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Patent 2630955 Summary

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(12) Patent: (11) CA 2630955
(54) English Title: COMPACT ELECTROSURGERY APPARATUSES
(54) French Title: APPAREILS D'ELECTROCHIRURGIE COMPACTS
Status: Granted
Bibliographic Data
(51) International Patent Classification (IPC):
  • A61B 18/00 (2006.01)
  • A61B 18/12 (2006.01)
(72) Inventors :
  • MORRIS, MARCIA L. (United States of America)
(73) Owners :
  • GENII, INC. (United States of America)
(71) Applicants :
  • GENII, INC. (United States of America)
(74) Agent: BORDEN LADNER GERVAIS LLP
(74) Associate agent:
(45) Issued: 2015-12-29
(22) Filed Date: 2008-05-08
(41) Open to Public Inspection: 2009-05-15
Examination requested: 2008-05-08
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data:
Application No. Country/Territory Date
11/940,595 United States of America 2007-11-15

Abstracts

English Abstract


A compact electrosurgical apparatus comprising: a housing having a front
panel, a back panel
generally parallel with the front panel, a top panel and a bottom panel each
extending in parallel
between the front and back panel, a left side panel and a right side panel
extending in parallel
between the front, back, top and bottom panels, wherein the panels define a
cavity; an
electrosurgical system located within the cavity, comprising a monopolar
output system, a
bipolar output system, an argon plasma coagulation output system, a processor
operatively
coupled to each output system of the electrosurgical system to control outputs
generated by each
output system; a high frequency generator operatively coupled to the
processor; and a gas
canister holder and control system for receiving a gas canister within the
cavity of the housing.


French Abstract

Un appareil électrochirurgical compact comprenant un boîtier pourvu dun panneau avant, dun panneau arrière généralement parallèle au panneau avant, dun panneau supérieur et dun panneau inférieur sétendant chacun parallèlement entre les panneaux avant et arrière, dun panneau latéral gauche et dun panneau latéral droit sétendant parallèlement entre les panneaux avant, arrière, supérieur et inférieur, les panneaux définissant une cavité; un système électrochirurgical situé dans la cavité, comprenant un système de sortie monopolaire, un système de sortie bipolaire, un système de sortie de coagulation au plasma dargon, un processeur relié fonctionnellement à chaque système de sortie du système électrochirurgical pour contrôler les sorties générées par chaque système de sortie; un générateur à haute fréquence relié fonctionnellement au processeur; et un support de cartouche de gaz et un système de contrôle pour recevoir une cartouche de gaz dans la cavité du boîtier.

Claims

Note: Claims are shown in the official language in which they were submitted.


CLAIMS:
1, A compact and portable electrosurgical apparatus comprising:
a unitary and enclosed housing that defines a cavity, said housing having an
exterior;
a high frequency alternating current electrosurgical system located within the

cavity, the electrosurgical system comprising:
a high frequency monopolar output system,
a high frequency bipolar output system, and
an argon plasma coagulation output system;
a processor located within the cavity, the processor operatively coupled to
each
of the output systems of the high frequency electrosurgical system to control
outputs
generated by each output system;
a high frequency generator located within the cavity and operatively coupled
to
the processor;
a gas canister holder comprising guide walls for guiding a gas canister of
compressed gas into place when said gas canister is being loaded into the
cavity, and
for holding said loaded gas canister, said guide walls adapted to encapsulate
said
loaded gas canister, said holder adapted to receive a gas canister through a
port in the
housing;
a gas canister control system, said gas canister control system comprising:
a pressure regulator operatively coupled to the processor,
a gas volume sensor operatively coupled to the processor, and
a gas flow conduit operatively coupled to the exterior of the housing
and to the pressure regulator,
wherein the gas canister holder and the gas canister control system are
located within
the cavity, and wherein in use, the gas canister is held by the gas canister
holder within
the housing; and
an electrosurgical system mode selector located on the exterior of the
housing,
and visible to a user in use, said electrosurgical system mode selector
operatively

coupled to each of the bipolar output system, the monopolar output system, and
the
argon plasma coagulation output system, wherein the electrosurgical system
mode
selector allows a user to select any one of output systems;
wherein all connectors among one or more of the high frequency alternating
current system, the processor, the generator, the gas canister holder, and the
gas
canister control system are located within the cavity.
2. The apparatus of claim 1, further comprising a lavage pump system
operatively
coupled to the processor located within the cavity.
3. The apparatus of claim 1 or 2, further comprising a port located in the
housing and
operatively coupled to the processor for receiving signals from a foot pedal
system
coupled to the port, wherein the foot pedal system provides a control and
signals to the
processor.
4. The apparatus of claim 1 or 2, further comprising a wireless foot pedal
operatively
coupled to the processor for controlling operation of the apparatus.
5. The apparatus of any one of claims 1 to 4, wherein the gas canister
control system
further comprises a gas probe socket located on the housing and operatively
coupled to
the gas flow conduit.
6. The apparatus of claim 5, wherein the processor generates a gas flow
rate control
signal to the pressure regulator to control the flow rate of gas from a gas
canister
coupled to the gas flow conduit.
7. The apparatus according to any one of claims 1 to 6, further comprising
a gas volume
indicator located on the housing and operatively coupled to the gas volume
sensor.
41

8. The apparatus of claim 7, wherein the gas volume indicator indicates
when the gas
canister needs to be changed.
9. The apparatus of claim 7 or 8, wherein the gas volume indicator
indicates the volume
of gas remaining in the gas canister.
10. The apparatus of any one of claims 6 to 9, wherein the gas volume
indicator is a visual
source or audible source.
11. The apparatus of any one of claims 1 to 10, further comprising a door
located in the
housing, which can be opened by a user to expose the gas canister holder so
that a user
can insert a gas canister in the cavity of the housing as well as remove the
gas canister
from the cavity of the housing.
12. The apparatus of any one of claims 1 to 11, wherein the electrosurgical
system mode
selector comprises a series of buttons, a rotatable dial, a movable lever, a
touch-
sensitive computer screen, or combination thereof.
13. The apparatus of any one of claims 1 to 12, further comprising a
bipolar probe socket
located on the housing and operatively coupled to the bipolar probe output
system, and
wherein the bipolar probe socket is optionally operatively coupled to a
bipolar probe.
14. The apparatus of claim 13, further comprising a bipolar wattage
indicator comprising a
gauge, digital screen, or other visual indication.
15. The apparatus of any one of claims 1 to 14, further comprising a
monopolar probe
socket located on the housing and operatively coupled to the monopolar probe
output
system, wherein the monopolar probe socket is optionally operatively coupled
to a
monopolar probe.
42

16. The apparatus of claim 15, further comprising a monopolar wattage
indicator
comprising a gauge, digital screen, or other visual indication.
17. The apparatus of any one of claims 1 to 16, further comprising a
selectable waveform
indicator operatively coupled to the processor, wherein the selectable
waveform
indicator is a series of buttons, a rotatable dial, a movable lever, a touch-
sensitive
computer screen, or another mechanism that allows for alternative waveform
selection.
18. The apparatus of claim 17, wherein the selectable waveform indicator is
pre-set with a
stand-by option (0 volts) and at least one of the following options: soft
coagulation,
coagulation, one or more blends, pulse cut, and cut.
19. The apparatus of any one of claims 1 to 18, further comprising a port
located in the
housing and operatively coupled to the processor for receiving a grounding
pad.
20. The apparatus of any one of claims 1 to 19, wherein the generator
produces power
between about 2 and about 300 watts.
21. The apparatus of any one of claims 1 to 20, wherein the generator
provides high
frequency alternating power in the bipolar output mode, the monopolar output
mode,
and the argon plasma coagulation system.
22. The apparatus of any one of claims 1 to 21, wherein the processor
generates a gas flow
rate of between about 0 and 5.0 L/min.
23. The apparatus of any one of claims 1 to 22, further comprising a gas
flow rate adjuster
located on the housing to allow a user to adjust the gas flow rate.
43

24. The apparatus of any one of claims 1 to 23, further comprising an argon
gas purge
control operably coupled to the pressure regulator for purging the gas
canister when
coupled to the pressure regulator.
25. The apparatus of any one of claims 1 to 24, further comprising one or
more pull-out
guides that indicate suggested monopolar selections or argon plasma
coagulation
settings.
26. The apparatus of any one of claims 1 to 25, wherein the gas canister
holder is
configured to hold a compact argon gas canister.
27. The apparatus of any one of claims 1 to 26, wherein the gas canister is
disposable.
28. The apparatus of any one of claims 1 to 27, wherein the gas canister
holder is adapted
to hold the gas canister in a horizontal position.
29. The apparatus of any one of claims 1 to 28, wherein the housing
comprises: a front
panel, a back panel generally parallel with the front panel, a top panel
extending
between the front and back panel, a bottom panel extending between the front
and
back panel, the bottom panel being generally parallel to the top panel, a left
side panel
extending between the front, back, top and bottom panels and a right side
panel
extending between the front, back, top and bottom panels, the right side panel
being
generally parallel to the left side panel, wherein the front, back, top,
bottom left and
right side panels define the housing cavity.
30. The compact electrosurgical apparatus of any one of claims 1 to 29,
wherein the
apparatus is less than about 15 inches tall.
31. The compact electrosurgical apparatus of any one of claims 1 to 30,
wherein the
apparatus is about 12 to about 20 inches wide.
44

32. The compact electrosurgical apparatus of any one of claims 1 to 31,
wherein the
apparatus is about 12 to about 20 inches deep.

Description

Note: Descriptions are shown in the official language in which they were submitted.


CA 02630955 2008-05-08
COMPACT ELECTROSURGERY APPARATUSES
TECHNICAL FIELD
This invention relates to apparatuses useful in electrosurgery.
BACKGROUND
Electrosurgery is surgery performed by electrical methods. Its development has

been driven by the clinical need to control bleeding during surgical
procedures. While
heat has been used medically to control bleeding for thousands of years, the
use of
electricity to produce heat in tissue has only been in general use since the
mid 1920's, and
in flexible endoscopy since the 1970's. Electrosurgery offers at least one
unique
advantage over mechanical cutting and thermal application: the ability to cut
and
coagulate tissue at the same time. This advantage makes it the ideal surgical
tool for the
gastroenterologist.
Electrosurgical Generators provide the high frequency electrical energy
required
to perform electrosurgery and some of these are equipped with an option to use
argon gas
enchanced electrosurgery. Argon gas enchanced or Argon Plasma Coagulation
(APC)
has been in long use in the operating room setting and is used intermittently,
usually for
parenchymal organ surgeries. The apparatus are typically large, heavy and
cumbersome
systems as shown in FIG. 1. The electrosurgical apparatus has a console system
11
mounted on a cart. Also located on the cart is a large gas canister 13,
particularly an
argon gas canister, that is coupled to the console to allow a user to perform
argon plasma
coagulation using the apparatus as is well known. Because the apparatus is so
large,
heavy and cumbersome, it is difficult to move from one location to another and
thus tends
to remain near or in one operating room.

CA 02630955 2008-05-08
About 10 years ago, argon plasma equipped electrosurgery systems were finally
adapted to be able to be used in flexible endoscopic procedures of the gut and
lung. This
required systems with a low flow rate of argon, and long, flexible accessories
suitable for
these closed procedures. APC is an ideal therapy for the blood rich gut and
lung, and its
use in flexible endoscopy has increased dramatically. However, when the old
operating
room argon equipped electrosurgery generators were modified for flexible
endoscopy
use, little was done to change the overall configuration of the apparatus.
This is a
disadvantage because flexible endoscopy is often done in multiple room
outpatient areas
where the lack of mobility of the current units becomes a limiting factor in
which and
how many, patients are able to receive, and benefit from, APC treatment.
SUMMARY
According to a first aspect of the invention, there is provided a compact
electrosurgical apparatus including a housing, an electrosurgical system, a
processor, a
high frequency generator and a gas canister hold and control system. The
housing has a
front panel, a back panel generally parallel with the front panel, a top panel
extending
between the front and back panel, a bottom panel extending between the front
and back
panel, the bottom panel being generally parallel to the top panel, a left side
panel
extending between the front, back, top and bottom panels and a right side
panel extending
between the front, back, top and bottom panels, the right side panel being
generally
parallel to the left side panel, wherein the front, back, top, bottom left and
right side
panels define a cavity. The electrosurgical system is located within the
cavity includes a
monopolar output system, a bipolar output system and an argon plasma
coagulation
2

CA 02630955 2008-05-08
output system. The processor located within the cavity is operatively coupled
to each
output system of the electrosurgical system to control outputs generated by
each output
system. The high frequency generator is located within the cavity and is
operatively
coupled to the processor. The gas canister holder and control system is
located within the
cavity of the housing for receiving a gas canister within the cavity of the
housing.
According to a second aspect of the invention, there is provided a compact
electrosurgical apparatus including a housing, an electrosurgical system, a
processor and
a gas canister hold and control system. The housing has a front panel, a back
panel
generally parallel with the front panel, a top panel extending between the
front and back
panel, a bottom panel extending between the front and back panel, the bottom
panel being
generally parallel to the top panel, a left side panel extending between the
front, back, top
and bottom panels and a right side panel extending between the front, back,
top and
bottom panels, the right side panel being generally parallel to the left side
panel, wherein
the front, back, top, bottom left and right side panels define a cavity. The
electrosurgical
system is located within the cavity. The processor located within the cavity
is operatively
coupled to each output system of the electrosurgical system to control outputs
generated
by each output system. The gas canister holder and control system is located
within the
cavity of the housing for receiving a gas canister within the cavity of the
housing.
According to a third aspect of the invention, there is provided a compact
electrosurgical apparatus including a housing, an electrosurgical system, a
processor and
a gas canister hold and control system. The housing has a front panel, a back
panel
generally parallel with the front panel, a top panel extending between the
front and back
panel, a bottom panel extending between the front and back panel, the bottom
panel being
3

CA 02630955 2008-05-08
generally parallel to the top panel, a left side panel extending between the
front, back, top
and bottom panels and a right side panel extending between the front, back,
top and
bottom panels, the right side panel being generally parallel to the left side
panel, wherein
the front, back, top, bottom left and right side panels define a cavity. The
electrosurgical
system is located within the cavity includes a monopolar output system, a
bipolar output
system and an argon plasma coagulation output system. The processor located
within the
cavity is operatively coupled to each output system of the electrosurgical
system to
control outputs generated by each output system. The gas canister holder and
control
system is located within the cavity of the housing for receiving a gas
canister within the
cavity of the housing.
Embodiments of the present invention provide a compact argon plasma capable
electrosurgical apparatus for electrosurgery, which is ideal for flexible
endoscopy. The
compact electrosurgical apparatus contains a processor, a foot pedal system,
an
electrosurgical system, a lavage pump system, and a high frequency generator;
wherein
the processor is operably linked to and controls the electrosurgical system,
the lavage
pump system, and the generator; wherein the electrosurgical system includes a
bipolar
output system, a monopolar output system, and an argon plasma coagulation
(APC)
output system; and wherein the processor receives signals from the foot pedal
system.
In certain embodiments, the apparatus contains an electrosurgical system,
which
includes ; a high frequency generator ; an adjustable bipolar output system
including a
bipolar mode selector, a bipolar probe socket, and a bipolar wattage
indicator; an
adjustable monopolar output system including a monopolar mode selector, a
monopolar
active cord/probe socket, monopolar selectable waveform indicator, a monopolar
wattage
4

CA 02630955 2015-03-09
indicator; an argon plasma coagulation (APC) system including an APC wattage
indicator;
APC probe socket, an argon gas source connector, argon gas purge control, an
argon gas
flow rate adjuster, an argon gas flow rate indicator, an APC mode selector,
and an argon
gas canister volume indicator; a ground pad (neutral electrode) contact
quality monitor,
contact quality monitor ground pad socket, a lavage pump system, with a
variable speed
control, and a control for priming, a processor, a mode indicator, which
indicates whether
monopolar mode, bipolar mode or APC mode has been selected; a digital display
area; and
optionally, one or more pull out guides.
In one aspect, the present invention provides a compact and portable
electrosurgical apparatus comprising: a unitary and enclosed housing that
defines a cavity,
said housing having an exterior; a high frequency alternating current
electrosurgical
system located within the cavity, the electrosurgical system comprising: a
high frequency
monopolar output system, a high frequency bipolar output system, and an argon
plasma
coagulation output system; a processor located within the cavity, the
processor operatively
coupled to each of the output systems of the high frequency electrosurgical
system to
control outputs generated by each output system; a high frequency generator
located
within the cavity and operatively coupled to the processor; a gas canister
holder
comprising guide walls for guiding a gas canister of compressed gas into place
when said
gas canister is being loaded into the cavity, and for holding said loaded gas
canister, said
guide walls adapted to encapsulate said loaded gas canister, said holder
adapted to receive
a gas canister through a port in the housing; a gas canister control system,
said gas canister
control system comprising: a pressure regulator operatively coupled to the
processor,
a gas volume sensor operatively coupled to the processor, and a gas flow
conduit
operatively coupled to the exterior of the housing and to the pressure
regulator,
5

CA 02630955 2015-03-09
wherein the gas canister holder and the gas canister control system are
located within the
cavity, and wherein in use, the gas canister is held by the gas canister
holder within the
housing; and an electrosurgical system mode selector located on the exterior
of the
housing, and visible to a user in use, said electrosurgical system mode
selector operatively
coupled to each of the bipolar output system, the monopolar output system, and
the argon
plasma coagulation output system, wherein the electrosurgical system mode
selector
allows a user to select any one of output systems; wherein all connectors
among one or
more of the high frequency alternating current system, the processor, the
generator, the gas
canister holder, and the gas canister control system are located within the
cavity.
Embodiments of the present invention provide a compact electrosurgical
apparatus
including a generator and a processor, both of which are operably linked to an

electrosurgical mode system. The electrosurgical mode system includes a
bipolar output
system, a monopolar output system, and an argon plasma coagulation (APC)
system. The
bipolar output system is activated by a bipolar mode selector, wherein the
bipolar mode
selector allows power to flow from the generator to a bipolar probe socket,
wherein the
processor controls the flow of power from the generator to the bipolar probe
socket, and
wherein a bipolar wattage indicator operably linked to the bipolar mode
selector displays
the amount of power flowing from the generator to the bipolar probe socket.
The monopolar output system is activated by a monopolar mode selector, wherein
the monopolar mode selector allows power to flow from the generator to a
monopolar
probe socket in a desired waveform, wherein the processor controls the flow of
power
from the generator to the monopolar probe socket and controls the wave form by
means of
a selectable waveform indicator, and wherein a monopolar wattage indicator
operably
5a

CA 02630955 2012-01-05
linked to the monopolar mode selector displays the amount of power flowing
from the
generator to the monopolar probe socket.
The argon plasma coagulation (APC) output system activated by an APC mode
selector, wherein the APC mode selector allows power to flow from the
generator to an
APC probe socket, wherein the processor controls the flow of power from the
generator
to the APC probe socket, and wherein an APC wattage indicator operably linked
to the
APC mode selector displays the amount of power flowing from the generator to
the APC
probe socket, and wherein the processor controls the flow of argon and
indicates a
selected flow rate by means of an APC gas flow rate indicator. An argon gas
canister is
attached to the APC system by means of an argon gas source connector. The APC
system also includes an APC gas flow rate adjuster so that the volume of gas
can be
modified, an APC flow rate indicator that gives a visual cue regarding the gas
flow rate, a
purge control that allows the operator to purge air or gas in the system, and
an argon gas
volume indicator that allows the operator to know how much argon is remaining
in the
canister.
In certain embodiments, the present invention provides a compact
electrosurgical
apparatus operated by a wireless foot pedal system. The apparatus contains a
foot pedal
system including a means for transmitting signals, and an electrosurgical
system
including processor and a means for receiving signals from the foot pedal
system.
Other features and advantages of the invention will be apparent from the
following detailed description, and from the claims. Unless otherwise defined,
all
technical and scientific terms used herein have the meaning commonly
understood by one
of ordinary skill in the art to which this invention belongs.
6

CA 02630955 2012-01-05
In case of conflict, the present specification, including definitions, will
control.
The disclosed materials, methods, and examples are illustrative only and not
intended to
be limiting. Skilled artisans will appreciate that methods and materials
similar or
equivalent to those described herein can be used to practice the invention.
BRIEF DESCRIPTION OF THE FIGURES
Figure 1 is a perspective view of a prior art electrosurgical apparatus.
Figure 2 depicts one embodiment of the electrosurgical apparatus of the
present
invention.
Figure 3 is a front view of one embodiment of the present apparatus.
Figure 4 is a top view of one embodiment of the foot pedal system.
Figure 5 is a flow chart indicating the interaction of the processor with the
bipolar
output system, the monopolar output system, the argon plasma coagulation (APC)
output
system, the foot pedal system, the lavage pump system and the gas canister
control
system.
Figure 6 depicts one embodiment of the apparatus of the present invention.
Figure 7 depicts one embodiment of the apparatus of the present invention.
Figure 8 depicts another embodiment of the apparatus of the present invention.
Figure 9 depicts a front view of an embodiment of a compact electrosurgical
apparatus according to the invention.
Figure 10 illustrates a cross-sectional view of the gas canister holder and
control
system located within the housing shown in Figure 9.
7

CA 02630955 2008-05-08
DETAILED DESCRIPTION
Monopolar and Bipolar Circuits
Since electricity requires a complete circuit in order for current to flow,
electrosurgical accessories are designed to be either monopolar or bipolar.
With a monopolar accessory, the circuit is completed via a grounding pad. In
essence, all of the electrons flow out of the accessory (the active
electrode), through the
patient, and return to the generator through the grounding pad. In monopolar
procedures,
correct placement of the grounding pad is important to ensure the best
dispersive effect of
the energy as it exits the patient.
Bipolar instruments have both the active and return electrodes built into the
tip
and are thus capable of completing the circuit through the probe without the
use of a
separate return electrode (grounding pad). The current flows out from the
positive pole
of the accessory, travels only through a bit of tissue, and is returned by the
opposite
electrode within the same probe to the generator.
Current Density
Current density is the defining variable in determining specific tissue
effects in
electrosurgery, yet it is the sum of the effects of several variables.
Current density is the measure of current concentration or, by definition, the

current per unit area. The rate of heat generation, and therefore the
resulting therapeutic
effect, is a function of the current density. It is a measure of intensity.
Mathematically,
8

CA 02630955 2008-05-08
the temperature rises as a square of the current density. Current that will
boil water on a
square millimeter area will not even feel warm on a square centimeter area.
The dramatic
difference in surface area between the active electrode and the grounding pad
is perhaps
the best-understood example of this principle. Current density depends on the
applied
voltage, current, and type of waveform, as well as the tissue impedance, the
size of the
electrode and the time that current is flowing.
The effect at the cellular level of the heating caused by sufficiently dense
high
frequency current varies. The application of high frequency energy intensely
to a precise
area rapidly heats the tissue to 100 C, causes intracellular water to turn to
steam, and
causes the cell membrane to explode. This exploding path along an electrode,
such as a
wire, is what is referred to as "electrosurgical cutting." In biological
tissue, voltage peaks
must be greater than 200Vp, and fairly sustained, in order to create current
intensity
sufficient to create this effect. With less total power applied, or for cells
located farther
from the electrode, the intracellular water is heated more slowly. At
temperatures
between 80 C and 100 C the water vapor escapes from the cell without bursting
the
membrane, leaving the cell dry and shrunken with proteins denatured.
Electrosurgical
coagulation has been the result. The ratio of the total number of cells 'cut'
to those
'coagulated' will determine the overall tissue effect.
Of the variables that impact tissue effect, the one that is the most
influenced by
electrosurgery generator design is that of the high frequency waveform, or
output mode.
A continuous high frequency waveform with a peak voltage of at least 200
(200Vp)
produces an intensity of current sufficient to create micro electric sparks
between the
active electrode and the target tissue. Such high current density along the
leading edge of
9

CA 02630955 2008-05-08
the electrode causes cells to literally explode, separating the tissue as if
it were cut. As
this cell vaporization continues, a micro steam layer is formed which helps to
propagate
the cutting effect.
Along the edges of the 'cut' there will always be a margin of cells whose
distance
from the active electrode allows them to heat more slowly. These cells simply
coagulate.
The depth of this coagulated margin is directly related to the height of the
peak voltage in
the cutting waveform, and the thickness of the electrode. Higher voltages
leave a thicker
margin of coagulation, and a thin wire leaves less coagulation than a flat
blade.
Even with a continuous waveform, if the voltage never goes above 200Vp, no
cutting can occur. Such outputs lack the intensity to initiate the initial
sparking necessary
to produce the cutting effect. Instead, a superficial coagulation results. To
produce a
deeper tissue effect with a lesser degree of electrosurgical cutting and an
increasingly
greater proportion of coagulated cells, the continuous waveform is interrupted
or
modulated. Interrupting the waveform delivers energy more slowly, even at the
equivalent power settings. To increase the depth of the coagulation the
voltage spikes are
increased. This is necessary because along the coagulating margins of the
electrode path,
the impedance is rising as the tissue is coagulated. The thin desiccated layer
of
coagulation produced by low voltage continuous waveforms do not limit the
penetration
of these high voltage spikes which force the current through the desiccated
layer,
increasing the depth of the coagulation. Varying the degree of modulation and
the
voltage peaks allows the designers of electrosurgical generators to create
output modes
that hope to predict a predominate tissue effect.

CA 02630955 2008-05-08
The next two variables that can be moderated to change tissue effect are the
power setting and the time the current flows. They are intimately related
since energy per
unit of time is power measured in watts, and time multiplied by power equals
total joules
of heat produced. Time has the distinction of being the only electrosurgical
variable that
is completely controlled by the operator.
The final temperature (T) of the target tissue is defined by the equation:
AT=J2pt/CD, where t= time of current flow and CD is tissue density and its
specific heat.
Given the same amount of tissue, the same temperature can be achieved by
selecting a
high power and a short time or a lower power with a longer time. In either
case, the same
total amount of energy may be delivered but the electrosurgical effect can be
radically
different. Imagine the difference in clinical effect between using a snare to
deliver power
set at 50 watts for 2 seconds, or 20 watts for 5 seconds. The total joules of
energy would
be equal (100 joules) but the tissue effect would not. Another observation is
that less
tissue destruction occurs if the same total energy is delivered in short
bursts rather than
continuously. The pauses give the underlying tissue a chance to dissipate the
heat.
The heat equation above can be related to the change in tissue effect with a
change in waveform by the equation:
V x C = P, where V= voltage, C = current, and P = power in watts.
If both the time and the power setting are kept constant, either a continuous
(cut)
or modulated (coag) waveform will deliver the same total energy. The tissue
effect
however, will change from one with little hemostasis and copious cutting to
one with
deep hemostasis and little electrosurgical cutting.
11

CA 02630955 2008-05-08
The physical law that relates all of the electrosurgical variables has been
elegantly
summarized by Ohm in the equation P=I2R. The P=V x C derivation of this
equation has
already been discussed in relating the type of waveform to total power. Ohm's
Law
defines another principle crucial to a clinical understanding of
electrosurgery: as
impedance in tissue rises, power (either current or voltage) decreases. The
narrow power
curve, ideal for bipolar probes is an excellent example of this fundamental
principal.
The narrow power curve works well to produce superficial coagulation with
either
a monopolar or a bipolar contact electrode. It is not ideal for procedures
such as snare
polypectomy, where maintaining adequate power to sustain at least some
electrosurgical
cutting along with deeper coagulation is needed. In order to keep power
constant in the
face of rising impedance, either voltage or current must be increased.
Argon Plasma Coagulation
Most materials are insulators in that the electrons are so tightly bound in
the
individual atoms that they do not permit a flow of electron charge. However,
if an
electric field acting on the material is high enough, the most loosely bound
electrons are
torn from their atoms allowing current flow. This process is called
ionization. Different
materials ionize more or less easily. Argon gas is one material that becomes
conductive
(ionized) quite easily. In its ionized state it is called, like all ionized
gases, a "plasma."
The first clinical applications of ionization were developed for use in open
surgery procedures. Argon proved ideal not only because it is ionized at
relatively low
voltages, but it also forms a stable plasma phase, is chemically inert and
inexpensive.
The basic mechanism of argon plasma coagulation (APC) is the conduction of
high frequency thermal energy to target tissue via the now fluid electrons in
the plasma
12

CA 02630955 2008-05-08
arc. Indications for its use are producing coagulation for hemostasis or
tissue
devitalization. APC has many desirable characteristics that differentiate it
from classic
contact desiccation. These include a non-contact route that adds speed and
convenience
especially when treating large or diffuse lesions. The arc is not
unidirectional but instead
follows the electric field to tissue seeking to complete the monopolar
circuit. APC
produces a fairly superficial eschar that is thinner, more flexible, and
adherent than those
produced with conventional means. The eschar is therefore less likely to re-
bleed.
An APC system will include a gas source with control and a specialized
electrosurgery generator to provide the voltage source. The actual ionization
of the argon
takes place when a slightly recessed electrode at the distal tip of the probe
accessory
activates gas flowing through the flexible probe lumen. The physician has
control of the
distance the probe tip is held from the tissue, the flow rate of the gas, the
power setting on
the generator, and the time of application.
The length of the plasma arc between the probe tip and tissue is directly
related to
the power setting and the resistance of the target tissue, and to a lesser
extent, the flow
rate of argon. While the design and advantages of APC systems are to provide a
non-
contact modality, the arc distance in vivo is usually only about 2 to 5 mm. It
is clearly
unsafe to embed the probe tip into the tissue while it is being activated.
Only the gas that
has been ionized conveys the thermal effect to tissue. Excess argon outside
the ionized
arc zone has no thermal effect. Since higher flow rates of gas add little to
the tissue
effect, but more to patient discomfort due to extra distension, flow rates are
commonly
set at less than 2.0 L/m.
13

CA 02630955 2008-05-08
Overall, power settings between 20 and 90 are most commonly reported. In
general, watts of 20 to 60 are used to produce hemostasis of superficial
vascular lesions,
and watts of 40 to 90 for tissue ablation. Power setting averages differ with
APC
generator models. As in all electrosurgery, time of application emerges as a
critical
physician controlled variable.
In summary, physicians control the electrosurgical effect through their choice
of
electrode, power setting, output mode and application time. The tissue
surrounding the
active electrode is heated to a depth dependent upon the current density and
the time
current is allowed to flow.
Desiccation/Broad Hemostasis: Desiccation or broad hemostasis results from
direct contact application of the active electrode with the target tissue.
This is
accomplished with either mono or bipolar circuit. It is most effectively
achieved with
broad electrodes, such as biopsy forceps, bipolar probes, or ball tip
electrodes. The
operator will use the lowest possible power and voltage settings so as to
minimize
unwanted sticking and sparking. The time of application will greatly affect
depth of
tissue injury. Rapid, broad non-contact hemostasis is achieved with argon
plasma
coagulation.
Fulguration: Fulguration is the non-contact application of a high voltage
current
without the assist of argon. The distinction between a "coag" waveform that
produces
desiccation and one that produces fulguration is a matter of the height of the
voltage
peaks and whether or not the electrode is in direct contact with tissue. High
voltages are
required to induce current to arc through highly resistant, plain air. Because
of
14

CA 02630955 2008-05-08
unpredictable direction and depth of penetration caused by these intense, high
voltage
sparks, true non-contact fulguration is rarely used in flexible endoscopy.
Coaption: Coaption is the concept of applying both pressure and current to
seal a
vessel. Coaption is most easily achieved with a bipolar probe and low voltage
bipolar
output, or a ball tip electrode with the lowest available voltage monopolar
setting.
Ablation: Ablation is used to destroy and eliminate surface tissue. It is most

effective with a broad contact electrode with a "blended" or "coag" output
with a duty
cycle of at least 6% to allow for some cutting and marked hemostasis. Argon
plasma
coagulation may also be used to effectively ablate tissue.
Cutting: For a cutting effect with minimal hemostasis, the thinnest wire
electrodes are chosen with the lowest voltage cut waveform. "Cut" waveforms
with
increasing voltage will increase the depth of the margin of hemostasis.
Selecting a
broader wire or moving the wire more slowly will also increase hemostasis, as
will
choosing a waveform with some modulation. Modulated waveforms with duty cycles
between 50 and 100% are common for cutting with hemostasis (coagulation).
Coagulation increases as the duty cycle decreases.
Instrument Components
The embodiments of the invention house in one compact unit an electrosurgery
generator (which can be used in either monopolar, bipolar or APC mode), an
argon
plasma coagulation (APC) unit with argon gas provided by a novel, compact
disposable
canister, and, optionally, a variable speed lavage pump designed to use
disposable tubing

CA 02630955 2008-05-08
products. In one embodiment the lavage pump system is a standalone unit that
may be
non-permanently coupled to the apparatus via a communicating plug in device.
The
electrosurgery apparatus incorporates abundant features for safety and
convenience
including a stand-by mode, handy active cord manager, and, in some
embodiments, a
wireless remote footpedal operation (a footpedal connection cable is also
provided for
optional use). The apparatus is operated by a compact foot pedal with stand-by

engage/disengage switch, for power and water activation pedals. It is
important that the
present apparatus is a small, compact unit that can easily fit onto a flexible
endoscope
cart or on small carts/shelves currently used in the medical profession. The
compact
electrosurgical apparatus of the embodiments of the present invention can be
used in a
wide variety of medical applications including, without limitation,
gastroenterology,
bronchoscopy, gynecology, urology, and cardiology.
The compact electrosurgical apparatus of the present invention is less than
about
inches tall, about 12 to 20 inches wide, and about 12 to 20 inches deep. In
one
15 embodiment, it is about 11 inches tall, about 16 inches wide and about
16 inches deep.
Also, because the embodiments of the compact electrosurgical apparatus of the
present
invention use a novel gas container that is housed within the unit itself and
that is much
smaller than those currently used, the weight of the apparatus in combination
with the gas
canister can be as much as 100 pounds lighter, and thus much more readily
moved by
medical personnel.
A. Bipolar Output System
The present apparatus includes a bipolar output system, which includes a
bipolar
mode selector, a bipolar probe socket, and a bipolar wattage indicator. In
certain
16

CA 02630955 2008-05-08
embodiments, the bipolar mode indicator can be pre-set to a default start
point setting.
The bipolar output range is from about 2 to 50 watts adjustable in 1 watt
increments. In
certain embodiments, the apparatus accepts any standard gastroenterology
bipolar
endostasis probe. The bipolar probe is plugged into the bipolar probe socket.
Bipolar
probes include a flexible tube enclosing a positive pole and a negative pole,
and a fluid
connection, such as a lumen for washing when attached to water output from the

integrated lavage pump. In certain embodiments, the bipolar wattage indicator
is a
gauge, a digital screen, or other visual indicator.
In certain embodiments, the bipolar output is a constant less than 200 volt
peak
(e.g., 190 volt peak) 100% duty cycle wave with a power/impedance curve that
conforms
to "Tucker's ideal output" for use with bipolar endoscopic hemostasis probes.
The unit is
compatible with any manufacturer of these probes. When used with an output
with this
ideal power/impedance curve, bipolar endostasis probes produce high current
and power
at low impedances (frank blood) with power and current quickly diminishing as
tissue is
coagulated and the impedance approaches about 100 to 500 ohms. This output
power
curve enhances the self limiting effect inherent to the performance of the
probe.
B. Monopolar Output System
In certain embodiments, the apparatus includes an adjustable monopolar output
system. The monopolar output system includes a monopolar mode selector, a
monopolar
active cord/probe socket, a set of waveform selection indicators each with the
ability to
be pre-set at chosen start point default watt settings, and a monopolar
wattage indicator.
17

CA 02630955 2008-05-08
The apparatus may further include a monopolar probe operably linked to the
apparatus by
means of the monopolar active cord/probe socket, wherein the monopolar probe
is a snare
accessory, a knife accessory, a monopolar ball tip fulgerator, hot biopsy
forceps, or other
device designed for therapeutic use.. In certain embodiments, the monopolar
wattage
indicator is a gauge, a digital screen, or other visual indicator. In certain
embodiments,
the waveform indicator includes a series of buttons, a rotatable dial, a
movable lever, a
touch-sensitive computer screen, or any other mechanism that allows for
alternative
waveform selection.
In certain embodiments "soft coag" is a 100% duty cycle, 190 Vp constant
voltage
waveform with a narrow power/impedance curve which will typically produce self
limited gentle tissue electrocoagulation with no ability to produce
electrosurgical cutting.
"Coag" is a modulated 6% duty cycle, moderately high crest factor waveform,
designed
to produce some electrosurgical cutting when concentrated along a thin
electrode, such as
a polypectomy snare wire, with concurrent production of significant
coagulation. In
certain embodiments "coag blend" is a modulated 18% duty cycle, waveform with
crest
factor below the "coag" mode intended to produce significant coagulation but
with
increased cutting. In certain embodiments "blend cut" is a modulated 50% duty
cycle
waveform designed to produce a balance of cells cut and coagulated in most
tissue types.
In certain embodiments "pulse cut" is a continuous 100% duty cycle 1.4 crest
factor wave
form with peak voltage constant at less than 500 Vp designed to produce nearly
all
cutting effects and interrupted at intervals of about every 600- to 700
milliseconds to
provide controlled incremental cutting. In certain embodiments "cut" is a
continuous
18

CA 02630955 2008-05-08
100% duty cycle 1.4 crest factor wave form with peak voltage constant at less
than 500
Vp designed to produce nearly all cutting effects.
In certain embodiments, the selected waveform watt output can be inhibited
with
a stand-by option (0 watts) for additional safety. Pre-set start point watt
selections can be
made from the following ranges all in one watt increments: soft coag (2 to 120
watts,
such as about 60 watts), coag (2 to 120 watts, such as about 25 watts), coag
blend (2 to
200 watts, such as about 25 watts), blend cut (2 to 200 watts, such as about
50 watts),
pulse cut (2 to 200 watts, such as about 60 watts), and cut (2 to 200 watts,
such as about
60 watts). Wattage can be varied by increasing or decreasing the wattage from
these pre-
set points.
Highly modulated waveforms are typical for snare polypectomy and endoscopic
mucosal resection (EMR), and in certain embodiments, the present apparatus
provides
these types: a 6% duty cycle "Coag", an 18% "Coag Blend" and a 50% "Blend
Cut." In
certain embodiments of sphincterotomy, a 250 maximum watt controlled voltage
100%
duty cycle with an interrupted "pulse cut" mode is offered, as this type of
output is
proving to be the desired output for limiting "zipper cuts", A standard 100%
duty cycle
controlled voltage "cut" mode is included. All modes may be pre-set to default
start point
watts. A 190 constant voltage continuous sine "soft coag" setting may also be
pre-set, for
use used with ball tip fulgerators. A high voltage (> 5000Vp) wave adequate to
produce
consistent ionization for APC may also be pre-set. Default start point
settings are helpful
for users and provide an automatic safety guideline. Wattage can be varied by
increasing
or decreasing the wattage from these pre-set points.
19

CA 02630955 2008-05-08
In certain embodiments, the compact electrosurgical apparatus has contact
quality
monitoring (CQM) for use with any standard split grounding pad for safety
during
monopolar procedures including APC. The unit uses processor control to monitor
tissue
impedance and adjust power output on demand in monopolar contact modes. These
features are accepted in the industry as the highest level of safety and
performance and
yet have not routinely been available in compact electrosurgery units targeted
to specialty
markets. Isolated, balanced output is a minimum safety standard. Split pads
with
Contact Quality Monitoring (CQM) help prevent grounding pad burns. Processor
control
for power on demand helps keep performance smooth and predictable. In certain
embodiments, all monopolar modes the CQM indicator lights are red for split
pads absent
or detecting impedances outside of the assigned ranges and green for pad
impedance in
the acceptable range, and yellow for single pad in use. In certain
embodiments, an
audible alarm sounds if the CQM detects impedances at the grounding pad
outside of
acceptable ranges anytime during the monopolar activation. The CQM indicator
lights
remain unlit when bipolar mode or pump alone modes are chosen. The CQM system
monitors all monopolar functions including APC.
The apparatus has monopolar outputs that have been shown to be safe and
clinically effective for snare polypectomy, snare endoscopic mucosal resection
(EMR),
knife or wire sphincterotomy (with cut or a pulse cut mode), monopolar ball
tip
fulgerators, hot biopsy forceps, and APC probes. Appropriate wattage settings
can
automatically default as start points with each output mode selected. The unit
can also
incorporate a simple programming sequence feature to save end user
preferences.
C. Generator

CA 02630955 2008-05-08
The present apparatus includes a generator, which is a voltage and high
frequency
alternating current source for the apparatus. The generator provides power for
one or
more of the following systems: the bipolar output system, the monopolar output
system,
the APC system, and the lavage pump system. The generator produces alternating
currents in frequency ranges greater than 200,000 Hz (hertz) but less than
600,000 Hz.
In certain embodiments, such as where an APC system is present, the APC system

is activated by the same power pedal as other functions. APC can also be pre-
set at any
start point between the watt range of about 10 to 100 watts.
D. Argon Plasma Coagulation (APC) System
In certain embodiments, the apparatus includes an argon plasma coagulation
(APC) system. The APC system includes an APC mode selector, an APC probe
socket, a
gas source connector, an APC flow rate adjuster, an APC flow rate indicator,
an APC
wattage indicator, and a gas canister volume indicator, and an argon gas purge
control.
The gas volume indicator provides an indication of the level of gas remaining
in the
canister. In certain embodiments, the apparatus also includes a grounding pad
that is
operably linked to the apparatus. In certain embodiments, the apparatus also
includes a
contact quality monitoring (CQM) indicator that indicates whether the
grounding pad is
effectively connected to the apparatus and/or effectively in contact with a
patient. The
CQM may be a visual source (e.g., a light) or audible source (e.g., a
mechanism that
makes an audible sound) or both if the grounding pad is not appropriately
positioned on
the patient, indicating impedance measures in an acceptable range (ranges meet

international standards) or if the grounding pad is not securely connected to
the
apparatus.
21

CA 02630955 2008-05-08
In certain embodiments, the apparatus recognizes any standard single or split
grounding pad, however the full CQM safety system is only engaged with dual or
split
pads. The apparatus constantly monitors the pad surface for adequate contact
area for
safety meeting current standards. In one embodiment, the CQM indicator is a
light
system using the following signals:
¨ Light off for bipolar selection;
¨ Light yellow when a single pad is engaged;
¨ Red light when no pad is engaged and Monopolar or APC modes are selected;
or an out of range impedance is detected with a dual pad and monopolar modes
¨ Green when dual pad is both plugged into the system, registers safe contact
with
a patient, and Monopolar or APC modes are selected.
In certain embodiments, and audible signaling system can be used in addition
to
the visual system. For example,
¨ No sound for bipolar selection;
¨ No sound when a single pad is engaged; but an audible alarm if safe
impedance
ranges are exceeded during operation with a single pad
¨ Steady "beep" when no pad is engaged and Monopolar or APC modes are
selected;
¨ One "beep" when dual pad is both plugged into the system, registers safe
contact with a patient, and Monopolar or APC modes are selected.
¨ Audible safety alarm tones if impedance measures at the pad site indicate an

unsafe range with either split or single pads.
22

CA 02630955 2008-05-08
CQM is a widely recognized safety feature and this signaling system takes into
account customer feedback concerning a desire for a system that is easy to
understand
and subtly alerts that a grounding pad is not needed with bipolar
applications.
In certain embodiments, the gas volume indicator is an indicator that is
activated
when gas decreases to a predetermined volume, such as a gauge that provides a
visual
indication of the remaining volume of gas in the canister; or a system of
indicator lights.
The gas volume indicator may be a visual source or audible source.
In certain embodiments, the apparatus includes a gas canister operably
connected
to the gas source connector. In certain embodiments, the canister is a compact
argon gas
source which is a disposable, compact canister and has a volume of 2 to 10
liters of
compressed 99.9 % pure medical grade argon. A unique advance that enables the
present
apparatus to achieve the market's desire for a truly compact APC system is the
novel use
of a small disposable canister for the argon gas. The canister easily attaches
to the
compact electrosurgical apparatus. In one embodiment, the canister simply
screws into a
specially designed port located within the housing of the apparatus with a
convenient
access door on the compact electrosurgical apparatus. For example, a pierce
top connects
the canister to a pressure regulator permanently housed within the unit. A
pressure
release valve inside the door allows for safe canister changes. The need for a
canister
change may be signaled automatically when a new canister is needed (e.g., by
the gas
volume indicator, such as a warning light on the front panel that will light
when there is
still sufficient gas to complete an average procedure). In certain
embodiments, the
canister is easy to insert and provides enough gas for 2 to 10 average
procedures. A
23

CA 02630955 2008-05-08
compact, disposable argon canister is important to the design of a small unit
to meet this
market need.
In certain embodiments, the APC flow rate adjuster allows a gas flow rate of
between about 0.2 and 3.0 L/min. Current research indicates that the most
desirable flow
rate for GI procedures is about 1.0 L/min. For bronchoscopic applications,
flow rates
between about 0.3 and 0.5 L/min are common. In certain embodiments, the flow
rate
adjuster is a dial, a push key; a digital output mechanism, a lever, or any
other means for
an adjusting the gas flow rate.
The apparatus requires the use of a disposable or reusable APC probe operably
linked to the APC probe socket, wherein in some embodiments the APC probe
consists of
a flexible hollow tube, having a proximal end and distal end, and an ionizing
electrode
positioned at the distal end of the probe tip. In certain embodiments the
present apparatus
can use back flow filtered APC probes or APC probes that require a separate
back flow
filter using standard probe sockets. In certain embodiments the apparatus may
use APC
probes novel and to be uniquely used with the apparatus via a novel APC probe
socket
design. In certain embodiments the system can use novel disposable ball tip
fulgerators
for monopolar non-APC hemostasis and tissue ablation. The system is compatible
with
any manufacturer's snares (EMR or polypectomy) hot biopsy forceps,
sphinctertomes,
and bipolar endostasis probes, as well as those manufacturer's active cords,
which are
various therapeutic accessories required for procedures done in endoscopy. In
certain
embodiments, the active cord is neatly stored when not in use.
E. Lavage Pump System
24

CA 02630955 2008-05-08
In certain embodiments, the apparatus also includes a lavage pump system. The
lavage pump system includes an attachment for tubing with an inlet port, and
outlet port,
a rate control adjuster, and a pump. The rate control adjuster includes a
series of buttons,
a rotatable dial, a movable lever, a touch-sensitive computer screen, or any
other
mechanism that allows for changing the rate of flow through the tubing
attached to the
lavage pump. In certain embodiments, the lavage pump further includes a means
for
preventing back-flow. In certain embodiments there is pump speed limit engaged
when
the bipolar mode is selected. Certain embodiments also include a bottle holder
affixed to
the apparatus to hold the lavage solution (e.g., sterile water) bottle, and/or
a lavage pump
bracket to hold any tubing that runs from the solution bottle to the lavage
pump.
A lavage pump provides the necessary water source for bipolar probes, and
serves
for all lavage functions. Flexible endoscope manufacturers increasingly
incorporate
internal desirable channels for washing. When attached to the generator
apparatus, with
the electronic interface mechanism, the pump on the present apparatus "self
limits" (i.e.,
automatically limits the flow rate) when bipolar is selected, providing added
safety.
Using disposable tubing and standard sterile water bottles reflect current
market best
practice. In certain embodiments, the lavage pump uses standard sterile water
bottles and
a completely disposable tubing system which meets or exceeds all current
guidelines for
lavage pump safety and cleanliness. Variable speeds make it suitable for
multiple lavage
applications.
F. Grounding Pad Socket

CA 02630955 2008-05-08
In certain embodiments, the apparatus includes a grounding pad socket. The
cord
from the grounding pad is inserted into the socket so as to provide a complete
circuit in
monopolar applications. In some embodiments this socket may be a standard
"Valley
Lab" type.
G. Foot Pedal System and Foot Pedal Connector
In certain embodiments, the apparatus further includes a foot pedal system,
wherein the foot pedal system has a water-activating mechanism, a standby
toggle switch,
a power-activating mechanism, and a connecting means, wherein the foot pedal
system is
operably linked to the foot pedal connector by means of the connecting means.
The
connecting means may be an electrical cord or a wireless transmitter. In
certain
embodiments, the foot pedal connector is an outlet, and in other embodiments,
the foot
pedal connector is an antenna or other wireless receiver.
The foot pedal may be compact, but not too small for operator convenience. It
is
electronic, water resistant and provides a near-instant response. It may
incorporate a
toggle switch to activate and deactivate the standby mode. In certain
embodiments an
additional control on the unit's front panel allows the 'stand-by' mode to be
engaged/disengaged by either the foot pedal operator or an assistant using the
hand
control on the unit. In certain embodiments, different colored pedals and
clear labels
indicate either water or power. Other systems with non-
integrated/communicating pumps
require a third, separate pedal for the pump function. Having the standby
toggle switch
allows the physician or operator to control the safety function of the standby
mode.
H. Processor
26

CA 02630955 2008-05-08
The apparatus includes a processor, such as a microprocessor, computer, or
other
means for sending and receiving electrical signals, and for controlling the
electrical
elements and processes of the apparatus. A processor regulates power output
from the
generator based on pre-set or case by case operator-directed levels. The pre-
set can be
adjusted via a programmable sequence and saved. The processor controls one or
more of
the bipolar output system, monopolar output system, the APC system, the lavage
pump
system, the grounding pad socket, the foot pedal system, and the generator, as
indicated
in Figure 5. In certain embodiments the processor provides power-up function
self-
testing, monitors changes in tissue impedance with all contact accessories to
regulate
power outputs as defined by the power/impedance performance curves, and
monitors all
safety functions. In certain embodiments, the processor may also include an
antenna to
transmit and/or receive signals from the foot pedal system.
I. Mode Indicator System
In certain embodiments, the apparatus includes a mode indicator system, which
indicates whether monopolar mode, bipolar mode or APC mode has been selected.
In
certain embodiments, the mode indicator is a series of buttons, a rotatable
dial, a movable
lever, a touch-sensitive computer screen; digital panel or any other mechanism
that
allows for alternative mode selection.
J. Pull-Out Guides
In certain embodiments, the apparatus includes one or more pull out guides to
indicate suggested monopolar selections or APC settings. In certain
embodiments,
essential, basic settings and use parameters are featured on simple pull out
laminated
cards attached to the underside of the unit. This feature incorporates a
"tried and true"
27

CA 02630955 2008-05-08
technology that customers appreciate and that can be considered important for
safety.
These guides are handy for physicians and nurses to refer to, in order to
remind them of
approved settings and use parameters. Laminated pull out tabs keep this
information
handy for quick review, but out of the way and not in patient view. Rarely
would the
staff have time to enter complicated computer screens to instantly pull up and
review this
basic information.
K. Exemplary Embodiments
The following is a description of an exemplary embodiment of the compact
electrosurgical apparatus of the present invention.
Figure 2 depicts one embodiment of the electrosurgical apparatus of the
present
invention. The apparatus 10 includes an electrosurgical system 20, a lavage
pump system
700, and a generator 30, wherein a processor 180 is operably linked to and
controls the
electrosurgical system 20, the lavage pump system 700, the generator 30 and
the gas
canister control system 1000, wherein the electrosurgical system includes a
bipolar output
system 200, a monopolar output system 100, and an argon plasma coagulation
(APC)
output system 300, and wherein the processor 180 may receive signals from a
foot pedal
system 900 by means of an antenna 181 or cable.
Figure 3 is a front view of one embodiment of the present apparatus 10. The
apparatus 10 includes an electrosurgical system 20 a lavage pump system 700, a
generator 30 and a gas canister control system (not shown) located in the
apparatus,
wherein a processor 180 is operably linked to and controls the electrosurgical
system 20,
the lavage pump system 700, the generator 30 and the gas canister control
system
wherein the electrosurgical system includes a bipolar output system 300, a
monopolar
28

CA 02630955 2008-05-08
output system 100, and an argon plasma coagulation (APC) output system 200,
and
wherein the processor 180 receives signals from a foot pedal system 900 by
means of an
antenna 181or a cable. The apparatus 10 includes a mode indicator system that
includes
three indicators: a Monopolar mode selector 101, an APC mode selector 201, and
a
Bipolar mode selector 301.
This embodiment of the compact electrosurgical apparatus 10 includes a
Monopolar output system 100. The Monopolar output system 100 includes a
Monopolar
mode selector 101, which indicates that the operator has selected to use a
Monopolar
application. The indicator activates a Monopolar mode indicator light 102 to
give a
visual cue that this mode has been selected. The Monopolar output system 100
also
includes a Monopolar wattage indicator 103 (depicted as a digital screen) that
shows the
level of wattage output. The operator can raise the wattage level by pressing
the
Monopolar wattage increase adjuster 104, or lower the wattage level by
pressing the
Monopolar wattage decrease adjuster 105. In other embodiments, the wattage
adjuster
can be a dial or other means for varying the wattage output. The apparatus
also provides
a Monopolar active cord/probe socket 106 into which the operator can insert an
active
cord to a desired accessory. The present embodiment also provides a Monopolar
selectable waveform indicator 109, which is shown in Fig. 1 as set of
alternative
selectable pre-set waveform indicators, which include the following: Monopolar
"soft
coag" pre-set waveform indicator 110, Monopolar "coag" pre-set waveform
indicator
120, Monopolar "coag blend" pre-set waveform indicator 130, Monopolar "blend"
pre-set
waveform indicator 140, Monopolar "pulse cut" pre-set waveform indicator 150,
Monopolar "cut" pre-set waveform indicator 160, and Monopolar "standby" pre-
set
29

CA 02630955 2008-05-08
waveform indicator 170. The apparatus shows which pre-set indicator was
selected by
activation of the appropriate indicator light: Monopolar "soft coag" pre-set
waveform
indicator light 111, Monopolar "coag" pre-set waveform indicator light 121,
Monopolar
"coag blend" pre-set waveform indicator light 131, Monopolar "blend" pre-set
waveform
indicator light 141, Monopolar "pulse cut" pre-set waveform indicator light
151,
Monopolar "cut" pre-set waveform indicator light 161, and Monopolar "standby"
pre-set
waveform indicator light 171.
This embodiment of the compact electrosurgical apparatus 10 includes an APC
output system 200. The APC output system 200 includes an APC mode selector
201,
which indicates that the operator has selected to use an APC application. The
indicator
activates an APC mode indicator light 202 to give a visual cue that this mode
has been
selected. The APC output system 200 also includes an APC wattage indicator 210

(depicted as a digital screen) that shows the level of wattage output. The
operator can
raise the wattage level by pressing the APC wattage increase adjuster 211, or
lower the
wattage level by pressing the APC wattage decrease adjuster 212. In other
embodiments,
the wattage adjuster can be a dial or other means for varying the wattage
output. The
apparatus also provides an APC probe socket 220 into which the operator can
insert a
desired accessory. The APC output system 200 also includes an APC gas flow
rate
indicator 230 (depicted as a digital screen) that shows the level of gas flow.
The operator
can raise the gas flow level by pressing the APC gas flow increase adjuster
231, or lower
the gas flow level by pressing the APC gas flow decrease adjuster 232. In
other
embodiments, the gas flow adjuster can be a dial or other means for varying
the gas flow
output. The apparatus also provides an APC gas volume indicator 240, which
activates

CA 02630955 2008-05-08
when the volume of remaining gas is low. The apparatus also provides a CQM
ground
pad socket 250, into which the ground pad can be connected to the apparatus.
The
apparatus also provides a CQM monitor 260, which is activated according to
indication
system previously mentioned. The apparatus also provides a gas access door 270
which
is used to access a gas canister hold and control assembly located inside the
apparatus.
More particularly, a gas canister, preferably an argon gas canister, is loaded
into the gas
canister hold which couples it to a control assembly as will be described in
further detail
with reference to Figure 10. An argon gas purge control 241 pre-fills an APC
probe with
an automatically measured amount of argon gas prior to activation.
This embodiment of the compact electrosurgical apparatus 10 includes a bipolar
output system 300. The Bipolar output system 300 includes a Bipolar mode
selector 301,
which indicates that the operator has selected to use a Bipolar application.
The indicator
activates a Bipolar mode indicator light 302 to give a visual cue that this
mode has been
selected. The Bipolar output system 300 also includes a Bipolar wattage
indicator 310
(depicted as a digital screen) that shows the level of wattage output. The
operator can
raise the wattage level by pressing the Bipolar wattage increase adjuster 311,
or lower the
wattage level by pressing the Bipolar wattage decrease adjuster 312. In other
embodiments, the wattage adjuster can be a dial or other means for varying the
wattage
output. The apparatus also provides a Bipolar probe socket 320 into which the
operator
can insert a desired accessory.
This embodiment of the compact electrosurgical apparatus 10 includes an
accessory cord storage bracket 600, which can be used to store cords from an
accessory
when not in use.
31

CA 02630955 2008-05-08
This embodiment of the compact electrosurgical apparatus 10 includes a Lavage
pump system 700. The Lavage pump system 700 includes a Lavage pump tubing
acceptor mechanism, as is well known to those of ordinary skill in the art.
The Lavage
pump system 700 also includes a Lavage pump rate control adjuster 710
(depicted as an
adjustable dial). This Lavage pump system 700 also includes a Lavage pump
bracket
720, which can store tubing used with the Lavage pump system 700, and includes
a
Lavage pump bottle holder 730 for holding solution bottles. This embodiment of
the
compact electrosurgical apparatus 10 includes a pullout settings guide 810,
and a pull out
selection guide 800. These guides are used by operators to assist in
determining which
settings to use for various procedures. A lavage pump system that may be used
with the
embodiments of the invention is commercially available from Byrne Medical,
Inc. of
Conroe, Texas.
This embodiment of the compact electrosurgical apparatus 10 includes a Foot
pedal system 900. Figure 4 is a top view of one embodiment of the foot pedal
system
900. The Foot pedal system 900 includes a Foot pedal fluid activator 910, a
Foot pedal
power activator 920, and a Foot pedal standby toggle switch 930. In certain
embodiments, the Foot pedal system 900 may include a Foot pedal antenna or
other
wireless transmitter 940 or Foot pedal connector 970 (i.e., a cord). In
certain
embodiments, the Foot pedal system 900 includes a Foot pedal connector socket
960 into
which a Foot pedal connector 970 can be removably plugged.
Figure 5 is a flow chart indicating the interaction of the processor 180 with
the
bipolar output system 300, the monopolar output system 100, the argon plasma
32

CA 02630955 2008-05-08
coagulation (APC) output system 200, the foot pedal system 900 and the lavage
pump
system 700 and the gas canister control system 1000.
As shown in Figure 6, one embodiment of the present invention is a compact
electrosurgical apparatus 10. The apparatus 10 includes an electrosurgical
system 20,
wherein an antenna 181 operably linked to the processor 180 receives signals
from a foot
pedal system 900 by means of a foot pedal antenna 940. The Foot pedal system
900
includes a foot pedal antenna 940 that transmits signals to the
electrosurgical system 20.
The electrosurgical system 20 receives the signals by means of an antenna 181,
which is
operably linked to the processor 180.
Figure 7 depicts one embodiment of the apparatus of the present invention,
where
the electrosurgical system mode selector is a dial 21. The foot pedal system
is coupled to
the electrosurgical system by means of a foot pedal connector 970 (e.g. an
electrical cord)
or wirelessly and the dial 21 is rotated to set positions for selecting
monopolar mode,
bipolar mode or APC mode. Figure 8 depicts one, where the electrosurgical
system mode
selector is a series of toggle buttons 21. The foot pedal system is connected
to the
electrosurgical system by means of a foot pedal connector 970 (e.g., an
electrical cord) or
wirelessly, and where the electrosurgical system mode selector is a series of
push keys
corresponding to the monopolar mode selector 101, the APC mode selector 201,
and the
Bipolar mode selector 301.
Figure 9 depicts a front view of an embodiment of a compact electrosurgical
apparatus according to the invention. The compact electrosurgical apparatus
includes a
housing 1010 that is generally in the shape of a rectangular box and
preferably measures
about 15 inches (length) by about 10 inches (height) by about 16 inches
(depth). The
33

CA 02630955 2008-05-08
housing includes a front panel 1012, a back panel (not shown) generally
parallel with the
front panel, a top panel 1014 extending between the front and back panel, a
bottom panel
1016 extending between the front and back panel, the bottom panel being
generally
parallel to the top panel, a left side panel 1018 extending between the front,
back, top and
bottom panels and a right side panel 1020 extending between the front, back,
top and
bottom panels, the right side panel being generally parallel to the left side
panel. The
front, back, top, bottom left and right side panels define a cavity within the
housing.
Located within the cavity is an electrosurgical system that includes a
monopolar output
system, a bipolar output system, and an argon plasma coagulation output system
such as
described above. Also located within the cavity is a processor that is
operatively coupled
to each output system of the electrosurgical system to control outputs
generated by each
output system. In addition, a high frequency generator is located within the
cavity and is
operatively coupled to the processor. Finally an argon gas canister holder and
control
system is also located within the cavity of the housing for receiving a gas
canister within
the cavity of the housing and controlling its operation, as will be described
in detail
hereinafter.
It will be understood by those of ordinary skill in the art, that the layout
of the
features on the front panel 1012 of the housing may be changed without
departing from
the scope of the embodiments of the invention. Located along the bottom of the
front
panel 1012 are a plurality of sockets for receiving accessory devices. In
particular, an
argon plasma coagulation probe socket 1022 is provided to receiver an argon
coagulation
probe (not shown) and operatively couple it to the argon plasma coagulation
output
system. A monopolar probe socket 1024 is provided to receive a monopolar probe
(not
34

CA 02630955 2008-05-08
shown) and operatively couple it to the monopolar output system and a bipolar
probe
socket 1026 is provided to receive a bipolar probe (not shown) and operatively
couple it
to the bipolar output system.
The front panel 1012 of the housing displays various parameters. There is a
display screen 1028, preferably an LED that displays various parameters to the
user
depending on the mode the electrosurgical apparatus is operating in.
This embodiment of the compact electrosurgical apparatus includes a Monopolar
output system. The Monopolar output system includes a Monopolar mode selector
1030,
which indicates that the operator has selected to use a Monopolar application.
The
selector activates a Monopolar mode indicator display in the display screen to
give a
visual cue that this mode has been selected. The Monopolar output system also
includes
a Monopolar wattage indicator (displayed on the display 1028) that shows the
level of
wattage output. The operator can raise the wattage level by pressing the
Monopolar
wattage increase adjuster 1032, or lower the wattage level by pressing the
Monopolar
wattage decrease adjuster 1034. In other embodiments, the wattage adjuster can
be a dial
or other means for varying the wattage output. The apparatus also provides a
Monopolar
active cord/probe socket 1024 into which the operator can insert an active
cord to a
desired accessory. The present embodiment also allows a user to select a
particular
monopolar waveform by pressing the monopolar mode selector 1030 a prescribed
number of times. The apparatus shows which pre-set indicator was selected by
activation
of the appropriate indicator light: Monopolar "soft coag" pre-set waveform
indicator
light 1036, Monopolar "coag" pre-set waveform indicator light 1038, Monopolar
"coag
blend" pre-set waveform indicator light 1040, Monopolar "blend CUT" pre-set
waveform

CA 02630955 2008-05-08
indicator light 1042, Monopolar "pulse cut" pre-set waveform indicator light
1044,
Monopolar "cut" pre-set waveform indicator light 1046, and Monopolar "standby"
pre-set
waveform indicator light 1048.
This embodiment of the compact electrosurgical apparatus includes an APC
output system. The APC output system includes an APC mode selector 1050and the
display 1028 provides a visual cue that this mode has been selected. The APC
output
system also includes an APC wattage indicator (displayed on the screen 1028)
that shows
the level of wattage output. The operator can raise the wattage level by
pressing the APC
wattage increase adjuster1032, or lower the wattage level by pressing the APC
wattage
decrease adjuster 1034. In other embodiments, the wattage adjuster can be a
dial or other
means for varying the wattage output. The apparatus also provides an APC probe
socket
1022 into which the operator can insert a desired accessory. The APC output
system also
includes an APC gas flow rate indicator (displayed on the screen) that shows
the level of
gas flow. The operator can raise the gas flow level by pressing the APC gas
flow
increase adjusterl 052, or lower the gas flow level by pressing the APC gas
flow decrease
adjuster 1054. In other embodiments, the gas flow adjuster can be a dial or
other means
for varying the gas flow output. The apparatus also provides an APC gas volume

indicator, which activates when the volume of remaining gas in the canister is
low and
the canister needs to be replaced. The gas volume indicator may be visual or
audible.
The apparatus also provides a CQM ground pad socket, into which the ground pad
can be
connected to the apparatus. The apparatus also provides a CQM monitor 1058,
which is
activated according to indication system previously mentioned and a CQRM
grounding
pad receptacle 1060.
36

CA 02630955 2008-05-08
This embodiment of the compact electrosurgical apparatus includes a bipolar
output system. The bipolar output system includes a bipolar mode selector 1062
and the
display provides a visual cue that this mode has been selected. The bipolar
output system
also includes a bipolar wattage indicator (displayed on the screen 1028) that
shows the
level of wattage output. The operator can raise the wattage level by pressing
the bipolar
wattage increase adjuster 1032, or lower the wattage level by pressing the
bipolar wattage
decrease adjuster 1034. In other embodiments, the wattage adjuster can be a
dial or other
means for varying the wattage output. The apparatus also provides a bipolar
probe socket
1026 into which the operator can insert a desired accessory.
This embodiment of the compact electrosurgical apparatus includes an accessory
cord storage bracket 1064, which can be used to store cords from an accessory
when not
in use.
Also located on the front panel is a gas canister access door 1066 which can
be
accessed by a user to expose a cavity for holding a gas canister located in
the cavity of
the housing. The door 1066 may be any type known to those of ordinary skill in
the art.
For example, it can be opened by a user simply pressing the door in a
particular location.
Located on the front panel next to the gas canister access door is a gas
volume indicator
1056 and a gas flow adjuster in the form of up/down switches 1052, 1054. The
gas
volume indicator 1056 preferably is controlled, as will be explained
hereinafter, to
activate when the gas canister needs replacement. As previously mentioned the
gas
volume indicator may be visual such as a light or it may be audible such as a
beep. In
addition, an output of a gas sensor, as will be described herein after, may
send a signal so
that a display is made on display screen of how much gas is currently in the
gas canister.
37

CA 02630955 2015-03-09
Also shown in FIG. 9 is a lavage system 1070 that is shown coupled to the
housing
of the apparatus. This coupling may be either permanent or temporary. The
lavage system
1070 includes a display screen 1072, flow rate control 1074, and a disposable
pump tubing
cartridge head 1076 as is well known to one of ordinary skill in the art and
need not be
described in further detail. As previously mentioned such lavage systems are
commercially available from Byrne Medical, Inc.
Figure 10 illustrates a cross-sectional view of the gas canister holder 1080
and
control system 1082 located within the housing shown in Figure 9. The front
panel of the
housing is shown at line 1012. Located on the exterior of the front panel of
the housing,
the term exterior meaning outside the cavity of the housing, is the
coagulation probe
socket 1022. Located inside the cavity of the housing are a gas canister
holder 1080 and
control system 1082. The gas canister control system includes a pierce
mechanism 1084, a
pressure regulator 1086, a gas volume sensor 1088 and gas flow conduit 1089.
The
pressure regulator 1086 is operatively coupled to the pierce mechanism 1084
and the
processor 180. The gas volume sensor 1088 is operatively coupled to the
processor 180.
The gas flow conduit 1089 is operatively coupled to the front panel of the
housing and the
pressure regulator 1086. The gas probe socket 1022 located on the front panel
of the
housing is operatively coupled to the gas flow conduit 1089. The pierce
mechanism 1084
may be hollow or solid as is well known. The apparatus also provides a gas
source
connector with seals 1090, which is used to connect the gas (e.g., argon)
canister to the
apparatus, and an argon gas purge control (1092, see Figure 9) that pre-fills
an APC probe
with an automatically measured amount of argon gas prior to activation.
38

CA 02630955 2008-05-08
The gas canister hold 1080 has the pierce mechanism 1084 extending therein and

exposed to couple with a gas canister. The hold includes seals 1094 around the
pierce
mechanism 1084 so that gas does not leak from the canister around the pierce
mechanism and escape from the cavity of the housing. The hold has guide walls
1096 to
smoothly guide a gas canister into place and screw threads 1098 located on the
guide wall
adjacent the pierce mechanism for coupling to the exterior of the gas
canister. Thus, in
use a user simply opens the gas canister door 1066 on the front panel and
screws a gas
canister into place so that the pierce mechanism pierces the seal of the gas
canister and
allows gas to flow into the pressure regulator. The pressure regulator
receives command
signals operatively from the gas flow regulator controls located on the front
panel of the
housing to control the amount of gas that is delivered to an argon coagulation
probe
coupled to socket 1022. A volume sensor outputs a signal to the gas volume
light on the
front panel when the gas canister needs to be replaced. In addition, or
alternatively, the
gas sensor can send a signal to the display screen on the front panel of the
housing
indicating that the gas canister needs to be replaced and/or the current
volume level in the
gas canister.
Various embodiments of the invention have been described. It should be
understood, however, that many variations and modifications may be made to
these
described embodiments while remaining within the scope of the present
invention.
39

Representative Drawing
A single figure which represents the drawing illustrating the invention.
Administrative Status

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Administrative Status

Title Date
Forecasted Issue Date 2015-12-29
(22) Filed 2008-05-08
Examination Requested 2008-05-08
(41) Open to Public Inspection 2009-05-15
(45) Issued 2015-12-29

Abandonment History

There is no abandonment history.

Maintenance Fee

Last Payment of $473.65 was received on 2023-04-28


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Next Payment if small entity fee 2024-05-08 $253.00
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Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Request for Examination $800.00 2008-05-08
Registration of a document - section 124 $100.00 2008-05-08
Application Fee $400.00 2008-05-08
Maintenance Fee - Application - New Act 2 2010-05-10 $100.00 2010-04-30
Maintenance Fee - Application - New Act 3 2011-05-09 $100.00 2011-04-06
Maintenance Fee - Application - New Act 4 2012-05-08 $100.00 2012-04-27
Maintenance Fee - Application - New Act 5 2013-05-08 $200.00 2013-04-09
Maintenance Fee - Application - New Act 6 2014-05-08 $200.00 2014-05-01
Maintenance Fee - Application - New Act 7 2015-05-08 $200.00 2015-04-27
Final Fee $300.00 2015-10-20
Maintenance Fee - Patent - New Act 8 2016-05-09 $200.00 2016-05-02
Maintenance Fee - Patent - New Act 9 2017-05-08 $200.00 2017-04-12
Maintenance Fee - Patent - New Act 10 2018-05-08 $250.00 2018-05-07
Maintenance Fee - Patent - New Act 11 2019-05-08 $250.00 2019-05-03
Maintenance Fee - Patent - New Act 12 2020-05-08 $250.00 2020-04-16
Maintenance Fee - Patent - New Act 13 2021-05-10 $255.00 2021-04-30
Maintenance Fee - Patent - New Act 14 2022-05-09 $254.49 2022-04-29
Maintenance Fee - Patent - New Act 15 2023-05-08 $473.65 2023-04-28
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
GENII, INC.
Past Owners on Record
MORRIS, MARCIA L.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Abstract 2008-05-08 1 4
Description 2008-05-08 39 1,599
Claims 2008-05-08 8 203
Claims 2011-02-23 8 202
Representative Drawing 2009-04-17 1 4
Cover Page 2009-05-08 1 23
Abstract 2011-01-24 1 20
Drawings 2011-01-24 9 99
Claims 2012-01-05 6 205
Description 2012-01-05 39 1,599
Claims 2012-09-21 6 203
Drawings 2012-09-21 9 107
Claims 2013-12-13 6 212
Description 2015-03-09 40 1,641
Drawings 2015-03-09 9 120
Claims 2015-03-09 6 190
Representative Drawing 2015-11-30 1 3
Cover Page 2015-11-30 2 37
Correspondence 2008-06-16 1 14
Assignment 2008-05-08 7 221
Prosecution-Amendment 2011-02-23 9 245
Prosecution-Amendment 2008-11-27 1 24
Fees 2010-04-30 1 201
Prosecution-Amendment 2010-09-07 2 54
Prosecution-Amendment 2011-09-23 2 86
Prosecution-Amendment 2011-01-24 14 248
Prosecution-Amendment 2011-01-31 1 15
Fees 2011-04-06 1 202
Drawings 2008-05-08 9 392
Prosecution-Amendment 2012-01-05 18 698
Prosecution-Amendment 2012-07-11 3 108
Prosecution-Amendment 2013-06-13 7 311
Prosecution-Amendment 2012-09-21 15 556
Fees 2013-04-09 1 163
Prosecution-Amendment 2013-12-13 17 708
Prosecution-Amendment 2014-09-09 9 476
Prosecution-Amendment 2015-03-09 30 1,477
Final Fee 2015-10-20 1 40