U.S. patent application number 16/024090 was filed with the patent office on 2019-07-04 for capacitive coupled return path pad with separable array elements.
The applicant listed for this patent is Ethicon LLC. Invention is credited to Jason L. Harris, Cameron R. Nott, Frederick E. Shelton, IV, Tamara Widenhouse, David C. Yates.
Application Number | 20190201090 16/024090 |
Document ID | / |
Family ID | 64734053 |
Filed Date | 2019-07-04 |
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United States Patent
Application |
20190201090 |
Kind Code |
A1 |
Shelton, IV; Frederick E. ;
et al. |
July 4, 2019 |
CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY
ELEMENTS
Abstract
A return pad of an electrosurgical system is disclosed. The
return pad includes a plurality of conductive members and a
plurality of sensing devices. The conductive members are configured
to receive radio frequency current applied to a patient. The
sensing devices are configured to detect at least one of the
following: a nerve control signal applied to the patient; and a
movement of an anatomical feature of the patient resulting from
application of the nerve control signal.
Inventors: |
Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Yates; David C.; (West Chester,
OH) ; Nott; Cameron R.; (Loveland, OH) ;
Widenhouse; Tamara; (Clarksville, OH) ; Harris; Jason
L.; (Lebanon, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon LLC |
Guaynabo |
PR |
US |
|
|
Family ID: |
64734053 |
Appl. No.: |
16/024090 |
Filed: |
June 29, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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62650898 |
Mar 30, 2018 |
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62650887 |
Mar 30, 2018 |
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62650877 |
Mar 30, 2018 |
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62650882 |
Mar 30, 2018 |
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62640417 |
Mar 8, 2018 |
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62640415 |
Mar 8, 2018 |
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62611341 |
Dec 28, 2017 |
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62611340 |
Dec 28, 2017 |
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62611339 |
Dec 28, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 18/1233 20130101;
A61B 90/37 20160201; A61B 2018/00994 20130101; A61B 18/1445
20130101; A61B 2017/07285 20130101; A61B 17/07207 20130101; A61B
2017/00221 20130101; A61B 5/1107 20130101; A61B 2562/0219 20130101;
A61B 18/16 20130101; A61B 2562/0247 20130101; A61B 18/12 20130101;
A61B 18/14 20130101; A61B 2017/07271 20130101; A61B 17/320092
20130101; A61B 2017/2926 20130101; A61B 2018/00875 20130101; A61B
2018/126 20130101; A61B 2090/065 20160201; A61B 90/30 20160201;
A61B 2018/00601 20130101; A61B 2217/007 20130101; A61B 5/4893
20130101; A61B 2018/0063 20130101; A61B 2034/2048 20160201; A61B
2017/07257 20130101; A61B 2018/167 20130101; A61N 7/00 20130101;
A61B 34/37 20160201; A61B 2017/00026 20130101; A61B 2218/008
20130101; A61B 17/29 20130101; A61B 34/30 20160201; A61B 2034/302
20160201; A61B 2018/00827 20130101; A61B 2090/066 20160201; A61B
90/361 20160201; A61B 2018/1253 20130101; A61B 2217/005 20130101;
A61B 34/20 20160201; A61B 2018/00892 20130101 |
International
Class: |
A61B 18/16 20060101
A61B018/16; A61B 17/072 20060101 A61B017/072; A61B 17/29 20060101
A61B017/29; A61B 17/32 20060101 A61B017/32; A61B 18/14 20060101
A61B018/14; A61B 34/30 20060101 A61B034/30; A61B 90/30 20060101
A61B090/30; A61B 90/00 20060101 A61B090/00 |
Claims
1. A return pad of an electrosurgical system, the return pad
comprising: a plurality of conductive members configured to receive
radio frequency current applied to a patient; and a plurality of
sensing devices configured to detect at least one of the following:
a nerve control signal applied to the patient; and a movement of an
anatomical feature of the patient resulting from application of the
nerve control signal.
2. The return pad of claim 1, wherein the plurality of conductive
members is further configured for capacitive coupling with the
patient.
3. The return pad of claim 1, further comprising a switching device
configured for selectively decoupling at least one of the plurality
of conductive members from another one of the plurality of
conductive members.
4. The return pad of claim 1, further comprising a switching device
configured for selectively decoupling each of the conductive
members from one another.
5. The return pad of claim 1, further comprising a switching device
configured for selectively decoupling the plurality of conductive
members from the patient.
6. The return pad of claim 1, further comprising a switching device
configured for selectively decoupling the plurality of conductive
members from a generator.
7. The return pad of claim 1, further comprising a switching device
configured for selectively coupling each of the plurality of
conductive members to a generator.
8. The return pad of claim 1, wherein the plurality of sensing
devices are configured as an array of sensing devices.
9. The return pad of claim 1, wherein each of the plurality of
sensing devices is coupled to a corresponding one of the plurality
of conductive members.
10. The return pad of claim 1, wherein each of the plurality of
conductive members is coupled to a corresponding one of the
plurality of sensing devices.
11. The return pad of claim 1, wherein at least one of the
plurality of sensing devices comprises one of the following: a
pressure sensor; an accelerometer; and a pressure sensor and an
accelerometer.
12. The return pad of claim 1, wherein each of the plurality of
sensing devices is further configured to output a signal indicative
of the detection.
13. An electrosurgical system, comprising: a generator configured
to supply an alternating current at a radiofrequency; an instrument
configured to apply the alternating current to a patient; a return
pad capacitively couplable to the patient, wherein the return pad
comprises: a plurality of conductive members configured to conduct
radio frequency current, wherein the plurality of conductive
members are capacitively couplable to a patient and are selectively
couplable to the generator; a plurality of sensing devices
configured to detect at least one of the following: a nerve control
signal applied to the patient; and a movement of an anatomical
feature of the patient resulting from application of the nerve
control signal; and a conductor coupled to the return pad and the
generator.
14. The electrosurgical system of claim 13, further comprising a
multi input-single output switching device coupled to each of the
plurality of sensing devices.
15. The electrosurgical system of claim 14, further comprising an
analog-to-digital converter coupled to the multi input-single
output switching device.
16. The electrosurgical system of claim 13, wherein the generator
is further configured to: generate the alternating current as a
high frequency waveform; generate a low frequency waveform which is
configured to stimulate a nerve of the patient; utilize the high
frequency waveform to modulate the low frequency waveform to form a
composite waveform; and supply the composite waveform to the
instrument.
17. The electrosurgical system of claim 14, wherein the generator
is further configured to amplitude modulate the low frequency
waveform to form the composite waveform.
18. A return pad of an electrosurgical system, the return pad
comprising: a plurality of electrodes configured for capacitive
coupling with a patient; and an array of sensing devices configured
to detect at least one of the following: a nerve control signal
applied to the patient; and a movement of an anatomical feature of
the patient resulting from application of the nerve control
signal.
19. The return pad of claim 18, wherein each sensing device of the
array of sensing devices is configured to output a signal
indicative of the detection.
20. The return pad of claim 18, wherein each sensing device of the
array of sensing devices is positioned on a corresponding one of
the plurality of electrodes.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C. .sctn.
119(e) of the earlier filing date of U.S. Provisional Patent
Application No. 62/650,898 filed on Mar. 30, 2018, titled
CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS,
the disclosure of which is hereby incorporated by reference in its
entirety.
[0002] This application also claims the benefit of priority under
35 U.S.C. .sctn. 119(e) to U.S. Provisional Patent Application Ser.
No. 62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING
CAPABILITIES, filed Mar. 30, 2018, to U.S. Provisional Patent
Application Ser. No. 62/650,877, titled SURGICAL SMOKE EVACUATION
SENSING AND CONTROLS, filed Mar. 30, 2018, and to U.S. Provisional
Patent Application Ser. No. 62/650,882, titled SMOKE EVACUATION
MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed Mar. 30, 2018, the
disclosure of each of which is herein incorporated by reference in
its entirety.
[0003] This application also claims the benefit of priority under
35 U.S.C. .sctn. 119(e) to U.S. Provisional Patent Application Ser.
No. 62/640,417, titled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND
CONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, and to Provisional
Patent Application Ser. No. 62/640,415, titled ESTIMATING STATE OF
ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR, filed Mar. 8,
2018, the disclosure of each of which is herein incorporated by
reference in its entirety.
[0004] This application also claims the benefit of priority under
35 U.S.C. .sctn. 119(e) to U.S. Provisional Patent Application Ser.
No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec.
28, 2017, to U.S. Provisional Patent Application Ser. No.
62/611,340, titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28,
2017, and to U.S. Provisional Patent Application Ser. No.
62/611,339, titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28,
2017, the disclosure of each of which is herein incorporated by
reference in its entirety.
BACKGROUND
[0005] This application discloses an invention which is related,
generally and in various aspects, to surgical systems and return
pads of electrosurgical systems.
[0006] Electrosurgical systems typically utilize a generator to
supply electrosurgical energy (e.g., alternating current at
radiofrequency levels) to an active electrode which applies the
electrosurgical energy to a patient's body. The electrosurgical
energy applied to the patient's body operates to heat tissue of the
patient (to seal and/or cut the tissue) and generally exits the
patient's body to a return pad which can be applied to the
patient's body or can be capacitively coupled to the patient's
body. The return pad is connected to return path wiring which in
turn is connected back to the generator. Stated differently, the
return pad and the return path wiring collectively form the
electrical return path of the electrosurgical system.
[0007] One concern associated with electrosurgery is whether the
dispersive electrode of the return pad is large enough and/or has
sufficient surface area to adequately capture and carry the
electrosurgical energy introduced into the patient's body so that
unwanted burning of the patient can be avoided. The return pad is
generally sized to keep the current density sufficiently low as the
electrosurgical energy exits the patient. Otherwise, heat can build
up within the patient and can result in a burn.
[0008] When electrosurgical energy is utilized to cut targeted
tissue of the patient, one concern is that one or more nerves may
be inadvertently injured and/or severed during the electrosurgery,
potentially resulting in the patient experiencing muscle weakness,
pain, numbness, paralysis and/or other undesired outcomes. Although
surgeons generally have a good idea of where nerves are located and
are thus able to avoid them, this is not always the case. For
example, if an area of a patient is deformed, damaged or otherwise
deviates from what is considered normal, determining the location
of a given nerve within the area can be difficult. When the
location of a given nerve within the area is not readily
discernible, the likelihood of inadvertently injuring or severing
the nerve is increased.
SUMMARY
[0009] In one aspect, a return pad of an electrosurgical system is
provided. The return pad comprising: a plurality of conductive
members configured to receive radio frequency current applied to a
patient; and a plurality of sensing devices configured to detect at
least one of the following: a nerve control signal applied to the
patient; and a movement of an anatomical feature of the patient
resulting from application of the nerve control signal.
[0010] In another aspect, an electrosurgical system is provided.
The electrosurgical system comprising: a generator configured to
supply an alternating current at a radiofrequency; an instrument
configured to apply the alternating current to a patient; a return
pad capacitively couplable to the patient, wherein the return pad
comprises: a plurality of conductive members configured to conduct
radio frequency current, wherein the plurality of conductive
members are capacitively couplable to a patient and are selectively
couplable to the generator; a plurality of sensing devices
configured to detect at least one of the following: a nerve control
signal applied to the patient; and a movement of an anatomical
feature of the patient resulting from application of the nerve
control signal; and a conductor coupled to the return pad and the
generator
[0011] In yet another aspect, a return pad of an electrosurgical
system is provided. The return pad comprising: a plurality of
electrodes configured for capacitive coupling with a patient; and
an array of sensing devices configured to detect at least one of
the following: a nerve control signal applied to the patient; and a
movement of an anatomical feature of the patient resulting from
application of the nerve control signal.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The features of various aspects are set forth with
particularity in the appended claims. The various aspects, however,
both as to organization and methods of operation, together with
further objects and advantages thereof, may best be understood by
reference to the following description, taken in conjunction with
the accompanying drawings as follows.
[0013] FIG. 1 is a block diagram of a computer-implemented
interactive surgical system, in accordance with at least one aspect
of the present disclosure.
[0014] FIG. 2 is a surgical system being used to perform a surgical
procedure in an operating room, in accordance with at least one
aspect of the present disclosure.
[0015] FIG. 3 is a surgical hub paired with a visualization system,
a robotic system, and an intelligent instrument, in accordance with
at least one aspect of the present disclosure.
[0016] FIG. 4 is a partial perspective view of a surgical hub
enclosure, and of a combo generator module slidably receivable in a
drawer of the surgical hub enclosure, in accordance with at least
one aspect of the present disclosure.
[0017] FIG. 5 is a perspective view of a combo generator module
with bipolar, ultrasonic, and monopolar contacts and a smoke
evacuation component, in accordance with at least one aspect of the
present disclosure.
[0018] FIG. 6 illustrates individual power bus attachments for a
plurality of lateral docking ports of a lateral modular housing
configured to receive a plurality of modules, in accordance with at
least one aspect of the present disclosure.
[0019] FIG. 7 illustrates a vertical modular housing configured to
receive a plurality of modules, in accordance with at least one
aspect of the present disclosure.
[0020] FIG. 8 illustrates a surgical data network comprising a
modular communication hub configured to connect modular devices
located in one or more operating theaters of a healthcare facility,
or any room in a healthcare facility specially equipped for
surgical operations, to the cloud, in accordance with at least one
aspect of the present disclosure.
[0021] FIG. 9 illustrates a computer-implemented interactive
surgical system, in accordance with at least one aspect of the
present disclosure.
[0022] FIG. 10 illustrates a surgical hub comprising a plurality of
modules coupled to the modular control tower, in accordance with at
least one aspect of the present disclosure.
[0023] FIG. 11 illustrates one aspect of a Universal Serial Bus
(USB) network hub device, in accordance with at least one aspect of
the present disclosure.
[0024] FIG. 12 illustrates a logic diagram of a control system of a
surgical instrument or tool, in accordance with at least one aspect
of the present disclosure.
[0025] FIG. 13 illustrates a control circuit configured to control
aspects of the surgical instrument or tool, in accordance with at
least one aspect of the present disclosure.
[0026] FIG. 14 illustrates a combinational logic circuit configured
to control aspects of the surgical instrument or tool, in
accordance with at least one aspect of the present disclosure.
[0027] FIG. 15 illustrates a sequential logic circuit configured to
control aspects of the surgical instrument or tool, in accordance
with at least one aspect of the present disclosure.
[0028] FIG. 16 illustrates a surgical instrument or tool comprising
a plurality of motors which can be activated to perform various
functions, in accordance with at least one aspect of the present
disclosure.
[0029] FIG. 17 is a schematic diagram of a robotic surgical
instrument configured to operate a surgical tool described herein,
in accordance with at least one aspect of the present
disclosure.
[0030] FIG. 18 illustrates a block diagram of a surgical instrument
programmed to control the distal translation of a displacement
member, in accordance with at least one aspect of the present
disclosure.
[0031] FIG. 19 is a schematic diagram of a surgical instrument
configured to control various functions, in accordance with at
least one aspect of the present disclosure.
[0032] FIG. 20 is a simplified block diagram of a generator
configured to provide inductorless tuning, among other benefits, in
accordance with at least one aspect of the present disclosure.
[0033] FIG. 21 illustrates an example of a generator, which is one
form of the generator of FIG. 20, in accordance with at least one
aspect of the present disclosure.
[0034] FIG. 22 illustrates an electrosurgical system, in accordance
with at least one aspect of the present disclosure.
[0035] FIG. 23 illustrates a return pad of the electrosurgical
system of FIG. 22, in accordance with at least one aspect of the
present disclosure.
[0036] FIG. 24 illustrates a plurality of electrodes of the return
pad of FIG. 23, in accordance with at least one aspect of the
present disclosure.
[0037] FIG. 25 illustrates an array of sensing devices of the
return pad of FIG. 23, in accordance with at least one aspect of
the present disclosure.
[0038] FIG. 26 illustrates a method for concurrently applying a
nerve stimulation signal and electrosurgical energy to a patient,
in accordance with at least one aspect of the present
disclosure.
DETAILED DESCRIPTION
[0039] Applicant of the present application owns the following U.S.
patent applications, filed on Jun. 29, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0040] U.S. patent application Ser. No. ______, titled CONTROLLING
A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS,
Attorney Docket No. END8543USNP/170760; [0041] U.S. patent
application Ser. No. ______, titled SYSTEMS FOR ADJUSTING END
EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION, Attorney
Docket No. END8543USNP1/170760-1; [0042] U.S. patent application
Ser. No. ______, titled SAFETY SYSTEMS FOR SMART POWERED SURGICAL
STAPLING, Attorney Docket No. END8543USNP2/170760-2; [0043] U.S.
patent application Ser. No. ______, titled SAFETY SYSTEMS FOR SMART
POWERED SURGICAL STAPLING, Attorney Docket No.
END8543USNP3/170760-3; [0044] U.S. patent application Ser. No.
______, titled SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE
DISTRIBUTION IRREGULARITIES, Attorney Docket No.
END8543USNP4/170760-4; [0045] U.S. patent application Ser. No.
______, titled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END
EFFECTOR TO CANCEROUS TISSUE, Attorney Docket No.
END8543USNP5/170760-5; [0046] U.S. patent application Ser. No.
______, titled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES,
Attorney Docket No. END8543USNP6/170760-6; [0047] U.S. patent
application Ser. No. ______, titled VARIABLE OUTPUT CARTRIDGE
SENSOR ASSEMBLY, Attorney Docket No. END8543USNP7/170760-7; [0048]
U.S. patent application Ser. No. ______, titled SURGICAL INSTRUMENT
HAVING A FLEXIBLE ELECTRODE, Attorney Docket No.
END8544USNP/170761; [0049] U.S. patent application Ser. No. ______,
titled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT, Attorney
Docket No. END8544USNP1/170761-1; [0050] U.S. patent application
Ser. No. ______, titled SURGICAL INSTRUMENT WITH A TISSUE MARKING
ASSEMBLY, Attorney Docket No. END8544USNP2/170761-2; [0051] U.S.
patent application Ser. No. ______, titled SURGICAL SYSTEMS WITH
PRIORITIZED DATA TRANSMISSION CAPABILITIES, Attorney Docket No.
END8544USNP3/170761-3; [0052] U.S. patent application Ser. No.
______, titled SURGICAL EVACUATION SENSING AND MOTOR CONTROL,
Attorney Docket No. END8545USNP/170762; [0053] U.S. patent
application Ser. No. ______, titled SURGICAL EVACUATION SENSOR
ARRANGEMENTS, Attorney Docket No. END8545USNP1/170762-1; [0054]
U.S. patent application Ser. No. ______, titled SURGICAL EVACUATION
FLOW PATHS, Attorney Docket No. END8545USNP2/170762-2; [0055] U.S.
patent application Ser. No. ______, titled SURGICAL EVACUATION
SENSING AND GENERATOR CONTROL, Attorney Docket No.
END8545USNP3/170762-3; [0056] U.S. patent application Ser. No.
______, titled SURGICAL EVACUATION SENSING AND DISPLAY, Attorney
Docket No. END8545USNP4/170762-4; [0057] U.S. patent application
Ser. No. ______, titled COMMUNICATION OF SMOKE EVACUATION SYSTEM
PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR
INTERACTIVE SURGICAL PLATFORM, Attorney Docket No.
END8546USNP/170763; [0058] U.S. patent application Ser. No. ______,
titled SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL
CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM, Attorney Docket No.
END8546USNP1/170763-1; [0059] U.S. patent application Ser. No.
______, titled SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION
CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION
DEVICE, Attorney Docket No. END8547USNP/170764; and [0060] U.S.
patent application Ser. No. ______, titled DUAL IN-SERIES LARGE AND
SMALL DROPLET FILTERS, Attorney Docket No. END8548USNP/170765.
[0061] Applicant of the present application owns the following U.S.
Provisional patent applications, filed on Jun. 28, 2018, the
disclosure of each of which is herein incorporated by reference in
its entirety: [0062] U.S. Provisional Patent Application Ser. No.
62/691,228, titled A METHOD OF USING REINFORCED FLEX CIRCUITS WITH
MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES; [0063] U.S.
Provisional Patent Application Ser. No. 62/691,227, titled
CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE
PARAMETERS; [0064] U.S. Provisional Patent Application Ser. No.
62/691,230, titled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[0065] U.S. Provisional Patent Application Ser. No. 62/691,219,
titled SURGICAL EVACUATION SENSING AND MOTOR CONTROL; [0066] U.S.
Provisional Patent Application Ser. No. 62/691,257, titled
COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD
IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
[0067] U.S. Provisional Patent Application Ser. No. 62/691,262,
titled SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR
COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and
[0068] U.S. Provisional Patent Application Ser. No. 62/691,251,
titled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[0069] Applicant of the present application owns the following U.S.
Provisional patent application, filed on Apr. 19, 2018, the
disclosure of which is herein incorporated by reference in its
entirety: [0070] U.S. Provisional Patent Application Ser. No.
62/659,900, titled METHOD OF HUB COMMUNICATION.
[0071] Applicant of the present application owns the following U.S.
patent applications, filed on Mar. 29, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0072] U.S. patent application Ser. No. 15/940,641, titled
INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION
CAPABILITIES; [0073] U.S. patent application Ser. No. 15/940,648,
titled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF
DEVICES AND DATA CAPABILITIES; [0074] U.S. patent application Ser.
No. 15/940,656, titled SURGICAL HUB COORDINATION OF CONTROL AND
COMMUNICATION OF OPERATING ROOM DEVICES; [0075] U.S. patent
application Ser. No. 15/940,666, titled SPATIAL AWARENESS OF
SURGICAL HUBS IN OPERATING ROOMS; [0076] U.S. patent application
Ser. No. 15/940,670, titled COOPERATIVE UTILIZATION OF DATA DERIVED
FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS; [0077] U.S.
patent application Ser. No. 15/940,677, titled SURGICAL HUB CONTROL
ARRANGEMENTS; [0078] U.S. patent application Ser. No. 15/940,632,
titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND
CREATE ANONYMIZED RECORD; [0079] U.S. patent application Ser. No.
15/940,640, titled COMMUNICATION HUB AND STORAGE DEVICE FOR STORING
PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD
BASED ANALYTICS SYSTEMS; [0080] U.S. patent application Ser. No.
15/940,645, titled SELF DESCRIBING DATA PACKETS GENERATED AT AN
ISSUING INSTRUMENT; [0081] U.S. patent application Ser. No.
15/940,649, titled DATA PAIRING TO INTERCONNECT A DEVICE MEASURED
PARAMETER WITH AN OUTCOME; [0082] U.S. patent application Ser. No.
15/940,654, titled SURGICAL HUB SITUATIONAL AWARENESS; [0083] U.S.
patent application Ser. No. 15/940,663, titled SURGICAL SYSTEM
DISTRIBUTED PROCESSING; [0084] U.S. patent application Ser. No.
15/940,668, titled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;
[0085] U.S. patent application Ser. No. 15/940,671, titled SURGICAL
HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;
[0086] U.S. patent application Ser. No. 15/940,686, titled DISPLAY
OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;
[0087] U.S. patent application Ser. No. 15/940,700, titled STERILE
FIELD INTERACTIVE CONTROL DISPLAYS; [0088] U.S. patent application
Ser. No. 15/940,629, titled COMPUTER IMPLEMENTED INTERACTIVE
SURGICAL SYSTEMS; [0089] U.S. patent application Ser. No.
15/940,704, titled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION
TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT; [0090] U.S. patent
application Ser. No. 15/940,722, titled CHARACTERIZATION OF TISSUE
IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT
REFRACTIVITY; and [0091] U.S. patent application Ser. No.
15/940,742, titled DUAL CMOS ARRAY IMAGING.
[0092] Applicant of the present application owns the following U.S.
patent applications, filed on Mar. 29, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0093] U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE
CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES; [0094] U.S. patent
application Ser. No. 15/940,653, titled ADAPTIVE CONTROL PROGRAM
UPDATES FOR SURGICAL HUBS; [0095] U.S. patent application Ser. No.
15/940,660, titled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION
AND RECOMMENDATIONS TO A USER; [0096] U.S. patent application Ser.
No. 15/940,679, titled CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF
LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF
LARGER DATA SET; [0097] U.S. patent application Ser. No.
15/940,694, titled CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL
FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION; [0098]
U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED
MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND
REACTIVE MEASURES; [0099] U.S. patent application Ser. No.
15/940,706, titled DATA HANDLING AND PRIORITIZATION IN A CLOUD
ANALYTICS NETWORK; and [0100] U.S. patent application Ser. No.
15/940,675, titled CLOUD INTERFACE FOR COUPLED SURGICAL
DEVICES.
[0101] Applicant of the present application owns the following U.S.
patent applications, filed on Mar. 29, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0102] U.S. patent application Ser. No. 15/940,627, titled DRIVE
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; [0103] U.S.
patent application Ser. No. 15/940,637, titled COMMUNICATION
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; [0104] U.S.
patent application Ser. No. 15/940,642, titled CONTROLS FOR
ROBOT-ASSISTED SURGICAL PLATFORMS; [0105] U.S. patent application
Ser. No. 15/940,676, titled AUTOMATIC TOOL ADJUSTMENTS FOR
ROBOT-ASSISTED SURGICAL PLATFORMS; [0106] U.S. patent application
Ser. No. 15/940,680, titled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL
PLATFORMS; [0107] U.S. patent application Ser. No. 15/940,683,
titled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL
PLATFORMS; [0108] U.S. patent application Ser. No. 15/940,690,
titled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
and [0109] U.S. patent application Ser. No. 15/940,711, titled
SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0110] Applicant of the present application owns the following U.S.
Provisional patent applications, filed on Mar. 28, 2018, the
disclosure of each of which is herein incorporated by reference in
its entirety: [0111] U.S. Provisional Patent Application Ser. No.
62/649,302, titled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED
COMMUNICATION CAPABILITIES; [0112] U.S. Provisional Patent
Application Ser. No. 62/649,294, titled DATA STRIPPING METHOD TO
INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD; [0113]
U.S. Provisional Patent Application Ser. No. 62/649,300, titled
SURGICAL HUB SITUATIONAL AWARENESS; [0114] U.S. Provisional Patent
Application Ser. No. 62/649,309, titled SURGICAL HUB SPATIAL
AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER; [0115] U.S.
Provisional Patent Application Ser. No. 62/649,310, titled COMPUTER
IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS; [0116] U.S. Provisional
Patent Application Ser. No. 62/649,291, titled USE OF LASER LIGHT
AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK
SCATTERED LIGHT; [0117] U.S. Provisional Patent Application Ser.
No. 62/649,296, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR
SURGICAL DEVICES; [0118] U.S. Provisional Patent Application Ser.
No. 62/649,333, titled CLOUD-BASED MEDICAL ANALYTICS FOR
CUSTOMIZATION AND RECOMMENDATIONS TO A USER; [0119] U.S.
Provisional Patent Application Ser. No. 62/649,327, titled
CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION
TRENDS AND REACTIVE MEASURES; [0120] U.S. Provisional Patent
Application Ser. No. 62/649,315, titled DATA HANDLING AND
PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; [0121] U.S.
Provisional Patent Application Ser. No. 62/649,313, titled CLOUD
INTERFACE FOR COUPLED SURGICAL DEVICES; [0122] U.S. Provisional
Patent Application Ser. No. 62/649,320, titled DRIVE ARRANGEMENTS
FOR ROBOT-ASSISTED SURGICAL PLATFORMS; [0123] U.S. Provisional
Patent Application Ser. No. 62/649,307, titled AUTOMATIC TOOL
ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and [0124] U.S.
Provisional Patent Application Ser. No. 62/649,323, titled SENSING
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0125] It is to be understood that at least some of the figures and
descriptions of the invention have been simplified to illustrate
elements that are relevant for a clear understanding of the
invention, while eliminating, for purposes of clarity, other
elements that those of ordinary skill in the art will appreciate
may also comprise a portion of the invention. However, because such
elements are well known in the art, and because they do not
facilitate a better understanding of the invention, a description
of such elements is not provided herein.
[0126] In the following detailed description, reference is made to
the accompanying drawings, which form a part hereof. In the
drawings, similar symbols and reference characters typically
identify similar components throughout several views, unless
context dictates otherwise. The illustrative aspects described in
the detailed description, drawings and claims are not meant to be
limiting. Other aspects may be utilized, and other changes may be
made, without departing from the scope of the technology described
herein.
[0127] The following description of certain examples of the
technology should not be used to limit its scope. Other examples,
features, aspects, embodiments and advantages of the technology
will become apparent to those skilled in the art from the following
description, which is by way of illustration, one of the best modes
contemplated for carrying out the technology. As will be realized,
the technology described herein is capable of other different and
obvious aspects, all without departing from the technology.
Accordingly, the drawings and descriptions should be regarded as
illustrative in nature and not restrictive.
[0128] It is further understood that any one or more of the
teachings, expressions, aspects, embodiments, examples, etc.
described herein may be combined with any one or more of the other
teachings, expressions, aspects, embodiments, examples, etc. that
are described herein. The following described teachings,
expressions, aspects, embodiments, examples, etc. should therefore
not be viewed in isolation relative to each other. Various suitable
ways in which the teachings herein may be combined will be readily
apparent to those of ordinary skill in the art in view of the
teachings herein. Such modifications and variations are intended to
be included within the scope of the claims.
[0129] Before explaining the various aspects of the electrosurgical
system, the return pad and the method in detail, it should be noted
that the various aspects disclosed herein are not limited in their
application or use to the details of construction and arrangement
of parts illustrated in the accompanying drawings and description.
Rather, the disclosed aspects may be positioned or incorporated in
other aspects, embodiments, variations and modifications thereof,
and may be practiced or carried out in various ways. Accordingly,
aspects of the electrosurgical system, return pad and method
disclosed herein are illustrative in nature and are not meant to
limit the scope or application thereof. Furthermore, unless
otherwise indicated, the terms and expressions employed herein have
been chosen for the purpose of describing the aspects for the
convenience of the reader and are not meant to limit the scope
thereof. In addition, it should be understood that any one or more
of the disclosed aspects, expressions of aspects, and/or examples
thereof, can be combined with any one or more of the other
disclosed aspects, expressions of aspects, and/or examples thereof,
without limitation.
[0130] Also, in the following description, it is to be understood
that terms such as inward, outward, upward, downward, above, below,
left, right, interior, exterior and the like are words of
convenience and are not to be construed as limiting terms.
Terminology used herein is not meant to be limiting insofar as
devices described herein, or portions thereof, may be attached or
utilized in other orientations. The various aspects will be
described in more detail with reference to the drawings.
[0131] As described in more detail hereinbelow, aspects of the
invention may be implemented by a computing device and/or a
computer program stored on a computer-readable medium. The
computer-readable medium may comprise a disk, a device, and/or a
propagated signal.
[0132] Referring to FIG. 1, a computer-implemented interactive
surgical system 100 includes one or more surgical systems 102 and a
cloud-based system (e.g., the cloud 104 that may include a remote
server 113 coupled to a storage device 105). Each surgical system
102 includes at least one surgical hub 106 in communication with
the cloud 104 that may include a remote server 113. In one example,
as illustrated in FIG. 1, the surgical system 102 includes a
visualization system 108, a robotic system 110, and a handheld
intelligent surgical instrument 112, which are configured to
communicate with one another and/or surgical hub 106. In some
aspects, a surgical system 102 may include an M number of hubs 106,
an N number of visualization systems 108, an O number of robotic
systems 110, and a P number of handheld intelligent surgical
instruments 112, where M, N, O, and P are integers greater than or
equal to one.
[0133] FIG. 3 depicts an example of a surgical system 102 being
used to perform a surgical procedure on a patient who is lying down
on an operating table 114 in a surgical operating room 116. A
robotic system 110 is used in the surgical procedure as a part of
the surgical system 102. The robotic system 110 includes a
surgeon's console 118, a patient side cart 120 (surgical robot),
and a surgical robotic hub 122. The patient side cart 120 can
manipulate at least one removably coupled surgical tool 117 through
a minimally invasive incision in the body of the patient while the
surgeon views the surgical site through the surgeon's console 118.
An image of the surgical site can be obtained by a medical imaging
device 124, which can be manipulated by the patient side cart 120
to orient the imaging device 124. The robotic hub 122 can be used
to process the images of the surgical site for subsequent display
to the surgeon through the surgeon's console 118.
[0134] Other types of robotic systems can be readily adapted for
use with the surgical system 102. Various examples of robotic
systems and surgical tools that are suitable for use with the
present disclosure are described in U.S. Provisional Patent
Application Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICAL
PLATFORM, filed Dec. 28, 2017, the disclosure of which is herein
incorporated by reference in its entirety.
[0135] Various examples of cloud-based analytics that are performed
by the cloud 104, and are suitable for use with the present
disclosure, are described in U.S. Provisional Patent Application
Ser. No. 62/611,340, titled CLOUD-BASED MEDICAL ANALYTICS, filed
Dec. 28, 2017, the disclosure of which is herein incorporated by
reference in its entirety.
[0136] In various aspects, the imaging device 124 includes at least
one image sensor and one or more optical components. Suitable image
sensors include, but are not limited to, Charge-Coupled Device
(CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS)
sensors.
[0137] The optical components of the imaging device 124 may include
one or more illumination sources and/or one or more lenses. The one
or more illumination sources may be directed to illuminate portions
of the surgical field. The one or more image sensors may receive
light reflected or refracted from the surgical field, including
light reflected or refracted from tissue and/or surgical
instruments.
[0138] The one or more illumination sources may be configured to
radiate electromagnetic energy in the visible spectrum as well as
the invisible spectrum. The visible spectrum, sometimes referred to
as the optical spectrum or luminous spectrum, is that portion of
the electromagnetic spectrum that is visible to (i.e., can be
detected by) the human eye and may be referred to as visible light
or simply light. A typical human eye will respond to wavelengths in
air that are from about 380 nm to about 750 nm.
[0139] The invisible spectrum (i.e., the non-luminous spectrum) is
that portion of the electromagnetic spectrum that lies below and
above the visible spectrum (i.e., wavelengths below about 380 nm
and above about 750 nm). The invisible spectrum is not detectable
by the human eye. Wavelengths greater than about 750 nm are longer
than the red visible spectrum, and they become invisible infrared
(IR), microwave, and radio electromagnetic radiation. Wavelengths
less than about 380 nm are shorter than the violet spectrum, and
they become invisible ultraviolet, x-ray, and gamma ray
electromagnetic radiation.
[0140] In various aspects, the imaging device 124 is configured for
use in a minimally invasive procedure. Examples of imaging devices
suitable for use with the present disclosure include, but not
limited to, an arthroscope, angioscope, bronchoscope,
choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope,
esophagogastro-duodenoscope (gastroscope), endoscope, laryngoscope,
nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and
ureteroscope.
[0141] In one aspect, the imaging device employs multi-spectrum
monitoring to discriminate topography and underlying structures. A
multi-spectral image is one that captures image data within
specific wavelength ranges across the electromagnetic spectrum. The
wavelengths may be separated by filters or by the use of
instruments that are sensitive to particular wavelengths, including
light from frequencies beyond the visible light range, e.g., IR and
ultraviolet. Spectral imaging can allow extraction of additional
information the human eye fails to capture with its receptors for
red, green, and blue. The use of multi-spectral imaging is
described in greater detail under the heading "Advanced Imaging
Acquisition Module" in U.S. Provisional Patent Application Ser. No.
62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28,
2017, the disclosure of which is herein incorporated by reference
in its entirety. Multi-spectrum monitoring can be a useful tool in
relocating a surgical field after a surgical task is completed to
perform one or more of the previously described tests on the
treated tissue.
[0142] It is axiomatic that strict sterilization of the operating
room and surgical equipment is required during any surgery. The
strict hygiene and sterilization conditions required in a "surgical
theater," i.e., an operating or treatment room, necessitate the
highest possible sterility of all medical devices and equipment.
Part of that sterilization process is the need to sterilize
anything that comes in contact with the patient or penetrates the
sterile field, including the imaging device 124 and its attachments
and components. It will be appreciated that the sterile field may
be considered a specified area, such as within a tray or on a
sterile towel, that is considered free of microorganisms, or the
sterile field may be considered an area, immediately around a
patient, who has been prepared for a surgical procedure. The
sterile field may include the scrubbed team members, who are
properly attired, and all furniture and fixtures in the area.
[0143] In various aspects, the visualization system 108 includes
one or more imaging sensors, one or more image processing units,
one or more storage arrays, and one or more displays that are
strategically arranged with respect to the sterile field, as
illustrated in FIG. 2. In one aspect, the visualization system 108
includes an interface for HL7, PACS, and EMR. Various components of
the visualization system 108 are described under the heading
"Advanced Imaging Acquisition Module" in U.S. Provisional Patent
Application Ser. No. 62/611,341, titled INTERACTIVE SURGICAL
PLATFORM, filed Dec. 28, 2017, the disclosure of which is herein
incorporated by reference in its entirety.
[0144] As illustrated in FIG. 2, a primary display 119 is
positioned in the sterile field to be visible to an operator at the
operating table 114. In addition, a visualization tower 111 is
positioned outside the sterile field. The visualization tower 111
includes a first non-sterile display 107 and a second non-sterile
display 109, which face away from each other. The visualization
system 108, guided by surgical hub 106, is configured to utilize
the displays 107, 109, and 119 to coordinate information flow to
operators inside and outside the sterile field. For example,
surgical hub 106 may cause the visualization system 108 to display
a snap-shot of a surgical site, as recorded by an imaging device
124, on a non-sterile display 107 or 109, while maintaining a live
feed of the surgical site on the primary display 119. The snap-shot
on the non-sterile display 107 or 109 can permit a non-sterile
operator to perform a diagnostic step relevant to the surgical
procedure, for example.
[0145] In one aspect, surgical hub 106 is also configured to route
a diagnostic input or feedback entered by a non-sterile operator at
the visualization tower 111 to the primary display 119 within the
sterile field, where it can be viewed by a sterile operator at the
operating table. In one example, the input can be in the form of a
modification to the snap-shot displayed on the non-sterile display
107 or 109, which can be routed to the primary display 119 by
surgical hub 106.
[0146] Referring to FIG. 2, a surgical instrument 112 is being used
in the surgical procedure as part of the surgical system 102.
Surgical hub 106 is also configured to coordinate information flow
to a display of the surgical instrument 112. For example, see U.S.
Provisional Patent Application Ser. No. 62/611,341, titled
INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure
of which is herein incorporated by reference in its entirety. A
diagnostic input or feedback entered by a non-sterile operator at
the visualization tower 111 can be routed by surgical hub 106 to
the surgical instrument display 115 within the sterile field, where
it can be viewed by the operator of the surgical instrument 112.
Example surgical instruments that are suitable for use with the
surgical system 102 are described under the heading "Surgical
Instrument Hardware" and in U.S. Provisional Patent Application
Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed
Dec. 28, 2017, the disclosure of which is herein incorporated by
reference in its entirety, for example.
[0147] Referring now to FIG. 3, a surgical hub 106 is depicted in
communication with a visualization system 108, a robotic system
110, and a handheld intelligent surgical instrument 112. Surgical
hub 106 includes a surgical hub display 135, an imaging module 138,
a generator module 140, a communication module 130, a processor
module 132, and a storage array 134. In certain aspects, as
illustrated in FIG. 3, surgical hub 106 further includes a smoke
evacuation module 126 and/or a suction/irrigation module 128.
[0148] During a surgical procedure, energy application to tissue,
for sealing and/or cutting, is generally associated with smoke
evacuation, suction of excess fluid, and/or irrigation of the
tissue. Fluid, power, and/or data lines from different sources are
often entangled during the surgical procedure. Valuable time can be
lost addressing this issue during a surgical procedure. Detangling
the lines may necessitate disconnecting the lines from their
respective modules, which may require resetting the modules.
Surgical hub modular enclosure 136 offers a unified environment for
managing the power, data, and fluid lines, which reduces the
frequency of entanglement between such lines.
[0149] Aspects of the present disclosure present a surgical hub for
use in a surgical procedure that involves energy application to
tissue at a surgical site. The surgical hub includes a surgical hub
enclosure and a combo generator module slidably receivable in a
docking station of surgical hub enclosure. The docking station
includes data and power contacts. The combo generator module
includes two or more of an ultrasonic energy generator component, a
bipolar RF energy generator component, and a monopolar RF energy
generator component that are housed in a single unit. In one
aspect, the combo generator module also includes a smoke evacuation
component, at least one energy delivery cable for connecting the
combo generator module to a surgical instrument, at least one smoke
evacuation component configured to evacuate smoke, fluid, and/or
particulates generated by the application of therapeutic energy to
the tissue, and a fluid line extending from the remote surgical
site to the smoke evacuation component.
[0150] In one aspect, the fluid line is a first fluid line and a
second fluid line extends from the remote surgical site to a
suction and irrigation module slidably received in surgical hub
enclosure. In one aspect, surgical hub enclosure comprises a fluid
interface.
[0151] Certain surgical procedures may require the application of
more than one energy type to the tissue. One energy type may be
more beneficial for cutting the tissue, while another different
energy type may be more beneficial for sealing the tissue. For
example, a bipolar generator can be used to seal the tissue while
an ultrasonic generator can be used to cut the sealed tissue.
Aspects of the present disclosure present a solution where a
surgical hub modular enclosure 136 is configured to accommodate
different generators, and facilitate an interactive communication
therebetween. One of the advantages of surgical hub modular
enclosure 136 is enabling the quick removal and/or replacement of
various modules.
[0152] Aspects of the present disclosure present a modular surgical
enclosure for use in a surgical procedure that involves energy
application to tissue. The modular surgical enclosure includes a
first energy-generator module, configured to generate a first
energy for application to the tissue, and a first docking station
comprising a first docking port that includes first data and power
contacts, wherein the first energy-generator module is slidably
movable into an electrical engagement with the power and data
contacts and wherein the first energy-generator module is slidably
movable out of the electrical engagement with the first power and
data contacts.
[0153] Further to the above, the modular surgical enclosure also
includes a second energy-generator module configured to generate a
second energy, different than the first energy, for application to
the tissue, and a second docking station comprising a second
docking port that includes second data and power contacts, wherein
the second energy-generator module is slidably movable into an
electrical engagement with the power and data contacts, and wherein
the second energy-generator module is slidably movable out of the
electrical engagement with the second power and data contacts.
[0154] In addition, the modular surgical enclosure also includes a
communication bus between the first docking port and the second
docking port, configured to facilitate communication between the
first energy-generator module and the second energy-generator
module.
[0155] Referring to FIGS. 3-7, aspects of the present disclosure
are presented for a surgical hub modular enclosure 136 that allows
the modular integration of a generator module 140, a smoke
evacuation module 126, and a suction/irrigation module 128.
Surgical hub modular enclosure 136 further facilitates interactive
communication between the modules 140, 126, 128. As illustrated in
FIG. 5, the generator module 140 can be a generator module with
integrated monopolar, bipolar, and ultrasonic components supported
in a single housing unit 139 slidably insertable into surgical hub
modular enclosure 136. As illustrated in FIG. 5, the generator
module 140 can be configured to connect to a monopolar device 146,
a bipolar device 147, and an ultrasonic device 148. Alternatively,
the generator module 140 may comprise a series of monopolar,
bipolar, and/or ultrasonic generator modules that interact through
surgical hub modular enclosure 136. Surgical hub modular enclosure
136 can be configured to facilitate the insertion of multiple
generators and interactive communication between the generators
docked into surgical hub modular enclosure 136 so that the
generators would act as a single generator.
[0156] In one aspect, surgical hub modular enclosure 136 comprises
a modular power and communication backplane 149 with external and
wireless communication headers to enable the removable attachment
of the modules 140, 126, 128 and interactive communication
therebetween.
[0157] In one aspect, surgical hub modular enclosure 136 includes
docking stations, or drawers, 151, herein also referred to as
drawers, which are configured to slidably receive the modules 140,
126, 128. FIG. 4 illustrates a partial perspective view of a
surgical hub enclosure 136, and a combo generator module 145
slidably receivable in a docking station 151 of the surgical hub
enclosure 136. A docking port 152 with power and data contacts on a
rear side of the combo generator module 145 is configured to engage
a corresponding docking port 150 with power and data contacts of a
corresponding docking station 151 of surgical hub modular enclosure
136 as the combo generator module 145 is slid into position within
the corresponding docking station 151 of surgical hub module
enclosure 136. In one aspect, the combo generator module 145
includes a bipolar, ultrasonic, and monopolar module and a smoke
evacuation module integrated together into a single housing unit
139, as illustrated in FIG. 5.
[0158] In various aspects, the smoke evacuation module 126 includes
a fluid line 154 that conveys captured/collected smoke and/or fluid
away from a surgical site and to, for example, the smoke evacuation
module 126. Vacuum suction originating from the smoke evacuation
module 126 can draw the smoke into an opening of a utility conduit
at the surgical site. The utility conduit, coupled to the fluid
line, can be in the form of a flexible tube terminating at the
smoke evacuation module 126. The utility conduit and the fluid line
define a fluid path extending toward the smoke evacuation module
126 that is received in surgical hub enclosure 136.
[0159] In various aspects, the suction/irrigation module 128 is
coupled to a surgical tool comprising an aspiration fluid line and
a suction fluid line. In one example, the aspiration and suction
fluid lines are in the form of flexible tubes extending from the
surgical site toward the suction/irrigation module 128. One or more
drive systems can be configured to cause irrigation and aspiration
of fluids to and from the surgical site.
[0160] In one aspect, the surgical tool includes a shaft having an
end effector at a distal end thereof and at least one energy
treatment associated with the end effector, an aspiration tube, and
an irrigation tube. The aspiration tube can have an inlet port at a
distal end thereof and the aspiration tube extends through the
shaft. Similarly, an irrigation tube can extend through the shaft
and can have an inlet port in proximity to the energy deliver
implement. The energy deliver implement is configured to deliver
ultrasonic and/or RF energy to the surgical site and is coupled to
the generator module 140 by a cable extending initially through the
shaft.
[0161] The irrigation tube can be in fluid communication with a
fluid source, and the aspiration tube can be in fluid communication
with a vacuum source. The fluid source and/or the vacuum source can
be housed in the suction/irrigation module 128. In one example, the
fluid source and/or the vacuum source can be housed in surgical hub
enclosure 136 separately from the suction/irrigation module 128. In
such example, a fluid interface can be configured to connect the
suction/irrigation module 128 to the fluid source and/or the vacuum
source.
[0162] In one aspect, the modules 140, 126, 128 and/or their
corresponding docking stations on surgical hub modular enclosure
136 may include alignment features that are configured to align the
docking ports of the modules into engagement with their
counterparts in the docking stations of surgical hub modular
enclosure 136. For example, as illustrated in FIG. 4, the combo
generator module 145 includes side brackets 155 that are configured
to slidably engage with corresponding brackets 156 of the
corresponding docking station 151 of surgical hub modular enclosure
136. The brackets cooperate to guide the docking port contacts of
the combo generator module 145 into an electrical engagement with
the docking port contacts of surgical hub modular enclosure
136.
[0163] In some aspects, the drawers 151 of surgical hub modular
enclosure 136 are the same, or substantially the same size, and the
modules are adjusted in size to be received in the drawers 151. For
example, the side brackets 155 and/or 156 can be larger or smaller
depending on the size of the module. In other aspects, the drawers
151 are different in size and are each designed to accommodate a
particular module.
[0164] Furthermore, the contacts of a particular module can be
keyed for engagement with the contacts of a particular drawer to
avoid inserting a module into a drawer with mismatching
contacts.
[0165] As illustrated in FIG. 4, the docking port 150 of one drawer
151 can be coupled to the docking port 150 of another drawer 151
through a communications link 157 to facilitate an interactive
communication between the modules housed in surgical hub modular
enclosure 136. The docking ports 150 of surgical hub modular
enclosure 136 may alternatively, or additionally, facilitate a
wireless interactive communication between the modules housed in
surgical hub modular enclosure 136. Any suitable wireless
communication can be employed, such as for example Air
Titan-Bluetooth.
[0166] FIG. 6 illustrates individual power bus attachments for a
plurality of lateral docking ports of a lateral modular housing 160
configured to receive a plurality of modules of a surgical hub 206.
The lateral modular housing 160 is configured to laterally receive
and interconnect the modules 161. The modules 161 are slidably
inserted into docking stations 162 of lateral modular housing 160,
which includes a backplane for interconnecting the modules 161. As
illustrated in FIG. 6, the modules 161 are arranged laterally in
the lateral modular housing 160. Alternatively, the modules 161 may
be arranged vertically in a lateral modular housing.
[0167] FIG. 7 illustrates a vertical modular housing 164 configured
to receive a plurality of modules 165 of the surgical hub 106. The
modules 165 are slidably inserted into docking stations, or
drawers, 167 of vertical modular housing 164, which includes a
backplane for interconnecting the modules 165. Although the drawers
167 of the vertical modular housing 164 are arranged vertically, in
certain instances, a vertical modular housing 164 may include
drawers that are arranged laterally. Furthermore, the modules 165
may interact with one another through the docking ports of the
vertical modular housing 164. In the example of FIG. 7, a display
177 is provided for displaying data relevant to the operation of
the modules 165. In addition, the vertical modular housing 164
includes a master module 178 housing a plurality of sub-modules
that are slidably received in the master module 178.
[0168] In various aspects, the imaging module 138 comprises an
integrated video processor and a modular light source and is
adapted for use with various imaging devices. In one aspect, the
imaging device is comprised of a modular housing that can be
assembled with a light source module and a camera module. The
housing can be a disposable housing. In at least one example, the
disposable housing is removably coupled to a reusable controller, a
light source module, and a camera module. The light source module
and/or the camera module can be selectively chosen depending on the
type of surgical procedure. In one aspect, the camera module
comprises a CCD sensor. In another aspect, the camera module
comprises a CMOS sensor. In another aspect, the camera module is
configured for scanned beam imaging. Likewise, the light source
module can be configured to deliver a white light or a different
light, depending on the surgical procedure.
[0169] During a surgical procedure, removing a surgical device from
the surgical field and replacing it with another surgical device
that includes a different camera or a different light source can be
inefficient. Temporarily losing sight of the surgical field may
lead to undesirable consequences. The module imaging device of the
present disclosure is configured to permit the replacement of a
light source module or a camera module midstream during a surgical
procedure, without having to remove the imaging device from the
surgical field.
[0170] In one aspect, the imaging device comprises a tubular
housing that includes a plurality of channels. A first channel is
configured to slidably receive the camera module, which can be
configured for a snap-fit engagement with the first channel. A
second channel is configured to slidably receive the light source
module, which can be configured for a snap-fit engagement with the
second channel. In another example, the camera module and/or the
light source module can be rotated into a final position within
their respective channels. A threaded engagement can be employed in
lieu of the snap-fit engagement.
[0171] In various examples, multiple imaging devices are placed at
different positions in the surgical field to provide multiple
views. The imaging module 138 can be configured to switch between
the imaging devices to provide an optimal view. In various aspects,
the imaging module 138 can be configured to integrate the images
from the different imaging device.
[0172] Various image processors and imaging devices suitable for
use with the present disclosure are described in U.S. Pat. No.
7,995,045, titled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR,
which issued on Aug. 9, 2011, which is herein incorporated by
reference in its entirety. In addition, U.S. Pat. No. 7,982,776,
titled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, which
issued on Jul. 19, 2011, which is herein incorporated by reference
in its entirety, describes various systems for removing motion
artifacts from image data. Such systems can be integrated with the
imaging module 138. Furthermore, U.S. Patent Application
Publication No. 2011/0306840, titled CONTROLLABLE MAGNETIC SOURCE
TO FIXTURE INTRACORPORAL APPARATUS, which published on Dec. 15,
2011, and U.S. Patent Application Publication No. 2014/0243597,
titled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL
PROCEDURE, which published on Aug. 28, 2014, the disclosure of each
of which is herein incorporated by reference in its entirety.
[0173] FIG. 8 illustrates a surgical data network 201 comprising a
modular communication hub 203 configured to connect modular devices
located in one or more operating theaters of a healthcare facility,
or any room in a healthcare facility specially equipped for
surgical operations, to a cloud-based system (e.g., the cloud 204
that may include a remote server 213 coupled to a storage device
205). In one aspect, the modular communication hub 203 comprises a
network hub 207 and/or a network switch 209 in communication with a
network router. The modular communication hub 203 also can be
coupled to a local computer system 210 to provide local computer
processing and data manipulation. The surgical data network 201 may
be configured as passive, intelligent, or switching. A passive
surgical data network serves as a conduit for the data, enabling it
to go from one device (or segment) to another and to the cloud
computing resources. An intelligent surgical data network includes
additional features to enable the traffic passing through the
surgical data network to be monitored and to configure each port in
the network hub 207 or network switch 209. An intelligent surgical
data network may be referred to as a manageable hub or switch. A
switching hub reads the destination address of each packet and then
forwards the packet to the correct port.
[0174] Modular devices 1a-1n located in the operating theater may
be coupled to the modular communication hub 203. The network hub
207 and/or the network switch 209 may be coupled to a network
router 211 to connect the devices 1a-1n to the cloud 204 or the
local computer system 210. Data associated with the devices 1a-1n
may be transferred to cloud-based computers via the router for
remote data processing and manipulation. Data associated with the
devices 1a-1n may also be transferred to the local computer system
210 for local data processing and manipulation. Modular devices
2a-2m located in the same operating theater also may be coupled to
a network switch 209. The network switch 209 may be coupled to the
network hub 207 and/or the network router 211 to connect to the
devices 2a-2m to the cloud 204. Data associated with the devices
2a-2n may be transferred to the cloud 204 via the network router
211 for data processing and manipulation. Data associated with the
devices 2a-2m may also be transferred to the local computer system
210 for local data processing and manipulation.
[0175] It will be appreciated that the surgical data network 201
may be expanded by interconnecting multiple network hubs 207 and/or
multiple network switches 209 with multiple network routers 211.
The modular communication hub 203 may be contained in a modular
control tower configured to receive multiple devices 1a-1n/2a-2m.
The local computer system 210 also may be contained in a modular
control tower. The modular communication hub 203 is connected to a
display 212 to display images obtained by some of the devices
1a-1n/2a-2m, for example during surgical procedures. In various
aspects, the devices 1a-1n/2a-2m may include, for example, various
modules such as an imaging module 138 coupled to an endoscope, a
generator module 140 coupled to an energy-based surgical device, a
smoke evacuation module 126, a suction/irrigation module 128, a
communication module 130, a processor module 132, a storage array
134, a surgical device coupled to a display, and/or a non-contact
sensor module, among other modular devices that may be connected to
the modular communication hub 203 of the surgical data network
201.
[0176] In one aspect, the surgical data network 201 may comprise a
combination of network hub(s), network switch(es), and network
router(s) connecting the devices 1a-1n/2a-2m to the cloud. Any one
of or all of the devices 1a-1n/2a-2m coupled to the network hub or
network switch may collect data in real time and transfer the data
to cloud computers for data processing and manipulation. It will be
appreciated that cloud computing relies on sharing computing
resources rather than having local servers or personal devices to
handle software applications. The word "cloud" may be used as a
metaphor for "the Internet," although the term is not limited as
such. Accordingly, the term "cloud computing" may be used herein to
refer to "a type of Internet-based computing," where different
services--such as servers, storage, and applications--are delivered
to the modular communication hub 203 and/or computer system 210
located in the surgical theater (e.g., a fixed, mobile, temporary,
or field operating room or space) and to devices connected to the
modular communication hub 203 and/or computer system 210 through
the Internet. The cloud infrastructure may be maintained by a cloud
service provider. In this context, the cloud service provider may
be the entity that coordinates the usage and control of the devices
1a-1n/2a-2m located in one or more operating theaters. The cloud
computing services can perform a large number of calculations based
on the data gathered by smart surgical instruments, robots, and
other computerized devices located in the operating theater.
Surgical hub hardware enables multiple devices or connections to be
connected to a computer that communicates with the cloud computing
resources and storage.
[0177] Applying cloud computer data processing techniques on the
data collected by the devices 1a-1n/2a-2m, the surgical data
network provides improved surgical outcomes, reduced costs, and
improved patient satisfaction. At least some of the devices
1a-1n/2a-2m may be employed to view tissue states to assess leaks
or perfusion of sealed tissue after a tissue sealing and cutting
procedure. At least some of the devices 1a-1n/2a-2m may be employed
to identify pathology, such as the effects of diseases, using the
cloud-based computing to examine data including images of samples
of body tissue for diagnostic purposes. This includes localization
and margin confirmation of tissue and phenotypes. At least some of
the devices 1a-1n/2a-2m may be employed to identify anatomical
structures of the body using a variety of sensors integrated with
imaging devices and techniques such as overlaying images captured
by multiple imaging devices. The data gathered by the devices
1a-1n/2a-2m, including image data, may be transferred to the cloud
204 or the local computer system 210 or both for data processing
and manipulation including image processing and manipulation. The
data may be analyzed to improve surgical procedure outcomes by
determining if further treatment, such as the application of
endoscopic intervention, emerging technologies, a targeted
radiation, targeted intervention, and precise robotics to
tissue-specific sites and conditions, may be pursued. Such data
analysis may further employ outcome analytics processing, and using
standardized approaches may provide beneficial feedback to either
confirm surgical treatments and the behavior of the surgeon or
suggest modifications to surgical treatments and the behavior of
the surgeon.
[0178] In one implementation, the operating theater devices 1a-1n
may be connected to the modular communication hub 203 over a wired
channel or a wireless channel depending on the configuration of the
devices 1a-1n to a network hub. The network hub 207 may be
implemented, in one aspect, as a local network broadcast device
that works on the physical layer of the Open System Interconnection
(OSI) model. The network hub provides connectivity to the devices
1a-1n located in the same operating theater network. The network
hub 207 collects data in the form of packets and sends them to the
router in half duplex mode. The network hub 207 does not store any
media access control/internet protocol (MAC/IP) to transfer the
device data. Only one of the devices 1a-1n can send data at a time
through the network hub 207. The network hub 207 has no routing
tables or intelligence regarding where to send information and
broadcasts all network data across each connection and to a remote
server 213 (FIG. 9) over the cloud 204. The network hub 207 can
detect basic network errors such as collisions, but having all
information broadcast to multiple ports can be a security risk and
cause bottlenecks.
[0179] In another implementation, the operating theater devices
2a-2m may be connected to a network switch 209 over a wired channel
or a wireless channel. The network switch 209 works in the data
link layer of the OSI model. The network switch 209 is a multicast
device for connecting the devices 2a-2m located in the same
operating theater to the network. The network switch 209 sends data
in the form of frames to the network router 211 and works in full
duplex mode. Multiple devices 2a-2m can send data at the same time
through the network switch 209. The network switch 209 stores and
uses MAC addresses of the devices 2a-2m to transfer data.
[0180] The network hub 207 and/or the network switch 209 are
coupled to the network router 211 for connection to the cloud 204.
The network router 211 works in the network layer of the OSI model.
The network router 211 creates a route for transmitting data
packets received from the network hub 207 and/or network switch 211
to cloud-based computer resources for further processing and
manipulation of the data collected by any one of or all the devices
1a-1n/2a-2m. The network router 211 may be employed to connect two
or more different networks located in different locations, such as,
for example, different operating theaters of the same healthcare
facility or different networks located in different operating
theaters of different healthcare facilities. The network router 211
sends data in the form of packets to the cloud 204 and works in
full duplex mode. Multiple devices can send data at the same time.
The network router 211 uses IP addresses to transfer data.
[0181] In one example, the network hub 207 may be implemented as a
USB hub, which allows multiple USB devices to be connected to a
host computer. The USB hub may expand a single USB port into
several tiers so that there are more ports available to connect
devices to the host system computer. The network hub 207 may
include wired or wireless capabilities to receive information over
a wired channel or a wireless channel. In one aspect, a wireless
USB short-range, high-bandwidth wireless radio communication
protocol may be employed for communication between the devices
1a-1n and devices 2a-2m located in the operating theater.
[0182] In other examples, the operating theater devices 1a-1n/2a-2m
may communicate to the modular communication hub 203 via Bluetooth
wireless technology standard for exchanging data over short
distances (using short-wavelength UHF radio waves in the ISM band
from 2.4 to 2.485 GHz) from fixed and mobile devices and building
personal area networks (PANs). In other aspects, the operating
theater devices 1a-1n/2a-2m may communicate to the modular
communication hub 203 via a number of wireless or wired
communication standards or protocols, including but not limited to
W-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20,
long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE,
GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as
well as any other wireless and wired protocols that are designated
as 3G, 4G, 5G, and beyond. The computing module may include a
plurality of communication modules. For instance, a first
communication module may be dedicated to shorter-range wireless
communications such as Wi-Fi and Bluetooth, and a second
communication module may be dedicated to longer-range wireless
communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO,
and others.
[0183] The modular communication hub 203 may serve as a central
connection for one or all of the operating theater devices
1a-1n/2a-2m and handles a data type known as frames. Frames carry
the data generated by the devices 1a-1n/2a-2m. When a frame is
received by the modular communication hub 203, it is amplified and
transmitted to the network router 211, which transfers the data to
the cloud computing resources by using a number of wireless or
wired communication standards or protocols, as described
herein.
[0184] The modular communication hub 203 can be used as a
standalone device or be connected to compatible network hubs and
network switches to form a larger network. The modular
communication hub 203 is generally easy to install, configure, and
maintain, making it a good option for networking the operating
theater devices 1a-1n/2a-2m.
[0185] FIG. 9 illustrates a computer-implemented interactive
surgical system 200. The computer-implemented interactive surgical
system 200 is similar in many respects to the computer-implemented
interactive surgical system 100. For example, the
computer-implemented interactive surgical system 200 includes one
or more surgical systems 202, which are similar in many respects to
the surgical systems 102. Each surgical system 202 includes at
least one surgical hub 206 in communication with a cloud 204 that
may include a remote server 213. In one aspect, the
computer-implemented interactive surgical system 200 comprises a
modular control tower 236 connected to multiple operating theater
devices such as, for example, intelligent surgical instruments,
robots, and other computerized devices located in the operating
theater. As shown in FIG. 10, the modular control tower 236
comprises a modular communication hub 203 coupled to a computer
system 210. As illustrated in the example of FIG. 9, the modular
control tower 236 is coupled to an imaging module 238 that is
coupled to an endoscope 239, a generator module 240 that is coupled
to an energy device 241, a smoke evacuation module 226, a
suction/irrigation module 228, a communication module 230, a
processor module 232, a storage array 234, a smart
device/instrument 235 optionally coupled to a display 237, and a
non-contact sensor module 242. The operating theater devices are
coupled to cloud computing resources and data storage via the
modular control tower 236. A robot hub 222 also may be connected to
the modular control tower 236 and to the cloud computing resources.
The devices/instruments 235, visualization systems 208, among
others, may be coupled to the modular control tower 236 via wired
or wireless communication standards or protocols, as described
herein. The modular control tower 236 may be coupled to a surgical
hub display 215 (e.g., monitor, screen) to display and overlay
images received from the imaging module, device/instrument display,
and/or other visualization systems 208. Surgical hub display also
may display data received from devices connected to the modular
control tower in conjunction with images and overlaid images.
[0186] FIG. 10 illustrates a surgical hub 206 comprising a
plurality of modules coupled to the modular control tower 236. The
modular control tower 236 comprises a modular communication hub
203, e.g., a network connectivity device, and a computer system 210
to provide local processing, visualization, and imaging, for
example. As shown in FIG. 10, the modular communication hub 203 may
be connected in a tiered configuration to expand the number of
modules (e.g., devices) that may be connected to the modular
communication hub 203 and transfer data associated with the modules
to the computer system 210, cloud computing resources, or both. As
shown in FIG. 10, each of the network hubs/switches in the modular
communication hub 203 includes three downstream ports and one
upstream port. The upstream network hub/switch is connected to a
processor to provide a communication connection to the cloud
computing resources and a local display 217. Communication to the
cloud 204 may be made either through a wired or a wireless
communication channel.
[0187] The surgical hub 206 employs a non-contact sensor module 242
to measure the dimensions of the operating theater and generate a
map of the surgical theater using either ultrasonic or laser-type
non-contact measurement devices. An ultrasound-based non-contact
sensor module scans the operating theater by transmitting a burst
of ultrasound and receiving the echo when it bounces off the
perimeter walls of an operating theater as described under the
heading "Surgical Hub Spatial Awareness Within an Operating Room"
in U.S. Provisional Patent Application Ser. No. 62/611,341, titled
INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, which is herein
incorporated by reference in its entirety, in which the sensor
module is configured to determine the size of the operating theater
and to adjust Bluetooth-pairing distance limits. A laser-based
non-contact sensor module scans the operating theater by
transmitting laser light pulses, receiving laser light pulses that
bounce off the perimeter walls of the operating theater, and
comparing the phase of the transmitted pulse to the received pulse
to determine the size of the operating theater and to adjust
Bluetooth pairing distance limits, for example.
[0188] The computer system 210 comprises a processor 244 and a
network interface 245. The processor 244 is coupled to a
communication module 247, storage 248, memory 249, non-volatile
memory 250, and input/output interface 251 via a system bus. The
system bus can be any of several types of bus structure(s)
including the memory bus or memory controller, a peripheral bus or
external bus, and/or a local bus using any variety of available bus
architectures including, but not limited to, 9-bit bus, Industrial
Standard Architecture (ISA), Micro-Charmel Architecture (MSA),
Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA
Local Bus (VLB), Peripheral Component Interconnect (PCI), USB,
Advanced Graphics Port (AGP), Personal Computer Memory Card
International Association bus (PCMCIA), Small Computer Systems
Interface (SCSI), or any other proprietary bus.
[0189] The processor 244 may be any single-core or multicore
processor such as those known under the trade name ARM Cortex by
Texas Instruments. In one aspect, the processor may be an
LM4F230H5QR ARM Cortex-M4F Processor Core, available from Texas
Instruments, for example, comprising an on-chip memory of 256 KB
single-cycle flash memory, or other non-volatile memory, up to 40
MHz, a prefetch buffer to improve performance above 40 MHz, a 32 KB
single-cycle serial random access memory (SRAM), an internal
read-only memory (ROM) loaded with StellarisWare.RTM. software, a 2
KB electrically erasable programmable read-only memory (EEPROM),
and/or one or more pulse width modulation (PWM) modules, one or
more quadrature encoder inputs (QEI) analogs, one or more 12-bit
analog-to-digital converters (ADCs) with 12 analog input channels,
details of which are available for the product datasheet.
[0190] In one aspect, the processor 244 may comprise a safety
controller comprising two controller-based families such as TMS570
and RM4.times., known under the trade name Hercules ARM Cortex R4,
also by Texas Instruments. The safety controller may be configured
specifically for IEC 61508 and ISO 26262 safety critical
applications, among others, to provide advanced integrated safety
features while delivering scalable performance, connectivity, and
memory options.
[0191] The system memory includes volatile memory and non-volatile
memory. The basic input/output system (BIOS), containing the basic
routines to transfer information between elements within the
computer system, such as during start-up, is stored in non-volatile
memory. For example, the non-volatile memory can include ROM,
programmable ROM (PROM), electrically programmable ROM (EPROM),
EEPROM, or flash memory. Volatile memory includes random-access
memory (RAM), which acts as external cache memory. Moreover, RAM is
available in many forms such as SRAM, dynamic RAM (DRAM),
synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM),
enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus
RAM (DRRAM).
[0192] The computer system 210 also includes
removable/non-removable, volatile/non-volatile computer storage
media, such as for example disk storage. The disk storage includes,
but is not limited to, devices like a magnetic disk drive, floppy
disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash
memory card, or memory stick. In addition, the disk storage can
include storage media separately or in combination with other
storage media including, but not limited to, an optical disc drive
such as a compact disc ROM device (CD-ROM), compact disc recordable
drive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or
a digital versatile disc ROM drive (DVD-ROM). To facilitate the
connection of the disk storage devices to the system bus, a
removable or non-removable interface may be employed.
[0193] It is to be appreciated that the computer system 210
includes software that acts as an intermediary between users and
the basic computer resources described in a suitable operating
environment. Such software includes an operating system. The
operating system, which can be stored on the disk storage, acts to
control and allocate resources of the computer system. System
applications take advantage of the management of resources by the
operating system through program modules and program data stored
either in the system memory or on the disk storage. It is to be
appreciated that various components described herein can be
implemented with various operating systems or combinations of
operating systems.
[0194] A user enters commands or information into the computer
system 210 through input device(s) coupled to the I/O interface
251. The input devices include, but are not limited to, a pointing
device such as a mouse, trackball, stylus, touch pad, keyboard,
microphone, joystick, game pad, satellite dish, scanner, TV tuner
card, digital camera, digital video camera, web camera, and the
like. These and other input devices connect to the processor
through the system bus via interface port(s). The interface port(s)
include, for example, a serial port, a parallel port, a game port,
and a USB. The output device(s) use some of the same types of ports
as input device(s). Thus, for example, a USB port may be used to
provide input to the computer system and to output information from
the computer system to an output device. An output adapter is
provided to illustrate that there are some output devices like
monitors, displays, speakers, and printers, among other output
devices that require special adapters. The output adapters include,
by way of illustration and not limitation, video and sound cards
that provide a means of connection between the output device and
the system bus. It should be noted that other devices and/or
systems of devices, such as remote computer(s), provide both input
and output capabilities.
[0195] The computer system 210 can operate in a networked
environment using logical connections to one or more remote
computers, such as cloud computer(s), or local computers. The
remote cloud computer(s) can be a personal computer, server,
router, network PC, workstation, microprocessor-based appliance,
peer device, or other common network node, and the like, and
typically includes many or all of the elements described relative
to the computer system. For purposes of brevity, only a memory
storage device is illustrated with the remote computer(s). The
remote computer(s) is logically connected to the computer system
through a network interface and then physically connected via a
communication connection. The network interface encompasses
communication networks such as local area networks (LANs) and wide
area networks (WANs). LAN technologies include Fiber Distributed
Data Interface (FDDI), Copper Distributed Data Interface (CDDI),
Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. WAN
technologies include, but are not limited to, point-to-point links,
circuit-switching networks like Integrated Services Digital
Networks (ISDN) and variations thereon, packet-switching networks,
and Digital Subscriber Lines (DSL).
[0196] In various aspects, the computer system 210 of FIG. 10, the
imaging module 238 and/or visualization system 208, and/or the
processor module 232 of FIGS. 9-10, may comprise an image
processor, image processing engine, media processor, or any
specialized digital signal processor (DSP) used for the processing
of digital images. The image processor may employ parallel
computing with single instruction, multiple data (SIMD) or multiple
instruction, multiple data (MIMD) technologies to increase speed
and efficiency. The digital image processing engine can perform a
range of tasks. The image processor may be a system on a chip with
multicore processor architecture.
[0197] The communication connection(s) refers to the
hardware/software employed to connect the network interface to the
bus. While the communication connection is shown for illustrative
clarity inside the computer system, it can also be external to the
computer system 210. The hardware/software necessary for connection
to the network interface includes, for illustrative purposes only,
internal and external technologies such as modems, including
regular telephone-grade modems, cable modems, and DSL modems, ISDN
adapters, and Ethernet cards.
[0198] FIG. 11 illustrates a functional block diagram of one aspect
of a USB network hub 300 device, according to one aspect of the
present disclosure. In the illustrated aspect, the USB network hub
device 300 employs a TUSB2036 integrated circuit hub by Texas
Instruments. The USB network hub 300 is a CMOS device that provides
an upstream USB transceiver port 302 and up to three downstream USB
transceiver ports 304, 306, 308 in compliance with the USB 2.0
specification. The upstream USB transceiver port 302 is a
differential root data port comprising a differential data minus
(DM0) input paired with a differential data plus (DP0) input. The
three downstream USB transceiver ports 304, 306, 308 are
differential data ports where each port includes differential data
plus (DP1-DP3) outputs paired with differential data minus
(DM1-DM3) outputs.
[0199] The USB network hub 300 device is implemented with a digital
state machine instead of a microcontroller, and no firmware
programming is required. Fully compliant USB transceivers are
integrated into the circuit for the upstream USB transceiver port
302 and all downstream USB transceiver ports 304, 306, 308. The
downstream USB transceiver ports 304, 306, 308 support both
full-speed and low-speed devices by automatically setting the slew
rate according to the speed of the device attached to the ports.
The USB network hub 300 device may be configured either in
bus-powered or self-powered mode and includes a surgical hub power
logic 312 to manage power.
[0200] The USB network hub 300 device includes a serial interface
engine 310 (SIE). The SIE 310 is the front end of the USB network
hub 300 hardware and handles most of the protocol described in
chapter 8 of the USB specification. The SIE 310 typically
comprehends signaling up to the transaction level. The functions
that it handles could include: packet recognition, transaction
sequencing, SOP, EOP, RESET, and RESUME signal
detection/generation, clock/data separation, non-return-to-zero
invert (NRZI) data encoding/decoding and bit-stuffing, CRC
generation and checking (token and data), packet ID (PID)
generation and checking/decoding, and/or
serial-parallel/parallel-serial conversion. The 310 receives a
clock input 314 and is coupled to a suspend/resume logic and frame
timer 316 circuit and a surgical hub repeater circuit 318 to
control communication between the upstream USB transceiver port 302
and the downstream USB transceiver ports 304, 306, 308 through port
logic circuits 320, 322, 324. The SIE 310 is coupled to a command
decoder 326 via interface logic to control commands from a serial
EEPROM via a serial EEPROM interface 330.
[0201] In various aspects, the USB network hub 300 can connect 127
functions configured in up to six logical layers (tiers) to a
single computer. Further, the USB network hub 300 can connect to
all peripherals using a standardized four-wire cable that provides
both communication and power distribution. The power configurations
are bus-powered and self-powered modes. The USB network hub 300 may
be configured to support four modes of power management: a
bus-powered hub, with either individual-port power management or
ganged-port power management, and the self-powered hub, with either
individual-port power management or ganged-port power management.
In one aspect, using a USB cable, the USB network hub 300, the
upstream USB transceiver port 302 is plugged into a USB host
controller, and the downstream USB transceiver ports 304, 306, 308
are exposed for connecting USB compatible devices, and so
forth.
[0202] FIG. 12 illustrates a logic diagram of a control system 470
of a surgical instrument or tool in accordance with one or more
aspects of the present disclosure. The system 470 comprises a
control circuit. The control circuit includes a microcontroller 461
comprising a processor 462 and a memory 468. One or more of sensors
472, 474, 476, for example, provide real-time feedback to the
processor 462. A motor 482, driven by a motor driver 492, operably
couples a longitudinally movable displacement member to drive the
I-beam knife element. A tracking system 480 is configured to
determine the position of the longitudinally movable displacement
member. The position information is provided to the processor 462,
which can be programmed or configured to determine the position of
the longitudinally movable drive member as well as the position of
a firing member, firing bar, and I-beam knife element. Additional
motors may be provided at the tool driver interface to control
I-beam firing, closure tube travel, shaft rotation, and
articulation. A display 473 displays a variety of operating
conditions of the instruments and may include touch screen
functionality for data input. Information displayed on the display
473 may be overlaid with images acquired via endoscopic imaging
modules.
[0203] In one aspect, the microcontroller 461 may be any
single-core or multicore processor such as those known under the
trade name ARM Cortex by Texas Instruments. In one aspect, the main
microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F Processor
Core, available from Texas Instruments, for example, comprising an
on-chip memory of 256 KB single-cycle flash memory, or other
non-volatile memory, up to 40 MHz, a prefetch buffer to improve
performance above 40 MHz, a 32 KB single-cycle SRAM, and internal
ROM loaded with StellarisWare.RTM. software, a 2 KB EEPROM, one or
more PWM modules, one or more QEI analogs, and/or one or more
12-bit ADCs with 12 analog input channels, details of which are
available for the product datasheet.
[0204] In one aspect, the microcontroller 461 may comprise a safety
controller comprising two controller-based families such as TMS570
and RM4.times., known under the trade name Hercules ARM Cortex R4,
also by Texas Instruments. The safety controller may be configured
specifically for IEC 61508 and ISO 26262 safety critical
applications, among others, to provide advanced integrated safety
features while delivering scalable performance, connectivity, and
memory options.
[0205] The microcontroller 461 may be programmed to perform various
functions such as precise control over the speed and position of
the knife and articulation systems. In one aspect, the
microcontroller 461 includes a processor 462 and a memory 468. The
electric motor 482 may be a brushed direct current (DC) motor with
a gearbox and mechanical links to an articulation or knife system.
In one aspect, a motor driver 492 may be an A3941 available from
Allegro Microsystems, Inc. Other motor drivers may be readily
substituted for use in the tracking system 480 comprising an
absolute positioning system. A detailed description of an absolute
positioning system is described in U.S. Patent Application
Publication No. 2017/0296213, titled SYSTEMS AND METHODS FOR
CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT, which
published on Oct. 19, 2017, which is herein incorporated by
reference in its entirety.
[0206] The microcontroller 461 may be programmed to provide precise
control over the speed and position of displacement members and
articulation systems. The microcontroller 461 may be configured to
compute a response in the software of the microcontroller 461. The
computed response is compared to a measured response of the actual
system to obtain an "observed" response, which is used for actual
feedback decisions. The observed response is a favorable, tuned
value that balances the smooth, continuous nature of the simulated
response with the measured response, which can detect outside
influences on the system.
[0207] In one aspect, the motor 482 may be controlled by the motor
driver 492 and can be employed by the firing system of the surgical
instrument or tool. In various forms, the motor 482 may be a
brushed DC driving motor having a maximum rotational speed of
approximately 25,000 RPM. In other arrangements, the motor 482 may
include a brushless motor, a cordless motor, a synchronous motor, a
stepper motor, or any other suitable electric motor. The motor
driver 492 may comprise an H-bridge driver comprising field-effect
transistors (FETs), for example. The motor 482 can be powered by a
power assembly releasably mounted to the handle assembly or tool
housing for supplying control power to the surgical instrument or
tool. The power assembly may comprise a battery which may include a
number of battery cells connected in series that can be used as the
power source to power the surgical instrument or tool. In certain
circumstances, the battery cells of the power assembly may be
replaceable and/or rechargeable. In at least one example, the
battery cells can be lithium-ion batteries which can be couplable
to and separable from the power assembly.
[0208] The motor driver 492 may be an A3941 available from Allegro
Microsystems, Inc. The A3941 492 is a full-bridge controller for
use with external N-channel power metal-oxide semiconductor
field-effect transistors (MOSFETs) specifically designed for
inductive loads, such as brush DC motors. The driver 492 comprises
a unique charge pump regulator that provides full (>10 V) gate
drive for battery voltages down to 7 V and allows the A3941 to
operate with a reduced gate drive, down to 5.5 V. A bootstrap
capacitor may be employed to provide the above battery supply
voltage required for N-channel MOSFETs. An internal charge pump for
the high-side drive allows DC (100% duty cycle) operation. The full
bridge can be driven in fast or slow decay modes using diode or
synchronous rectification. In the slow decay mode, current
recirculation can be through the high-side or the lowside FETs. The
power FETs are protected from shoot-through by resistor-adjustable
dead time. Integrated diagnostics provide indications of
undervoltage, overtemperature, and power bridge faults and can be
configured to protect the power MOSFETs under most short circuit
conditions. Other motor drivers may be readily substituted for use
in the tracking system 480 comprising an absolute positioning
system.
[0209] The tracking system 480 comprises a controlled motor drive
circuit arrangement comprising a position sensor 472 according to
one aspect of this disclosure. The position sensor 472 for an
absolute positioning system provides a unique position signal
corresponding to the location of a displacement member. In one
aspect, the displacement member represents a longitudinally movable
drive member comprising a rack of drive teeth for meshing
engagement with a corresponding drive gear of a gear reducer
assembly. In other aspects, the displacement member represents the
firing member, which could be adapted and configured to include a
rack of drive teeth. In yet another aspect, the displacement member
represents a firing bar or the I-beam, each of which can be adapted
and configured to include a rack of drive teeth. Accordingly, as
used herein, the term displacement member is used generically to
refer to any movable member of the surgical instrument or tool such
as the drive member, the firing member, the firing bar, the I-beam,
or any element that can be displaced. In one aspect, the
longitudinally movable drive member is coupled to the firing
member, the firing bar, and the --I-beam. Accordingly, the absolute
positioning system can, in effect, track the linear displacement of
the I-beam by tracking the linear displacement of the
longitudinally movable drive member. In various other aspects, the
displacement member may be coupled to any position sensor 472
suitable for measuring linear displacement. Thus, the
longitudinally movable drive member, the firing member, the firing
bar, or the I-beam, or combinations thereof, may be coupled to any
suitable linear displacement sensor. Linear displacement sensors
may include contact or non-contact displacement sensors. Linear
displacement sensors may comprise linear variable differential
transformers (LVDT), differential variable reluctance transducers
(DVRT), a slide potentiometer, a magnetic sensing system comprising
a movable magnet and a series of linearly arranged Hall effect
sensors, a magnetic sensing system comprising a fixed magnet and a
series of movable, linearly arranged Hall effect sensors, an
optical sensing system comprising a movable light source and a
series of linearly arranged photo diodes or photo detectors, an
optical sensing system comprising a fixed light source and a series
of movable linearly, arranged photo diodes or photo detectors, or
any combination thereof.
[0210] The electric motor 482 can include a rotatable shaft that
operably interfaces with a gear assembly that is mounted in meshing
engagement with a set, or rack, of drive teeth on the displacement
member. A sensor element may be operably coupled to a gear assembly
such that a single revolution of the position sensor 472 element
corresponds to some linear longitudinal translation of the
displacement member. An arrangement of gearing and sensors can be
connected to the linear actuator, via a rack and pinion
arrangement, or a rotary actuator, via a spur gear or other
connection. A power source supplies power to the absolute
positioning system and an output indicator may display the output
of the absolute positioning system. The displacement member
represents the longitudinally movable drive member comprising a
rack of drive teeth formed thereon for meshing engagement with a
corresponding drive gear of the gear reducer assembly. The
displacement member represents the longitudinally movable firing
member, firing bar, I-beam, or combinations thereof.
[0211] A single revolution of the sensor element associated with
the position sensor 472 is equivalent to a longitudinal linear
displacement d1 of the of the displacement member, where d1 is the
longitudinal linear distance that the displacement member moves
from point "a" to point "b" after a single revolution of the sensor
element coupled to the displacement member. The sensor arrangement
may be connected via a gear reduction that results in the position
sensor 472 completing one or more revolutions for the full stroke
of the displacement member. The position sensor 472 may complete
multiple revolutions for the full stroke of the displacement
member.
[0212] A series of switches, where n is an integer greater than
one, may be employed alone or in combination with a gear reduction
to provide a unique position signal for more than one revolution of
the position sensor 472. The state of the switches are fed back to
the microcontroller 461 that applies logic to determine a unique
position signal corresponding to the longitudinal linear
displacement d1+d2+ . . . dn of the displacement member. The output
of the position sensor 472 is provided to the microcontroller 461.
The position sensor 472 of the sensor arrangement may comprise a
magnetic sensor, an analog rotary sensor like a potentiometer, or
an array of analog Hall-effect elements, which output a unique
combination of position signals or values.
[0213] The position sensor 472 may comprise any number of magnetic
sensing elements, such as, for example, magnetic sensors classified
according to whether they measure the total magnetic field or the
vector components of the magnetic field. The techniques used to
produce both types of magnetic sensors encompass many aspects of
physics and electronics. The technologies used for magnetic field
sensing include search coil, fluxgate, optically pumped, nuclear
precession, SQUID, Hall-effect, anisotropic magnetoresistance,
giant magnetoresistance, magnetic tunnel junctions, giant
magnetoimpedance, magnetostrictive/piezoelectric composites,
magnetodiode, magnetotransistor, fiber-optic, magneto-optic, and
microelectromechanical systems-based magnetic sensors, among
others.
[0214] In one aspect, the position sensor 472 for the tracking
system 480 comprising an absolute positioning system comprises a
magnetic rotary absolute positioning system. The position sensor
472 may be implemented as an AS5055EQFT single-chip magnetic rotary
position sensor available from Austria Microsystems, AG. The
position sensor 472 is interfaced with the microcontroller 461 to
provide an absolute positioning system. The position sensor 472 is
a low-voltage and low-power component and includes four Hall-effect
elements in an area of the position sensor 472 that is located
above a magnet. A high-resolution ADC and a smart power management
controller are also provided on the chip. A coordinate rotation
digital computer (CORDIC) processor, also known as the
digit-by-digit method and Volder's algorithm, is provided to
implement a simple and efficient algorithm to calculate hyperbolic
and trigonometric functions that require only addition,
subtraction, bitshift, and table lookup operations. The angle
position, alarm bits, and magnetic field information are
transmitted over a standard serial communication interface, such as
a serial peripheral interface (SPI) interface, to the
microcontroller 461. The position sensor 472 provides 12 or 14 bits
of resolution. The position sensor 472 may be an AS5055 chip
provided in a small QFN 16-pin 4.times.4.times.0.85 mm package.
[0215] The tracking system 480 comprising an absolute positioning
system may comprise and/or be programmed to implement a feedback
controller, such as a PID, state feedback, and adaptive controller.
A power source converts the signal from the feedback controller
into a physical input to the system: in this case the voltage.
Other examples include a PWM of the voltage, current, and force.
Other sensor(s) may be provided to measure physical parameters of
the physical system in addition to the position measured by the
position sensor 472. In some aspects, the other sensor(s) can
include sensor arrangements such as those described in U.S. Pat.
No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR
SYSTEM, which issued on May 24, 2016, which is herein incorporated
by reference in its entirety; U.S. Patent Application Publication
No. 2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR
SYSTEM, which published on Sep. 18, 2014, which is herein
incorporated by reference in its entirety; and U.S. patent
application Ser. No. 15/628,175, titled TECHNIQUES FOR ADAPTIVE
CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING
INSTRUMENT, filed Jun. 20, 2017, which is herein incorporated by
reference in its entirety. In a digital signal processing system,
an absolute positioning system is coupled to a digital data
acquisition system where the output of the absolute positioning
system will have a finite resolution and sampling frequency. The
absolute positioning system may comprise a compare-and-combine
circuit to combine a computed response with a measured response
using algorithms, such as a weighted average and a theoretical
control loop, that drive the computed response towards the measured
response. The computed response of the physical system takes into
account properties like mass, inertial, viscous friction,
inductance resistance, etc., to predict what the states and outputs
of the physical system will be by knowing the input.
[0216] The absolute positioning system provides an absolute
position of the displacement member upon power-up of the
instrument, without retracting or advancing the displacement member
to a reset (zero or home) position as may be required with
conventional rotary encoders that merely count the number of steps
forwards or backwards that the motor 482 has taken to infer the
position of a device actuator, drive bar, knife, or the like.
[0217] A sensor 474, such as, for example, a strain gauge or a
micro-strain gauge, is configured to measure one or more parameters
of the end effector, such as, for example, the amplitude of the
strain exerted on the anvil during a clamping operation, which can
be indicative of the closure forces applied to the anvil. The
measured strain is converted to a digital signal and provided to
the processor 462. Alternatively, or in addition to the sensor 474,
a sensor 476, such as, for example, a load sensor, can measure the
closure force applied by the closure drive system to the anvil. The
sensor 476, such as, for example, a load sensor, can measure the
firing force applied to an I-beam in a firing stroke of the
surgical instrument or tool. The I-beam is configured to engage a
wedge sled, which is configured to upwardly cam staple drivers to
force out staples into deforming contact with an anvil. The I-beam
also includes a sharpened cutting edge that can be used to sever
tissue as the I-beam is advanced distally by the firing bar.
Alternatively, a current sensor 478 can be employed to measure the
current drawn by the motor 482. The force required to advance the
firing member can correspond to the current drawn by the motor 482,
for example. The measured force is converted to a digital signal
and provided to the processor 462.
[0218] In one form, the strain gauge sensor 474 can be used to
measure the force applied to the tissue by the end effector. A
strain gauge can be coupled to the end effector to measure the
force on the tissue being treated by the end effector. A system for
measuring forces applied to the tissue grasped by the end effector
comprises a strain gauge sensor 474, such as, for example, a
micro-strain gauge, that is configured to measure one or more
parameters of the end effector, for example. In one aspect, the
strain gauge sensor 474 can measure the amplitude or magnitude of
the strain exerted on a jaw member of an end effector during a
clamping operation, which can be indicative of the tissue
compression. The measured strain is converted to a digital signal
and provided to a processor 462 of the microcontroller 461. A load
sensor 476 can measure the force used to operate the knife element,
for example, to cut the tissue captured between the anvil and the
staple cartridge. A magnetic field sensor can be employed to
measure the thickness of the captured tissue. The measurement of
the magnetic field sensor also may be converted to a digital signal
and provided to the processor 462.
[0219] The measurements of the tissue compression, the tissue
thickness, and/or the force required to close the end effector on
the tissue, as respectively measured by the sensors 474, 476, can
be used by the microcontroller 461 to characterize the selected
position of the firing member and/or the corresponding value of the
speed of the firing member. In one instance, a memory 468 may store
a technique, an equation, and/or a lookup table which can be
employed by the microcontroller 461 in the assessment.
[0220] The control system 470 of the surgical instrument or tool
also may comprise wired or wireless communication circuits to
communicate with the modular communication hub as shown in FIGS.
8-11.
[0221] FIG. 13 illustrates a control circuit 500 configured to
control aspects of the surgical instrument or tool according to one
aspect of this disclosure. The control circuit 500 can be
configured to implement various processes described herein. The
control circuit 500 may comprise a microcontroller comprising one
or more processors 502 (e.g., microprocessor, microcontroller)
coupled to at least one memory circuit 504. The memory circuit 504
stores machine-executable instructions that, when executed by the
processor 502, cause the processor 502 to execute machine
instructions to implement various processes described herein. The
processor 502 may be any one of a number of single-core or
multicore processors known in the art. The memory circuit 504 may
comprise volatile and non-volatile storage media. The processor 502
may include an instruction processing unit 506 and an arithmetic
unit 508. The instruction processing unit may be configured to
receive instructions from the memory circuit 504 of this
disclosure.
[0222] FIG. 14 illustrates a combinational logic circuit 510
configured to control aspects of the surgical instrument or tool
according to one aspect of this disclosure. The combinational logic
circuit 510 can be configured to implement various processes
described herein. The combinational logic circuit 510 may comprise
a finite state machine comprising a combinational logic 512
configured to receive data associated with the surgical instrument
or tool at an input 514, process the data by the combinational
logic 512, and provide an output 516.
[0223] FIG. 15 illustrates a sequential logic circuit 520
configured to control aspects of the surgical instrument or tool
according to one aspect of this disclosure. The sequential logic
circuit 520 or the combinational logic 522 can be configured to
implement various processes described herein. The sequential logic
circuit 520 may comprise a finite state machine. The sequential
logic circuit 520 may comprise a combinational logic 522, at least
one memory circuit 524, and a clock 529, for example. The at least
one memory circuit 524 can store a current state of the finite
state machine. In certain instances, the sequential logic circuit
520 may be synchronous or asynchronous. The combinational logic 522
is configured to receive data associated with the surgical
instrument or tool from an input 526, process the data by the
combinational logic 522, and provide an output 528. In other
aspects, the circuit may comprise a combination of a processor
(e.g., processor 502, FIG. 13) and a finite state machine to
implement various processes herein. In other aspects, the finite
state machine may comprise a combination of a combinational logic
circuit (e.g., combinational logic circuit 510, FIG. 14) and the
sequential logic circuit 520.
[0224] FIG. 16 illustrates a surgical instrument or tool comprising
a plurality of motors which can be activated to perform various
functions. In certain instances, a first motor can be activated to
perform a first function, a second motor can be activated to
perform a second function, a third motor can be activated to
perform a third function, a fourth motor can be activated to
perform a fourth function, and so on. In certain instances, the
plurality of motors of robotic surgical instrument 600 can be
individually activated to cause firing, closure, and/or
articulation motions in the end effector. The firing, closure,
and/or articulation motions can be transmitted to the end effector
through a shaft assembly, for example.
[0225] In certain instances, the surgical instrument system or tool
may include a firing motor 602. The firing motor 602 may be
operably coupled to a firing motor drive assembly 604 which can be
configured to transmit firing motions, generated by the motor 602
to the end effector, in particular to displace the I-beam element.
In certain instances, the firing motions generated by the motor 602
may cause the staples to be deployed from the staple cartridge into
tissue captured by the end effector and/or the cutting edge of the
I-beam element to be advanced to cut the captured tissue, for
example. The I-beam element may be retracted by reversing the
direction of the motor 602.
[0226] In certain instances, the surgical instrument or tool may
include a closure motor 603. The closure motor 603 may be operably
coupled to a closure motor drive assembly 605 which can be
configured to transmit closure motions, generated by the motor 603
to the end effector, in particular to displace a closure tube to
close the anvil and compress tissue between the anvil and the
staple cartridge. The closure motions may cause the end effector to
transition from an open configuration to an approximated
configuration to capture tissue, for example. The end effector may
be transitioned to an open position by reversing the direction of
the motor 603.
[0227] In certain instances, the surgical instrument or tool may
include one or more articulation motors 606a, 606b, for example.
The motors 606a, 606b may be operably coupled to respective
articulation motor drive assemblies 608a, 608b, which can be
configured to transmit articulation motions generated by the motors
606a, 606b to the end effector. In certain instances, the
articulation motions may cause the end effector to articulate
relative to the shaft, for example.
[0228] As described above, the surgical instrument or tool may
include a plurality of motors which may be configured to perform
various independent functions. In certain instances, the plurality
of motors of the surgical instrument or tool can be individually or
separately activated to perform one or more functions while the
other motors remain inactive. For example, the articulation motors
606a, 606b can be activated to cause the end effector to be
articulated while the firing motor 602 remains inactive.
Alternatively, the firing motor 602 can be activated to fire the
plurality of staples, and/or to advance the cutting edge, while the
articulation motor 606 remains inactive. Furthermore the closure
motor 603 may be activated simultaneously with the firing motor 602
to cause the closure tube and the I-beam element to advance
distally as described in more detail hereinbelow.
[0229] In certain instances, the surgical instrument or tool may
include a common control module 610 which can be employed with a
plurality of motors of the surgical instrument or tool. In certain
instances, the common control module 610 may accommodate one of the
plurality of motors at a time. For example, the common control
module 610 can be couplable to and separable from the plurality of
motors of the robotic surgical instrument individually. In certain
instances, a plurality of the motors of the surgical instrument or
tool may share one or more common control modules such as the
common control module 610. In certain instances, a plurality of
motors of the surgical instrument or tool can be individually and
selectively engaged with the common control module 610. In certain
instances, the common control module 610 can be selectively
switched from interfacing with one of a plurality of motors of the
surgical instrument or tool to interfacing with another one of the
plurality of motors of the surgical instrument or tool.
[0230] In at least one example, the common control module 610 can
be selectively switched between operable engagement with the
articulation motors 606a, 606b and operable engagement with either
the firing motor 602 or the closure motor 603. In at least one
example, as illustrated in FIG. 16, a switch 614 can be moved or
transitioned between a plurality of positions and/or states. In a
first position 616, the switch 614 may electrically couple the
common control module 610 to the firing motor 602; in a second
position 617, the switch 614 may electrically couple the common
control module 610 to the closure motor 603; in a third position
618a, the switch 614 may electrically couple the common control
module 610 to the first articulation motor 606a; and in a fourth
position 618b, the switch 614 may electrically couple the common
control module 610 to the second articulation motor 606b, for
example. In certain instances, separate common control modules 610
can be electrically coupled to the firing motor 602, the closure
motor 603, and the articulations motor 606a, 606b at the same time.
In certain instances, the switch 614 may be a mechanical switch, an
electromechanical switch, a solid-state switch, or any suitable
switching mechanism.
[0231] Each of the motors 602, 603, 606a, 606b may comprise a
torque sensor to measure the output torque on the shaft of the
motor. The force on an end effector may be sensed in any
conventional manner, such as by force sensors on the outer sides of
the jaws or by a torque sensor for the motor actuating the
jaws.
[0232] In various instances, as illustrated in FIG. 16, the common
control module 610 may comprise a motor driver 626 which may
comprise one or more H-Bridge FETs. The motor driver 626 may
modulate the power transmitted from a power source 628 to a motor
coupled to the common control module 610 based on input from a
microcontroller 620 (the "controller"), for example. In certain
instances, the microcontroller 620 can be employed to determine the
current drawn by the motor, for example, while the motor is coupled
to the common control module 610, as described above.
[0233] In certain instances, the microcontroller 620 may include a
microprocessor 622 (the "processor") and one or more non-transitory
computer-readable mediums or memory units 624 (the "memory"). In
certain instances, the memory 624 may store various program
instructions, which when executed may cause the processor 622 to
perform a plurality of functions and/or calculations described
herein. In certain instances, one or more of the memory units 624
may be coupled to the processor 622, for example.
[0234] In certain instances, the power source 628 can be employed
to supply power to the microcontroller 620, for example. In certain
instances, the power source 628 may comprise a battery (or "battery
pack" or "power pack"), such as a lithium-ion battery, for example.
In certain instances, the battery pack may be configured to be
releasably mounted to a handle for supplying power to the surgical
instrument 600. A number of battery cells connected in series may
be used as the power source 628. In certain instances, the power
source 628 may be replaceable and/or rechargeable, for example.
[0235] In various instances, the processor 622 may control the
motor driver 626 to control the position, direction of rotation,
and/or velocity of a motor that is coupled to the common control
module 610. In certain instances, the processor 622 can signal the
motor driver 626 to stop and/or disable a motor that is coupled to
the common control module 610. It should be understood that the
term "processor" as used herein includes any suitable
microprocessor, microcontroller, or other basic computing device
that incorporates the functions of a computer's central processing
unit (CPU) on an integrated circuit or, at most, a few integrated
circuits. The processor is a multipurpose, programmable device that
accepts digital data as input, processes it according to
instructions stored in its memory, and provides results as output.
It is an example of sequential digital logic, as it has internal
memory. Processors operate on numbers and symbols represented in
the binary numeral system.
[0236] In one instance, the processor 622 may be any single-core or
multicore processor such as those known under the trade name ARM
Cortex by Texas Instruments. In certain instances, the
microcontroller 620 may be an LM 4F230H5QR, available from Texas
Instruments, for example. In at least one example, the Texas
Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Core
comprising an on-chip memory of 256 KB single-cycle flash memory,
or other non-volatile memory, up to 40 MHz, a prefetch buffer to
improve performance above 40 MHz, a 32 KB single-cycle SRAM, an
internal ROM loaded with StellarisWare.RTM. software, a 2 KB
EEPROM, one or more PWM modules, one or more QEI analogs, one or
more 12-bit ADCs with 12 analog input channels, among other
features that are readily available for the product datasheet.
Other microcontrollers may be readily substituted for use with the
module 4410. Accordingly, the present disclosure should not be
limited in this context.
[0237] In certain instances, the memory 624 may include program
instructions for controlling each of the motors of the surgical
instrument 600 that are couplable to the common control module 610.
For example, the memory 624 may include program instructions for
controlling the firing motor 602, the closure motor 603, and the
articulation motors 606a, 606b. Such program instructions may cause
the processor 622 to control the firing, closure, and articulation
functions in accordance with inputs from algorithms or control
programs of the surgical instrument or tool.
[0238] In certain instances, one or more mechanisms and/or sensors
such as, for example, sensors 630 can be employed to alert the
processor 622 to the program instructions that should be used in a
particular setting. For example, the sensors 630 may alert the
processor 622 to use the program instructions associated with
firing, closing, and articulating the end effector. In certain
instances, the sensors 630 may comprise position sensors which can
be employed to sense the position of the switch 614, for example.
Accordingly, the processor 622 may use the program instructions
associated with firing the I-beam of the end effector upon
detecting, through the sensors 630 for example, that the switch 614
is in the first position 616; the processor 622 may use the program
instructions associated with closing the anvil upon detecting,
through the sensors 630 for example, that the switch 614 is in the
second position 617; and the processor 622 may use the program
instructions associated with articulating the end effector upon
detecting, through the sensors 630 for example, that the switch 614
is in the third or fourth position 618a, 618b.
[0239] FIG. 17 is a schematic diagram of a robotic surgical
instrument 700 configured to operate a surgical tool described
herein according to one aspect of this disclosure. The robotic
surgical instrument 700 may be programmed or configured to control
distal/proximal translation of a displacement member,
distal/proximal displacement of a closure tube, shaft rotation, and
articulation, either with single or multiple articulation drive
links. In one aspect, the surgical instrument 700 may be programmed
or configured to individually control a firing member, a closure
member, a shaft member, and/or one or more articulation members.
The surgical instrument 700 comprises a control circuit 710
configured to control motor-driven firing members, closure members,
shaft members, and/or one or more articulation members.
[0240] In one aspect, the robotic surgical instrument 700 comprises
a control circuit 710 configured to control an anvil 716 and an
I-beam 714 (including a sharp cutting edge) portion of an end
effector 702, a removable staple cartridge 718, a shaft 740, and
one or more articulation members 742a, 742b via a plurality of
motors 704a-704e. A position sensor 734 may be configured to
provide position feedback of the I-beam 714 to the control circuit
710. Other sensors 738 may be configured to provide feedback to the
control circuit 710. A timer/counter 731 provides timing and
counting information to the control circuit 710. An energy source
712 may be provided to operate the motors 704a-704e, and a current
sensor 736 provides motor current feedback to the control circuit
710. The motors 704a-704e can be operated individually by the
control circuit 710 in a open-loop or closed-loop feedback
control.
[0241] In one aspect, the control circuit 710 may comprise one or
more microcontrollers, microprocessors, or other suitable
processors for executing instructions that cause the processor or
processors to perform one or more tasks. In one aspect, a
timer/counter 731 provides an output signal, such as the elapsed
time or a digital count, to the control circuit 710 to correlate
the position of the I-beam 714 as determined by the position sensor
734 with the output of the timer/counter 731 such that the control
circuit 710 can determine the position of the I-beam 714 at a
specific time (t) relative to a starting position or the time (t)
when the I-beam 714 is at a specific position relative to a
starting position. The timer/counter 731 may be configured to
measure elapsed time, count external events, or time external
events.
[0242] In one aspect, the control circuit 710 may be programmed to
control functions of the end effector 702 based on one or more
tissue conditions. The control circuit 710 may be programmed to
sense tissue conditions, such as thickness, either directly or
indirectly, as described herein. The control circuit 710 may be
programmed to select a firing control program or closure control
program based on tissue conditions. A firing control program may
describe the distal motion of the displacement member. Different
firing control programs may be selected to better treat different
tissue conditions. For example, when thicker tissue is present, the
control circuit 710 may be programmed to translate the displacement
member at a lower velocity and/or with lower power. When thinner
tissue is present, the control circuit 710 may be programmed to
translate the displacement member at a higher velocity and/or with
higher power. A closure control program may control the closure
force applied to the tissue by the anvil 716. Other control
programs control the rotation of the shaft 740 and the articulation
members 742a, 742b.
[0243] In one aspect, the control circuit 710 may generate motor
set point signals. The motor set point signals may be provided to
various motor controllers 708a-708e. The motor controllers
708a-708e may comprise one or more circuits configured to provide
motor drive signals to the motors 704a-704e to drive the motors
704a-704e as described herein. In some examples, the motors
704a-704e may be brushed DC electric motors. For example, the
velocity of the motors 704a-704e may be proportional to the
respective motor drive signals. In some examples, the motors
704a-704e may be brushless DC electric motors, and the respective
motor drive signals may comprise a PWM signal provided to one or
more stator windings of the motors 704a-704e. Also, in some
examples, the motor controllers 708a-708e may be omitted and the
control circuit 710 may generate the motor drive signals
directly.
[0244] In one aspect, the control circuit 710 may initially operate
each of the motors 704a-704e in an open-loop configuration for a
first open-loop portion of a stroke of the displacement member.
Based on the response of the robotic surgical instrument 700 during
the open-loop portion of the stroke, the control circuit 710 may
select a firing control program in a closed-loop configuration. The
response of the instrument may include a translation distance of
the displacement member during the open-loop portion, a time
elapsed during the open-loop portion, the energy provided to one of
the motors 704a-704e during the open-loop portion, a sum of pulse
widths of a motor drive signal, etc. After the open-loop portion,
the control circuit 710 may implement the selected firing control
program for a second portion of the displacement member stroke. For
example, during a closed-loop portion of the stroke, the control
circuit 710 may modulate one of the motors 704a-704e based on
translation data describing a position of the displacement member
in a closed-loop manner to translate the displacement member at a
constant velocity.
[0245] In one aspect, the motors 704a-704e may receive power from
an energy source 712. The energy source 712 may be a DC power
supply driven by a main alternating current power source, a
battery, a super capacitor, or any other suitable energy source.
The motors 704a-704e may be mechanically coupled to individual
movable mechanical elements such as the I-beam 714, anvil 716,
shaft 740, articulation 742a, and articulation 742b via respective
transmissions 706a-706e. The transmissions 706a-706e may include
one or more gears or other linkage components to couple the motors
704a-704e to movable mechanical elements. A position sensor 734 may
sense a position of the I-beam 714. The position sensor 734 may be
or include any type of sensor that is capable of generating
position data that indicate a position of the I-beam 714. In some
examples, the position sensor 734 may include an encoder configured
to provide a series of pulses to the control circuit 710 as the
I-beam 714 translates distally and proximally. The control circuit
710 may track the pulses to determine the position of the I-beam
714. Other suitable position sensors may be used, including, for
example, a proximity sensor. Other types of position sensors may
provide other signals indicating motion of the I-beam 714. Also, in
some examples, the position sensor 734 may be omitted. Where any of
the motors 704a-704e is a stepper motor, the control circuit 710
may track the position of the I-beam 714 by aggregating the number
and direction of steps that the motor 704 has been instructed to
execute. The position sensor 734 may be located in the end effector
702 or at any other portion of the instrument. The outputs of each
of the motors 704a-704e include a torque sensor 744a-744e to sense
force and have an encoder to sense rotation of the drive shaft.
[0246] In one aspect, the control circuit 710 is configured to
drive a firing member such as the I-beam 714 portion of the end
effector 702. The control circuit 710 provides a motor set point to
a motor control 708a, which provides a drive signal to the motor
704a. The output shaft of the motor 704a is coupled to a torque
sensor 744a. The torque sensor 744a is coupled to a transmission
706a which is coupled to the I-beam 714. The transmission 706a
comprises movable mechanical elements such as rotating elements and
a firing member to control the movement of the I-beam 714 distally
and proximally along a longitudinal axis of the end effector 702.
In one aspect, the motor 704a may be coupled to the knife gear
assembly, which includes a knife gear reduction set that includes a
first knife drive gear and a second knife drive gear. A torque
sensor 744a provides a firing force feedback signal to the control
circuit 710. The firing force signal represents the force required
to fire or displace the I-beam 714. A position sensor 734 may be
configured to provide the position of the I-beam 714 along the
firing stroke or the position of the firing member as a feedback
signal to the control circuit 710. The end effector 702 may include
additional sensors 738 configured to provide feedback signals to
the control circuit 710. When ready to use, the control circuit 710
may provide a firing signal to the motor control 708a. In response
to the firing signal, the motor 704a may drive the firing member
distally along the longitudinal axis of the end effector 702 from a
proximal stroke start position to a stroke end position distal to
the stroke start position. As the firing member translates
distally, an I-beam 714, with a cutting element positioned at a
distal end, advances distally to cut tissue located between the
staple cartridge 718 and the anvil 716.
[0247] In one aspect, the control circuit 710 is configured to
drive a closure member such as the anvil 716 portion of the end
effector 702. The control circuit 710 provides a motor set point to
a motor control 708b, which provides a drive signal to the motor
704b. The output shaft of the motor 704b is coupled to a torque
sensor 744b. The torque sensor 744b is coupled to a transmission
706b which is coupled to the anvil 716. The transmission 706b
comprises movable mechanical elements such as rotating elements and
a closure member to control the movement of the anvil 716 from the
open and closed positions. In one aspect, the motor 704b is coupled
to a closure gear assembly, which includes a closure reduction gear
set that is supported in meshing engagement with the closure spur
gear. The torque sensor 744b provides a closure force feedback
signal to the control circuit 710. The closure force feedback
signal represents the closure force applied to the anvil 716. The
position sensor 734 may be configured to provide the position of
the closure member as a feedback signal to the control circuit 710.
Additional sensors 738 in the end effector 702 may provide the
closure force feedback signal to the control circuit 710. The
pivotable anvil 716 is positioned opposite the staple cartridge
718. When ready to use, the control circuit 710 may provide a
closure signal to the motor control 708b. In response to the
closure signal, the motor 704b advances a closure member to grasp
tissue between the anvil 716 and the staple cartridge 718.
[0248] In one aspect, the control circuit 710 is configured to
rotate a shaft member such as the shaft 740 to rotate the end
effector 702. The control circuit 710 provides a motor set point to
a motor control 708c, which provides a drive signal to the motor
704c. The output shaft of the motor 704c is coupled to a torque
sensor 744c. The torque sensor 744c is coupled to a transmission
706c which is coupled to the shaft 740. The transmission 706c
comprises movable mechanical elements such as rotating elements to
control the rotation of the shaft 740 clockwise or counterclockwise
up to and over 360.degree.. In one aspect, the motor 704c is
coupled to the rotational transmission assembly, which includes a
tube gear segment that is formed on (or attached to) the proximal
end of the proximal closure tube for operable engagement by a
rotational gear assembly that is operably supported on the tool
mounting plate. The torque sensor 744c provides a rotation force
feedback signal to the control circuit 710. The rotation force
feedback signal represents the rotation force applied to the shaft
740. The position sensor 734 may be configured to provide the
position of the closure member as a feedback signal to the control
circuit 710. Additional sensors 738 such as a shaft encoder may
provide the rotational position of the shaft 740 to the control
circuit 710.
[0249] In one aspect, the control circuit 710 is configured to
articulate the end effector 702. The control circuit 710 provides a
motor set point to a motor control 708d, which provides a drive
signal to the motor 704d. The output shaft of the motor 704d is
coupled to a torque sensor 744d. The torque sensor 744d is coupled
to a transmission 706d which is coupled to an articulation member
742a. The transmission 706d comprises movable mechanical elements
such as articulation elements to control the articulation of the
end effector 702 .+-.65.degree.. In one aspect, the motor 704d is
coupled to an articulation nut, which is rotatably journaled on the
proximal end portion of the distal spine portion and is rotatably
driven thereon by an articulation gear assembly. The torque sensor
744d provides an articulation force feedback signal to the control
circuit 710. The articulation force feedback signal represents the
articulation force applied to the end effector 702. Sensors 738,
such as an articulation encoder, may provide the articulation
position of the end effector 702 to the control circuit 710.
[0250] In another aspect, the articulation function of the robotic
surgical system 700 may comprise two articulation members, or
links, 742a, 742b. These articulation members 742a, 742b are driven
by separate disks on the robot interface (the rack) which are
driven by the two motors 708d, 708e. When the separate firing motor
704a is provided, each of articulation links 742a, 742b can be
antagonistically driven with respect to the other link in order to
provide a resistive holding motion and a load to the head when it
is not moving and to provide an articulation motion as the head is
articulated. The articulation members 742a, 742b attach to the head
at a fixed radius as the head is rotated. Accordingly, the
mechanical advantage of the push-and-pull link changes as the head
is rotated. This change in the mechanical advantage may be more
pronounced with other articulation link drive systems.
[0251] In one aspect, the one or more motors 704a-704e may comprise
a brushed DC motor with a gearbox and mechanical links to a firing
member, closure member, or articulation member. Another example
includes electric motors 704a-704e that operate the movable
mechanical elements such as the displacement member, articulation
links, closure tube, and shaft. An outside influence is an
unmeasured, unpredictable influence of things like tissue,
surrounding bodies, and friction on the physical system. Such
outside influence can be referred to as drag, which acts in
opposition to one of electric motors 704a-704e. The outside
influence, such as drag, may cause the operation of the physical
system to deviate from a desired operation of the physical
system.
[0252] In one aspect, the position sensor 734 may be implemented as
an absolute positioning system. In one aspect, the position sensor
734 may comprise a magnetic rotary absolute positioning system
implemented as an AS5055EQFT single-chip magnetic rotary position
sensor available from Austria Microsystems, AG. The position sensor
734 may interface with the control circuit 710 to provide an
absolute positioning system. The position may include multiple
Hall-effect elements located above a magnet and coupled to a CORDIC
processor, also known as the digit-by-digit method and Volder's
algorithm, that is provided to implement a simple and efficient
algorithm to calculate hyperbolic and trigonometric functions that
require only addition, subtraction, bitshift, and table lookup
operations.
[0253] In one aspect, the control circuit 710 may be in
communication with one or more sensors 738. The sensors 738 may be
positioned on the end effector 702 and adapted to operate with the
robotic surgical instrument 700 to measure the various derived
parameters such as the gap distance versus time, tissue compression
versus time, and anvil strain versus time. The sensors 738 may
comprise a magnetic sensor, a magnetic field sensor, a strain
gauge, a load cell, a pressure sensor, a force sensor, a torque
sensor, an inductive sensor such as an eddy current sensor, a
resistive sensor, a capacitive sensor, an optical sensor, and/or
any other suitable sensor for measuring one or more parameters of
the end effector 702. The sensors 738 may include one or more
sensors. The sensors 738 may be located on the staple cartridge 718
deck to determine tissue location using segmented electrodes. The
torque sensors 744a-744e may be configured to sense force such as
firing force, closure force, and/or articulation force, among
others. Accordingly, the control circuit 710 can sense (1) the
closure load experienced by the distal closure tube and its
position, (2) the firing member at the rack and its position, (3)
what portion of the staple cartridge 718 has tissue on it, and (4)
the load and position on both articulation rods.
[0254] In one aspect, the one or more sensors 738 may comprise a
strain gauge, such as a micro-strain gauge, configured to measure
the magnitude of the strain in the anvil 716 during a clamped
condition. The strain gauge provides an electrical signal whose
amplitude varies with the magnitude of the strain. The sensors 738
may comprise a pressure sensor configured to detect a pressure
generated by the presence of compressed tissue between the anvil
716 and the staple cartridge 718. The sensors 738 may be configured
to detect impedance of a tissue section located between the anvil
716 and the staple cartridge 718 that is indicative of the
thickness and/or fullness of tissue located therebetween.
[0255] In one aspect, the sensors 738 may be implemented as one or
more limit switches, electromechanical devices, solid-state
switches, Hall-effect devices, magneto-resistive (MR) devices,
giant magneto-resistive (GMR) devices, magnetometers, among others.
In other implementations, the sensors 738 may be implemented as
solid-state switches that operate under the influence of light,
such as optical sensors, IR sensors, ultraviolet sensors, among
others. Still, the switches may be solid-state devices such as
transistors (e.g., FET, junction FET, MOSFET, bipolar, and the
like). In other implementations, the sensors 738 may include
electrical conductorless switches, ultrasonic switches,
accelerometers, and inertial sensors, among others.
[0256] In one aspect, the sensors 738 may be configured to measure
forces exerted on the anvil 716 by the closure drive system. For
example, one or more sensors 738 can be at an interaction point
between the closure tube and the anvil 716 to detect the closure
forces applied by the closure tube to the anvil 716. The forces
exerted on the anvil 716 can be representative of the tissue
compression experienced by the tissue section captured between the
anvil 716 and the staple cartridge 718. The one or more sensors 738
can be positioned at various interaction points along the closure
drive system to detect the closure forces applied to the anvil 716
by the closure drive system. The one or more sensors 738 may be
sampled in real time during a clamping operation by the processor
of the control circuit 710. The control circuit 710 receives
real-time sample measurements to provide and analyze time-based
information and assess, in real time, closure forces applied to the
anvil 716.
[0257] In one aspect, a current sensor 736 can be employed to
measure the current drawn by each of the motors 704a-704e. The
force required to advance any of the movable mechanical elements
such as the I-beam 714 corresponds to the current drawn by one of
the motors 704a-704e. The force is converted to a digital signal
and provided to the control circuit 710. The control circuit 710
can be configured to simulate the response of the actual system of
the instrument in the software of the controller. A displacement
member can be actuated to move an I-beam 714 in the end effector
702 at or near a target velocity. The robotic surgical instrument
700 can include a feedback controller, which can be one of any
feedback controllers, including, but not limited to a PID, a state
feedback, a linear-quadratic (LQR), and/or an adaptive controller,
for example. The robotic surgical instrument 700 can include a
power source to convert the signal from the feedback controller
into a physical input such as case voltage, PWM voltage, frequency
modulated voltage, current, torque, and/or force, for example.
Additional details are disclosed in U.S. patent application Ser.
No. 15/636,829, titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR
ROBOTIC SURGICAL INSTRUMENT, filed Jun. 29, 2017, which is herein
incorporated by reference in its entirety.
[0258] FIG. 18 illustrates a block diagram of a surgical instrument
750 programmed to control the distal translation of a displacement
member according to one aspect of this disclosure. In one aspect,
the surgical instrument 750 is programmed to control the distal
translation of a displacement member such as the I-beam 764. The
surgical instrument 750 comprises an end effector 752 that may
comprise an anvil 766, an I-beam 764 (including a sharp cutting
edge), and a removable staple cartridge 768.
[0259] The position, movement, displacement, and/or translation of
a linear displacement member, such as the I-beam 764, can be
measured by an absolute positioning system, sensor arrangement, and
position sensor 784. Because the I-beam 764 is coupled to a
longitudinally movable drive member, the position of the I-beam 764
can be determined by measuring the position of the longitudinally
movable drive member employing the position sensor 784.
Accordingly, in the following description, the position,
displacement, and/or translation of the I-beam 764 can be achieved
by the position sensor 784 as described herein. A control circuit
760 may be programmed to control the translation of the
displacement member, such as the I-beam 764. The control circuit
760, in some examples, may comprise one or more microcontrollers,
microprocessors, or other suitable processors for executing
instructions that cause the processor or processors to control the
displacement member, e.g., the I-beam 764, in the manner described.
In one aspect, a timer/counter 781 provides an output signal, such
as the elapsed time or a digital count, to the control circuit 760
to correlate the position of the I-beam 764 as determined by the
position sensor 784 with the output of the timer/counter 781 such
that the control circuit 760 can determine the position of the
I-beam 764 at a specific time (t) relative to a starting position.
The timer/counter 781 may be configured to measure elapsed time,
count external events, or time external events.
[0260] The control circuit 760 may generate a motor set point
signal 772. The motor set point signal 772 may be provided to a
motor controller 758. The motor controller 758 may comprise one or
more circuits configured to provide a motor drive signal 774 to the
motor 754 to drive the motor 754 as described herein. In some
examples, the motor 754 may be a brushed DC electric motor. For
example, the velocity of the motor 754 may be proportional to the
motor drive signal 774. In some examples, the motor 754 may be a
brushless DC electric motor and the motor drive signal 774 may
comprise a PWM signal provided to one or more stator windings of
the motor 754. Also, in some examples, the motor controller 758 may
be omitted, and the control circuit 760 may generate the motor
drive signal 774 directly.
[0261] The motor 754 may receive power from an energy source 762.
The energy source 762 may be or include a battery, a super
capacitor, or any other suitable energy source. The motor 754 may
be mechanically coupled to the I-beam 764 via a transmission 756.
The transmission 756 may include one or more gears or other linkage
components to couple the motor 754 to the I-beam 764. A position
sensor 784 may sense a position of the I-beam 764. The position
sensor 784 may be or include any type of sensor that is capable of
generating position data that indicate a position of the I-beam
764. In some examples, the position sensor 784 may include an
encoder configured to provide a series of pulses to the control
circuit 760 as the I-beam 764 translates distally and proximally.
The control circuit 760 may track the pulses to determine the
position of the I-beam 764. Other suitable position sensors may be
used, including, for example, a proximity sensor. Other types of
position sensors may provide other signals indicating motion of the
I-beam 764. Also, in some examples, the position sensor 784 may be
omitted. Where the motor 754 is a stepper motor, the control
circuit 760 may track the position of the I-beam 764 by aggregating
the number and direction of steps that the motor 754 has been
instructed to execute. The position sensor 784 may be located in
the end effector 752 or at any other portion of the instrument.
[0262] The control circuit 760 may be in communication with one or
more sensors 788. The sensors 788 may be positioned on the end
effector 752 and adapted to operate with the surgical instrument
750 to measure the various derived parameters such as gap distance
versus time, tissue compression versus time, and anvil strain
versus time. The sensors 788 may comprise a magnetic sensor, a
magnetic field sensor, a strain gauge, a pressure sensor, a force
sensor, an inductive sensor such as an eddy current sensor, a
resistive sensor, a capacitive sensor, an optical sensor, and/or
any other suitable sensor for measuring one or more parameters of
the end effector 752. The sensors 788 may include one or more
sensors.
[0263] The one or more sensors 788 may comprise a strain gauge,
such as a micro-strain gauge, configured to measure the magnitude
of the strain in the anvil 766 during a clamped condition. The
strain gauge provides an electrical signal whose amplitude varies
with the magnitude of the strain. The sensors 788 may comprise a
pressure sensor configured to detect a pressure generated by the
presence of compressed tissue between the anvil 766 and the staple
cartridge 768. The sensors 788 may be configured to detect
impedance of a tissue section located between the anvil 766 and the
staple cartridge 768 that is indicative of the thickness and/or
fullness of tissue located therebetween.
[0264] The sensors 788 may be configured to measure forces exerted
on the anvil 766 by a closure drive system. For example, one or
more sensors 788 can be at an interaction point between a closure
tube and the anvil 766 to detect the closure forces applied by a
closure tube to the anvil 766. The forces exerted on the anvil 766
can be representative of the tissue compression experienced by the
tissue section captured between the anvil 766 and the staple
cartridge 768. The one or more sensors 788 can be positioned at
various interaction points along the closure drive system to detect
the closure forces applied to the anvil 766 by the closure drive
system. The one or more sensors 788 may be sampled in real time
during a clamping operation by a processor of the control circuit
760. The control circuit 760 receives real-time sample measurements
to provide and analyze time-based information and assess, in real
time, closure forces applied to the anvil 766.
[0265] A current sensor 786 can be employed to measure the current
drawn by the motor 754. The force required to advance the I-beam
764 corresponds to the current drawn by the motor 754. The force is
converted to a digital signal and provided to the control circuit
760.
[0266] The control circuit 760 can be configured to simulate the
response of the actual system of the instrument in the software of
the controller. A displacement member can be actuated to move an
I-beam 764 in the end effector 752 at or near a target velocity.
The surgical instrument 750 can include a feedback controller,
which can be one of any feedback controllers, including, but not
limited to a PID, a state feedback, LQR, and/or an adaptive
controller, for example. The surgical instrument 750 can include a
power source to convert the signal from the feedback controller
into a physical input such as case voltage, PWM voltage, frequency
modulated voltage, current, torque, and/or force, for example.
[0267] The actual drive system of the surgical instrument 750 is
configured to drive the displacement member, cutting member, or
I-beam 764, by a brushed DC motor with gearbox and mechanical links
to an articulation and/or knife system. Another example is the
electric motor 754 that operates the displacement member and the
articulation driver, for example, of an interchangeable shaft
assembly. An outside influence is an unmeasured, unpredictable
influence of things like tissue, surrounding bodies and friction on
the physical system. Such outside influence can be referred to as
drag which acts in opposition to the electric motor 754. The
outside influence, such as drag, may cause the operation of the
physical system to deviate from a desired operation of the physical
system.
[0268] Various example aspects are directed to a surgical
instrument 750 comprising an end effector 752 with motor-driven
surgical stapling and cutting implements. For example, a motor 754
may drive a displacement member distally and proximally along a
longitudinal axis of the end effector 752. The end effector 752 may
comprise a pivotable anvil 766 and, when configured for use, a
staple cartridge 768 positioned opposite the anvil 766. A clinician
may grasp tissue between the anvil 766 and the staple cartridge
768, as described herein. When ready to use the instrument 750, the
clinician may provide a firing signal, for example by depressing a
trigger of the instrument 750. In response to the firing signal,
the motor 754 may drive the displacement member distally along the
longitudinal axis of the end effector 752 from a proximal stroke
begin position to a stroke end position distal of the stroke begin
position. As the displacement member translates distally, an I-beam
764 with a cutting element positioned at a distal end, may cut the
tissue between the staple cartridge 768 and the anvil 766.
[0269] In various examples, the surgical instrument 750 may
comprise a control circuit 760 programmed to control the distal
translation of the displacement member, such as the I-beam 764, for
example, based on one or more tissue conditions. The control
circuit 760 may be programmed to sense tissue conditions, such as
thickness, either directly or indirectly, as described herein. The
control circuit 760 may be programmed to select a firing control
program based on tissue conditions. A firing control program may
describe the distal motion of the displacement member. Different
firing control programs may be selected to better treat different
tissue conditions. For example, when thicker tissue is present, the
control circuit 760 may be programmed to translate the displacement
member at a lower velocity and/or with lower power. When thinner
tissue is present, the control circuit 760 may be programmed to
translate the displacement member at a higher velocity and/or with
higher power.
[0270] In some examples, the control circuit 760 may initially
operate the motor 754 in an open loop configuration for a first
open loop portion of a stroke of the displacement member. Based on
a response of the instrument 750 during the open loop portion of
the stroke, the control circuit 760 may select a firing control
program. The response of the instrument may include, a translation
distance of the displacement member during the open loop portion, a
time elapsed during the open loop portion, energy provided to the
motor 754 during the open loop portion, a sum of pulse widths of a
motor drive signal, etc. After the open loop portion, the control
circuit 760 may implement the selected firing control program for a
second portion of the displacement member stroke. For example,
during the closed loop portion of the stroke, the control circuit
760 may modulate the motor 754 based on translation data describing
a position of the displacement member in a closed loop manner to
translate the displacement member at a constant velocity.
Additional details are disclosed in U.S. patent application Ser.
No. 15/720,852, titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY
OF A SURGICAL INSTRUMENT, filed Sep. 29, 2017, which is herein
incorporated by reference in its entirety.
[0271] FIG. 19 is a schematic diagram of a surgical instrument 790
configured to control various functions according to one aspect of
this disclosure. In one aspect, the surgical instrument 790 is
programmed to control distal translation of a displacement member
such as the I-beam 764. The surgical instrument 790 comprises an
end effector 792 that may comprise an anvil 766, an I-beam 764, and
a removable staple cartridge 768 which may be interchanged with an
RF cartridge 796 (shown in dashed line).
[0272] In one aspect, sensors 788 may be implemented as a limit
switch, electromechanical device, solid-state switches, Hall-effect
devices, MR devices, GMR devices, magnetometers, among others. In
other implementations, the sensors 638 may be solid-state switches
that operate under the influence of light, such as optical sensors,
IR sensors, ultraviolet sensors, among others. Still, the switches
may be solid-state devices such as transistors (e.g., FET, junction
FET, MOSFET, bipolar, and the like). In other implementations, the
sensors 788 may include electrical conductorless switches,
ultrasonic switches, accelerometers, and inertial sensors, among
others.
[0273] In one aspect, the position sensor 784 may be implemented as
an absolute positioning system comprising a magnetic rotary
absolute positioning system implemented as an AS5055EQFT
single-chip magnetic rotary position sensor available from Austria
Microsystems, AG. The position sensor 784 may interface with the
control circuit 760 to provide an absolute positioning system. The
position may include multiple Hall-effect elements located above a
magnet and coupled to a CORDIC processor, also known as the
digit-by-digit method and Volder's algorithm, that is provided to
implement a simple and efficient algorithm to calculate hyperbolic
and trigonometric functions that require only addition,
subtraction, bitshift, and table lookup operations.
[0274] In one aspect, the I-beam 764 may be implemented as a knife
member comprising a knife body that operably supports a tissue
cutting blade thereon and may further include anvil engagement tabs
or features and channel engagement features or a foot. In one
aspect, the staple cartridge 768 may be implemented as a standard
(mechanical) surgical fastener cartridge. In one aspect, the RF
cartridge 796 may be implemented as an RF cartridge. These and
other sensors arrangements are described in commonly owned U.S.
patent application Ser. No. 15/628,175, titled TECHNIQUES FOR
ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND
CUTTING INSTRUMENT, filed Jun. 20, 2017, which is herein
incorporated by reference in its entirety.
[0275] The position, movement, displacement, and/or translation of
a linear displacement member, such as the I-beam 764, can be
measured by an absolute positioning system, sensor arrangement, and
position sensor represented as position sensor 784. Because the
I-beam 764 is coupled to the longitudinally movable drive member,
the position of the I-beam 764 can be determined by measuring the
position of the longitudinally movable drive member employing the
position sensor 784. Accordingly, in the following description, the
position, displacement, and/or translation of the I-beam 764 can be
achieved by the position sensor 784 as described herein. A control
circuit 760 may be programmed to control the translation of the
displacement member, such as the I-beam 764, as described herein.
The control circuit 760, in some examples, may comprise one or more
microcontrollers, microprocessors, or other suitable processors for
executing instructions that cause the processor or processors to
control the displacement member, e.g., the I-beam 764, in the
manner described. In one aspect, a timer/counter 781 provides an
output signal, such as the elapsed time or a digital count, to the
control circuit 760 to correlate the position of the I-beam 764 as
determined by the position sensor 784 with the output of the
timer/counter 781 such that the control circuit 760 can determine
the position of the I-beam 764 at a specific time (t) relative to a
starting position. The timer/counter 781 may be configured to
measure elapsed time, count external events, or time external
events.
[0276] The control circuit 760 may generate a motor set point
signal 772. The motor set point signal 772 may be provided to a
motor controller 758. The motor controller 758 may comprise one or
more circuits configured to provide a motor drive signal 774 to the
motor 754 to drive the motor 754 as described herein. In some
examples, the motor 754 may be a brushed DC electric motor. For
example, the velocity of the motor 754 may be proportional to the
motor drive signal 774. In some examples, the motor 754 may be a
brushless DC electric motor and the motor drive signal 774 may
comprise a PWM signal provided to one or more stator windings of
the motor 754. Also, in some examples, the motor controller 758 may
be omitted, and the control circuit 760 may generate the motor
drive signal 774 directly.
[0277] The motor 754 may receive power from an energy source 762.
The energy source 762 may be or include a battery, a super
capacitor, or any other suitable energy source. The motor 754 may
be mechanically coupled to the I-beam 764 via a transmission 756.
The transmission 756 may include one or more gears or other linkage
components to couple the motor 754 to the I-beam 764. A position
sensor 784 may sense a position of the I-beam 764. The position
sensor 784 may be or include any type of sensor that is capable of
generating position data that indicate a position of the I-beam
764. In some examples, the position sensor 784 may include an
encoder configured to provide a series of pulses to the control
circuit 760 as the I-beam 764 translates distally and proximally.
The control circuit 760 may track the pulses to determine the
position of the I-beam 764. Other suitable position sensors may be
used, including, for example, a proximity sensor. Other types of
position sensors may provide other signals indicating motion of the
I-beam 764. Also, in some examples, the position sensor 784 may be
omitted. Where the motor 754 is a stepper motor, the control
circuit 760 may track the position of the I-beam 764 by aggregating
the number and direction of steps that the motor has been
instructed to execute. The position sensor 784 may be located in
the end effector 792 or at any other portion of the instrument.
[0278] The control circuit 760 may be in communication with one or
more sensors 788. The sensors 788 may be positioned on the end
effector 792 and adapted to operate with the surgical instrument
790 to measure the various derived parameters such as gap distance
versus time, tissue compression versus time, and anvil strain
versus time. The sensors 788 may comprise a magnetic sensor, a
magnetic field sensor, a strain gauge, a pressure sensor, a force
sensor, an inductive sensor such as an eddy current sensor, a
resistive sensor, a capacitive sensor, an optical sensor, and/or
any other suitable sensor for measuring one or more parameters of
the end effector 792. The sensors 788 may include one or more
sensors.
[0279] The one or more sensors 788 may comprise a strain gauge,
such as a micro-strain gauge, configured to measure the magnitude
of the strain in the anvil 766 during a clamped condition. The
strain gauge provides an electrical signal whose amplitude varies
with the magnitude of the strain. The sensors 788 may comprise a
pressure sensor configured to detect a pressure generated by the
presence of compressed tissue between the anvil 766 and the staple
cartridge 768. The sensors 788 may be configured to detect
impedance of a tissue section located between the anvil 766 and the
staple cartridge 768 that is indicative of the thickness and/or
fullness of tissue located therebetween.
[0280] The sensors 788 may be configured to measure forces exerted
on the anvil 766 by the closure drive system. For example, one or
more sensors 788 can be at an interaction point between a closure
tube and the anvil 766 to detect the closure forces applied by a
closure tube to the anvil 766. The forces exerted on the anvil 766
can be representative of the tissue compression experienced by the
tissue section captured between the anvil 766 and the staple
cartridge 768. The one or more sensors 788 can be positioned at
various interaction points along the closure drive system to detect
the closure forces applied to the anvil 766 by the closure drive
system. The one or more sensors 788 may be sampled in real time
during a clamping operation by a processor portion of the control
circuit 760. The control circuit 760 receives real-time sample
measurements to provide and analyze time-based information and
assess, in real time, closure forces applied to the anvil 766.
[0281] A current sensor 786 can be employed to measure the current
drawn by the motor 754. The force required to advance the I-beam
764 corresponds to the current drawn by the motor 754. The force is
converted to a digital signal and provided to the control circuit
760.
[0282] An RF energy source 794 is coupled to the end effector 792
and is applied to the RF cartridge 796 when the RF cartridge 796 is
loaded in the end effector 792 in place of the staple cartridge
768. The control circuit 760 controls the delivery of the RF energy
to the RF cartridge 796.
[0283] Additional details are disclosed in U.S. patent application
Ser. No. 15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE
CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME,
filed Jun. 28, 2017, which is herein incorporated by reference in
its entirety.
[0284] FIG. 20 is a simplified block diagram of a generator 800
configured to provide inductorless tuning, among other benefits.
Additional details of the generator 800 are described in U.S. Pat.
No. 9,060,775, titled SURGICAL GENERATOR FOR ULTRASONIC AND
ELECTROSURGICAL DEVICES, which issued on Jun. 23, 2015, which is
herein incorporated by reference in its entirety. The generator 800
may comprise a patient isolated stage 802 in communication with a
non-isolated stage 804 via a power transformer 806. A secondary
winding 808 of the power transformer 806 is contained in the
isolated stage 802 and may comprise a tapped configuration (e.g., a
center-tapped or a non-center-tapped configuration) to define drive
signal outputs 810a, 810b, 810c for delivering drive signals to
different surgical instruments, such as, for example, an ultrasonic
surgical instrument, an RF electrosurgical instrument, and a
multifunction surgical instrument which includes ultrasonic and RF
energy modes that can be delivered alone or simultaneously. In
particular, drive signal outputs 810a, 810c may output an
ultrasonic drive signal (e.g., a 420V root-mean-square (RMS) drive
signal) to an ultrasonic surgical instrument, and drive signal
outputs 810b, 810c may output an RF electrosurgical drive signal
(e.g., a 100V RMS drive signal) to an RF electrosurgical
instrument, with the drive signal output 810b corresponding to the
center tap of the power transformer 806.
[0285] In certain forms, the ultrasonic and electrosurgical drive
signals may be provided simultaneously to distinct surgical
instruments and/or to a single surgical instrument, such as the
multifunction 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
multifunction ultrasonic/electrosurgical instrument may be either a
therapeutic or sub-therapeutic level signal where the
sub-therapeutic signal can be used, for example, to monitor tissue
or instrument conditions and provide feedback to the generator. For
example, the ultrasonic and RF signals can be delivered separately
or simultaneously from a generator with a single output port in
order to provide the desired output signal to the surgical
instrument, as will be discussed in more detail below. Accordingly,
the generator can combine the ultrasonic and electrosurgical RF
energies and deliver the combined energies to the multifunction
ultrasonic/electrosurgical instrument. Bipolar electrodes can be
placed on one or both jaws of the end effector. One jaw may be
driven by ultrasonic energy in addition to electrosurgical RF
energy, working simultaneously. The ultrasonic energy may be
employed to dissect tissue, while the electrosurgical RF energy may
be employed for vessel sealing.
[0286] The non-isolated stage 804 may comprise a power amplifier
812 having an output connected to a primary winding 814 of the
power transformer 806. In certain forms, the power amplifier 812
may comprise a push-pull amplifier. For example, the non-isolated
stage 804 may further comprise a logic device 816 for supplying a
digital output to a digital-to-analog converter (DAC) circuit 818,
which in turn supplies a corresponding analog signal to an input of
the power amplifier 812. In certain forms, the logic device 816 may
comprise a programmable gate array (PGA), a FPGA, programmable
logic device (PLD), among other logic circuits, for example. The
logic device 816, by virtue of controlling the input of the power
amplifier 812 via the DAC circuit 818, 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
810a, 810b, 810c. In certain forms and as discussed below, the
logic device 816, in conjunction with a processor (e.g., a DSP
discussed below), may implement a number of DSP-based and/or other
control algorithms to control parameters of the drive signals
output by the generator 800.
[0287] Power may be supplied to a power rail of the power amplifier
812 by a switch-mode regulator 820, e.g., a power converter. In
certain forms, the switch-mode regulator 820 may comprise an
adjustable buck regulator, for example. The non-isolated stage 804
may further comprise a first processor 822, 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 DSP processor 822 may control the operation of
the switch-mode regulator 820 responsive to voltage feedback data
received from the power amplifier 812 by the DSP processor 822 via
an ADC circuit 824. In one form, for example, the DSP processor 822
may receive as input, via the ADC circuit 824, the waveform
envelope of a signal (e.g., an RF signal) being amplified by the
power amplifier 812. The DSP processor 822 may then control the
switch-mode regulator 820 (e.g., via a PWM output) such that the
rail voltage supplied to the power amplifier 812 tracks the
waveform envelope of the amplified signal. By dynamically
modulating the rail voltage of the power amplifier 812 based on the
waveform envelope, the efficiency of the power amplifier 812 may be
significantly improved relative to a fixed rail voltage amplifier
schemes.
[0288] In certain forms, the logic device 816, in conjunction with
the DSP processor 822, may implement a digital synthesis circuit
such as a direct digital synthesizer control scheme to control the
waveform shape, frequency, and/or amplitude of drive signals output
by the generator 800. In one form, for example, the logic device
816 may implement a DDS control algorithm by recalling waveform
samples stored in a dynamically updated lookup 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 an ultrasonic transducer, 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 800 is impacted by various sources of
distortion present in the output drive circuit (e.g., the power
transformer 806, the power amplifier 812), 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 822, 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.
[0289] The non-isolated stage 804 may further comprise a first ADC
circuit 826 and a second ADC circuit 828 coupled to the output of
the power transformer 806 via respective isolation transformers
830, 832 for respectively sampling the voltage and current of drive
signals output by the generator 800. In certain forms, the ADC
circuits 826, 828 may be configured to sample at high speeds (e.g.,
80 mega samples per second (MSPS)) to enable oversampling of the
drive signals. In one form, for example, the sampling speed of the
ADC circuits 826, 828 may enable approximately 200.times.
(depending on frequency) oversampling of the drive signals. In
certain forms, the sampling operations of the ADC circuit 826, 828
may be performed by a single ADC circuit receiving input voltage
and current signals via a two-way multiplexer. The use of
high-speed sampling in forms of the generator 800 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 ADC circuits 826, 828 may
be received and processed (e.g., first-in-first-out (FIFO) buffer,
multiplexer) by the logic device 816 and stored in data memory for
subsequent retrieval by, for example, the DSP processor 822. 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 816 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.
[0290] 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 822, for example, with the
frequency control signal being supplied as input to a DDS control
algorithm implemented by the logic device 816.
[0291] 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
proportional-integral-derivative (PID) control algorithm, in the
DSP processor 822. 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 816 and/or the full-scale output voltage
of the DAC circuit 818 (which supplies the input to the power
amplifier 812) via a DAC circuit 834.
[0292] The non-isolated stage 804 may further comprise a second
processor 836 for providing, among other things user interface (UI)
functionality. In one form, the UI processor 836 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 836 may include
audible and visual user feedback, communication with peripheral
devices (e.g., via a USB interface), communication with a foot
switch, communication with an input device (e.g., a touch screen
display) and communication with an output device (e.g., a speaker).
The UI processor 836 may communicate with the DSP processor 822 and
the logic device 816 (e.g., via SPI buses). Although the UI
processor 836 may primarily support UI functionality, it may also
coordinate with the DSP processor 822 to implement hazard
mitigation in certain forms. For example, the UI processor 836 may
be programmed to monitor various aspects of user input and/or other
inputs (e.g., touch screen inputs, foot switch inputs, temperature
sensor inputs) and may disable the drive output of the generator
800 when an erroneous condition is detected.
[0293] In certain forms, both the DSP processor 822 and the UI
processor 836, for example, may determine and monitor the operating
state of the generator 800. For the DSP processor 822, the
operating state of the generator 800 may dictate, for example,
which control and/or diagnostic processes are implemented by the
DSP processor 822. For the UI processor 836, the operating state of
the generator 800 may dictate, for example, which elements of a UI
(e.g., display screens, sounds) are presented to a user. The
respective DSP and UI processors 822, 836 may independently
maintain the current operating state of the generator 800 and
recognize and evaluate possible transitions out of the current
operating state. The DSP processor 822 may function as the master
in this relationship and determine when transitions between
operating states are to occur. The UI processor 836 may be aware of
valid transitions between operating states and may confirm if a
particular transition is appropriate. For example, when the DSP
processor 822 instructs the UI processor 836 to transition to a
specific state, the UI processor 836 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 836,
the UI processor 836 may cause the generator 800 to enter a failure
mode.
[0294] The non-isolated stage 804 may further comprise a controller
838 for monitoring input devices (e.g., a capacitive touch sensor
used for turning the generator 800 on and off, a capacitive touch
screen). In certain forms, the controller 838 may comprise at least
one processor and/or other controller device in communication with
the UI processor 836. In one form, for example, the controller 838
may comprise a processor (e.g., a Meg168 8-bit controller available
from Atmel) configured to monitor user input provided via one or
more capacitive touch sensors. In one form, the controller 838 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.
[0295] In certain forms, when the generator 800 is in a "power off"
state, the controller 838 may continue to receive operating power
(e.g., via a line from a power supply of the generator 800, such as
the power supply 854 discussed below). In this way, the controller
838 may continue to monitor an input device (e.g., a capacitive
touch sensor located on a front panel of the generator 800) for
turning the generator 800 on and off. When the generator 800 is in
the power off state, the controller 838 may wake the power supply
(e.g., enable operation of one or more DC/DC voltage converters 856
of the power supply 854) if activation of the "on/off" input device
by a user is detected. The controller 838 may therefore initiate a
sequence for transitioning the generator 800 to a "power on" state.
Conversely, the controller 838 may initiate a sequence for
transitioning the generator 800 to the power off state if
activation of the "on/off" input device is detected when the
generator 800 is in the power on state. In certain forms, for
example, the controller 838 may report activation of the "on/off"
input device to the UI processor 836, which in turn implements the
necessary process sequence for transitioning the generator 800 to
the power off state. In such forms, the controller 838 may have no
independent ability for causing the removal of power from the
generator 800 after its power on state has been established.
[0296] In certain forms, the controller 838 may cause the generator
800 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.
[0297] In certain forms, the isolated stage 802 may comprise an
instrument interface circuit 840 to, for example, provide a
communication interface between a control circuit of a surgical
instrument (e.g., a control circuit comprising handpiece switches)
and components of the non-isolated stage 804, such as, for example,
the logic device 816, the DSP processor 822, and/or the UI
processor 836. The instrument interface circuit 840 may exchange
information with components of the non-isolated stage 804 via a
communication link that maintains a suitable degree of electrical
isolation between the isolated and non-isolated stages 802, 804,
such as, for example, an IR-based communication link. Power may be
supplied to the instrument interface circuit 840 using, for
example, a low-dropout voltage regulator powered by an isolation
transformer driven from the non-isolated stage 804.
[0298] In one form, the instrument interface circuit 840 may
comprise a logic circuit 842 (e.g., logic circuit, programmable
logic circuit, PGA, FPGA, PLD) in communication with a signal
conditioning circuit 844. The signal conditioning circuit 844 may
be configured to receive a periodic signal from the logic circuit
842 (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 instrument control circuit (e.g., by
using a conductive pair in a cable that connects the generator 800
to the surgical instrument) 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 844 may comprise an ADC circuit for generating samples of a
voltage signal appearing across inputs of the control circuit
resulting from passage of interrogation signal therethrough. The
logic circuit 842 (or a component of the non-isolated stage 804)
may then determine the state or configuration of the control
circuit based on the ADC circuit samples.
[0299] In one form, the instrument interface circuit 840 may
comprise a first data circuit interface 846 to enable information
exchange between the logic circuit 842 (or other element of the
instrument interface circuit 840) and a first data circuit disposed
in or otherwise associated with a surgical instrument. In certain
forms, for example, a first data circuit may be disposed in a cable
integrally attached to a surgical instrument handpiece or in an
adaptor for interfacing a specific surgical instrument type or
model with the generator 800. The first data circuit 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 first data
circuit. In certain forms, the first data circuit may comprise a
non-volatile storage device, such as an EEPROM device. In certain
forms, the first data circuit interface 846 may be implemented
separately from the logic circuit 842 and comprise suitable
circuitry (e.g., discrete logic devices, a processor) to enable
communication between the logic circuit 842 and the first data
circuit. In other forms, the first data circuit interface 846 may
be integral with the logic circuit 842.
[0300] In certain forms, the first 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. This information may be read by the instrument
interface circuit 840 (e.g., by the logic circuit 842), transferred
to a component of the non-isolated stage 804 (e.g., to logic device
816, DSP processor 822, and/or UI processor 836) for presentation
to a user via an output device and/or for controlling a function or
operation of the generator 800. Additionally, any type of
information may be communicated to the first data circuit for
storage therein via the first data circuit interface 846 (e.g.,
using the logic circuit 842). Such information may comprise, for
example, an updated number of operations in which the surgical
instrument has been used and/or dates and/or times of its
usage.
[0301] As discussed previously, a surgical instrument may be
detachable from a handpiece (e.g., the multifunction surgical
instrument may be detachable from the handpiece) 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 instruments to address this
issue is problematic from a compatibility standpoint, however. For
example, designing a surgical instrument 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 instruments with current generator platforms.
[0302] Additionally, forms of the generator 800 may enable
communication with instrument-based data circuits. For example, the
generator 800 may be configured to communicate with a second data
circuit contained in an instrument (e.g., the multifunction
surgical instrument). In some forms, the second data circuit may be
implemented in a many similar to that of the first data circuit
described herein. The instrument interface circuit 840 may comprise
a second data circuit interface 848 to enable this communication.
In one form, the second data circuit interface 848 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.
[0303] In some forms, the second data circuit may store information
about the electrical and/or ultrasonic properties of an associated
ultrasonic transducer, end effector, or ultrasonic drive system.
For example, the first data circuit 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 848 (e.g., using the logic circuit 842). 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 800 and provide an indication to a
user (e.g., a light emitting diode indication or other visible
indication) based on the received data.
[0304] In certain forms, the second data circuit and the second
data circuit interface 848 may be configured such that
communication between the logic circuit 842 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 handpiece to the generator 800). In one form, for
example, information may be communicated to and from the second
data circuit using a one-wire bus communication scheme implemented
on existing cabling, such as one of the conductors used transmit
interrogation signals from the signal conditioning circuit 844 to a
control circuit in a handpiece. In this way, design changes or
modifications to the surgical instrument 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 instrument.
[0305] In certain forms, the isolated stage 802 may comprise at
least one blocking capacitor 850-1 connected to the drive signal
output 810b 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 850-2 may be provided in series with the
blocking capacitor 850-1, with current leakage from a point between
the blocking capacitors 850-1, 850-2 being monitored by, for
example, an ADC circuit 852 for sampling a voltage induced by
leakage current. The samples may be received by the logic circuit
842, for example. Based changes in the leakage current (as
indicated by the voltage samples), the generator 800 may determine
when at least one of the blocking capacitors 850-1, 850-2 has
failed, thus providing a benefit over single-capacitor designs
having a single point of failure.
[0306] In certain forms, the non-isolated stage 804 may comprise a
power supply 854 for delivering DC power at a suitable voltage and
current. The power supply may comprise, for example, a 400 W power
supply for delivering a 48 VDC system voltage. The power supply 854
may further comprise one or more DC/DC voltage converters 856 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 800. As discussed above in connection with the controller
838, one or more of the DC/DC voltage converters 856 may receive an
input from the controller 838 when activation of the "on/off" input
device by a user is detected by the controller 838 to enable
operation of, or wake, the DC/DC voltage converters 856.
[0307] FIG. 21 illustrates an example of a generator 900, which is
one form of the generator 800 (FIG. 20). The generator 900 is
configured to deliver multiple energy modalities to a surgical
instrument. The generator 900 provides RF and ultrasonic signals
for delivering energy to a surgical instrument either independently
or simultaneously. The RF and ultrasonic signals may be provided
alone or in combination and may be provided simultaneously. As
noted above, at least one generator output can deliver multiple
energy modalities (e.g., ultrasonic, bipolar or monopolar RF,
irreversible and/or reversible electroporation, and/or microwave
energy, among others) through a single port, and these signals can
be delivered separately or simultaneously to the end effector to
treat tissue.
[0308] The generator 900 comprises a processor 902 coupled to a
waveform generator 904. The processor 902 and waveform generator
904 are configured to generate a variety of signal waveforms based
on information stored in a memory coupled to the processor 902, not
shown for clarity of disclosure. The digital information associated
with a waveform is provided to the waveform generator 904 which
includes one or more DAC circuits to convert the digital input into
an analog output. The analog output is fed to an amplifier 1106 for
signal conditioning and amplification. The conditioned and
amplified output of the amplifier 906 is coupled to a power
transformer 908. The signals are coupled across the power
transformer 908 to the secondary side, which is in the patient
isolation side. A first signal of a first energy modality is
provided to the surgical instrument between the terminals labeled
ENERGY.sub.1 and RETURN. A second signal of a second energy
modality is coupled across a capacitor 910 and is provided to the
surgical instrument between the terminals labeled ENERGY.sub.2 and
RETURN. It will be appreciated that more than two energy modalities
may be output and thus the subscript "n" may be used to designate
that up to n ENERGYn terminals may be provided, where n is a
positive integer greater than 1. It also will be appreciated that
up to "n" return paths RETURNn may be provided without departing
from the scope of the present disclosure.
[0309] A first voltage sensing circuit 912 is coupled across the
terminals labeled ENERGY.sub.1 and the RETURN path to measure the
output voltage therebetween. A second voltage sensing circuit 924
is coupled across the terminals labeled ENERGY.sub.2 and the RETURN
path to measure the output voltage therebetween. A current sensing
circuit 914 is disposed in series with the RETURN leg of the
secondary side of the power transformer 908 as shown to measure the
output current for either energy modality. If different return
paths are provided for each energy modality, then a separate
current sensing circuit should be provided in each return leg. The
outputs of the first and second voltage sensing circuits 912, 924
are provided to respective isolation transformers 916, 922 and the
output of the current sensing circuit 914 is provided to another
isolation transformer 918. The outputs of the isolation
transformers 916, 928, 922 in the on the primary side of the power
transformer 908 (non-patient isolated side) are provided to a one
or more ADC circuit 926. The digitized output of the ADC circuit
926 is provided to the processor 902 for further processing and
computation. The output voltages and output current feedback
information can be employed to adjust the output voltage and
current provided to the surgical instrument and to compute output
impedance, among other parameters. Input/output communications
between the processor 902 and patient isolated circuits is provided
through an interface circuit 920. Sensors also may be in electrical
communication with the processor 902 by way of the interface
circuit 920.
[0310] In one aspect, the impedance may be determined by the
processor 902 by dividing the output of either the first voltage
sensing circuit 912 coupled across the terminals labeled
ENERGY.sub.1/RETURN or the second voltage sensing circuit 924
coupled across the terminals labeled ENERGY.sub.2/RETURN by the
output of the current sensing circuit 914 disposed in series with
the RETURN leg of the secondary side of the power transformer 908.
The outputs of the first and second voltage sensing circuits 912,
924 are provided to separate isolations transformers 916, 922 and
the output of the current sensing circuit 914 is provided to
another isolation transformer 916. The digitized voltage and
current sensing measurements from the ADC circuit 926 are provided
the processor 902 for computing impedance. As an example, the first
energy modality ENERGY.sub.1 may be ultrasonic energy and the
second energy modality ENERGY.sub.2 may be RF energy. Nevertheless,
in addition to ultrasonic and bipolar or monopolar RF energy
modalities, other energy modalities include irreversible and/or
reversible electroporation and/or microwave energy, among others.
Also, although the example illustrated in FIG. 21 shows a single
return path RETURN may be provided for two or more energy
modalities, in other aspects, multiple return paths RETURNn may be
provided for each energy modality ENERGYn. Thus, as described
herein, the ultrasonic transducer impedance may be measured by
dividing the output of the first voltage sensing circuit 912 by the
current sensing circuit 914 and the tissue impedance may be
measured by dividing the output of the second voltage sensing
circuit 924 by the current sensing circuit 914.
[0311] As shown in FIG. 21, the generator 900 comprising at least
one output port can include a power transformer 908 with a single
output and with multiple taps to provide power in the form of one
or more energy modalities, such as ultrasonic, bipolar or monopolar
RF, irreversible and/or reversible electroporation, and/or
microwave energy, among others, for example, to the end effector
depending on the type of treatment of tissue being performed. For
example, the generator 900 can deliver energy with higher voltage
and lower current to drive an ultrasonic transducer, with lower
voltage and higher current to drive RF electrodes for sealing
tissue, or with a coagulation waveform for spot coagulation using
either monopolar or bipolar RF electrosurgical electrodes. The
output waveform from the generator 900 can be steered, switched, or
filtered to provide the frequency to the end effector of the
surgical instrument. The connection of an ultrasonic transducer to
the generator 900 output would be preferably located between the
output labeled ENERGY.sub.1 and RETURN as shown in FIG. 21. In one
example, a connection of RF bipolar electrodes to the generator 900
output would be preferably located between the output labeled
ENERGY.sub.2 and RETURN. In the case of monopolar output, the
preferred connections would be active electrode (e.g., pencil or
other probe) to the ENERGY.sub.2 output and a suitable return pad
connected to the RETURN output.
[0312] Additional details are disclosed in U.S. Patent Application
Publication No. 2017/0086914, titled TECHNIQUES FOR OPERATING
GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND
SURGICAL INSTRUMENTS, which published on Mar. 30, 2017, which is
herein incorporated by reference in its entirety.
[0313] FIG. 22 illustrates an electrosurgical system 60000, in
accordance with at least one aspect of the present disclosure. The
electrosurgical system 60000 includes a generator 60002, an
electrosurgical instrument 60004 and a return pad 60006. The
generator 60002 supplies alternating current at radiofrequency
levels to the electrosurgical instrument 60004 via a first
conductor/cable 60008. The electrosurgical instrument 60004
includes an electrode tip (i.e., an active electrode) which can be
positioned at a target tissue of a patient. The electrosurgical
instrument 60004 receives the alternating current from the
generator 60002 and delivers the alternating current to the target
tissue of a patient 60010 via the electrode tip. The alternating
current is received at the target tissue, and the resistance from
the tissue creates heat which provides the desired effect (e.g.,
sealing and/or cutting) at the surgical site. The alternating
current is conducted through the patient's body and ultimately is
received by the return pad 60006. The alternating current received
by the return pad 60006 is carried back to the generator 60002 via
a second conductor/cable 60012 to complete the closed path followed
by the alternating current.
[0314] According to various aspects, the generator 60002 is similar
to the generator 900 described above, and may include, for example,
a processor and a waveform generator similar to the processor 902
and the waveform generator 904 described above.
[0315] The electrosurgical instrument 60004 may be configured for
monopolar operation where electrosurgical energy supplied by the
generator 60002 is introduced into the patient's tissue by an
active electrode of the surgical instrument 60004 and is return to
the generator 60002 via the return pad 6006. According to various
aspects, the electrosurgical instrument 60004 includes a handpiece
or pencil and an electrode tip. The electrode tip serves as the
active electrode of the electrosurgical system 60000 and introduces
electrosurgical energy to the target tissue of a patient 60010.
Specifically, an electrical discharge is delivered from electrode
tip to the patient 60010 in order to cause heating of cellular
matter of the patient 60010 that is in close contact with or
adjacent to electrode tip. The tissue heating takes place at an
appropriately high temperature to allow the electrosurgical
instrument 60004 to be used to perform electrosurgery.
[0316] FIG. 23 illustrates the return pad 60006 of the
electrosurgical system 60000 of FIG. 22, in accordance with at
least one aspect of the present disclosure. The return pad 60006
can be similar to the MEGA SOFT.RTM. patient return electrode
commercially available from Megadyne Medical Products, Inc. in that
the return pad 60006 can include a sleeve or covering 60014, can be
separated a small distance from the patient's body, can be
capacitively coupled with the patient's body and is configured to
carry the amount of current introduced into the patient's body by
the electrosurgical instrument 60004, but is different.
[0317] The return pad 60006 is different from the MEGA SOFT.RTM.
patient return electrode commercially available from Megadyne
Medical Products, Inc. in that in lieu of one return electrode, the
return pad includes a plurality of electrodes 60016 (See FIG. 24)
which can be capacitively coupled with the patient's body and
collectively are configured to carry the amount of current
introduced into the patient's body by the electrosurgical
instrument 60004. For this capacitive coupling, the patient's body
effectively acts as one plate of a capacitor and collectively the
plurality of electrodes of the return pad effectively act together
as the other plate of the capacitor. A more detailed description of
capacitive coupling can be found, for example, in U.S. Pat. No.
6,214,000, titled CAPACITIVE REUSABLE ELECTROSURGICAL RETURN
ELECTRODE, issued Apr. 10, 2001 and in U.S. Pat. No. 6,582,424,
titled CAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE, issued
Jun. 24, 2003, the entire contents of which are each incorporated
by reference. Although the return pad 60006 is shown in FIG. 23 as
being substantially rectangular, it will be appreciated that the
return pad 60006 can be of any suitable shape.
[0318] FIG. 24 illustrates a plurality of electrodes 60016 of the
return pad 60006 of FIG. 23, in accordance with at least one aspect
of the present disclosure. For purposes of clarity, the sleeve or
covering 60014 of the return pad 60006 is not shown in FIG. 24.
Although four electrodes 60016 are shown in FIG. 24, it will be
appreciated that the return pad 60006 may include any number of
electrodes 60016. For example, according to various aspects, the
return pad 60006 includes sixteen electrodes 60016. Also, although
the individual electrodes 60016 are shown in FIG. 24 as being
substantially rectangular, it will be appreciated that the
individual electrodes can be of any suitable shape.
[0319] The electrodes 60016 of the return pad 60006 can be
considered the return electrodes of the electrosurgical system
60000 of FIG. 22, and can also be considered to be segmented
electrodes as the electrodes 60016 can be selectively decoupled
from the patient's body and/or the generator 60002. The electrodes
60016 of the return pad 60006 can also be coupled together to
effectively act as one large electrode. For example, according to
various aspects, each of the electrodes 60016 of the return pad
60006 can be connected by respective conductive members 60018 to
inputs of a switching device 60020 as shown in FIG. 24. When the
switching device 60020 is in an open position as shown in FIG. 24,
the respective electrodes 60016 of the return pad 60006 are
decoupled from one another as well as from the patient's body
and/or the generator 60002. In contrast, when the switching device
60020 is in a closed position, the respective electrodes 60016 of
the return pad 60006 are coupled together to effectively act as one
large electrode.
[0320] The switching device 60020 can be controlled by a processing
circuit (e.g., a processing circuit of the generator 60002 of the
electrosurgical system, a processing circuit of the surgical hub
206, a processing circuit of the surgical hub 106, etc.). For
purposes of simplicity, the processing circuit is not shown in FIG.
24. According to various aspects, the switching device 60020 shown
in FIG. 24 can be incorporated into the return pad 60006. According
to other aspects, the switching device 60006 shown in FIG. 24 can
be incorporated into the second conductor/cable 60012 of the
electrosurgical system 60000 of FIG. 22. The return pad 60006 can
also include a plurality of sensing devices 60022 (See FIG.
25).
[0321] By being able to couple the plurality of electrodes 60016
together for use during an electrosurgical procedure, the total
effective size of the electrodes 60016 of the return pad 60006 is
large enough and/or has sufficient surface area to keep the current
density sufficiently low to mitigate the likelihood of any unwanted
burning of the patient 60010.
[0322] FIG. 25 illustrates an array of sensing devices 60022 of the
return pad 60006 of FIG. 23, in accordance with at least one aspect
of the present disclosure. For purposes of clarity, the sleeve or
covering 60014 of the return pad 60006 is not shown in FIG. 25.
According to various aspects, the number of sensing devices 60022
corresponds to the number of electrodes 60016 such that there is
one sensing device 60022 for each electrode 60016, and each sensing
device 60022 is mounted to or integrated with a corresponding
electrode 60016. However, although the number of sensing devices
60022 shown in FIG. 25 corresponds to the number of electrodes
60016, it will be appreciated that the return pad 60006 may include
any number of sensing devices 60022. For example, for aspects of
the return pad 60006 which include sixteen electrodes 60016, the
return pad 60006 may only include four or eight sensing devices
60022. Although the sensing devices 60022 are shown in FIG. 25 as
being centered on the corresponding electrodes 60016, it will be
appreciated that the sensing devices 60022 can be positioned on any
portion of the corresponding electrodes 60016 and can be positioned
differently on different electrodes 60016.
[0323] The sensing devices 60022 are configured to detect a
monopolar nerve control signal applied to the patient and/or a
movement of an anatomical feature of the patient (e.g., a muscle
twitch) resulting from application of the nerve control signal. The
monopolar nerve control signal may be applied by the
electrosurgical instrument 60004 of the electrosurgical system
60000 of FIG. 22, or may be applied by a different surgical
instrument which is coupled to a different generator. Each sensing
device 60022 may include, for example, a pressure sensor, an
accelerometer, combinations thereof, etc. and is configured to
output a signal indicative of the detected nerve control signal
and/or the detected movement of an anatomical feature of the
patient. Such pressure sensors may include for example,
piezoresistive strain gauges, capacitive pressure sensors,
electromagnetic pressure sensors and/or piezoelectric pressure
sensors. Such accelerometers may include, for example, mechanical
accelerometers, capacitive accelerometers, piezoelectric
accelerometers, electromagnetic accelerometers and/or
microelectromechanical system (MEMS) accelerometers. The respective
output signals of the respective sensing devices 60022 may be in
the form of analog signals and/or digital signals.
[0324] Using Coulomb's law and the respective locations of the
active electrode of the electrosurgical instrument 60004, the
patient's body and the respective sensing devices 60022, the
respective output signals of the respected sensing devices 60022,
which are indicative of a detected nerve control signal and/or
movement of an anatomical feature of the patient, can be analyzed
to determine the location of a nerve within the patient's body.
Coulomb's law states that E=K(Q/r.sup.2), where E is the threshold
current required at a nerve to stimulate the nerve, K is a
constant, Q is the minimal current from the nerve stimulation
electrode and r is the distance from the nerve. The further the
nerve stimulation electrode is from the nerve, the current needed
to stimulate the nerve is proportionately greater. A constant
current stimulus can thus be utilized to estimate the distance from
the nerve stimulation electrode to the nerve. In general, the
respective strengths of the output signals of the respective
sensing devices 60022 are indicative of how close or far the
respective sensing devices 60022 are from the stimulated nerve of
the patient 60010.
[0325] According to various aspects, the analysis of the respective
output signals of the respective sensing devices 60022 can be
performed by a processing circuit of the generator 60002 of the
electrosurgical system 60000 of FIG. 22, by a processing circuit of
a nerve monitoring system which is separate from the generator
60002 of the electrosurgical system 60000 of FIG. 22, by a
processing circuit of the surgical hub 206, by a processing circuit
of the surgical hub 106, etc. The analysis can be performed in real
time or in near-real time. According to various aspects, the
respective output signals serve as inputs to a monopolar nerve
stimulation algorithm which is executed by the processing
circuit.
[0326] As shown in FIG. 25, according to various aspects, the
output signals of the respective sensing devices 60022 can be input
into a multiple input-single output switching device 60024 (e.g., a
multiplexer) via respective conductive members 60026. By
controlling the selection signals S.sub.0, S.sub.1 to the multiple
input-single output switching device 60024, the multiple
input-single output switching device 60024 can be controlled to
output only one of the output signals of the respective sensing
devices 60024 at a time for the above-described analysis. For
example, with reference to FIG. 25, by setting the selection
signals S.sub.0, S.sub.1 to 0,0, the output signal from the sensing
device 60022 associated with the electrode 60016 in the upper left
hand corner of FIG. 25 can be output by the multiple input-single
output switching device 60024 for analysis by the applicable
processing circuit. By setting the selection signals S.sub.0,
S.sub.1 to 0,1, the output signal from the sensing device 60022
associated with the electrode 60016 in the upper right hand corner
of FIG. 25 can be output by the multiple input-single output
switching device 60024 for analysis by the applicable processing
circuit. By setting the selection signals S.sub.0, S.sub.1 to 1,0,
the output signal from the sensing device 60022 associated with the
electrode 60016 in the lower left hand corner of FIG. 25 can be
output by the multiple input-single output switching device 60024
for analysis by the applicable processing circuit. By setting the
selection signals S.sub.0, S.sub.1 to 1,1, the output signal from
the sensing device 60022 associated with the electrode 60016 in the
lower right hand corner of FIG. 25 can be output by the multiple
input-single output switching device 60024 for analysis by the
applicable processing circuit.
[0327] The selection signals S.sub.0, S.sub.1 can be provided to
the multiple input-single output switching device 60024 by a
processing circuit such as, for example, a processing circuit of
the generator 60002 of the electrosurgical system 60000 of FIG. 22,
a processing circuit of a nerve monitoring system which is separate
from the generator 60002 of the electrosurgical system 60000 of
FIG. 22, by a processing circuit of the surgical hub 206, by a
processing circuit of the surgical hub 106, etc. For purposes of
simplicity, the processing circuit is not shown in FIG. 25. By
providing the various selection signals at a fast enough rate, the
output signals of the respective sensing devices can effectively be
scanned at a rate which allows for the timely analysis of all of
the output signals of the respective sensing devices to determine
the position of the stimulated nerve.
[0328] According to various aspects, the multiple input-single
output switching device 60024 shown in FIG. 25 can be incorporated
into the return pad 60006. According to other aspects, the multiple
input-single output switching device 60024 shown in FIG. 25 can be
incorporated into the second conductor/cable 60012 of the
electrosurgical system 60000 of FIG. 22.
[0329] The control of the multiple input-single output switching
device 60024 was described above in the context of a four input-one
output switching device, corresponding to the four sensing devices
60022 shown in FIG. 25. It will be appreciated that for aspects
where there are more than four sensing devices 60022 (e.g., sixteen
sensing devices), the output signals of the more than more than
four sensing devices 60022 will be input to the multiple
input-single output switching device 60024, and more than two
selection signals (e.g., S.sub.0, S.sub.1, S.sub.2 and S.sub.3) are
required to control the output of the multiple input-single output
switching device 60024.
[0330] For aspects where the output signals of the sensing devices
60024 are analog signals, the output of the multiple input-single
output switching device 60024 can be converted into a corresponding
digital signal by an analog-to-digital converter 60026 (shown as
dashed lines in FIG. 25) prior to the performance of the analysis
of the output signals by the applicable processing circuit.
[0331] By incorporating an array of sensing devices 60022 into a
plurality of electrodes 60016 of the return pad 60006, the position
of a nerve of the patient relative to the electrode tip of the
electrosurgical instrument 60004 can be determined. The determined
nerve location can be presented to the surgeon, thereby mitigating
the likelihood of the surgeon inadvertently injuring or severing
the nerve while utilizing the electrode tip to cut target tissue of
the patient 60010.
[0332] According to various aspects, the detection of the nerve
control signal and/or the movement of an anatomical feature of the
patient by the sensing devices 60022 can be performed while the
electrodes 60016 of the return pad 60006 are coupled to one another
or while the electrodes 60016 are uncoupled from one another. For
example, with regard to performing the detection when the
respective electrodes 60016 of the return pad 60006 are uncoupled
from one another, after positioning the patient 60010 on the
operating table but before starting a surgical procedure, the
return pad 60006 can be placed in a "sensing mode" by controlling
the switching device 60020 shown in FIG. 24 to uncouple the
respective electrodes 60016 of the return pad 60006 from one
another. While the respective electrodes 60016 are uncoupled from
one another, a nerve and/or a nerve bundle can be stimulated with
an electrosurgical instrument 60004 as described above, and the
respective output signals of the sensing devices 60022 of the
return pad 60006 can be analyzed as described above to identify
where the nerve, nerve bundle and/or nerve nexuses associated
therewith are located. The locations may be input into a monopolar
nerve stimulation algorithm profile which may reside, for example,
in a memory circuit of the generator 60002, in a memory circuit of
a different generator which is coupled to surgical instrument other
than the electrosurgical instrument 60004, etc. Once the locations
are input into the monopolar nerve stimulation algorithm profile,
the locations are effectively isolated from the capacitive
operation of the electrodes 60016 of the return pad 60006 and are
used as sensing nodes of the monopolar nerve stimulation algorithm
profile to inform the surgeon as the surgeon approaches a nerve
and/or a nerve bundle while performing a tissue cutting procedure.
According to various aspects, the surgeon may be informed of the
nearby location of the nerve and/or nerve bundle via an audible
warning, a visual warning, a vibratory warning, etc.
[0333] With regard to performing the detection when the respective
electrodes 60016 of the return pad 60006 are coupled with one
another, according to various aspects, as described in more detail
below with reference to FIG. 26, the generator 60002 of the
electrosurgical system 60000 of FIG. 22 can generate a high
frequency waveform (the alternating current at radio frequency)
which is modulated on a carrier wave, where the carrier wave is of
a low enough frequency to stimulate a nerve of the patient. This
allows for the sensing of the nerve control signal and/or the
movement of an anatomical feature to be concurrent with the
capacitive coupling of the respective electrodes 60016 of the
return pad 60006 with the patient's body. By applying a specific
waveform to the patient 60010 and sensing a specific response,
there is a high level of confidence that the movement of the
anatomical feature is a result of the applied waveform and not just
some general movement. The modulation can be adjusted over time to
stimulate different nerve sizes. According to various aspects, the
modulation can be varied in amplitude over time in order to allow
the applicable processing circuit to determine the distance the
nerve and/or nerve bundle is from the signal without having to
constantly stimulate the nerve and/or nerve bundle.
[0334] FIG. 26 illustrates a method 60030 for concurrently applying
a nerve stimulation signal and electrosurgical energy to a patient,
in accordance with at least one aspect of the present disclosure.
As the first step 60032 in this illustrative procedure, the
generator 60002 generates an alternating current at a
radiofrequency level as a high frequency waveform. According to
various aspects, a waveform generator of the generator 60002
performs this step.
[0335] For the second step 60034, the generator 60002 generates a
low frequency waveform which is configured to stimulate a nerve of
the patient. According to various aspects, the low frequency
waveform is a monopolar nerve control signal and a waveform
generator of the generator 60002 performs this step.
[0336] For the third step 60036, the generator 60002 utilizes the
high frequency waveform generated at step 60032 to modulate the low
frequency waveform generated at step 60034 to form a composite
waveform. According to various aspects, a waveform generator of the
generator 60002 performs this step. According to other embodiments,
a processing circuit of the generator 60002 performs this step.
[0337] For the fourth step 60038, the generator 60002 supplies the
composite waveform generated at step 60036 to the electrosurgical
instrument 60004.
[0338] For the fifth step 60040, the electrode (i.e., the active
electrode) of electrosurgical instrument 60004 applies the
composite waveform to the patient 60010. The high frequency
waveform operates to heat the target tissue of the patient 60010
and exits the patient's body before being received by the
electrodes 60016 of the return pad 60006. The low frequency
waveform operates to stimulate a nerve of the patient and/or cause
a movement of an anatomical feature of the patient (e.g., a muscle
twitch) resulting from application of the nerve control signal.
[0339] For the sixth step 60042, the plurality of electrodes 60016
which are coupled together via the switching device 60020, receive
the electrosurgical energy exiting the patient's body and pass the
electrosurgical energy back to the generator 60002 by way of the
respective conductive members 60018, the switching device 60020 and
the second conductor/cable 60012.
[0340] For the seventh step 60044, the sensing devices 60022 detect
the monopolar nerve control signal applied to the patient 60010
and/or a movement of an anatomical feature of the patient 60010
(e.g., a muscle twitch) resulting from application of the nerve
control signal, and generate respective output signals
corresponding thereto. The outputs of the respective sensing
devices 60022 are sampled as described above and forwarded to a
processing circuit for analysis. The processing circuit can be, for
example, a processing circuit of the generator 60002 of the
electrosurgical system 60000 of FIG. 22, a processing circuit of a
nerve monitoring system which is separate from the generator 60002
of the electrosurgical system 60000 of FIG. 22, by a processing
circuit of the surgical hub 206, by a processing circuit of the
surgical hub 106, etc.
[0341] For the eighth step 60046, the applicable processing circuit
analyzes the output signals and determines where the nerve, nerve
bundle and/or nerve nexuses associated with the output signals are
located. As described above, according to various aspects, the
respective output signals can serve as inputs to a monopolar nerve
stimulation algorithm which is executed by the processing circuit,
and the monopolar nerve stimulation algorithm operates to help
prevent the surgeon from cutting or damaging the nerve, nerve
bundle and/or nerve nexuses.
EXAMPLES
[0342] Various aspects of the subject matter described herein are
set out in the following numbered examples.
Example 1
[0343] A return pad of an electrosurgical system, the return pad
comprising: a plurality of conductive members configured to receive
radio frequency current applied to a patient; and a plurality of
sensing devices configured to detect at least one of the following:
a nerve control signal applied to the patient; and a movement of an
anatomical feature of the patient resulting from application of the
nerve control signal.
Example 2
[0344] The return pad of Example 1, wherein the plurality of
conductive members is further configured for capacitive coupling
with the patient.
Example 3
[0345] The return pad of any one of Examples 1-2, further
comprising a switching device configured for selectively decoupling
at least one of the plurality of conductive members from another
one of the plurality of conductive members.
Example 4
[0346] The return pad of any one of Examples 1-3, further
comprising a switching device configured for selectively decoupling
each of the conductive members from one another.
Example 5
[0347] The return pad of any one of Examples 1-4, further
comprising a switching device configured for selectively decoupling
the plurality of conductive members from the patient.
Example 6
[0348] The return pad of any one of Examples 1-5, further
comprising a switching device configured for selectively decoupling
the plurality of conductive members from a generator.
Example 7
[0349] The return pad of any one of Examples 1-6, further
comprising a switching device configured for selectively coupling
each of the plurality of conductive members to a generator.
Example 8
[0350] The return pad of any one of Examples 1-7, wherein the
plurality of sensing devices are configured as an array of sensing
devices.
Example 9
[0351] The return pad of any one of Examples 1-8, wherein each of
the plurality of sensing devices is coupled to a corresponding one
of the plurality of conductive members.
Example 10
[0352] The return pad of any one of Examples 1-9, wherein each of
the plurality of conductive members is coupled to a corresponding
one of the plurality of sensing devices.
Example 11
[0353] The return pad of any one of Examples 1-10, wherein at least
one of the plurality of sensing devices comprises one of the
following: a pressure sensor; an accelerometer; and a pressure
sensor and an accelerometer.
Example 12
[0354] The return pad of any one of Examples 1-11, wherein each of
the plurality of sensing devices is further configured to output a
signal indicative of the detection.
Example 13
[0355] An electrosurgical system, comprising: a generator
configured to supply an alternating current at a radiofrequency; an
instrument configured to apply the alternating current to a
patient; a return pad capacitively couplable to the patient,
wherein the return pad comprises: a plurality of conductive members
configured to conduct radio frequency current, wherein the
plurality of conductive members are capacitively couplable to a
patient and are selectively couplable to the generator; a plurality
of sensing devices configured to detect at least one of the
following: a nerve control signal applied to the patient; and a
movement of an anatomical feature of the patient resulting from
application of the nerve control signal; and a conductor coupled to
the return pad and the generator.
Example 14
[0356] The electrosurgical system of Example 13, further comprising
a multi input-single output switching device coupled to each of the
plurality of sensing devices.
Example 15
[0357] The electrosurgical system of Example 14, further comprising
an analog-to-digital converter coupled to the multi input-single
output switching device.
Example 16
[0358] The electrosurgical system of any one of Examples 1-15,
wherein the generator is further configured to: generate the
alternating current as a high frequency waveform; generate a low
frequency waveform which is configured to stimulate a nerve of the
patient; utilize the high frequency waveform to modulate the low
frequency waveform to form a composite waveform; and supply the
composite waveform to the instrument.
Example 17
[0359] The electrosurgical system of any one of Examples 1-16,
wherein the generator is further configured to amplitude modulate
the low frequency waveform to form the composite waveform.
Example 18
[0360] A return pad of an electrosurgical system, the return pad
comprising: a plurality of electrodes configured for capacitive
coupling with a patient; and an array of sensing devices configured
to detect at least one of the following: a nerve control signal
applied to the patient; and a movement of an anatomical feature of
the patient resulting from application of the nerve control
signal.
Example 19
[0361] The return pad of Example 18, wherein each sensing device of
the array of sensing devices is configured to output a signal
indicative of the detection.
Example 20
[0362] The return pad of any one of Examples 18-19, wherein each
sensing device of the array of sensing devices is positioned on a
corresponding one of the plurality of electrodes.
[0363] 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
modifications, variations, changes, substitutions, combinations,
and equivalents to those forms may be implemented and will occur to
those skilled in the art without departing from the scope of the
present disclosure. 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.
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, combinations, and variations as falling
within the scope of the disclosed forms. The appended claims are
intended to cover all such modifications, variations, changes,
substitutions, modifications, and equivalents.
[0364] 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, and/or examples can be implemented, individually and/or
collectively, by a wide range of hardware, software, firmware, or
virtually any combination thereof. 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
one or more program products 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.
[0365] Instructions used to program logic to perform various
disclosed aspects can be stored within a memory in the system, such
as dynamic random access memory (DRAM), cache, flash memory, or
other storage. Furthermore, the instructions can be distributed via
a network or by way of other computer readable media. Thus a
machine-readable medium may include any mechanism for storing or
transmitting information in a form readable by a machine (e.g., a
computer), but is not limited to, floppy diskettes, optical disks,
compact disc, read-only memory (CD-ROMs), and magneto-optical
disks, read-only memory (ROMs), random access memory (RAM),
erasable programmable read-only memory (EPROM), electrically
erasable programmable read-only memory (EEPROM), magnetic or
optical cards, flash memory, or a tangible, machine-readable
storage used in the transmission of information over the Internet
via electrical, optical, acoustical or other forms of propagated
signals (e.g., carrier waves, infrared signals, digital signals,
etc.). Accordingly, the non-transitory computer-readable medium
includes any type of tangible machine-readable medium suitable for
storing or transmitting electronic instructions or information in a
form readable by a machine (e.g., a computer).
[0366] As used throughout this description, the term "wireless" and
its derivatives may be used to describe circuits, devices, systems,
methods, techniques, communications channels, etc., that may
communicate data through the use of modulated electromagnetic
radiation through a non-solid medium. The term does not imply that
the associated devices do not contain any wires, although in some
aspects they might not. The communication module may implement any
of a number of wireless or wired communication standards or
protocols, including but not limited to W-Fi (IEEE 802.11 family),
WiMAX (IEEE 802.16 family), IEEE 802.20, long term evolution (LTE),
Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT,
Bluetooth, Ethernet derivatives thereof, as well as any other
wireless and wired protocols that are designated as 3G, 4G, 5G, and
beyond. The computing module may include a plurality of
communication modules. For instance, a first communication module
may be dedicated to shorter range wireless communications such as
Wi-Fi and Bluetooth and a second communication module may be
dedicated to longer range wireless communications such as GPS,
EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.
[0367] As used in any aspect herein, the term "control circuit" may
refer to, for example, hardwired circuitry, programmable circuitry
(e.g., a computer processor comprising one or more individual
instruction processing cores, processing unit, processor,
microcontroller, microcontroller unit, controller, digital signal
processor (DSP), programmable logic device (PLD), programmable
logic array (PLA), or field programmable gate array (FPGA)), state
machine circuitry, firmware that stores instructions executed by
programmable circuitry, and any combination thereof. The control
circuit may, collectively or individually, be embodied as circuitry
that forms part of a larger system, for example, an integrated
circuit (IC), an application-specific integrated circuit (ASIC), a
system on-chip (SoC), desktop computers, laptop computers, tablet
computers, servers, smart phones, etc. Accordingly, as used herein
"control circuit" 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.
[0368] As used herein a processor or processing unit is an
electronic circuit which performs operations on some external data
source, usually memory or some other data stream. The term is used
herein to refer to the central processor (central processing unit)
in a system or computer systems (especially systems on a chip
(SoCs)) that combine a number of specialized "processors."
[0369] As used herein, a system on a chip or system on chip (SoC or
SOC) is an integrated circuit (also known as an "IC" or "chip")
that integrates all components of a computer or other electronic
systems. It may contain digital, analog, mixed-signal, and often
radio-frequency functions--all on a single substrate. A SoC
integrates a microcontroller (or microprocessor) with advanced
peripherals like graphics processing unit (GPU), W-Fi module, or
coprocessor. A SoC may or may not contain built-in memory.
[0370] As used herein, a microcontroller or controller is a system
that integrates a microprocessor with peripheral circuits and
memory. A microcontroller (or MCU for microcontroller unit) may be
implemented as a small computer on a single integrated circuit. It
may be similar to a SoC; an SoC may include a microcontroller as
one of its components. A microcontroller may contain one or more
core processing units (CPUs) along with memory and programmable
input/output peripherals. Program memory in the form of
Ferroelectric RAM, NOR flash or OTP ROM is also often included on
chip, as well as a small amount of RAM. Microcontrollers may be
employed for embedded applications, in contrast to the
microprocessors used in personal computers or other general purpose
applications consisting of various discrete chips.
[0371] As used herein, the term controller or microcontroller may
be a stand-alone IC or chip device that interfaces with a
peripheral device. This may be a link between two parts of a
computer or a controller on an external device that manages the
operation of (and connection with) that device.
[0372] Any of the processors or microcontrollers described herein,
may be implemented by any single core or multicore processor such
as those known under the trade name ARM Cortex by Texas
Instruments. In one aspect, the processor may be an LM4F230H5QR ARM
Cortex-M4F Processor Core, available from Texas Instruments, for
example, comprising on-chip memory of 256 KB single-cycle flash
memory, or other non-volatile memory, up to 40 MHz, a prefetch
buffer to improve performance above 40 MHz, a 32 KB single-cycle
serial random access memory (SRAM), internal read-only memory (ROM)
loaded with StellarisWare.RTM. software, 2 KB electrically erasable
programmable read-only memory (EEPROM), one or more pulse width
modulation (PWM) modules, one or more quadrature encoder inputs
(QEI) analog, one or more 12-bit Analog-to-Digital Converters (ADC)
with 12 analog input channels, details of which are available for
the product datasheet.
[0373] In one aspect, the processor may comprise a safety
controller comprising two controller-based families such as TMS570
and RM4.times. known under the trade name Hercules ARM Cortex R4,
also by Texas Instruments. The safety controller may be configured
specifically for IEC 61508 and ISO 26262 safety critical
applications, among others, to provide advanced integrated safety
features while delivering scalable performance, connectivity, and
memory options.
[0374] As used in any aspect herein, the term "logic" may refer to
an app, software, firmware and/or circuitry configured to perform
any of the aforementioned operations. Software may be embodied as a
software package, code, instructions, instruction sets and/or data
recorded on non-transitory computer readable storage medium.
Firmware may be embodied as code, instructions or instruction sets
and/or data that are hard-coded (e.g., nonvolatile) in memory
devices.
[0375] As used in any aspect herein, the terms "component,"
"system," "module" and the like can refer to a computer-related
entity, either hardware, a combination of hardware and software,
software, or software in execution.
[0376] As used in any aspect herein, 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
and/or logic states 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 and/or
states.
[0377] A network may include a packet switched network. The
communication devices may be capable of communicating with each
other using a selected packet switched network communications
protocol. One example communications protocol may include an
Ethernet communications protocol which may be capable permitting
communication using a Transmission Control Protocol/Internet
Protocol (TCP/IP). The Ethernet protocol may comply or be
compatible with the Ethernet standard published by the Institute of
Electrical and Electronics Engineers (IEEE) titled "IEEE 802.3
Standard", published in December, 2008 and/or later versions of
this standard. Alternatively or additionally, the communication
devices may be capable of communicating with each other using an
X.25 communications protocol. The X.25 communications protocol may
comply or be compatible with a standard promulgated by the
International Telecommunication Union-Telecommunication
Standardization Sector (ITU-T). Alternatively or additionally, the
communication devices may be capable of communicating with each
other using a frame relay communications protocol. The frame relay
communications protocol may comply or be compatible with a standard
promulgated by Consultative Committee for International Telegraph
and Telephone (CCITT) and/or the American National Standards
Institute (ANSI). Alternatively or additionally, the transceivers
may be capable of communicating with each other using an
Asynchronous Transfer Mode (ATM) communications protocol. The ATM
communications protocol may comply or be compatible with an ATM
standard published by the ATM Forum titled "ATM-MPLS Network
Interworking 2.0" published August 2001, and/or later versions of
this standard. Of course, different and/or after-developed
connection-oriented network communication protocols are equally
contemplated herein.
[0378] Unless specifically stated otherwise as apparent from the
foregoing disclosure, it is appreciated that, throughout the
foregoing disclosure, discussions using terms such as "processing,"
"computing," "calculating," "determining," "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.
[0379] 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.
[0380] The terms "proximal" and "distal" are used herein with
reference to a clinician manipulating the handle portion of the
surgical instrument. The term "proximal" refers to the portion
closest to the clinician and the term "distal" refers to the
portion located away from the clinician. It will be further
appreciated that, for convenience and clarity, spatial terms such
as "vertical", "horizontal", "up", "down", "left" and "right" may
be used herein with respect to the drawings. However, surgical
instruments are used in many orientations and positions, and these
terms are not intended to be limiting and/or absolute.
[0381] Modular devices include the modules (as described in
connection with FIGS. 3 and 9, for example) that are receivable
within a surgical hub and the surgical devices or instruments that
can be connected to the various modules in order to connect or pair
with the corresponding surgical hub. The modular devices include,
for example, intelligent surgical instruments, medical imaging
devices, suction/irrigation devices, smoke evacuators, energy
generators, ventilators, insufflators, and displays. The modular
devices described herein can be controlled by control algorithms.
The control algorithms can be executed on the modular device
itself, on the surgical hub to which the particular modular device
is paired, or on both the modular device and the surgical hub
(e.g., via a distributed computing architecture). In some
exemplifications, the modular devices' control algorithms control
the devices based on data sensed by the modular device itself
(i.e., by sensors in, on, or connected to the modular device). This
data can be related to the patient being operated on (e.g., tissue
properties or insufflation pressure) or the modular device itself
(e.g., the rate at which a knife is being advanced, motor current,
or energy levels). For example, a control algorithm for a surgical
stapling and cutting instrument can control the rate at which the
instrument's motor drives its knife through tissue according to
resistance encountered by the knife as it advances.
[0382] Those skilled in the art will recognize 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.
[0383] 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." 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 flow diagrams 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.
[0384] It is worthy to note that any reference to "one aspect," "an
aspect," "an exemplification," "one exemplification," and the like
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 an exemplification," and "in one exemplification" 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.
[0385] Any patent application, patent, non-patent publication, or
other disclosure material referred to in this specification and/or
listed in any Application Data Sheet is incorporated by reference
herein, to the extent that the incorporated materials is 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.
[0386] 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.
* * * * *