U.S. patent application number 17/170178 was filed with the patent office on 2021-08-05 for surgical instrument with user adaptable algorithms.
The applicant listed for this patent is Ethicon LLC. Invention is credited to Ryan M. Asher, Benjamin M. Boyd, Benjamin D. Dickerson, Craig N. Faller, Thomas C. Gallmeyer, Jacob S. Gee, John A. Hibner, Paul F. Riestenberg, Rafael J. Ruiz Ortiz, Charles J. Scheib, William B. Weisenburgh, II.
Application Number | 20210236195 17/170178 |
Document ID | / |
Family ID | 1000005523440 |
Filed Date | 2021-08-05 |
United States Patent
Application |
20210236195 |
Kind Code |
A1 |
Asher; Ryan M. ; et
al. |
August 5, 2021 |
SURGICAL INSTRUMENT WITH USER ADAPTABLE ALGORITHMS
Abstract
Various forms are directed to systems and methods for dissection
and coagulation of tissue. A surgical instrument includes an end
effector configured to dissect and seal tissue at a distal end
thereof, and a selector switch having a plurality of surgical
modes. A generator is electrically coupled to the surgical
instrument and is configured to deliver energy to the end effector.
Each surgical mode of the selector switch corresponds to an
algorithm for controlling the power delivered from the generator to
the end effector, and each algorithm corresponding to the plurality
of surgical modes is configured to allow a user to control the
power output level of the generator.
Inventors: |
Asher; Ryan M.; (Cincinnati,
OH) ; Faller; Craig N.; (Batavia, OH) ;
Scheib; Charles J.; (Loveland, OH) ; Riestenberg;
Paul F.; (North Bend, OH) ; Gee; Jacob S.;
(Cincinnati, OH) ; Boyd; Benjamin M.; (Fairborn,
OH) ; Dickerson; Benjamin D.; (San Francisco, CA)
; Ruiz Ortiz; Rafael J.; (Mason, OH) ;
Weisenburgh, II; William B.; (Maineville, OH) ;
Gallmeyer; Thomas C.; (Ann Arbor, MI) ; Hibner; John
A.; (Mason, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon LLC |
Guaynabo |
PR |
US |
|
|
Family ID: |
1000005523440 |
Appl. No.: |
17/170178 |
Filed: |
February 8, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16048970 |
Jul 30, 2018 |
10952788 |
|
|
17170178 |
|
|
|
|
14788468 |
Jun 30, 2015 |
10034704 |
|
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16048970 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/00732
20130101; A61B 18/1445 20130101; A61B 2017/00199 20130101; A61B
2018/00994 20130101; A61B 2018/128 20130101; A61B 2018/00708
20130101; A61B 2018/00875 20130101; A61B 18/1206 20130101; A61B
2017/0003 20130101; A61B 90/03 20160201; A61B 2018/00607 20130101;
A61B 2017/00115 20130101; A61B 2017/320094 20170801; A61B 2090/0803
20160201; A61B 2018/00958 20130101; A61B 2017/00026 20130101; A61B
2018/00761 20130101; A61B 2017/320093 20170801; A61B 2017/320095
20170801; A61B 2017/00017 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61B 90/00 20060101 A61B090/00; A61B 18/12 20060101
A61B018/12 |
Claims
1. An apparatus for dissection and coagulation of tissue,
comprising: a surgical instrument having an end effector configured
to dissect and seal tissue at a distal end thereof, the surgical
instrument including a selector switch thereon having a plurality
of surgical modes; a generator electrically coupled to the surgical
instrument and configured to deliver energy to the end effector;
wherein each surgical mode of the selector switch corresponds to an
algorithm for controlling the power delivered from the generator to
the end effector.
2. The apparatus of claim 1, wherein each algorithm corresponding
to the plurality of surgical modes is configured to allow a user to
control a power output level of the generator.
3. The apparatus of claim 2, wherein a maximum and minimum power
output of the generator is controlled by the user.
4. The apparatus of claim 2, wherein each algorithm is configured
to allow the user to modify timing of a drop in the power output
during each surgical mode.
5. The apparatus of claim 1, wherein the algorithm corresponding to
each of the plurality of surgical modes is configured to be
modified by a user to allow customization of each of the plurality
of surgical modes.
6. The apparatus of claim 1, wherein the surgical instrument
includes a closure switch configured to move between a first
position in which the end effector is opened to allow tissue to be
positioned within the end effector and a second position in which
the end effector is closed such that tissue to held by the end
effector.
7. The apparatus of claim 6, wherein the generator is configured to
deliver power to the end effector when the closure switch is in the
second position and the end effector is closed.
8. The apparatus of claim 6, wherein one or more of the algorithms
corresponding to the plurality of surgical modes includes a
threshold counter for counting the number of activations of the end
effector when the closure switch is in the second position such
that the power output from the generator activates more
quickly.
9. The apparatus of claim 6, wherein an adaptive energy mode of the
generator is enabled such that adaptive energy can be delivered
from the generator to the end effector when the closure switch is
in the second position and the end effector is closed on the
tissue.
10. The apparatus of claim 6, wherein an angle of closure of the
end effector can be detected when the closure switch is positioned
between the first and second positions, the angle of closure of the
end effector being used to adjust the energy delivered from the
generator to the end effector.
11. The apparatus of claim 10, wherein a frequency slope of the
energy delivered from the generator can be varied depending on the
angle of closure of the end effector.
12. An apparatus for dissection and coagulation of tissue,
comprising: a surgical instrument having an end effector configured
to dissect and seal tissue at a distal end thereof; a generator
electrically coupled to the surgical instrument and configured to
deliver energy to the end effector; and a surgical mode selector
input having a plurality of surgical modes for selection by a user
such that each surgical mode corresponds to an algorithm for
controlling the power output from the generator.
13. The apparatus of claim 12, wherein the surgical mode selector
input is in the form of a selector switch on the surgical
instrument such that the selector switch can be toggled between the
plurality of surgical modes to control the power output to the end
effector.
14. The apparatus of claim 12, wherein the surgical mode selector
input is in the form of a receptacle for an input device located on
the generator.
15. The apparatus of claim 14, wherein the input device is an radio
frequency identification (RFID) swipe key.
16. The apparatus of claim 14, wherein the input device is a
universal serial bus (USB).
17. The apparatus of claim 14, wherein the input device includes
customized surgical modes for controlling the power output of the
generator to the end effector.
18. The apparatus of claim 17, wherein the surgical mode selector
input is in the form of an external communication device in
communication with the generator.
19. The apparatus of claim 18, wherein the external communication
device is configured to wirelessly communicate with the
generator.
20. The apparatus for dissection and coagulation of tissue,
comprising: an end effector positioned on a distal end of a
surgical instrument that is configured to dissect and seal tissue;
a closure switch on the surgical instrument that is configured to
control the end effector such that the end effector is opened when
the closure switch is in a first positon and the end effector is
closed when the closure switch is in a second position; a generator
electrically coupled to the surgical instrument and configured to
deliver energy to the end effector; and a surgical mode selector
input having a plurality of surgical modes for selection by a user
such that each surgical mode corresponds to an algorithm for
controlling the power output from the generator; wherein the
generator is configured to deliver power to the end effector when
the end effector is closed around a tissue when the closure switch
is in the second position.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application claiming
priority under 35 U.S.C. .sctn. 120 to U.S. patent application Ser.
No. 16/048,970, entitled SURGICAL INSTRUMENT WITH USER ADAPTABLE
ALGORITHMS, filed Jul. 30, 2018, now U.S. Patent Application
Publication No. 2019/0021783, which is a continuation application
claiming priority under 35 U.S.C. .sctn. 120 to U.S. patent
application Ser. No. 14/788,468, entitled SURGICAL INSTRUMENT WITH
USER ADAPTABLE ALGORITHMS, filed Jun. 30, 2015, which issued on
Jul. 31, 2018 as U.S. Pat. No. 10,034,704, the entire disclosures
of which are hereby incorporated by reference herein.
TECHNICAL FIELD
[0002] The present disclosure generally relates to ultrasonic
surgical systems and, more particularly, to ultrasonic and
electrosurgical systems that allows surgeons to perform cutting and
coagulation and adapt and customize algorithms for performing such
procedures.
BACKGROUND
[0003] Ultrasonic surgical instruments are finding increasingly
widespread applications in surgical procedures by virtue of the
unique performance characteristics of such instruments. Depending
upon specific instrument configurations and operational parameters,
ultrasonic surgical instruments can provide substantially
simultaneous cutting of tissue and hemostasis by coagulation,
desirably minimizing patient trauma. The cutting action is
typically realized by an-end effector, or blade tip, at the distal
end of the instrument, which transmits ultrasonic energy to tissue
brought into contact with the end effector. Ultrasonic instruments
of this nature can be configured for open surgical use,
laparoscopic, or endoscopic surgical procedures including
robotic-assisted procedures.
[0004] Some surgical instruments utilize ultrasonic energy for both
precise cutting and controlled coagulation. Ultrasonic energy cuts
and coagulates by using lower temperatures than those used by
electrosurgery. Vibrating at high frequencies (e.g., 55,500 times
per second), the ultrasonic blade denatures protein in the tissue
to form a sticky coagulum. Pressure exerted on tissue with the
blade surface collapses blood vessels and allows the coagulum to
form a hemostatic seal. The precision of cutting and coagulation is
controlled by the surgeon's technique and adjusting the power
level, blade edge, tissue traction, and blade pressure.
[0005] Electrosurgical devices for applying electrical energy to
tissue in order to treat and/or destroy the tissue are also finding
increasingly widespread applications in surgical procedures. An
electrosurgical device typically includes a hand piece, an
instrument having a distally-mounted end effector (e.g., one or
more electrodes). The end effector can be positioned against the
tissue such that electrical current is introduced into the tissue.
Electrosurgical devices can be configured for bipolar or monopolar
operation. During bipolar operation, current is introduced into and
returned from the tissue by active and return electrodes,
respectively, of the end effector. During monopolar operation,
current is introduced into the tissue by an active electrode of the
end effector and returned through a return electrode (e.g., a
grounding pad) separately located on a patient's body. Heat
generated by the current flowing through the tissue may form
hemostatic seals within the tissue and/or between tissues and thus
may be particularly useful for sealing blood vessels, for example.
The end effector of an electrosurgical device may also include a
cutting member that is movable relative to the tissue and the
electrodes to transect the tissue.
[0006] Electrical energy applied by an electrosurgical device can
be transmitted to the instrument by a generator in communication
with the hand piece. The electrical energy may be in the form of
radio frequency ("RF") energy. RF energy is a form of electrical
energy that may be in the frequency range of 300 kilohertz (kHz) to
1 megahertz (MHz). In application, an electrosurgical device can
transmit low frequency RF energy through tissue, which causes ionic
agitation, or friction, in effect resistive heating, thereby
increasing the temperature of the tissue. Because a sharp boundary
is created between the affected tissue and the surrounding tissue,
surgeons can operate with a high level of precision and control,
without sacrificing un-targeted adjacent tissue. The low operating
temperatures of RF energy is useful for removing, shrinking, or
sculpting soft tissue while simultaneously sealing blood vessels.
RF energy works particularly well on connective tissue, which is
primarily comprised of collagen and shrinks when contacted by
heat.
[0007] A challenge of using these medical devices is the inability
to control and customize the power output depending on the type of
procedures being performed. It would be desirable to provide a
surgical instrument that overcomes some of the deficiencies of
current instruments. The surgical system described herein overcomes
those deficiencies.
FIGURES
[0008] The novel features of the described forms are set forth with
particularity in the appended claims. The described forms, however,
both as to organization and methods of operation, may be best
understood by reference to the following description, taken in
conjunction with the accompanying drawings in which:
[0009] FIG. 1 illustrates one form of a surgical system comprising
a generator and various surgical instruments usable therewith;
[0010] FIG. 2 is a diagram of the ultrasonic surgical instrument of
FIG. 1;
[0011] FIG. 3 is a diagram of the surgical system of FIG. 1;
[0012] FIG. 4 is a model illustrating motional branch current in
one form;
[0013] FIG. 5 is a structural view of a generator architecture in
one form;
[0014] FIG. 6 illustrates one form of a drive system of a
generator, which creates the ultrasonic electrical signal for
driving an ultrasonic transducer;
[0015] FIG. 7 illustrates one form of a drive system of a generator
comprising a tissue impedance module;
[0016] FIG. 8 illustrates one form of a surgical instrument having
a selector switch thereon for selecting a surgical mode;
[0017] FIG. 9 is a logic flow diagram for selecting a surgical mode
corresponding to a tissue algorithm that may be implemented in one
form of a generator;
[0018] FIG. 10 is a logic flow diagram for customizing a surgical
mode corresponding to a tissue algorithm;
[0019] FIG. 11 is one form of a logic flow diagram for selecting a
surgical mode corresponding to a tissue algorithm using the
position of an end effector of a surgical instrument as an
algorithm input;
[0020] FIG. 12 is another form of a logic flow diagram for
selecting a surgical mode corresponding to a tissue algorithm using
the position of an end effector of a surgical instrument as an
algorithm input; and
[0021] FIG. 13 is a logic flow diagram for customizing a surgical
mode corresponding to a tissue algorithm including a counter for
counting the number of closures of an end effector of a surgical
instrument.
DESCRIPTION
[0022] Before explaining various forms of ultrasonic surgical
instruments in detail, it should be noted that the illustrative
forms are not limited in application or use to the details of
construction and arrangement of parts illustrated in the
accompanying drawings and description. The illustrative forms may
be implemented or incorporated in other forms, variations and
modifications, and may be practiced or carried out in various ways.
Further, unless otherwise indicated, the terms and expressions
employed herein have been chosen for the purpose of describing the
illustrative forms for the convenience of the reader and are not
for the purpose of limitation thereof.
[0023] Further, it is understood that any one or more of the
following-described forms, expressions of forms, examples, can be
combined with any one or more of the other following-described
forms, expressions of forms, and examples.
[0024] Various forms are directed to improved ultrasonic surgical
instruments configured for effecting tissue dissecting, cutting,
and/or coagulation during surgical procedures. In one form, an
ultrasonic surgical instrument apparatus is configured for use in
open surgical procedures, but has applications in other types of
surgery, such as laparoscopic, endoscopic, and robotic-assisted
procedures. Versatile use is facilitated by selective use of
ultrasonic energy.
[0025] The various forms will be described in combination with an
ultrasonic instrument as described herein. Such description is
provided by way of example, and not limitation, and is not intended
to limit the scope and applications thereof. For example, any one
of the described forms is useful in combination with a multitude of
ultrasonic instruments including those described in, for example,
U.S. Pat. Nos. 5,938,633; 5,935,144; 5,944,737; 5,322,055;
5,630,420; and 5,449,370.
[0026] As will become apparent from the following description, it
is contemplated that forms of the surgical instrument described
herein may be used in association with an oscillator unit of a
surgical system, whereby ultrasonic energy from the oscillator unit
provides the desired ultrasonic actuation for the present surgical
instrument. It is also contemplated that forms of the surgical
instrument described herein may be used in association with a
signal generator unit of a surgical system, whereby electrical
energy in the form of radio frequencies (RF), for example, is used
to provide feedback to the user regarding the surgical instrument.
The ultrasonic oscillator and/or the signal generator unit may be
non-detachably integrated with the surgical instrument or may be
provided as separate components, which can be electrically
attachable to the surgical instrument.
[0027] One form of the present surgical apparatus is particularly
configured for disposable use by virtue of its straightforward
construction. However, it is also contemplated that other forms of
the present surgical instrument can be configured for
non-disposable or multiple uses. Detachable connection of the
present surgical instrument with an associated oscillator and
signal generator unit is presently disclosed for single-patient use
for illustrative purposes only. However, non-detachable integrated
connection of the present surgical instrument with an associated
oscillator and/or signal generator unit is also contemplated.
Accordingly, various forms of the presently described surgical
instruments may be configured for single use and/or multiple use
with either detachable and/or non-detachable integral oscillator
and/or signal generator unit, without limitation, and all
combinations of such configurations are contemplated to be within
the scope of the present disclosure.
[0028] With reference to FIGS. 1-5, one form of a surgical system
10 including an ultrasonic surgical instrument is illustrated. FIG.
1 illustrates one form of a surgical system 10 comprising a
generator 1002 and various surgical instruments 1004, 1006 usable
therewith. FIG. 2 is a diagram of the ultrasonic surgical
instrument 1004 of FIG. 1. The generator 1002 is configurable for
use with surgical devices. According to various forms, the
generator 1002 may be configurable for use with different surgical
devices of different types including, for example, the ultrasonic
device 1004 and electrosurgical or RF surgical devices, such as,
the RF device 1006. Although in the form of FIG. 1, the generator
1002 is shown separate from the surgical devices 1004, 1006, in one
form, the generator 1002 may be formed integrally with either of
the surgical devices 1004, 1006 to form a unitary surgical system.
The generator 1002 comprises an input device 1045 located on a
front panel of the generator 1002 console. The input device 1045
may comprise any suitable device that generates signals suitable
for programming the operation of the generator 1002.
[0029] FIG. 3 is a diagram of the surgical system 10 of FIG. 1. In
various forms, the generator 1002 may comprise several separate
functional elements, such as modules and/or blocks. Different
functional elements or modules may be configured for driving the
different kinds of surgical devices 1004, 1006. For example, an
ultrasonic generator module 1008 may drive ultrasonic devices such
as the ultrasonic device 1004. An electrosurgery/RF generator
module 1010 may drive the electrosurgical device 1006. For example,
the respective modules 1008, 1010 may generate respective drive
signals for driving the surgical devices 1004, 1006. In various
forms, the ultrasonic generator module 1008 and/or the
electrosurgery/RF generator module 1010 each may be formed
integrally with the generator 1002. Alternatively, one or more of
the modules 1008, 1010 may be provided as a separate circuit module
electrically coupled to the generator 1002. (The modules 1008 and
1010 are shown in phantom to illustrate this option.) Also, in some
forms, the electrosurgery/RF generator module 1010 may be formed
integrally with the ultrasonic generator module 1008, or vice
versa. Also, in some forms, the generator 1002 may be omitted
entirely and the modules 1008, 1010 may be executed by processors
or other hardware within the respective instruments 1004, 1006.
[0030] In accordance with the described forms, the ultrasonic
generator module 1008 may produce a drive signal or signals of
particular voltages, currents, and frequencies, e.g., 55,500 cycles
per second (Hz). The drive signal or signals may be provided to the
ultrasonic device 1004, and specifically to the transducer 1014,
which may operate, for example, as described above. The transducer
1014 and a waveguide extending through the shaft 1015 (waveguide
not shown in FIG. 2) may collectively form an ultrasonic drive
system driving an ultrasonic blade 1017 of an end effector 1026. In
one form, the generator 1002 may be configured to produce a drive
signal of a particular voltage, current, and/or frequency output
signal that can be stepped or otherwise modified with high
resolution, accuracy, and repeatability.
[0031] The generator 1002 may be activated to provide the drive
signal to the transducer 1014 in any suitable manner. For example,
the generator 1002 may comprise a foot switch 1020 coupled to the
generator 1002 via a footswitch cable 1022. A clinician may
activate the transducer 1014 by depressing the foot switch 1020. In
addition, or instead of the foot switch 1020 some forms of the
ultrasonic device 1004 may utilize one or more switches positioned
on the hand piece that, when activated, may cause the generator
1002 to activate the transducer 1014. In one form, for example, the
one or more switches may comprise a pair of toggle buttons 1036a,
1036b (FIG. 2), for example, to determine an operating mode of the
device 1004. When the toggle button 1036a is depressed, for
example, the ultrasonic generator 1002 may provide a maximum drive
signal to the transducer 1014, causing it to produce maximum
ultrasonic energy output. Depressing toggle button 1036b may cause
the ultrasonic generator 1002 to provide a user-selectable drive
signal to the transducer 1014, causing it to produce less than the
maximum ultrasonic energy output. The device 1004 additionally or
alternatively may comprise a second switch (not shown) to, for
example, indicate a position of a jaw closure trigger for operating
jaws of the end effector 1026. Also, in some forms, the ultrasonic
generator 1002 may be activated based on the position of the jaw
closure trigger, (e.g., as the clinician depresses the jaw closure
trigger to close the jaws, ultrasonic energy may be applied).
[0032] Additionally or alternatively, the one or more switches may
comprises a toggle button 1036c that, when depressed, causes the
generator 1002 to provide a pulsed output. The pulses may be
provided at any suitable frequency and grouping, for example. In
certain forms, the power level of the pulses may be the power
levels associated with toggle buttons 1036a, 1036b (maximum, less
than maximum), for example.
[0033] It will be appreciated that a device 1004 may comprise any
combination of the toggle buttons 1036a, 1036b, 1036c. For example,
the device 1004 could be configured to have only two toggle
buttons: a toggle button 1036a for producing maximum ultrasonic
energy output and a toggle button 1036c for producing a pulsed
output at either the maximum or less than maximum power level. In
this way, the drive signal output configuration of the generator
1002 could be 5 continuous signals and 5 or 4 or 3 or 2 or 1 pulsed
signals. In certain forms, the specific drive signal configuration
may be controlled based upon, for example, EEPROM settings in the
generator 1002 and/or user power level selection(s).
[0034] In certain forms, a two-position switch may be provided as
an alternative to a toggle button 1036c. For example, a device 1004
may include a toggle button 1036a for producing a continuous output
at a maximum power level and a two-position toggle button 1036b. In
a first detented position, toggle button 1036b may produce a
continuous output at a less than maximum power level, and in a
second detented position the toggle button 1036b may produce a
pulsed output (e.g., at either a maximum or less than maximum power
level, depending upon the EEPROM settings).
[0035] In accordance with the described forms, the
electrosurgery/RF generator module 1010 may generate a drive signal
or signals with output power sufficient to perform bipolar
electrosurgery using radio frequency (RF) energy. In bipolar
electrosurgery applications, the drive signal may be provided, for
example, to electrodes of the electrosurgical device 1006, for
example. Accordingly, the generator 1002 may be configured for
therapeutic purposes by applying electrical energy to the tissue
sufficient for treating the tissue (e.g., coagulation,
cauterization, tissue welding).
[0036] The generator 1002 may comprise an input device 1045 (FIG.
1) located, for example, on a front panel of the generator 1002
console. The input device 1045 may comprise any suitable device
that generates signals suitable for programming the operation of
the generator 1002. In operation, the user can program or otherwise
control operation of the generator 1002 using the input device
1045. The input device 1045 may comprise any suitable device that
generates signals that can be used by the generator (e.g., by one
or more processors contained in the generator) to control the
operation of the generator 1002 (e.g., operation of the ultrasonic
generator module 1008 and/or electrosurgery/RF generator module
1010). In various forms, the input device 1045 includes one or more
of buttons, switches, thumbwheels, keyboard, keypad, touch screen
monitor, pointing device, remote connection to a general purpose or
dedicated computer. In other forms, the input device 1045 may
comprise a suitable user interface, such as one or more user
interface screens displayed on a touch screen monitor, for example.
Accordingly, by way of the input device 1045, the user can set or
program various operating parameters of the generator, such as, for
example, current (I), voltage (V), frequency (f), and/or period (T)
of a drive signal or signals generated by the ultrasonic generator
module 1008 and/or electrosurgery/RF generator module 1010.
[0037] The generator 1002 may also comprise an output device 1047
(FIG. 1), such as an output indicator, located, for example, on a
front panel of the generator 1002 console. The output device 1047
includes one or more devices for providing a sensory feedback to a
user. Such devices may comprise, for example, visual feedback
devices (e.g., a visual feedback device may comprise incandescent
lamps, light emitting diodes (LEDs), graphical user interface,
display, analog indicator, digital indicator, bar graph display,
digital alphanumeric display, LCD display screen, LED indicators),
audio feedback devices (e.g., an audio feedback device may comprise
speaker, buzzer, audible, computer generated tone, computerized
speech, voice user interface (VUI) to interact with computers
through a voice/speech platform), or tactile feedback devices
(e.g., a tactile feedback device comprises any type of vibratory
feedback, haptic actuator).
[0038] Although certain modules and/or blocks of the generator 1002
may be described by way of example, it can be appreciated that a
greater or lesser number of modules and/or blocks may be used and
still fall within the scope of the forms. Further, although various
forms 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.
Also, in some forms, the various modules described herein may be
implemented utilizing similar hardware positioned within the
instruments 1004, 1006 (i.e., the generator 1002 may be
omitted).
[0039] In one form, the ultrasonic generator drive module 1008 and
electrosurgery/RF drive module 1010 may comprise one or more
embedded applications implemented as firmware, software, hardware,
or any combination thereof. The modules 1008, 1010 may comprise
various executable modules such as software, programs, data,
drivers, application program interfaces (APIs), and so forth. The
firmware may be stored in nonvolatile memory (NVM), such as in
bit-masked read-only memory (ROM) or flash memory. In various
implementations, storing the firmware in ROM may preserve flash
memory. The NVM may comprise other types of memory including, for
example, programmable ROM (PROM), erasable programmable ROM
(EPROM), electrically erasable programmable ROM (EEPROM), or
battery backed random-access memory (RAM) such as dynamic RAM
(DRAM), Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM
(SDRAM).
[0040] In one form, the modules 1008, 1010 comprise a hardware
component implemented as a processor for executing program
instructions for monitoring various measurable characteristics of
the devices 1004, 1006 and generating a corresponding output
control signals for operating the devices 1004, 1006. In forms in
which the generator 1002 is used in conjunction with the device
1004, the output control signal may drive the ultrasonic transducer
1014 in cutting and/or coagulation operating modes. Electrical
characteristics of the device 1004 and/or tissue may be measured
and used to control operational aspects of the generator 1002
and/or provided as feedback to the user. In forms in which the
generator 1002 is used in conjunction with the device 1006, the
output control signal may supply electrical energy (e.g., RF
energy) to the end effector 1032 in cutting, coagulation and/or
desiccation modes. Electrical characteristics of the device 1006
and/or tissue may be measured and used to control operational
aspects of the generator 1002 and/or provide feedback to the user.
In various forms, as previously discussed, the hardware component
may be implemented as a DSP, PLD, ASIC, circuits, and/or registers.
In one form, the processor may be configured to store and execute
computer software program instructions to generate the step
function output signals for driving various components of the
devices 1004, 1006, such as the ultrasonic transducer 1014 and the
end effectors 1026, 1032.
[0041] FIG. 4 illustrates an equivalent circuit 1050 of an
ultrasonic transducer, such as the ultrasonic transducer 1014,
according to one form. The circuit 1050 comprises a first
"motional" branch having a serially connected inductance L.sub.s,
resistance R.sub.s and capacitance C.sub.s that define the
electromechanical properties of the resonator, and a second
capacitive branch having a static capacitance C.sub.o. Drive
current I.sub.g may be received from a generator at a drive voltage
V.sub.g, with motional current I.sub.m flowing through the first
branch and current I.sub.g-I.sub.m flowing through the capacitive
branch. Control of the electromechanical properties of the
ultrasonic transducer may be achieved by suitably controlling
I.sub.g and V.sub.g. As explained above, conventional generator
architectures may include a tuning inductor Lt (shown in phantom in
FIG. 4) for tuning out in a parallel resonance circuit the static
capacitance C.sub.o at a resonant frequency so that substantially
all of generator's current output I.sub.g flows through the
motional branch. In this way, control of the motional branch
current I.sub.m is achieved by controlling the generator current
output I.sub.g. The tuning inductor Lt is specific to the static
capacitance C.sub.o of an ultrasonic transducer, however, and a
different ultrasonic transducer having a different static
capacitance requires a different tuning inductor Lt. Moreover,
because the tuning inductor Lt is matched to the nominal value of
the static capacitance C.sub.o at a single resonant frequency,
accurate control of the motional branch current I.sub.m is assured
only at that frequency, and as frequency shifts down with
transducer temperature, accurate control of the motional branch
current is compromised.
[0042] Forms of the generator 1002 do not rely on a tuning inductor
Lt to monitor the motional branch current I.sub.m. Instead, the
generator 1002 may use the measured value of the static capacitance
C.sub.o in between applications of power for a specific ultrasonic
surgical device 1004 (along with drive signal voltage and current
feedback data) to determine values of the motional branch current
I.sub.m on a dynamic and ongoing basis (e.g., in real-time). Such
forms of the generator 1002 are therefore able to provide virtual
tuning to simulate a system that is tuned or resonant with any
value of static capacitance C.sub.o at any frequency, and not just
at single resonant frequency dictated by a nominal value of the
static capacitance C.sub.o.
[0043] FIG. 5 is a simplified block diagram of one form of the
generator 1002 for proving inductorless tuning as described above,
among other benefits. Additional details of the generator 1002 are
described in commonly assigned U.S. patent application Ser. No.
12/896,360, entitled "Surgical Generator For Ultrasonic And
Electrosurgical Devices," now U.S. Pat. No. 9,060,775, the
disclosure of which is incorporated herein by reference in its
entirety. With reference to FIG. 5, the generator 1002 may comprise
a patient isolated stage 1052 in communication with a non-isolated
stage 1054 via a power transformer 1056. A secondary winding 1058
of the power transformer 1056 is contained in the isolated stage
1052 and may comprise a tapped configuration (e.g., a center-tapped
or a non-center-tapped configuration) to define drive signal
outputs 1060a, 1060b, 1060c for outputting drive signals to
different surgical devices, such as, for example, an ultrasonic
surgical device 1004 and an electrosurgical device 1006. In
particular, drive signal outputs 1060a, 1060c may output an
ultrasonic drive signal (e.g., a 420V RMS drive signal) to an
ultrasonic surgical device 1004, and drive signal outputs 1060b,
1060c may output an electrosurgical drive signal (e.g., a 100V RMS
drive signal) to an electrosurgical device 1006, with output 1060b
corresponding to the center tap of the power transformer 1056.
[0044] In certain forms, the ultrasonic and electrosurgical drive
signals may be provided simultaneously to distinct surgical
instruments and/or to a single surgical instrument having the
capability to deliver both ultrasonic and electrosurgical energy to
tissue. It will be appreciated that the electrosurgical signal,
provided either to a dedicated electrosurgical instrument and/or to
a combined ultrasonic/electrosurgical instrument may be either a
therapeutic or sub-therapeutic level signal.
[0045] The non-isolated stage 1054 may comprise a power amplifier
1062 having an output connected to a primary winding 1064 of the
power transformer 1056. In certain forms the power amplifier 1062
may be comprise a push-pull amplifier. For example, the
non-isolated stage 1054 may further comprise a logic device 1066
for supplying a digital output to a digital-to-analog converter
(DAC) 1068, which in turn supplies a corresponding analog signal to
an input of the power amplifier 1062. In certain forms the logic
device 1066 may comprise a programmable gate array (PGA), a
field-programmable gate array (FPGA), programmable logic device
(PLD), among other logic circuits, for example. The logic device
1066, by virtue of controlling the input of the power amplifier
1062 via the DAC 1068, may therefore control any of a number of
parameters (e.g., frequency, waveform shape, waveform amplitude) of
drive signals appearing at the drive signal outputs 1060a, 1060b,
1060c. In certain forms and as discussed below, the logic device
1066, in conjunction with a processor (e.g., a digital signal
processor discussed below), may implement a number of digital
signal processing (DSP)-based and/or other control algorithms to
control parameters of the drive signals output by the generator
1002.
[0046] Power may be supplied to a power rail of the power amplifier
1062 by a switch-mode regulator 1070. In certain forms the
switch-mode regulator 1070 may comprise an adjustable buck
regulator, for example. The non-isolated stage 1054 may further
comprise a first processor 1074, which in one form may comprise a
DSP processor such as an Analog Devices ADSP-21469 SHARC DSP,
available from Analog Devices, Norwood, Mass., for example,
although in various forms any suitable processor may be employed.
In certain forms the processor 1074 may control operation of the
switch-mode power converter 1070 responsive to voltage feedback
data received from the power amplifier 1062 by the DSP processor
1074 via an analog-to-digital converter (ADC) 1076. In one form,
for example, the DSP processor 1074 may receive as input, via the
ADC 1076, the waveform envelope of a signal (e.g., an RF signal)
being amplified by the power amplifier 1062. The DSP processor 1074
may then control the switch-mode regulator 1070 (e.g., via a
pulse-width modulated (PWM) output) such that the rail voltage
supplied to the power amplifier 1062 tracks the waveform envelope
of the amplified signal. By dynamically modulating the rail voltage
of the power amplifier 1062 based on the waveform envelope, the
efficiency of the power amplifier 1062 may be significantly
improved relative to a fixed rail voltage amplifier schemes.
[0047] In certain forms, the logic device 1066, in conjunction with
the DSP processor 1074, may implement a direct digital synthesizer
(DDS) control scheme to control the waveform shape, frequency
and/or amplitude of drive signals output by the generator 1002. In
one form, for example, the logic device 1066 may implement a DDS
control algorithm by recalling waveform samples stored in a
dynamically-updated look-up table (LUT), such as a RAM LUT, which
may be embedded in an FPGA. This control algorithm is particularly
useful for ultrasonic applications in which an ultrasonic
transducer, such as the ultrasonic transducer 1014, may be driven
by a clean sinusoidal current at its resonant frequency. Because
other frequencies may excite parasitic resonances, minimizing or
reducing the total distortion of the motional branch current may
correspondingly minimize or reduce undesirable resonance effects.
Because the waveform shape of a drive signal output by the
generator 1002 is impacted by various sources of distortion present
in the output drive circuit (e.g., the power transformer 1056, the
power amplifier 1062), voltage and current feedback data based on
the drive signal may be input into an algorithm, such as an error
control algorithm implemented by the DSP processor 1074, which
compensates for distortion by suitably pre-distorting or modifying
the waveform samples stored in the LUT on a dynamic, ongoing basis
(e.g., in real-time). In one form, the amount or degree of
pre-distortion applied to the LUT samples may be based on the error
between a computed motional branch current and a desired current
waveform shape, with the error being determined on a
sample-by-sample basis. In this way, the pre-distorted LUT samples,
when processed through the drive circuit, may result in a motional
branch drive signal having the desired waveform shape (e.g.,
sinusoidal) for optimally driving the ultrasonic transducer. In
such forms, the LUT waveform samples will therefore not represent
the desired waveform shape of the drive signal, but rather the
waveform shape that is required to ultimately produce the desired
waveform shape of the motional branch drive signal when distortion
effects are taken into account.
[0048] The non-isolated stage 1054 may further comprise an ADC 1078
and an ADC 1080 coupled to the output of the power transformer 1056
via respective isolation transformers 1082, 1084 for respectively
sampling the voltage and current of drive signals output by the
generator 1002. In certain forms, the ADCs 1078, 1080 may be
configured to sample at high speeds (e.g., 80 MSPS) to enable
oversampling of the drive signals. In one form, for example, the
sampling speed of the ADCs 1078, 1080 may enable approximately
200.times. (depending on frequency) oversampling of the drive
signals. In certain forms, the sampling operations of the ADC 1078,
1080 may be performed by a singe ADC receiving input voltage and
current signals via a two-way multiplexer. The use of high-speed
sampling in forms of the generator 1002 may enable, among other
things, calculation of the complex current flowing through the
motional branch (which may be used in certain forms to implement
DDS-based waveform shape control described above), accurate digital
filtering of the sampled signals, and calculation of real power
consumption with a high degree of precision. Voltage and current
feedback data output by the ADCs 1078, 1080 may be received and
processed (e.g., FIFO buffering, multiplexing) by the logic device
1066 and stored in data memory for subsequent retrieval by, for
example, the DSP processor 1074. As noted above, voltage and
current feedback data may be used as input to an algorithm for
pre-distorting or modifying LUT waveform samples on a dynamic and
ongoing basis. In certain forms, this may require each stored
voltage and current feedback data pair to be indexed based on, or
otherwise associated with, a corresponding LUT sample that was
output by the logic device 1066 when the voltage and current
feedback data pair was acquired. Synchronization of the LUT samples
and the voltage and current feedback data in this manner
contributes to the correct timing and stability of the
pre-distortion algorithm.
[0049] In certain forms, the voltage and current feedback data may
be used to control the frequency and/or amplitude (e.g., current
amplitude) of the drive signals. In one form, for example, voltage
and current feedback data may be used to determine impedance phase.
The frequency of the drive signal may then be controlled to
minimize or reduce the difference between the determined impedance
phase and an impedance phase setpoint (e.g., 0.degree.), thereby
minimizing or reducing the effects of harmonic distortion and
correspondingly enhancing impedance phase measurement accuracy. The
determination of phase impedance and a frequency control signal may
be implemented in the DSP processor 1074, for example, with the
frequency control signal being supplied as input to a DDS control
algorithm implemented by the logic device 1066.
[0050] In another form, for example, the current feedback data may
be monitored in order to maintain the current amplitude of the
drive signal at a current amplitude setpoint. The current amplitude
setpoint may be specified directly or determined indirectly based
on specified voltage amplitude and power setpoints. In certain
forms, control of the current amplitude may be implemented by
control algorithm, such as, for example, a PID control algorithm,
in the processor 1074. Variables controlled by the control
algorithm to suitably control the current amplitude of the drive
signal may include, for example, the scaling of the LUT waveform
samples stored in the logic device 1066 and/or the full-scale
output voltage of the DAC 1068 (which supplies the input to the
power amplifier 1062) via a DAC 1086.
[0051] The non-isolated stage 1054 may further comprise a second
processor 1090 for providing, among other things user interface
(UI) functionality. In one form, the UI processor 1090 may comprise
an Atmel AT91SAM9263 processor having an ARM 926EJ-S core,
available from Atmel Corporation, San Jose, Calif., for example.
Examples of UI functionality supported by the UI processor 1090 may
include audible and visual user feedback, communication with
peripheral devices (e.g., via a Universal Serial Bus (USB)
interface), communication with the footswitch 1020, communication
with an input device 1009 (e.g., a touch screen display) and
communication with an output device 1047 (e.g., a speaker). The UI
processor 1090 may communicate with the processor 1074 and the
logic device 1066 (e.g., via serial peripheral interface (SPI)
buses). Although the UI processor 1090 may primarily support UI
functionality, it may also coordinate with the DSP processor 1074
to implement hazard mitigation in certain forms. For example, the
UI processor 1090 may be programmed to monitor various aspects of
user input and/or other inputs (e.g., touch screen inputs,
footswitch 1020 inputs (FIG. 3), temperature sensor inputs) and may
disable the drive output of the generator 1002 when an erroneous
condition is detected.
[0052] In certain forms, both the DSP processor 1074 and the UI
processor 1090, for example, may determine and monitor the
operating state of the generator 1002. For the DSP processor 1074,
the operating state of the generator 1002 may dictate, for example,
which control and/or diagnostic processes are implemented by the
DSP processor 1074. For the UI processor 1090, the operating state
of the generator 1002 may dictate, for example, which elements of a
user interface (e.g., display screens, sounds) are presented to a
user. The respective DSP and UI processors 1074, 1090 may
independently maintain the current operating state of the generator
1002 and recognize and evaluate possible transitions out of the
current operating state. The DSP processor 1074 may function as the
master in this relationship and determine when transitions between
operating states are to occur. The UI processor 1090 may be aware
of valid transitions between operating states and may confirm if a
particular transition is appropriate. For example, when the DSP
processor 1074 instructs the UI processor 1090 to transition to a
specific state, the UI processor 1090 may verify that requested
transition is valid. In the event that a requested transition
between states is determined to be invalid by the UI processor
1090, the UI processor 1090 may cause the generator 1002 to enter a
failure mode.
[0053] The non-isolated stage 1054 may further comprise a
controller 1096 for monitoring input devices 1045 (e.g., a
capacitive touch sensor used for turning the generator 1002 on and
off, a capacitive touch screen). In certain forms, the controller
1096 may comprise at least one processor and/or other controller
device in communication with the UI processor 1090. In one form,
for example, the controller 1096 may comprise a processor (e.g., a
Mega168 8-bit controller available from Atmel) configured to
monitor user input provided via one or more capacitive touch
sensors. In one form, the controller 1096 may comprise a touch
screen controller (e.g., a QT5480 touch screen controller available
from Atmel) to control and manage the acquisition of touch data
from a capacitive touch screen.
[0054] In certain forms, when the generator 1002 is in a "power
off" state, the controller 1096 may continue to receive operating
power (e.g., via a line from a power supply of the generator 1002,
such as the power supply 2011 discussed below). In this way, the
controller 196 may continue to monitor an input device 1045 (e.g.,
a capacitive touch sensor located on a front panel of the generator
1002) for turning the generator 1002 on and off. When the generator
1002 is in the power off state, the controller 1096 may wake the
power supply (e.g., enable operation of one or more DC/DC voltage
converters 2013 of the power supply 2011) if activation of the
"on/off" input device 1045 by a user is detected. The controller
1096 may therefore initiate a sequence for transitioning the
generator 1002 to a "power on" state. Conversely, the controller
1096 may initiate a sequence for transitioning the generator 1002
to the power off state if activation of the "on/off" input device
1045 is detected when the generator 1002 is in the power on state.
In certain forms, for example, the controller 1096 may report
activation of the "on/off" input device 1045 to the processor 1090,
which in turn implements the necessary process sequence for
transitioning the generator 1002 to the power off state. In such
forms, the controller 196 may have no independent ability for
causing the removal of power from the generator 1002 after its
power on state has been established.
[0055] In certain forms, the controller 1096 may cause the
generator 1002 to provide audible or other sensory feedback for
alerting the user that a power on or power off sequence has been
initiated. Such an alert may be provided at the beginning of a
power on or power off sequence and prior to the commencement of
other processes associated with the sequence.
[0056] In certain forms, the isolated stage 1052 may comprise an
instrument interface circuit 1098 to, for example, provide a
communication interface between a control circuit of a surgical
device (e.g., a control circuit comprising hand piece switches) and
components of the non-isolated stage 1054, such as, for example,
the programmable logic device 1066, the DSP processor 1074 and/or
the UI processor 190. The instrument interface circuit 1098 may
exchange information with components of the non-isolated stage 1054
via a communication link that maintains a suitable degree of
electrical isolation between the stages 1052, 1054, such as, for
example, an infrared (IR)-based communication link. Power may be
supplied to the instrument interface circuit 1098 using, for
example, a low-dropout voltage regulator powered by an isolation
transformer driven from the non-isolated stage 1054.
[0057] In one form, the instrument interface circuit 198 may
comprise a logic device 2000 (e.g., logic circuit, programmable
logic circuit, PGA, FPGA, PLD) in communication with a signal
conditioning circuit 2002. The signal conditioning circuit 2002 may
be configured to receive a periodic signal from the logic circuit
2000 (e.g., a 2 kHz square wave) to generate a bipolar
interrogation signal having an identical frequency. The
interrogation signal may be generated, for example, using a bipolar
current source fed by a differential amplifier. The interrogation
signal may be communicated to a surgical device control circuit
(e.g., by using a conductive pair in a cable that connects the
generator 102 to the surgical device) and monitored to determine a
state or configuration of the control circuit. The control circuit
may comprise a number of switches, resistors and/or diodes to
modify one or more characteristics (e.g., amplitude, rectification)
of the interrogation signal such that a state or configuration of
the control circuit is uniquely discernable based on the one or
more characteristics. In one form, for example, the signal
conditioning circuit 2002 may comprises an ADC for generating
samples of a voltage signal appearing across inputs of the control
circuit resulting from passage of interrogation signal
therethrough. The logic device 2000 (or a component of the
non-isolated stage 1054) may then determine the state or
configuration of the control circuit based on the ADC samples.
[0058] In one form, the instrument interface circuit 1098 may
comprise a first data circuit interface 2004 to enable information
exchange between the logic circuit 2000 (or other element of the
instrument interface circuit 1098) and a first data circuit
disposed in or otherwise associated with a surgical device. In
certain forms, for example, a first data circuit 2006 (FIG. 2) may
be disposed in a cable integrally attached to a surgical device
hand piece, or in an adaptor for interfacing a specific surgical
device type or model with the generator 1002. The data circuit 2006
may be implemented in any suitable manner and may communicate with
the generator according to any suitable protocol including, for
example, as described herein with respect to the circuit 6006. In
certain forms, the first data circuit may comprise a non-volatile
storage device, such as an electrically erasable programmable
read-only memory (EEPROM) device. In certain forms and referring
again to FIG. 5, the first data circuit interface 2004 may be
implemented separately from the logic device 2000 and comprise
suitable circuitry (e.g., discrete logic devices, a processor) to
enable communication between the programmable logic device 2000 and
the first data circuit. In other forms, the first data circuit
interface 2004 may be integral with the logic device 2000.
[0059] In certain forms, the first data circuit 2006 may store
information pertaining to the particular surgical device with which
it is associated. Such information may include, for example, a
model number, a serial number, a number of operations in which the
surgical device has been used, and/or any other type of
information. This information may be read by the instrument
interface circuit 1098 (e.g., by the logic device 2000),
transferred to a component of the non-isolated stage 1054 (e.g., to
logic device 1066, DSP processor 1074 and/or UI processor 1090) for
presentation to a user via an output device 1047 and/or for
controlling a function or operation of the generator 1002.
Additionally, any type of information may be communicated to first
data circuit 2006 for storage therein via the first data circuit
interface 2004 (e.g., using the logic device 2000). Such
information may comprise, for example, an updated number of
operations in which the surgical device has been used and/or dates
and/or times of its usage.
[0060] As discussed previously, a surgical instrument may be
detachable from a hand piece (e.g., instrument 1024 may be
detachable from hand piece) to promote instrument
interchangeability and/or disposability. In such cases,
conventional generators may be limited in their ability to
recognize particular instrument configurations being used and to
optimize control and diagnostic processes accordingly. The addition
of readable data circuits to surgical device instruments to address
this issue is problematic from a compatibility standpoint, however.
For example, designing a surgical device to remain backwardly
compatible with generators that lack the requisite data reading
functionality may be impractical due to, for example, differing
signal schemes, design complexity, and cost. Forms of instruments
discussed herein address these concerns by using data circuits that
may be implemented in existing surgical instruments economically
and with minimal design changes to preserve compatibility of the
surgical devices with current generator platforms.
[0061] Additionally, forms of the generator 1002 may enable
communication with instrument-based data circuits. For example, the
generator 1002 may be configured to communicate with a second data
circuit 2007 contained in an instrument (e.g., instrument 1024) of
a surgical device (FIG. 2). In some forms, the second data circuit
2007 may be implemented in a many similar to that of the data
circuit 6006 described herein. The instrument interface circuit
1098 may comprise a second data circuit interface 2010 to enable
this communication. In one form, the second data circuit interface
2010 may comprise a tri-state digital interface, although other
interfaces may also be used. In certain forms, the second data
circuit may generally be any circuit for transmitting and/or
receiving data. In one form, for example, the second data circuit
may store information pertaining to the particular surgical
instrument with which it is associated. Such information may
include, for example, a model number, a serial number, a number of
operations in which the surgical instrument has been used, and/or
any other type of information. In some forms, the second data
circuit 2007 may store information about the electrical and/or
ultrasonic properties of an associated transducer 1014, end
effector 1026, or ultrasonic drive system. For example, the first
data circuit 2006 may indicate a burn-in frequency slope, as
described herein. Additionally or alternatively, any type of
information may be communicated to second data circuit for storage
therein via the second data circuit interface 2010 (e.g., using the
logic device 2000). Such information may comprise, for example, an
updated number of operations in which the instrument has been used
and/or dates and/or times of its usage. In certain forms, the
second data circuit may transmit data acquired by one or more
sensors (e.g., an instrument-based temperature sensor). In certain
forms, the second data circuit may receive data from the generator
1002 and provide an indication to a user (e.g., an LED indication
or other visible indication) based on the received data.
[0062] In certain forms, the second data circuit and the second
data circuit interface 2010 may be configured such that
communication between the logic device 2000 and the second data
circuit can be effected without the need to provide additional
conductors for this purpose (e.g., dedicated conductors of a cable
connecting a hand piece to the generator 1002). In one form, for
example, information may be communicated to and from the second
data circuit using a 1-wire bus communication scheme implemented on
existing cabling, such as one of the conductors used transmit
interrogation signals from the signal conditioning circuit 2002 to
a control circuit in a hand piece. In this way, design changes or
modifications to the surgical device that might otherwise be
necessary are minimized or reduced. Moreover, because different
types of communications implemented over a common physical channel
can be frequency-band separated, the presence of a second data
circuit may be "invisible" to generators that do not have the
requisite data reading functionality, thus enabling backward
compatibility of the surgical device instrument.
[0063] In certain forms, the isolated stage 1052 may comprise at
least one blocking capacitor 2096-1 connected to the drive signal
output 1060b to prevent passage of DC current to a patient. A
single blocking capacitor may be required to comply with medical
regulations or standards, for example. While failure in
single-capacitor designs is relatively uncommon, such failure may
nonetheless have negative consequences. In one form, a second
blocking capacitor 2096-2 may be provided in series with the
blocking capacitor 2096-1, with current leakage from a point
between the blocking capacitors 2096-1, 2096-2 being monitored by,
for example, an ADC 2098 for sampling a voltage induced by leakage
current. The samples may be received by the logic circuit 2000, for
example. Based changes in the leakage current (as indicated by the
voltage samples in the form of FIG. 5), the generator 1002 may
determine when at least one of the blocking capacitors 2096-1,
2096-2 has failed. Accordingly, the form of FIG. 5 provides a
benefit over single-capacitor designs having a single point of
failure.
[0064] In certain forms, the non-isolated stage 1054 may comprise a
power supply 2011 for outputting DC power at a suitable voltage and
current. The power supply may comprise, for example, a 400 W power
supply for outputting a 48 VDC system voltage. The power supply
2011 may further comprise one or more DC/DC voltage converters 2013
for receiving the output of the power supply to generate DC outputs
at the voltages and currents required by the various components of
the generator 1002. As discussed above in connection with the
controller 1096, one or more of the DC/DC voltage converters 2013
may receive an input from the controller 1096 when activation of
the "on/off" input device 1045 by a user is detected by the
controller 1096 to enable operation of, or wake, the DC/DC voltage
converters 2013.
[0065] Having described operational details of various forms of the
surgical system 10 (FIG. 1) operations for the above surgical
system 10 may be further described generally in terms of a process
for cutting and coagulating tissue employing a surgical instrument
comprising an input device 1045 and the generator 1002. Although a
particular process is described in connection with the operational
details, it can be appreciated that the process merely provides an
example of how the general functionality described herein can be
implemented by the surgical system 10. Further, the given process
does not necessarily have to be executed in the order presented
herein unless otherwise indicated. As previously discussed, the
input devices 1045 may be employed to program the output (e.g.,
impedance, current, voltage, frequency) of the surgical devices
1002, 1006 (FIG. 1).
[0066] FIG. 6 illustrates one form of a drive system 32 of the
generator 1002, which creates an ultrasonic electrical signal for
driving an ultrasonic transducer, also referred to as a drive
signal. The drive system 32 is flexible and can create an
ultrasonic electrical drive signal 416 at a desired frequency and
power level setting for driving the ultrasonic transducer 50. In
various forms, the generator 1002 may comprise several separate
functional elements, such as modules and/or blocks. Although
certain modules and/or blocks may be described by way of example,
it can be appreciated that a greater or lesser number of modules
and/or blocks may be used and still fall within the scope of the
forms. Further, although various forms 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.
[0067] In one form, the generator 1002 drive system 32 may comprise
one or more embedded applications implemented as firmware,
software, hardware, or any combination thereof. The generator 1002
drive system 32 may comprise various executable modules such as
software, programs, data, drivers, application program interfaces
(APIs), and so forth. The firmware may be stored in nonvolatile
memory (NVM), such as in bit-masked read-only memory (ROM) or flash
memory. In various implementations, storing the firmware in ROM may
preserve flash memory. The NVM may comprise other types of memory
including, for example, programmable ROM (PROM), erasable
programmable ROM (EPROM), electrically erasable programmable ROM
(EEPROM), or battery backed random-access memory (RAM) such as
dynamic RAM (DRAM), Double-Data-Rate DRAM (DDRAM), and/or
synchronous DRAM (SDRAM).
[0068] In one form, the generator 1002 drive system 32 comprises a
hardware component implemented as a processor 400 for executing
program instructions for monitoring various measurable
characteristics of the ultrasonic surgical instrument 1004 (FIG. 1)
and generating a step function output signal for driving the
ultrasonic transducer in cutting and/or coagulation operating
modes. It will be appreciated by those skilled in the art that the
generator 1002 and the drive system 32 may comprise additional or
fewer components and only a simplified version of the generator
1002 and the drive system 32 are described herein for conciseness
and clarity. In various forms, as previously discussed, the
hardware component may be implemented as a DSP, PLD, ASIC,
circuits, and/or registers. In one form, the processor 400 may be
configured to store and execute computer software program
instructions to generate the step function output signals for
driving various components of the ultrasonic surgical instrument
1004, such as a transducer, an end effector, and/or a blade.
[0069] In one form, under control of one or more software program
routines, the processor 400 executes the methods in accordance with
the described forms to generate a step function formed by a
stepwise waveform of drive signals comprising current (I), voltage
(V), and/or frequency (f) for various time intervals or periods
(T). The stepwise waveforms of the drive signals may be generated
by forming a piecewise linear combination of constant functions
over a plurality of time intervals created by stepping the
generator 30 drive signals, e.g., output drive current (I), voltage
(V), and/or frequency (f). The time intervals or periods (T) may be
predetermined (e.g., fixed and/or programmed by the user) or may be
variable. Variable time intervals may be defined by setting the
drive signal to a first value and maintaining the drive signal at
that value until a change is detected in a monitored
characteristic. Examples of monitored characteristics may comprise,
for example, transducer impedance, tissue impedance, tissue
heating, tissue transection, tissue coagulation, and the like. The
ultrasonic drive signals generated by the generator 30 include,
without limitation, ultrasonic drive signals capable of exciting
the ultrasonic transducer 50 in various vibratory modes such as,
for example, the primary longitudinal mode and harmonics thereof as
well flexural and torsional vibratory modes.
[0070] In one form, the executable modules comprise one or more
step function algorithm(s) 402 stored in memory that when executed
causes the processor 400 to generate a step function formed by a
stepwise waveform of drive signals comprising current (I), voltage
(V), and/or frequency (f) for various time intervals or periods
(T). The stepwise waveforms of the drive signals may be generated
by forming a piecewise linear combination of constant functions
over two or more time intervals created by stepping the generator's
1002 output drive current (I), voltage (V), and/or frequency (f).
The drive signals may be generated either for predetermined fixed
time intervals or periods (T) of time or variable time intervals or
periods of time in accordance with the one or more stepped output
algorithm(s) 402. Under control of the processor 400, the generator
1002 steps (e.g., increment or decrement) the current (I), voltage
(V), and/or frequency (f) up or down at a particular resolution for
a predetermined period (T) or until a predetermined condition is
detected, such as a change in a monitored characteristic (e.g.,
transducer impedance, tissue impedance). The steps can change in
programmed increments or decrements. If other steps are desired,
the generator 1002 can increase or decrease the step adaptively
based on measured system characteristics.
[0071] In operation, the user can program the operation of the
generator 1002 using the input device 406 located on the front
panel of the generator 1002 console. The input device 406 may
comprise any suitable device that generates signals 408 that can be
applied to the processor 400 to control the operation of the
generator 1002. In various forms, the input device 406 includes
buttons, switches, thumbwheels, keyboard, keypad, touch screen
monitor, pointing device, remote connection to a general purpose or
dedicated computer. In other forms, the input device 406 may
comprise a suitable user interface. Accordingly, by way of the
input device 406, the user can set or program the current (I),
voltage (V), frequency (f), and/or period (T) for programming the
step function output of the generator 30. The processor 400 then
displays the selected power level by sending a signal on line 410
to an output indicator 412.
[0072] In various forms, the output indicator 412 may provide
visual, audible, and/or tactile feedback to the surgeon to indicate
the status of a surgical procedure, such as, for example, when
tissue cutting and coagulating is complete based on a measured
characteristic of the ultrasonic surgical instrument 1004, e.g.,
transducer impedance, tissue impedance, or other measurements as
subsequently described. By way of example, and not limitation,
visual feedback comprises any type of visual indication device
including incandescent lamps or light emitting diodes (LEDs),
graphical user interface, display, analog indicator, digital
indicator, bar graph display, digital alphanumeric display. By way
of example, and not limitation, audible feedback comprises any type
of buzzer, computer generated tone, computerized speech, voice user
interface (VUI) to interact with computers through a voice/speech
platform. By way of example, and not limitation, tactile feedback
comprises any type of vibratory feedback provided through an
instrument housing handle assembly.
[0073] In one form, the processor 400 may be configured or
programmed to generate a digital current signal 414 and a digital
frequency signal 418. These signals 414, 418 are applied to a
direct digital synthesizer (DDS) circuit 420 to adjust the
amplitude and the frequency (f) of the current output signal 416 to
the transducer. The output of the DDS circuit 420 is applied to an
amplifier 422 whose output is applied to a transformer 424. The
output of the transformer 424 is the signal 416 applied to the
ultrasonic transducer, which is coupled to a blade by way of a
waveguide.
[0074] In one form, the generator 1002 comprises one or more
measurement modules or components that may be configured to monitor
measurable characteristics of the ultrasonic instrument 1004 (FIG.
1). In the illustrated form, the processor 400 may be employed to
monitor and calculate system characteristics. As shown, the
processor 400 measures the impedance Z of the transducer by
monitoring the current supplied to the transducer 50 and the
voltage applied to the transducer. In one form, a current sense
circuit 426 is employed to sense the current flowing through the
transducer and a voltage sense circuit 428 is employed to sense the
output voltage applied to the transducer. These signals may be
applied to the analog-to-digital converter 432 (ADC) via an analog
multiplexer 430 circuit or switching circuit arrangement. The
analog multiplexer 430 routes the appropriate analog signal to the
ADC 432 for conversion. In other forms, multiple ADCs 432 may be
employed for each measured characteristic instead of the
multiplexer 430 circuit. The processor 400 receives the digital
output 433 of the ADC 432 and calculates the transducer impedance Z
based on the measured values of current and voltage. The processor
400 adjusts the output drive signal 416 such that it can generate a
desired power versus load curve. In accordance with programmed step
function algorithms 402, the processor 400 can step the drive
signal 416, e.g., the current or frequency, in any suitable
increment or decrement in response to the transducer impedance
Z.
[0075] Having described operational details of various forms of the
surgical system 10, operations for the above surgical system 10 may
be further described in terms of a process for cutting and
coagulating a blood vessel employing a surgical instrument
comprising the input device 1045 and the transducer impedance
measurement capabilities described with reference to FIG. 6.
Although a particular process is described in connection with the
operational details, it can be appreciated that the process merely
provides an example of how the general functionality described
herein can be implemented by the surgical system 10. Further, the
given process does not necessarily have to be executed in the order
presented herein unless otherwise indicated.
[0076] In various forms, feedback is provided by the output
indicator 412 shown in FIGS. 6 and 7. The output indicator 412 is
particularly useful in applications where the tissue being
manipulated by the end effector is out of the user's field of view
and the user cannot see when a change of state occurs in the
tissue. The output indicator 412 communicates to the user that a
change in tissue state has occurred. As previously discussed, the
output indicator 412 may be configured to provide various types of
feedback to the user including, without limitation, visual,
audible, and/or tactile feedback to indicate to the user (e.g.,
surgeon, clinician) that the tissue has undergone a change of state
or condition of the tissue. By way of example, and not limitation,
as previously discussed, visual feedback comprises any type of
visual indication device including incandescent lamps or LEDs,
graphical user interface, display, analog indicator, digital
indicator, bar graph display, digital alphanumeric display. By way
of example, and not limitation, audible feedback comprises any type
of buzzer, computer generated tone, computerized speech, VUI to
interact with computers through a voice/speech platform. By way of
example, and not limitation, tactile feedback comprises any type of
vibratory feedback provided through the instrument housing handle
assembly. The change of state of the tissue may be determined based
on transducer and tissue impedance measurements as previously
described, or based on voltage, current, and frequency
measurements.
[0077] In one form, the various executable modules (e.g.,
algorithms) comprising computer readable instructions can be
executed by the processor 400 (FIGS. 6, 7) portion of the generator
1002. In various forms, the operations described with respect to
the algorithms may be implemented as one or more software
components, e.g., programs, subroutines, logic; one or more
hardware components, e.g., processors, DSPs, PLDs, ASICs, circuits,
registers; and/or combinations of software and hardware. In one
form, the executable instructions to perform the algorithms may be
stored in memory. When executed, the instructions cause the
processor 400 to determine a change in tissue state provide
feedback to the user by way of the output indicator 412. In
accordance with such executable instructions, the processor 400
monitors and evaluates the voltage, current, and/or frequency
signal samples available from the generator 1002 and according to
the evaluation of such signal samples determines whether a change
in tissue state has occurred. As further described below, a change
in tissue state may be determined based on the type of ultrasonic
instrument and the power level that the instrument is energized at.
In response to the feedback, the operational mode of the ultrasonic
surgical instrument 1004 may be controlled by the user or may be
automatically or semi-automatically controlled.
[0078] The surgical instruments described herein can also include
features to allow a user, such as a clinician, to select from a
plurality of surgical modes based on the type of surgical procedure
being performed and the type of tissue being treated by an end
effector of a surgical instrument. Each surgical mode corresponds
to an algorithm for controlling the power output from a generator,
such as generator 1002, that is delivered to the end effector of
the surgical instrument. As illustrated in FIG. 8, a surgical
instrument 20 can include a selector switch 22 that allows a
clinician to select between various surgical modes.
[0079] Various algorithms can be used to allow for the selection of
a plurality of surgical modes. In one form, a surgical mode can be
based on the tissue being treated by the end effector. The surgical
mode can also vary by the type of energy being delivered by the
generator. It is possible for the generator to deliver energy that
is adaptive based on changes to the tissue as the tissue is being
treated by the end effector. In one form, the generator can monitor
the temperature of the tissue and adjust the frequency of the
output to regulate the temperature change in the tissue. In one
form, the surgical instrument can include a switch for disabling
the adaptive energy such that the user can control the delivery of
adaptive energy from the generator regardless of the selected
surgical mode. For example, one surgical mode can be selected for
cutting avascular tissue and can include a high power output from
the generator that is optimized for transection speed. Another
surgical mode can be selected for coagulating tissue or vessels and
can include low power output from the generator that is optimized
for hemostasis of vessels. Another surgical mode can be selected
for the treatment of solid organs and can include a lower power
level output without adaptive energy from the generator that is
optimized for the hemostasis of solid organs.
[0080] Although FIG. 8 illustrates a selector switch to control the
selection of a surgical mode, various other techniques can be
employed to allow a user to select a surgical mode. In one form,
software on the surgical instrument can be used. For example, the
surgical instruments can include a display such that the plurality
of available surgical modes can be selected using the display.
Similarly, in another form, the generator, such as generator 1002,
can include software and a display such that the plurality of
available surgical modes can be selected using the display on the
generator. In another form, software can be included, either in the
generator or the surgical instrument, to allow voice activation of
a surgical mode. In another form, an external communication device
can be used to communicate with either the generator or the
surgical instrument to allow for the selection of a surgical mode.
For example, any type of personal communication device can
communicate with either the generator or the surgical instrument
using a variety of techniques, including but not limited to short
range radio, WiFi, or bluetooth technologies. The personal
communication device can include software having the plurality of
surgical modes such that a user can select one or more desired
surgical modes using the personal communication device.
[0081] FIG. 9 illustrates a logic flow diagram 30 of one form of
selecting a surgical mode corresponding to a tissue algorithm that
may be implemented in one form of a generator. With reference now
to the logic flow diagram 30 shown in FIG. 9 and the surgical
system 10 of FIG. 1, a user selects 32 a surgical mode that
corresponding to an algorithm for controlling the generator 1002
using a selector switch, such as the selector switch 22 of FIG. 8.
The selected algorithm is used to control 34 the power output from
the generator 1002. The power output from the generator 1002 is
delivered 36 to the end effector of the surgical instrument such
that the end effector can be used to treat tissue positioned within
the end effector. A user determines 38 if an additional surgical
mode is required to continue the surgical procedure being
performed. If an additional surgical mode is not needed, the
generator 1002 can be deactivated 40. If an additional surgical
mode is required to continue the procedure, the user can select 42
another of the plurality of surgical modes to continue and complete
the procedure. Any number of surgical modes can be selected in
succession until the surgical procedure is completed.
[0082] Different clinicians often have different techniques for
using ultrasonic surgical instruments and systems as described
herein. In some forms, algorithms that can be customized and
modified by a clinician can be employed. There are various aspects
of the surgical mode algorithms that can be customized by a user.
In one form, the power output from the generator and/or the timing
of any drop in power can be selected. In one form, feedback from
any component of the surgical system 10 can be selected, including
the functionality of any monitors of audio feedback, such that the
user can customize the feedback received during a surgical
procedure.
[0083] The user also can communicate with the surgical system in a
variety of ways to allow the use of the customized surgical modes.
In one form, the generator can include a receptacle for receiving
an input device having customized surgical modes thereon. For
example, the input device can be in the form of an RFID swipe key,
a USB device, or some form of digital passcode. The input device
can also be in the form of a personal communication device that
allows the user to create and modify customized surgical modes
thereon and communicate, either wired and wirelessly with the
generator. The input device can communicate the customized surgical
modes to the generator such that, when a surgical mode is selected
for use in a surgical procedure, the generator will deliver an
output that corresponds to the setting customized for that
particular user.
[0084] FIG. 10 illustrates a logic flow diagram 50 of one form of
customizing a surgical mode corresponding to a tissue algorithm
that may be implemented in one form of a generator. With reference
now to the logic flow diagram 50 shown in FIG. 10 and the surgical
system 10 of FIG. 1, a user selects 52 a surgical mode for
customization that corresponding to an algorithm for controlling
the generator 1002. The selected algorithm is customized by
selecting 54 a desired power output from the generator 1002. For
example, a user can select 54 a minimum and/or maximum power output
to be delivered by the generator during the use of that surgical
mode. The selected algorithm is customized by selecting 56 a power
drop and timing of the power drop for the power output from the
generator during the use of that surgical mode. The customized
algorithm is communicated 58 to the generator 1002 using any of the
techniques described herein. It will be appreciate that any aspect
of the power output from the generator 1002 can be customized and
modified by a user to create a custom algorithm for use during a
surgical procedure.
[0085] It can also be advantageous to employ techniques to lengthen
the life of the energy pads on the end effectors. For example, the
pad life can be improved by waiting for closure of the end effector
around the tissue as both energy delivered to the pads without
tissue compressed therebetween and friction can decreased the life
and number of uses of the end effector pads. In various forms, this
and other problems may be addressed by configuring a surgical
instrument with a closure switch indicating when the end effector
is fully closed with tissue therebetween. The generator may be
configured to refrain from activating the surgical instrument until
or unless the closure switch indicates that the clamp arm is fully
closed. The closure switch can have various forms, including being
positioned in a handle of a surgical device. The closure switch may
be in electrical communication with the generator, such as
generator 1002, for example. In one form, the generator is
programmed not to activate the surgical instrument unless the
switch indicates that the end effector is closed. For example, if
the generator receives an activation request from one or more of
the switches described herein, it may respond to the activation
request only if the closure switch is activated to indicate that
the end effector is closed. This allows the position of the end
effector and the state of the closure switch to be used as an input
to an algorithm for controlling the power output of the
generator.
[0086] In another form, the generator is programmed not to activate
any type of adaptive energy unless the switch indicates that the
end effector is closed. For example, if the generator receives an
activation request from one or more of the switches described
herein, it may respond to the activation request with adaptive
energy only if the closure switch is activated to indicate that the
end effector is closed. If the closure switch is not activated,
indicating that the end effector is open, the generator can respond
by delivering non-adaptive energy that can be used in certain
surgical situations, such as back cutting or transecting a solid
organ. If the closure switch is activated, indicating that the end
effector is closed, the generator can respond by delivering
adaptive energy that will be activated for the full activation
cycle of the selected surgical mode, and can be used to most
surgical situations such as any normal use of the end effector on
tissue or vessels.
[0087] As illustrated in FIG. 2, the surgical instrument can
include a trigger that is used to move the end effector 1026. In
one form, the trigger moves the end effector between a first
position in which the end effector is opened and a second position
in which the end effector is closed on a tissue for treatment. When
the end effector is closed, the generator can deliver adaptive
energy to the end effector to treat the tissue.
[0088] FIG. 11 illustrates a logic flow diagram 60 for selecting a
surgical mode corresponding to a tissue algorithm using the
position of an end effector of a surgical instrument as an
algorithm input. With reference now to the logic flow diagram 60
shown in FIG. 11 and the surgical system 10 of FIG. 1, a user
selects 62 a surgical mode corresponding to an algorithm for
controlling the generator 1002. The selected algorithm is used to
control 64 the power output from the generator. Before the power is
delivered to the end effector, the positon of the closure switch on
the surgical instrument is checked 66. For example, the positon of
the trigger used to control the end effector is used an input to
the algorithm. When the closure switch, or trigger, is in a first
position such that switch and the end effector are open, the
adaptive energy mode of the generator is disabled such that the
adaptive energy cannot be delivered 68 to the end effector. When
the closure switch, or trigger, is in a second position such that
switch and the end effector are closed on the tissue to be treated,
the adaptive energy mode of the generator is enabled such that the
adaptive energy can be delivered 70 to the end effector.
[0089] In one form, it is possible to measure the position of the
end effector to more precisely control the power output from the
generator based on the position of the end effector relative to the
tissue. In addition to the end effector being opened or closed
around tissue, the end effector can also be partially closed around
tissue. The angle of the partial closure of the end effector can be
used to modify the power output from the generator rather that just
activate or deactivate the adaptive energy delivered therefrom.
FIG. 12 illustrates another form of a logic flow diagram 80 for
selecting a surgical mode corresponding to a tissue algorithm using
the position of an end effector of a surgical instrument as an
algorithm input. With reference now to the logic flow diagram 80
shown in FIG. 12 and the surgical system 10 of FIG. 1, a user
selects 82 a surgical mode corresponding to an algorithm for
controlling the generator 1002. The selected algorithm is used to
control 84 the power output from the generator. Before the power is
delivered to the end effector, the positon of the closure switch on
the surgical instrument is checked 86. For example, the positon of
the trigger used to control the end effector is used an input to
the algorithm. When the closure switch, or trigger, is in a first
position such that switch and the end effector are open, the
adaptive energy mode of the generator is disabled such that the
adaptive energy cannot be delivered 88 to the end effector. When
the closure switch, or trigger, is in a second position such that
switch and the end effector are closed on the tissue to be treated,
the adaptive energy mode of the generator is enabled such that the
adaptive energy can be delivered 92 to the end effector.
Measurement of the angle of closure of the end effector is used to
adjust 90 the energy delivered from the generator 1002. In one
form, the frequency slope of the energy can be varied depending on
the angle of closure of the end effector. As the pressure on the
tissue by the end effector increases and the angle of closure
decreases, the power can be altered depending on the desired effect
on tissue for the selected surgical mode. For example, the energy
can be decreased to maintain constant cutting of the tissue as the
angle of closure decreases.
[0090] The pad life of the end effectors can also be improved by
taking in account the number of activation of the end effectors
when the end effectors are closed on tissue. Thus, the adaptive
energy delivered from the generator can be varied as a function of
the number of closed activations of the end effectors. In one form,
the adaptive energy can be delivered closer to the start of an
activation cycle for a selected surgical mode as the number of
closed activations of the end effectors increases. For example, a
counter can be employed that tracks the number of closed
activations of the end effectors and can be used as an input to the
algorithm for controlling the energy delivered to the end effectors
from the generator. Thus, the delivered adaptive energy can be
varied based on the number of activations of the energy pads on the
end effectors.
[0091] FIG. 13 illustrates another form of a logic flow diagram 100
for selecting a surgical mode corresponding to a tissue algorithm
using the position of an end effector of a surgical instrument as
an algorithm input. With reference now to the logic flow diagram
100 shown in FIG. 13 and the surgical system 10 of FIG. 1, a user
selects 102 a surgical mode corresponding to an algorithm for
controlling the generator 1002. The selected algorithm is used to
control 104 the power output from the generator. Before the power
is delivered to the end effector, the positon of the closure switch
on the surgical instrument is checked 106. For example, the positon
of the trigger used to control the end effector is used an input to
the algorithm. When the closure switch, or trigger, is in a first
position such that switch and the end effector are open, the
adaptive energy mode of the generator is disabled such that the
adaptive energy cannot be delivered 108 to the end effector. When
the closure switch, or trigger, is in a second position such that
switch and the end effector are closed on the tissue to be treated,
a counter that measures the number of closed activations of the end
effectors is increased 110. It is possible to compare 112 the
counter to a threshold, for example, that could inform a user that
the energy pads on the end effectors should be replaced as there
have been a large number of closed activations. The adaptive energy
mode of the generator is enabled such that the adaptive energy can
be delivered 114 to the end effector. The adaptive energy delivered
will be affected by the counter as the counter will be used as an
input for the algorithm that controls the energy delivered by the
generator.
[0092] As explained above, there are a plurality of surgical modes
that can be utilized for controlling the output from the generator.
The following table, Table 1, illustrates exemplary surgical modes
and algorithms for controlling the power output from the
generator.
TABLE-US-00001 TABLE 1 Surgical Mode Generator output Effect on
tissue Solid organ mode Adaptive energy is disabled The end
effector is hot enough to and closure switch seal bloody tissue and
can be used detection is disabled when the end effector is
partially open Wet field mode The overall current setpoint Tissue
sealing in a wet field is increases for higher heat increased as
the system overdrives to and faster cutting account for the heat
sinking fluid Marching mode Adaptive energy delivery is delayed The
end effector heats up, the and drops current less during the
transection time decreases, and the activation cycle, and if it is
active pad life is preserved for a threshold amount of time then
the adaptive energy is re-engaged to a normal level to increase the
pad life. The maximum button set point for current increases.
Low-heat mode High and low current is pulsed after Cutting speed is
increased and the an impedance threshold is met heat at the end
effector is lowered Adaptive energy The time before adaptive energy
is Slow transections are prevented delay triggered in an activation
cycle is increased
[0093] While various details have been set forth in the foregoing
description, it will be appreciated that the various aspects of the
serial communication protocol for medical device may be practiced
without these specific details. For example, for conciseness and
clarity selected aspects have been shown in block diagram form
rather than in detail. Some portions of the detailed descriptions
provided herein may be presented in terms of instructions that
operate on data that is stored in a computer memory. Such
descriptions and representations are used by those skilled in the
art to describe and convey the substance of their work to others
skilled in the art. In general, an algorithm refers to a
self-consistent sequence of steps leading to a desired result,
where a "step" refers to a manipulation of physical quantities
which may, though need not necessarily, take the form of electrical
or magnetic signals capable of being stored, transferred, combined,
compared, and otherwise manipulated. It is common usage to refer to
these signals as bits, values, elements, symbols, characters,
terms, numbers, or the like. These and similar terms may be
associated with the appropriate physical quantities and are merely
convenient labels applied to these quantities.
[0094] Unless specifically stated otherwise as apparent from the
foregoing discussion, it is appreciated that, throughout the
foregoing description, discussions using terms such as "processing"
or "computing" or "calculating" or "determining" or "displaying" or
the like, refer to the action and processes of a computer system,
or similar electronic computing device, that manipulates and
transforms data represented as physical (electronic) quantities
within the computer system's registers and memories into other data
similarly represented as physical quantities within the computer
system memories or registers or other such information storage,
transmission or display devices.
[0095] It is worthy to note that any reference to "one aspect," "an
aspect," "one form," or "an form" means that a particular feature,
structure, or characteristic described in connection with the
aspect is included in at least one aspect. Thus, appearances of the
phrases "in one aspect," "in an aspect," "in one form," or "in an
form" in various places throughout the specification are not
necessarily all referring to the same aspect. Furthermore, the
particular features, structures or characteristics may be combined
in any suitable manner in one or more aspects.
[0096] Some aspects may be described using the expression "coupled"
and "connected" along with their derivatives. It should be
understood that these terms are not intended as synonyms for each
other. For example, some aspects may be described using the term
"connected" to indicate that two or more elements are in direct
physical or electrical contact with each other. In another example,
some aspects may be described using the term "coupled" to indicate
that two or more elements are in direct physical or electrical
contact. The term "coupled," however, also may mean that two or
more elements are not in direct contact with each other, but yet
still co-operate or interact with each other.
[0097] It is worthy to note that any reference to "one aspect," "an
aspect," "one form," or "an form" means that a particular feature,
structure, or characteristic described in connection with the
aspect is included in at least one aspect. Thus, appearances of the
phrases "in one aspect," "in an aspect," "in one form," or "in an
form" in various places throughout the specification are not
necessarily all referring to the same aspect. Furthermore, the
particular features, structures or characteristics may be combined
in any suitable manner in one or more aspects.
[0098] Although various forms have been described herein, many
modifications, variations, substitutions, changes, and equivalents
to those forms may be implemented and will occur to those skilled
in the art. Also, where materials are disclosed for certain
components, other materials may be used. It is therefore to be
understood that the foregoing description and the appended claims
are intended to cover all such modifications and variations as
falling within the scope of the disclosed forms. The following
claims are intended to cover all such modification and
variations.
[0099] In a general sense, those skilled in the art will recognize
that the various aspects described herein which can be implemented,
individually and/or collectively, by a wide range of hardware,
software, firmware, or any combination thereof can be viewed as
being composed of various types of "electrical circuitry."
Consequently, as used herein "electrical circuitry" includes, but
is not limited to, electrical circuitry having at least one
discrete electrical circuit, electrical circuitry having at least
one integrated circuit, electrical circuitry having at least one
application specific integrated circuit, electrical circuitry
forming a general purpose computing device configured by a computer
program (e.g., a general purpose computer configured by a computer
program which at least partially carries out processes and/or
devices described herein, or a microprocessor configured by a
computer program which at least partially carries out processes
and/or devices described herein), electrical circuitry forming a
memory device (e.g., forms of random access memory), and/or
electrical circuitry forming a communications device (e.g., a
modem, communications switch, or optical-electrical equipment).
Those having skill in the art will recognize that the subject
matter described herein may be implemented in an analog or digital
fashion or some combination thereof.
[0100] The foregoing detailed description has set forth various
forms of the devices and/or processes via the use of block
diagrams, flowcharts, and/or examples. Insofar as such block
diagrams, flowcharts, and/or examples contain one or more functions
and/or operations, it will be understood by those within the art
that each function and/or operation within such block diagrams,
flowcharts, or examples can be implemented, individually and/or
collectively, by a wide range of hardware, software, firmware, or
virtually any combination thereof. In one form, several portions of
the subject matter described herein may be implemented via
Application Specific Integrated Circuits (ASICs), Field
Programmable Gate Arrays (FPGAs), digital signal processors (DSPs),
or other integrated formats. However, those skilled in the art will
recognize that some aspects of the forms disclosed herein, in whole
or in part, can be equivalently implemented in integrated circuits,
as one or more computer programs running on one or more computers
(e.g., as one or more programs running on one or more computer
systems), as one or more programs running on one or more processors
(e.g., as one or more programs running on one or more
microprocessors), as firmware, or as virtually any combination
thereof, and that designing the circuitry and/or writing the code
for the software and or firmware would be well within the skill of
one of skill in the art in light of this disclosure. In addition,
those skilled in the art will appreciate that the mechanisms of the
subject matter described herein are capable of being distributed as
a program product in a variety of forms, and that an illustrative
form of the subject matter described herein applies regardless of
the particular type of signal bearing medium used to actually carry
out the distribution. Examples of a signal bearing medium include,
but are not limited to, the following: a recordable type medium
such as a floppy disk, a hard disk drive, a Compact Disc (CD), a
Digital Video Disk (DVD), a digital tape, a computer memory, etc.;
and a transmission type medium such as a digital and/or an analog
communication medium (e.g., a fiber optic cable, a waveguide, a
wired communications link, a wireless communication link (e.g.,
transmitter, receiver, transmission logic, reception logic, etc.),
etc.).
[0101] All of the above-mentioned U.S. patents, U.S. patent
application publications, U.S. patent applications, foreign
patents, foreign patent applications, non-patent publications
referred to in this specification and/or listed in any Application
Data Sheet, or any other disclosure material are incorporated
herein by reference, to the extent not inconsistent herewith. As
such, and to the extent necessary, the disclosure as explicitly set
forth herein supersedes any conflicting material incorporated
herein by reference. Any material, or portion thereof, that is said
to be incorporated by reference herein, but which conflicts with
existing definitions, statements, or other disclosure material set
forth herein will only be incorporated to the extent that no
conflict arises between that incorporated material and the existing
disclosure material.
[0102] One skilled in the art will recognize that the herein
described components (e.g., operations), devices, objects, and the
discussion accompanying them are used as examples for the sake of
conceptual clarity and that various configuration modifications are
contemplated. Consequently, as used herein, the specific exemplars
set forth and the accompanying discussion are intended to be
representative of their more general classes. In general, use of
any specific exemplar is intended to be representative of its
class, and the non-inclusion of specific components (e.g.,
operations), devices, and objects should not be taken limiting.
[0103] With respect to the use of substantially any plural and/or
singular terms herein, those having skill in the art can translate
from the plural to the singular and/or from the singular to the
plural as is appropriate to the context and/or application. The
various singular/plural permutations are not expressly set forth
herein for sake of clarity.
[0104] The herein described subject matter sometimes illustrates
different components contained within, or connected with, different
other components. It is to be understood that such depicted
architectures are merely exemplary, and that in fact many other
architectures may be implemented which achieve the same
functionality. In a conceptual sense, any arrangement of components
to achieve the same functionality is effectively "associated" such
that the desired functionality is achieved. Hence, any two
components herein combined to achieve a particular functionality
can be seen as "associated with" each other such that the desired
functionality is achieved, irrespective of architectures or
intermedial components. Likewise, any two components so associated
can also be viewed as being "operably connected," or "operably
coupled," to each other to achieve the desired functionality, and
any two components capable of being so associated can also be
viewed as being "operably couplable," to each other to achieve the
desired functionality. Specific examples of operably couplable
include but are not limited to physically mateable and/or
physically interacting components, and/or wirelessly interactable,
and/or wirelessly interacting components, and/or logically
interacting, and/or logically interactable components.
[0105] In some instances, one or more components may be referred to
herein as "configured to," "configurable to," "operable/operative
to," "adapted/adaptable," "able to," "conformable/conformed to,"
etc. Those skilled in the art will recognize that "configured to"
can generally encompass active-state components and/or
inactive-state components and/or standby-state components, unless
context requires otherwise.
[0106] While particular aspects of the present subject matter
described herein have been shown and described, it will be apparent
to those skilled in the art that, based upon the teachings herein,
changes and modifications may be made without departing from the
subject matter described herein and its broader aspects and,
therefore, the appended claims are to encompass within their scope
all such changes and modifications as are within the true spirit
and scope of the subject matter described herein. It will be
understood by those within the art that, in general, terms used
herein, and especially in the appended claims (e.g., bodies of the
appended claims) are generally intended as "open" terms (e.g., the
term "including" should be interpreted as "including but not
limited to," the term "having" should be interpreted as "having at
least," the term "includes" should be interpreted as "includes but
is not limited to," etc.). It will be further understood by those
within the art that if a specific number of an introduced claim
recitation is intended, such an intent will be explicitly recited
in the claim, and in the absence of such recitation no such intent
is present. For example, as an aid to understanding, the following
appended claims may contain usage of the introductory phrases "at
least one" and "one or more" to introduce claim recitations.
However, the use of such phrases should not be construed to imply
that the introduction of a claim recitation by the indefinite
articles "a" or "an" limits any particular claim containing such
introduced claim recitation to claims containing only one such
recitation, even when the same claim includes the introductory
phrases "one or more" or "at least one" and indefinite articles
such as "a" or "an" (e.g., "a" and/or "an" should typically be
interpreted to mean "at least one" or "one or more"); the same
holds true for the use of definite articles used to introduce claim
recitations.
[0107] In addition, even if a specific number of an introduced
claim recitation is explicitly recited, those skilled in the art
will recognize that such recitation should typically be interpreted
to mean at least the recited number (e.g., the bare recitation of
"two recitations," without other modifiers, typically means at
least two recitations, or two or more recitations). Furthermore, in
those instances where a convention analogous to "at least one of A,
B, and C, etc." is used, in general such a construction is intended
in the sense one having skill in the art would understand the
convention (e.g., "a system having at least one of A, B, and C"
would include but not be limited to systems that have A alone, B
alone, C alone, A and B together, A and C together, B and C
together, and/or A, B, and C together, etc.). In those instances
where a convention analogous to "at least one of A, B, or C, etc."
is used, in general such a construction is intended in the sense
one having skill in the art would understand the convention (e.g.,
"a system having at least one of A, B, or C" would include but not
be limited to systems that have A alone, B alone, C alone, A and B
together, A and C together, B and C together, and/or A, B, and C
together, etc.). It will be further understood by those within the
art that typically a disjunctive word and/or phrase presenting two
or more alternative terms, whether in the description, claims, or
drawings, should be understood to contemplate the possibilities of
including one of the terms, either of the terms, or both terms
unless context dictates otherwise. For example, the phrase "A or B"
will be typically understood to include the possibilities of "A" or
"B" or "A and B."
[0108] With respect to the appended claims, those skilled in the
art will appreciate that recited operations therein may generally
be performed in any order. Also, although various operational flows
are presented in a sequence(s), it should be understood that the
various operations may be performed in other orders than those
which are illustrated, or may be performed concurrently. Examples
of such alternate orderings may include overlapping, interleaved,
interrupted, reordered, incremental, preparatory, supplemental,
simultaneous, reverse, or other variant orderings, unless context
dictates otherwise. Furthermore, terms like "responsive to,"
"related to," or other past-tense adjectives are generally not
intended to exclude such variants, unless context dictates
otherwise.
[0109] In certain cases, use of a system or method may occur in a
territory even if components are located outside the territory. For
example, in a distributed computing context, use of a distributed
computing system may occur in a territory even though parts of the
system may be located outside of the territory (e.g., relay,
server, processor, signal-bearing medium, transmitting computer,
receiving computer, etc. located outside the territory).
[0110] A sale of a system or method may likewise occur in a
territory even if components of the system or method are located
and/or used outside the territory. Further, implementation of at
least part of a system for performing a method in one territory
does not preclude use of the system in another territory.
[0111] Although various forms have been described herein, many
modifications, variations, substitutions, changes, and equivalents
to those forms may be implemented and will occur to those skilled
in the art. Also, where materials are disclosed for certain
components, other materials may be used. It is therefore to be
understood that the foregoing description and the appended claims
are intended to cover all such modifications and variations as
falling within the scope of the disclosed forms. The following
claims are intended to cover all such modification and
variations.
[0112] In summary, numerous benefits have been described which
result from employing the concepts described herein. The foregoing
description of the one or more forms has been presented for
purposes of illustration and description. It is not intended to be
exhaustive or limiting to the precise form disclosed. Modifications
or variations are possible in light of the above teachings. The one
or more forms were chosen and described in order to illustrate
principles and practical application to thereby enable one of
ordinary skill in the art to utilize the various forms and with
various modifications as are suited to the particular use
contemplated. It is intended that the claims submitted herewith
define the overall scope.
Examples
[0113] In one general aspect, a surgical instrument assembly
embodying the principles of the described forms is configured to
permit selective dissection, cutting, coagulation, and clamping of
tissue during surgical procedures. A generator may generate at
least one electrical signal, which may be monitored against a first
set of logic conditions. When the first set of logic conditions is
met, a first response of the generator may be triggered.
[0114] In certain forms, ultrasonic impedance of the surgical
instrument is monitored. When the ultrasonic impedance of the
surgical instrument exceeds a threshold impedance, a resonant
frequency of the at least one electrical signal may be stored as a
baseline frequency. Also, the first response of the generator may
be triggered when either the first set of logic conditions is met
or the resonant frequency of the at least one electrical signal
differs from the baseline frequency by a baseline deviation
threshold.
[0115] In certain forms, load events at an end effector of the
surgical instrument may be monitored. The first response of the
generator may be triggered when the first set of logic conditions
is met and a load event is detected.
[0116] In accordance with one general form, there is provided a
switch assembly for an ultrasonic surgical instrument that includes
a handle housing that is configured to be supported in one hand. In
at least one form, the switch assembly comprises a first switch
arrangement that is operably supported on a forward portion of the
handle housing and is selectively movable relative to at least one
first switch contact. The switch assembly further comprises a
second switch arrangement that may comprise at least one of a right
switch button and a left switch button. The right switch button may
be movably supported on a right side of the handle housing and be
selectively movable relative to at least one right switch contact
supported by the handle housing. The left switch button may be
movably supported on a left side of the handle housing and be
selectively movable relative to at least one left switch contact
supported by the handle housing. The first and second switch
arrangements may be configured to be selectively operated by a
single hand supporting the handle housing.
[0117] In accordance with at least one other general form, there is
provided an ultrasonic surgical instrument. In at least one form,
the ultrasonic surgical instrument comprises a generator for
generating ultrasonic signals and a handle assembly that includes a
handle housing that is configured to be operably supported in one
hand. The instrument may further comprise a switch assembly that
includes a first switch arrangement that is operably supported on a
forward portion of the handle housing and is selectively movable
relative to at least one first switch contact that communicates
with the generator. The switch assembly may further include a
second switch arrangement that comprises at least one of a right
switch button and a left switch button. The right switch button may
be movably supported on a right side of the handle housing and be
selectively movable relative to at least one right switch contact
that is supported by the handle housing. The at least one right
switch contact may communicate with the generator. The left switch
button may be movably supported on a left side of the handle
housing and be selectively movable relative to at least one left
switch contact that is supported by the handle housing and may
operably communicate with the generator. The first and second
switch arrangements may be configured to be selectively operated by
a single hand supporting the handle housing.
[0118] In accordance with still another general form, there is
provided a switch assembly for an ultrasonic surgical instrument
that includes a handle housing that is configured to be supported
in one hand. In at least one form, the switch assembly comprises a
button assembly that is movably supported by the handle housing for
selective axial and pivotal travel relative to a right switch
contact, a central switch contact and a left switch contact such
that axial movement of the button assembly in a first direction
causes the button assembly to actuate the central switch contact
and pivotal movement of the button assembly in a first pivotal
direction causes the button assembly to actuate the left switch
contact and pivotal movement of the button assembly in a second
pivotal direction causes the button assembly to actuate the right
switch contact.
[0119] According to various forms, the connector module may be a
modular component that may be provided as an accessory with the
ultrasonic surgical instrument or components thereof but not
attached thereto or may be used to repair, replace, or retrofit
ultrasonic surgical instruments. In certain forms, however, the
connector module may be associated with the handle assembly or the
ultrasonic transducer. In one form, the connector module may
comprise an assembly that may be easily removed and/or replaced by
a user. The connector module may also comprise removable features
allowing the user to, for example, remove and/or replace rotation
couplings, switch conductors, or links. Accordingly, in certain
forms, one or more connector modules may be included in a kit. The
kit may comprise various rotation couplings configured for
adaptable use with one or more ultrasonic transducers or hand
pieces. The kit may include connector modules, rotation couplings,
or housings comprising various configurations of user interfaces
that may require one, two, or more conductive paths.
[0120] In one aspect, the present disclosure is directed to an
ultrasonic surgical instrument. The ultrasonic instrument may
comprise an end effector, a waveguide extending proximally from the
end effector along a longitudinal axis, and a connector module for
receiving an ultrasonic hand piece. The connector module may
comprise a housing defining a spindle extending along the
longitudinal axis, a coupling positioned on the spindle and
rotatable relative to the housing, a first conductor mechanically
coupled to the housing and extending at least partially around the
longitudinal axis, and a first link rotatable about the
longitudinal axis relative to the first conductor between a first
position and a second position. The first link may comprise a first
contact positioned to electrically contact the first conductor when
the first link is in the first position and the second position and
a second contact electrically coupled to the first contact and
positioned to electrically contact the ultrasonic hand piece when
the first link is in the first position and the second
position.
[0121] In one aspect, the first and second conductors each comprise
a conductive lead configured to electrically couple to a user
interface configured for receiving power control signals from a
user. The ultrasonic hand piece may be adapted to electrically
couple to a generator and rotationally couple to the first and
second links when received by the connector module. The connector
module may be configured to electrically couple the user interface
circuit and the generator via the ultrasonic hand piece when the
first and second links are in respective first and second
positions. In one aspect, the user interface comprises a toggle
switch operatively coupled to a handle assembly and the connector
module is secured to the handle assembly. The ultrasonic hand piece
may be rotatable relative to the handle assembly when received by
the connector module. In one aspect, the housing electrically
isolates the first and second conductors with respect to each
other.
[0122] Various aspects of the subject matter described herein are
directed to an apparatus, comprising a circuit configured to
transmit a signal as a serial protocol over a pair of electrical
conductors. The serial protocol may be defined as a series of
pulses distributed over at least one transmission frame. At least
one pulse in the transmission frame is simultaneously encoded by
modulating an amplitude of the pulse to represent one of two first
logic states and modulating a width of the pulse to represent one
of two second logic states.
[0123] Various aspects of the subject matter described herein are
directed to an instrument, comprising a circuit configured to
transmit a signal as a serial protocol over a pair of electrical
conductors. The serial protocol may be defined as a series of
pulses distributed over at least one transmission frame. At least
one pulse in the transmission frame may be simultaneously encoded
by modulating an amplitude of the pulse to represent one of two
first logic states and modulating a width of the pulse to represent
one of two second logic states. The instrument may also comprise an
output device coupled to an output of the circuit; and an input
device coupled to an input of the circuit.
[0124] Various aspects of the subject matter described herein are
directed to a generator, comprising a conditioning circuit
configured to communicate to an instrument over a two wire
interface. The generator may comprises a control circuit configured
to transmit a signal as a serial protocol over a pair of electrical
conductors. The serial protocol may be defined as a series of
pulses distributed over at least one transmission frame. At least
one pulse in the transmission frame is simultaneously encoded by
modulating an amplitude of the pulse to represent one of two first
logic states and modulating a width of the pulse to represent one
of two second logic states. The generator may also comprise an
energy circuit configured to drive the instrument.
[0125] Various aspects are directed to methods of driving an end
effector coupled to an ultrasonic drive system of an ultrasonic
surgical instrument. A trigger signal may be received. In response
to the trigger signal, a first drive signal may be provided to the
ultrasonic drive system to drive the end effector at a first power
level. The first drive signal may be maintained for a first period.
At the end of the first period a second drive signal may be
provided to the ultrasonic drive system to drive the end effector
at a second power level less than the first power level.
[0126] In another aspect, after receiving a trigger signal, a
surgical system generates feedback indicating that the ultrasonic
surgical instrument is activated while maintaining the ultrasonic
instrument in a deactivated state. At an end of the threshold time
period, the ultrasonic surgical instrument is activated by
providing a drive signal to the ultrasonic drive system to drive
the end effector.
[0127] In another aspect, the ultrasonic surgical instrument is
activated by generating a drive signal provided to the ultrasonic
drive system to drive the end effector. A plurality of input
variables may be applied to a multi-variable model to generate a
multi-variable model output, where the multi-variable model output
corresponds to an effect of the ultrasonic instrument on tissue.
The plurality of input variables may comprise at least one variable
describing the drive signal and at least one variable describing a
property of the ultrasonic surgical instrument. When the
multi-variable model output reaches a threshold value, feedback may
be generated indicating a corresponding state of at least one of
the ultrasonic surgical instrument and tissue acted upon by the
ultrasonic surgical instrument.
[0128] In another aspect, in response to a trigger signal, a first
drive signal at a first power level is provided to the ultrasonic
drive system to drive the end effector. The first drive signal is
maintained at the first level for a first period. A second drive
signal is provided to the ultrasonic drive system to drive the end
effector at a second power level less than the first power level. A
plurality of input variables may be applied to a multi-variable
model to generate a multi-variable model output. The multi-variable
model output may correspond to an effect of the ultrasonic
instrument on tissue, and the plurality of variables may comprise
at least one variable describing the drive signal and at least one
variable describing a property of the ultrasonic surgical
instrument. After the multi-variable model output exceeds a
threshold value for a threshold time period, a first response may
be triggered.
[0129] While several forms have been illustrated and described, it
is not the intention of the applicant to restrict or limit the
scope of the appended claims to such detail. Numerous variations,
changes, and substitutions will occur to those skilled in the art
without departing from the scope of the invention. Moreover, the
structure of each element associated with the described forms can
be alternatively described as a means for providing the function
performed by the element. Accordingly, it is intended that the
described forms be limited only by the scope of the appended
claims.
[0130] Reference throughout the specification to "various forms,"
"some forms," "one form," or "an form" means that a particular
feature, structure, or characteristic described in connection with
the form is included in at least one form. Thus, appearances of the
phrases "in various forms," "in some forms," "in one form," or "in
an form" in places throughout the specification are not necessarily
all referring to the same form. Furthermore, the particular
features, structures, or characteristics may be combined in any
suitable manner in one or more forms. Thus, the particular
features, structures, or characteristics illustrated or described
in connection with one form may be combined, in whole or in part,
with the features structures, or characteristics of one or more
other forms without limitation.
* * * * *