off' 1SOA, "VLOW' 1S0B, "LOW" 1SOC, "MED" 1SOD, "HIGH"
150E and "VHIGH" 1SOF. The Seal Intensity front panel settings 1S0 adjust the seal parameter values of the Seal Parameter Table as shown by Figs. 9B and 9C. The selected Seal Parameter Table, adjusted by the Seal Intensity front panel settings 1S0 is then utilized by an RF generation system, as described above, and an initial ItF sealing pulse is then started.
The Seal Intensity front panel settings, as shown in Figs. 9B and 9C, represent approximate parametric values of several preferred embodiments, identified as an example to achieve vessel 1 o sealing performance in clinical procedures. The variety of tissue types and surgical procedures requires the use of one or more Seal Intensity front panel settings.
Fig. 16 is a logic flow diagram that illustrates a method in accordance with the vessel sealing system. At step A', a 1tF pulse is applied to tissue. At step B', the current or tissue impedance t s rate of change is continuously monitored. At step C', a determination is made whether the tissue impedance rate of change has passed a predetermined Iimit. If yes, at step D', RF pulsing is terminated and any previously changed pulse parameters are reset back to the original defaults. If no, the process proceeds to step E'.
2o At step E', a determination is made as to whether the ItF pulse has ended.
If no, the process loops back to step B'. If yes, the process proceeds to step F'. At step F', the ending current or tissue impedance is measured. At step G', the measured ending values are used for determining if the seal cycle should end (based on the current level or ending impedance of the last few 1tF
pulses which did not change by more than a predetenmined amount). If yes, the process 2S terminates at step H'. If no, the process continues at step I', where the ending values are used for determining the pulse parameters, i.e., the power, pulse width, current and/or voltage levels, and the duty cycle of the subsequent 1tF pulse from an entry in one of a plurality of lookup tables.
The process then loops back to step A'. One of the plurality of lookup tables is selected manually or automatically, based on a choice of an electrosurgical tool or instrument.
While the system has been particularly shown and~described with respect to preferred embodiments thereof, it will be understood by those skilled in the art that changes in form and details may be made therein without departing from its scope and spirit.
In this regard, conventional overvaltage techniques use a means of clamping or clipping the excess overvoltage using avalanche devices such as diodes, zener diodes and transorbs, so as to limit the operating levels. In these techniques the excess energy, as well as the forward conduction energy, is absorbed by the protection device and inefficiently dissipated in the form of heat. Moxe advanced prior art techniciues actively clamp only the excess energy using a predetermined comparator reference va~.ue, but still absorb and dissipate the excess energy in the fo~an of heat.
U.S. Patent No.: 5,594,636 discloses a system for AC to AC
power conversion using switched citation. This system addresses overvoltage conditions which occur during switched cv~autation by incorporating ari active output voltage sensing end clamping using an active clamp voltage regulator which energizes to limit the output. The active clamp switches in a resistive load to dissipate the excess energy caused by the overvoltage condition.
Other patents in this area include U.S. Patent No.:
5,500,616, which discloses an overvoltage clamp circuit, and D.S. Patent No.: 5,596,966, which discloses an isolated half-bridge power module. Both of these patents identify output overvoltage limiting for all power devices, and overvoitage limit protection is provided for power devices by using proportionately scaled zeners to monitor a~xld track the output off voltage of each device to prevent power device failure.
The zener device is circuit configured such that it provides feedback to the gate of the power device, When zener . . 9 avalanche occurs the polder device partially turns an, absorbing the excess overvoltage energy in conjunction with the connective load.
Reference can also be had to U.S. Patent No.: 9,546,222 for disclosing an Inverter incorporating overvoltage clamping.
Dvervoltage clamping is provided by using diode clamping devices referenced to DC power sources. The DC power sources provide a predetermined reference voltage to clamp the overvoltage condition, absorbing the excess energy through clamp diodes which dissipate the excess voltage in the form of heat.
It would be advantageous as to provide an electrosurgical generator having improved overvoltage limit and transient energy suppression.
The foregoing and other problems are overcome by methods and apparatus in accordance with embodiments disclosed herein.
An electrosurgical generator includes a controlling data processor that executes software algorithms providing a number of new and useful features. These features preferably include the generation of an initial pulse, thSt is a lvw power pulse of RF energy that is used to sense at least one electrical characteristic of the tissue prior tv starting an electrosurgical desiccation cycle, such as a tissue sealing 3Q cycle. The sensed electrical characteristic is then used as an input into the deterad.natian of initial sealing parametersr thereby tasking the selling procedure adaptive to the characteristics of the tissue to be sealed. Another feature preferably provided measures the time required for the tissue to begin desiccating, preferably by observa,nq an electricah transient at the beginning of an RF energy pulse, to determine and/or modify further seal parameters. Another preferable feature performs a tissue temperature control function by adjusting the duty cycle of the RF energy pulses applied to the tissue, thereby avoiding the problems that can result frown excessive tissue heating. A further preferable feature controllably decreases the RF pulse voltage With each pulse of RF energy so that as the tissue desiccates and shrinks (thereby reducing the spacing between the surgical tool electrodesl, arcing between the electrodes is avoided, as is the tissue destruction that may result from uncontrolled arcing. Preferably a Seal Intensity operator control is provided that enables the operator to control the sealing of tissue by varying parameters other than simply the RF power.
The system disclosed herein preferably further provides a unique method for overvoltage limiting and transient energy suppression. An electrosurgical system uses dynamic, real-time automatic detuning of the RF energy delivered to the tissue of interest. More specifically, this technique automatically limits excess output RF voltages by dynamically changing the tuning in a resonant source of RF .
electrosurgical energy, and by altering the shape of the RF
source signal used to develop the output AF signal. The inventive technique limits the excess output transient RF
energy by a resonant detuning of the generator. This occurs 1~
in a manner which does not clip or significantly distort the generated RF output signal used in a clinical environment for electrosurgical applications.
A method for electrosurgically sealing a tissue, in accordance with this disclosure, preferably includes the steps of (A) applying an initial pulse of RF energy to the tissue, the pulse having characteristics selected so as not to appreciably heat the tissue; (B) measuring a value of at least one electrical characteristic of the tissue in response to the applied first pulse; (C) in accordance with the measured at least one electrical characteristic, determining an initial set of pulse parameters for use during the next RF energy pulse that is applied to the tissue; and (D) varying the pulse parameters of subsequent RF energy pulses individually in accordance with at least one characteristic of an electrical transient that occurs during each individual subsequent RF energy pulse. The method terminates the generation of subsequent RF energy pulses based upon a reduction in the output voltage or upon a determination that the electrical transient is absent.
The at least one characteristic that controls the variation of the pulse parameters is preferably a width of the electrical transient that occurs at the beginning of each subsequent RF energy pulse. The initial set of pulse parameters include a magnitude of a starting current and voltage, and the pulse parameters that are varied include a pulse duty cycle and a pulse amplitude. Preferably, the subsequent RF energy pulses are each reduced or modified in amplitude by a controlled amount from a previous RF energy pulse, thereby compensating for a decrees a in the spacing between the surgical.tool~electrodes due to desiccation of the tissue between the electrodes.
The step of determining an initial set of pulse parameters preferably includes a step of using the measured value 'of at least one electrical characteristic of the tissue to'readout the initial set of pulse parameters from an entry in a lookup table .
. - . .
The step of. determining an initial set of pulse parameters may also preferably include a step of reading out the initial :' set of pulse para~aeters from an entry in one of a plurality of lookup tables, where'the looitup table is selected either 7.5 manually or automatically, based on the electrosurgical instrument or tool. that is beingwused. ~ .
The method also preferably includes a step of modifying predetermined ones of the pulse parameters in accordance With a control input from an operator. The predetermined . ones of the pulse parameters that are modified include a pulse power, a pulse starting current and voltage level, a pulse voltage decay scale factor, and a pulse dwell time.
Preferably.a circuit is coupled to:the output of the electro$u~rgical generator for protecting the output against , .
an~overPoltage.aondition~ and includes.a suppressor that detunea a tuned resonant circuit at the output for reducing a . magnitude of a voltage appearing at the output'. In accordance .30 with this aspect of the disclosure, the circuit has a ' capacitance network in parallel with an inductance that forms a portion of the output stage of the generator. A vo7.tage actuated switch, such as a transorb, couples an additional capacitance across the network upon an occurrence of an overvoltage condition, thereby detuning the resonant network and reducing the raagaitude of the voltage output, no~scx~~r=opt os ~ Dc~s The above set forth and other features of the invention are made more apparent in the ensuing Detailed Description when read in con3unction with the attached Drawings, wherein:
Fig. lA is a graph that plots output power versus tissue impedance (Z) in ohms, in accordance Nith the operative of a prior art electrosurgical generator:
Fig. 18 is a graph that plots output power versus impedance in ohms, in accordance with the operation of an electrosurgical generator that is an aspect of this disclosure;
Fig. 2 is a simplified block diagram of an electrosurgical System that can be used to practice the teachings of this disclosure:
Fig. 3 is a perspective view of one embodiment of a surgical instrument having bipolar forceps that are suitable for practicing this disclosure Fig. 4 is an enlarged, perspective view o~ a distal end of the bipolar forceps shown in Fig. 3;
~ . . .
' za ~~
Fig. 5 is a.perspective view of an embediment'o~ a surgical instrument having forceps that are suitable for use in an~ , endoscopic surgical procedure utilizing the electrosurgical .system disclosed herein:
Fig. 6A is a simplified block diagram of a presently , preferred embodiment:of the power control circuit of the eleetrosurgiGal generator of Fig. 2:
~,p . -Fig. 6B depicts the organization of a seal parameter lookup table tZLTT~ shown in F3c~. 6A=~
Fig. 7A and 7B illustrates a presently preferred electrosurgical generator output waveform of RM5 current vs. time for .
' implementing at least the first pulse of the pulsed operat~:on .
made that is an aspect of this disclosure; ' .
Fig. 8 depicts a fu7,l set of elsctxoaurg3.cal RF pulses in ' accordance with this disclosure, and illustrates the voltage, .
current and.poWer characteristics of the pulses, as Hell as 'the response of the tissue impedance to the applied RF
pulses; ~ ~ ' z5 Fig. 9A illustrates a Seal Tntensity control that forma a ' part of this disclosure, while Figs. 9B and 9C show a preferred variation in certain parameter-s from the seal parameter LUT based on different Seal..Intensity settings;
Fig. 10 is a simplified block diagram of a circuit for achieving an overvoltage limiting r and transient energy suppression energy function;
Fig. 11 is a waveform diagram illustrating the effect of the operation of the circuit in Fig.
5 10;
Fig. 12 is a logic flow diagram that illustrates a method in accordance with the system disclosed herein;
10 Fig. 13 is a more detailed logic flow diagram that illustrates a method in accordance with the system disclosed herein;
Fig. 14 is a chart illustrating a fixed number of pulses determined from the measured impedance and the RMS current pulse width;
Fig. 15 illustrates a Seal Intensity control that forms a part of this disclosure; and Fig. 16 is a logic flow diagram that illustrates another method in accordance with the system disclosed herein.
DETAILED DESCRIPTION OF THE IyREFERRED EMBODIMENT
An electrosurgical system 1, which can be used to practice this invention, is shown in Fig. 2. The system 1 can be used for sealing vessels 3 and other tissues of a patient, including ducts, veins, arteries and vascular tissue. The system 1 includes an electro-surgical generator 2 and a surgical tool, also referred to herein as a surgical instrument 4.
The surgical instrument 4 is illustrated by way of example, and as will become apparent from the discussion below, other instruments can be utilized. The electrosurgical generator 2, which is of most interest to the teachings herein, includes several interconnected sub-units, including an RF drive circuit 2A, a power control circuit 2B, a variable D.C. power supply 2C and an output amplifier 2D. The surgical instrument 4 is electrically connected to the electrosurgical generator 2 using a plug 5 for receiving 1.6 ..
i controlled electrosurgical power therefrom. The surgical instrument A has some type of end effector member 6, such as a forceps or hemostat, capable of grasping and holding the vessels and tissues of the patient. The member 6, also referred to simply as end effector 6, is assumed, in this embodiment, to be capable of applying and maintaining a relatively constant level of pressure on the vessel 3.
The member 6 is provided in the form of bipolar electrosurgiaal forasps using two generally opposing electrodes disposed on inner opposing surfaces of the member 6, and which are both electrically coupled to the output of the electrosurgical generator 2. Durinq use, different electric potentials are applied to each electrode. In that tissue is an electrical conductor, when the forceps are utilised to clamp or grasp the vessel 3 therebetween, the electrical energy output from the electrosurgical generator 2 is transferred through the intervening tissue. Hoth open surgical procedures and endoscopic surgical procedures can be performed with suitably adapted .surgi.cal inst~uaents 9. It should also be noted that the member 6 could be monopolar forceps that utilize one active electrode, with the other (return) electroda'ox pad being attached externally to the patient, or a combination of bipolar and monopalar forceps.
By way of further explanation, Fig. 3 is a perspective view of one embodiment of the surgical instrument 4 having a bipolar end effector implemented as forceps 6A while Fig. 4 is an enlarged, perspective view of a distal end of the bipolar forceps 6A shown in Fig. 3.
Referring now to Figs. 3 and 9, a~bipolar surgical instrument 9 for use with open surgical procedures includes s mechanical forceps 20 and an electrode assembly 21. In the drawings and in the description which follows, the term "proximal", as is traditional, refers to the end of the instrument 4 which is closer to the user, while the term "distal~ refers to the end Nhich is fuxthex from the user.
Mechanical forceps 20 includes first and second members 9 and 11 which each have an elongated shaft 12 and 14, respectively. Shafts 12 and Z4 each include a proximal end and a distal end. Each proxi~aal end of each shaft portion 12, 14 includes a handle member 16 and 18 attached thereto to allow a user to effect movement of the two shaft portions 7.2 and 14 relative to one another. Extending from the distal end of each shaft portion 12 and 14 are end effactors 22 and 24, respectively. The end effectors 22 and 29 are movable relative to one another in response to movement of handle members 16 and 18. These end effectors members 6A can be referred to collectively as bipolar forceps.
Preferably, shaft portions 12 and 14 are affixed to one another at a point proximate the end effectors 22 and 24 about a pivot 25. As such, movement of the handles 16 and I8 imparts movement of the end effectors 22 and 24 from an open position, wherein the end ef~ectors 22 and 24 are disposed in spaced relat~.on relative to one another, to a clamping or closed position, wherein the end effectors 22 and 24 cooperate to grasp the tubular vessel 3 therebetween. Either one or both of the end effectors 22, 24 can be u~ovabls.
As is best seen in Fig. 4, end ei~fector 24 includes an upper or first jaw member 44 which has an inner facing surface and a plurality of mechanical interfaces disposed thereon which are dimensioned to releasable engage a portion of an electrode assembly 21, which may be disposable. Preferably, the mechanical interfaces include sockets 41 which are disposed at least partia7.ly through the inner facing surface of jaw member 44 and which are dimensioned to receive a complimentary detent attached to an upper electrode 21A of the disposable electrode assembly 21. The upp~r eleetxode 21A
is disposed across from a corxespoading lower electrode 218.
The and effectvr 22 includes a second or lower jaw member 42 which has an inner facing surface which opposes the inner facing surface of the first jaw member 44.
Preferably, shaft members 12 and 14 of the mechanical forceps are designed to transmit a particular desired force to the opposing inner facing surfaces of the jaw members 22 and 24 when clamped. In paxticular, since the shaft members 12 and 20 14 effectively act together in a spring~like manner (i.~., bending that behaqee like a~ spring), the length, width, height and deflection of the shaft members 12 and 19 directly iu~aCts the overall transmitted force imposed on opposing jaw members 42 and 94. Preferably, jaw members 22 and 24 are more rigid than the shaft members 12 and 14 and the strain energy stored i.n the shaft members 12 and 14 provides a constant closure force between the jaw members 42 and 49.
Each shaft member 12 and l4 also includes a ratchet portion 32 and 34. Preferably, each ratchet, e.g., 32, extends from the pxoxirnal end of its respective shaft member 12 towards the other ratchet 34 in a generally vertically aligned manner such that the inner facing surfaces of each ratchet 32 and 34 abut one another when the end effectors 22 and.24 are moved from the open position to the closed position. Each ratchet 32 and 34 includes a plurality of flanges which project from the Inner facing surface of each ratchet 32 and 34 such that the ratchets 32 and 34 can interlock in at least one position. In the embodiment shown in Eig, 3, the ratchets 32 and 34 interlock at several different positions. Preferably, each ratchet position ho~.ds a specific, i.e., constant.
strain energy in the shaft members 12 and 14 which, in turn, transmits a specific force to the end effectors 22 and 24 and, thus, to the electrodes 21A and 21B. Also, preferably a stop is provided on one or both of the end effectors 22, 24 to maintain a lareferred gap between the ~ aws . .
In some cases it may be preferable to include other mechanisms to control and/or limit the movement of the jaw members 42 and 44 relative to one another. For example, a 24 ratchet and pawl system could be~utilized to~segment the movement of the two handles into discrete units which, in turn, impart discrete movexaent to the jaw members 42 and 44 relative to one another.
Fig. 5 is a perspective view of an embodiment of the surgical instrument 4 having end eftector members or forceps 6B that are suitable for an endoscopic surgical procedure. The end effeetor member 6B is depicted as sealing the tubular vessel 3 through a cannula assembly 130, 132.
The surgical instrument 4 fvr use With endosscopic surgical procedures includes a drive rod assembly 50 which is coupled to a handle assembly 54. The drive rod assembly 50 includes an elongated hollow shaft portion 52 having a proximal end 5 and a distal end. An end effector assembly 68 is attached to the distal end of shaft 52 and includes a pair of opposing jaw members. Preferably, handle assembly 54 is attached to the proximal end of sh~att 52 and includes an activator 56 for imparting movement of the forceps jaw members of end effect:or 10 ~nober 6B from an open position, wherein the jaw members area disposed in spaced relation relative to one another, to a clamping or closed position, wherein the jaw members cooperate to grasp tissue tharebetween.
Z5 Activatar 56 includes a movable handle 58 having an aperture 60 defined therein for receiving at least one of the operator's fingers and a fixed handle 62 having an aperture 64 defined therein for receiving an operator's thumb.
Movable handle 58 is selectiqely moveable from a first 20 position relative to fined handle 62 to a second position in the fixed handle 62 to close the jaw a~abexs. preferably, fixed handle 62 includes a ehannnl 66 which extends proximally for receiving a ratchet 66 which i9 coupled to movable handle 58. This structure allows for progressive closure of the end effector assembly, as well as a locking engagement of the opposing jaw members. In some cases it may be preferable to include other mechanisms to control and/or limit the movement of handle 58 relative to handle 62 such as, e.g., hydraulic, semi-hydraulic and/or gearing systems.
As with instrument 4, a stop can also be prov~,ded to caaintain a preferred.gap between the jaw members.
The handle 62 i.nciudes handle sectians~62a and 62b, and is generally hollow such that a cavity is formed therein for housing various internal caatt~onents. For example, the cavity can house a PC board which connects the electrosuzgical energy being transmitted from'the electrosurgical generator 2 to each haw member, via connector 5. More particularly, electrosurgical energy generated from the electrosurgical . generator 2 is transmitted to the handle PC board by a cable 5A. The PC.board diverts the electrosurgicai energy from ' the generator into two different electrical potentials which are transmitted to each jaw member by a separate terminal clip. The handle 62 may also~house circuitry that .
conmnunicate8 With~the generator 2, far example, identifying characteristics of the electrosuxqical tool 4 for use by the - electrosurgical generator 2, whe=e the electrosurg~.cal generator 2 may select a particrilar seal parameter lookup w table based on those characteristics (as described below).
Preferably, a lost motion mechanism 3.s positioned between each of the handle sections 62a and 62b'for maintaining a .~ predetermined or maxi~aum clamping force for' sealing'"tis~ua between the jaw members.
Having thus described two exemplary and non~limiting embodiments of surgical instruments 4 that can be employed , with the eleatrosurgical generator.2, a description will noW
be provided of various aspects of the inventive electrosurgical generator 2.
22~
Fig. 6A~is a block diagram that~iLlustrates the power control circuit 2B of Fig. Z in greater detail. The power control . . circuit ZB includes a suitably prograasued data processor.?Q .~ , ' . that is preferai~ly implemented, as one or more~microcontroiler devices. In a most preferred embodiment there are two pr3.ncipal mi.crocontrollers, referred to as a main ~miarocoatroller ?OA and a feedback microcontroller 709. These . twQ u4icrocontrolhrs are. capable of comcsxnicating. using .
shared data that is scored and retrieved fro~a a shared .
. 10 .vread/write memory ?Z. A control program fox the data . processor 70~'is stored in a program memory 74, and includes . ~ ., ' ' software 'routines-and algorithms for ~eontxolling the overall 'operation of the eleatrosuiQical ge~xator 2. xn general, the ~~~~feedback microcontroller ?0B has a digital. output bus Coupled . .15 to an input of a digital to analog converter (DAC) block '?6 .. . . ' ~xhich outputs aa' ana3.og siguai: This, ~s a system control _ . ~ ~ ,... _ voltage ~SCv),;~which is applied to the variable DC power ..supply 2C to'oontrcl the magnitude of the voltage and current y ~ . of output RF poises . ~ ' . .
.. -. .~ An~an$Zog to digital converter (ADC) block ?8 reaeivea analog inputs and sources a digital, input bus of the feedback microoontroller ?0B. using the ADC block,?B the microcontroller ?0B is apprised of the value of the actual output voltage and the actual butput current, thereby closing, .
the feedback loop with the 8CY signal. The values of th$
output voltage and carte»t,~n be_used for determining tissue ' wimpedance, power and energy delivery for the overall, . , .
;general control of the applied RF energy waveform.. .
It should be noted that at least the ADC block 78'can be an internal block of the feedback microcontroller .
' 7oB, and need not be a separate, external .
cobc~panent. It should be further dated that the same analog signals can be digitized and read into the master microcontroller 70A, thereby providing redundancy. The.ma$ ter mierocontrolJ.er 70A controls the state ton/off) of the high voltage (e. g., 190V mar) pow~r supply as a safety precaution, controls the front panel display(s), such as a Seai Intensity display, described below and shown in Fig. 9A, and also receives various input switch closures, such as a Seal Intensity selected by an operator.
.10 It is noted that in a preferred embod~.ment of the electrosurgical generator 2 a third (waveform) rnicrocontroller 74C is employed to generate the desired 970 kHz sinusoidal waveform tihat forms the basis of the RF pulses applied to the tissue to ba sealed, such as the vessel 3 (Fig. 2). The waveform microcontroller 70C is controlled by the feedback microcontroller 708 and is progranQaed thereby.
An output signal line from the feedback microcontroller 70B
is coupled to a Reset input of the waveform mi.croeontroller~
70C to easeritially turn the wavefor~a microcontrollsr 70C on and off to provide the pulsed RF signnl in accordance with an aspect of this disclosure. This particular arrangement is, of course, not to be viewed in a limiting sense upon the ' . practice of this system, as those skilled in the art may derive a number of methods and circuits for generating the desired RF pulses in accordance with the teachings found herein.
As an overview, the software algorithm$ executed by the data processor 70 provide the following features. First, and referring now also to the preferred waveform depicted in Fig.
.
?, a low power initial pulse of RF~energy is used to sense at .
least one electrical characteristic of the tissue prior to starti.ng~ the seal cycle. Second. the sensed electrical characteristic of the tissue is used as an input into tha~
5~ deteratination of the initial sealing parameters, thereby making the sealing procedure adaptive to the characteristics . , of the tissue to be sealed. Thixd, the technique measures the time required for the tissue to begin desiccating, preferably by observing as electrical transient , to determine and/or modify further seal parameters..Fourth, the technique performs a tissue tes~perature~ control function' by adjusting the duty cycle of RF pulses applied to the tissue, thereby . ..
avoiding excessive tissue heating and the.pxoblems that arise .
fr~a excessive tissue heating. This ie preferably .
~15 accomplished by~usi.ng at least one calculated seal parameter related to the time required tar the tissue to begin , desiccating. Fifth, the technique controllably changes the RF pulse voltage with each pulse of RF energy DEL as the tissue desiccates and shrinks tthercby' reducing .the spacing, between the surgical instru~aent.electrodes~; arcing between the instrument electrodes (e.g. 2IA,and 218. of Fig. 4) is avoided, as is the tissue 'destruct~:oii that may re$ult from .
such uncontrolled arc~.ng. This is also preferably accomplished by using at least one calculated seal parameter that is related to the time required for the tissue to begin desiccating. Sixth, the above-mentioned Seal Intensity front panel control (Fig. 9A1 enables the operator to control the sealing of tissue by varying parameters other than simply the RF power. These various aspects of this disclosure are now described in further detail.
v ~ ~~ a . ~ 25 ~ . . . .
Referring now also to the logic flow diagram of Fig. 13, the impedance sensing feature is imphemented~at the beginning of ' . the seal cycle, wherein the eiectrosurgical generator 2 , ..
senses at least one ~e7.eetric~tl characteristic of the tissue, .5 for example, impedance, I y phase rotation, or the output ' Current, by using n short burst of RF energy (Fig, 13, Steps A and 8). The electrical characteristic of the tissue may be measured at any freguent~ or power level, but preferably is per~for~ned at the sa~ae fregvency as the . intended working ' ~ ~ . .
14.~ frequency.(e.Q., 470 kEZz). In a most preferred case the short .
burst of RF.energy (prefBrably less than about'2ti0 millisecond, at~d more pret~rably about 100 ~ millisecond) . is a .
~- 470 kHz else wave pith approximaxely 5i1 of power. The initial pulse RF power is made low, and the pulse time is made. as 15 short as possible, to~~enable an~~.nitial tissue electrical .
characteristic maasuremdcnt to be made .t~~.thout excessively heating the tissue.
.~ .
In a most preferred embodiment the electr~.cal characteristic 20 .serised'is the tissue impedance Which is employed to determine an initial set of parameters that are input ~o the sealing algorithm, and which are used to control the selection of sealing parameters, including the starting power, current ~
. aad~voltage (Fig. Z3, Step C). Other sealing parameters may 2~ i include duty cycle and pulse width: Generally, if the sensed impedance is in the lower ranges, then the initial power and :. starting voltage are made relatively lower, the assumption being that the tissue will desiccate faster and require less energy. Tf the sensed impedance is in the higher ranges, the ~a initial pawer and starting voltage are made relatively higher, the assumption being that the tissue will desiccate slower and require more energy.
i In other embodiments at least one of~any'other tissue electrical characteristic, for example, the voltage or current, can be used to set the parameters.,Thesa initial parameters are prefgiably modified in accordance With the setting of the Seal intensity control input (Fig. 13, Step D), as will be described in further detail .below.
.Referring again to Fig. 13, Step C, the sensed i~npedance~ is ~10 employed to determine ~rh3ch set of values axe used from~a seal parameter lookup table (LUT) 80 (eee Figs. 6A and 6H). ' The seal parameter look up table iaay one of a~plurality that' .
are stored in~the generator or accessible to'the generator.
. Furthermore, the seal parameter table may be~seleetec~ , 15~ manually or automatically, based on, for~exartple, the electrosurgical tool or ~r~strumant be~5.ng ~aplnyed. The, specific values read from the heal parameter LtTT 80 Fig. 68) .
. are then adjusted based on the Seal Intensity front panel setting 82' (Fig. Z3, Step D) , as 'is ~ shown sabre clearly in .
20 Figa. 9A and 9H. xn a preferred, but sot limiting embodiment, the values read fro~a the seal parameter'hDT 80 comprise the power, the maximum voltage'; starting voltage, minimum voltage, voltage decay, voltage ramp, maximum RF on time, maximum cool scale factor, pulse minimum, pulse dwell time, pulse off time, . 25.~ current and the desired pulse width. In a preferred, but not ' limiting embodiment, the seal parameter values adjusted by the Seal Intensity front panel setting 82 (Figs. 9A and 9B) comprise the power, starting voltage, voltage decay, and pulse dwell time.
SO
~ , . . , ~ 2?
Figure 1B is a graph that plots autput power versus_fmpeda=ice in ohms for the disclosed electrosurgieal,generator. The . ~ plot labeled "Intensity Bar 1" shows the electrosurgical .
.generator por~er output versus impedance when the "VLOW"
. 5 setting 82A (Fig. 9A} of the Seal Intensity.front~panel.
setting 82 is selected. The plot labeled intensity Bar 2 .
shows the power output of the electrosurgical generator when the "LOW" settin~i 82B of the Seai Intensity front panel setting 92 is Selected. The,plot labeled,Intensity Bars~3', ~~ , . XO 4, 5,_sho'tvs the power output of the electxosurgical venerator - . ~ ~ when the "1~D" 82C, ~ "IiIGH"' $2D or YEixGHa 82E Seal , Intensit:y ' ' .~ .front panel settings 82 are selected: The 8ea1 Intensity ~ - , . .
front ,.panel , settings .82 ad just the sea~.~.paraineter values as . , . ;;
. shown in Fig. 9B. These values may be adjusted depending on 15 instrument used, tissue characteristics or surgical intent.
r . .
. Discussing this aspect of the disclosure now in further . ' ' ' detail, and ~sferri~g as well to Fig's: T ~ and ~8, the selected Seal Parameter Table, adjusted by'the Seal Intensity .front .pa~e3...settings is then utilized by the RF energy geaer~tion ~systera and'.an initial RF.sealing pulse is then staxted. v '~ Asweachwpulse i~WRF -energy is ~-applied to the tissue, the current initially rises tc~ a ma~ci~aum (Pulse Peak), end .t#~en, as the tissue desiccates and the impedance rises due to loss of moisture in the tissue, the current falls. Reference in th~.s xegard can be had to the circled areas designated as "A'~s . : in the Ice, waveform of F~.g. 8 , The actual width of the resulting electrical transient, preferably a current . transient "A", is an important factor in determining what type and amount'of tissue is between the jaws (electrodes).~f the surgical instrument 4 (measur~d from "Full Power RF
Start" to "Poise Low and Stable~.)~The actual current ., . ' transient or pulse width is also. employed to detarcnine the changes to, ar the values of, the parameters of the poise duty cycle ~"Ih~tell.Time") and tc the change of the pulse .
voltage, as well as other parameters. This parameter can also~be used to determine whether the tissue aeal~has been . completed, or if the surgical instrument 4 has shorted.
As an alternative to directly measuring the pulse width, the rate of change of an electrical characteristic (for.exanipie . current, voltage, ~impedanoe,~ete.) of the transient aA"
(shown in Fig:~~7B) may be measured periodically (indicated by the reference number 90 shown in Fi.g. 7H) over the tune the transient occurs. The~rate of change of the .electrical ~ ..
characteristic may be proportional.to the width Ot 95 of the , tzansieat '"A", defined by the relationship:
At cc deldt ZO where de/dt is the change in the electrical charaeteri9tic over time: .This rate of change may then be used to provide an indication of the Width of the transient "A" in detexzaining.the type and amount of tissue that is between the haws (electrodes) of th~ surgical instrument 4,~as Well as ' the $ubsecluent pulse duty cycle ("Dwell Time"), the amount of subsequent pulse volt~.ge reduction, as well as other parameters.
~efe~ring to-E'ig. 13.~Step E, a subsequent RF enexgy pulse is applied to the~tissue, and the pulse width of the leading edge current transient'is,.m~asured'(Fig. 13, Step F). A
determination'is made if the current transient is present.. If it is, control passes via connector "a" to Step H, otherwise control passes via connector "b" to Step K.
Assuming that the current transient i.s present, and referring to Fig. 13, Step A, if the current transient pule a . .
is wide, for example, approximately in the range of 500-1000 ms, th~n one can assume the presence of a large amount of tissue, or tissue that requires mare RF energy to desiccate.
Thus, the Dwell Time is increased, and an increase or small reduction is made in the amplitude of the next RF pulse (see the Vrms waveform in Fig. 8, and Fig. 13, Step I). If the current transient pulse is narrow, for example, about 250 ms or less (indicating that the tissue impedance rapidly rose), then one can assume a small amount of tissue, of a tissue type that requires little RF energy to desiccate is present_ Other ranges of current transient pulse widths can also be used.
The relationship between the current transient pulse width and the tissue characteristics may be empirically derived. In this case the Dwell Time can be made shorter, and a larger reduction in the amplitude of the next RF pulse can be made as well (Fig. 13, Step J).
Zf a current pulse is not observed at Fig. 13, Step G, it may _25 be assumed that either the instrument 4 has shorted, the tissue has not yet begun to desiccate,~or that the tissue has been fully desiccated and, thus, the seal cycle is comp3ete.
The determ~.nation of which of the above has occurred is preferably made by observing the tissue impedance at fig.~l3, Steps K and M. If the impedance is less than a low~threshold value (THREBHL), then a shorted instrument 9 is assumed (Fig.
13, Step L), while if the impedance~is greater than a high threshold value (THRESHH), then a complete tissue seal is assumed (Fig. 13, Step N).
5 If the tissue impedance is otherwise found to be between the high and low threshold values, a determination is made as to whether the Max RF On Time has been exceeded. If the Max RF
On Time has been exceeded, it is assumed that the seal cannot be successfully completed for some reason and the sealing 10 procedure is terminated. If the Max RF On Time has not been exceeded then it is assumed that the tissue has not yet received enough RF energy to start desiccation, and the seal cycle continues (connector "c").
15 After the actual pulse width measurement has been completed, the Dwell Time is determined based on the actual pulse Width and on the Dwell Time field in the seal parameter LUT 80(see Fig. 6B.) The RF pulse is continued until the Dwell Time has elapsed, effectively determining the total time that RF
20 energy is delivered for that pulse. The RF pulse is then turned off or reduced to a very low Level for an amount of time specified by the Pulse Off field. This low level allows some moisture to return to the tissue.
25 Based on the initial Desired Pulse Width field of the seal parameter LUT 80 for the first pulse, or, for subsequent pulses, the actual pulse width of the previous pulse, the desired voltage limit kept constant or adjusted based on the Voltage Decay and Voltage Ramp fields. The desired voltage limit Is kept constant or raised during. the pulse if the actual pulse width is greater than the Desired Pulse Width field (or last actual) pulse width), and is kept constaht or lowered if the actual pulse width is less than the Desired Pulse Width field <or the ' last actual pulse width).
When the Desired Voltage has'been reduced to the Minimum ,Voltage field, then the~RF energy pulsing is terminated and the electrosurgicai generator 2 enters a cool-down period having a duration that is set by the Maximum Cool SF field end the actual pulse w~.dth of the first pulse.
xo~
Several of the ~oragoing and other terms are defined with greater specificity as follows (see also Fig. 7).
The Actual Pulse width is the t~rne from pulse. start to pulse 1~5 low. The Pulse Peak is the point where the current reaches ~a maximum value, and does not exceed this value for some predeteriai:ned period of tine (measured in mil7.isecoads) . The ' peak value of the ~u3.se, Peak eaa be reached until the Pulse Peak-X% value is reached, which is the point.whera the 20 ' current bas~decrea$ed to souse predetermined determi»ed percentage, X,of the value of Pulse Peak. Pulse 3~ow is the .~ ~ ' point where the current reaches a low point, and 'does not go.
.lower for another predetermined period of time. The value of the. Maximum RF On Time or~MAX Pulsa Time is preferably 25 ~ preprogranened to some value that cannot be readily changed.
The RF pulse is terminated automatically if the Pulse Peak is .
' reached but tha Pulse Peak-X% value is not obtained with-the~
duration set by the Maximum RF On Time field of the seal para~oneter LUT 80.
30' ' 32 ' Referring to Fig. 68, the seal par~uaeter hUT.80 is employed by the feedback microcontroller 70H in determining how to set the various outputs that impact the RF output of the ..
electxoaurgical generator 2. The seal parameter Zv'r 80 is .
partitioned into a plurality of storage regions, each being associated with a particular measured initial impedance.
More particularly, the Impedance Range defines a plurality of impedance breakpoints (in ohms) Which are employed to determine which net of variables are to be used for a particular sealing cyche. The particular Impedance Range that ~.s selected ie.basatl on the above described dance Sense State (Fig. 7) that is executed at the start of the aeah cycle. The individual data fields of the'seal parameter LDT
84 are defined as foliaws.
The actual values for the Impedanco Ranges of Low, Med how, . Med High, or High, are preferably contained.in one of a ' plurality of. tables stored in the generator 2, o~ othexwise~.~
.. . accessible tQ the generator 2.. A speci'fis table may be "
selected automatically, for example, based on signals received from the electroaurgical tool 4 being used, ar by the operator indicating what electrosurgical tool is iri.'use. ' ' ..
Power is the RF power setting to be ussd (in Watts~~:..Max .. ,. 25 . Voltage is the greatest value that the output, voltage can achieve (e.g., range 0 - about~190Yy. Start Voltage is the .
greatest valu~a that the first pulse voltage can adhieve (e.c~.,,.x~nge 0 - about 190V). Subsequent pulse voltage values. -are typically modified downwards from this value. The SO Minimum Voltage is the voltage endpoint, and the seal ' cycle can be assumed to be complete when the RF pulse . voltage has been reduced to this value. The Voltage Decay scale factor is the rate (in volts) at which the desired voltage is lowered if the ct~rre~nt Actual E~ulse Width is less than the Desired Pulse Width. The.
Voltage Ramp scale factor is the rate at which the desired voltage will be ineroaaed if the Actual Pulse l~idth is greater than the Desired Pulse Width. The Maximum RF On Time is the maximum amount of time (e. g., about 5-20 seconds!) that the RF power can be delivered, as desoribed above. The Msxiawm Cool Down Time det~rminem the generator oool down time, also as described above. Pulse Minimum establishes the minimum Desired Pulse ~iidth value. It c~ be noted that for eaoh RF pulse, the Dssirad, Pulse Width is. equal to the Actual Pulse Width from the previous pulse, or the Desired Pulse field if the first pulse. Tha Dwell Time scale factor was also discussed previously, and is the Lime (iri milliseconds) that the RF pulse is continued after the current drops to the Pulse Low and Stable point (see Fig. 7). Pulse Ott is the off time (in milliseconds) between RF pulses. Desired Pulse Width is a targeted pulse Width and determines when the Desired Voltage (Vast) is raised, lowered or kept constant. If the~Actual Pulse Width is less'fihan th~a Desired Pulse Width, then Vset is decreased, while if the Actual Pulse Width is gxeater than the Desired Pulse Width, then Vset is increased. If the Actual Pulse Width ie equal to the Desired Pulse Width, ~25 then Vset ie kept constant. The Desired Pulse Width is used ae the Desired Pul$e'T~idth for each sequential pulse.
.In general, a new Desired Pulse Width cannot be greater than a previous Desired Pulse width, and cannot be less than Pulse Minimum.
Hy applying the series of RF pulses to the tissue, the surgical generator 2 effectively raises the tissue 34 .
temperature to a certain level, and than maintains the teiaperature relatively constant. If the RF pulse width is too long, then the tissu~ may be excessively heated and may stick to the electrodes 21A, 218 of the surgical instrument 4, and/or an explosive vaporization of tissue fluid may damage the tissue, such as the vessel 3. If the RF pulse width is too narrow, then the tissue will not reach a temperature that is high enough t4 properly seal. As such, it cetn be appreciated that a proper balance of duty cycle to tissue .type is important.
During the pulse off cycle that is made possible in accordance with the teachings herein, the tissue relaxes, thereby allowing the steam to exit without tissue destruction. They tissue responds by rehydrating, which in turn i.owers the tissue impedance. The lower impedance allows the delivery of more current in the next pulse. This type of pulsed operation thus tends to regulate the tissue temperature so that the temperature does not rise to nn undesirable level, while still performing the desired electrosurgical procedure, and may also allow more energy to be delivered, and thus achieving better desiccation.
As each RF pulse is delivered to the tissue., the tissue desiccates and shrinks due to pressure being applied by the jaws of the surgical instrument 4. The inventors have realized that if the voltage applied to the tissue is not reduced, then as the spacing between the haws Qf the surgical instrument 9 is gradually reduced due to shrinking of the tissue, an undesirable arcing can develop which may vapor~.ze the tissue, resulting in bleeding.
r As is made evident in the V~ trace of Fig. 8, and as was described above, the voltage of each successive RF pulse can be controllably decreased, thereby compensating for the 5 desiccation-induced narrowing of the gap between the surgica 1 instrument electrodes 21A and 218. That is, the difference in electric potential between the electrodes is decreased as the gap between the electrodes decreases., thereby avoiding arcing. ~ .
As was noted'previous7.y, the Seal Intensity front panel adjustment is.not a simple RF power control. The adjustment .' of the seal intensity is acco~aplished.by adjusting the power of the electrosurgical generator 2, as.weZl as the generator . .y voltage, the duty cycle of the RF pulses, the length of time of the seal cycle (e.g.y number of RF pulses), and the rata .of voltage reduetion for suceessive RF pulses. Figs. 9H and 9C
. illustrate an exemplary set of~parameters (Power, Start Voltage, Voltage Decay and Dwell Time) ,' and 'how they modify.. ~ . ... .
the contents of the seal parameter LUT 80 depending on the ~~
setting.of the Seal Intensity control B2 shown in Fig. 9A.
Generally, high~r~settings of the Seal Intensity control 82.
increase the seal time. and the energy delivered while lower settings decrease the seal~time and the energy delivered.
In the Fig. 9B embodiment, it is instinctive to note that for the Medium, High and Very High Seal Intensity settings the RF Power remains unchanged, while variations are made w instead in the Start Voltage, Voltage Decay and Dwell Time ' 30' Parameters.
Based on the foregoing it can be appreciated that ari aspect of this disclosure is a method far eleatroaurgically sealing a tissue. Referring to Fig. 12, the method includes steps of:
(A) applying an initial pulse of RF energy to the tiasue,~the pulse having characteristics ealeeted so as not to ex~Pssively'heat the tissue: (9) measuring at least one electrical characteristic of the tissue in response to the 'applied pulse: (C) in accordance with the measured electrical characteristic , determining an initial set of pulse parameters for use during a first RF energy pulse that is applied to .the tissue: and (D) varying the. pulse par~neters .of individual ones of subsequent RF energy pulses in accordance with tit least one aharaoteristic of an electric current transient that occurs at the beginning of each individual one (pulses) of the subsequent RF energy pulses.
The method can terminate the generation of subsequent RF
energy pulses upon a determination that the current transient is absent yr that the voltage has been reduced to a predefined'level. In another embodiment of the present invention, the initial pulse may be combined with at least the first subsequent pulse..
Reference is now made to Figs. 10 and 11 for a description of a novel over-voltage limit and transient energy suppression '25 aspect of the system disclosed herein.
. A bi-directional transorb T91 normally is non-operational.
As long as the operating RF output levels stay below the turn-on threshaid of TS1, eleatrosurgical energy is provided at a controlled~rate of tissue desiaoation. However, in the event that rapid biasue desiccation oaaurs, or that arcing is present in the surgical tissue field, the RF output may exhibit operating voltage levels in excess of the normal RF
levels used to achieve the contxolled rate of tissue desiccation. rf the excess voltage present is left unrestrained, the tissue 3 racy begin to exhibit undesirable clinical effects contrary to the desired clinical outcome.
The TS1 is a strategic threshold that is set to turn on above normal operating levels, but below and just prior to the RF
output reaching an excess voltage Level where undesirable tissue effects begin to occur. The voltage applied across TS1 is proportionately scaled to follow the RF output voltage delivered to the tissue 3. The transorb TSl is selected such that its turn on response is faster than the generator source RF signal. This allows the transorb TSl to automatically track and respond quickly in the first cycle of an excess RF
output overvoltaqe condition.
z~
Note should be made in Fig. 10 of the capacitor components or network C2, C3, arid C4 that parallel the magnetic dxive network (MDNl) which has an inductive characteristic and is contained within the eleatrosurgical generator 2. The comdbination of the inductive MON1 and the cspacitive networks forms a resonant tuned network which yields the waveshape canfiguration of the RF source signal shown in Fig. 11:
A turn on of tranaorb device TS1, which functions as a voltage controlled switch, instantaneously connects the serial capacitance C1 across the capacitor netwoxk C2, C3, and Gg. Rn immediate change then appears in the tuning of the resonant network iasntioned above, which then instantaneously sltezs the waveshape of the RF source signal shown in Fig. 11. The time base T1 of the nominally half-sine signal shown increases incrementally in width out to time T2, which automatically lowers the peak voltage of the AF output signal. The peak voltage decreases because the Voltage-Time product of the signal shown in Fig. ll~is constant for a given operating quiescence. The concept of a Voltage-Time product is well known to those skilled in the art, and is not further discussed h4rein.
As the peak voltage decreases, the excess overvoltage is automatically limited and is restricted to operating levels below that which cause negative clinical effects. trace the excess RF output voltage level falls below the tranaorb threshold, the TSl device turns off and the electrosurgical generator 2 returns to a controlled rate of tissue desiccation.
In the event that arcing is present in the surgical tissue field, undesirable excess transient RF energy may exist and may be reflected in the RF output of the electrosurgiCal generator 2. This in turn may generate a cozreaponding excess RF output voltage that creates sufficient transient overvaltage to turn on the transorb TS1. In this condition the cycle repeats as described above, Where T81 turns on, alters the resonant tuned network comprised of the magnetic and capacitive components, and thus also alters the RF source signal waveshape. This automatically reduces the excess overvoltage.
In accordance with this aspect of the disclosure, the excess RF transient en~rgy is suppressed and the overvoltage is limf.ted by the dynamic, real-time automatic datuning of the RF energy delivered to the tissue being treated.
_ . .39 2t should be noted that the embodiment of Figs. 10 and 11 can be used to improve the operation of conventional electrosurgical generators, as well as with the novel pulsed output electrosurgical generator 2 that was described previously. ' ,~ .
~~In an additional embodiment the measured electrical characteristic of the tissue,. preferably the. impedance (Zi), and the RMS cuz~rent pulse width (P") may be used to detertaine a fixed voltage reduction factor (V~) to be. used for' .
Su~SeQueIlt pulses, and to determine a.fixed number of pulses ~(Pa) to be delivered for the sealing procedure. The , , . .
relationship among ire voltage reduction factor, the measured ~..
1S impedance ~nd.the liMS current pulse width may be defined as ' ' V~ = F (Z=, P") , and the relationship , among the number of ' purses, the measured impedance arid the RMS curirent pulse .
. width may be defined' as Pf s F~ (Z=. P") ~ . Zn Fig. 14 ~s fixed number of pulses. P~~ 100 -determined fra~a the'maasured impedance and the RMS.~urrent pulse width are shown,' Each subsequent pulse may be reduced by the fixed voltage reduction factor (vae~) 110, also determined from the . ' measured impedance and the RMS current'pulse width.
In a further additional embodiment, tissue sealing is accomplished by the electrosurgical system described above by continuously monitoring or sensing the current or tissue impedance rate of change. If the rate of change increases above a predetermined limit, then 1:ZF
pulsing is automatically terminated by controlling the electrosurgical generator 2 accordingly and any previously changed pulse parameters (e.g., power, voltage and current increments) are reset to the original default values. In this embodiment, the ending current or tissue impedance, i.e., the current or tissue impedance at the end of each RF pulse, is also continuously monitored or sensed. The ending values are then used to determine the pulse parameters for the subsequent RF
pulse; to determine if the seal cycle should end (based on the ending values of the last few RF
pulses which did not change by more than a predetermined amount); and to determine the duty cycle of the subsequent 1:ZF pulse.
Further, in this embodiment,1',tF power, pulse width, current andlor voltage levels of subsequent RF pulses can be kept constant or modified on a pulse-by-pulse basis depending on whether the tissue has responded to the previously applied RF energy or pulse (i.e., if the tissue impedance has begun to rise). For example, if the tissue has not responded to a previously applied RF pulse, the 1ZF power output, pulse width, current and/or voltage levels are increased for the subsequent RF pulse.
Hence, since these RF pulse parameters can subsequently be modified following the initial RF
pulse, the initial set of RF pulse parameters, i.e., a magnitude of a starting RF power level, a magnitude of a starting voltage level, a magnitude of the starting pulse width, and a magnitude of a starting current level, are selected accordingly such that the fast or initial RF pulse does not excessively heat the tissue. One or more of these starting levels are modified during subsequent RF pulses to account for varying tissue properties, if the tissue has not responded to the previously applied RF pulse which includes the initial 1tF pulse.
The above functions are implemented by a seal intensity algorithm represented as a set of programmable instructions configured for being executed by at least one processing unit of a 3o vessel sealing system. The vessel sealing system includes a Seal Intensity control panel for manually adjusting the starting voltage level, in a similar fashion as described above with reference to Figs. 9A and 9B.
As shown in Fig. 15, a preferred Seal Intensity control panel of the present inventive embodiment includes six settings, i.e., "Off' 1SOA, "VLOW' 1S0B, "LOW" 1SOC, "MED" 1SOD, "HIGH"
150E and "VHIGH" 1SOF. The Seal Intensity front panel settings 1S0 adjust the seal parameter values of the Seal Parameter Table as shown by Figs. 9B and 9C. The selected Seal Parameter Table, adjusted by the Seal Intensity front panel settings 1S0 is then utilized by an RF generation system, as described above, and an initial ItF sealing pulse is then started.
The Seal Intensity front panel settings, as shown in Figs. 9B and 9C, represent approximate parametric values of several preferred embodiments, identified as an example to achieve vessel 1 o sealing performance in clinical procedures. The variety of tissue types and surgical procedures requires the use of one or more Seal Intensity front panel settings.
Fig. 16 is a logic flow diagram that illustrates a method in accordance with the vessel sealing system. At step A', a 1tF pulse is applied to tissue. At step B', the current or tissue impedance t s rate of change is continuously monitored. At step C', a determination is made whether the tissue impedance rate of change has passed a predetermined Iimit. If yes, at step D', RF pulsing is terminated and any previously changed pulse parameters are reset back to the original defaults. If no, the process proceeds to step E'.
2o At step E', a determination is made as to whether the ItF pulse has ended.
If no, the process loops back to step B'. If yes, the process proceeds to step F'. At step F', the ending current or tissue impedance is measured. At step G', the measured ending values are used for determining if the seal cycle should end (based on the current level or ending impedance of the last few 1tF
pulses which did not change by more than a predetenmined amount). If yes, the process 2S terminates at step H'. If no, the process continues at step I', where the ending values are used for determining the pulse parameters, i.e., the power, pulse width, current and/or voltage levels, and the duty cycle of the subsequent 1tF pulse from an entry in one of a plurality of lookup tables.
The process then loops back to step A'. One of the plurality of lookup tables is selected manually or automatically, based on a choice of an electrosurgical tool or instrument.
While the system has been particularly shown and~described with respect to preferred embodiments thereof, it will be understood by those skilled in the art that changes in form and details may be made therein without departing from its scope and spirit.
Claims (9)
1. A system for electrosurgically sealing tissue, comprising an electrosurgical generator comprising an RF energy source and a controller for controlling the operation of an electrosurgical generator, said electrosurgical generator having an output for coupling to a surgical instrument comprising electrodes for coupling RF energy generated by said electrosurgical generator to tissue to be sealed; said controller being operable for causing said electrosurgical generator to apply an initial pulse of RF energy to the tissue and for measuring a value of an electrical characteristic of the tissue in response to the applied initial pulse, said controlling being responsive to the measured electrical characteristic for determining an initial set of pulse parameters for at least one subsequent pulse and for then keeping constant or varying the pulse parameters of individual pulses of further subsequent RF energy pulses in accordance with a change in the electrical characteristic of the tissue as determined from at least one characteristic of an electrical transient that occurs during each individual pulse of the subsequent RF energy pulses.
2. A system as in claim 1, wherein the electrical characteristic is comprised of an electrical impedance.
3. A system as in claim 1, wherein the at least one characteristic of the electrical transient is the rate of change of the electrical transient.
4. A system as in claim 1, wherein said initial set of pulse parameters are selected from the group consisting of a magnitude of a starting power, a magnitude of a starting voltage, a magnitude of a starting current and pulse width.
5. A system as in claim 1, wherein the pulse parameters that are varied for individual pulses of further subsequent RF energy pulses are selected from the group consisting of RF power output, current, voltage, pulse width and duty cycle.
6. A system as in claim 1, further comprising one of a plurality of pulse parameter lookup tables that is readably coupled to said controller, and wherein said controller, when determining said initial set of pulse parameters, uses said impedance value to readout said initial set of pulse parameters from said one of the plurality of pulse parameter lookup tables.
7. A system as in claim 1, wherein said one of a plurality of pulse parameter lookup tables is selected manually or automatically, based on a choice of an electrosurgical tool or instrument.
8. A system as in claim 1, wherein said controller is responsive to a control input from an operator for modifying any one of said pulse parameters.
9. A system as in claim 1, wherein said controller is responsive to a determination that said electrical transient is absent for terminating a generation of subsequent RF energy pulses.
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US10/626,390 US7364577B2 (en) | 2002-02-11 | 2003-07-24 | Vessel sealing system |
US10/626,390 | 2003-07-24 |
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CA2475178A1 true CA2475178A1 (en) | 2005-01-24 |
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CA002475178A Abandoned CA2475178A1 (en) | 2003-07-24 | 2004-07-20 | Vessel sealing system |
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EP (1) | EP1500378A1 (en) |
JP (2) | JP2005040616A (en) |
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CA (1) | CA2475178A1 (en) |
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-
2003
- 2003-07-24 US US10/626,390 patent/US7364577B2/en not_active Expired - Fee Related
-
2004
- 2004-07-07 EP EP04015981A patent/EP1500378A1/en not_active Withdrawn
- 2004-07-07 AU AU2004203068A patent/AU2004203068B2/en not_active Ceased
- 2004-07-20 CA CA002475178A patent/CA2475178A1/en not_active Abandoned
- 2004-07-23 JP JP2004216626A patent/JP2005040616A/en active Pending
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2008
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2010
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- 2010-05-06 JP JP2010106816A patent/JP2010221044A/en active Pending
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2012
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2013
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2016
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AU2004203068B2 (en) | 2009-12-10 |
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AU2010200914A1 (en) | 2010-04-01 |
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US9375271B2 (en) | 2016-06-28 |
JP2005040616A (en) | 2005-02-17 |
US20130041367A1 (en) | 2013-02-14 |
US20140100559A1 (en) | 2014-04-10 |
US8287528B2 (en) | 2012-10-16 |
US9375270B2 (en) | 2016-06-28 |
AU2004203068A1 (en) | 2005-02-10 |
US20170027633A1 (en) | 2017-02-02 |
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