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Sommaire du brevet 3120194 

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Disponibilité de l'Abrégé et des Revendications

L'apparition de différences dans le texte et l'image des Revendications et de l'Abrégé dépend du moment auquel le document est publié. Les textes des Revendications et de l'Abrégé sont affichés :

  • lorsque la demande peut être examinée par le public;
  • lorsque le brevet est émis (délivrance).
(12) Demande de brevet: (11) CA 3120194
(54) Titre français: SYSTEME ELECTROCHIRURGICAL
(54) Titre anglais: ELECTROSURGICAL SYSTEM
Statut: Examen
Données bibliographiques
(51) Classification internationale des brevets (CIB):
  • A61B 18/12 (2006.01)
(72) Inventeurs :
  • SIAZON, KEVIN (Etats-Unis d'Amérique)
  • POPE, RYAN (Etats-Unis d'Amérique)
  • RODRIGUEZ, VINCENT (Etats-Unis d'Amérique)
  • AUGUSTUS, DEVON (Etats-Unis d'Amérique)
  • NGUYEN, DUY (Etats-Unis d'Amérique)
  • ELLIOTT, PATRICK (Etats-Unis d'Amérique)
(73) Titulaires :
  • APPLIED MEDICAL RESOURCES CORPORATION
(71) Demandeurs :
  • APPLIED MEDICAL RESOURCES CORPORATION (Etats-Unis d'Amérique)
(74) Agent: BORDEN LADNER GERVAIS LLP
(74) Co-agent:
(45) Délivré:
(86) Date de dépôt PCT: 2018-11-16
(87) Mise à la disponibilité du public: 2020-05-22
Requête d'examen: 2022-09-14
Licence disponible: S.O.
Cédé au domaine public: S.O.
(25) Langue des documents déposés: Anglais

Traité de coopération en matière de brevets (PCT): Oui
(86) Numéro de la demande PCT: PCT/US2018/061646
(87) Numéro de publication internationale PCT: US2018061646
(85) Entrée nationale: 2021-05-14

(30) Données de priorité de la demande: S.O.

Abrégés

Abrégé français

L'invention porte sur un système électrochirurgical comprenant un instrument électrochirurgical bipolaire et un générateur électrochirurgical. L'instrument électrochirurgical bipolaire est conçu afin d'obturer de manière étanche et de couper un tissu capturé entre des mâchoires de l'instrument. Les mâchoires comprennent des électrodes positionnées, mises en forme et/ou orientées de manières particulières afin d'obturer le tissu de manière étanche. Le générateur électrochirurgical est conçu afin de fournir de l'énergie RF à travers l'instrument, de surveiller l'énergie RF fournie et d'ajuster ou de mettre fin à l'énergie RF fournie afin d'obturer le tissu de manière étanche et optimale.


Abrégé anglais

An electrosurgical system is provided and includes a bipolar electrosurgical instrument and an electrosurgical generator. The bipolar electrosurgical instrument is arranged to seal and cut tissue captured between jaws of the instrument. The jaws include particularly positioned, shaped and/or oriented electrodes to perform the sealing of tissue. The electrosurgical generator is arranged to supply RF energy through the instrument, monitor the supplied RF energy and adjust or terminate the supplied RF energy to optimally seal the tissue.

Revendications

Note : Les revendications sont présentées dans la langue officielle dans laquelle elles ont été soumises.


Claims:
1. An electrosurgical system comprising:
an electrosurgical instrument having a handle assembly and jaws connected to
the handle
assembly; and
an electrosurgical generator removably coupled to the electrosurgical
instrument, the
electrosurgical generator configured to supply RF energy to the
electrosurgical instrument
starting at a predefined first voltage and increasing to a predefined second
voltage within a
predetermined first time period.
2. The system of claim 1 wherein the generator is configured to adjust
voltage of the
supplied RF energy to start at a predefined third voltage.
3. The system of claim 1 wherein the generator is configured to adjust
voltage of the
supplied RF energy to start at a predefined third voltage after an expiration
of the predetermined
first time period.
4. The system of claim 1 wherein the generator is configured to adjust
voltage of the
supplied RF energy to start at a predefined third voltage after voltage of the
supplied RF energy
reaches the predefined second voltage.
5. The system of any one of claims 2-4 wherein the generator is configured
to adjust voltage
of the supplied RF energy to increase from the predefined third voltage to a
predefined fourth
voltage within a predetermined second time period.
6. The system of claim 5 wherein the predetermined first time period is
shorter than the
predetermined second time period.
7. The system of claim 5 or 6 wherein the predefined fourth voltage is
greater than the
predefined third voltage.
8. The system of claim 5 or 6 wherein the predefined third voltage is
greater than the
predefined fourth voltage.
- 24 -

9. The system of any one of claims 5-8 wherein the generator is configured
to adjust voltage
of the supplied RF energy to be held constant at a predefined fifth voltage.
10. The system of claim 9 wherein the predefined fourth voltage and the
predefined fifth
voltage are equal.
11. The system of claim 9 wherein the predefined fourth voltage is greater
than the
predefined fifth voltage.
12. The system of claim 9 wherein the generator is configured to hold the
voltage of the
supplied RF energy constant at the predefined fifth voltage for a
predetermined third time period.
13. The system of claim 12 wherein the predetermined third time period is
greater than the
predetermined second time period.
14. The system of claim 13 wherein the predetermined third time period is
greater than the
predetermined first time period.
15. The system of claim 12 wherein the generator is configured to halt the
supplied RF
energy to the electrosurgical instrument upon expiration of the predetermined
third time period.
16. The system of any one of the previous claims wherein the generator is
configured to halt
the supplied RF energy to the electrosurgical instrument when phase of the
supplied RF energy
equals or exceeds a predetermined phase threshold.
17. The system of any one of the previous claims wherein the generator is
configured to halt
the supplied RF energy to the electrosurgical instrument when current of the
supplied RF energy
equals or exceeds a predetermined current threshold.
18. The system of claim 15 wherein the generator is configured to halt the
supplied RF
energy to the electrosurgical instrument when power of the supplied RF energy
equals or exceeds
a predetermined power threshold.
- 25 -

19. The system of claim 1, 16, 17 or 18 wherein the jaws of the
electrosurgical instrument
comprises at least one electrode having a plurality of outcropping.
20. The system of claim 19 wherein the jaws are curved and the
electrosurgical instrument
further comprises a blade movable through the curved jaws between the
outcroppings.
- 26 -

Description

Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.


CA 03120194 2021-05-14
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ELECTROSURGICAL SYSTEM
Background
[0001] The present application relates generally to electrosurgical systems
and methods and
more particularly relates to electrosurgical generators and associated
instruments for sealing and
cutting tissue.
[0002] Electrosurgical devices or instruments have become available that
use electrical
energy to perform certain surgical tasks. Typically, electrosurgical
instruments are surgical
instruments such as graspers, scissors, tweezers, blades, and/or needles that
include one or more
electrodes that are configured to be supplied with electrical energy from an
electrosurgical
generator. The electrical energy can be used to coagulate, fuse, or cut tissue
to which it is
applied.
[0003] Electrosurgical instruments typically fall within two
classifications: monopolar and
bipolar. In monopolar instruments, electrical energy is supplied to one or
more electrodes on the
instrument with high current density while a separate return electrode is
electrically coupled to a
patient and is often designed to minimize current density. Monopolar
electrosurgical instruments
can be useful in certain procedures, but can include a risk of certain types
of patient injuries such
as electrical burns often at least partially attributable to functioning of
the return electrode. In
bipolar electrosurgical instruments, one or more electrodes are electrically
coupled to a source of
electrical energy of a first polarity and one or more other electrodes is
electrically coupled to a
source of electrical energy of a second polarity opposite the first polarity.
Bipolar electrosurgical
instruments, which operate without separate return electrodes, can deliver
electrical signals to a
focused tissue area with reduced risks.
[0004] Even with the relatively focused surgical effects of bipolar
electrosurgical
instruments, however, surgical outcomes are often highly dependent on surgeon
skill. For
example, thermal tissue damage and necrosis can occur in instances where
electrical energy is
delivered for a relatively long duration or where a relatively high-powered
electrical signal is
delivered even for a short duration. The rate at which a tissue will achieve
the desired fusing,
sealing or cutting effect upon the application of electrical energy varies
based on the tissue type
and can also vary based on pressure applied to the tissue by an
electrosurgical device. However,
it can be difficult for a surgeon to assess how quickly a mass of combined
tissue types grasped in
an electrosurgical instrument will be sealed a desirable amount.
- 1 ¨

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Summary
[0005]
In accordance with various embodiments, an electrosurgical instrument is
provided
that is configured to fuse and cut tissue. In various embodiments, the
electrosurgical device or
instrument includes a first jaw and a second jaw opposing the first jaw to
grasp tissue between
the first and second jaws. The first jaw includes an electrode and the second
jaw includes an
electrode. The electrodes of the first and second jaws are arranged to seal
tissue between the first
and second jaws using radio frequency energy.
[0006]
In accordance with various embodiments, an electrosurgical system is provided
and
comprises an electrosurgical instrument having a handle assembly and jaws
connected to the
handle assembly and an electrosurgical generator removably coupled to the
electrosurgical
instrument.
The electrosurgical generator is configured to supply RF energy to the
electrosurgical instrument starting at a predefined first voltage and
increasing to a predefined
second voltage within a predetermined first time period. In various
embodiments, the generator
is configured to adjust voltage of the supplied RF energy to start at a
predefined third voltage
after an expiration of the predetermined first time period and/or after
voltage of the supplied RF
energy reaches the predefined second voltage. In various embodiments, the
generator is
configured to adjust voltage of the supplied RF energy to be held constant at
a predefined voltage
or at the voltage once and/or after the expiration of a predetermined second
time period.
[0007]
In accordance with various embodiments, an electrosurgical system for sealing
tissue
is provided. The system in various embodiments comprises an electrosurgical
generator and an
electrosurgical instrument or device. The generator includes an RF amplifier
and a controller.
The RF amplifier supplies RF energy through a removably coupled
electrosurgical instrument
configured to seal tissue with only RF energy. The controller and/or RF sense
are arranged to
monitor and/or measure the supplied RF energy and/or components thereof. In
various
embodiments, the controller signals the RF amplifier to adjust, e.g.,
increase, hold, decrease
and/or stop, voltage of the supplied RF energy at predetermined points or
conditions of a sealing
cycle. In various embodiments, the controller signals the RF amplifier to halt
the supplied RF
energy or initiate termination of the supplied RF energy from the RF
amplifier.
[0008]
In various embodiments, an electrosurgical generator is provided and comprises
an
RF amplifier configured to supply RF energy to an electrosurgical instrument
in which the
supplied RF energy having a voltage spike. In various embodiments, an
electrosurgical
generator is provided and is configured to supply RF energy to an
electrosurgical instrument
based on a control script provided by the electrosurgical instrument to adjust
voltage of the
- 2 -

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supplied RF energy based on predefined conditions included in the control
script. In various
embodiments, an electrosurgical instrument is provide and configured to house
and provide a
control script to an electrosurgical generator in which the control script is
configured to cause the
electrosurgical generator to adjust voltage of the supplied RF energy based on
predefined
conditions identified in the control script.
[0009] The various features and embodiments provided throughout can be used
alone, or in
combination with other features and/or embodiments other than as expressly
described and
although specific combinations of embodiments and features or aspects of
various embodiments
may not be explicitly described such combinations however are contemplated and
within the
scope of the present inventions. Many of the attendant features of the present
inventions will be
more readily appreciated as the same becomes better understood by reference to
the foregoing
and following description and considered in connection with the accompanying
drawings.
Brief Description of the Drawings
[0010] The present inventions may be better understood taken in connection
with the
accompanying drawings in which the reference numerals designate like parts
throughout the
figures thereof.
[0011] FIG. 1 is a perspective view of an electrosurgical system in
accordance with various
embodiments of the present invention.
[0012] FIGS. 2-3 are perspective views of an electrosurgical instrument in
accordance with
various embodiments of the present invention.
[0013] FIGS. 4-5 are perspective views of a distal end of the
electrosurgical instrument in
accordance with various embodiments of the present invention.
[0014] FIGS. 6-9 are graphical representations of samples of experimental
data for a sealing
process with an electrosurgical system in accordance with various embodiments
of the present
invention.
[0015] FIG. 10 is a flow chart illustrating operations of an
electrosurgical system in
accordance with various embodiments of the present invention.
[0016] FIG. 11 is a schematic block diagram of portions of an
electrosurgical system in
accordance with various embodiments of the present invention.
[0017] FIG. 12 is a flow chart illustrating operations of an
electrosurgical system in
accordance with various embodiments of the present invention.
- 3 -

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Detailed Description
[0018] Generally, an electrosurgical system is provided that includes an
electrosurgical
generator and a removably coupled electrosurgical instrument that are
configured to optimally
seal or fuse tissue. The RF energy is supplied by the electrosurgical
generator that is arranged to
provide the appropriate RF energy to seal the tissue. The generator in
accordance with various
embodiments determines the appropriate RF energy and the appropriate manner to
deliver the RF
energy for the particular connected electrosurgical instrument, the particular
tissue in contact
with the instrument and/or a particular surgical procedure. Operationally, RF
sealing or fusing of
tissue between the jaws is provided to decrease sealing time and/or thermal
spread.
[0019] In accordance with various embodiments, the electrosurgical system
applies RF
energy having a high voltage for a short duration to provide an RF energy
spike. Subsequently,
the electrosurgical system reduces the voltage of the supplied RF energy while
continuing to
apply RF energy. The electrosurgical system also continuously monitors the
supplied RF energy
to detect short or open conditions. The system also determines the shift from
the high voltage
RF energy spike to the reduced voltage RF energy supply and determination of
tissue or vessel
fusion or sealing, thereby ceasing or terminating the supply of RF energy.
[0020] Referring to FIGS. 1-2, an exemplary embodiment of electrosurgical
system is
illustrated including an electrosurgical generator 10 and a removably
connectable electrosurgical
instrument 20. The electrosurgical instrument 20 can be electrically coupled
to the generator via
a cabled connection 30 to a tool or device port 12 on the generator. The
electrosurgical
instrument 20 may include audio, tactile and/or visual indicators to apprise a
user of a particular
predetermined status of the instrument such as a start and/or end of a fusion
or cut operation. In
other embodiments, the electrosurgical instrument 20 can be reusable and/or
connectable to
another electrosurgical generator for another surgical procedure. In some
embodiments, a
manual controller such as a hand or foot switch can be connectable to the
generator and/or
instrument to allow predetermined selective control of the instrument such as
to commence a
fusion or cut operation.
[0021] In accordance with various embodiments, the electrosurgical
generator 10 is
configured to generate radiofrequency (RF) electrosurgical energy and to
receive data or
information from the electrosurgical instrument 20 electrically coupled to the
generator. The
generator 10 in one embodiment outputs RF energy (e.g., 375VA, 150V, 5A at
350kHz) and in
one embodiment is configured to measure current and/or voltage of the RF
energy and/or to
calculate power of the RF energy or a phase angle or difference between RF
output voltage and
- 4 -

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RF output current during activation or supply of RF energy. The generator
regulates voltage,
current and/or power and monitors RF energy output (e.g., voltage, current,
power and/or phase).
In one embodiment, the generator 10 stops RF energy output under predefined
conditions such as
when a device switch is de-asserted (e.g., fuse button released), a time value
is met, and/or active
phase angle, current, voltage or power and/or changes thereto is greater than,
less than or equal
to a stop value, threshold or condition and/or changes thereto.
[0022] The electrosurgical generator 10 comprises at least one advanced
bipolar tool port 12,
a standard bipolar tool port 16, and an electrical power port 14. In other
embodiments,
electrosurgical units can comprise different numbers of ports. For example, in
some
embodiments, an electrosurgical generator can comprise more or fewer than two
advanced
bipolar tool ports, more or fewer than the standard bipolar tool port, and
more or fewer than the
power port. In one embodiment, the electrosurgical generator comprises only
two advanced
bipolar tool ports.
[0023] In accordance with various embodiments, each advanced bipolar tool
port 12 is
configured to be coupled to an electrosurgical instrument having an attached
or integrated
memory module. The standard bipolar tool port 16 is configured to receive a
non-specialized
bipolar electrosurgical tool that differs from the advanced bipolar
electrosurgical instrument
connectable to the advanced bipolar tool port 12. The electrical power port 14
is configured to
receive or be connected to a direct current (DC) accessory device that differs
from the non-
specialized bipolar electrosurgical tool and the advanced electrosurgical
instrument. The
electrical power port 14 is configured to supply direct current voltage. For
example, in some
embodiments, the power port 14 can provide approximately 12 Volts DC. The
power port 14
can be configured to power a surgical accessory, such as a respirator, pump,
light, or another
surgical accessory. Thus, in addition to replacing electrosurgical generator
for standard or non-
specialized bipolar tools, the electrosurgical generator can also replace a
surgical accessory
power supply. In some embodiments, replacing presently-existing generators and
power
supplies with the electrosurgical generator can reduce the amount of storage
space required on
storage racks cards or shelves in the number of mains power cords required in
a surgical
workspace.
[0024] In accordance with various embodiments, the electrosurgical
generator 10 can
comprise a display 15. The display can be configured to indicate the status of
the electrosurgical
system including, among other information, the status of the one or more
electrosurgical
instruments and/or accessories, connectors or connections thereto.
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[0025] The electrosurgical generator in accordance with various embodiments
can comprise
a user interface such as a plurality of buttons 17. The buttons can allow user
interaction with the
electrosurgical generator such as, for example, requesting an increase or
decrease in the electrical
energy supplied to one or more instruments coupled to the electrosurgical
generator. In other
embodiments, the display 15 can be a touch screen display thus integrating
data display and user
interface functionalities. In one embodiment, the electrosurgical tool or
instrument 20 can
further comprise of one or more memory modules. In some embodiments, the
memory
comprises operational data concerning the instrument and/or other instruments.
For example, in
some embodiments, the operational data may include information regarding
electrode
configuration/reconfiguration, the instrument uses, operational time, voltage,
power, phase
and/or current settings, and/or particular operational states, conditions,
scripts, processes or
procedures. In one embodiment, the generator initiates reads and/or writes to
the memory
module.
[0026] In accordance with various embodiments, the generator provides the
capability to
read the phase difference or phase angle between the voltage and current of
the RF energy sent
through the connected electrosurgical instrument while RF energy is active.
While tissue is
being fused, phase readings are used to detect different states during the
fuse or seal and cut
process.
[0027] The generator in accordance with various embodiments does not
monitor or control
current, power or impedance. The generator regulates voltage and can adjust
voltage.
Electrosurgical power delivered is a function of applied voltage, current and
tissue impedance.
The generator through the regulation of voltage can affect the electrosurgical
power being
delivered. However, by increasing or decreasing voltage, delivered
electrosurgical power does
not necessarily increase or decrease. Power reactions are caused by the power
interacting with
the tissue or the state of the tissue without any control by a generator other
than by the generator
supplying power.
[0028] The generator once it starts to deliver electrosurgical power does
so continuously,
e.g., every 150ms, until a fault occurs or a specific parameter is reached. In
one example, the
jaws of the electrosurgical instrument can be opened and thus compression
relieved at any time
before, during and after the application of electrosurgical power. The
generator in one
embodiment also does not pause or wait a particular duration or a
predetermined time delay to
commence termination of the electrosurgical energy.
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[0029] With reference to FIGS. 3-5, in accordance with various embodiments,
a bipolar
electrosurgical instrument 20 is provided. In the illustrated embodiment, the
instrument 20
includes an actuator 24 coupled to an elongate rotatable shaft 26. The
elongate shaft 26 has a
proximal end and a distal end defining a central longitudinal axis
therebetween. At the distal end
of the shaft 26 are jaws 22 and at the proximal end is the actuator. In one
embodiment, the
actuator is a pistol-grip like handle.
[0030] The actuator 24 includes a movable handle 23 and a stationary handle
or housing 28
with the movable handle 23 coupled and movable relative to the stationary
housing. In
accordance with various embodiments, the movable handle 23 is slidably and
pivotally coupled
to the stationary housing. In operation, the movable handle 23 is manipulated
by a user, e.g., a
surgeon to actuate the jaws, for example, selectively opening and closing the
jaws.
[0031] In accordance with various embodiments, the actuator 24 includes a
latch mechanism
to maintain the movable handle 23 in a second position with respect to the
stationary housing 28.
In various embodiments, the movable handle comprises a latch arm which engages
a matching
latch contained within stationary handle for holding the movable handle at a
second or closed
position. The actuator in various embodiments also comprises a wire harness
that includes
insulated individual electrical wires or leads contained within a single
sheath. The wire harness
can exit the stationary housing at a lower surface thereof and form part of
the cabled connection.
The wires within the harness can provide electrical communication between the
instrument and
the electrosurgical generator and/or accessories thereof.
[0032] In various embodiments, a switch is connected to a user manipulated
activation
button 29 and is activated when the activation button is depressed. In one
aspect, once activated,
the switch completes a circuit by electrically coupling at least two leads
together. As such, an
electrical path is then established from an electrosurgical generator to the
actuator to supply RF
energy. In various embodiments, the instrument comprises a translatable
mechanical cutting
blade that can be coupled to a blade actuator such as a blade lever or trigger
25 of the actuator.
The mechanical cutting blade is actuated by the blade trigger 25 to divide the
tissue between the
jaws.
[0033] In one embodiment, the actuator includes a rotation shaft assembly
including a
rotation knob 27 which is disposed on an outer cover tube of the elongate
shaft 26. The rotation
knob allows a surgeon to rotate the shaft of the device while gripping the
actuator 24. In
accordance with various embodiments, the elongate shaft 26 comprises an
actuation tube
coupling the jaws 22 with the actuator.
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[0034] Attached to the distal end of the elongate shaft are jaws 22 that
comprise a first jaw
31 and a second jaw 33. In one embodiment, a jaw pivot pin pivotally couples
the first and
second jaws and allows the first jaw to be movable and pivot relative to the
second jaw. In
various embodiments, one jaw is fixed with respect to the elongate shaft such
that the opposing
jaw pivots with respect to the fixed jaw between an open and a closed
position. In other
embodiments, both jaws can be pivotally coupled to the elongate shaft such
that both jaws can
pivot with respect to each other.
[0035] The first or upper jaw 31 includes an electrode plate or pad.
Similarly, the second or
lower jaw 33 includes an electrode. The electrode of the upper jaw 31 and the
electrode of the
lower jaw 33 are electrically coupled to the electrosurgical generator 10 via
wires and connectors
to supply RF energy to tissue grasped between the electrodes. The electrodes,
as such, are
arranged to have opposing polarity and to transmit RF energy therebetween. The
upper jaw in
various embodiments also includes an upper jaw support with an assembly spacer
positioned
between the upper jaw support and the electrode. The upper jaw also includes
an overmold or is
overmolded. The lower jaw includes a lower jaw support and the electrode. In
the illustrated
embodiment, the electrode is integrated or incorporated in the lower jaw
support and thus the
lower jaw support and the electrode form a monolithic structure and electrical
connection. A
blade channel extends longitudinally along the length of the upper jaw, the
lower jaw or both
through which the blade operationally traverses. Surrounding a portion of the
blade channel are
one or more conductive posts. The conductive posts assist in strengthening the
blade channel
and support the tissue to be cut. The conductive posts also assist in ensuring
the tissue being cut
adjacent or proximate to the blade channel is fused as the conductive posts
also participate in the
transmission of RF energy to the tissue grasped between the jaws. The lower
jaw also includes
an overmold or is overmolded.
[0036] In accordance with various embodiments, the electrodes have a
generally planar
sealing surface arranged to atraumatically contact and compress tissue
captured between the
jaws. The sealing surface in various embodiments include outcroppings (e.g.,
four outcroppings)
uniformly spaced along the length of the jaw with branches disposed between
the outcroppings.
As such, the overall footprint of the sealing surface or area is reduced
thereby increasing current
density applied to the tissue and decreasing the current requirements for the
supply of RF energy
as a whole. Sealing of the tissue is thus enhanced causing high burst pressure
averages in both in
vivo and ex vivo conditions.
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[0037] The electrode sealing surface also provides cutouts or spaces 34, 35
between the
sealing surface and the edges of the jaws and between outcroppings to allow
tissue room to
shrink or move and reduces tissue stress due to the shrinkage or contraction
of the tissue during
the sealing cycle and stress caused by compression of tissue at the edges of
the jaws. Similarly,
the gradual spacing removes current density peaks at the edges of the
electrode.
[0038] In various embodiments, the outcroppings keep the seal width 32
consistent while
leaving room for the conductive posts in which a consistent seal width of the
seal surface limits
the total seal surface area. In various embodiments, the upper jaw includes an
outer seal surface
profile that matches the lower jaw profile preventing non-linear current
transfer through the
tissue. The upper jaw, as such, in various embodiments, includes outcroppings
to match the
outcroppings of the lower jaw. Also, additional area at the outcroppings of
the upper jaw
enhances localized strength of a conductive stop landing surface. Also, the
outcroppings of the
upper jaw provides a landing surface or area 37 for the interaction of the
conductive posts of the
lower jaws that enhances localized strength of the landing area. In various
embodiments, the
outcroppings are conductive and include a sealing or inner surface through
which tissue been the
jaws are compressed and RF energy is supplied to the tissue between the jaws.
[0039] The electrodes of the upper and lower jaws in various embodiments
have a seal
surface in which the width of the seal surface is uniform and follows along
the pattern of the
plurality of outcroppings. As such, the seal surface has elongate portions
with curved portions
spaced between the elongate portions and the width of the seal surface is
uniform, constant or
remains unchanged throughout. The seal surface of the upper and lower jaws are
minimized and
as such has a reduced surface area relative to the overall surface area
capable of be formed for
the given overall dimensions of the jaw.
[0040] In various embodiments, the sealing surface of at least one of the
jaws includes a
blade pocket or cutout that is arranged to collect and/or clear eschar, debris
or coagulated blood.
As such, the blade being locked, misaligned or prevented or restricted in
returning is avoided and
thereby enhancing the return of the blade back to its initial or precut
position. In various
embodiments, one or more blade pockets or cutouts 36, 39 are disposed at a
distal end of the
sealing surface and in various embodiments extend from a distal end of the
blade channel. In
various embodiments, the blade pocket is an enlarged bulbous opening at the
end of the blade
channel being elongate and uniform. As such, the blade pocket eases blade
actuation and
ensures automatic blade retraction when eschar builds up on the seal surface
and in blade
channel of the jaws. The distal blade pocket on both upper and lower jaws in
various
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embodiments provide accumulated eschar to be pushed forward and out of the
blade channel.
The pocket also allows new eschar to push out older eschar build up out of the
jaws to ease
cleaning or more effective cleaning of the instrument.
[0041] In various embodiments, the jaws are curved to increase
visualization and mobility of
the jaws at the targeted surgical site and during the surgical procedure. The
jaws have a
proximal elongate portion that is denoted or aligned with straight lines and a
curved distal
portion denoting or defining a curve that is connected to the straight lines.
In various
embodiments, the proximal most portion of the proximal elongate portion has or
delimits a
diameter that equals or does not exceed a maximum outer diameter of the jaws
or elongate shaft.
The jaws in various embodiments have a maximum outer diameter in which the
proximal most
portion of the jaw and the distal most portion of the jaws remains within the
maximum outer
diameter. The curved distal potion has or delimits a diameter that is smaller
than the maximum
outer diameter and the diameter of the proximal most portion of the proximal
elongate portion.
In various embodiments, the jaw has a deeper inner curve cut-out than the
outer curve and in
various embodiments the tip of the jaws are tapered for blunt dissection. The
jaws include a
blade channel having an proximal elongate channel curving to a distal curved
channel in which
the proximal elongate channel is parallel and offset to the longitudinal axis
of the elongate shaft
of the electrosurgical instrument. As such, visibility and mobility at the
jaws are maintained or
enhanced without increasing jaw dimensions that may further reduce the
surgical working area
or require larger access devices or incisions into the patient's body.
[0042] In some embodiments, electrode geometry of the conductive pads of
the jaw
assembly ensures that the sealing area or surface completely encloses the
distal portion of the
cutting path. In accordance with various embodiments, the dimensions of the
jaw surfaces are
such that it is appropriately proportioned with regards to the optimal
pressure applied to the
tissue between the jaws for the potential force the force mechanism can
create. Its surface area is
also electrically significant with regards to the surface area contacting the
tissue. This proportion
of the surface area and the thickness of the tissue have been optimized with
respect to its
relationship to the electrical relative properties of the tissue.
[0043] In various embodiments, the lower jaw 33 and an associated
conductive pad have an
upper outer surface arranged to be in contact with tissue. The upper surfaces
are angled or
sloped and mirror images of each other with such positioning or orientation
facilitating focused
current densities and securement of tissue. In various embodiments, the lower
jaw is made of
stainless steel and is as rigid as or more rigid than the conductive pad. In
various embodiments,
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the lower jaw comprises rigid insulators made of a non-conductive material and
are as rigid as or
more rigid than the lower jaw or the conductive pad. In various embodiments,
the lower jaw and
the conductive pad are made of the same material.
[0044] In accordance with various embodiments, the RF energy control
process, script or
system to seal or fuse tissue is divided into one or more control sections. In
the illustrated
embodiments, the control process, script or system comprises four sections, a
voltage spike,
voltage reduction and ramp, a ramp termination and an RF end. In various
embodiments, the
control process, script or system comprises one or more sections in various
combinations or
orders thereof. If errors or an unexpected result from a section or between
sections occur, the
process terminates. In various embodiments, such errors comprises a short or
open detection. In
one embodiment, a short detection error is determined by the generator when a
measured phase
angle of the supplied RF energy by the generator equals or exceeds a
predetermined value, e.g.,
sixty degrees. In one embodiment, an open detection error is determined by the
generator when
a measured current of the supplied RF energy equals or exceeds a predetermined
value, e.g., 2 or
4 Amps. Completion of the control process without errors indicates a
successful tissue seal. A
successful tissue seal in accordance with various embodiments is recognized as
the tissue seal
being able to withstand a predetermined range of burst pressures or a specific
threshold pressure.
[0045] In accordance with various embodiments, it has been identified that
tissue seal
formation is dependent on denaturization and cross linkage of the native
collagen present in
vasculature extra cellular matrix which starts at about 60 C. It was also
identified that the
strength of this matrix is highly dependent on desiccation of the seal site
via vaporization of
water present in the sealed tissue. Additionally, at a temperature of at least
80 C, bonds between
the denatured collagen and other living tissues can be created. Furthermore,
it was identified that
collagen degrades in response to duration under elevated temperature rather
than the peak
temperature of exposure. As such, exposing tissue to high temperature
conditions, e.g., 100 C,
for the duration of a relatively short seal cycle does not impact the
structure of the collagen but
allows for vaporization of water. The total time to seal tissue, in accordance
with various
embodiments, is reliant on heating the structure to the high temperature,
e.g., 100 C, to vaporize
water such that the denatured collagen crosslinks and bonds to tissue and to
limit collagen-water
hydrogen bonding. To optimize seal time, it was therefore found to be
desirable to achieve
100 C within the grasped tissue as quickly as possible to begin the
desiccation process.
[0046] As such, in accordance with various embodiments, after RF energy has
been initiated
and/or various device checks are performed, the generator employs through the
supplied RF
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energy a high voltage spike or pulse. In various embodiment, the voltage
potential of the RF
energy applied to the tissue driven as a spike such that a high amount of
power is applied at the
start of the seal cycle in order to maximize energy transfer, and by proxy
tissue temperature.
[0047] In accordance with various embodiments of the electrosurgical
generator and
removable instruments it was identified that while rapid heating is desirable
to vaporize latent
fluid as quickly as possible for seal time optimization, vaporization
happening too quickly can
cause the seal structure to fail as the extra vapor struggles to escape. Such
identification in some
instances may only be observed through burst pressure testing. Once the
voltage spike is
complete, the system reduces the voltage to a predetermined level and slowly
ramps up the
voltage of the supplied RF energy. While the ramp occurs, in various
embodiments, sufficient
power is being applied to the tissue to maintain a temperature sufficient for
desiccation. This
allows for continuous vaporization at a rate that does not cause seal
structural failures and
enhances vessel sealing performance.
[0048] In various embodiments, a high peak voltage provides a seal in a
shorter amount of
time due to higher energy transfer, however it has been shown experimentally
that application of
high voltage levels may cause the sealed tissue to adhere to the active
electrodes. As such, it has
been found that termination of the voltage ramp at a lower peak voltage and
holding that voltage
output constant at the end allows for continued energy application while
reducing the potential
for tissue adherence. Determination of when to terminate this ramp, in
accordance with various
embodiments, is conducted by monitoring the phase and current of the supplied
RF energy. As
the tissue desiccates, the phase will become more capacitive and will draw
less current. By
terminating the ramp at a fixed current value as it falls and when the phase
is capacitive, the
desiccation level of the tissue can be categorized. This variable voltage set
point allows the seal
cycle to adjust the energy application based on electrical and structural
differences in tissues
being sealed.
[0049] In various embodiments, in order to achieve the appropriate
temperature of the tissue
to cause the associated tissue effect, the phase angle, current and/or power
of the applied RF
energy are measured, calculated and/or monitored. FIGS. 6-9 provide a
graphical representation
of an exemplary seal cycle in accordance with various embodiments. As
illustrated, voltage
111a is shown relative to other RF output readings or indicators such as power
111b, impedance
111c, energy 111d, current 111f and phase 111g. Additionally, although shown
in FIGS. 6-9, in
various embodiments, the generator is configured to not measure or calculate
one or more of the
indicators or readings, e.g., temperature, to reduce operational and power
costs and
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consumptions and/or the number of parts of the generator. The additional
information or
readings are generally provided or shown for contextual purposes.
Additionally, in various
embodiments, impedance or temperature readings are not used or measured being
imprecise or
impractical.
[0050] As shown, the voltage of the RF energy 111a is increased to a high
point in the seal
cycle in the initial moments of the seal cycle and for a period relatively
short compared to the
total seal time to generate the voltage spike of RF energy 121, 122. During
this voltage spike or
pulse, energy transfer is maximized, exemplified by the power 111b and current
111f of the
applied RF energy increasing to their highest points in the seal cycle.
Subsequently, the voltage
of the RF energy 111a is reduced 123 and ramped up 124,125, slowly, relative
to the voltage
spike. In various embodiments, the slow voltage ramp by the system seeks to
maintain the tissue
between the jaws close to 100 degrees C and thereby control the boiling rate
of water in the
tissue. In accordance with various embodiments, in order to achieve the
appropriate tissue effect
of sealing the tissue, the phase angle, current and power of the applied RF
energy are monitored.
The phase angle of the applied RF energy crossing zero or becoming negative
and/or the current
being less than 60% the applicable current, e.g., less than 3000mA, indicates
that tissue between
the jaws have become more capacitive and thereby drawing less current as water
boils or
otherwise vaporizes from the tissue being sealed 131, 132. Voltage of the RF
energy is then held
constant 126, 133 to reduce the potential for tissue adherence. At seal
completion 141, e.g.,
within a predetermined time frame or period according to the system, RF energy
supplied by the
system is terminated or RF energy supply halted, disrupted or stopped. In
various embodiments,
the system determines the completion of the seal when the power of the
supplied RF energy fails
below a predetermined power threshold 142, such as 4% of the maximum power or
15 volt-
amperes. In various embodiments, the ramp of RF energy is terminated and after
a predefined
time period according to the system, RF energy supplied by the system is
terminated or RF
energy supply halted, disrupted or stopped.
[0051] In various embodiments, the time period in which the generator
generates the voltage
spike of RF energy is smaller than the overall seal cycle and/or the time
period in which the
generator causes the voltage of the RF energy to be reduced and ramped up
slowly. In various
embodiments, the time period in which the generator holds the voltage of the
RF energy
constant, is smaller than the overall seal cycle and/or greater than the time
period in which the
generator generates the voltage spike of RF energy.
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[0052]
In various embodiments, the system identifies unintended current draw provided
for
example in some tissue bundles that draw the maximum current or power that can
be supplied by
the generator. While the system is under such a current condition, the supply
of RF energy
required to seal the tissue may not be sufficient or be efficiently supplied
by the system. In
various embodiments, to handle such a condition, the system determines if the
current of the RF
energy output is greater than 95% the allowable maximum current, e.g., 4750mA.
If so, the
system waits or delays further to ensure that the current has sufficiently
dropped indicating that
sufficient desiccation of the tissue has occurred. If after such a delay the
current has not
sufficiently dropped, an error is indicated and/or RF energy being supplied is
halted. In
accordance with various embodiments, the system determines or confirms that
the current has
sufficiently dropped if the current falls below 90% of the maximum, e.g.,
4500mA. As such, the
system determines that the current condition has ceased and/or the tissue has
started boiling.
[0053]
In one embodiment, as illustrated in FIG. 10, an electrosurgical process such
as a
tissue fusion or sealing process starts with depressing a switch or moving an
actuator on the tool
(51), which based on a positive result of initial checks, the generator
supplies RF energy having a
predetermined voltage from the generator to the electrosurgical tool and
ultimately to the tissue
(52). After RF power is turned on and is being supplied continuously by the
generator, the
generator monitors the supplied RF energy (53). At or upon a predefined or
predetermined
point, condition or threshold (54) being reached or exceeded, voltage of the
supply of RF energy
and the predefined point are adjusted or newly selected (55) and the generator
continues to
monitor the supplied RF energy (52). Should the predefined condition mark the
end of the
fusion or seal cycle, e.g., tissue seal is complete, and such a condition is
reached or exceeded, the
generator terminates or halts the supply of RF energy (57). In various
embodiments, an
acoustical and/or visual signal is provided indicating that the tissue is
fused or sealed (or that an
error has occurred (e.g., shorting of the electrodes) and/or an unexpected
condition has occurred
(e.g., permissible although unexpected switch release)).
In accordance with various
embodiments, the predefined point, condition or threshold and/or
initialization checks are
determined based on a tool algorithm or script provided for a connected
electrosurgical tool,
procedure or preference.
[0054]
Referring now to FIG. 11, in one embodiment, the electrosurgical generator 10
is
connected to AC main input and a power supply 41 converts the AC voltage from
the AC main
input to DC voltages for powering various circuitry of the generator. The
power supply also
supplies DC voltage to an RF amplifier 42 that generates RF energy. In one
embodiment, the RF
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amplifier 42 converts 100VDC from the power supply to a sinusoidal waveform
with a
frequency of 350kHz which is delivered through a connected electrosurgical
instrument. RF
sense circuitry 43 measures/calculates voltage, current, power and phase at
the output of the
generator in which RF energy is supplied to a connected electrosurgical
instrument 20. The
measured/calculated information is supplied to a controller 44.
[0055] In one embodiment, the RF sense analyzes the measured AC voltage and
current from
the RF amplifier and generates DC signals for control signals including
voltage, current, power,
and phase that are sent to the controller for further processing. In one
embodiment, RF sense 43
measures the output voltage and current and calculates the root means square
(RMS) of the
voltage and current, apparent power of the RF output energy and the phase
angle between the
voltage and current of the RF energy being supplied through a connected
electrosurgical
instrument. In particular, the voltage and current of the output RF energy are
processed by
analog circuitry of the RF sense to generate real and imaginary components of
both voltage and
current. These signals are processed by an field-programmable gate array
(FPGA) to give
different measurements relating to voltage and current, including the RMS
measurements of the
AC signals, phase shift between voltage and current, and power. Accordingly,
in one
embodiment, the output voltage and current are measured in analog, converted
to digital,
processed by an FPGA to calculate RMS voltage and current, apparent power and
phase angle
between voltage and current, and then are converted back to analog for the
controller.
[0056] In one embodiment, controller 44 controls or signals the RF
amplifier 42 to affect the
output RF energy. For example, the controller utilizes the information
provided by the RF sense
43 to determine if RF energy should be outputted, adjusted or terminated. In
one embodiment,
the controller determines if or when a predetermined current, power and/or
phase threshold has
been reached or exceeded to determine when to terminate the output of RF
energy. In various
embodiments, the controller performs a fusion or sealing process described in
greater detail
herein and in some embodiments the controller receives the instructions and
settings or script
data to perform the sealing process from data transmitted from the
electrosurgical instrument.
As such, in various embodiments, the controller causes or adjusts the voltage
of the RF energy
being supplied by the RF Amplifier starting, holding and/or ending at
predefined voltages and/or
over predetermined time periods and/or based predetermined thresholds.
[0057] The RF Amplifier 42 generates high power RF energy to be passed
through a
connected electrosurgical instrument and in one example, an electrosurgical
instrument for
fusing or sealing tissue. In various embodiments, the RF Amplifier supplies RF
energy to or
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through the electrosurgical instrument starting at a predefined first voltage
and increasing to a
predefined second voltage within a predetermined first time period. The RF
Amplifier in
accordance with various embodiments is configured to convert a 100VDC power
source to a
high power sinusoidal waveform with a frequency of 350kHz which is delivered
to the connected
electrosurgical device. The RF Sense 43 interprets the measured AC voltage and
current from
the RF amplifier 42 and generates DC control signals, including voltage,
current, power, and
phase, that is interpreted by the controller 44.
[0058] The generator including the controller and/or RF sense monitors
and/or measures the
RF energy being supplied is as expected. In various embodiments, the system,
e.g., the
controller and/or RF sense, monitors the voltage and/or current of the RF
energy to ensure the
voltage and the current are above predefined threshold values. The system,
e.g., the controller
and/or RF sense, also monitors, measures and/or calculates the phase and/or
power of the
supplied RF energy. The system, e.g., the controller and/or RF sense, ensures
that the voltage,
current, phase and/or power of the supplied RF energy is within an predefined
voltage, current,
phase and/or power window or range. In one embodiment, the voltage, current,
phase and/or
power window are respectively delimited by a predefined maximum voltage,
current, phase
and/or power and a predefined minimum voltage, current, phase and/or power. If
the voltage,
current, phase and/or power of the RF energy moves out of its respective
window, an error is
indicated. In one embodiment, the respective window slides or is adjusted by
the system as RF
energy is being supplied to seal the tissue between the jaws of the
instrument. The adjustment of
the respective window is to ensure that supplied RF energy is as expected. The
system in various
embodiments monitors the phase and/or current or rate of phase and/or current
of the supplied
RF energy to determine if the phase and/or current has reached or crossed a
predefined phase
and/or current threshold and if phase and/or current crossing has occurred, RF
energy is supplied
for a predefined time period before terminating.
[0059] In accordance with various embodiments, an operations engine of
controller 44
enables the generator to be configurable to accommodate different operational
scenarios
including but not limited to different and numerous electrosurgical tools,
surgical procedures and
preferences. The operations engine receives and interprets data from an
external source to
specifically configure operation of the generator based on the received data.
[0060] The operations engine receives configuration data from a database
script file that is
read from a memory device of the electrosurgical instrument. The script
defines the state logic
used by the generator. Based on the state determined and measurements made by
the generator,
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the script can define or set output levels as well as shutoff criteria. The
script, in one
embodiment, includes trigger events that include indications of a short
condition, for example,
when a measured phase is greater than 60 degrees, or an open condition, for
example, when a
measured current is less than 2 Amps.
[0061] Exemplary RF energy control process, script or system for the
electrosurgical
generator and associated electrosurgical tools for fusing or sealing tissue in
accordance with
various embodiments are shown in FIGS. 12. In various embodiments, as
illustrated in FIG. 12,
for example, RF energy is supplied by the generator through the connected
electrosurgical tool
(71) in which the generator sets the voltage of the supplied RF energy to
generate the RF energy
to have a voltage spike (72). The generator monitors or waits a predefined
time period or spike
duration (73) while continuing to supply RF energy (72). Once the spike
duration 121 has
expired or passed, the generator adjusts the voltage of the supplied RF energy
to a predefined
minimum value 123 and the generator causes the voltage of the RF energy to
gradually ramp or
increase 124 to a predefined voltage level 125 (74). The generator also
monitors at least the
phase, voltage, current, power and/or change/rate thereof of the supplied RF
energy (75). If a
phase and current condition is reached or equals, exceeds or falls below a
predetermined
threshold or value (75), voltage is held constant 126 and/or the ramp
terminated 133 (77). In
various embodiments, if a phase condition or threshold is reached or falls
below a predetermined
phase threshold value 132 and/or a current condition or value is reached or
falls below a
predetermined current threshold value 131 (75), the generator adjusts the
voltage of the supplied
RF energy to be constant (77). If the phase and current condition or threshold
is not reached or
crossed, the generator monitors or waits a predefined time period or ramp
duration (76) while
continuing to supply RF energy (74) and monitoring the phase and current
conditions (75). If the
ramp duration has expired or passed, the generator adjusts the voltage of the
supplied RF energy
to be constant (77). With the RF energy being held constant, the generator
monitors or waits a
predefined time period or hold duration (78) while continuing to supply RF
energy (77). Once
the hold duration has expired or passed, the monitors or waits a predefined
time period or end
duration (79) while continuing to supply RF energy. If the end duration has
expired or passed,
the process is done or termination procedures are initiated and/or RF energy
supplied by the
generator is stopped (81). If the end duration has not expired or passed, the
generator determines
if a power condition or threshold is reached or falls below a predetermined
power threshold or
value 142 (80). If the power condition or threshold is reached or crossed, the
process is done or
termination procedures are initiated and/or RF energy supplied by the
generator is stopped (81).
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If the power condition or threshold is not reached or crossed, the generator
continues to supply
RF energy, while monitoring the power condition and end duration time period.
[0062] In various embodiments, prior to the start of the process, impedance
is measured to
determine a short or open condition through a low voltage measurement signal
delivered to a
connected electrosurgical tool. In one embodiment, passive impedance is
measured to determine
if the tissue grasped is within the operating range of the electrosurgical
tool (2-200S2). If the
initial impedance check is passed, RF energy is supplied to the
electrosurgical tool. After which
impedance/resistance is not measured or ignored.
[0063] In various embodiments, voltage of the RF energy is applied in a
ramping fashion
(74) starting from 35-45% to at most 65-100% of a global voltage setting or,
in one embodiment,
an user selected level. In various embodiments, the voltage of the RF energy
is applied in a
ramping fashion starting from 35-40 volts, e.g., a predefined third voltage,
to 65-90 volts, e.g., a
predefined fourth voltage, over 1.5-4 seconds, e.g., a predetermined second
time period. In
various embodiments, the voltage is held constant at a voltage, smaller than
and/or equal to the at
a predefined voltage equal and/or below the end of the ramp voltage, e.g., the
predefined fourth
voltage, and/or for a predetermined time period. In various embodiments, this
time period is
greater than time periods for the voltage spike and/or the time period
determined for the voltage
ramp. In various embodiments, voltage of the RF energy is applied as a voltage
spike (72)
starting from 30-40% to at most 75-100% of a global voltage setting or, in one
embodiment, an
user selected level. In various embodiments, the voltage of the RF energy is
applied in as a
voltage spike starting from 35-40 volts, e.g., a predefined first voltage, to
75-90 volts, e.g., a
predefined second voltage, over 50-300ms seconds, e.g., a predetermined first
time period.
[0064] In accordance with various embodiments, phase is monitored in
conjunction with
current for open and short events while RF energy is being applied and in one
embodiment after
phase and/or change of phase stop or endpoints is reached to evaluate or
determine if a false
indication of fusion (caused by an open or short) has been reached.
[0065] In accordance with various embodiments, the generator is configured
to provide
additional regulation of various parameters or functions related to the output
of the RF energy,
voltage, current, power and/or phase and the operations engine is configured
to utilize the
various parameters or functions to adjust the output of RF energy. In one
exemplary
embodiment, the control circuitry provides additional regulation controls for
direct regulation of
phase in which voltage, current and/or power output would be adjusted to
satisfy specified phase
regulation set points provided by the operations engine.
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[0066] In accordance with various embodiments, the generator utilizes the
monitored,
measured and/or calculated values of voltage, power, current and/or phase,
e.g., control
indicators, to recognize and act or perform operation conditions. In various
embodiments,
additional measurements or calculations based on the measured values related
to RF output
regulation circuitry are provided by the script or operations engine to
recognize and act upon
additional or different events related to or trigger by the additional
measurements or calculations
relative to other measurements or thresholds. The additional measurements in
one embodiment
include error signals in combination with a pulse width modulation (PWM) duty
cycle used to
regulate the output of voltage, current and/or power or other similar
regulation parameters.
Different or additional events or indicators that could be identified and
triggered in various
embodiments could be transitions from one regulation control to another
regulation control (e.g.
current regulation to power regulation). In various embodiments, subsequent
impedance or
temperature checks or measurements are not performed being imprecise and/or
impractical.
[0067] In various embodiments, the generator utilizes many states, control
points or checks
to identify a phase, current or power value and respectively for a positive or
negative trend. An
error is signaled if the generator does not identify an expected trend. The
multistate checks
increase or enhance the generator resolution in identifying an expected RF
output trend over
different types of tissue.
[0068] In various embodiments, the generator also monitors the phase or
current and/or rate
of phase or current to determine if the connected electrosurgical tool has
experienced an
electrical open or short condition. In one example, the generator identifies
an electrical short
condition of the connected electrosurgical instrument by monitoring the phase
of the applied or
supplied RF energy and if the monitored phase is greater than a predefined
maximum phase
value, an electrical short condition is identified. Similarly, in one example,
the generator
identifies an electrical open condition of the connected electrosurgical
instrument by monitoring
the current of the applied or supplied RF energy and if the monitored current
is less than a
predefined minimum current, an electrical open condition is identified. In
either or both cases,
the generator upon discovery of the open and/or short conditions indicates an
error and RF
energy being supplied is halted.
[0069] In various embodiments, the predefined process as described
throughout the
application is loaded into a memory module embedded into a connector removably
connected to
a plug and/or cable connection to an electrosurgical instrument. In various
embodiments, the
device script or process is programmed onto an adapter PCBA contained within
the device
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connector or hardwired into circuitry within the device connector during
manufacture/assembly.
The script source file is written in a custom text-based language and is then
compiled by a script
compiler into a script database file that is only readable by the generator.
The script file contains
parameters specifically chosen to configure the generator to output a specific
voltage (e.g., 100v
(RMS)), current (e.g., 5000mA (RMS)), and power level (e.g., 300VA).
In various
embodiments, a device key programmer device reads and then programs the script
database file
into the memory of the adapter PCBA.
[0070]
Turning now to some of the operational aspects of the electrosurgical tool or
instrument described herein in accordance with various embodiments, once a
vessel or tissue
bundle has been identified for fusing, the first and second jaws 31, 33 are
placed around the
tissue. The handle 21 is squeezed and thereby pivots the jaws together to
effectively grasp the
tissue. The actuator has a first or initial position in which the jaws 22 are
in an open position
with the handle 23 positioned away or spaced from the housing 28.
[0071]
The depression of the fuse button 29 by the surgeon causes the application of
the
radio frequency energy to the tissue between the jaws. Once the tissue has
been fused, the
actuator can be reopened by the handle being released and moved away from
stationary housing
28. To cut tissue between the jaws, the user can actuate the blade trigger 25.
When the blade
trigger is moved proximally, a cutting blade moves distally to divide the
tissue between the jaws.
When the surgeon releases the blade trigger, the blade spring resets the
cutting blade to its
original position. In accordance with various embodiments, the actuator has a
cut position in
which the jaws 22 are in a closed position, the movable handle is closed and
latched and the
blade trigger has been depressed advancing the cutting blade to its distal
most position.
[0072]
In various embodiments, an intermediate or unlatched position is provided in
which
the jaws are in a closed or proximate position but the handle is unlatched. As
such, if the handle
is released, the handle will return to its original or initial position. In
one embodiment, the blade
trigger may not be activated to cut tissue between the jaws but the fuse
button or switch may be
activated to fuse tissue between the jaws. In various embodiments, a latched
position is provided
in which the jaws are in a closed or proximate position and the handle is
latched. As such, if the
handle is released, the handle will not return to its original or initial
position. In one
embodiment, the fuse button or switch may be activated to fuse tissue between
the closed jaws
and/or the blade trigger may be activated to cut tissue between the jaws.
[0073]
As described, in accordance with various embodiments, the electrosurgical
instrument
has a first (open) state in which the jaws are spaced from each other and thus
the handle is also
- 20 -

CA 03120194 2021-05-14
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spaced from the stationary housing. The instrument is thus positioned to grasp
tissue between
the jaws. In the second (intermediate) state of the instrument, the jaws are
proximate to each
other to grasp tissue between the jaws and likewise the handle and housing are
proximate to each
other. The surgeon can revert back to the first state by opening the jaws and
thus positioning the
jaws again to grasp the tissue or other tissue. In the third (closed) state of
the instrument, the
handle is moved further closer to the stationary housing and latches to the
stationary housing.
Movement to the third state, tissue grasped between the jaws can be cut
through the activation of
the blade lever. Movement to the third state, in which the handle is latched
to the housing,
reduces the potential of unintentionally releasing the tissue. Also,
inadvertent cutting of tissue or
along the wrong tissue lines are avoided. Additionally, this state allows the
application of
constant and continuous predefined compression or range of compression on the
tissue between
the jaws before, during and after the activation of the RF energy, thereby
enhancing the sealing
or fusion of the tissue between the jaws. In accordance with various
embodiments, application
of RF energy can occur once the handle and jaws are in at least the second
state and once the
fuse button is activated by the surgeon.
[0074] It is noted that in various embodiments to avoid false readings, the
electrosurgical
generator does not measure resistance or impedance of the tissue during the
supply of RF energy
to the tissue. In accordance with various embodiments, an electrosurgical
system is provided
that decreases thermal spread and provides efficient power delivery for
sealing vessels or tissue
in contact with a bipolar electrosurgical instrument through the controlled
and efficient supply of
RF energy.
[0075] As described throughout the application, the electrosurgical
generator ultimately
supplies RF energy to a connected electrosurgical instrument. The
electrosurgical generator
ensures that the supplied RF energy does not exceed specified parameters and
detects faults or
error conditions. In various embodiments, an electrosurgical instrument
provides the commands
or logic used to appropriately apply RF energy for a surgical procedure. An
electrosurgical
instrument for example includes memory having commands and parameters that
dictate the
operation of the instrument in conjunction with the electrosurgical generator.
For example, in a
simple case, the generator can supply the RF energy but the connected
instrument decides how
much or how long energy is applied. The generator, however, does not allow the
supply of RF
energy to exceed a set threshold even if directed to by the connected
instrument thereby
providing a check or assurance against a faulty instrument command.
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CA 03120194 2021-05-14
WO 2020/101711 PCT/US2018/061646
[0076] As described generally above and described in further detail below,
various
electrosurgical instruments, tools or devices can be used in the
electrosurgical systems described
herein. For example, electrosurgical graspers, scissors, tweezers, probes,
needles, and other
instruments incorporating one, some, or all of the aspects discussed herein
can provide various
advantages in an electrosurgical system. Various electrosurgical instruments
and generator
embodiments and combinations thereof are discussed throughout the application.
It is
contemplated that one, some, or all of the features discussed generally
throughout the application
can be included in any of the embodiments of the instruments, generators and
combinations
thereof discussed herein. For example, it can be desirable that each of the
instruments described
include a memory for interaction with the generator as previously described
and vice versa.
However, in other embodiments, the instruments and/or generators described can
be configured
to interact with a standard bipolar radio frequency power source without
interaction of an
instrument memory. Further, although various embodiments may be described in
terms of
modules and/or blocks to facilitate description, such modules and/or blocks
may be implemented
by one or more hardware components, e.g., processors, Digital Signal
Processors (DSPs),
Programmable Logic Devices (PLDs), Application Specific Integrated Circuits
(ASICs), circuits,
registers and/or software components, e.g., programs, subroutines, logic
and/or combinations of
hardware and software components. Likewise, such software components may be
interchanged
with hardware components or a combination thereof and vice versa.
[0077] Further examples of the electrosurgical unit, instruments and
connections there
between and operations and/or functionalities thereof are described in US
Patent Application
Nos. 12/416,668, filed April 1, 2009, entitled "Electrosurgical System";
12/416,751, filed April
1, 2009, entitled "Electrosurgical System"; 12/416,695, filed April 1, 2009,
entitled
"Electrosurgical System"; 12/416,765, filed April 1, 2009, entitled
"Electrosurgical System"; and
12/416,128, filed March 31, 2009, entitled "Electrosurgical System"; the
entire disclosures of
which are hereby incorporated by reference as if set in full herein. Certain
aspects of these
electrosurgical generators, tools and systems are discussed herein, and
additional details and
examples with respect to various embodiments are described in US Provisional
Application Nos.
61/994,215, filed May 16, 2014, entitled "Electrosurgical Fusion Device";
61/944,185, filed May
16, 2014, "Electrosurgical Generator with Synchronous Detector"; 61/994,415,
filed May 16,
2014, "Electrosurgical System"; and 61/944,192, filed May 16, 2014, entitled
"Electrosurgical
Generator", the entire disclosures of which are hereby incorporated by
reference as if set in full
herein.
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CA 03120194 2021-05-14
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[0078] The above description is provided to enable any person skilled in
the art to make and
use the surgical devices and perform the methods described herein and sets
forth the best modes
contemplated by the inventors of carrying out their inventions. Various
modifications, however,
will remain apparent to those skilled in the art. It is contemplated that
these modifications are
within the scope of the present disclosure. Additionally, different
embodiments or aspects of
such embodiments may be shown in various figures and described throughout the
specification.
However, it should be noted that although shown or described separately each
embodiment and
aspects thereof may be combined with one or more of the other embodiments and
aspects thereof
unless expressly stated otherwise. It is merely for easing readability of the
specification that
each combination is not expressly set forth. Also, embodiments of the present
invention should
be considered in all respects as illustrative and not restrictive.
-23 -

Dessin représentatif
Une figure unique qui représente un dessin illustrant l'invention.
États administratifs

2024-08-01 : Dans le cadre de la transition vers les Brevets de nouvelle génération (BNG), la base de données sur les brevets canadiens (BDBC) contient désormais un Historique d'événement plus détaillé, qui reproduit le Journal des événements de notre nouvelle solution interne.

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Pour une meilleure compréhension de l'état de la demande ou brevet qui figure sur cette page, la rubrique Mise en garde , et les descriptions de Brevet , Historique d'événement , Taxes périodiques et Historique des paiements devraient être consultées.

Historique d'événement

Description Date
Rapport d'examen 2024-09-26
Modification reçue - réponse à une demande de l'examinateur 2024-03-21
Modification reçue - modification volontaire 2024-03-21
Rapport d'examen 2023-11-23
Inactive : Rapport - Aucun CQ 2023-11-23
Lettre envoyée 2022-10-31
Requête d'examen reçue 2022-09-14
Toutes les exigences pour l'examen - jugée conforme 2022-09-14
Exigences pour une requête d'examen - jugée conforme 2022-09-14
Représentant commun nommé 2021-11-13
Inactive : Page couverture publiée 2021-07-02
Lettre envoyée 2021-06-14
Inactive : CIB en 1re position 2021-06-04
Lettre envoyée 2021-06-04
Demande reçue - PCT 2021-06-04
Inactive : CIB attribuée 2021-06-04
Exigences pour l'entrée dans la phase nationale - jugée conforme 2021-05-14
Demande publiée (accessible au public) 2020-05-22

Historique d'abandonnement

Il n'y a pas d'historique d'abandonnement

Taxes périodiques

Le dernier paiement a été reçu le 2023-11-10

Avis : Si le paiement en totalité n'a pas été reçu au plus tard à la date indiquée, une taxe supplémentaire peut être imposée, soit une des taxes suivantes :

  • taxe de rétablissement ;
  • taxe pour paiement en souffrance ; ou
  • taxe additionnelle pour le renversement d'une péremption réputée.

Les taxes sur les brevets sont ajustées au 1er janvier de chaque année. Les montants ci-dessus sont les montants actuels s'ils sont reçus au plus tard le 31 décembre de l'année en cours.
Veuillez vous référer à la page web des taxes sur les brevets de l'OPIC pour voir tous les montants actuels des taxes.

Historique des taxes

Type de taxes Anniversaire Échéance Date payée
Enregistrement d'un document 2021-05-14 2021-05-14
Taxe nationale de base - générale 2021-05-14 2021-05-14
TM (demande, 2e anniv.) - générale 02 2020-11-16 2021-05-14
TM (demande, 3e anniv.) - générale 03 2021-11-16 2021-11-12
Requête d'examen - générale 2023-11-16 2022-09-14
TM (demande, 4e anniv.) - générale 04 2022-11-16 2022-11-11
TM (demande, 5e anniv.) - générale 05 2023-11-16 2023-11-10
Titulaires au dossier

Les titulaires actuels et antérieures au dossier sont affichés en ordre alphabétique.

Titulaires actuels au dossier
APPLIED MEDICAL RESOURCES CORPORATION
Titulaires antérieures au dossier
DEVON AUGUSTUS
DUY NGUYEN
KEVIN SIAZON
PATRICK ELLIOTT
RYAN POPE
VINCENT RODRIGUEZ
Les propriétaires antérieurs qui ne figurent pas dans la liste des « Propriétaires au dossier » apparaîtront dans d'autres documents au dossier.
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Description du
Document 
Date
(aaaa-mm-jj) 
Nombre de pages   Taille de l'image (Ko) 
Description 2024-03-20 23 2 096
Revendications 2024-03-20 16 967
Description 2021-05-13 23 1 421
Dessins 2021-05-13 12 274
Revendications 2021-05-13 3 83
Abrégé 2021-05-13 2 77
Dessin représentatif 2021-05-13 1 25
Demande de l'examinateur 2024-09-25 3 139
Modification / réponse à un rapport 2024-03-20 54 2 861
Courtoisie - Lettre confirmant l'entrée en phase nationale en vertu du PCT 2021-06-13 1 587
Courtoisie - Certificat d'enregistrement (document(s) connexe(s)) 2021-06-03 1 367
Courtoisie - Réception de la requête d'examen 2022-10-30 1 422
Demande de l'examinateur 2023-11-22 4 184
Demande d'entrée en phase nationale 2021-05-13 14 523
Rapport de recherche internationale 2021-05-13 8 261
Requête d'examen 2022-09-13 3 63