U.S. patent application number 16/182240 was filed with the patent office on 2019-07-04 for powered stapling device configured to adjust force, advancement speed, and overall stroke of cutting member based on sensed para.
The applicant listed for this patent is Ethicon LLC. Invention is credited to Gregory J. Bakos, Chester O. Baxter, III, Jason L. Harris, Frederick E. Shelton, IV.
Application Number | 20190201034 16/182240 |
Document ID | / |
Family ID | 64664420 |
Filed Date | 2019-07-04 |
View All Diagrams
United States Patent
Application |
20190201034 |
Kind Code |
A1 |
Shelton, IV; Frederick E. ;
et al. |
July 4, 2019 |
POWERED STAPLING DEVICE CONFIGURED TO ADJUST FORCE, ADVANCEMENT
SPEED, AND OVERALL STROKE OF CUTTING MEMBER BASED ON SENSED
PARAMETER OF FIRING OR CLAMPING
Abstract
A surgical stapling instrument is disclosed. The surgical
stapling instrument includes an end effector configured to clamp a
tissue, a cutting member, a motor coupled to the cutting member,
the motor configured to move the cutting member between a first
position and a second position, and a control circuit coupled to
the motor. The control circuit is configured to sense a parameter
associated with clamping of the end effector or firing of the
cutting member, or a combination of clamping of the end effector
and firing of the cutting member, and control the motor to adjust a
torque applied to the cutting member by the motor, a speed at which
the motor drive the cutting member, or a distance to which the
motor drives the cutting member according to the parameter, or any
combination of adjusting the torque, the speed, and the
distance.
Inventors: |
Shelton, IV; Frederick E.;
(Hillsboro, OH) ; Bakos; Gregory J.; (Mason,
OH) ; Harris; Jason L.; (Lebanon, OH) ;
Baxter, III; Chester O.; (Loveland, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ethicon LLC |
Guaynabo |
PR |
US |
|
|
Family ID: |
64664420 |
Appl. No.: |
16/182240 |
Filed: |
November 6, 2018 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62729185 |
Sep 10, 2018 |
|
|
|
62659900 |
Apr 19, 2018 |
|
|
|
62692748 |
Jun 30, 2018 |
|
|
|
62692768 |
Jun 30, 2018 |
|
|
|
62692747 |
Jun 30, 2018 |
|
|
|
62650898 |
Mar 30, 2018 |
|
|
|
62650887 |
Mar 30, 2018 |
|
|
|
62650882 |
Mar 30, 2018 |
|
|
|
62650877 |
Mar 30, 2018 |
|
|
|
62640417 |
Mar 8, 2018 |
|
|
|
62640415 |
Mar 8, 2018 |
|
|
|
62611341 |
Dec 28, 2017 |
|
|
|
62611340 |
Dec 28, 2017 |
|
|
|
62611339 |
Dec 28, 2017 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00022
20130101; A61B 17/320016 20130101; A61B 2090/373 20160201; A61B
2017/2927 20130101; A61B 2017/07285 20130101; A61B 90/37 20160201;
A61B 2018/0063 20130101; A61B 2018/1253 20130101; A61B 2090/064
20160201; G16H 20/40 20180101; A61B 18/00 20130101; A61B 2017/00199
20130101; A61B 2017/00115 20130101; G16H 50/20 20180101; A61B
2017/00734 20130101; G16H 40/67 20180101; A61B 2090/376 20160201;
A61B 17/068 20130101; A61B 2018/145 20130101; A61B 2017/00044
20130101; A61B 2017/00221 20130101; A61B 2018/126 20130101; A61B
2017/00809 20130101; A61B 2217/007 20130101; A61B 2017/07257
20130101; A61B 2217/005 20130101; G16H 30/40 20180101; A61B 18/1206
20130101; A61B 2018/1273 20130101; A61B 2034/2059 20160201; A61B
2017/00017 20130101; A61B 2017/00398 20130101; A61B 17/1155
20130101; A61B 2017/00026 20130101; A61B 2090/066 20160201; A61B
34/30 20160201; A61B 2034/2048 20160201; A61B 34/37 20160201; A61B
2018/00601 20130101; H04L 67/10 20130101; A61B 90/361 20160201 |
International
Class: |
A61B 17/32 20060101
A61B017/32; A61B 17/068 20060101 A61B017/068 |
Claims
1. A surgical stapling instrument comprising: an end effector
configured to clamp a tissue; a cutting member; a motor coupled to
the cutting member, the motor configured to move the cutting member
between a first position and a second position; and a control
circuit coupled to the motor, the control circuit configured to:
sense a parameter associated with clamping of the end effector; and
control the motor to adjust a torque applied to the cutting member
by the motor.
2. The surgical stapling instrument of claim 1, wherein the cutting
member is independently actuatable from the end effector.
3. The surgical stapling instrument of claim 1, wherein the
parameter comprises a tissue gap, force during closure of the end
effector, tissue creep stabilization, or force during firing, or
any combination thereof.
4. The surgical stapling instrument of claim 1, wherein the control
circuit is configured to control the motor to drive the cutting
member in either a load control mode or a stroke control mode
according to an adjustable control parameter.
5. The surgical stapling instrument of claim 1, wherein the control
circuit is configured to control an advancement rate at which the
motor drives the cutting member according to initial conditions as
the motor begins driving the cutting member from the first
position.
6. The surgical instrument of claim 1, wherein the control circuit
is configured to control the motor to adjust a speed at which the
motor drives the cutting member.
7. The surgical instrument of claim 1, wherein the control circuit
is configured to control the motor to adjust a distance to which
the motor drives the cutting member according to the parameter.
8. The surgical instrument of claim 1, wherein the control circuit
is configured to control the motor to adjust any combination of the
torque, the speed, or the distance.
9. A surgical stapling instrument comprising: an end effector
configured to clamp a tissue; a cutting member; a motor coupled to
the cutting member, the motor configured to move the cutting member
between a first position and a second position; and a control
circuit coupled to the motor, the control circuit configured to:
sense a parameter associated with firing of the cutting member; and
control the motor to adjust a torque applied to the cutting member
by the motor.
10. The surgical stapling instrument of claim 9, wherein the
cutting member is independently actuatable from the end
effector.
11. The surgical stapling instrument of claim 9, wherein the
parameter comprises a tissue gap, force during closure of the end
effector, tissue creep stabilization, or force during firing, or
any combination thereof.
12. The surgical stapling instrument of claim 9, wherein the
control circuit is configured to control the motor to drive the
cutting member in either a load control mode or a stroke control
mode according to an adjustable control parameter.
13. The surgical stapling instrument of claim 9, wherein the
control circuit is configured to control an advancement rate at
which the motor drives the cutting member according to initial
conditions as the motor begins driving the cutting member from the
first position.
14. The surgical instrument of claim 9, wherein the control circuit
is configured to control the motor to adjust a speed at which the
motor drives the cutting member.
15. The surgical instrument of claim 9, wherein the control circuit
is configured to control the motor to adjust a distance to which
the motor drives the cutting member according to the parameter.
16. The surgical instrument of claim 9, wherein the control circuit
is configured to control the motor to adjust any combination of the
torque, the speed, or the distance.
17. A powered stapling device, comprising: a circular stapling head
assembly; an anvil; a trocar coupled to the anvil and coupled to a
motor, wherein the motor in configured to advance and retract the
trocar; and a control circuit coupled to the motor, wherein the
control circuit is configured to: determine a position of the
trocar in one of a plurality of zones; and set an anvil closure
rate based on the determined position of the trocar.
18. The powered stapling device of claim 17, wherein the plurality
of zones comprises: a first zone during attachment of the trocar to
the anvil; a second zone during retraction of the trocar and
closure of the anvil; a third zone during verification of
attachment of the trocar to the anvil; and a fourth zone during
application of a high closure load.
19. The powered stapling device of claim 18, wherein the control
circuit is configured to: set the closure rate of the anvil to a
first velocity when the trocar is in the first zone to ensure
proper attachment of the trocar to the anvil; set the closure rate
of the anvil to a second velocity, which is greater than the first
velocity, when the trocar is in the second position during the
retraction of the trocar and the closure of the anvil; set the
closure rate of the anvil to a third velocity, which is less than
the second velocity, to verify attachment of the trocar to the
anvil; set the closure rate of the anvil to a fourth velocity,
which is less than the third velocity, when the trocar is the
fourth zone during application of a high closure load.
20. The powered stapling device of claim 17, wherein the control
circuit is configured to: determine the closure rate of the trocar;
determine the closure rate of the anvil; compare the closure rate
of the trocar to the closure rate of the anvil to determine a
difference between the closure rate of the trocar to the closure
rate of the anvil; and at a difference greater than a predetermined
value, extend and retract the trocar to reset the anvil.
21. The powered stapling device of claim 17, wherein the control
circuit is configured to verify attachment of the trocar to the
anvil and to slow the closure rate of the trocar under tissue
load.
22. The powered stapling device of claim 17, further comprising: a
knife coupled to the motor; a sensor located on the anvil, wherein
the sensor is configured to detect tissue contact and force applied
to the anvil, wherein the sensor is coupled to the anvil, wherein
the control circuit is configured to: monitor anvil displacement;
monitor tissue contact with the anvil; monitor a force to close of
the anvil; compare the force to close to a predetermined threshold;
and set a first initial knife velocity and advance the knife at a
first velocity profile suitable for cutting normal tissue toughness
when the force to close is less than the predetermined threshold;
or set a second initial knife velocity and advance the knife at a
second velocity profile suitable for cutting heavy tissue toughness
when the force to close is greater than or equal to the
predetermined threshold.
23. The powered stapling device of claim 22, wherein to advance the
knife at the second velocity profile, the control circuit is
further configured to: set the second initial knife velocity to a
velocity that is less than the first initial knife velocity;
monitor knife contact with tissue; increase motor velocity to
increase knife velocity when tissue contact is detected; monitor
completion of cut; and stop the motor when completion of cut is
detected.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority under 35 U.S.C.
.sctn. 119(e) to U.S. Provisional Patent Application No.
62/729,185, titled POWERED STAPLING DEVICE THAT IS CAPABLE OF
ADJUSTING FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING
MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING OR
CLAMPING, filed on Sep. 10, 2018, the disclosure of which is herein
incorporated by reference in its entirety.
[0002] The present application also claims priority under 35 U.S.C.
.sctn. 119(e) to U.S. Provisional Patent Application No.
62/659,900, titled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER
DEVICE, filed on Jun. 30, 2018, to U.S. Provisional Patent
Application No. 62/692,748, titled SMART ENERGY ARCHITECTURE, filed
on Jun. 30, 2018, and to U.S. Provisional Patent Application No.
62/692,768, titled SMART ENERGY DEVICES, filed on Jun. 30, 2018,
the disclosure of each of which is herein incorporated by reference
in its entirety.
[0003] The present application also claims priority under 35 U.S.C.
.sctn. 119(e) to U.S. Provisional Patent Application No.
62/692,747, titled METHOD OF HUB COMMUNICATION, filed on Apr. 19,
2018, the disclosure of each of which is herein incorporated by
reference in its entirety.
[0004] The present application also claims priority under 35 U.S.C.
.sctn. 119(e) to U.S. Provisional Patent Application No. 62/650,898
filed on Mar. 30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD
WITH SEPARABLE ARRAY ELEMENTS, 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. 62/650,882, titled SMOKE
EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed Mar. 30,
2018, and to U.S. Provisional Patent Application Ser. No.
62/650,877, titled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS,
filed Mar. 30, 2018, the disclosure of each of which is herein
incorporated by reference in its entirety.
[0005] The present application also claims 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 U.S.
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.
[0006] The present application also claims 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
[0007] The present disclosure relates to various surgical systems.
Surgical procedures are typically performed in surgical operating
theaters or rooms in a healthcare facility such as, for example, a
hospital. A sterile field is typically created around the patient.
The sterile field may include the scrubbed team members, who are
properly attired, and all furniture and fixtures in the area.
Various surgical devices and systems are utilized in performance of
a surgical procedure.
SUMMARY
[0008] In one aspect, the present disclosure provides a surgical
stapling instrument that includes an end effector configured to
clamp a tissue; a cutting member; a motor coupled to the cutting
member, the motor configured to move the cutting member between a
first position and a second position; and a control circuit coupled
to the motor, the control circuit configured to: sense a parameter
associated with clamping of the end effector; and control the motor
to adjust a torque applied to the cutting member by the motor.
[0009] In another aspect, the present disclosure provides a
surgical stapling instrument that includes an end effector
configured to clamp a tissue; a cutting member; a motor coupled to
the cutting member, the motor configured to move the cutting member
between a first position and a second position; and a control
circuit coupled to the motor, the control circuit configured to:
sense a parameter associated with firing of the cutting member; and
control the motor to adjust a torque applied to the cutting member
by the motor.
[0010] In yet another aspect, the present disclosure provides a
powered stapling device that includes a circular stapling head
assembly; an anvil; a trocar coupled to the anvil and coupled to
motor, wherein the motor in configured to advance and retract the
trocar; and a control circuit coupled to the motor, wherein the
control circuit is configured to: determine a position of the
trocar in one of a plurality of zones; and set an anvil closure
rate based on the determined position of the trocar.
FIGURES
[0011] The various aspects described herein, 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.
[0012] FIG. 1 is a block diagram of a computer-implemented
interactive surgical system, in accordance with at least one aspect
of the present disclosure.
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] FIG. 9 illustrates a computer-implemented interactive
surgical system, in accordance with at least one aspect of the
present disclosure.
[0021] 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.
[0022] 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.
[0023] FIG. 12 is a block diagram of a cloud computing system
comprising a plurality of smart surgical instruments coupled to
surgical hubs that may connect to the cloud component of the cloud
computing system, in accordance with at least one aspect of the
present disclosure.
[0024] FIG. 13 is a functional module architecture of a cloud
computing system, in accordance with at least one aspect of the
present disclosure.
[0025] FIG. 14 illustrates a diagram of a situationally aware
surgical system, in accordance with at least one aspect of the
present disclosure.
[0026] FIG. 15 is a timeline depicting situational awareness of a
surgical hub, in accordance with at least one aspect of the present
disclosure.
[0027] FIG. 16 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.
[0028] FIG. 17 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.
[0029] FIG. 18 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.
[0030] FIG. 19 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.
[0031] FIG. 20 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.
[0032] FIG. 21 is a schematic diagram of a surgical instrument
configured to operate a surgical tool described herein, in
accordance with at least one aspect of the present disclosure.
[0033] FIG. 22 illustrates a block diagram of a surgical instrument
configured to control various functions, in accordance with at
least one aspect of the present disclosure.
[0034] FIG. 23 is a schematic diagram of a surgical instrument
configured to control various functions, in accordance with at
least one aspect of the present disclosure.
[0035] FIG. 24 depicts a perspective view of a circular stapling
surgical instrument, in accordance with at least one aspect of the
present disclosure.
[0036] FIG. 25 depicts an exploded view of the handle and shaft
assemblies of the instrument of FIG. 24, in accordance with at
least one aspect of the present disclosure.
[0037] FIG. 26 depicts a cross sectional view of the handle
assembly of the instrument of FIG. 24, in accordance with at least
one aspect of the present disclosure.
[0038] FIG. 27 depicts an enlarged, partial cross sectional view of
the motor and battery assemblies of FIG. 24, in accordance with at
least one aspect of the present disclosure.
[0039] FIG. 28A depicts a side elevational view of an operational
mode selection assembly of the instrument of FIG. 24, with a first
gear disengaged from a second gear, in accordance with at least one
aspect of the present disclosure.
[0040] FIG. 28B depicts a side elevational view of the operational
mode selection assembly of FIG. 28A, with the first gear engaged
with the second gear, in accordance with at least one aspect of the
present disclosure.
[0041] FIG. 29A depicts an enlarged longitudinal cross-section view
of a stapling head assembly of the instrument of FIG. 24 showing an
anvil in an open position, in accordance with at least one aspect
of the present disclosure.
[0042] FIG. 29B depicts an enlarged longitudinal cross-sectional
view of the stapling head assembly of FIG. 29A showing the anvil in
a closed position, in accordance with at least one aspect of the
present disclosure.
[0043] FIG. 29C depicts an enlarged longitudinal cross-sectional
view of the stapling head assembly of FIG. 29A showing a staple
driver and blade in a fired position, in accordance with at least
one aspect of the present disclosure.
[0044] FIG. 30 depicts an enlarged partial cross-sectional view of
a staple formed against the anvil, in accordance with at least one
aspect of the present disclosure.
[0045] FIG. 31 is a diagram of graph and associated powered
stapling device illustrating anvil closure rate adjustment at
certain key points along a trocar's retraction stroke, in
accordance with at least one aspect of the present disclosure.
[0046] FIG. 32 is a view of a circular stapler, in accordance with
at least one aspect of the present disclosure.
[0047] FIG. 33 is a logic flow diagram of a process depicting a
control program or a logic configuration to adjust a closure rate
of the anvil portion of the powered stapling device at certain key
points along the retraction stroke of a trocar, in accordance with
at least one aspect of the present disclosure.
[0048] FIG. 34 is a diagram of graph and associated power stapling
device diagram illustrating trocar position over time, in
accordance with at least one aspect of the present disclosure.
[0049] FIG. 35 is a logic flow diagram of a process depicting a
control program or a logic configuration to detect
multi-directional seating motions on the trocar to drive the anvil
into proper seating, in accordance with at least one aspect of the
present disclosure.
[0050] FIG. 36 is a partial schematic diagram of a circular powered
stapling device showing anvil closure on the left side and knife
201616 actuation on the right side, in accordance with at least one
aspect of the present disclosure.
[0051] FIG. 37 is a graphical representation of anvil displacement
(.delta..sub.Anvil) along the vertical axis as a function of force
to close (FTC) a clamp along the horizontal axis, in accordance
with at least one aspect of the present disclosure.
[0052] FIG. 38 is a graphical representation 201630 of knife 201616
displacement (.delta..sub.Knife) along the vertical axis as a
function of knife 201616 velocity (V.sub.K mm/sec) along the
horizontal axis on the left and also as a function of knife 201616
force (F.sub.K lbs) along the horizontal axis on the right, in
accordance with at least one aspect of the present disclosure.
[0053] FIG. 39 is a logic flow diagram of a process depicting a
control program or a logic configuration to detect the tissue gap
and force-to-fire to adjust the knife stroke and speed, in
accordance with at least one aspect of the present disclosure.
[0054] FIG. 40 is a logic flow diagram of a process depicting a
control program or a logic configuration to advance the knife
201616 under a heavy tissue toughness velocity profile with a
velocity spike as shown in FIG. 38, in accordance with at least one
aspect of the present disclosure.
DESCRIPTION
[0055] Applicant of the present application owns the following U.S.
patent applications, filed on Nov. 6, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0056] U.S. patent application Ser. No. ______, titled SURGICAL
NETWORK, INSTRUMENT, AND CLOUD RESPONSES BASED ON VALIDATION OF
RECEIVED DATASET AND AUTHENTICATION OF ITS SOURCE AND INTEGRITY,
Attorney Docket No. END9012USNP1/180511-1; [0057] U.S. patent
application Ser. No. ______, titled SURGICAL SYSTEM FOR PRESENTING
INFORMATION INTERPRETED FROM EXTERNAL DATA, Attorney Docket No.
END9012USNP2/180511-2; [0058] U.S. patent application Ser. No.
______, titled MODIFICATION OF SURGICAL SYSTEMS CONTROL PROGRAMS
BASED ON MACHINE LEARNING, Attorney Docket No.
END9012USNP3/180511-3; [0059] U.S. patent application Ser. No.
______, titled ADJUSTMENT OF DEVICE CONTROL PROGRAMS BASED ON
STRATIFIED CONTEXTUAL DATA IN ADDITION TO THE DATA, Attorney Docket
No. END9012USNP4/180511-4; [0060] U.S. patent application Ser. No.
______, titled SURGICAL HUB AND MODULAR DEVICE RESPONSE ADJUSTMENT
BASED ON SITUATIONAL AWARENESS, Attorney Docket No.
END9012USNP5/180511-5; [0061] U.S. patent application Ser. No.
______, titled DETECTION AND ESCALATION OF SECURITY RESPONSES OF
SURGICAL INSTRUMENTS TO INCREASING SEVERITY THREATS, Attorney
Docket No. END9012USNP6/180511-6; [0062] U.S. patent application
Ser. No. ______, titled INTERACTIVE SURGICAL SYSTEM, Attorney
Docket No. END9012USNP7/180511-7; [0063] U.S. patent application
Ser. No. ______, titled AUTOMATED DATA SCALING, ALIGNMENT, AND
ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN SURGICAL NETWORKS,
Attorney Docket No. END9012USNP8/180511-8; [0064] U.S. patent
application Ser. No. ______, titled SENSING THE PATIENT POSITION
AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD ELECTRODE TO
PROVIDE SITUATIONAL AWARENESS TO A SURGICAL NETWORK, Attorney
Docket No. END9013USNP1/180512-1; [0065] U.S. patent application
Ser. No. ______, titled POWERED SURGICAL TOOL WITH PREDEFINED
ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING END EFFECTOR
PARAMETER, Attorney Docket No. END9014USNP1/180513-1; [0066] U.S.
patent application Ser. No. ______, titled ADJUSTMENTS BASED ON
AIRBORNE PARTICLE PROPERTIES, Attorney Docket No.
END9016USNP1/180515-1; [0067] U.S. patent application Ser. No.
______, titled ADJUSTMENT OF A SURGICAL DEVICE FUNCTION BASED ON
SITUATIONAL AWARENESS, Attorney Docket No. END9016USNP2/180515-2;
[0068] U.S. patent application Ser. No. ______, titled REAL-TIME
ANALYSIS OF COMPREHENSIVE COST OF ALL INSTRUMENTATION USED IN
SURGERY UTILIZING DATA FLUIDITY TO TRACK INSTRUMENTS THROUGH
STOCKING AND IN-HOUSE PROCESSES, Attorney Docket No.
END9018USNP1/180517-1; [0069] U.S. patent application Ser. No.
______, titled USAGE AND TECHNIQUE ANALYSIS OF SURGEON/STAFF
PERFORMANCE AGAINST A BASELINE TO OPTIMIZE DEVICE UTILIZATION AND
PERFORMANCE FOR BOTH CURRENT AND FUTURE PROCEDURES, Attorney Docket
No. END9018USNP2/180517-2; [0070] U.S. patent application Ser. No.
______, titled IMAGE CAPTURING OF THE AREAS OUTSIDE THE ABDOMEN TO
IMPROVE PLACEMENT AND CONTROL OF A SURGICAL DEVICE IN USE, Attorney
Docket No. END9018USNP3/180517-3; [0071] U.S. patent application
Ser. No. ______, titled COMMUNICATION OF DATA WHERE A SURGICAL
NETWORK IS USING CONTEXT OF THE DATA AND REQUIREMENTS OF A
RECEIVING SYSTEM/USER TO INFLUENCE INCLUSION OR LINKAGE OF DATA AND
METADATA TO ESTABLISH CONTINUITY, Attorney Docket No.
END9018USNP4/180517-4; [0072] U.S. patent application Ser. No.
______, titled SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME
ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING
DIFFERENCES FROM THE OPTIMAL SOLUTION, Attorney Docket No.
END9018USNP5/180517-5; [0073] U.S. patent application Ser. No.
______, titled CONTROL OF A SURGICAL SYSTEM THROUGH A SURGICAL
BARRIER, Attorney Docket No. END9019USNP1/180518-1; [0074] U.S.
patent application Ser. No. ______, titled SURGICAL NETWORK
DETERMINATION OF PRIORITIZATION OF COMMUNICATION, INTERACTION, OR
PROCESSING BASED ON SYSTEM OR DEVICE NEEDS, Attorney Docket No.
END9032USNP1/180519-1; [0075] U.S. patent application Ser. No.
______, titled WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER
DEVICE WITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND
SITUATIONAL AWARENESS OF DEVICES, Attorney Docket No.
END9032USNP2/180519-2; [0076] U.S. patent application Ser. No.
______, titled ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF
STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING,
Attorney Docket No. END9034USNP1/180521-1; [0077] U.S. patent
application Ser. No. ______, titled STAPLING DEVICE WITH BOTH
COMPULSORY AND DISCRETIONARY LOCKOUTS BASED ON SENSED PARAMETERS,
Attorney Docket No. END9034USNP2/180521-2; [0078] U.S. patent
application Ser. No. ______, titled VARIATION OF RADIO FREQUENCY
AND ULTRASONIC POWER LEVEL IN COOPERATION WITH VARYING CLAMP ARM
PRESSURE TO ACHIEVE PREDEFINED HEAT FLUX OR POWER APPLIED TO
TISSUE, Attorney Docket No. END9035USNP1/180522-1; and [0079] U.S.
patent application Ser. No. ______, titled ULTRASONIC ENERGY DEVICE
WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLD
CONTROL PRESSURE AT A CUT PROGRESSION LOCATION, Attorney Docket No.
END9035USNP2/180522-2.
[0080] Applicant of the present application owns the following U.S.
patent applications, filed on Sep. 10, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0081] U.S. Provisional Patent Application No. 62/729,183, titled A
CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE
THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR USAGE;
[0082] U.S. Provisional Patent Application No. 62/729,177, titled
AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON
PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE
TRANSMISSION; [0083] U.S. Provisional Patent Application No.
62/729,176, titled INDIRECT COMMAND AND CONTROL OF A FIRST
OPERATING ROOM SYSTEM THROUGH THE USE OF A SECOND OPERATING ROOM
SYSTEM WITHIN A STERILE FIELD WHERE THE SECOND OPERATING ROOM
SYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES; [0084] U.S.
Provisional Patent Application No. 62/729,185, titled POWERED
STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE, ADVANCEMENT
SPEED, AND OVERALL STROKE OF CUTTING MEMBER OF THE DEVICE BASED ON
SENSED PARAMETER OF FIRING OR CLAMPING; [0085] U.S. Provisional
Patent Application No. 62/729,184, titled POWERED SURGICAL TOOL
WITH A PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING AT
LEAST ONE END EFFECTOR PARAMETER AND A MEANS FOR LIMITING THE
ADJUSTMENT; [0086] U.S. Provisional Patent Application No.
62/729,182, titled SENSING THE PATIENT POSITION AND CONTACT
UTILIZING THE MONO POLAR RETURN PAD ELECTRODE TO PROVIDE
SITUATIONAL AWARENESS TO THE HUB; [0087] U.S. Provisional Patent
Application No. 62/729,191, titled SURGICAL NETWORK RECOMMENDATIONS
FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE
HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION; [0088] U.S.
Provisional Patent Application No. 62/729,195, titled ULTRASONIC
ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE
THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION LOCATION; and
[0089] U.S. Provisional Patent Application No. 62/729,186, titled
WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A
STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS
OF DEVICES.
[0090] Applicant of the present application owns the following U.S.
patent applications, filed on Aug. 28, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0091] U.S. patent application Ser. No. 16/115,214, titled
ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM
THEREFOR; [0092] U.S. patent application Ser. No. 16/115,205,
titled TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL
SYSTEM THEREFOR; [0093] U.S. patent application Ser. No.
16/115,233, titled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING
COMBINED ELECTRICAL SIGNALS; [0094] U.S. patent application Ser.
No. 16/115,208, titled CONTROLLING AN ULTRASONIC SURGICAL
INSTRUMENT ACCORDING TO TISSUE LOCATION; [0095] U.S. patent
application Ser. No. 16/115,220, titled CONTROLLING ACTIVATION OF
AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF
TISSUE; [0096] U.S. patent application Ser. No. 16/115,232, titled
DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM; [0097]
U.S. patent application Ser. No. 16/115,239, titled DETERMINING THE
STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO
FREQUENCY SHIFT; [0098] U.S. patent application Ser. No.
16/115,247, titled DETERMINING THE STATE OF AN ULTRASONIC END
EFFECTOR; [0099] U.S. patent application Ser. No. 16/115,211,
titled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS; [0100]
U.S. patent application Ser. No. 16/115,226, titled MECHANISMS FOR
CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN
ELECTROSURGICAL INSTRUMENT; [0101] U.S. patent application Ser. No.
16/115,240, titled DETECTION OF END EFFECTOR IMMERSION IN LIQUID;
[0102] U.S. patent application Ser. No. 16/115,249, titled
INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;
[0103] U.S. patent application Ser. No. 16/115,256, titled
INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP;
[0104] U.S. patent application Ser. No. 16/115,223, titled BIPOLAR
COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON
ENERGY MODALITY; and [0105] U.S. patent application Ser. No.
16/115,238, titled ACTIVATION OF ENERGY DEVICES.
[0106] Applicant of the present application owns the following U.S.
patent applications, filed on Aug. 23, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0107] U.S. Provisional Patent Application No. 62/721,995, titled
CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE
LOCATION; [0108] U.S. Provisional Patent Application No.
62/721,998, titled SITUATIONAL AWARENESS OF ELECTROSURGICAL
SYSTEMS; [0109] U.S. Provisional Patent Application No. 62/721,999,
titled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE
COUPLING; [0110] U.S. Provisional Patent Application No.
62/721,994, titled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY
ADJUSTS PRESSURE BASED ON ENERGY MODALITY; and [0111] U.S.
Provisional Patent Application No. 62/721,996, titled RADIO
FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL
SIGNALS.
[0112] Applicant of the present application owns the following U.S.
patent applications, filed on Jun. 30, 2018, the disclosure of each
of which is herein incorporated by reference in its entirety:
[0113] U.S. Provisional Patent Application No. 62/692,747, titled
SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE; [0114] U.S.
Provisional Patent Application No. 62/692,748, titled SMART ENERGY
ARCHITECTURE; and [0115] U.S. Provisional Patent Application No.
62/692,768, titled SMART ENERGY DEVICES.
[0116] 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:
[0117] U.S. patent application Ser. No. 16/024,090, titled
CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;
[0118] U.S. patent application Ser. No. 16/024,057, titled
CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE
PARAMETERS; [0119] U.S. patent application Ser. No. 16/024,067,
titled SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON
PERIOPERATIVE INFORMATION; [0120] U.S. patent application Ser. No.
16/024,075, titled SAFETY SYSTEMS FOR SMART POWERED SURGICAL
STAPLING; [0121] U.S. patent application Ser. No. 16/024,083,
titled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING; [0122]
U.S. patent application Ser. No. 16/024,094, titled SURGICAL
SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION
IRREGULARITIES; [0123] U.S. patent application Ser. No. 16/024,138,
titled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO
CANCEROUS TISSUE; [0124] U.S. patent application Ser. No.
16/024,150, titled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;
[0125] U.S. patent application Ser. No. 16/024,160, titled VARIABLE
OUTPUT CARTRIDGE SENSOR ASSEMBLY; [0126] U.S. patent application
Ser. No. 16/024,124, titled SURGICAL INSTRUMENT HAVING A FLEXIBLE
ELECTRODE; [0127] U.S. patent application Ser. No. 16/024,132,
titled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT; [0128] U.S.
patent application Ser. No. 16/024,141, titled SURGICAL INSTRUMENT
WITH A TISSUE MARKING ASSEMBLY; [0129] U.S. patent application Ser.
No. 16/024,162, titled SURGICAL SYSTEMS WITH PRIORITIZED DATA
TRANSMISSION CAPABILITIES; [0130] U.S. patent application Ser. No.
16/024,066, titled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[0131] U.S. patent application Ser. No. 16/024,096, titled SURGICAL
EVACUATION SENSOR ARRANGEMENTS; [0132] U.S. patent application Ser.
No. 16/024,116, titled SURGICAL EVACUATION FLOW PATHS; [0133] U.S.
patent application Ser. No. 16/024,149, titled SURGICAL EVACUATION
SENSING AND GENERATOR CONTROL; [0134] U.S. patent application Ser.
No. 16/024,180, titled SURGICAL EVACUATION SENSING AND DISPLAY;
[0135] U.S. patent application Ser. No. 16/024,245, titled
COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD
IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
[0136] U.S. patent application Ser. No. 16/024,258, titled SMOKE
EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR
INTERACTIVE SURGICAL PLATFORM; [0137] U.S. patent application Ser.
No. 16/024,265, titled SURGICAL EVACUATION SYSTEM WITH A
COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A
SMOKE EVACUATION DEVICE; and [0138] U.S. patent application Ser.
No. 16/024,273, titled DUAL IN-SERIES LARGE AND SMALL DROPLET
FILTERS.
[0139] 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: [0140] U.S. Provisional Patent Application Ser. No.
62/691,228, titled A METHOD OF USING REINFORCED FLEX CIRCUITS WITH
MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES; [0141] U.S.
Provisional Patent Application Ser. No. 62/691,227, titled
CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE
PARAMETERS; [0142] U.S. Provisional Patent Application Ser. No.
62/691,230, titled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[0143] U.S. Provisional Patent Application Ser. No. 62/691,219,
titled SURGICAL EVACUATION SENSING AND MOTOR CONTROL; [0144] 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;
[0145] 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
[0146] U.S. Provisional Patent Application Ser. No. 62/691,251,
titled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[0147] 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: [0148] U.S. Provisional Patent Application Ser. No.
62/659,900, titled METHOD OF HUB COMMUNICATION.
[0149] Applicant of the present application owns the following U.S.
Provisional patent applications, filed on Mar. 30, 2018, the
disclosure of each of which is herein incorporated by reference in
its entirety: [0150] U.S. Provisional Patent Application No.
62/650,898 filed on Mar. 30, 2018, titled CAPACITIVE COUPLED RETURN
PATH PAD WITH SEPARABLE ARRAY ELEMENTS; [0151] U.S. Provisional
Patent Application Ser. No. 62/650,887, titled SURGICAL SYSTEMS
WITH OPTIMIZED SENSING CAPABILITIES; [0152] U.S. Provisional Patent
Application Ser. No. 62/650,882, titled SMOKE EVACUATION MODULE FOR
INTERACTIVE SURGICAL PLATFORM; and [0153] U.S. Provisional Patent
Application Ser. No. 62/650,877, titled SURGICAL SMOKE EVACUATION
SENSING AND CONTROLS.
[0154] 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:
[0155] U.S. patent application Ser. No. 15/940,641, titled
INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION
CAPABILITIES; [0156] U.S. patent application Ser. No. 15/940,648,
titled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF
DEVICES AND DATA CAPABILITIES; [0157] U.S. patent application Ser.
No. 15/940,656, titled SURGICAL HUB COORDINATION OF CONTROL AND
COMMUNICATION OF OPERATING ROOM DEVICES; [0158] U.S. patent
application Ser. No. 15/940,666, titled SPATIAL AWARENESS OF
SURGICAL HUBS IN OPERATING ROOMS; [0159] U.S. patent application
Ser. No. 15/940,670, titled COOPERATIVE UTILIZATION OF DATA DERIVED
FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS; [0160] U.S.
patent application Ser. No. 15/940,677, titled SURGICAL HUB CONTROL
ARRANGEMENTS; [0161] U.S. patent application Ser. No. 15/940,632,
titled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND
CREATE ANONYMIZED RECORD; [0162] 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; [0163] U.S. patent application Ser. No.
15/940,645, titled SELF DESCRIBING DATA PACKETS GENERATED AT AN
ISSUING INSTRUMENT; [0164] U.S. patent application Ser. No.
15/940,649, titled DATA PAIRING TO INTERCONNECT A DEVICE MEASURED
PARAMETER WITH AN OUTCOME; [0165] U.S. patent application Ser. No.
15/940,654, titled SURGICAL HUB SITUATIONAL AWARENESS; [0166] U.S.
patent application Ser. No. 15/940,663, titled SURGICAL SYSTEM
DISTRIBUTED PROCESSING; [0167] U.S. patent application Ser. No.
15/940,668, titled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;
[0168] U.S. patent application Ser. No. 15/940,671, titled SURGICAL
HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;
[0169] U.S. patent application Ser. No. 15/940,686, titled DISPLAY
OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;
[0170] U.S. patent application Ser. No. 15/940,700, titled STERILE
FIELD INTERACTIVE CONTROL DISPLAYS; [0171] U.S. patent application
Ser. No. 15/940,629, titled COMPUTER IMPLEMENTED INTERACTIVE
SURGICAL SYSTEMS; [0172] 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; [0173] U.S. patent
application Ser. No. 15/940,722, titled CHARACTERIZATION OF TISSUE
IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT
REFRACTIVITY; [0174] U.S. patent application Ser. No. 15/940,742,
titled DUAL CMOS ARRAY IMAGING; [0175] U.S. patent application Ser.
No. 15/940,636, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR
SURGICAL DEVICES; [0176] U.S. patent application Ser. No.
15/940,653, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL
HUBS; [0177] U.S. patent application Ser. No. 15/940,660, titled
CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS
TO A USER; [0178] 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;
[0179] U.S. patent application Ser. No. 15/940,694, titled
CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED
INDIVIDUALIZATION OF INSTRUMENT FUNCTION; [0180] U.S. patent
application Ser. No. 15/940,634, titled CLOUD-BASED MEDICAL
ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE
MEASURES; [0181] U.S. patent application Ser. No. 15/940,706,
titled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS
NETWORK; [0182] U.S. patent application Ser. No. 15/940,675, titled
CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES; [0183] U.S. patent
application Ser. No. 15/940,627, titled DRIVE ARRANGEMENTS FOR
ROBOT-ASSISTED SURGICAL PLATFORMS; [0184] U.S. patent application
Ser. No. 15/940,637, titled COMMUNICATION ARRANGEMENTS FOR
ROBOT-ASSISTED SURGICAL PLATFORMS; [0185] U.S. patent application
Ser. No. 15/940,642, titled CONTROLS FOR ROBOT-ASSISTED SURGICAL
PLATFORMS; [0186] U.S. patent application Ser. No. 15/940,676,
titled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL
PLATFORMS; [0187] U.S. patent application Ser. No. 15/940,680,
titled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; [0188]
U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE
SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; [0189] U.S.
patent application Ser. No. 15/940,690, titled DISPLAY ARRANGEMENTS
FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and [0190] U.S. patent
application Ser. No. 15/940,711, titled SENSING ARRANGEMENTS FOR
ROBOT-ASSISTED SURGICAL PLATFORMS.
[0191] 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: [0192] U.S. Provisional Patent Application Ser. No.
62/649,302, titled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED
COMMUNICATION CAPABILITIES; [0193] U.S. Provisional Patent
Application Ser. No. 62/649,294, titled DATA STRIPPING METHOD TO
INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD; [0194]
U.S. Provisional Patent Application Ser. No. 62/649,300, titled
SURGICAL HUB SITUATIONAL AWARENESS; [0195] U.S. Provisional Patent
Application Ser. No. 62/649,309, titled SURGICAL HUB SPATIAL
AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER; [0196] U.S.
Provisional Patent Application Ser. No. 62/649,310, titled COMPUTER
IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS; [0197] 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; [0198] U.S. Provisional Patent Application Ser.
No. 62/649,296, titled ADAPTIVE CONTROL PROGRAM UPDATES FOR
SURGICAL DEVICES; [0199] U.S. Provisional Patent Application Ser.
No. 62/649,333, titled CLOUD-BASED MEDICAL ANALYTICS FOR
CUSTOMIZATION AND RECOMMENDATIONS TO A USER; [0200] U.S.
Provisional Patent Application Ser. No. 62/649,327, titled
CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION
TRENDS AND REACTIVE MEASURES; [0201] U.S. Provisional Patent
Application Ser. No. 62/649,315, titled DATA HANDLING AND
PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; [0202] U.S.
Provisional Patent Application Ser. No. 62/649,313, titled CLOUD
INTERFACE FOR COUPLED SURGICAL DEVICES; [0203] U.S. Provisional
Patent Application Ser. No. 62/649,320, titled DRIVE ARRANGEMENTS
FOR ROBOT-ASSISTED SURGICAL PLATFORMS; [0204] U.S. Provisional
Patent Application Ser. No. 62/649,307, titled AUTOMATIC TOOL
ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and [0205] U.S.
Provisional Patent Application Ser. No. 62/649,323, titled SENSING
ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0206] Applicant of the present application owns the following U.S.
Provisional patent applications, filed on Mar. 8, 2018, the
disclosure of each of which is herein incorporated by reference in
its entirety: [0207] U.S. Provisional Patent Application Ser. No.
62/640,417, titled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND
CONTROL SYSTEM THEREFOR; and [0208] U.S. Provisional Patent
Application Ser. No. 62/640,415, titled ESTIMATING STATE OF
ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.
[0209] Applicant of the present application owns the following U.S.
Provisional patent applications, filed on Dec. 28, 2017, the
disclosure of each of which is herein incorporated by reference in
its entirety: [0210] U.S. Provisional Provisional Patent
Application Ser. No. 62/611,341, titled INTERACTIVE SURGICAL
PLATFORM; [0211] U.S. Provisional Patent Application Ser. No.
62/611,340, titled CLOUD-BASED MEDICAL ANALYTICS; and [0212] U.S.
Provisional Patent Application Ser. No. 62/611,339, titled ROBOT
ASSISTED SURGICAL PLATFORM.
[0213] Before explaining various aspects of surgical devices and
generators in detail, it should be noted that the illustrative
examples are not limited in application or use to the details of
construction and arrangement of parts illustrated in the
accompanying drawings and description. The illustrative examples
may be implemented or incorporated in other aspects, variations and
modifications, and may be practiced or carried out in various ways.
Further, unless otherwise indicated, the terms and expressions
employed herein have been chosen for the purpose of describing the
illustrative examples for the convenience of the reader and are not
for the purpose of limitation thereof. Also, it will be appreciated
that one or more of the following-described aspects, expressions of
aspects, and/or examples, can be combined with any one or more of
the other following-described aspects, expressions of aspects
and/or examples.
Surgical Hubs
[0214] 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 the 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.
[0215] In various aspects, the intelligent instruments 112 as
described herein with reference to FIGS. 1-7 may be implemented as
a circular powered stapling device 201800 (FIGS. 24-30), 201502
(FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40). The
intelligent instruments 112 (e.g., devices 1a-1.sub.n) such as the
circular powered stapling device 201800 (FIGS. 24-30), 201502
(FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) are
configured to operate in a surgical data network 201 as described
with reference to FIG. 8.
[0216] FIG. 2 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.
[0217] 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.
[0218] 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.
[0219] 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.
[0220] 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.
[0221] 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.
[0222] 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.
[0223] 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.
[0224] 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.
[0225] 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.
[0226] 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.
[0227] 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 the 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, the
hub 106 may cause the visualization system 108 to display a
snapshot 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 snapshot 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.
[0228] In one aspect, the 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 snapshot displayed on the non-sterile display
107 or 109, which can be routed to the primary display 119 by the
hub 106.
[0229] Referring to FIG. 2, a surgical instrument 112 is being used
in the surgical procedure as part of the surgical system 102. The
hub 106 is also configured to coordinate information flow to a
display of the surgical instrument 112. For example, coordinate
information flow is further described 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. A diagnostic input or
feedback entered by a non-sterile operator at the visualization
tower 111 can be routed by the 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" 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.
[0230] Referring now to FIG. 3, a hub 106 is depicted in
communication with a visualization system 108, a robotic system
110, and a handheld intelligent surgical instrument 112. The hub
106 includes a 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,
the hub 106 further includes a smoke evacuation module 126 and/or a
suction/irrigation module 128.
[0231] 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. The
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.
[0232] 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 hub
enclosure and a combo generator module slidably receivable in a
docking station of the 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.
[0233] 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 the hub
enclosure. In one aspect, the hub enclosure comprises a fluid
interface.
[0234] 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 hub
modular enclosure 136 is configured to accommodate different
generators, and facilitate an interactive communication
therebetween. One of the advantages of the hub modular enclosure
136 is enabling the quick removal and/or replacement of various
modules.
[0235] 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,
[0236] 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.
[0237] 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.
[0238] Referring to FIGS. 3-7, aspects of the present disclosure
are presented for a 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. The 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 the 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 the hub modular enclosure
136. The hub modular enclosure 136 can be configured to facilitate
the insertion of multiple generators and interactive communication
between the generators docked into the hub modular enclosure 136 so
that the generators would act as a single generator.
[0239] In one aspect, the 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.
[0240] In one aspect, the 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 the hub modular enclosure 136
as the combo generator module 145 is slid into position within the
corresponding docking station 151 of the 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.
[0241] 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 the hub enclosure 136.
[0242] 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.
[0243] 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.
[0244] 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 the 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.
[0245] In one aspect, the modules 140, 126, 128 and/or their
corresponding docking stations on the 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 the 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 the 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 the hub
modular enclosure 136.
[0246] In some aspects, the drawers 151 of the 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.
[0247] 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.
[0248] 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 the hub modular
enclosure 136. The docking ports 150 of the hub modular enclosure
136 may alternatively, or additionally, facilitate a wireless
interactive communication between the modules housed in the hub
modular enclosure 136. Any suitable wireless communication can be
employed, such as for example Air Titan-Bluetooth.
[0249] 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.
[0250] 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.
[0251] 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.
[0252] 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.
[0253] 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.
[0254] 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.
[0255] 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 INTRACORPOREAL 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, each of which is
herein incorporated by reference in its entirety.
[0256] 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.
[0257] 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.
[0258] 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.
[0259] 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. The
hub hardware enables multiple devices or connections to be
connected to a computer that communicates with the cloud computing
resources and storage.
[0260] 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.
[0261] 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.
[0262] 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.
[0263] 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.
[0264] 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.
[0265] 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
Wi-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.
[0266] 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.
[0267] 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.
[0268] 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 evacuator 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 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. The hub display also may display
data received from devices connected to the modular control tower
in conjunction with images and overlaid images.
[0269] 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.
[0270] 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.
[0271] 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.
[0272] 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.
[0273] In one aspect, the processor 244 may comprise a safety
controller comprising two controller-based families such as TMS570
and RM4x, 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.
[0274] 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).
[0275] 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.
[0276] 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.
[0277] 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.
[0278] 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).
[0279] 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.
[0280] 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.
[0281] In various aspects, the devices/instruments 235 described
with reference to FIGS. 9-10, may be implemented as a circular
powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33),
201532 (FIGS. 34-35), 201610 (FIGS. 36-40). Accordingly, the
circular powered stapling device 201800 (FIGS. 24-30), 201502
(FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) is
configured to interface with the modular control tower 236 ant the
surgical hub 206. Once connected to the surgical hub 206 the
circular powered stapling device 201800 (FIGS. 24-30), 201502
(FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) is
configured to interface with the cloud 204, the server 213, other
hub connected instruments, the hub display 215, or the
visualization system 209, or combinations thereof. Further, once
connected to hub 206, the circular powered stapling device 201800
(FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610
(FIGS. 36-40) may utilize the processing circuits available in the
hub local computer system 210.
[0282] FIG. 11 illustrates a functional block diagram of one aspect
of a USB network hub 300 device, in accordance with at least 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.
[0283] 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 hub power logic 312
to manage power.
[0284] 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 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.
[0285] 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.
[0286] Additional details regarding the structure and function of
the surgical hub and/or surgical hub networks can be found in U.S.
Provisional Patent Application No. 62/659,900, titled METHOD OF HUB
COMMUNICATION, filed Apr. 19, 2018, which is hereby incorporated by
reference herein in its entirety.
Cloud System Hardware and Functional Modules
[0287] FIG. 12 is a block diagram of the computer-implemented
interactive surgical system, in accordance with at least one aspect
of the present disclosure. In one aspect, the computer-implemented
interactive surgical system is configured to monitor and analyze
data related to the operation of various surgical systems that
include surgical hubs, surgical instruments, robotic devices and
operating theaters or healthcare facilities. The
computer-implemented interactive surgical system comprises a
cloud-based analytics system. Although the cloud-based analytics
system is described as a surgical system, it is not necessarily
limited as such and could be a cloud-based medical system
generally. As illustrated in FIG. 12, the cloud-based analytics
system comprises a plurality of surgical instruments 7012 (may be
the same or similar to instruments 112), a plurality of surgical
hubs 7006 (may be the same or similar to hubs 106), and a surgical
data network 7001 (may be the same or similar to network 201) to
couple the surgical hubs 7006 to the cloud 7004 (may be the same or
similar to cloud 204). Each of the plurality of surgical hubs 7006
is communicatively coupled to one or more surgical instruments
7012. The hubs 7006 are also communicatively coupled to the cloud
7004 of the computer-implemented interactive surgical system via
the network 7001. The cloud 7004 is a remote centralized source of
hardware and software for storing, manipulating, and communicating
data generated based on the operation of various surgical systems.
As shown in FIG. 12, access to the cloud 7004 is achieved via the
network 7001, which may be the Internet or some other suitable
computer network. Surgical hubs 7006 that are coupled to the cloud
7004 can be considered the client side of the cloud computing
system (i.e., cloud-based analytics system). Surgical instruments
7012 are paired with the surgical hubs 7006 for control and
implementation of various surgical procedures or operations as
described herein.
[0288] In addition, surgical instruments 7012 may comprise
transceivers for data transmission to and from their corresponding
surgical hubs 7006 (which may also comprise transceivers).
Combinations of surgical instruments 7012 and corresponding hubs
7006 may indicate particular locations, such as operating theaters
in healthcare facilities (e.g., hospitals), for providing medical
operations. For example, the memory of a surgical hub 7006 may
store location data. As shown in FIG. 12, the cloud 7004 comprises
central servers 7013 (which may be same or similar to remote server
113 in FIG. 1 and/or remote server 213 in FIG. 9), hub application
servers 7002, data analytics modules 7034, and an input/output
("I/O") interface 7007. The central servers 7013 of the cloud 7004
collectively administer the cloud computing system, which includes
monitoring requests by client surgical hubs 7006 and managing the
processing capacity of the cloud 7004 for executing the requests.
Each of the central servers 7013 comprises one or more processors
7008 coupled to suitable memory devices 7010 which can include
volatile memory such as random-access memory (RAM) and non-volatile
memory such as magnetic storage devices. The memory devices 7010
may comprise machine executable instructions that when executed
cause the processors 7008 to execute the data analytics modules
7034 for the cloud-based data analysis, operations, recommendations
and other operations described below. Moreover, the processors 7008
can execute the data analytics modules 7034 independently or in
conjunction with hub applications independently executed by the
hubs 7006. The central servers 7013 also comprise aggregated
medical data databases 2212, which can reside in the memory
2210.
[0289] Based on connections to various surgical hubs 7006 via the
network 7001, the cloud 7004 can aggregate data from specific data
generated by various surgical instruments 7012 and their
corresponding hubs 7006. Such aggregated data may be stored within
the aggregated medical databases 7011 of the cloud 7004. In
particular, the cloud 7004 may advantageously perform data analysis
and operations on the aggregated data to yield insights and/or
perform functions that individual hubs 7006 could not achieve on
their own. To this end, as shown in FIG. 12, the cloud 7004 and the
surgical hubs 7006 are communicatively coupled to transmit and
receive information. The I/O interface 7007 is connected to the
plurality of surgical hubs 7006 via the network 7001. In this way,
the I/O interface 7007 can be configured to transfer information
between the surgical hubs 7006 and the aggregated medical data
databases 7012. Accordingly, the I/O interface 7007 may facilitate
read/write operations of the cloud-based analytics system. Such
read/write operations may be executed in response to requests from
hubs 7006. These requests could be transmitted to the hubs 7006
through the hub applications. The I/O interface 7007 may include
one or more high speed data ports, which may include universal
serial bus (USB) ports, IEEE 1394 ports, as well as Wi-Fi and
Bluetooth I/O interfaces for connecting the cloud 7004 to hubs
7006. The hub application servers 7002 of the cloud 7004 are
configured to host and supply shared capabilities to software
applications (e.g. hub applications) executed by surgical hubs
7006. For example, the hub application servers 7002 may manage
requests made by the hub applications through the hubs 7006,
control access to the aggregated medical data databases 7011, and
perform load balancing. The data analytics modules 7034 are
described in further detail with reference to FIG. 13.
[0290] The particular cloud computing system configuration
described in the present disclosure is specifically designed to
address various issues arising in the context of medical operations
and procedures performed using medical devices, such as the
surgical instruments 7012, 112. In particular, the surgical
instruments 7012 may be digital surgical devices configured to
interact with the cloud 7004 for implementing techniques to improve
the performance of surgical operations. Various surgical
instruments 7012 and/or surgical hubs 7006 may comprise touch
controlled user interfaces such that clinicians may control aspects
of interaction between the surgical instruments 7012 and the cloud
7004. Other suitable user interfaces for control such as auditory
controlled user interfaces can also be used.
[0291] FIG. 13 is a block diagram which illustrates the functional
architecture of the computer-implemented interactive surgical
system, in accordance with at least one aspect of the present
disclosure. The cloud-based analytics system includes a plurality
of data analytics modules 7034 that may be executed by the
processors 7008 of the cloud 7004 for providing data analytic
solutions to problems specifically arising in the medical field. As
shown in FIG. 13, the functions of the cloud-based data analytics
modules 7034 may be assisted via hub applications 7014 hosted by
the hub application servers 7002 that may be accessed on surgical
hubs 7006. The cloud processors 7008 and hub applications 7014 may
operate in conjunction to execute the data analytics modules 7034.
Application program interfaces (APIs) 7016 define the set of
protocols and routines corresponding to the hub applications 7014.
Additionally, the APIs 7016 manage the storing and retrieval of
data into and from the aggregated medical data databases 7011 for
the operations of the applications 7014. The caches 7018 also store
data (e.g., temporarily) and are coupled to the APIs 7016 for more
efficient retrieval of data used by the applications 7014. The data
analytics modules 7034 in FIG. 13 include modules for resource
optimization 7020, data collection and aggregation 7022,
authorization and security 7024, control program updating 7026,
patient outcome analysis 7028, recommendations 7030, and data
sorting and prioritization 7032. Other suitable data analytics
modules could also be implemented by the cloud 7004, according to
some aspects. In one aspect, the data analytics modules are used
for specific recommendations based on analyzing trends, outcomes,
and other data.
[0292] For example, the data collection and aggregation module 7022
could be used to generate self-describing data (e.g., metadata)
including identification of notable features or configuration
(e.g., trends), management of redundant data sets, and storage of
the data in paired data sets which can be grouped by surgery but
not necessarily keyed to actual surgical dates and surgeons. In
particular, pair data sets generated from operations of surgical
instruments 7012 can comprise applying a binary classification,
e.g., a bleeding or a non-bleeding event. More generally, the
binary classification may be characterized as either a desirable
event (e.g., a successful surgical procedure) or an undesirable
event (e.g., a misfired or misused surgical instrument 7012). The
aggregated self-describing data may correspond to individual data
received from various groups or subgroups of surgical hubs 7006.
Accordingly, the data collection and aggregation module 7022 can
generate aggregated metadata or other organized data based on raw
data received from the surgical hubs 7006. To this end, the
processors 7008 can be operationally coupled to the hub
applications 7014 and aggregated medical data databases 7011 for
executing the data analytics modules 7034. The data collection and
aggregation module 7022 may store the aggregated organized data
into the aggregated medical data databases 2212.
[0293] The resource optimization module 7020 can be configured to
analyze this aggregated data to determine an optimal usage of
resources for a particular or group of healthcare facilities. For
example, the resource optimization module 7020 may determine an
optimal order point of surgical stapling instruments 7012 for a
group of healthcare facilities based on corresponding predicted
demand of such instruments 7012. The resource optimization module
7020 might also assess the resource usage or other operational
configurations of various healthcare facilities to determine
whether resource usage could be improved. Similarly, the
recommendations module 7030 can be configured to analyze aggregated
organized data from the data collection and aggregation module 7022
to provide recommendations. For example, the recommendations module
7030 could recommend to healthcare facilities (e.g., medical
service providers such as hospitals) that a particular surgical
instrument 7012 should be upgraded to an improved version based on
a higher than expected error rate, for example. Additionally, the
recommendations module 7030 and/or resource optimization module
7020 could recommend better supply chain parameters such as product
reorder points and provide suggestions of different surgical
instrument 7012, uses thereof, or procedure steps to improve
surgical outcomes. The healthcare facilities can receive such
recommendations via corresponding surgical hubs 7006. More specific
recommendations regarding parameters or configurations of various
surgical instruments 7012 can also be provided. Hubs 7006 and/or
surgical instruments 7012 each could also have display screens that
display data or recommendations provided by the cloud 7004.
[0294] The patient outcome analysis module 7028 can analyze
surgical outcomes associated with currently used operational
parameters of surgical instruments 7012. The patient outcome
analysis module 7028 may also analyze and assess other potential
operational parameters. In this connection, the recommendations
module 7030 could recommend using these other potential operational
parameters based on yielding better surgical outcomes, such as
better sealing or less bleeding. For example, the recommendations
module 7030 could transmit recommendations to a surgical hub 7006
regarding when to use a particular cartridge for a corresponding
stapling surgical instrument 7012. Thus, the cloud-based analytics
system, while controlling for common variables, may be configured
to analyze the large collection of raw data and to provide
centralized recommendations over multiple healthcare facilities
(advantageously determined based on aggregated data). For example,
the cloud-based analytics system could analyze, evaluate, and/or
aggregate data based on type of medical practice, type of patient,
number of patients, geographic similarity between medical
providers, which medical providers/facilities use similar types of
instruments, etc., in a way that no single healthcare facility
alone would be able to analyze independently.
[0295] The control program updating module 7026 could be configured
to implement various surgical instrument 7012 recommendations when
corresponding control programs are updated. For example, the
patient outcome analysis module 7028 could identify correlations
linking specific control parameters with successful (or
unsuccessful) results. Such correlations may be addressed when
updated control programs are transmitted to surgical instruments
7012 via the control program updating module 7026. Updates to
instruments 7012 that are transmitted via a corresponding hub 7006
may incorporate aggregated performance data that was gathered and
analyzed by the data collection and aggregation module 7022 of the
cloud 7004. Additionally, the patient outcome analysis module 7028
and recommendations module 7030 could identify improved methods of
using instruments 7012 based on aggregated performance data.
[0296] The cloud-based analytics system may include security
features implemented by the cloud 7004. These security features may
be managed by the authorization and security module 7024. Each
surgical hub 7006 can have associated unique credentials such as
username, password, and other suitable security credentials. These
credentials could be stored in the memory 7010 and be associated
with a permitted cloud access level. For example, based on
providing accurate credentials, a surgical hub 7006 may be granted
access to communicate with the cloud to a predetermined extent
(e.g., may only engage in transmitting or receiving certain defined
types of information). To this end, the aggregated medical data
databases 7011 of the cloud 7004 may comprise a database of
authorized credentials for verifying the accuracy of provided
credentials. Different credentials may be associated with varying
levels of permission for interaction with the cloud 7004, such as a
predetermined access level for receiving the data analytics
generated by the cloud 7004.
[0297] Furthermore, for security purposes, the cloud could maintain
a database of hubs 7006, instruments 7012, and other devices that
may comprise a "black list" of prohibited devices. In particular, a
surgical hub 7006 listed on the black list may not be permitted to
interact with the cloud, while surgical instruments 7012 listed on
the black list may not have functional access to a corresponding
hub 7006 and/or may be prevented from fully functioning when paired
to its corresponding hub 7006. Additionally or alternatively, the
cloud 7004 may flag instruments 7012 based on incompatibility or
other specified criteria. In this manner, counterfeit medical
devices and improper reuse of such devices throughout the
cloud-based analytics system can be identified and addressed.
[0298] The surgical instruments 7012 may use wireless transceivers
to transmit wireless signals that may represent, for example,
authorization credentials for access to corresponding hubs 7006 and
the cloud 7004. Wired transceivers may also be used to transmit
signals. Such authorization credentials can be stored in the
respective memory devices of the surgical instruments 7012. The
authorization and security module 7024 can determine whether the
authorization credentials are accurate or counterfeit. The
authorization and security module 7024 may also dynamically
generate authorization credentials for enhanced security. The
credentials could also be encrypted, such as by using hash based
encryption. Upon transmitting proper authorization, the surgical
instruments 7012 may transmit a signal to the corresponding hubs
7006 and ultimately the cloud 7004 to indicate that the instruments
7012 are ready to obtain and transmit medical data. In response,
the cloud 7004 may transition into a state enabled for receiving
medical data for storage into the aggregated medical data databases
7011. This data transmission readiness could be indicated by a
light indicator on the instruments 7012, for example. The cloud
7004 can also transmit signals to surgical instruments 7012 for
updating their associated control programs. The cloud 7004 can
transmit signals that are directed to a particular class of
surgical instruments 7012 (e.g., electrosurgical instruments) so
that software updates to control programs are only transmitted to
the appropriate surgical instruments 7012. Moreover, the cloud 7004
could be used to implement system wide solutions to address local
or global problems based on selective data transmission and
authorization credentials. For example, if a group of surgical
instruments 7012 are identified as having a common manufacturing
defect, the cloud 7004 may change the authorization credentials
corresponding to this group to implement an operational lockout of
the group.
[0299] The cloud-based analytics system may allow for monitoring
multiple healthcare facilities (e.g., medical facilities like
hospitals) to determine improved practices and recommend changes
(via the recommendations module 2030, for example) accordingly.
Thus, the processors 7008 of the cloud 7004 can analyze data
associated with an individual healthcare facility to identify the
facility and aggregate the data with other data associated with
other healthcare facilities in a group. Groups could be defined
based on similar operating practices or geographical location, for
example. In this way, the cloud 7004 may provide healthcare
facility group wide analysis and recommendations. The cloud-based
analytics system could also be used for enhanced situational
awareness. For example, the processors 7008 may predictively model
the effects of recommendations on the cost and effectiveness for a
particular facility (relative to overall operations and/or various
medical procedures). The cost and effectiveness associated with
that particular facility can also be compared to a corresponding
local zone of other facilities or any other comparable
facilities.
[0300] The data sorting and prioritization module 7032 may
prioritize and sort data based on criticality (e.g., the severity
of a medical event associated with the data, unexpectedness,
suspiciousness). This sorting and prioritization may be used in
conjunction with the functions of the other data analytics modules
7034 described above to improve the cloud-based analytics and
operations described herein. For example, the data sorting and
prioritization module 7032 can assign a priority to the data
analysis performed by the data collection and aggregation module
7022 and patient outcome analysis modules 7028. Different
prioritization levels can result in particular responses from the
cloud 7004 (corresponding to a level of urgency) such as escalation
for an expedited response, special processing, exclusion from the
aggregated medical data databases 7011, or other suitable
responses. Moreover, if necessary, the cloud 7004 can transmit a
request (e.g. a push message) through the hub application servers
for additional data from corresponding surgical instruments 7012.
The push message can result in a notification displayed on the
corresponding hubs 7006 for requesting supporting or additional
data. This push message may be required in situations in which the
cloud detects a significant irregularity or outlier and the cloud
cannot determine the cause of the irregularity. The central servers
7013 may be programmed to trigger this push message in certain
significant circumstances, such as when data is determined to be
different from an expected value beyond a predetermined threshold
or when it appears security has been compromised, for example.
[0301] In various aspects, the surgical instrument(s) 7012
described above with reference to FIGS. 12 and 13, may be
implemented as a circular powered stapling device 201800 (FIGS.
24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS.
36-40). Accordingly, the circular powered stapling device 201800
(FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610
(FIGS. 36-40) is configured to interface with the surgical hub 7006
and the network 2001, which is configured to interface with cloud
7004. Accordingly, the processing power provided by the central
servers 7013 and the data analytics module 7034 are configured to
process information (e.g., data and control) from the circular
powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33),
201532 (FIGS. 34-35), 201610 (FIGS. 36-40). Additional details
regarding the cloud analysis system can be found in U.S.
Provisional Patent Application No. 62/659,900, titled METHOD OF HUB
COMMUNICATION, filed Apr. 19, 2018, which is hereby incorporated by
reference herein in its entirety.
Situational Awareness
[0302] Although an "intelligent" device including control
algorithms that respond to sensed data can be an improvement over a
"dumb" device that operates without accounting for sensed data,
some sensed data can be incomplete or inconclusive when considered
in isolation, i.e., without the context of the type of surgical
procedure being performed or the type of tissue that is being
operated on. Without knowing the procedural context (e.g., knowing
the type of tissue being operated on or the type of procedure being
performed), the control algorithm may control the modular device
incorrectly or suboptimally given the particular context-free
sensed data. For example, the optimal manner for a control
algorithm to control a surgical instrument in response to a
particular sensed parameter can vary according to the particular
tissue type being operated on. This is due to the fact that
different tissue types have different properties (e.g., resistance
to tearing) and thus respond differently to actions taken by
surgical instruments. Therefore, it may be desirable for a surgical
instrument to take different actions even when the same measurement
for a particular parameter is sensed. As one specific example, the
optimal manner in which to control a surgical stapling and cutting
instrument in response to the instrument sensing an unexpectedly
high force to close its end effector will vary depending upon
whether the tissue type is susceptible or resistant to tearing. For
tissues that are susceptible to tearing, such as lung tissue, the
instrument's control algorithm would optimally ramp down the motor
in response to an unexpectedly high force to close to avoid tearing
the tissue. For tissues that are resistant to tearing, such as
stomach tissue, the instrument's control algorithm would optimally
ramp up the motor in response to an unexpectedly high force to
close to ensure that the end effector is clamped properly on the
tissue. Without knowing whether lung or stomach tissue has been
clamped, the control algorithm may make a suboptimal decision.
[0303] One solution utilizes a surgical hub including a system that
is configured to derive information about the surgical procedure
being performed based on data received from various data sources
and then control the paired modular devices accordingly. In other
words, the surgical hub is configured to infer information about
the surgical procedure from received data and then control the
modular devices paired to the surgical hub based upon the inferred
context of the surgical procedure. FIG. 14 illustrates a diagram of
a situationally aware surgical system 5100, in accordance with at
least one aspect of the present disclosure. In some
exemplifications, the data sources 5126 include, for example, the
modular devices 5102 (which can include sensors configured to
detect parameters associated with the patient and/or the modular
device itself), databases 5122 (e.g., an EMR database containing
patient records), and patient monitoring devices 5124 (e.g., a
blood pressure (BP) monitor and an electrocardiography (EKG)
monitor).
[0304] A surgical hub 5104, which may be similar to the hub 106 in
many respects, can be configured to derive the contextual
information pertaining to the surgical procedure from the data
based upon, for example, the particular combination(s) of received
data or the particular order in which the data is received from the
data sources 5126. The contextual information inferred from the
received data can include, for example, the type of surgical
procedure being performed, the particular step of the surgical
procedure that the surgeon is performing, the type of tissue being
operated on, or the body cavity that is the subject of the
procedure. This ability by some aspects of the surgical hub 5104 to
derive or infer information related to the surgical procedure from
received data can be referred to as "situational awareness." In one
exemplification, the surgical hub 5104 can incorporate a
situational awareness system, which is the hardware and/or
programming associated with the surgical hub 5104 that derives
contextual information pertaining to the surgical procedure from
the received data.
[0305] The situational awareness system of the surgical hub 5104
can be configured to derive the contextual information from the
data received from the data sources 5126 in a variety of different
ways. In one exemplification, the situational awareness system
includes a pattern recognition system, or machine learning system
(e.g., an artificial neural network), that has been trained on
training data to correlate various inputs (e.g., data from
databases 5122, patient monitoring devices 5124, and/or modular
devices 5102) to corresponding contextual information regarding a
surgical procedure. In other words, a machine learning system can
be trained to accurately derive contextual information regarding a
surgical procedure from the provided inputs. In another
exemplification, the situational awareness system can include a
lookup table storing pre-characterized contextual information
regarding a surgical procedure in association with one or more
inputs (or ranges of inputs) corresponding to the contextual
information. In response to a query with one or more inputs, the
lookup table can return the corresponding contextual information
for the situational awareness system for controlling the modular
devices 5102. In one exemplification, the contextual information
received by the situational awareness system of the surgical hub
5104 is associated with a particular control adjustment or set of
control adjustments for one or more modular devices 5102. In
another exemplification, the situational awareness system includes
a further machine learning system, lookup table, or other such
system, which generates or retrieves one or more control
adjustments for one or more modular devices 5102 when provided the
contextual information as input.
[0306] A surgical hub 5104 incorporating a situational awareness
system provides a number of benefits for the surgical system 5100.
One benefit includes improving the interpretation of sensed and
collected data, which would in turn improve the processing accuracy
and/or the usage of the data during the course of a surgical
procedure. To return to a previous example, a situationally aware
surgical hub 5104 could determine what type of tissue was being
operated on; therefore, when an unexpectedly high force to close
the surgical instrument's end effector is detected, the
situationally aware surgical hub 5104 could correctly ramp up or
ramp down the motor of the surgical instrument for the type of
tissue.
[0307] As another example, the type of tissue being operated can
affect the adjustments that are made to the compression rate and
load thresholds of a surgical stapling and cutting instrument for a
particular tissue gap measurement. A situationally aware surgical
hub 5104 could infer whether a surgical procedure being performed
is a thoracic or an abdominal procedure, allowing the surgical hub
5104 to determine whether the tissue clamped by an end effector of
the surgical stapling and cutting instrument is lung (for a
thoracic procedure) or stomach (for an abdominal procedure) tissue.
The surgical hub 5104 could then adjust the compression rate and
load thresholds of the surgical stapling and cutting instrument
appropriately for the type of tissue.
[0308] As yet another example, the type of body cavity being
operated in during an insufflation procedure can affect the
function of a smoke evacuator. A situationally aware surgical hub
5104 could determine whether the surgical site is under pressure
(by determining that the surgical procedure is utilizing
insufflation) and determine the procedure type. As a procedure type
is generally performed in a specific body cavity, the surgical hub
5104 could then control the motor rate of the smoke evacuator
appropriately for the body cavity being operated in. Thus, a
situationally aware surgical hub 5104 could provide a consistent
amount of smoke evacuation for both thoracic and abdominal
procedures.
[0309] As yet another example, the type of procedure being
performed can affect the optimal energy level for an ultrasonic
surgical instrument or radio frequency (RF) electrosurgical
instrument to operate at. Arthroscopic procedures, for example,
require higher energy levels because the end effector of the
ultrasonic surgical instrument or RF electrosurgical instrument is
immersed in fluid. A situationally aware surgical hub 5104 could
determine whether the surgical procedure is an arthroscopic
procedure. The surgical hub 5104 could then adjust the RF power
level or the ultrasonic amplitude of the generator (i.e., "energy
level") to compensate for the fluid filled environment. Relatedly,
the type of tissue being operated on can affect the optimal energy
level for an ultrasonic surgical instrument or RF electrosurgical
instrument to operate at. A situationally aware surgical hub 5104
could determine what type of surgical procedure is being performed
and then customize the energy level for the ultrasonic surgical
instrument or RF electrosurgical instrument, respectively,
according to the expected tissue profile for the surgical
procedure. Furthermore, a situationally aware surgical hub 5104 can
be configured to adjust the energy level for the ultrasonic
surgical instrument or RF electrosurgical instrument throughout the
course of a surgical procedure, rather than just on a
procedure-by-procedure basis. A situationally aware surgical hub
5104 could determine what step of the surgical procedure is being
performed or will subsequently be performed and then update the
control algorithms for the generator and/or ultrasonic surgical
instrument or RF electrosurgical instrument to set the energy level
at a value appropriate for the expected tissue type according to
the surgical procedure step.
[0310] As yet another example, data can be drawn from additional
data sources 5126 to improve the conclusions that the surgical hub
5104 draws from one data source 5126. A situationally aware
surgical hub 5104 could augment data that it receives from the
modular devices 5102 with contextual information that it has built
up regarding the surgical procedure from other data sources 5126.
For example, a situationally aware surgical hub 5104 can be
configured to determine whether hemostasis has occurred (i.e.,
whether bleeding at a surgical site has stopped) according to video
or image data received from a medical imaging device. However, in
some cases the video or image data can be inconclusive. Therefore,
in one exemplification, the surgical hub 5104 can be further
configured to compare a physiologic measurement (e.g., blood
pressure sensed by a BP monitor communicably connected to the
surgical hub 5104) with the visual or image data of hemostasis
(e.g., from a medical imaging device 124 (FIG. 2) communicably
coupled to the surgical hub 5104) to make a determination on the
integrity of the staple line or tissue weld. In other words, the
situational awareness system of the surgical hub 5104 can consider
the physiological measurement data to provide additional context in
analyzing the visualization data. The additional context can be
useful when the visualization data may be inconclusive or
incomplete on its own.
[0311] Another benefit includes proactively and automatically
controlling the paired modular devices 5102 according to the
particular step of the surgical procedure that is being performed
to reduce the number of times that medical personnel are required
to interact with or control the surgical system 5100 during the
course of a surgical procedure. For example, a situationally aware
surgical hub 5104 could proactively activate the generator to which
an RF electrosurgical instrument is connected if it determines that
a subsequent step of the procedure requires the use of the
instrument. Proactively activating the energy source allows the
instrument to be ready for use a soon as the preceding step of the
procedure is completed.
[0312] As another example, a situationally aware surgical hub 5104
could determine whether the current or subsequent step of the
surgical procedure requires a different view or degree of
magnification on the display according to the feature(s) at the
surgical site that the surgeon is expected to need to view. The
surgical hub 5104 could then proactively change the displayed view
(supplied by, e.g., a medical imaging device for the visualization
system 108) accordingly so that the display automatically adjusts
throughout the surgical procedure.
[0313] As yet another example, a situationally aware surgical hub
5104 could determine which step of the surgical procedure is being
performed or will subsequently be performed and whether particular
data or comparisons between data will be required for that step of
the surgical procedure. The surgical hub 5104 can be configured to
automatically call up data screens based upon the step of the
surgical procedure being performed, without waiting for the surgeon
to ask for the particular information.
[0314] Another benefit includes checking for errors during the
setup of the surgical procedure or during the course of the
surgical procedure. For example, a situationally aware surgical hub
5104 could determine whether the operating theater is setup
properly or optimally for the surgical procedure to be performed.
The surgical hub 5104 can be configured to determine the type of
surgical procedure being performed, retrieve the corresponding
checklists, product location, or setup needs (e.g., from a memory),
and then compare the current operating theater layout to the
standard layout for the type of surgical procedure that the
surgical hub 5104 determines is being performed. In one
exemplification, the surgical hub 5104 can be configured to compare
the list of items for the procedure scanned by a suitable scanner
for example and/or a list of devices paired with the surgical hub
5104 to a recommended or anticipated manifest of items and/or
devices for the given surgical procedure. If there are any
discontinuities between the lists, the surgical hub 5104 can be
configured to provide an alert indicating that a particular modular
device 5102, patient monitoring device 5124, and/or other surgical
item is missing. In one exemplification, the surgical hub 5104 can
be configured to determine the relative distance or position of the
modular devices 5102 and patient monitoring devices 5124 via
proximity sensors, for example. The surgical hub 5104 can compare
the relative positions of the devices to a recommended or
anticipated layout for the particular surgical procedure. If there
are any discontinuities between the layouts, the surgical hub 5104
can be configured to provide an alert indicating that the current
layout for the surgical procedure deviates from the recommended
layout.
[0315] As another example, a situationally aware surgical hub 5104
could determine whether the surgeon (or other medical personnel)
was making an error or otherwise deviating from the expected course
of action during the course of a surgical procedure. For example,
the surgical hub 5104 can be configured to determine the type of
surgical procedure being performed, retrieve the corresponding list
of steps or order of equipment usage (e.g., from a memory), and
then compare the steps being performed or the equipment being used
during the course of the surgical procedure to the expected steps
or equipment for the type of surgical procedure that the surgical
hub 5104 determined is being performed. In one exemplification, the
surgical hub 5104 can be configured to provide an alert indicating
that an unexpected action is being performed or an unexpected
device is being utilized at the particular step in the surgical
procedure.
[0316] Overall, the situational awareness system for the surgical
hub 5104 improves surgical procedure outcomes by adjusting the
surgical instruments (and other modular devices 5102) for the
particular context of each surgical procedure (such as adjusting to
different tissue types) and validating actions during a surgical
procedure. The situational awareness system also improves surgeons'
efficiency in performing surgical procedures by automatically
suggesting next steps, providing data, and adjusting displays and
other modular devices 5102 in the surgical theater according to the
specific context of the procedure.
[0317] In one aspect, as described hereinbelow with reference to
FIGS. 24-40, the modular device 5102 is implemented as a circular
powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33),
201532 (FIGS. 34-35), 201610 (FIGS. 36-40). Accordingly, the
modular device 5102 implemented as a circular powered stapling
device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS.
34-35), 201610 (FIGS. 36-40) is configured to operate as a data
source 5126 and to interact with the database 5122 and patient
monitoring devices 5124. The modular device 5102 implemented as a
circular powered stapling device 201800 (FIGS. 24-30), 201502
(FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) is
further configured to interact with the surgical hub 5104 to
provide information (e.g., data and control) to the surgical hub
5104 and receive information (e.g., data and control) from the
surgical hub 5104.
[0318] Referring now to FIG. 15, a timeline 5200 depicting
situational awareness of a hub, such as the surgical hub 106 or 206
(FIGS. 1-11), for example, is depicted. The timeline 5200 is an
illustrative surgical procedure and the contextual information that
the surgical hub 106, 206 can derive from the data received from
the data sources at each step in the surgical procedure. The
timeline 5200 depicts the typical steps that would be taken by the
nurses, surgeons, and other medical personnel during the course of
a lung segmentectomy procedure, beginning with setting up the
operating theater and ending with transferring the patient to a
post-operative recovery room.
[0319] The situationally aware surgical hub 106, 206 receives data
from the data sources throughout the course of the surgical
procedure, including data generated each time medical personnel
utilize a modular device that is paired with the surgical hub 106,
206. The surgical hub 106, 206 can receive this data from the
paired modular devices and other data sources and continually
derive inferences (i.e., contextual information) about the ongoing
procedure as new data is received, such as which step of the
procedure is being performed at any given time. The situational
awareness system of the surgical hub 106, 206 is able to, for
example, record data pertaining to the procedure for generating
reports, verify the steps being taken by the medical personnel,
provide data or prompts (e.g., via a display screen) that may be
pertinent for the particular procedural step, adjust modular
devices based on the context (e.g., activate monitors, adjust the
field of view (FOV) of the medical imaging device, or change the
energy level of an ultrasonic surgical instrument or RF
electrosurgical instrument), and take any other such action
described above.
[0320] As the first step 5202 in this illustrative procedure, the
hospital staff members retrieve the patient's EMR from the
hospital's EMR database. Based on select patient data in the EMR,
the surgical hub 106, 206 determines that the procedure to be
performed is a thoracic procedure.
[0321] Second step 5204, the staff members scan the incoming
medical supplies for the procedure. The surgical hub 106, 206
cross-references the scanned supplies with a list of supplies that
are utilized in various types of procedures and confirms that the
mix of supplies corresponds to a thoracic procedure. Further, the
surgical hub 106, 206 is also able to determine that the procedure
is not a wedge procedure (because the incoming supplies either lack
certain supplies that are necessary for a thoracic wedge procedure
or do not otherwise correspond to a thoracic wedge procedure).
[0322] Third step 5206, the medical personnel scan the patient band
via a scanner that is communicably connected to the surgical hub
106, 206. The surgical hub 106, 206 can then confirm the patient's
identity based on the scanned data.
[0323] Fourth step 5208, the medical staff turns on the auxiliary
equipment. The auxiliary equipment being utilized can vary
according to the type of surgical procedure and the techniques to
be used by the surgeon, but in this illustrative case they include
a smoke evacuator, insufflator, and medical imaging device. When
activated, the auxiliary equipment that are modular devices can
automatically pair with the surgical hub 106, 206 that is located
within a particular vicinity of the modular devices as part of
their initialization process. The surgical hub 106, 206 can then
derive contextual information about the surgical procedure by
detecting the types of modular devices that pair with it during
this pre-operative or initialization phase. In this particular
example, the surgical hub 106, 206 determines that the surgical
procedure is a VATS procedure based on this particular combination
of paired modular devices. Based on the combination of the data
from the patient's EMR, the list of medical supplies to be used in
the procedure, and the type of modular devices that connect to the
hub, the surgical hub 106, 206 can generally infer the specific
procedure that the surgical team will be performing. Once the
surgical hub 106, 206 knows what specific procedure is being
performed, the surgical hub 106, 206 can then retrieve the steps of
that procedure from a memory or from the cloud and then
cross-reference the data it subsequently receives from the
connected data sources (e.g., modular devices and patient
monitoring devices) to infer what step of the surgical procedure
the surgical team is performing.
[0324] Fifth step 5210, the staff members attach the EKG electrodes
and other patient monitoring devices to the patient. The EKG
electrodes and other patient monitoring devices are able to pair
with the surgical hub 106, 206. As the surgical hub 106, 206 begins
receiving data from the patient monitoring devices, the surgical
hub 106, 206 thus confirms that the patient is in the operating
theater.
[0325] Sixth step 5212, the medical personnel induce anesthesia in
the patient. The surgical hub 106, 206 can infer that the patient
is under anesthesia based on data from the modular devices and/or
patient monitoring devices, including EKG data, blood pressure
data, ventilator data, or combinations thereof, for example. Upon
completion of the sixth step 5212, the pre-operative portion of the
lung segmentectomy procedure is completed and the operative portion
begins.
[0326] Seventh step 5214, the patient's lung that is being operated
on is collapsed (while ventilation is switched to the contralateral
lung). The surgical hub 106, 206 can infer from the ventilator data
that the patient's lung has been collapsed, for example. The
surgical hub 106, 206 can infer that the operative portion of the
procedure has commenced as it can compare the detection of the
patient's lung collapsing to the expected steps of the procedure
(which can be accessed or retrieved previously) and thereby
determine that collapsing the lung is the first operative step in
this particular procedure.
[0327] Eighth step 5216, the medical imaging device (e.g., a scope)
is inserted and video from the medical imaging device is initiated.
The surgical hub 106, 206 receives the medical imaging device data
(i.e., video or image data) through its connection to the medical
imaging device. Upon receipt of the medical imaging device data,
the surgical hub 106, 206 can determine that the laparoscopic
portion of the surgical procedure has commenced. Further, the
surgical hub 106, 206 can determine that the particular procedure
being performed is a segmentectomy, as opposed to a lobectomy (note
that a wedge procedure has already been discounted by the surgical
hub 106, 206 based on data received at the second step 5204 of the
procedure). The data from the medical imaging device 124 (FIG. 2)
can be utilized to determine contextual information regarding the
type of procedure being performed in a number of different ways,
including by determining the angle at which the medical imaging
device is oriented with respect to the visualization of the
patient's anatomy, monitoring the number or medical imaging devices
being utilized (i.e., that are activated and paired with the
surgical hub 106, 206), and monitoring the types of visualization
devices utilized. For example, one technique for performing a VATS
lobectomy places the camera in the lower anterior corner of the
patient's chest cavity above the diaphragm, whereas one technique
for performing a VATS segmentectomy places the camera in an
anterior intercostal position relative to the segmental fissure.
Using pattern recognition or machine learning techniques, for
example, the situational awareness system can be trained to
recognize the positioning of the medical imaging device according
to the visualization of the patient's anatomy. As another example,
one technique for performing a VATS lobectomy utilizes a single
medical imaging device, whereas another technique for performing a
VATS segmentectomy utilizes multiple cameras. As yet another
example, one technique for performing a VATS segmentectomy utilizes
an infrared light source (which can be communicably coupled to the
surgical hub as part of the visualization system) to visualize the
segmental fissure, which is not utilized in a VATS lobectomy. By
tracking any or all of this data from the medical imaging device,
the surgical hub 106, 206 can thereby determine the specific type
of surgical procedure being performed and/or the technique being
used for a particular type of surgical procedure.
[0328] Ninth step 5218, the surgical team begins the dissection
step of the procedure. The surgical hub 106, 206 can infer that the
surgeon is in the process of dissecting to mobilize the patient's
lung because it receives data from the RF or ultrasonic generator
indicating that an energy instrument is being fired. The surgical
hub 106, 206 can cross-reference the received data with the
retrieved steps of the surgical procedure to determine that an
energy instrument being fired at this point in the process (i.e.,
after the completion of the previously discussed steps of the
procedure) corresponds to the dissection step. In certain
instances, the energy instrument can be an energy tool mounted to a
robotic arm of a robotic surgical system.
[0329] Tenth step 5220, the surgical team proceeds to the ligation
step of the procedure. The surgical hub 106, 206 can infer that the
surgeon is ligating arteries and veins because it receives data
from the surgical stapling and cutting instrument indicating that
the instrument is being fired. Similarly to the prior step, the
surgical hub 106, 206 can derive this inference by
cross-referencing the receipt of data from the surgical stapling
and cutting instrument with the retrieved steps in the process. In
certain instances, the surgical instrument can be a surgical tool
mounted to a robotic arm of a robotic surgical system.
[0330] Eleventh step 5222, the segmentectomy portion of the
procedure is performed. The surgical hub 106, 206 can infer that
the surgeon is transecting the parenchyma based on data from the
surgical stapling and cutting instrument, including data from its
cartridge. The cartridge data can correspond to the size or type of
staple being fired by the instrument, for example. As different
types of staples are utilized for different types of tissues, the
cartridge data can thus indicate the type of tissue being stapled
and/or transected. In this case, the type of staple being fired is
utilized for parenchyma (or other similar tissue types), which
allows the surgical hub 106, 206 to infer that the segmentectomy
portion of the procedure is being performed.
[0331] Twelfth step 5224, the node dissection step is then
performed. The surgical hub 106, 206 can infer that the surgical
team is dissecting the node and performing a leak test based on
data received from the generator indicating that an RF or
ultrasonic instrument is being fired. For this particular
procedure, an RF or ultrasonic instrument being utilized after
parenchyma was transected corresponds to the node dissection step,
which allows the surgical hub 106, 206 to make this inference. It
should be noted that surgeons regularly switch back and forth
between surgical stapling/cutting instruments and surgical energy
(i.e., RF or ultrasonic) instruments depending upon the particular
step in the procedure because different instruments are better
adapted for particular tasks. Therefore, the particular sequence in
which the stapling/cutting instruments and surgical energy
instruments are used can indicate what step of the procedure the
surgeon is performing. Moreover, in certain instances, robotic
tools can be utilized for one or more steps in a surgical procedure
and/or handheld surgical instruments can be utilized for one or
more steps in the surgical procedure. The surgeon(s) can alternate
between robotic tools and handheld surgical instruments and/or can
use the devices concurrently, for example. Upon completion of the
twelfth step 5224, the incisions are closed up and the
post-operative portion of the procedure begins.
[0332] Thirteenth step 5226, the patient's anesthesia is reversed.
The surgical hub 106, 206 can infer that the patient is emerging
from the anesthesia based on the ventilator data (i.e., the
patient's breathing rate begins increasing), for example.
[0333] Lastly, the fourteenth step 5228 is that the medical
personnel remove the various patient monitoring devices from the
patient. The surgical hub 106, 206 can thus infer that the patient
is being transferred to a recovery room when the hub loses EKG, BP,
and other data from the patient monitoring devices. As can be seen
from the description of this illustrative procedure, the surgical
hub 106, 206 can determine or infer when each step of a given
surgical procedure is taking place according to data received from
the various data sources that are communicably coupled to the
surgical hub 106, 206.
[0334] In various aspects, the circular powered stapling device
201800 (FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35),
201610 (FIGS. 36-40) is configured to operate in a situational
awareness in a hub environment, such as the surgical hub 106 or 206
(FIGS. 1-11), for example, as depicted by the timeline 5200.
Situational awareness is further described in U.S. Provisional
Patent Application Ser. No. 62/659,900, titled METHOD OF HUB
COMMUNICATION, filed Apr. 19, 2018, which is herein incorporated by
reference in its entirety. In certain instances, operation of a
robotic surgical system, including the various robotic surgical
systems disclosed herein, for example, can be controlled by the hub
106, 206 based on its situational awareness and/or feedback from
the components thereof and/or based on information from the cloud
104.
Surgical Instrument Hardware
[0335] FIG. 16 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
knife element, trocar, or anvil of a powered circular stapling
device. 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 knife element. Additional motors may
be provided at the tool driver interface to control knife 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.
[0336] 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.
[0337] In one aspect, the microcontroller 461 may comprise a safety
controller comprising two controller-based families such as TMS570
and RM4x, 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.
[0338] 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.
[0339] 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.
[0340] 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.
[0341] 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.
[0342] 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 knife, 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 knife,
trocar or anvil of a powered circular stapling device, 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 knife. Accordingly, the absolute positioning system
can, in effect, track the linear displacement of the knife 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 knife, 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.
[0343] 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, knife, or combinations thereof.
[0344] 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.
[0345] 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.
[0346] 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.
[0347] 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.
[0348] 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.
[0349] 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.
[0350] 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 a knife in a firing stroke of the surgical
instrument or tool. The knife 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 knife also
includes a sharpened cutting edge that can be used to sever tissue
as the knife 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.
[0351] 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.
[0352] 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.
[0353] 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.
1-14. The control system 470 may be employed by the motorized
circular stapling instrument 201800 (FIGS. 24-30), 201502 (FIGS.
31-32), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) to control
aspects of the motorized circular stapling instruments 201800,
201502, 201532 201610. Aspects of the control system 470 may be
employed by the motorized circular stapling instruments 201800,
201502, 201532, 201610 to sense the position of the anvil, tissue
compression forces, among others, by employing 472, 474, 476, the
tracking system 480, and current sensor 478 to provide feedback to
the controller 461.
[0354] FIG. 17 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.
[0355] FIG. 18 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.
[0356] FIG. 19 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. 17) 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. 18) and the
sequential logic circuit 520.
[0357] FIG. 20 illustrates a surgical instrument 600 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 the 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. In one aspect, the surgical
instrument 600 is representative of a hand held surgical
instrument. In another aspect, the surgical instrument 600 is
representative of a robotic surgical instrument. In other aspects,
the surgical instrument 600 is representative of a combination of a
hand held and robotic surgical instrument. In various aspects, the
surgical stapler 600 may be representative of a linear stapler or a
circular stapler.
[0358] 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 knife 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
knife element to be advanced to cut the captured tissue, for
example. The knife element may be retracted by reversing the
direction of the motor 602.
[0359] 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. In a circular stapler implementation, the motor 603
may be coupled to a trocar portion of a circular stapler portion of
a powered stapling device. The motor 603 can be employed to advance
and retract the trocar.
[0360] 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.
[0361] 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 knife element to advance distally
as described in more detail hereinbelow.
[0362] 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 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.
[0363] 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. 20, 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.
[0364] 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.
[0365] In various instances, as illustrated in FIG. 20, 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.
[0366] 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.
[0367] 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.
[0368] 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.
[0369] 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.
[0370] 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.
[0371] 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 knife 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.
[0372] The surgical instrument 600 may comprise wired or wireless
communication circuits to communicate with the modular
communication hub as shown in FIGS. 1-14. The surgical instrument
600 may be the motorized circular stapling instrument 201800 (FIGS.
24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS.
36-40).
[0373] FIG. 21 is a schematic diagram of a surgical instrument 700
configured to operate a surgical tool described herein according to
one aspect of this disclosure. The 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. In one aspect, the surgical instrument 700 is
representative of a hand held surgical instrument. In another
aspect, the surgical instrument 700 is representative of a robotic
surgical instrument. In other aspects, the surgical instrument 700
is representative of a combination of a hand held and robotic
surgical instrument. In various aspects, the surgical stapler 700
may be representative of a linear stapler or a circular
stapler.
[0374] In one aspect, the surgical instrument 700 comprises a
control circuit 710 configured to control an anvil 716 and a knife
714 (or cutting element 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 knife 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 an open-loop or closed-loop feedback
control.
[0375] 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 knife 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 knife 714 at a
specific time (t) relative to a starting position or the time (t)
when the knife 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.
[0376] 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.
[0377] 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.
[0378] 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 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.
[0379] 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 knife 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 knife 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 knife 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
knife 714 translates distally and proximally. The control circuit
710 may track the pulses to determine the position of the knife
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 knife 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 knife 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.
[0380] In one aspect, the control circuit 710 is configured to
drive a firing member such as the knife 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 knife 714. The transmission 706a
comprises movable mechanical elements such as rotating elements and
a firing member to control the movement of the knife 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 knife 714. A position sensor 734 may be
configured to provide the position of the knife 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, a knife 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.
[0381] 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.
[0382] 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.
[0383] In a circular stapler implementation, the transmission 706c
element is coupled to the trocar to advance or retract the trocar.
In one aspect, the shaft 740 is part of a closure system that
comprises a trocar 201904 and a trocar actuator 201906 as discussed
in more detail with reference to FIGS. 29A-29 hereinbelow.
Accordingly, the control circuit 710 controls the motor control
circuit 708c to control the motor 704c to advance or retract the
trocar. A torque sensor 744c is provided to measure the torque
applied by the shaft of the motor 704c to the transmission
components 706c employed in advancing and retracting the trocar.
The position sensor 734 may include a variety of sensors to track
the position of the trocar, the anvil 716, or the knife 714, or any
combination thereof. Other sensors 738 may be employed to measure a
variety of parameters including position or velocity of the trocar,
the anvil 716, or the knife 714, or any combination thereof. The
torque sensor 744c, the position sensor 734, and the sensors 738
are coupled to the control circuit 710 as inputs to various
processes for controlling the operation of the surgical instrument
700 in a desired manner.
[0384] 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.
[0385] 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.
[0386] 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.
[0387] 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.
[0388] 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
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.
[0389] 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.
[0390] 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.
[0391] 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.
[0392] 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 knife 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 a knife 714 in the end effector 702
at or near a target velocity. The 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 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.
[0393] The surgical instrument 700 may comprise wired or wireless
communication circuits to communicate with the modular
communication hub as shown in FIGS. 1-14. The surgical instrument
700 may be the motorized circular stapling instrument 201800 (FIGS.
24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS.
36-40).
[0394] FIG. 22 illustrates a block diagram of a surgical instrument
750 configured to control various functions, 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 knife 764, or other suitable
cutting element. The surgical instrument 750 comprises an end
effector 752 that may comprise an anvil 766, a knife 764 (including
a sharp cutting edge), and a removable staple cartridge 768.
[0395] The position, movement, displacement, and/or translation of
a linear displacement member, such as the knife 764, can be
measured by an absolute positioning system, sensor arrangement, and
position sensor 784. Because the knife 764 is coupled to a
longitudinally movable drive member, the position of the knife 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 knife 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 knife 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 knife 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 knife 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
knife 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.
[0396] 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.
[0397] 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 knife 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 knife 764. In one aspect,
the transmission is coupled to a trocar actuator of a circular
stapler to advance or retract the trocar. A position sensor 784 may
sense a position of the knife 764, the trocar, or the anvil 766, or
a combination thereof. 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 knife 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 knife 764
translates distally and proximally. The control circuit 760 may
track the pulses to determine the position of the knife 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 knife 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 knife 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.
[0398] In a circular stapler implementation, the transmission 756
element may be coupled to the trocar to advance or retract the
trocar, to the knife 764 to advance or retract the knife 764, or
the anvil 766 to advance or retract the anvil 766. These functions
may be implemented with a single motor using suitable clutching
mechanism or may be implemented using separate motors as shown with
reference to FIG. 21, for example. In one aspect, the transmission
756 is part of a closure system that comprises a trocar 201904 and
a trocar actuator 201906 as discussed in more detail with reference
to FIGS. 29A-29C hereinbelow. Accordingly, the control circuit 760
controls the motor control circuit 758 to control the motor 754 to
advance or retract the trocar. Similarly, the motor 754 may be
configured to advance or retract the knife 764 and advance or
retract the anvil 766. A torque sensor may be provided to measure
the torque applied by the shaft of the motor 754 to the
transmission components 756 employed in advancing and retracting
the trocar, the knife 764, or the anvil 766, or combinations
thereof. The position sensor 784 may include a variety of sensors
to track the position of the trocar, the knife 764, or the anvil
766, or any combination thereof. Other sensors 788 may be employed
to measure a variety of parameters including position or velocity
of the trocar, the knife 764, or the anvil 766, or any combination
thereof. The torque sensor, the position sensor 784, and the
sensors 788 are coupled to the control circuit 760 as inputs to
various processes for controlling the operation of the surgical
instrument 750 in a desired manner.
[0399] 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. In one aspect, the sensors 788 may be configured to
determine the position of a trocar of a circular stapler.
[0400] 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.
[0401] The sensors 788 may be is 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.
[0402] A current sensor 786 can be employed to measure the current
drawn by the motor 754. The force required to advance the knife 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.
[0403] 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 a
knife 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.
[0404] The actual drive system of the surgical instrument 750 is
configured to drive the displacement member, cutting member, or
knife 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.
[0405] 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, a knife
764 with a cutting element positioned at a distal end, may cut the
tissue between the staple cartridge 768 and the anvil 766.
[0406] 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 knife 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.
[0407] 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.
[0408] The surgical instrument 750 may comprise wired or wireless
communication circuits to communicate with the modular
communication hub as shown in FIGS. 1-14. The surgical instrument
750 may be the motorized circular stapling instrument 201800 (FIGS.
24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS.
36-40).
[0409] FIG. 23 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 knife 764. The surgical instrument 790 comprises an end
effector 792 that may comprise an anvil 766, a knife 764, and a
removable staple cartridge 768 which may be interchanged with an RF
cartridge 796 (shown in dashed line).
[0410] With reference to FIGS. 21-23, in various aspects, sensors
738, 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 738, 788 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 738, 788 may include electrical conductorless switches,
ultrasonic switches, accelerometers, and inertial sensors, among
others.
[0411] In one aspect, the position sensor 734, 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 734, 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.
[0412] In one aspect, the knife 714, 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 718, 768 may be
implemented as a standard (mechanical) surgical fastener cartridge,
which may be a linear staple cartridge or a circular staple
cartridge. In one aspect, the RF cartridge 796 (FIG. 23) 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.
[0413] The position, movement, displacement, and/or translation of
a linear displacement member, such as the trocar, the knife 714,
764, or the anvil 716, 766 can be measured by an absolute
positioning system, sensor arrangement, and position sensor
represented as position sensor 734, 784. Because the knife 714, 764
is coupled to the longitudinally movable drive member, the position
of the trocar, the knife 714, 764, or the anvil 716, 766 can be
determined by measuring the position of the longitudinally movable
drive member employing the position sensor 734, 784. Accordingly,
in the following description, the position, displacement, and/or
translation of the trocar, the knife 764, or the anvil 716, 766 can
be achieved by the position sensor 734, 784 as described herein. A
control circuit 710, 760 may be programmed to control the
translation of the displacement member, such as the trocar, the
knife 764, or the anvil 716, 766 as described herein. The control
circuit 710, 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 trocar, the knife 764,
or the anvil 716, 766 in the manner described. In one aspect, a
timer/counter 731, 781 provides an output signal, such as the
elapsed time or a digital count, to the control circuit 710, 760 to
correlate the position of trocar, the knife 714, 764, or the anvil
716, 766 as determined by the position sensor 734, 784 with the
output of the timer/counter 731, 781 such that the control circuit
710, 760 can determine the position of the trocar, the knife 714,
764, or the anvil 716, 766 at a specific time (t) relative to a
starting position. The timer/counter 731, 781 may be configured to
measure elapsed time, count external events, or time external
events.
[0414] The control circuit 710, 760 may generate a motor set point
signal 772. The motor set point signal 772 (to each motor when
multiple motors are used) may be provided to a motor controller
708a-e, 758. The motor controller 708a-e, 758 may comprise one or
more circuits configured to provide a motor drive signal 774 to the
motor 704a-e, 754 to drive the motor 704a-e, 754 as described
herein. In some examples, the motor 704a-e, 754 may be a brushed DC
electric motor. For example, the velocity of the motor 704a-e, 754
may be proportional to the motor drive signal 774. In some
examples, the motor 704a-e, 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 704a-e, 754.
Also, in some examples, the motor controller 708a-e, 758 may be
omitted, and the control circuit 710, 760 may generate the motor
drive signal 774 directly.
[0415] The motor 704a-e, a battery, a super capacitor, or any other
suitable energy source. The motor 704a-e, 754 may be mechanically
coupled to the trocar, the knife 764, or the anvil 716, 766 via a
transmission 706a-e, 756. The transmission 706a-e, 756 may include
one or more gears or other linkage components to couple the motor
704a-e, 754 to the trocar, the knife 764, or the anvil 716, 766. A
position sensor 734, 784 may sense a position of the trocar, the
knife 714, 764, or the anvil 716, 766. The position sensor 734, 784
may be or include any type of sensor that is capable of generating
position data that indicate a position of the trocar, the knife
764, or the anvil 716, 766. In some examples, the position sensor
734, 784 may include an encoder configured to provide a series of
pulses to the control circuit 710, 760 as the trocar, the knife
764, or the anvil 716, 766 translates distally and proximally. The
control circuit 710, 760 may track the pulses to determine the
position of the trocar, the knife 714, 764, or the anvil 716, 766.
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 trocar, the knife
764, or the anvil 716, 766. Also, in some examples, the position
sensor 734, 784 may be omitted. Where the motor 704a-e, 754 is a
stepper motor, the control circuit 710, 760 may track the position
of the trocar, the knife 714, 764, or the anvil 716, 766 by
aggregating the number and direction of steps that the motor
704a-e, 754 has been instructed to execute. The position sensor
734, 784 may be located in the end effector 702, 752, 792 or at any
other portion of the instrument.
[0416] The control circuit 710, 760 may be in communication with
one or more sensors 738, 788. The sensors 738, 788 may be
positioned on the end effector 702, 752, 792 and adapted to operate
with the surgical instrument 700, 750, 790 to measure the various
derived parameters such as gap distance versus time, tissue
compression versus time, and anvil strain versus time. The sensors
738, 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
702, 752, 792. The sensors 738, 788 may include one or more
sensors.
[0417] The one or more sensors 738, 788 may comprise a strain
gauge, such as a micro-strain gauge, configured to measure the
magnitude of the strain in the anvil 716, 766 during a clamped
condition. The strain gauge provides an electrical signal whose
amplitude varies with the magnitude of the strain. The sensor 738,
788 may comprise a pressure sensor configured to detect a pressure
generated by the presence of compressed tissue between the anvil
716, 766 and the staple cartridge 718, 768. The sensors 738, 788
may be configured to detect impedance of a tissue section located
between the anvil 716, 766 and the staple cartridge 718, 768 that
is indicative of the thickness and/or fullness of tissue located
therebetween.
[0418] The sensors 738, 788 may be is configured to measure forces
exerted on the anvil 716, 766 by the closure drive system. For
example, one or more sensors 738, 788 can be at an interaction
point between a closure tube and the anvil 716, 766 to detect the
closure forces applied by a closure tube to the anvil 716, 766. The
forces exerted on the anvil 716, 766 can be representative of the
tissue compression experienced by the tissue section captured
between the anvil 716, 766 and the staple cartridge 738, 768. The
one or more sensors 738, 788 can be positioned at various
interaction points along the closure drive system to detect the
closure forces applied to the anvil 716, 766 by the closure drive
system. The one or more sensors 738, 788 may be sampled in real
time during a clamping operation by a processor portion of the
control circuit 710, 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 716, 766.
[0419] A current sensor 736, 786 can be employed to measure the
current drawn by the motor 704a-e, 754. The force required to
advance the trocar, the knife 714, 764, or the anvil 716, 766
corresponds to the current drawn by the motor 704a-e, 754. The
force is converted to a digital signal and provided to the control
circuit 710, 760.
[0420] With reference to FIG. 23, 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.
[0421] The surgical instrument 790 may comprise wired or wireless
communication circuits to communicate with the modular
communication hub as shown in FIGS. 1-14. The surgical instrument
790 may be the motorized circular stapling instrument 201800 (FIGS.
24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS.
36-40).
[0422] 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.
Motorized Circular Stapling Surgical Instrument
[0423] In some instances, it may be desirable to provide motorized
control of a circular stapling instrument. The examples below
include merely an illustrative version of a circular stapling
instrument where a single motor can be used to control both
clamping and cutting/stapling of tissue via a single rotary drive.
FIG. 24 shows an example motorized circular stapling instrument
201800. The Instrument 201800 of this example comprises a stapling
head assembly 201802, an anvil 201804, a shaft assembly 201806, a
handle assembly 201808, and a rotation knob 201812. The stapling
head assembly 201802 selectively couples with the anvil 201804. The
stapling head assembly 201802 is operable to clamp tissue between
staple pockets and staple forming pockets of the anvil 201804. The
stapling head assembly 201802 comprises a cylindrical knife that is
operable to sever tissue captured between stapling head assembly
201802 and the anvil 201804. The stapling head assembly 201802
drives staples through the tissue captured between stapling head
assembly 201802 and the anvil 201804. The stapling instrument
201800 may be used to create a secure anastomosis (e.g., an
end-to-end anastomosis) within a gastro-intestinal tract of a
patient or elsewhere. An outer tubular member 201810 is coupled to
the actuator handle assembly 201808. The outer tubular member
201810 provides a mechanical ground between the stapling head
assembly 201802 and the handle assembly 201808.
[0424] The stapling head assembly 201802 is operable to clamp
tissue, sever tissue, and staple tissue all in response to a single
rotary input communicated via the shaft assembly 201806.
Accordingly, actuation inputs translated linearly through shaft
assembly 201806 are not required for the stapling head assembly
201802, though the stapling head assembly 201802 may comprise a
translating clutch feature. By way of example only, at least part
of stapling head assembly 201802 may be configured in accordance
with at least some of the teachings of U.S. patent application Ser.
No. 13/716,318, entitled "Motor Driven Rotary Input Circular
Stapler with Modular End Effector," filed on Dec. 17, 2012, and
published as U.S. Pat. Pub. No. 2014/0166728 on Jun. 19, 2014, the
disclosure of which is incorporated by reference herein. Other
suitable configurations for the stapling head assembly 201802 will
be apparent to those of ordinary skill in the art in view of the
teachings herein.
[0425] The shaft assembly 201806 couples the handle assembly 201808
with the stapling head assembly 201802. The shaft assembly 201806
comprises a single actuation feature, rotary driver actuator 201814
shown in FIG. 25. The driver actuator 201814 is operable to drive
the stapling head assembly 201802 to clamp tissue, sever tissue,
and staple tissue. Accordingly, linear actuation through the shaft
assembly 201806 is not required, though the rotary driver actuator
201814 may translate longitudinally to shift between a tissue
clamping mode and a tissue cutting/stapling mode. For instance, the
driver actuator 201814 may translate from a first longitudinal
position, in which rotation of the driver actuator 201814 provides
clamping of tissue at the stapling head assembly 201802, to a
second longitudinal position, in which rotation of driver actuator
210814 provides cutting and stapling of tissue at the stapling head
assembly 201802. Some versions of the shaft assembly 201806 may
include one or more flexible sections. An example of a shaft
assembly that is configured with flexible sections and that may be
incorporated into shaft assembly 201806 is disclosed in U.S. patent
application Ser. No. 13/716,323, entitled "Motor Driven Rotary
Input Circular Stapler with Lockable Flexible Shaft," filed on Dec.
17, 2012, and published as U.S. Pat. Pub. No. 2014/0166718 on Jun.
19, 2014, the disclosure of which is incorporated by reference
herein. Alternatively, the shaft assembly 201806 may be rigid along
the length of the shaft assembly 201806 or have one or more
flexible sections configured in some other fashion.
[0426] The handle assembly 201808 is shown in FIGS. 25-27. The
handle assembly 201808 comprises a handle housing 201816, a motor
housing 201818, a motor 201820, a battery 201822, a rotation knob
201812, and a firing ring 201826. The motor housing 201818 is
positioned within the handle housing 201816. The handle housing
201816 comprises ribs (201827, 201828, 201830, 201832) extending
inwardly into the handle housing 201816 to support the motor
housing 201818, as shown in FIG. 26. The battery 201822 is
positioned proximal to the motor 201820 within the motor housing
201818. The battery 201822 may be removed from the motor housing
201818 to be replaced, discarded, or recharged. As best seen in
FIG. 27, the battery 201822 comprises electrical contacts 201834,
201836 extending distally from the battery 201822. The motor 201820
comprises electrical contacts 201838, 201840 extending proximally
from the motor 201820. The battery electrical contact 201836 and
the motor electrical contact 201840 are coupled via a conductive
metal band 201842. A screw 201844 couples the band 201842 to the
motor housing 201818 to fix the position of the band 201842
relative to the motor housing 201818. Accordingly, the band 201842
is configured to constantly couple the battery electrical contact
201836 and the motor electrical contact 201840.
[0427] As shown in FIG. 27, a battery electrical contact 201846 is
coupled to a conductive metal band 201848. The metal band 201848 is
secured to the motor housing 201818 via a conductive screw 201854.
The motor electrical contact 201838 is coupled to a conductive
metal band 201852. The metal band 201852 is secured to the motor
housing 201818 via a conductive screw 201850. The motor housing
201818 is formed of an electrically insulative material (e.g.,
plastic) and comprises annular contacts 201856, 201858 wrapped
around the motor housing 201818. Screws 201850, 201854 are each
coupled with a respective annular contact 201856, 201858 to
electrically couple the battery electrical contact 201834 and the
motor electrical contact 201838 to the annular contacts 201856,
201858, respectively.
[0428] Another conductive metal band 201860 is secured to the
handle housing 201816. Each end of the metal band 201860 forms a
respective spring contact 201862, 201864. The motor housing 201818
translates proximally and/or distally relative to handle housing
201816 to selectively couple and/or decouple the spring contacts
201862, 201864 with annular contacts 201856, 201858. In particular,
when the motor housing 201818 is in a distal position, the spring
contact 201862 engages the annular contact 201856 and the spring
contact 201864 engages the annular contact 201858 to couple the
battery 201822 with the motor 201820 and supply power to the motor
201820. It should be understood that, since the spring contacts
201862, 201864 are part of the same conductive metal band 201860,
and since the contacts 201836, 201840 are already coupled via a
band 201866, the engagement between the spring contacts 201862,
201864 and the annular contacts 201856, 201858 completes a circuit
between the battery 201822 and the motor 201820. This positioning
is used to provide motorized actuation of the stapling head
assembly 201802. When the motor housing 201818 is in a proximal
position, the spring contacts 201862, 201864 are decoupled from the
annular contacts 201856, 201858, such that the battery 201822 is
decoupled from the motor 201820 and the motor 201820 does not
receive power. This positioning is used to provide manual actuation
of stapling head assembly 201802. The annular shape of the annular
contacts 201856, 201858 enables proper contact between the spring
contacts 201862, 201864 and the annular contacts 201856, 201858
regardless of the angular position of the motor housing 201818
within the handle housing 201816. In some versions, the band 201860
may include a break that is coupled with an external switch, such
that a user may actuate the external switch in order to complete
the coupling between the battery 201822 and the motor 201820 after
the motor housing 201818 is in the distal position.
[0429] A proximal end of motor housing 201818 is fixedly secured to
rotation knob 201812, as shown in FIG. 25. In one aspect, rotation
knob 201812 may be coupled to a motor to rotate the rotation knob
201812. Rotation knob 201812 protrudes proximally from handle
housing 201816 and comprises splines 201868 extending distally from
rotation knob 201812. Handle housing 201816 comprises corresponding
teeth 201870 to selectively engage splines 201868. Rotation knob
201812 is pulled and/or pushed to translate motor housing 201818
within handle housing 201816. When rotation knob 201812 is in a
proximal position, splines 201868 are disengaged from handle
housing 201816 such that rotation knob 201812 and motor housing
201818 are free to rotate relative to handle housing 201816. This
positioning is used to provide manual actuation of stapling head
assembly 201802. When rotation knob 201812 is in a distal position,
splines 201868 engage corresponding teeth 201870 in handle housing
201816 to lock rotation knob 201812 and motor housing 201818 from
rotating relative to handle housing 201816. Splines 201868 and
teeth 201870 thus provide a mechanical ground for motor housing
201818 relative to handle housing 201816. This positioning is used
to provide motorized actuation of stapling head assembly 201802 as
will be described in greater detail below. Rotation knob 201812 is
biased to the distal position by a resilient member 201872 in
handle housing 201816. In particular, resilient member 201872
extends distally from rib 201828 of handle housing 201816 to a
first gear 201874, which is unitarily secured to the distal end of
motor housing 201818. When rotation knob 201812 is in the proximal
position, resilient member 201872 compresses between first gear
201874 and rib 201828 to resiliently bias handle housing 201816 to
the distal position.
[0430] An operational mode selection assembly is positioned distal
to motor housing 201818 within handle housing 201816. As shown in
FIGS. 28A-28B, the operational mode selection assembly comprises a
first gear 201874 and a second gear 201878, with first gear 201874
being coaxially and slidably disposed about second gear 201878.
First gear 201874 comprises square teeth aligned around an inner
opening of first gear 201874. The square teeth define a
circumferentially spaced array of recesses. Second gear 201878
comprises a shaft 201880, splines 201876, and annular flanges
201882, as shown in FIGS. 28A-28B. Shaft 201880 has a distally
presented opening. Distally presented opening is hexagonal to
receive proximal end 201896 of driver actuator 201814, which is
also hexagonal (FIG. 25). Shaft 201880 also has a proximally
presented opening (not shown) that is semi-circular to complement
and receive drive shaft 201886 extending distally from motor
201820. Other suitable shapes and configurations of shafts 201896,
201886 may used to couple second gear 201878 with shafts 201896,
201886.
[0431] As shown in FIG. 28A, splines 201876 of second gear 201878
are positioned on a proximal end of shaft 201880 and extend
distally. Splines 201876 correspond to teeth of first gear 201874,
such that splines 201876 are configured to fit within the recesses
defined between the teeth. A pair of annular flanges 201882 are
positioned at a distal end of shaft 201880 and extend outwardly to
engage an inwardly extending annular rib 201884 of handle housing
201816, thereby fixing the longitudinal position of second gear
201878 within handle housing 201816. While annular rib 201884 fixes
the longitudinal position of second gear 201878 within handle
housing 2001816, annular rib 201884 nevertheless allows second gear
201878 to rotate relative to handle housing 201816. Other suitable
engagement features to longitudinally fix second gear 201878 will
be apparent to one with ordinary skill in the art based on the
teachings herein.
[0432] First gear 201874 is positioned around second gear 201878,
as shown in FIGS. 28A-28B. First gear 201874 is fixedly coupled to
a distal end of motor housing 201818 such that first gear 201874
translates and rotates unitarily with motor housing 201818. When
motor housing 201818 is in a proximal position, as shown in FIG.
28B, motor 201820 and first gear 201874 are also in a proximal
position. In this position, drive shaft 201886 of motor 201820 is
disengaged from second gear 201878 and teeth of first gear 201874
engage splines of second gear 201878. Thus, when rotation knob
201812 rotates, motor housing 201818 and first gear 201874 also
rotate. This positioning thereby provides manual actuation of
stapling head assembly 201802. With teeth of first gear 2018784
engaged with splines 201876, rotation knob 201812 thereby rotates
second gear 201878 relative to motor housing 201818. When motor
housing 201818 is in a distal position, as shown in FIG. 28A, motor
201820 and first gear 291874 are also in a distal position. Motor
201820 is engaged with second gear 201878 via shafts 201886,
201880. First gear 201874 slides over shaft 201880 of second gear
201878 to disengage splines 201876. Thus, the rotation of drive
shaft 201886 of motor 201820 thereby rotates second gear 201878.
This positioning thereby provides motorized actuation of stapling
head assembly 201802. In other words, when knob 201812 and motor
housing 201818 are in a distal position as shown in FIG. 28A, motor
201820 rotates second gear 201878. When knob 201812 and motor
housing 201818 are in a proximal position as shown in FIG. 28B,
knob 201812 rotates second gear 201878.
[0433] Referring back to FIGS. 25-26, a distal end of second gear
201878 is coupled to driver actuator 201814, such that rotation of
second gear 201878 rotates driver actuator 201814. Accordingly,
when second gear 201878 is rotated, driver actuator 201814 is
rotated to adjust the gap distance d between anvil 201804 and
stapling head assembly 201802. Handle housing 201816 further
comprises firing ring 201826 and coupling member 201890. Coupling
member 201890 is secured around recess 201892 of driver actuator
201814, as shown in FIG. 25. Accordingly, coupling member 201890
translates with driver actuator 201814, but driver actuator 201814
is free to rotate within coupling member 201890. Coupling member
201890 comprises protrusions extending outwardly that connect
coupling member 201890 to firing ring 201826. The protrusions of
coupling member 201890 extends through slot 201894 of housing
assembly 201816, as shown in FIG. 25. Slot 201894 extends
circumferentially about part of handle assembly 201816. Firing ring
201826 is wrapped around handle housing 201816 and is rotatable and
translatable relative to handle housing 201816 to manually drive
the protrusions of coupling member 201890 through slot 201894.
[0434] When firing ring 201826 is in a distal position, protrusions
of coupling member 201890 are positioned within slot 201894 of
handle housing 201816. When coupling member 201890 is positioned
within slot 201894, coupling member 201890 couples driver actuator
201814 with features in stapling head assembly 201802 operable to
adjust the gap distance d between anvil 201804 and stapling head
assembly 201802. For instance, if coupling member 201890 is rotated
clockwise within slot 201894, the gap distance d is decreased to
close anvil 201804 relative to stapling head assembly 201802. If
coupling member 201890 is rotated counterclockwise within slot
201894, the gap distance d is increased to open anvil 201804
relative to stapling head assembly 201802. A resilient member
201888 is positioned proximal to coupling member 201890 to bias
coupling member 201890 distally (FIG. 25). Coupling member 201890
of firing ring 201826 may then be translated proximally through
slots. When firing ring 201826 is in the proximal position,
protrusions of coupling member 201890 are positioned within a slot.
When coupling member 201890 is positioned within a slot, coupling
member 201890 couples driver actuator 201814 with features in
stapling head assembly 201802 that drive a knife and staples in
response to rotation of driver actuator 201814. For instance, if
coupling member 201890 is rotated clockwise within a slot, stapling
head assembly 201802 drives a knife and staples. The configuration
of the slot prevents coupling member 201890 from being rotated
counterclockwise. Other suitable coupling member 201890 rotation
configurations will be apparent to one with ordinary skill in view
of the teachings herein.
[0435] As shown in FIG. 26, a switch 201898 is positioned in handle
housing 201816 to align with coupling member 201890. When the
motorized operational mode is selected, switch 201898 is configured
to electrically couple motor 201820 and battery 201822 when switch
201898 is depressed, and switch 201898 is configured to
electrically decouple motor 201820 and battery 201822 when switch
201898 is not depressed. Coupling member 201890 is configured to
engage and depress switch 201898 when coupling member 201890 is
rotated.
[0436] Referring now to FIGS. 29A-29C, in the present example,
instrument 201800 comprises a closure system and a firing system.
The closure system comprises a trocar 201904, a trocar actuator
201906, and a rotating knob 201812 (FIG. 24). As previously
discussed, the rotation knob 201812 may be coupled to a motor to
rotate the rotation knob 201812 in a clockwise or counterclockwise
direction. An anvil 201804 may be coupled to a distal end of trocar
201904. Rotating knob 201812 is operable to longitudinally
translate trocar 201904 relative to stapling head assembly 201802,
thereby translating anvil 201804 when anvil 201804 is coupled to
trocar 201904, to clamp tissue between anvil 201804 and stapling
head assembly 201804. The firing system comprises a trigger, a
trigger actuation assembly, a driver actuator 201908, and a staple
driver 201910. Staple driver 201910 includes a cutting element,
such as a knife 201912, configured to sever tissue when staple
driver 201910 is actuated longitudinally. In addition, staples
201902 are positioned distal to a plurality of staple driving
members 201914 of staple driver 201910 such that staple driver
201910 also drives staples 201902 distally when staple driver
201910 is actuated longitudinally. Thus, when staple driver 201910
is actuated via driver actuator 201908, knife 201912 members 201914
substantially simultaneously sever tissue 201916 and drive staples
201902 distally relative to stapling head assembly 201802 into
tissue. The components and functionalities of the closure system
and firing system will now be described in greater detail.
[0437] As shown in FIGS. 29A-29C, anvil 201804 is selectively
coupleable to instrument 201800 to provide a surface against which
staples 201902 may be bent to staple material contained between
stapling head assembly 201802 and anvil 201804. Anvil 201804 of the
present example is selectively coupleable to a trocar or pointed
rod 201904 that extends distally relative to stapling head assembly
201802. Referring to FIGS. 29A-29C, anvil 201804 is selectively
coupleable via the coupling of a proximal shaft 201918 of anvil
201904 to a distal tip of trocar 201904. Anvil 201804 comprises a
generally circular anvil head 201920 and a proximal shaft 201918
extending proximally from anvil head 201920. In the example shown,
proximal shaft 201918 comprises a tubular member 201922 having
resiliently biased retaining clips 201924 to selectively couple
anvil 201804 to trocar 201904, though this is merely optional, and
it should be understood that other retention features for coupling
anvil 201804 to trocar 201904 may be used as well. For example,
C-clips, clamps, threading, pins, adhesives, etc. may be employed
to couple anvil 201804 to trocar 201904. In addition, while anvil
201804 is described as selectively coupleable to trocar 201904, in
some versions proximal shaft 201918 may include a one-way coupling
feature such that anvil 201804 cannot be removed from trocar 201904
once anvil 201804 is attached. By way of example one-way features
include barbs, one way snaps, collets, collars, tabs, bands, etc.
Of course still other configurations for coupling anvil 201804 to
trocar 201904 will be apparent to one of ordinary skill in the art
in view of the teachings herein. For instance, trocar 201904 may
instead be a hollow shaft and proximal shaft 201918 may comprise a
sharpened rod that is insertable into the hollow shaft.
[0438] Anvil head 201920 of the present example comprises a
plurality of staple forming pockets 201936 formed in a proximal
face 201940 of anvil head 201920. Accordingly, when anvil 201804 is
in the closed position and staples 201902 are driven out of
stapling head assembly 201802 into staple forming pockets 201936,
as shown in FIG. 29C, legs 201938 of staples 201902 are bent to
form completed staples.
[0439] With anvil 201804 as a separate component, it should be
understood that anvil 201804 may be inserted and secured to a
portion of tissue 201916 prior to being coupled to stapling head
assembly 201802. By way of example only, anvil 201804 may be
inserted into and secured to a first tubular portion of tissue
201916 while instrument 201800 is inserted into and secured to a
second tubular portion of tissue 201916. For instance, the first
tubular portion of tissue 201916 may be sutured to or about a
portion of anvil 201804, and the second tubular portion of tissue
201916 may be sutured to or about trocar 201904.
[0440] As shown in FIG. 29A, anvil 201804 is then coupled to trocar
201904. Trocar 201904 of the present example is shown in a distal
most actuated position. Such an extended position for trocar 201904
may provide a larger area to which tissue 201916 may be coupled
prior to attachment of anvil 201804. In addition, the extended
position of trocar 20190400 may also provide for easier attachment
of anvil 201804 to trocar 201904. Trocar 201904 further includes a
tapered distal tip. Such a tip may be capable of piercing through
tissue and/or aiding the insertion of anvil 201804 on to trocar
201904, though the tapered distal tip is merely optional. For
instance, in other versions trocar 201904 may have a blunt tip. In
addition, or in the alternative, trocar 201904 may include a
magnetic portion (not shown) which may attract anvil 201804 towards
trocar 201904. Of course still further configurations and
arrangements for anvil 201804 and trocar 201904 will be apparent to
one of ordinary skill in the art in view of the teachings
herein.
[0441] When anvil 201804 is coupled to trocar 201904, the distance
between a proximal face of the anvil 201804 and a distal face of
stapling head assembly 201802 defines a gap distance d. Trocar
201904 of the present example is translatable longitudinally
relative to stapling head assembly 201802 via an adjusting knob
201812 (FIG. 24) located at a proximal end of actuator handle
assembly 201808 (FIG. 24), as will be described in greater detail
below. Accordingly, when anvil 201804 is coupled to trocar 201904,
rotation of adjusting knob 201812 enlarges or reduces gap distance
d by actuating anvil 201804 relative to stapling head assembly
201802. For instance, as shown sequentially in FIGS. 29A-29B, anvil
201804 is shown actuating proximally relative to actuator handle
assembly 201808 from an initial, open position to a closed
position, thereby reducing the gap distance d and the distance
between the two portions of tissue 201916 to be joined. Once the
gap distance d is brought within a predetermined range, stapling
head assembly 201802 may be fired, as shown in FIG. 29C, to staple
and sever tissue 201916 between anvil 201804 and stapling head
assembly 201802. Stapling head assembly 201802 is operable to
staple and sever tissue 201916 by a trigger of actuator handle
assembly 201808, as will be described in greater detail below.
[0442] Still referring to FIGS. 29A-29C, a user sutures a portion
of tissue 201916 about tubular member 201944 such that anvil head
201920 is located within a portion of the tissue 201916 to be
stapled. When tissue 201916 is attached to anvil 201804, retaining
clips 201924 and a portion of tubular member 201922 protrude out
from tissue 201916 such that the user may couple anvil 201804 to
trocar 201904. With tissue 201916 coupled to trocar 201904 and/or
another portion of stapling head assembly 201802, the user attaches
anvil 201804 to trocar 201904 and actuates anvil 201804 proximally
towards stapling head assembly 201802 to reduce the gap distance d.
Once instrument 201800 is within the operating range, the user then
staples together the ends of tissue 201916, thereby forming a
substantially contiguous tubular portion of tissue 201916.
[0443] Stapling head assembly 201802 of the present example is
coupled to a distal end of shaft assembly 201806 and comprises a
tubular casing 201926 housing a slidable staple driver 201910 and a
plurality of staples 201902 contained within staple pockets 201928.
Shaft assembly 201806 of the present example comprises an outer
tubular member 201942 and a driver actuator 201908. Staples 201902
and staple pockets 201928 are disposed in a circular array about
tubular casing 201926. In the present example, staples 201902 and
staple pockets 201928 are disposed in a pair of concentric annular
rows of staples 201902 and staple pockets 201928. Staple driver
201910 is operable to actuate longitudinally within tubular casing
201926 in response to rotation of actuator handle assembly 201808
(FIG. 24). As shown in FIGS. 29A-29C, staple driver 201910
comprises a flared cylindrical member having a trocar opening
201930, a central recess 201932, and a plurality of members 201914
disposed circumferentially about central recess 201932 and
extending distally relative to shaft assembly 201806. Each member
201914 is configured to contact and engage a corresponding staple
201902 of the plurality of staples 201902 within staple pockets
201928. Accordingly, when staple driver 201910 is actuated distally
relative to actuator handle assembly 201808, each member 201914
drives a corresponding staple 201902 out of its staple pocket
201928 through a staple aperture 201934 formed in a distal end of
tubular casing 201926. Because each member 201914 extends from
staple driver 201910, the plurality of staples 201902 is driven out
of stapling head assembly 201802 at substantially the same time.
When anvil 201804 is in the closed position, staples 201902 are
driven into staple forming pockets 201936 to bend legs 201938 of
the staples 201902, thereby stapling the material located between
anvil 201804 and stapling head assembly 201808. FIG. 30 depicts by
way of example staple 201902 driven by a member 201914 into a
staple forming pocket 201928 of anvil 201804 to bend legs
201938.
[0444] The motorized circular stapling instrument 201800, 201502,
201532, 201610 described herein with reference to FIGS. 24-30 may
be controlled using any of the control circuits described in
connection with FIGS. 16-23. For example, the control system 470
described with reference to FIG. 16. Further, the motorized
circular stapling instrument 201800, 201502, 201532, 201610 may be
employed in a hub and cloud environment as described in connection
with FIGS. 1-15.
Circular Stapler Control Algorithms
[0445] In various aspects, the present disclosure provides a
powered stapling device that is configured with circular stapler
control algorithms to adjust the force, advancement speed, and
overall stroke of the cutting member of the device based on at
least one sensed parameter of firing or clamping. In another
aspect, the cutting member of the device is independently
actuatable from both firing and closing. In yet another aspect, the
sensed parameter may be a final tissue gap, force during closure,
tissue creep stabilization, or force during firing. Still in other
aspects, the knife actuation is capable of being run in either load
control or stroke control with adjustable limits on the control
parameter. Both maximum applicable force as well as overall total
stroke range can be adjusted. The controlled parameter could have
secondary limits on the non-controlled function. In yet another
aspect, the advancement rate of the cutting member being adjustable
to a predefined rate based on the conditions of the device at the
start of cutting.
Adjustment of Cutting Parameters
[0446] In one aspect, a powered stapling device is configured to
adjust the force, advancement speed, and overall stroke of the
cutting member of the device based on at least one sensed parameter
of firing or clamping. In one aspect, the cutting member of the
device is independently actuatable from both firing and closing. In
another aspect, the sensed parameter comprises the final tissue
gap, force during closure, tissue creep stabilization, or force
during firing. In one aspect, the knife actuation is configured to
be run in either load control or stroke control with adjustable
limits on the control parameter. For example, both maximum
applicable force and overall total stroke range can be adjusted.
The controlled parameter could have secondary limits on the
non-controlled function. In one aspect, the advancement rate of the
cutting member is adjustable to a predefined rate based on the
conditions of the device at the start of cutting.
Adjustment of Closure Rate or Direction Based on Sensed
Attachment
[0447] In various aspects, the closure rate or direction of a
circular stapler, or a combination thereof, can be adjusted based
on the sensed attachment, relative to the fully attached state, of
the anvil. In one aspect, the present disclosure provides a
digitally enabled circular stapler algorithm for determining the
variation the closure rate of the anvil at key locations of the
trocar to ensure proper seating of the anvil on the trocar. FIG. 31
is a diagram 201500 of a powered stapling device 201502 and a graph
201504 illustrating the closure rate adjustment of an anvil 201514
portion of the powered stapling device 201502 at certain key points
along the retraction stroke of a trocar 201510, in accordance with
at least one aspect of the present disclosure. The powered stapling
device 201502 is similar to the motorized circular stapling
instrument 201800 described herein with reference to FIGS. 24-30,
may be controlled using any of the control circuits described in
connection with FIGS. 16-23, and may be employed in a hub and cloud
environment as described in connection with FIGS. 1-15. The anvil
201514 includes an anvil head 201515 and an anvil shank 201517. The
trocar 201510 can be advanced and retracted in the direction
indicated by arrow 201516. In one aspect, the closure rate of the
anvil 210514 can be adjusted at certain key points along the
retraction stroke of the trocar 201510 to improve the final seating
of the anvil 201514 on the trocar 201510 if the trocar 201510 is
marginally attached but not fully attached to the anvil 201514.
[0448] The powered stapling device 201502, shown on the left side
of FIG. 31, includes a circular stapling head assembly 201506 with
a seating collar 201508 that receives the trocar 201510
therethrough. The trocar 201510 engages the anvil 201514 via a
locking feature 201512. The trocar 210510 is movable, e.g.,
advanced and retracted, in the directions indicated by arrow
201516. A cutting element, such as a knife 201519, severs tissue
when the circular stapling head assembly 201506 is driven towards
the anvil 201514. In one aspect, the closure rate of the anvil
201514 can be adjusted at certain key points along the retraction
stroke of the anvil 201510 in order to, for example, improve the
final seating of the anvil 201514 on the trocar 201510 if the
trocar 210510 is marginally attached but not fully attached to the
anvil 201514. Accordingly, the closure rate of the anvil 201514 can
be varied at key locations to ensure proper seating. The position
or displacement of the trocar 210510 as it is advanced or retracted
by a trocar actuator coupled to a motor, as previously described
with reference to FIGS. 24-30, may be detected by a plurality of
proximity sensors disposed along the displacement path of the
trocar 210510. In some aspects, the position or displacement of the
trocar 210510 may be tracked using the tracking system 480 (FIG.
16) or the position sensors 734, 784 (FIGS. 21, 23).
[0449] On the right side of FIG. 31, the graph 201504 illustrates
the closure rate of the anvil 201514 as a function of the position
of the trocar 201510 at certain key points, labeled as ".delta.
Trocar" along the vertical axis and "V.sub.closure mm/sec" along
the horizontal axis, in accordance with at least one aspect of the
present disclosure. An anvil 201514 closure rate velocity profile
curve 201505 is plotted as a function of the position of the trocar
201510. The closure rate of the anvil 201514 can be slow at a first
zone 201518 to ensure proper attachment of the trocar 210510 to the
anvil 201514, faster at a second zone 201520 during closure, slower
again at a third zone 201522 to verify attachment, and then even
slower at a fourth zone 201524 during application of a high closure
load.
[0450] The anvil 201514 closure rate adjustment at certain key
points along the trocar's 201510 retraction stroke improves the
final seating of the anvil 201514 on the trocar 201510 if it
marginally attached but not fully attached. At trocar 201510
position .delta..sub.0 the anvil 201514 is in a fully open position
201521 and at trocar 201510 position .delta..sub.4 the anvil 201514
is in a fully closed position 201523. Between the trocar 201510
fully open position 201521 .delta..sub.0 and fully closed position
.delta..sub.4 the closure rate of the anvil 201514 is adjusted
based on the position of the trocar 201510. For example, at the
first zone 201518, as the trocar 201510 moves from the fully opened
position 201521 .delta..sub.0 to a first trocar 201510 position
.delta..sub.1, the closure rate of the anvil 201514 is slow
(between 0-2 mm/sec) to ensure proper attachment of the anvil
201514 to the trocar 201510. At the second zone 201520, when the
trocar 201510 moves from .delta..sub.1 to .delta..sub.2, the anvil
201514 is closed at a constant quick closure rate (3 mm/sec). When
the trocar 201510 moves from .delta..sub.2 to .delta..sub.3
position, in the third zone 201522, the closure rate of the anvil
201514 is slowed to verify full attachment of the anvil 201514 to
the trocar 201510. Finally, when the trocar 201510 moves from
.delta..sub.3 to .delta..sub.4 position, in the fourth zone 201524,
the closure rate of the anvil 201514 is slowed once again during
high closure loads.
[0451] FIG. 32 is a section view of the powered stapling device
201502 shown in FIG. 31 in a closed configuration, e.g., the
circular stapling head assembly 201506 advanced towards the anvil
201514. As shown in FIG. 32, the circular stapling head assembly
201506 and the trocar 201510 are shown in an advanced configuration
to grasp tissue in the tissue gap 210511 defined between the anvil
201514 and the circular stapling head assembly 201506. As described
herein, the trocar 201510 may be advanced or retracted by a motor
coupled to, for example, a trocar actuator, as previously described
with reference to FIGS. 24-30. A knife 201519 is employed to sever
tissue captured between the anvil 201514 and the trocar 201510. The
knife 201519 is coupled to a motor, which is configured to advance
and retract the knife 201519. A control circuit is employed to
control the motor and to control the rate of advancement/retraction
of the trocar 201510 or the knife 201519 or a combination
thereof.
[0452] FIG. 33 is a logic flow diagram of a process 201700
depicting a control program or a logic configuration to adjust a
closure rate of the anvil 201514 portion of the powered stapling
device 201502 at certain key points along the retraction stroke of
a trocar 201510, in accordance with at least one aspect of the
present disclosure. This process 201700 may be implemented with any
of the control circuits described with reference to FIGS. 16-23.
This process 201700 may be implemented in a hub or cloud computing
environment described with reference to FIGS. 1-15, for
example.
[0453] In particular, the process 201700 depicted in FIG. 33 will
now be described with reference to the control circuit 760 of FIG.
22. The control circuit 760 determines 201702 the position of the
trocar 201510 based on information received from position sensor
784. Alternatively, the position of the trocar 201510 may be
determined based on information received from the sensors 788 or
the timer/counter 781 circuit or a combination thereof. Based on
the position of the trocar 201510, the control circuit 760 controls
the closure rate of the anvil 201514 (V.sub.closure mm/sec) as a
function of the position of the trocar 201510 at certain key
points, in accordance with at least one aspect of the present
disclosure. Accordingly, when the position of the trocar 201510 is
located in a first zone 201518, where the anvil 201514 is attached
to the trocar 201510, the process 201700 continues along the yes
(Y) branch and the control circuit 760 sets 201704 the closure rate
of the anvil 201514 to slow to ensure proper attachment of the
trocar 210510 to the anvil 201514. Otherwise the process 201700
continues along the no (N) branch. When the position of the trocar
201510 is located in a second zone 201520, referred to as a quick
gross closure zone, the process 201700 continues along the yes (Y)
branch and the control circuit 760 sets 201706 the closure rate of
the anvil 201514 to fast to rapidly close the anvil 201514.
Otherwise the process 201700 continues along the no (N) branch.
When the position of the trocar 201510 is located in a third zone
201522, referred to as a verification zone, the process continues
along the yes (Y) branch and the control circuit 760 sets 201708
the closure rate of the anvil 201514 to slow to verify full
attachment of the anvil 201514 to the trocar 201510. Otherwise the
process 201700 continues along the no (N) branch. When the position
of the trocar 201510 is located in a fourth zone 201524, referred
to as a high closure load zone, the process 201700 continues along
the yes (Y) branch and the control circuit 760 sets 201710 the
closure rate of the anvil 201514 to a slower rate than in the
previous verification zone 201522 during the application of a high
closure load. Once the anvil 201514 is fully closed trocar 201510
to capture tissue therebetween, the control circuit 760 actuates
the knife 201519 to sever the tissue.
[0454] In one aspect, the present disclosure provides a digitally
enabled circular stapler adaptive algorithm for determining
multi-directional seating motions on the trocar to drive the anvil
into proper seating. FIG. 34 is a diagram 201530 of a powered
stapling device 201532 and a graph 201534 illustrating detection of
closure rates of the trocar 201540 and the anvil 201544, in
accordance with at least one aspect of the present disclosure. The
powered stapling device 201532 is similar to the motorized circular
stapling instrument 201800 described herein with reference to FIGS.
24-30, may be controlled using any of the control circuits
described in connection with FIGS. 16-23, and may be employed in a
hub and cloud environment as described in connection with FIGS.
1-15. The anvil 201544 includes an anvil head 201545 and an anvil
shank 201547. The trocar 201540 can be advanced and retracted in
the direction indicated by arrow 201546. In one aspect, if the
anvil shank 201547 is detected pulling loose from the trocar
201540, the powered stapling device 210530 could stop retraction or
reverse and advance towards an open position 201541 until the
instability of the anvil 201544 seating is resolved. If the anvil
201544 is pulled fully off, the powered stapling device 210530
could fully open 201541 indicating to the user to try re-attaching
the anvil shank 201547 to the trocar 201540.
[0455] The powered stapling device 201532, shown on the left side
of FIG. 34, includes a circular stapling head assembly 201536 with
a seating collar 201538 that receives the trocar 201540
therethrough. The trocar 201540 engages the anvil 201544 via a
locking feature 201542. The trocar 210540 is movable, e.g.,
advanced and retracted, in the directions indicated by arrow
201546. A cutting element, such as a knife 201548, severs tissue
when the circular stapling head assembly 201536 is driven towards
the anvil 201544.
[0456] In one aspect, the closure rates of the trocar 201540 and
the anvil 201544 can be detected and any discrepancy between the
closure rates of the two components could generate an automatic
extension of the trocar 201540 and then retraction of the trocar
201540 in order to fully seat the anvil 201544 on the trocar
201540. In one aspect, any discrepancy between the closure rates of
the trocar 201540 and the anvil 201544 may be provided to a control
circuit or processor to operate a motor coupled to the trocar
201540 to generate an automatic extension of the trocar 201540 and
then re-retraction in order to fully seat the anvil 201544 on the
trocar 201540. If the anvil shank 201547 is detected pulling loose
from the trocar 201540 the smart powered stapling device 201532
could stop retraction or even reverse and advance towards open
until the instability of seating the anvil 201544 is resolved. If
the anvil 201544 were pulled fully off it could even fully open
indicating to the user to try re-attaching the anvil shank 201547
to the trocar 201540. As shown FIG. 34, the control algorithm can
be configured to extend the trocar 201540 back towards the open
position 201541 to reset the anvil 201544 if an anvil 201544
detachment is sensed, prior to then re-verifying attachment of the
anvil 201544 and proceeding as normal upon confirming that the
anvil 201544 is attached.
[0457] Accordingly, the system can be configured for
multi-directional seating motions on the trocar 201540 to drive the
anvil 201544 into proper seating. For example, if the anvil shank
201547 is detected as pulling loose from the trocar 201540, the
smart powered stapling device 201530 could be configured to stop
retraction or even reverse and advance towards open until the
instability of seating the anvil 201544 is resolved. If the anvil
201544 were pulled fully off, the smart powered stapling device
201532 could even be configured to fully open, indicating to the
user to try reattaching the anvil shank 201547 to the trocar
201540.
[0458] On the right side of FIG. 34, the graph 201534 illustrates
the position of the trocar 201510 as a function of time at certain
key points, labeled as ".delta. Trocar" along the vertical axis and
"t" along the horizontal axis, in accordance with at least one
aspect of the present disclosure. A trocar 201540 position profile
curve 201549 is plotted as a function of time (t). With reference
to the trocar 201540 position profile curve 201549, the trocar
201540 moves from a fully open position 201541 towards a fully
closed position 201543 over a first period 201556 at a quick
closure rate. During a second period 201558, the trocar 201540
moves into the verification zone 201547 where the anvil locking
feature 201542 engages the seating collar 201538, at a slow rate to
verify that the anvil locking feature 201542 has properly engaged
the seating collar 201538. In the illustrated example, an anvil
201544 detached initiation is sensed at time 201552. Upon sensing
that the anvil 201544 is detached, the trocar 201540 is advanced
towards an open position and back over a third period 201560. The
trocar 201540 then moves slowly during a fourth period 201562 until
it is confirmed or verified that the anvil 201544 is attached to
the trocar 201540 at time 201554. Thereafter, the trocar 201540
moves towards the closed position 201543 very slowly during a fifth
period 201564 under high tissue load before the knife 201548 is
advanced to sever the tissue captured between the anvil 201544 and
the circular stapling head assembly 201536.
[0459] FIG. 35 is a logic flow diagram of a process 201720
depicting a control program or a logic configuration to detect
multi-directional seating motions on the trocar 201540 to drive the
anvil 201544 into proper seating, in accordance with at least one
aspect of the present disclosure. This process 201720 may be
implemented with any of the control circuits described herein with
reference to FIGS. 16-23. This process 201720 may be implemented in
a hub or cloud computing environment described with reference to
FIGS. 1-15, for example.
[0460] In particular, the process 201720 depicted in FIG. 35 will
now be described with reference to the control circuit 760 of FIG.
22. The control circuit 760 determines 201722 the closure rate of
the trocar 201540 based on information received from position
sensor 784. The control circuit 760 then determines 201724 the
closure rate of the anvil 201544 based on information received from
position sensor 784. Alternatively, the closure rate of the trocar
201540 or the anvil 201544 may be determined based on information
received from the sensors 788 or the timer/counter 781 circuit or a
combination thereof. The control circuit 760 compares 207126 the
closure rates of the trocar 201540 and the anvil 201544. When there
is no discrepancy between the closure rates of the trocar 201540
and the anvil 201544, the process 201720 continues along the no (N)
branch and loops until there is a discrepancy between the closure
rates of the trocar 201540 and the anvil 201544. When there is a
discrepancy between the closure rates of the trocar 201540 and the
anvil 201544, the process 201720 continues along the yes (Y) branch
and the control circuit 760 extends and retracts 207128 the trocar
201540 to reset the anvil 201544. Subsequently, the process 201720
verifies 201130 the attachment of the trocar 201540 and anvil
201544. If the attachment is verified, the process 201720 continues
along the yes (Y) branch and the control circuit 760 slows 207132
the closure rate of the trocar 201540 under tissue load. If the
attachment is not verified, the process 201720 continues along the
no (N) branch and loops until the attachment of the trocar 201540
to the anvil 201544 is verified. Once the anvil 201544 is fully
closed on the trocar 201540 to capture tissue therebetween, the
control circuit 760 actuates the knife 201548 to sever the
tissue.
Adjustment of Knife Speed/End Points Based on Tissue Parameters
[0461] In various aspects, the knife speed of a circular stapler
and end points can be adjusted based on the sensed toughness or
thickness of the tissue between the anvil and cartridge.
Accordingly, the circular stapler control algorithm can be
configured to detect the tissue gap and force-to-fire to adjust the
knife stroke and speed. In one aspect, the present disclosure
provides a digitally enabled circular stapler adaptive algorithm
for detecting tissue gap and force-to-fire to adjust knife stroke
and knife speed, in accordance with at least one aspect of the
present disclosure.
[0462] Generally, FIGS. 36-38 represent a circular powered stapling
device 201610 and a series of graphs depicting force-to-close (FTC)
a clamp relative to the position of the anvil 201612
(.delta..sub.Anvil) and knife 201616 velocity (V.sub.K) and knife
201616 force (F.sub.K) relative to the position of the knife 201616
(.delta..sub.Knife), in accordance with at least one aspect of the
present disclosure. Using sensed data at different points along
length of the shank 201621, a control algorithm can generate a map
of tissue gap or reaction force vector of the anvil 201612,
monitoring for a high or low side when compressed on tissue. When
firing, the system measures forces acting on a compression element
201620 comprising a force sensor and adjusts to act evenly along
the force vector of the shank to provide even and complete
cutting.
[0463] In particular, FIG. 36 is a partial schematic diagram of a
circular powered stapling device 201610 showing anvil 201612
closure on the left side and knife 201616 actuation on the right
side, in accordance to at least one aspect of the present
disclosure. The circular powered stapling device 201610 comprises
an anvil 201612 that is movable from a fully open position
.delta..sub.A2 to a fully closed position .delta..sub.A0. An
intermediate position .delta..sub.A1 represents the point at which
the anvil 201612 contacts tissue located between the anvil 201612
and the circular stapler 201614. One or more position sensors
located along the length of the anvil shank 201621 monitor the
position of the anvil 201612. In one aspect, the position sensor
may be located within the seating collar 201618. The compression
element 201620 may comprise a force sensor, such as a strain gauge
for example, to monitor the force applied to the tissue and to
detect the point of initial contact of the anvil 201612 with the
tissue, shown as intermediate position .delta..sub.A1. The position
sensor and the force sensor interface with any of the control
circuits described herein with reference to FIGS. 16-23, for
example, which implement the circular stapler control algorithm.
The circular powered stapling device 201610 also comprises a
movable cutting element such as a knife 201616 that is movable from
a fully retracted position .delta..sub.A0 to a fully extended
position .delta..sub.A2 to achieve a complete tissue cut. The
intermediate position .delta..sub.A1 of the knife 201616 represents
the point at which the knife 201616 contacts with the compression
element 201620 comprising a strain gauge or other contact or
proximity sensor.
[0464] The power stapling device 201610 includes motors, sensors,
and control circuits as described herein in connection with FIGS.
16-30. The motors are controlled by the control circuits to move
the anvil 201612 and the knife 201616. One or more position sensors
located on the power stapling device 201610 provide the position of
the anvil 201612 and the knife 201616 to the control circuit.
Additional sensors such as force sensors 201620 also provide tissue
contact and force acting on the anvil 201612 and the knife 201616
to the control circuit. The control circuit employs the position of
the anvil 201612, the position of the knife 201616, initial tissue
contact, or force acting of the anvil 201612 or knife 201616 to
implement the circular stapler control algorithm described
hereinbelow in connection with FIG. 39.
[0465] FIG. 37 is a graphical representation 201600 of anvil 201612
displacement (.delta..sub.Anvil) along the vertical axis as a
function of force-to-close (FTC) a clamp along the horizontal axis,
in accordance with at least one aspect of the present disclosure.
The vertical line represents a FTC threshold 201606 that indicates
tissue toughness. The left side of the FTC threshold 201606
represents tissue having normal toughness and the right side of the
FTC threshold 201606 represents tissue having heavy toughness. As
the anvil 201612 is retracted from the fully open position
.delta..sub.A2 to the intermediate position .delta..sub.A1, where
the anvil 201612 initially contacts tissue, the FTC is
substantially low (.about.0). As the anvil 201612 continues closing
past this point towards the circular stapler 201614 to the fully
retracted position .delta..sub.A0 minus the compressed tissue
thickness, the FTC is nonlinear. Each tissue type from normal to
heavy toughness will produce a different FTC curve. For example,
the first FTC curve 201604, shown in broken line, spans from
.about.0 to .about.100 lbs., where the maximum FTC is below the FTC
threshold 201606. The second FTC curve 201602, shown in solid line,
spans from .about.0 to .about.200 lbs., where the maximum FTC
exceeds the FTC threshold 201606. As previously discussed, the FTC
is measured by force sensors located in the compression element
201620 and coupled to the control circuit.
[0466] FIG. 38 is a graphical representation 201630 of knife 201616
displacement (.delta..sub.Knife) along the vertical axis as a
function of knife 201616 velocity (V.sub.K mm/sec) along the
horizontal axis on the left and also as a function of knife 201616
force (F.sub.K lbs) along the horizontal axis on the right, in
accordance with at least one aspect of the present disclosure. On
the left is a graphical representation 201632 of knife 201616
displacement (.delta..sub.Knife) along the vertical axis as a
function of knife 201616 velocity (V.sub.K mm/sec) along the
horizontal axis. On the right is a graphical representation 201634
of knife 201616 displacement (.delta..sub.Knife) along the vertical
axis as a function of knife 201616 force (F.sub.K lbs) along the
horizontal axis. The curves in dashed line 201638, 20142 in each of
the graphical representations 201632, 201634 represent tissue of
normal toughness whereas the curves in solid line 201636, 201640
represent tissue of heavy toughness.
[0467] Turning to the graphical representation 201632 on the left,
for normal tissue toughness, as shown by the normal tissue knife
velocity profile 201638, the initial velocity of the knife 201616
for normal tissue toughness starts at a first velocity, e.g., just
over 4 mm/sec, at the initial knife position .delta..sub.K0. The
knife 201616 continues at that velocity until it reaches knife
position .delta..sub.K1 where the knife 201616 contacts tissue and
slows the velocity of the knife 201616 as it cuts through the
tissue until the knife 201616 reaches knife position .delta..sub.K2
indicating a complete cut and the control circuit stops the motor
and hence stops the knife 201616. Turning to the graphical
representation 201634 on the right, for normal tissue toughness, as
shown by the normal tissue knife force curve 201642, the force
acting on the knife 201616 is 0 lbs. at the initial knife position
.delta..sub.K0 and varies nonlinearly until the knife 201616
reaches knife position .delta..sub.K2 until the cut is
complete.
[0468] Turning to the graphical representation 201632 on the left,
for heavy tissue toughness, as shown by the heavy tissue knife
velocity profile 201636, the initial velocity of the knife 201616
for heavy tissue toughness starts at a second velocity, e.g., just
over 3 mm/sec, which is lower relative to the first velocity, at
the initial knife position .delta..sub.K0, which is less than the
initial velocity for normal tissue toughness. The knife 201616
continues at that velocity until it reaches knife position
.delta..sub.K1 where the knife 201616 contacts tissue. At this
point the velocity of the knife 201616 starts to slow down
nonlinearly as it cuts through the tissue for a short displacement
of the knife 201616. The control circuit detects that the knife
201616 contacted tissue and in response increases the velocity of
the motor to increase the velocity of the knife 201616, e.g., to
the initial velocity until the knife 201616, until the knife 201616
reaches position .delta. indicating a complete cut and the control
circuit stops the motor and hence stops the knife 201616. This is
shown as velocity spike 201644 to improve cutting of tissue of
heavy toughness. Turning to the graphical representation 201634 on
the right, for heavy tissue toughness, as shown by the heavy tissue
knife force curve 201640, the force acting on the knife 201616 is 0
lbs. at the initial knife position .delta..sub.K0 and varies
nonlinearly until the knife 201616 reaches knife position
.delta..sub.K2 and the cut is complete. A comparison of the normal
and heavy tissue knife force curves 201640, 201642 shows that, with
lower velocity and adding the velocity spike 201644 shortly after
tissue contact with the knife 201616, the knife 201616 experiences
a lower force when cutting tissue of heavy toughness than it
experiences when cutting tissue of normal toughness.
[0469] FIG. 39 is a logic flow diagram of a process 201720
depicting a control program or a logic configuration to detect the
tissue gap and force-to-fire to adjust the knife stroke and speed,
in accordance with at least one aspect of the present disclosure.
This process 201750 may be implemented with any of the control
circuits described with reference to FIGS. 16-23. This process
201750 may be implemented in a hub or cloud computing environment
described with reference to FIGS. 1-15, for example.
[0470] In particular, the process 201750 depicted in FIG. 39 will
now be described with reference to the control circuit 760 of FIG.
22 and the circular powered stapling device 201610 shown in FIGS.
36-38. The control circuit 760 monitors 201752 the displacement of
the anvil 201612 based on position feedback received from the
position sensor 784. As previously discussed, in one aspect, the
position sensor 784 may be embedded in the shank 201612 of the
anvil 201612. As the anvil 201612 is displaced, the control circuit
760 monitors 201754 contact of the anvil 201612 with tissue
positioned between the anvil 201612 and the circular stapler
201614. In one aspect, tissue contact may be provided by a force
sensor embedded in the compression element 201620. The force sensor
is represented as the sensors 788 element of the surgical
instrument 790 shown in FIG. 22. The force sensor 788 is employed
to monitor 201756 the force-to-close (FTC) a clamp, which is the
closing force of the anvil 201612 onto the tissue positioned
between the anvil 201612 and the circular stapler 201614. The
control circuit 760 compares 201758 the FTC to a predetermined
threshold. When the FTC is below the predetermined threshold, the
control circuit 760 sets the velocity of the motor 754 to advance
201760 the knife 201616 using a normal tissue toughness velocity
profile 201638 as shown in FIG. 38. When the FTC is above the
predetermined threshold, the control circuit 760 sets the velocity
of the motor 754 to advance 201762 the knife 201616 using a heavy
tissue toughness velocity profile 201636 with a velocity spike
201644 as shown in FIG. 38.
[0471] FIG. 40 is a logic flow diagram of a process 201762
depicting a control program or a logic configuration to advance
201762 the knife 201616 under a heavy tissue toughness velocity
profile 201636 with a velocity spike 201644 as shown in FIG. 38, in
accordance with at least one aspect of the present disclosure. This
process 201762 may be implemented with any of the control circuits
described with reference to FIGS. 16-23. This process 201750 may be
implemented in a hub or cloud computing environment described with
reference to FIGS. 1-15, for example.
[0472] In particular, the process 201762 depicted in FIG. 40 will
now be described with reference to the control circuit 760 of FIG.
22 and the circular powered stapling device 201610 shown in FIGS.
36-38. When heavy tissue toughness is detected, the control circuit
760 sets 201770 the initial velocity of the knife 201616 a lower
knife velocity relative to the knife velocity used for cutting
normal tissue toughness. In one aspect, a slower knife velocity in
heavy tissue toughness conditions promotes a better cut. The
control circuit 760 monitors 201772 when the knife 201616 contacts
the tissue. As previously discussed, tissue contact may be detected
by a force sensor embedded in the compression element 201620. As
shown in FIG. 38, when the knife 201616 contacts tissue the knife
201616 naturally slows down. Accordingly, once the control circuit
760 detects that the knife 201616 has contacted tissue, the tissue
contact is detected, the control circuit 760 increases 201774 the
velocity of the motor 754 to increase the velocity of the knife
201616 cutting through the tissue. The control circuit 760 monitors
201776 the completion of the cut and maintains 201778 the velocity
of the motor 740 until completion of the cut is detected and then
stops 201780 the motor 740.
[0473] Various aspects of the subject matter described herein are
set out in the following numbered examples:
Example 1
[0474] A surgical stapling instrument comprising: an end effector
configured to clamp a tissue; a cutting member; a motor coupled to
the cutting member, the motor configured to move the cutting member
between a first position and a second position; and a control
circuit coupled to the motor, the control circuit configured to:
sense a parameter associated with clamping of the end effector; and
control the motor to adjust a torque applied to the cutting member
by the motor.
Example 2
[0475] The surgical stapling instrument of Example 1, wherein the
cutting member is independently actuatable from the end
effector.
Example 3
[0476] The surgical stapling instrument of any one of Examples 1-2,
wherein the parameter comprises a tissue gap, force during closure
of the end effector, tissue creep stabilization, or force during
firing, or any combination thereof.
Example 4
[0477] The surgical stapling instrument of any one of Examples 1-3,
wherein the control circuit is configured to control the motor to
drive the cutting member in either a load control mode or a stroke
control mode according to an adjustable control parameter.
Example 5
[0478] The surgical stapling instrument of any one of Examples 1-4,
wherein the control circuit is configured to control an advancement
rate at which the motor drives the cutting member according to
initial conditions as the motor begins driving the cutting member
from the first position.
Example 6
[0479] The surgical instrument of any one of Examples 1-5, wherein
the control circuit is configured to control the motor to adjust a
speed at which the motor drives the cutting member.
Example 7
[0480] The surgical instrument of any one of Examples 1-6, wherein
the control circuit is configured to control the motor to adjust a
distance to which the motor drives the cutting member according to
the parameter.
Example 8
[0481] The surgical instrument of any one of Examples 1-7, wherein
the control circuit is configured to control the motor to adjust
any combination of the torque, the speed, or the distance.
Example 9
[0482] A surgical stapling instrument comprising: an end effector
configured to clamp a tissue; a cutting member; a motor coupled to
the cutting member, the motor configured to move the cutting member
between a first position and a second position; and a control
circuit coupled to the motor, the control circuit configured to:
sense a parameter associated with firing of the cutting member; and
control the motor to adjust a torque applied to the cutting member
by the motor.
Example 10
[0483] The surgical stapling instrument of Example 9, wherein the
cutting member is independently actuatable from the end
effector.
Example 11
[0484] The surgical stapling instrument of any one of Examples
9-10, wherein the parameter comprises a tissue gap, force during
closure of the end effector, tissue creep stabilization, or force
during firing, or any combination thereof.
Example 12
[0485] The surgical stapling instrument of any one of Examples
9-11, wherein the control circuit is configured to control the
motor to drive the cutting member in either a load control mode or
a stroke control mode according to an adjustable control
parameter.
Example 13
[0486] The surgical stapling instrument of any one of Examples
9-12, wherein the control circuit is configured to control an
advancement rate at which the motor drives the cutting member
according to initial conditions as the motor begins driving the
cutting member from the first position.
Example 14
[0487] The surgical instrument of any one of Examples 9-13, wherein
the control circuit is configured to control the motor to adjust a
speed at which the motor drives the cutting member.
Example 15
[0488] The surgical instrument of any one of Examples 9-14, wherein
the control circuit is configured to control the motor to adjust a
distance to which the motor drives the cutting member according to
the parameter.
Example 16
[0489] The surgical instrument of any one of Examples 9-15, wherein
the control circuit is configured to control the motor to adjust
any combination of the torque, the speed, or the distance.
Example 17
[0490] A powered stapling device, comprising: a circular stapling
head assembly; an anvil; a trocar coupled to the anvil and coupled
to a motor, wherein the motor in configured to advance and retract
the trocar; and a control circuit coupled to the motor, wherein the
control circuit is configured to: determine a position of the
trocar in one of a plurality of zones; and set an anvil closure
rate based on the determined position of the trocar.
Example 18
[0491] The powered stapling device of Example 17, wherein the
plurality of zones comprises: a first zone during attachment of the
trocar to the anvil; a second zone during retraction of the trocar
and closure of the anvil; a third zone during verification of
attachment of the trocar to the anvil; and a fourth zone during
application of a high closure load.
Example 19
[0492] The powered stapling device of any one of Examples 17-18,
wherein the control circuit is configured to: set the closure rate
of the anvil to a first velocity when the trocar is in the first
zone to ensure proper attachment of the trocar to the anvil; set
the closure rate of the anvil to a second velocity, which is
greater than the first velocity, when the trocar is in the second
position during the retraction of the trocar and the closure of the
anvil; set the closure rate of the anvil to a third velocity, which
is less than the second velocity, to verify attachment of the
trocar to the anvil; set the closure rate of the anvil to a fourth
velocity, which is less than the third velocity, when the trocar is
the fourth zone during application of a high closure load.
Example 20
[0493] The powered stapling device of any one of Examples 17-19,
wherein the control circuit is configured to: determine the closure
rate of the trocar; determine the closure rate of the anvil;
compare the closure rate of the trocar to the closure rate of the
anvil to determine a difference between the closure rate of the
trocar to the closure rate of the anvil; and at a difference
greater than a predetermined value, extend and retract the trocar
to reset the anvil.
Example 21
[0494] The powered stapling device of any one of Examples 17-20,
wherein the control circuit is configured to verify attachment of
the trocar to the anvil and to slow the closure rate of the trocar
under tissue load.
Example 22
[0495] The powered stapling device of any one of Examples 17-21,
further comprising: a knife coupled to the motor; a sensor located
on the anvil, wherein the sensor is configured to detect tissue
contact and force applied to the anvil, wherein the sensor is
coupled to the anvil, wherein the control circuit is configured to:
monitor anvil displacement; monitor tissue contact with the anvil;
monitor a force to close of the anvil; compare the force to close
to a predetermined threshold; and set a first initial knife
velocity and advance the knife at a first velocity profile suitable
for cutting normal tissue toughness when the force to close is less
than the predetermined threshold; or set a second initial knife
velocity and advance the knife at a second velocity profile
suitable for cutting heavy tissue toughness when the force to close
is greater than or equal to the predetermined threshold.
Example 23
[0496] The powered stapling device of any one of Examples 17-22,
wherein to advance the knife at the second velocity profile, the
control circuit is further configured to: set the second initial
knife velocity to a velocity that is less than the first initial
knife velocity; monitor knife contact with tissue; increase motor
velocity to increase knife velocity when tissue contact is
detected; monitor completion of cut; and stop the motor when
completion of cut is detected.
[0497] While several forms have been illustrated and described, it
is not the intention of 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.
[0498] 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.
[0499] 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).
[0500] As used in any aspect herein, the term "control circuit" may
refer to, for example, hardwired circuitry, programmable circuitry
(e.g., a computer processor including 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.
[0501] 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.
[0502] 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.
[0503] 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.
[0504] 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.
[0505] 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.
[0506] 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.
[0507] 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", and "down" 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.
[0508] 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.
[0509] 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."
[0510] 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.
[0511] 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.
[0512] 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.
[0513] 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.
* * * * *