U.S. patent number RE39,358 [Application Number 10/323,004] was granted by the patent office on 2006-10-17 for electrosurgery system and method.
This patent grant is currently assigned to Gyrus Medical Limited. Invention is credited to Colin C. O. Goble.
United States Patent |
RE39,358 |
Goble |
October 17, 2006 |
Electrosurgery system and method
Abstract
An electrosurgical generator has output terminals for connection
to active and return electrodes respectively of an electrosurgical
instrument and, connected to the output terminals via at least one
isolation capacitor, a radio frequency (r.f.) source which may be
pulsed by a pulsing circuit. To permit tissue removal at a high
rate, the source and the pulsing circuit are arranged so as to
generate a pulsed r.f. output signal having a peek-to-peek voltage
of at least 1250V, a mark-to-space ratio not more than 1:1, and a
pulse length not more than 100 .mu.s.
Inventors: |
Goble; Colin C. O. (Egham,
GB) |
Assignee: |
Gyrus Medical Limited (Reading,
GB)
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Family
ID: |
10853981 |
Appl.
No.: |
10/323,004 |
Filed: |
December 19, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
09343542 |
Jun 30, 1999 |
06228081 |
May 8, 2001 |
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Foreign Application Priority Data
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May 21, 1999 [GB] |
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9911956 |
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Current U.S.
Class: |
606/34; 606/41;
606/37 |
Current CPC
Class: |
A61B
18/1206 (20130101) |
Current International
Class: |
A61B
18/04 (20060101) |
Field of
Search: |
;606/32-35,37-42
;607/101-102 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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A1-195 42 418 |
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May 1997 |
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DE |
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1-195 42 418 |
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May 1997 |
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DE |
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754 427 |
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Jan 1997 |
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EP |
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1 321 364 |
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Jun 1973 |
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GB |
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1 557 083 |
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Dec 1979 |
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GB |
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A-2 132 893 |
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Jul 1984 |
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GB |
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2 132 893 |
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Jul 1984 |
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GB |
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95/18576 |
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Jul 1995 |
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WO |
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Primary Examiner: Gibson; Roy D.
Attorney, Agent or Firm: Oliff & Berridge, PLC
Claims
What is claimed is:
1. An electrosurgical generator comprising a source of radio
frequency (r.f.) energy, an active output terminal, a return output
terminal, a d.c. isolation capacitance between the source and the
active output terminal, and a pulsing circuit for the source,
wherein the source and the pulsing circuit are arranged to generate
a pulsed r.f. output signal at the output terminals, which signal
has a peak-to-peak voltage of at least 1250V, a pulse mark-to-space
ratio of no greater than 1:1, and a pulse length of no greater than
100 .mu.s.
2. A generator according to claim 1, wherein the pulse repetition
rate is between 5 Hz and 15 kHz.
3. A generator according to claim 1, including a d.c. voltage
detector connected between the active and return output terminals,
and wherein the pulsing circuit forms part of a control circuit
configured to control the r.f. energy delivered from the output
terminals in response to a d.c. voltage detector by the doctor.
4. A generator according to claim 1, wherein the control circuit
and the detector are operable to control the delivered r.f. energy
so as to limit the d.c. voltage.
5. An electrosurgical generator comprising a source of r.f. energy,
a pair of output terminals coupled the source, and a pulsing
circuit for the source, wherein the pulsing circuit and the source
are arranged, in a pulsed mode of operation, to deliver to the
output terminals a peak current of at least 3 A into a 50 ohm load
and a peak-to-peak voltage of at least 1250V into 1 kilohm
load.
6. A generator according to claim 5, wherein the pulse repetition
rate in the pulsed mode being less than 12 kHz, and wherein the
generator is capable of delivering a peak power of at least 200 W
in the pulsed mode.
7. An eelctrosurgery system comprising a generator having a source
of radio frequency (r.f.) energy and, coupled to the generator, an
bipolar electrosurgical instrument having an electrode assembly
with a least a pair of electrode for operating in a wet-field,
wherein the generator is adapted to deliver r.f. energy to the
electrode assembly as a pulse modulated r.f. signal which, in use
with the pair of electrodes immersed in liquid has a peak current
of at least 3 A and a peak-to-peak voltage of at least 1250V.
8. A system according to claim 7, wherein the ratio of peak power
to average power is greater than 4:1.
9. A system according to claim 8, wherein the ratio of peak power
.[.of.]. .Iadd.to .Iaddend.average power is greater than 20:1.
10. A system according to claim 7, wherein the generator is capable
of delivering a peak power of 200 W in a pulsed made of operation,
the ratio of peak power is .[.of.]. .Iadd.to .Iaddend.average power
being at least 4:1.
11. An electrosurgery system comprising a generator including a
source of radio frequency (r.f.) energy and, coupled to the
generator, an electrosurgical instrument having a treatment
electrode, wherein the system includes an electrode temperature
sensing arrangement and the generator is adapted to supply the r.f.
energy to the electrode as a pulse modulated r.f. signal, the
mark-to-space ratio of the modulation being dynamically variable in
response to a temperature signal from the temperature sensing
arrangement representative of the electrode temperature.Iadd.,
wherein r.f. energy is delivered to the electrode as a pulsed
signal having a pulse repetition rate between 5 Hz and 2 kHz and
with a peak-to-peak voltage value of at least 1250V.Iaddend..
.[.12. A system according to claim 11, wherein r.f. energy is
delivered to the electrode as a pulsed signal having a pulse
repetition rate between 5 Hz and 2 kHz and with a peak-to-peak
voltage value of at least 1250V..].
13. A system according to claim .[.12,.]. .Iadd.11,
.Iaddend.wherein the generator includes a pulse modulator arranged
to modulate the r.f. energy so as to produce a pulsed signal having
alternate `off` and `on` periods during which the peak-to-peak
output voltage of the generator us substantially zero and at least
1250V respectively, the duration of the `on` periods being
controlled in response to the temperature signal reaching a
predetermined threshold value.
14. A system according to claim 11, wherein the temperature sensing
arrangement has a response time which is less than the modulation
period.
15. A system according to claim 11, wherein the temperature sensing
arrangement is responsive to thermionic emission from the
electrode.
16. A system according to claim 15, wherein the temperature sensing
arrangement includes a d.c. voltage detector arranged to detect a
d.c. offset on the treatment electrode.
17. A system according to claim 16, wherein the temperature sensing
arrangement and the pulse modulator are adapted to control the
modulation of the generator output signal so as to limit the d.c.
offset to a predetermined d.c. voltage level.
18. A system according to claim 17, wherein the predetermined d.c.
voltage level is in the region of from 50V to 100V.
19. A system according to claim 11, wherein the mark-to-space ratio
is 1:1 or less during at least the majority of the time the
generator is activated.
20. A system according to claim 19, wherein the peak-to-peak output
voltage is greater than or equal to 1500V.
21. A method of operating an electrosurgery system including an
electrosurgical r.f. generator and an electrode assembly having a
treatment electrode coupled to the generator, wherein the method
comprises applying to the electrode a pulse modulated r.f. signal
produced by the generator, generating a temperature signal
indicative of the temperature of the electrode, and dynamically
varying at least the mark-to-space ratio of the pulse modulation of
the r.f. signal in order to control the temperature of the
electrode.
22. A method according to claim 21, wherein the pulse repetition
rate of the r.f. signal is between 5Hz and 2 kHz with a
peak-to-peak voltage of at least 1250V.
23. A method according to claim 22, wherein the pulsed signal has
alternate `on` and `off` periods during which the peak-to-peak
output voltage of the generator is substantially zero and at least
1250V respectively, the duration of the `on` periods being
controlled in response to the temperature signal reaching a
predetermined threshold value.
24. A method according to claim 21, wherein the temperature signal
is responsive to changes in electrode temperature occurring within
one pulse cycle.
25. A method according to claim 21, including detecting a d.c.
offset voltage on the treatment electrode due to thermionic
emission from the electrode and generating the temperature signal
as a function of the offset voltage.
26. A method according to claim 21, wherein the mark-to-space ratio
of the pulse modulation is 1:1 or less during at least the majority
of the time the r.f. signal is applied to the electrode.
27. A method of performing electrosurgical tissue cutting or
ablation in which r.f. energy is applied to an electrosurgical
instrument so as to promote arcing at a treatment electrode of the
instrument, wherein the energy is applied as a pulsed r.f. signal
having a peak-to-peak voltage of at least 1250V, a pulse
mark-to-space ratio of no greater than 1:1 and a pulse length of no
greater than 100 .mu.s.
28. A method according to claim 27, wherein the mark-to-space ratio
is dynamically regulated to maximise the temperature of the
electrode without substantial electrode burning.
29. A method according to claim 27, wherein the electrosurgical
instrument has an electrode assembly with at least two electrodes,
including an active electrode and a return electrode, wherein the
tissue cutting or ablation is performed in the presence of a
conducting liquid supplied to the site of the operation such that
electrosurgical currents pass from the active electrode to the
return electrode through said liquid, and wherein application of
the pulsed r.f. signal causes a layerof vapour to form and collapse
repeatedly at the active electrode, the layer being formed when the
pulsed signal is `on` and collapsing when the said signal is
`off`.
30. A method according to claim 27, wherein the peak current is at
least 3 A.
.Iadd.31. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes for operating in a wet
field, wherein the generator is adapted to deliver r.f. energy to
the electrode assembly as a pulse modulated r.f. signal which, in
use with the pair of electrodes immersed in liquid has a peak
current of at least 3 A, a modulation rate of between 5 Hz and 2
kHz, a pulse length of between 100 .mu.s and 5 ms, and a power
delivery such that, in use, a vapour pocket is established at one
of the electrodes within the first half of each energy pulse.
.Iaddend.
.Iadd.32. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes for operating in a wet
field, wherein the generator is adapted to deliver r.f. energy to
the electrode assembly as a pulse modulated r.f. signal which, in
use with the pair of electrodes immersed in liquid has a peak
current of at least 3 A, a modulation rate of between 5 Hz and 2
kHz, a pulse length of between 100 .mu.s and 5 ms, and a power
delivery such that, in use, a vapour pocket is established at one
of the electrodes within the first energy pulse. .Iaddend.
.Iadd.33. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes for operating in a wet
field, wherein the generator is adapted to deliver r.f. energy to
the electrode assembly as a pulse modulated r.f. signal which, in
use with the pair of electrodes immersed in liquid has a peak
current of at least 3 A, a modulation rate of between 5 Hz and 2
kHz and a power delivery such that, in use, a vapour pocket is
established within 5 ms. .Iaddend.
.Iadd.34. An electrosurgical generator comprising a source of radio
frequency (r.f.) energy, an active output terminal, a return output
terminal, a d.c. isolation capacitance between the source and the
active output terminal, and a pulsing circuit for the source,
wherein the source and the pulsing circuit are arranged to generate
a pulsed r.f. output signal at the output terminals, which signal
has a peak current of at least 3 A, a modulation rate of between 5
Hz and 2 kHz, a pulse length of between 100 .mu.s and 5 ms, and a
power delivery such that the peak power is at least 200 W.
.Iaddend.
.Iadd.35. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes for operating in a wet
field, wherein the generator is adapted to deliver r.f. energy to
the electrode assembly as a pulse modulated r.f. signal which, in
use with the pair of electrodes immersed in liquid has a peak
current of at least 3 A, and is sufficient to perform
electrosurgical removal of tissue. .Iaddend.
.Iadd.36. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes for operating in a wet
field, wherein the generator is adapted to deliver r.f. energy to
the electrode assembly as a pulse modulated r.f. signal which, in
use with the pair of electrodes immersed in liquid has a peak
current of at least 3 A and a power delivery such that a peak power
is at least 200 W, and is sufficient to perform electrosurgical
removal of tissue. .Iaddend.
.Iadd.37. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes for operating in a wet
field, wherein the generator is adapted to deliver r.f. energy to
the electrode assembly as a pulse modulated r.f. signal which, in
use with the pair of electrodes immersed in liquid has a peak
current of at least 3 A, a power delivery such that a peak power is
at least 200 W and a ratio of peak power to average power being at
least 4:1. .Iaddend.
.Iadd.38. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes, wherein the generator
is adapted to deliver r.f. energy to the electrode assembly as a
pulse modulated r.f. signal which, in use with the pair of
electrodes has a peak current of at least 3 A, and is sufficient to
perform electrosurgical removal of tissue. .Iaddend.
.Iadd.39. An electrosurgery system comprising a generator having a
source of radio frequency (r.f.) energy and, coupled to the
generator, a bipolar electrosurgical instrument having an electrode
assembly with at least a pair of electrodes, wherein the generator
is adapted to deliver r.f. energy to the electrode assembly as a
pulse modulated r.f. signal which, in use with the pair of
electrodes has a peak current of at least 3 A, a modulation rate of
between 5 Hz and 2 kHz and a pulse length of between 100 .mu.s and
5 ms. .Iaddend.
Description
.Iadd.More than one reissue application has been filed for the
reissue of U.S. Pat. No. 6,228,081. The other reissue application
is Reissue Application No. 11/436,186 filed May 18, 2006. The other
reissue application is a continuation reissue application of
Reissue Application No. 10/323,004 filed Dec. 19, 2002.
.Iaddend.
FIELD OF THE INVENTION
This invention relates to an electrosurgery system, an
electrosurgical generator, and methods of operating the system and
performing electrosurgery.
BACKGROUND OF THE INVENTION
The cutting or removal of tissue electrosurgically using an
instrument having a tip with one or more active electrodes supplied
with a radio frequency (r.f.) voltage usually involves cell rupture
as a result of arcs between the active electrode and the tissue
being treated or, in the case of underwater electrosurgery, between
the active electrode or electrodes and a conductive liquid such as
saline overlying the tissue to be treated. As described in
EP-A-0754437, electrode destruction can occur if sufficient radio
frequency power is supplied to an electrode to cause burning or
melting of the electrode material, and this can be avoided by
sensing peak electrode voltage and applying feedback to reduce the
applied power so as to set a maximum peak voltage. It will be
understood that for a given power setting, the temperature of the
electrode depends on the rate at which heat can be dissipated
which, in turn, depends on such variables as the degree of tissue
engagement, electrode structure, and fluid flow around the
electrode. Consequently, to avoid electrode destruction the peak
voltage limit must be set at a sufficiently low level to prevent
damage in the worst case dissipation situations, i.e. when there is
an absence of cooling fluid and/or the electrode is surrounded by
tissue.
In the absence of such control, the temperature of the electrode
follows an asymptotic curve as shown in FIG. 1. The saline absorbs
power until the point of vaporisation is reached at time `t.sub.1`.
When the saline is vaporised, the active tip temperature rises more
rapidly until, at time `t.sub.2`, active electrode destruction
occurs at a temperature of 1600.degree. C. (melting point of
platinum). This destruction temperature is indicated by temperature
`T.sub.D` in FIG. 1. The time taken to reach this temperature after
vaporisation occurs is dependent on both thermal capacity and
thermal dissipation mechanisms. A low mass electrode heats up
faster. The principal dissipation mechanism is infra-red emission
and is, therefore, dependent on surface area.
Limitation of peak voltage is used, as described above, to control
the applied r.f. power so as to prevent the electrode temperature
reaching T.sub.D under all normal operating conditions. It will be
appreciated that this limits the rate at which tissue can be
removed.
It is an object of the present invention to provide a means of
increasing the rate of tissue removal.
SUMMARY OF THE INVENTION
According to a first aspect of the present invention, an
electrosurgical generator comprises a source of radio frequency
(r.f.) energy, an active output terminal, a return output terminal,
a d.c. isolation capacitance between the source and the active
output terminal, and a pulsing circuit for the source, wherein the
source and the pulsing circuit are arranged to generate a pulsed
r.f. output signal at the output terminals, which signal has a
peak-to-peak voltage of at least 1250V, a pulse mark-to-space ratio
1:1 or less, and a pulse length of 100 .mu.s or less. The pulse
repetition rate is preferably between 5 Hz and 15 kHz or, more
preferably, below 2 kHz. Advantageously, the mark-to-space ratio of
the modulation is dynamically variable in response to a temperature
signal from a temperature sensing arrangement, the signal being
representative of the temperature of an electrode when coupled to
the active output terminal.
The preferred generator includes a pulse modulator arranged to
modulate the r.f. energy so as to produce a pulsed signal having
alternate `off` and `on` periods during which the peak-to-peak
output voltage of the generator is substantially zero and at least
1250V respectively, the duration of the `on` periods being
controlled in response to the temperature signal reaching a
predetermined threshold value. When the load impedance drops to 50
ohms the peak current is at least 3 A.
It is possible to control the mark-to-space ratio on a
pulse-by-pulse basis by using a temperature sensing arrangement
having a response time which is less than the modulation period.
Such an arrangement is one which is responsive to thermionic
emission from the electrode, detected by monitoring the d.c. offset
voltage on the output terminal coupled to the treatment electrode
resulting from the thermionic effect.
According to a second aspect of the invention, an electrosurgical
generator comprises a source of r.f. energy, a pair of output
terminals coupled to the source, and a pulsing circuit for the
source, wherein the pulsing circuit and the source are arranged, in
a pulsed mode of operation, to deliver to the output terminals a
peak current of at least 3 A into a 50 ohm load and a peak-to-peak
voltage of at least 1250V into a 1 kilohm load.
According to a third aspect of the invention, an electrosurgery
system comprises a generator having a source of radio frequency
(r.f.) energy and, coupled to the generator, an bipolar
electrosurgical instrument having an electrode assembly with at
least a pair of electrodes for operating in a wet field, wherein
the generator is adapted to deliver r.f. energy to the electrode
assembly as a pulse modulated r.f. signal which, in use with the
pair of electrodes immersed in liquid, has a peak current of at
least 3 A and a peak-to-peak voltage of at least 1250V.
According to a fourth aspect of the invention, there is provided an
electrosurgery system comprising a generator including a source of
radio frequency (r.f.) energy and, coupled to the generator, an
electrosurgical instrument having a treatment electrode, wherein
the system includes an electrode temperature sensing arrangement
and the generator is adapted to supply the r.f. energy to thee
electrode as a pulse modulated r.f. signal, the mark-to-space ratio
of the modulation being dynamically variable in response to a
temperature signal from the temperature sensing arrangement
representative of the electrode temperature.
The generator and system disclosed in this specification make of
the property that the tissue removal rate increases
disproportionally with the applied peak voltage. Accordingly, by
pulsing the output signal and increasing the peak voltage beyond
that which would normally create destructive conditions for the
electrode, it is possible to increase the tissue removal rate
without a corresponding increase in the applied power. The way in
which the tissue removal rate varies is best understood by
considering some examples. For instance, an electrode using a
peak-to-peak voltage of 1250V yields approximately twice the tissue
removal rate of an electrode operating at 1000V. Thus if an
electrode is driven at a voltage of 1250V peak-to-peak with a 50%
duty cycle, the removal rate is approximately equivalent to that
achieved with continuous application of a voltage of 1000V
peak-to-peak. However, it is possible to use higher voltages still.
An electrode normally limited to 1000V peak-to-peak can be operated
at up to 1500V peak-to-peak and the removal rate can be doubled
again. Thus, an electrode powered at a 50% duty cycle at a voltage
of 1500V peak-to-peak will have approximately twice the removal
rate of an electrode operating continuously with 1000V
peak-to-peak.
Higher-than-normal peak voltages cause higher temperatures when
used in a continuous mode of operation. However, in the presence of
liquid, the "off" period of a pulsed signal, allows quenching and
cooling of the electrode by the liquid, which causes the electrode
temperature to remain below the electrode destructive value T.sub.D
shown in FIG. 1, despite the higher applied voltage. It follows
that if, during treatment, the electrode is used in such a way as
to prevent cooling by the quenching effect of the liquid, it is
likely to be destroyed as a result of heat accumulation. Such a
condition can arise when the electrode is buried in tissue. It is
for this reason that it is beneficial to use electrode temperature
sensing to limit the application of r.f. energy to the electrode
when operating at high peak-to-peak voltages. Conveniently then,
the mark-to-space ratio (the duty cycle) of the pulse-modulated
r.f. signal is reduced when the temperature signal reaches a
predetermined level corresponding to an electrode temperature
approaching the temperature at which destruction occurs (usually
the melting point of the electrode material). The temperature
signal may be derived from the d.c. offset voltage produced at the
relevant generator terminal due to thermionic emission at the
treatment electrode.
In this way, it is possible to perform electrosurgical removal of
tissue at a higher rate than previously, not only due to being able
to operate at higher temperature in other than worst case
dissipation conditions, but also due to the high removal rate
associated with high instantaneous voltage.
It is possible, within the scope of the invention, to drive a
treatment electrode at much lower pulse mark-to-space ratios,
depending on the applied voltage, the average power delivered, the
electrode configuration and the rate at which heat is dissipated
from the electrode due to, for instance the rate of flow of fluid
adjacent the electrode. Accordingly, advantageous tissue removal
rates can be achieved with a duty cycle as low as 5% and
peak-to-peak voltages in the region of 3 kV or 4 kV. Indeed, it is
possible to achieve rapid tissue removal with instantaneous power
levels of up to 10 kW peak currents 20 A (i.e. both within `on`
bursts) and a pulse repetition rate of 2 kHz or higher. The pulse
length, i.e. the duration of the `on` bursts may be as short as 5
ms or even 1 ms. Such pulse lengths may be shorter than the thermal
response time constant of the treatment electrode. Particular
benefits can be achieved with high instantaneous power and short
pulses when high liquid pumping rates are used since with high
voltages vaporisation and tissue removal tends to occur very
quickly, so that less of the incident energy is lost due to the
flow of heated liquid away from the electrode.
Typically, the control circuitry of the generator and the detector
are operable to limit the d.c. offset to a predetermined d.c.
voltage level in the region of from 50V to 100V. In practice, the
actual voltage level depends on electrode configuration and
electrode material. Thus, if a platinum electrode is used, the
voltage limit is set to that which occurs when the electrode
voltage approaches 1600.degree. C., the melting point of
platinum.
In a preferred embodiment of the invention, the generator has an
output terminal connectible to the treatment electrode and isolated
from the r.f. source at d.c., and the detector has (i) a detection
input which is connected to the output terminal and (ii) an
isolation device connecting the detector to the control circuit.
The detector may be powered from the generator r.f. output energy
by having a power supply circuit coupled to the generator output
terminal and including a rectifier for rectifying the r.f.
electrosurgery signal applied to the output terminal. This is
permissible since the thermionic effect does not occur until the
r.f. output voltage reaches a level consistent with arcing. The
fact that the detector does not function at lower voltages is, as a
result, no disadvantage. Typically, to achieve isolation at the
output of the detector, it comprises an oscillator for generating
an alternating measurement signal representative of the d.c.
offset, and the isolation device comprises an opto-isolator coupled
to receive the alternating measurement signal and to feed it to the
control circuit. The preferred detector also includes a reverse
polarity d.c. offset detector as a fault condition indicator which
can be used to disable the r.f. source when, for instance, in use
of a bipolar electrode assembly in a conductive fluid field, a lack
of fluid causes d.c. polarity reversal.
According to a further aspect of the invention, there is provided a
method of operating an electrosurgery system including an
electrosurgical r.f. generator and an electrode assembly having a
treatment electrode coupled to the generator, wherein the method
comprises applying to the electrode a pulse-modulated r.f. signal
produced by the generator, generating a temperature signal
indicative of the temperature of the electrode, and dynamically
varying at least the mark-to-space ration of the pulse modulation
of the r.f. signal in order to control the temperature of the
electrode.
According to yet a further aspect of the invention, a method of
performing electrosurgical tissue cutting or ablation comprises
applying r.f. energy to an electrosurgical instrument so as to
promote arcing at a treatment electrode of the instrument, wherein
the energy is applied as a pulsed r.f. signal with a peak-to-peak
voltage of at least 1250V and a pulse mark-to-space ratio of 1:1 or
less. The r.f. energy may be regulated by regulating the
mark-to-space ratio dynamically to maximise the temperature of the
electrode without substantial electrode damage, the d.c. voltage
being limited to a threshold value of less than 100V.
The invention will be described below by way of example with
reference to the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
in the drawings:
FIG. 1 is a graph showing the thermal response of an
electrosurgical electrode to which radio frequency power is applied
to an unregulated manner, the electrode being immersed in a
conductive liquid;
FIG. 2 is a diagram showing an electrosurgery system in accordance
with the invention;
FIG. 3 is a fragmentary view of an electrode assembly for tissue
ablation, shown in use immersed in a conductive liquid;
FIG. 4 is an electrical block diagram of the system shown in FIG.
2;
FIG. 5 is a graph showing the variation of electrode temperature
with time using the same scales as FIG. 1, but with the applied
radio frequency power pulsed;
FIGS. 6A and 6B are, respectively, a generator output waveform and
an electrode temperature graph showing the effect of varying the
mark-to-space ratio according to electrode temperature; and
FIGS. 7A and 7B are circuit diagrams of a d.c. offset detector.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is applicable primarily but not exclusively
to wet field electrosurgery. Referring to FIG. 2, the system
comprises a generator 10 having an output socket 10S which provides
a radio frequency (r.f.) output for an electrosurgical instrument
in the form of a handpiece 12 via a connection cord 14. Activation
of the generator may be performed from the handpiece 12 via a
control connection in cord 14 or by means of a foot switch unit 16,
as shown, connected separately to the rear of the generator 10 by a
foot switch connection cord 18. In the illustrated embodiment, the
foot switch unit 16 has two foot switches 16A and 16B for selecting
different generator modes such as a desiccation mode and a
vaporisation mode. The generator front panel has push buttons 20
and 22 for setting power levels, which are indicated in a display
24. Push buttons 26 are provided as an alternative means for mode
selection.
Handpiece 12 mounts a detechable electrode assembly 28 having a
dual electrode structure, as shown in the fragmentary view of FIG.
3.
FIG. 3 is an enlarged view of the distal end of the electrode
assembly 28. At its extreme distal end the assembly has an active
electrode 30 which, in this embodiment, is formed as a coiled wire
connected to a central conductor 32. The coil wire may be made of
platinum. Proximally of the active electrode 30 and spaced from the
latter by a longitudinally and radially extending ceramic insulator
34 is a return electrode 36. The return electrode 36 is arranged
coaxially around the inner conductor 32 as a sleeve which extends
as a tubular shaft 40 to the proximal end of the assembly 28 (see
FIG. 1) where it is connected in the handpiece 12 to a conductor in
the connection cord 14. Similarly, the inner conductor 32 extends
to the handpiece 12 and is connected to another conductor in cord
14. Insulation between the inner conductor 32 and the return
electrode 36 is provided by the insulator 34 which is constructed
as a sleeve extending inside the return electrode to insulate an
inner extension (not shown) of the active electrode 30 from the
return electrode 36. To promote greater power density at the active
electrode than at the return electrode, the surface area of the
return electrode is considerably greater than that of the active
electrode. With regard to typical dimensions, at the distal end of
the electrode assembly, the diameter of the return electrode is
typically in the region of from 1 mm to 3 mm, with the longitudinal
extent of the exposed part of the return electrode being typically
between 1 mm and 5 mm and the longitudinal spacing from the active
electrode being between 1 mm and 5 mm. The electrode assembly 28
has an insulating sheath 42 which covers shaft 40 and terminates
proximally of the ceramic insulator 34 to leave the distal end of
shift 40 exposed as the return electrode 36.
In operation as an instrument for cutting or removing tissue in a
conductive fluid field, the electrode assembly 28 is applied as
shown in FIG. 3 to the tissue 44 to be treated, the operation site
being immersed in a normal saline (0.9% w/v) solution 46 immersing
both the active electrode 30 and the return electrode 36.
The electrode assembly is effectively bipolar, with only one of the
electrodes (active electrode 30) axially extending to the distal
end of the unit. This means that the return electrode, in normal
circumstances in a wet field, remains spaced from the tissue being
treated and a current path exists between the tissue and the return
electrode via the conductive liquid in contact with the return
electrode. The conductive liquid 46 may be regarded, as far as the
delivery of bipolar electrosurgical energy is concerned, as a low
impedance extension of the tissue.
When sufficient r.f. voltage is applied between the electrodes 30,
36, power dissipation in the conductive liquid 46 causes the liquid
to vaporize, initially forming small vapour bubbles on the surface
of the active electrode 30, which ultimately coalesce until the
electrode is completely enveloped in a pocket of vapour 50. Vapour
pocket 50 is sustained by discharges 52 across the vapour pocket
between the active electrode 30 and the vapour-to-saline interface.
The majority of power dissipation now occurs within this pocket
with consequent heating of the active electrode, the amount of
energy dissipated being a function of the delivered power. By
holding the active electrode 30 adjacent the surface of the tissue
44, as shown in FIG. 3, so that the vapor pocket intercepts the
tissue surface, tissue removal occurs by cell rupture due to the
arcing occurring between the electrode and the tissue.
This mode of operation can be maintained over a comparatively wide
range of power levels, but increasing the delivered power beyond
this range causes a rapid rise in electrode temperature as
described above with reference to FIG. 1, potentially damaging the
electrode. The point at which this occurs depends on the speed with
which heat can be removed from the electrode which, as will be
appreciated, is affected by convection due to flow of the fluid 46
past the electrode 20, the proximity of the electrode 30 to the
tissue and, in the worst case, burying of the electrode 30 in the
tissue. It follows that, while a peak voltage limit may be
established to prevent a runaway temperature rise at the electrode,
such limit, to be effective, has to be set at a level which will
prevent such a rise in the worst case thermal dissipation
conditions.
In describing above the system with reference to FIGS. 1 to 3, the
thermal characteristics of the electrode referred to are those
obtained with substantially continuous application of r.f. power.
The applicants have found that by applying pulse modulation so that
an r.f. voltage is applied between the electrode as a pulsed signal
in which the pulse is alternately at a predetermined non-zero level
and substantially zero, higher levels of tissue ablation can be
achieved without the electrode reaching the electrode destruction
temperature T.sub.D (see FIG. 1). High power pulsing of the
electrode with a peak voltage higher than that obtained when peak
voltage is used to limit electrode temperature. This takes
advantage of the fact that the tissue removal rate is
disproportionate to voltage. For instance, operating the generator
at a peak-to-peak voltage of 1250V yields approximately twice the
tissue removal rate compared with operation at 1000V. If the
generator is operated at 1250V peak-to-peak with a 50% duty cycle,
the removal rate is approximately equivalent to that achieved of
continuous application of a voltage of 1000V peak-to-peak. However,
it is possible to use higher voltages still. A system with an
electrode assembly normally limited to 1000V peak-to-peak can be
operated up to 1500V peak-to-peak and the removal rate can be
doubled again. Thus, an electrode used on a 50% duty cycle with
1500V peak-to-peak will have approximately twice the removal rate
of an electrode operating with continuous r.f. power at 1000V
peak-to-peak.
Referring to FIG. 4, in a system in which pulsed r.f. power can be
applied from a generator 10 to an electrode assembly 28 as a pulsed
signal, and r.f. output stage 60 is coupled to a pulse modulator 61
so that a pulsed electrosurgical signal (typically having a carrier
frequency in the range of from 100 kHz to 5 MHz) is fed via a
series isolating capacitor 62 to an active output terminal 64 of
the generator 10. A return terminal 66 of the generator is also
coupled to the r.f. stage, likewise via an isolation capacitor
68.
The pulse modulator 61 is actuated by a processor 70 which, in
turn, receives mode signals from the front panel of the generator
or the foot switches (see FIG. 1). Accordingly, the generator may
have a vaporisation mode in which the r.f. power stage 60 is
modulated by the pulse modulator 61 with a mark-to-space ratio of
1:1 or less (i.e. successive "on" times representing a 50% duty
cycle or less). The frequency of the modulation is typically 300
Hz. The processor 70 also controls the peak voltage of the r.f.
output stage 60 according to mode. In addition, the processor has a
temperature signal input 74 allowing control of the pulse modulator
61 in response to electrode temperature, as will be described in
detail below.
A representation of the variation of the electrode temperature with
time when r.f. power is applied at a relatively high peak-to-peak
voltage with 100% pulse modulation depth is shown in FIG. 5. The
mark-to-space ratio is 1:1. In other words, power is only applied
for 50% of the time. This yields two potential benefits. Compared
with continuous 1000V peak-to-peak operation, application of pulsed
power at 1000V peak-to-peak results in a reduction in the averaged
delivered power by as much as 25%. Since the peak delivered power
is higher (i.e. during the r.f. burst when the pulse modulation is
a logic level 1, the electrode is less susceptible to quenching
effects caused by high flow rates of saline passed the electrode.
This is explained by considering the saline at the surface of the
active electrode. The ability to vaporise this saline is defined by
the power it absorbs before leaving the electrode surface. When
convection due to fluid flow is high, the silane refresh rate is
high and, therefore, the power absorbed by per unit volume of
saline at the electrode surface is smaller. If the waveform crest
factor is increased by the use of modulation, as described above,
but with similar average power levels, then the power absorbed per
unit volume of saline during each power burst is higher.
The above described advantages are achieved because, during the
"off" period of the modulation, the electrode is quenched and
cooled. It is for this reason that the electrode temperature never
reaches the steady state destructive value t.sub.D. If the
electrode is used in such a manner that cooling by quenching is
interrupted, there is a damage that the electrode will be destroyed
by heat accumulation. This condition can arise when the electrode
is burried in tissue. Accordingly, in accordance with the
invention, the pulsing of the electrosurgical power is performed in
conjunction with temperature monitoring, as provided for by the
temperature signal input 74 to the process 70 in FIG. 4. The
temperature signal applied to the input 74 is produced by an
electrode temperature sensing arrangement, which may take a number
of forms, for instance, a circuit for measuring a d.c. offset
voltage across terminals 74 and 66 due to the thermionic effect
occurring when the active electrode becomes very hot.
Processor 70 acts in such a way as to modify the mark-to-space
ratio of the pulse modulation generated by pulse modulator 61
according to the level of the electrode temperature signal applies
on input 54. Specifically, in this embodiment, a characteristic of
the electrode temperature signal applied to the input 74 is
compared with a threshold value which is a function of the maximum
allowed temperature, so that the pulse modulator applied on "on"
signal to the r.f. output stage 60 until the temperature signal
reaches the predetermined threshold value, whereupon the r.f.
output stage is switched off for a predetermined period.
This manner of operating is illustrated in FIGS. 6A and 6B. Since
the electrode temperature can be monitored, the "on" burst can be
sustained longer than would be possible without such monitoring so
that the electrode reaches a higher temperature without fear of
electrode burning. The length of each "on" burst is controlled
according to the rate at which the electrode is cooled during the
"off" periods, e.g. by allowing the burst to continue until a
control temperature T.sub.C being a predetermined threshold
temperature below the destruction temperature T.sub.D. It will be
understood that during the period "A" shown in FIG. 6B, the
conditions at the electrode reduce the rate of heat dissipation
from the electrode, whilst in the period "B" dissipation is
increased. Consequently, during period A, the "on" bursts are
shorter whereas in period B, they are longer. As explained above,
this combination of pulsed operation with temperature feedback
allows the use of higher peak voltages without the electrode
temperature reaching the destructive level, with a consequent
improvement is tissue removal rate. In effect, the modulation is
adaptive according to electrode temperature.
The modulation rate is primarily dependent upon the time taken for
the vapour pocket around the active electrode to collapse, so that
the electrode can be cooled. Ideally, power is reapplied as soon as
the quenching occurs, in order that the resulting saline is not
lost by either convection or flow. The burst length is preferably
sufficiently long that re-establishing the vapour pocket occurs at
least within the first half of the "on" burst. Modulation rates of
5 Hz to 2 kHz are appropriate.
As mentioned above, temperature sensing is done indirectly by
monitoring the thermionic effect, as will now be described with
reference to FIGS. 7A and 7B.
Referring to FIG. 7A, the preferred system in accordance with the
invention includes an r.f. output stage in the form of a source 60
delivering an electrosurgical voltage via coupling capacitors 62,
63 between first and second output terminals 64, 66 to which the
active and return electrodes of the electrode assembly 28 are
respectively connected. When arcing occurs at the active electrode
30, as shown in FIG. 3, thermionic emission from the electrode
occurs when the electrode is spaced from the tissue 44, dependent
on the temperature of the electrode, leading to the build up of a
positive potential on the active output terminal 64. In effect, the
combination of the heated active electrode 30, the tissue, the
conductive fluid 46, and the return electrode 36 together act as a
rectifier, the conductive solution behaving as the anode and the
active electrode as the cathode of the rectifier respectively. The
hotter the active electrode, the greater is the rectification and
the greater the d.c. offset voltage on the output terminal 64 of
the generator.
The temperature-dependent positive potential (the d.c. offset
voltage) is monitored using a detector connected as a shunt input
across the generator output, on the output terminal side of the
isolation capacitance. The detector has an input circuit with a
series r.f. choke 78 coupled to the output terminal 64, and a
smoothing capacitor 80 coupled to the common rail 81 which is
connected to the return terminal 66. Therefore, d.c. component of
the voltage at the active output terminal 64 accumulates at the
junction of the choke 78 and the smoothing capacitor 80 where it is
applied to a potential divider 82, 84 which present an input
resistance of at least 2 M.OMEGA., and typically between 50 and 100
M.OMEGA., the output of the potential divider 82, 84 is applied to
a high temperature buffer 86 the output of which provides a driving
signal to a voltage controlled oscillator (VCO) 88. Providing an
input impedance in the region of 50 to 100 M.OMEGA., yields a
detection current in the region of 1 .mu.A for d.c. offsets in the
region of 50 to 100V. Maintaining a low detection current has the
advantage that never stimulation due to a direct current between
the target tissue and the return electrode is avoided.
Conversion of the d.c. offset voltage to an alternating signal in
the VCO 88 allows the signal to be transmitted to an isolated
control circuit (not shown in FIG. 7A) connected to the output 90
of the detector via an opto-isolator 92, for controlling the r.f.
energy applied to the generator output terminals so as, for example
to limit the offset voltage. An indication of the d.c. offset is
communicated in this way across the safety isolation barrier
between the output terminals of the generator and the power
generating and control circuit. In the control circuitry, the
alternating signal can be converted back to a d.c. level using a
monostable and low pass filter, or may be counted by a gated
counter and conveyed digitally. In either case, the control circuit
is arranged to reduce the average output power of source 60 when
the d.c. offset voltage reaches a predetermined value (typically
within the range 50 to 100V), by altering the mark-to-space ratio
of the pulse modulation as described above. Accordingly, by
selecting a threshold d.c. offset voltage related to the maximum
safe operating temperature of the active electrode, the r.f. power
delivered to the active electrode can be maximized in different
thermal dissipation conditions. The processor 70 of the generator
(see FIG. 4) receives a temperature signal which may be the direct
output of the opto-isolator 82, in which case the threshold value
for the pulse width control is a frequency value, or a
frequency-to-voltage converter (not shown) may be interposed, in
which case the threshold value is a preset voltage value.
When the bipolar electrode assembly shown in FIG. 3 is used
incorrectly, for example when there is insufficient saline around
the assembly, it is possible for arcing to occur at the return
electrode 36. In such circumstances, the d.c. offset polarity
reverses so that the active terminal 64 becomes negative with
respect to the return. The detector illustrated in FIG. 7A includes
a reverse polarity detection circuit in the form of a comparator 94
bypassing the VCO 88 and having an output coupled to one input of,
for instance, an OR-gate 96 the other input of which receives the
alternating output from the VCO 88. The other input of the
comparator 94 is coupled to a negative voltage reference. Normally,
the output of comparator 94 is low, which means that the
alternating signal developed by the VCO passes through OR-gate 94
to the opto-isolator 92. However, when the d.c. offset voltage on
output terminal 64 of the generator turns negative by more than an
amount depending on the negative reference voltage applied to
comparator 94, the output of comparator 94 becomes high and OR-gate
96 blocks the alternating signal from the VCO 88, and the lack of
an alternating signal applied to the control circuit from the
detector output 90 can be used as a fault indication to shut off
the r.f. source 60.
In this embodiment, power for the buffer 86, VCO 88, comparator 94,
and OR-gate 96 is derived from the r.f. voltage itself delivered to
the output terminals 64 and 66 of the generator, avoiding the need
for a further isolation barrier. A suitable power supply for this
purpose is illustrated in FIG. 7B. A step-down transformer 100
coupled between the output terminals 64 and 66 of the generator
drives a bridge rectifier 102 to deliver a d.c voltage at power
supply output terminals 104 across a smoothing capacitor 106.
Connection of the secondary winding of the transformer 100 with a
centre tap to the return output temrinal 66, and thus the common
rail of the detector, allows the buffer 86 to be provided with a
dual-polarity supply in order to accommodate positive and negative
d.c. offset voltages. The fact that deriving power from the r.f.
output in this way results in the detector being inoperative at low
voltages in no disadvantage since the thermionic effect relied upon
as the control stimulus does not occur until the r.f. output
voltage of the generator reaches a level constituent with arcing at
the active electrode.
Use of the invention is not restricted to wet field (underwater)
electrosurgery. Arcing also occurs with monopolar or bipolar
electrosurgery instruments in dry field surgery and power can be
controlled using the thermionic effect in the same way as described
above.
* * * * *