Variation of radio frequency and ultrasonic power levels in conjunction with different clamp arm pressures to achieve a given heat flux or power applied to the tissue.

Abstract

To disclose a surgical instrument and a system and method for using the surgical instrument.SOLUTION: A surgical instrument comprises an end effector comprising an ultrasonic blade and clamp arm, an electrode, an ultrasonic transducer, and a sensor coupled to a control circuit. The electrode receives electrosurgical energy from a generator and applies the electrosurgical energy to the end effector to weld a tissue based on the generator generating a drive signal. The ultrasonic transducer ultrasonically oscillates the ultrasonic blade in response to the drive signal. The control circuit receives a signal from the sensor indicative of a surgical parameter, determines a weld time of a surgical operation based on the sensor signal, and varies one or more of a clamp arm pressure applied by the clamp arm and a power level of the electrosurgical energy to maintain one or more of a predefined heat flux or power applied to tissue loaded in the end effector.SELECTED DRAWING: Figure 24A

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Nonprovisional Patent Application No. 16 / 182,235, filed November 6, 2018, entitled "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," the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 729,195, filed September 10, 2018, entitled “ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION LOCATION,” the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 692,747, filed June 30, 2018, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE," U.S. Provisional Patent Application No. 62 / 692,748, filed June 30, 2018, entitled "SMART ENERGY ARCHITECTURE," and U.S. Provisional Patent Application No. 62 / 692,768, filed June 30, 2018, entitled "SMART ENERGY DEVICES," the disclosures of each of which are incorporated herein by reference in their entireties.

[0004] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," the disclosures of which are incorporated herein by reference in their entireties.

[0005] This application is further incorporated by reference under 35 U.S.C. §119(e) in its entirety with respect to U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," U.S. Provisional Patent Application No. 62 / 650,887, filed March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," U.S. Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and U.S. Provisional Patent Application No. 62 / 650,883, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND METHOD FOR INTERACTIVE SURGICAL PLATFORM," each of which is hereby incorporated by reference in its entirety. This application claims priority to U.S. Provisional Patent Application No. 62 / 650,877, filed March 30, 2018, entitled "METHOD CONTROLS."

[0006] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and U.S. Provisional Patent Application No. 62 / 640,415, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR," the disclosures of each of which are incorporated herein by reference in their entireties.

[0007] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017; and U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety. [Background technology]

[0008] The present disclosure relates to various surgical systems. Surgical procedures are typically performed in an operating room or room within a medical facility, such as a hospital. A sterile field is typically formed around the patient. The sterile field may include properly clothed, cleansed team members, as well as all equipment and fixtures within the area. Various surgical devices and systems are utilized in the performance of the surgical procedure. [Brief description of the drawings]

[0009] The various aspects described herein, both as to organization and method of operation, together with further objects and advantages thereof, can best be understood by reference to the following description taken in conjunction with the accompanying drawings in which: [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Diagram 2] 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one embodiment of the present disclosure. [Diagram 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. [Figure 4]FIG. 13 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, according to at least one embodiment of the present disclosure. [Diagram 5] FIG. 1 is a perspective view of a combination generator module including bipolar, ultrasonic, and monopolar contacts and smoke evacuation components according to at least one embodiment of the present disclosure. [Figure 6] 1 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a vertical modular housing configured to receive a plurality of modules, according to at least one embodiment of the present disclosure. [Figure 8] 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room in a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one embodiment of the present disclosure. [Figure 9] 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates a surgical hub comprising a plurality of modules coupled to a modular control tower in accordance with at least one embodiment of the present disclosure. [Figure 11] 1 illustrates one embodiment of a Universal Serial Bus (USB) network hub device in accordance with at least one embodiment of the present disclosure. [Figure 12] FIG. 1 is a block diagram of a cloud computing system including a plurality of smart surgical instruments coupled to a surgical hub that can be connected to a cloud component of the cloud computing system in accordance with at least one aspect of the present disclosure. [Figure 13] 1 is a functional module architecture of a cloud computing system in accordance with at least one aspect of the present disclosure. [Figure 14] FIG. 1 is a diagram of a situationally aware surgical system according to at least one aspect of the present disclosure. [Figure 15] 1 is a timeline illustrating situational awareness of a surgical hub, in accordance with at least one embodiment of the present disclosure. [Figure 16] FIG. 1 is a circuit diagram of a robotic surgical instrument configured to operate the surgical tools described herein, in accordance with at least one aspect of the present disclosure. [Figure 17] FIG. 1 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member, in accordance with at least one embodiment of the present disclosure. [Figure 18] FIG. 1 is a circuit diagram of a surgical instrument configured to control various functions, according to at least one embodiment of the present disclosure. [Figure 19] 1 illustrates an embodiment of a generator in accordance with at least one aspect of the present disclosure. [Figure 20] FIG. 2 is a structural diagram of a generator architecture, in accordance with at least one embodiment of the present disclosure. [Figure 21] 1 illustrates a generator circuit split into multiple stages, with a first stage circuit in common with a second stage circuit, in accordance with at least one embodiment of the present disclosure. [Figure 22] 1 shows a diagram of one embodiment of a surgical instrument with a feedback system for use with the surgical instrument, according to one embodiment of the recited disclosure. [Figure 23A] 1 is a graph including a graph of clamping force as a function of time and an associated graph showing progression of coagulation and cut position along the length of the blade as a function of time, according to at least one embodiment of the present disclosure. [Figure 23B] 1 is a graph including a graph of clamping force as a function of time and an associated graph showing progression of coagulation and cut position along the length of the blade as a function of time, according to at least one embodiment of the present disclosure. [Figure 24A] 13A-13C show examples of controlling the clamping force applied and electrosurgical energy delivered by segments of an end effector electrode and an end effector, according to at least one embodiment of the present disclosure. [Figure 24B] 13A-13C show examples of controlling the clamping force applied and electrosurgical energy delivered by segments of an end effector electrode and an end effector, according to at least one embodiment of the present disclosure. [Figure 25A] 11 is a graph illustrating control of energization or power delivery of an electrosurgical electrode in accordance with at least one embodiment of the present disclosure. [Figure 25B] 11 is a graph illustrating control of energization or power delivery of an electrosurgical electrode in accordance with at least one embodiment of the present disclosure. [Figure 26A] 11 is a series of graphs illustrating adjustment of power levels to achieve predictable sealing times in accordance with at least one embodiment of the present disclosure. [Figure 26B] 11 is a series of graphs illustrating adjustment of power levels to achieve predictable sealing times in accordance with at least one embodiment of the present disclosure. [Figure 26C] 11 is a series of graphs illustrating adjustment of power levels to achieve predictable sealing times in accordance with at least one embodiment of the present disclosure. [Figure 26D] 11 is a series of graphs illustrating adjustment of power levels to achieve predictable sealing times in accordance with at least one embodiment of the present disclosure. [Figure 26E] 11 is a series of graphs illustrating adjustment of power levels to achieve predictable sealing times in accordance with at least one embodiment of the present disclosure. [Figure 27A] 1 is a graph and flow chart illustrating an approach for delivering energy according to a power curve, in accordance with at least one embodiment of the present disclosure. [Figure 27B] 1 is a graph and flow chart illustrating an approach for delivering energy according to a power curve, in accordance with at least one embodiment of the present disclosure. [Figure 27C] 1 is a graph and flow chart illustrating an approach for delivering energy according to a power curve, in accordance with at least one embodiment of the present disclosure. [Figure 27D]1 is a graph and flow chart illustrating an approach for delivering energy according to a power curve, in accordance with at least one embodiment of the present disclosure. [Figure 27E] 1 is a graph and flow chart illustrating an approach for delivering energy according to a power curve, in accordance with at least one embodiment of the present disclosure. [Figure 27F] 1 is a graph and flow chart illustrating an approach for delivering energy according to a power curve, in accordance with at least one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The applicant of this application owns the following U.S. patent applications, filed November 6, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: No. 16 / 182,224, entitled “SURGICAL NETWORK, INSTRUMENT, AND CLOUD RESPONSES BASED ON VALIDATION OF RECEIVED DATASET AND AUTHENTICATION OF ITS SOURCE AND INTEGRITY”; U.S. Patent Application No. 16 / 182,230, entitled "SURGICAL SYSTEM FOR PRESENTING INFORMATION INTERPRETED FROM EXTERNAL DATA"; U.S. Patent Application Serial No. 16 / 182,233, entitled "MODIFICATION OF SURGICAL SYSTEMS CONTROL PROGRAMS BASED ON MACHINE LEARNING"; U.S. Patent Application Serial No. 16 / 182,239, entitled “ADJUSTMENT OF DEVICE CONTROL PROGRAMS BASED ON STRATIFIED CONTEXTUAL DATA IN ADDITION TO THE DATA”; U.S. Patent Application No. 16 / 182,243, entitled "SURGICAL HUB AND MODULAR DEVICE RESPONSE ADJUSTMENT BASED ON SITUATIONAL AWARENESS"; U.S. patent application Ser. No. 16 / 182,248, entitled "DETECTION AND ESCALATION OF SECURITY RESPONSES OF SURGICAL INSTRUMENTS TO INCREASING SEVERITY THREATS"; · U.S. Patent Application Serial No. 16 / 182,251, entitled "INTERACTIVE SURGICAL SYSTEM"; U.S. Patent Application Serial No. 16 / 182,260, entitled “AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN SURGICAL NETWORKS”; U.S. patent application Ser. No. 16 / 182,267, entitled “SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO A SURGICAL NETWORK”; U.S. Patent Application Serial No. 16 / 182,249, entitled “POWERED SURGICAL TOOL WITH PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING END EFFECTOR PARAMETER”; U.S. Patent Application Serial No. 16 / 182,246, entitled "ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES"; U.S. Patent Application Serial No. 16 / 182,256, entitled "ADJUSTMENT OF A SURGICAL DEVICE FUNCTION BASED ON SITUATIONAL AWARENESS"; U.S. Patent Application Serial No. 16 / 182,242, entitled “REAL-TIME ANALYSIS OF COMPREHENSIVE COST OF ALL INSTRUMENTATION USED IN SURGERY UTILIZING DATA FLUIDITY TO TRACK INSTRUMENTS THROUGH STOCKING AND IN-HOUSE PROCESSES”; U.S. Patent Application No. 16 / 182,255, entitled “USAGE AND TECHNIQUE ANALYSIS OF SURGEON / STAFF PERFORMANCE AGAINST A BASELINE TO OPTIMIZE DEVICE UTILIZATION AND PERFORMANCE FOR BOTH CURRENT AND FUTURE PROCEDURES”; U.S. Patent Application Serial No. 16 / 182,269, entitled “IMAGE CAPTURING OF THE AREAS OUTSIDE THE ABDOMEN TO IMPROVE PLACEMENT AND CONTROL OF A SURGICAL DEVICE IN USE”; No. 16 / 182,278, entitled “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”; U.S. Patent Application Serial No. 16 / 182,290, entitled "SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION"; U.S. Patent Application Serial No. 16 / 182,232, entitled "CONTROL OF A SURGICAL SYSTEM THROUGH A SURGICAL BARRIER"; U.S. patent application Ser. No. 16 / 182,227, entitled "SURGICAL NETWORK DETERMINATION OF PRIORITIZATION OF COMMUNICATION, INTERACTION, OR PROCESSING BASED ON SYSTEM OR DEVICE NEEDS"; U.S. Patent Application Serial No. 16 / 182,231, entitled "WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF DEVICES"; U.S. Patent Application Serial No. 16 / 182,229, entitled “ADJUSTMENT OF STAPLE HEIGHT OF AT LEAST ONE ROW OF STAPLES BASED ON THE SENSED TISSUE THICKNESS OR FORCE IN CLOSING”; U.S. patent application Ser. No. 16 / 182,234, entitled "STAPLING DEVICE WITH BOTH COMPULSORY AND DISCRETIONARY LOCKOUTS BASED ON SENSED PARAMETERS"; No. 16 / 182,240, entitled “POWERED STAPLING DEVICE CONFIGURED TO ADJUST FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER BASED ON SENSED PARAMETER OF FIRING OR CLAMPING”; and U.S. Patent Application No. 16 / 182,238, entitled “ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION LOCATION.”

[0011] The applicant of this application owns the following U.S. patent applications, filed September 10, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Provisional Patent Application No. 62 / 729,183, entitled “A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR USAGE”; No. 62 / 729,177, entitled “AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION”; No. 62 / 729,176, entitled “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”; U.S. Provisional Patent Application No. 62 / 729,185, entitled “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”; U.S. Provisional Patent Application No. 62 / 729,184, entitled “POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING AT LEAST ONE END EFFECTOR PARAMETER AND A MEANS FOR LIMITING THE ADJUSTMENT”; U.S. Provisional Patent Application No. 62 / 729,182, entitled “SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB”; U.S. Provisional Patent Application No. 62 / 729,191, entitled “SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION”; U.S. Provisional Patent Application No. 62 / 729,195, entitled “ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION LOCATION”; and · U.S. Provisional Patent Application No. 62 / 729,186, entitled “WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF DEVICES.”

[0012] The applicant of this application owns the following U.S. patent applications, filed August 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Patent Application Serial No. 16 / 115,214, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR"; · U.S. Patent Application Serial No. 16 / 115,205, entitled “TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”; U.S. Patent Application No. 16 / 115,233, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS"; U.S. Patent Application Serial No. 16 / 115,208, entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION”; U.S. Patent Application Serial No. 16 / 115,220, entitled “CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE”; · U.S. Patent Application Serial No. 16 / 115,232, entitled “DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM”; U.S. Patent Application Serial No. 16 / 115,239, entitled “DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT”; · U.S. Patent Application Serial No. 16 / 115,247, entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR"; · U.S. Patent Application Serial No. 16 / 115,211, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS"; U.S. Patent Application Serial No. 16 / 115,226, entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT"; U.S. Patent Application Serial No. 16 / 115,240, entitled “DETECTION OF END EFFECTOR IMMERSION IN LIQUID”; U.S. Patent Application No. 16 / 115,249, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING"; U.S. Patent Application Serial No. 16 / 115,256, entitled “INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP”; U.S. Patent Application Serial No. 16 / 115,223, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," and · U.S. Patent Application No. 16 / 115,238, entitled “ACTIVATION OF ENERGY DEVICES.”

[0013] The applicant of this application owns the following U.S. patent applications, filed August 23, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: · U.S. Provisional Patent Application No. 62 / 721,995, entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION”; · U.S. Provisional Patent Application No. 62 / 721,998, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS"; U.S. Provisional Patent Application No. 62 / 721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING"; U.S. Provisional Patent Application No. 62 / 721,994, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY"; and · U.S. Provisional Patent Application No. 62 / 721,996, entitled “RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS.”

[0014] The applicant of this application owns the following U.S. patent applications, filed June 30, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: · U.S. Provisional Patent Application No. 62 / 692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE"; · U.S. Provisional Patent Application No. 62 / 692,748, entitled "SMART ENERGY ARCHITECTURE"; and · U.S. Provisional Patent Application No. 62 / 692,768, entitled “SMART ENERGY DEVICES.”

[0015] The applicant of this application owns the following U.S. patent applications, filed June 29, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Patent Application Serial No. 16 / 024,090, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS"; U.S. Patent Application Serial No. 16 / 024,057, entitled “CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS”; U.S. Patent Application Serial No. 16 / 024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION"; · U.S. Patent Application Serial No. 16 / 024,075, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING"; · U.S. Patent Application Serial No. 16 / 024,083, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING"; U.S. Patent Application No. 16 / 024,094, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES"; U.S. Patent Application No. 16 / 024,138, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE"; · U.S. Patent Application Serial No. 16 / 024,150, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES"; · U.S. Patent Application Serial No. 16 / 024,160, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY"; · U.S. Patent Application Serial No. 16 / 024,124, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; · U.S. Patent Application Serial No. 16 / 024,132, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT"; U.S. Patent Application Serial No. 16 / 024,141, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY"; U.S. Patent Application Serial No. 16 / 024,162, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES"; · U.S. Patent Application Serial No. 16 / 024,066, entitled “SURGICAL EVACUATION SENSING AND MOTOR CONTROL”; · U.S. Patent Application Serial No. 16 / 024,096, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS"; · U.S. Patent Application Serial No. 16 / 024,116, entitled "SURGICAL EVACUATION FLOW PATHS"; · U.S. Patent Application Serial No. 16 / 024,149, entitled “SURGICAL EVACUATION SENSING AND GENERATOR CONTROL”; · U.S. Patent Application Serial No. 16 / 024,180, entitled “SURGICAL EVACUATION SENSING AND DISPLAY”; U.S. Patent Application No. 16 / 024,245, entitled “COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”; U.S. Patent Application No. 16 / 024,258, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Patent Application Serial No. 16 / 024,265, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and · U.S. Patent Application No. 16 / 024,273, entitled “DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.”

[0016] The applicant of this application owns the following U.S. provisional patent applications, filed June 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES"; U.S. Provisional Patent Application No. 62 / 691,227, entitled “CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS”; · U.S. Provisional Patent Application No. 62 / 691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; · U.S. Provisional Patent Application No. 62 / 691,219, entitled “SURGICAL EVACUATION SENSING AND MOTOR CONTROL”; U.S. Provisional Patent Application No. 62 / 691,257, entitled “COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”; U.S. Provisional Patent Application No. 62 / 691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and · U.S. Provisional Patent Application No. 62 / 691,251, entitled “DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.”

[0017] The applicant of this application owns the following U.S. provisional patent applications, filed April 19, 2018, the disclosures of which are incorporated herein by reference in their entireties: · U.S. Provisional Patent Application No. 62 / 659,900, entitled “METHOD OF HUB COMMUNICATION.”

[0018] The applicant of this application owns the following U.S. provisional patent applications, filed March 30, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled “CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS”; · U.S. Provisional Patent Application No. 62 / 650,887, entitled “SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES”; U.S. Provisional Patent Application No. 62 / 650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and · U.S. Provisional Patent Application No. 62 / 650,877, entitled “SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.”

[0019] The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: · U.S. Patent Application Serial No. 15 / 940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; U.S. Patent Application Serial No. 15 / 940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES"; U.S. Patent Application No. 15 / 940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES"; · U.S. Patent Application Serial No. 15 / 940,666, entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS"; U.S. Patent Application No. 15 / 940,670, entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS"; · U.S. Patent Application Serial No. 15 / 940,677, entitled "SURGICAL HUB CONTROL ARRANGEMENTS"; U.S. Patent Application No. 15 / 940,632, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; U.S. Patent Application Serial No. 15 / 940,640, entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS"; U.S. Patent Application Serial No. 15 / 940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT"; U.S. patent application Ser. No. 15 / 940,649, entitled “DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME”; · U.S. Patent Application No. 15 / 940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS"; · U.S. Patent Application Serial No. 15 / 940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING"; · U.S. Patent Application No. 15 / 940,668, entitled “AGGREGATION AND REPORTING OF SURGICAL HUB DATA”; · U.S. Patent Application No. 15 / 940,671, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"; U.S. Patent Application Serial No. 15 / 940,686, entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE"; · U.S. Patent Application No. 15 / 940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS"; U.S. Patent Application No. 15 / 940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS"; U.S. Patent Application No. 15 / 940,704, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT"; U.S. Patent Application No. 15 / 940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY"; U.S. patent application Ser. No. 15 / 940,742, entitled "DUAL CMOS ARRAY IMAGING"; U.S. Patent Application No. 15 / 940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; · U.S. Patent Application No. 15 / 940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS"; U.S. Patent Application No. 15 / 940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; U.S. Patent Application No. 15 / 940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET"; U.S. Patent Application No. 15 / 940,694, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION"; U.S. Patent Application No. 15 / 940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; U.S. Patent Application No. 15 / 940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; U.S. Patent Application No. 15 / 940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES"; U.S. Patent Application No. 15 / 940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application Serial No. 15 / 940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,680, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application Serial No. 15 / 940,683, entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and · U.S. Patent Application No. 15 / 940,711, entitled “SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.”

[0020] The applicant of this application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: · U.S. Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; · U.S. Provisional Patent Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; · U.S. Provisional Patent Application No. 62 / 649,300, entitled “SURGICAL HUB SITUATIONAL AWARENESS”; · U.S. Provisional Patent Application No. 62 / 649,309, entitled “SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER”; · U.S. Provisional Patent Application No. 62 / 649,310, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”; U.S. Provisional Patent Application No. 62 / 649,291, entitled “USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”; U.S. Provisional Patent Application No. 62 / 649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; · U.S. Provisional Patent Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; U.S. Provisional Patent Application No. 62 / 649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; · U.S. Provisional Patent Application No. 62 / 649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; U.S. Provisional Patent Application No. 62 / 649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES"; · U.S. Provisional Patent Application No. 62 / 649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Provisional Patent Application No. 62 / 649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and · U.S. Provisional Patent Application No. 62 / 649,323, entitled “SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.”

[0021] The applicant of this application owns the following U.S. provisional patent applications, filed March 8, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Provisional Patent Application No. 62 / 640,417, entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR”; and · U.S. Provisional Patent Application No. 62 / 640,415, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.”

[0022] The applicant of this application owns the following U.S. provisional patent applications, filed December 28, 2017, the disclosures of each of which are incorporated by reference in their entirety herein: · U.S. Provisional Patent Application No. U.S. Provisional Patent Application No. 62 / 611,341 entitled “INTERACTIVE SURGICAL PLATFORM”; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," and · U.S. Provisional Patent Application No. 62 / 611,339, entitled “ROBOT ASSISTED SURGICAL PLATFORM.”

[0023] Before describing the various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied or incorporated in other aspects, variations, and modifications and may be practiced or carried out in various ways. Moreover, unless otherwise specified, the terms and phrases used herein have been selected for the convenience of the reader and for the purpose of describing the illustrative embodiments and not for the purpose of limiting them. Furthermore, it should be understood that one or more of the aspects, embodiment of the aspects, and / or embodiments described below can be combined with any one or more of the other aspects, embodiment of the aspects, and / or embodiments described below.

[0024] Surgical Hub 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., cloud 104, which may include a remote server 113 coupled to storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with cloud 104, which may include a remote server 113. In one embodiment, as shown in FIG. 1, surgical system 102 includes visualization system 108, robotic system 110, and handheld intelligent surgical instrument 112 configured to communicate with each other and / or with hub 106. In some aspects, surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers equal to or greater than 1.

[0025] In various aspects, the intelligent instruments 112 described herein with reference to Figures 1-7 may be implemented as ultrasonic and combination energy surgical instruments 7012 as described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, 27A-27F. Intelligent instruments 112 (e.g., devices 1a-1n), such as ultrasonic / combination surgical instruments 7012 as described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, 27A-27F, are configured to operate within a surgical data network 201 as described with reference to Figure 8.

[0026] FIG. 2 illustrates an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in a surgical room 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 during minimally invasive incision of the patient's body while the surgeon views the surgical site via the surgeon's console 118. Images 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 images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

[0027] Other types of robotic systems can be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0028] Various examples of cloud-based analytics performed by cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017, the disclosure of which is incorporated by reference in its entirety herein.

[0029] In various embodiments, the image capture 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.

[0030] 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.

[0031] The one or more illumination sources may be configured to emit electromagnetic energy in the visible and invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may also be referred to as visible light, or simply light. A typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.

[0032] The invisible spectrum (i.e., the non-radiative spectrum) is the 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 above about 750 nm are longer than the red visible spectrum, which constitutes invisible infrared (IR), microwave, and wireless electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which constitutes invisible ultraviolet, X-ray, and gamma ray electromagnetic radiation.

[0033] In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

[0034] In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within a specific wavelength range across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments sensitive to light from specific wavelengths including frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging can allow for the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is described in detail in U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, in the section entitled "Advanced Imaging Acquisition Module," the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool to reposition the surgical field after a surgical procedure is completed to perform one or more of the above-mentioned tests on the treated tissue.

[0035] It is self-evident that any surgical procedure requires strict sterilization of the operating room and surgical equipment. The strict sanitary and sterile conditions required in the "surgical theater", i.e., operating room or procedure room, require the utmost sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field may be considered a specific area that is deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding the patient who is prepared for the surgical procedure. The sterile field may include cleaned team members in appropriate clothing, as well as all the equipment and fixtures in the area.

[0036] In various aspects, the visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field, as shown in Figure 2, one or more image processing units, one or more storage arrays, and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. The various components of the visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0037] As shown in FIG. 2, the primary display 119 is positioned within the sterile field so as to be visible to the operator of the operating table 114. In addition, the 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 facing away from each other. A 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 can cause the visualization system 108 to maintain a live view of the surgical site on the primary display 119 while displaying snapshots of the surgical site recorded by the imager 124 on the non-sterile displays 107 or 109. The snapshots on the non-sterile displays 107 or 109 can, for example, enable the non-sterile operator to perform diagnostic steps related to the surgical procedure.

[0038] In one aspect, the hub 106 is also configured to send diagnostic input or feedback entered by a non-sterile operator located in the sterile field at the visualization tower 111 to the primary display 119 in the sterile field for viewing by a sterile operator at the operating table. In one example, the input may be in the form of a correction to a snapshot displayed on the non-sterile display 107 or 109 that can be sent by the hub 106 to the primary display 119.

[0039] 2, a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 is also configured to coordinate information flow to the display of the surgical instrument 112. For example, the flow of coordinate information is further described in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 may be sent by the hub 106 to the surgical instrument display 115 in the sterile field, where the diagnostic input or feedback may be viewed by the operator of the surgical instrument 112. Examples of exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," under the heading "Surgical Instrument Hardware," the disclosure of which is incorporated herein by reference in its entirety.

[0040] 3, the hub 106 is shown 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 (which may include a monopolar generator 142, a bipolar generator 144, and / or an ultrasonic generator 143), a communications module 130, a processor module 132, and a storage array 134. In certain aspects, as shown in FIG. 3, the hub 106 further includes a smoke evacuation module 126, a suction / irrigation module 128, and / or an OR mapping module 133.

[0041] During a surgical procedure, the application of energy to tissue for sealing and / or cutting is typically accompanied by smoke evacuation, aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become entangled during a surgical procedure. Valuable time may be lost addressing this issue during a surgical procedure. Untangling the lines may require unplugging the lines from their corresponding modules, which may require resetting the modules. The modular housing 136 of the hub provides a unified environment for managing the power, data, and fluid lines, reducing the frequency of such tangling between lines.

[0042] Aspects of the present disclosure present a surgical hub for use in a surgical procedure involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. The combination 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 housed within a single unit. In one aspect, the combination generator module further includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.

[0043] In one aspect, the fluid line is a first fluid line and a second fluid line extends from a remote surgical site to an aspiration and irrigation module that is slidably received within the hub housing. In one aspect, the hub housing includes a fluid interface.

[0044] Certain surgical procedures may require the application of more than one energy type to tissue. One energy type may be more beneficial for cutting tissue, while another different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the modular housing 136 of the hub is configured to house different generators and facilitate bidirectional communication between them. One advantage of the modular housing 136 of the hub is that it allows for quick removal and / or replacement of various modules.

[0045] Aspects of the present disclosure present a modular surgical housing for use in a surgical procedure involving application of energy to tissue, the modular surgical housing including a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including first data and power contacts, the first energy generator module slidably movable into electrical engagement with the power and data contacts, and the first energy generator module slidably movable out of electrical engagement with the first power and data contacts.

[0046] In addition to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts, and the second energy generator module is slidably movable out of electrical engagement with the second power and data contacts.

[0047] Additionally, the modular surgical housing further 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.

[0048] 3-7, aspects of the disclosure are presented relating to a hub modular housing 136 that allows for modular integration of a generator module 140, a smoke evacuation module 126, and an aspiration / irrigation module 128. The hub modular housing 136 further facilitates bidirectional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 may be a generator module that includes integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 that is slidably insertable into the hub modular housing 136. As shown in FIG. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular housing 136. The hub modular housing 136 may be configured to facilitate the insertion of multiple generators and bidirectional communication between the generators docked to the hub modular housing 136 such that the multiple generators function as a single generator.

[0049] In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 with external and wireless communication headers to enable removable attachment of and bidirectional communication between the modules 140, 126, 128.

[0050] In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and a combination generator module 145 slidably receivable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combination generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into position within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic, and monopolar modules and a smoke evacuation module integrated together with a single housing unit 139, as shown in FIG.

[0051] In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured / collected smoke and / or fluid away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw smoke into openings in utility conduits at the surgical site. Utility conduits coupled to the fluid lines may be in the form of flexible tubing that terminates at the smoke evacuation module 126. The utility conduits and fluid lines define a fluid pathway that extends toward the smoke evacuation module 126, which is received within the hub housing 136.

[0052] In various aspects, the aspiration / irrigation module 128 is coupled to a surgical tool that includes aspiration and suction fluid lines. In one embodiment, the aspiration and suction fluid lines are in the form of flexible tubing that extends from the surgical site towards the aspiration / irrigation module 128. One or more drive systems can be configured to effect irrigation and suction of fluids to and from the surgical site.

[0053] In one aspect, the surgical tool includes a shaft having an end effector at its distal end, at least one energy treatment portion associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and have an inlet port proximate to the energy delivery instrument. The energy delivery instrument is configured to deliver ultrasonic and / or RF energy to the surgical site and is initially coupled to the generator module 140 by a cable extending through the shaft.

[0054] The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or vacuum source can be housed within the aspiration / irrigation module 128. In one embodiment, the fluid source and / or vacuum source can be housed within the hub housing 136 separate from the aspiration / irrigation module 128. In such an embodiment, the fluid interface can be configured to connect the aspiration / irrigation module 128 to the fluid source and / or vacuum source.

[0055] In one aspect, the modules 140, 126, 128 and / or their corresponding docking stations on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules to engage with their counterparts in the docking stations of the hub modular housing 136. For example, as shown in FIG. 4 , the combination generator module 145 includes side brackets 155 configured to slidably engage with corresponding brackets 156 of the corresponding docking stations 151 of the hub modular housing 136. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136.

[0056] In some aspects, the drawers 151 of the hub's modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different sizes, each designed to accommodate a particular module.

[0057] Additionally, to prevent inserting a module into a drawer with incompatible contacts, the contacts of a particular module may be keyed to engage with the contacts of a particular drawer.

[0058] 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate bidirectional communication between the modules housed within the hub modular housing 136. Alternatively or in addition, the docking port 150 of the hub modular housing 136 may facilitate wireless bidirectional communication between the modules housed within the hub modular housing 136. Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.

[0059] 6 illustrates individual power bus attachments of multiple lateral docking ports of a lateral modular housing 160 configured to receive multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect modules 161. The modules 161 are slidably inserted into a docking station 162 of the lateral modular housing 160 that includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the modules 161 are disposed laterally within the lateral modular housing 160. Alternatively, the modules 161 may be disposed vertically within the lateral modular housing.

[0060] 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 a docking station or drawer 167 of the vertical modular housing 164 that includes a backplane for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are vertically arranged, in certain cases the vertical modular housing 164 may include horizontally arranged drawers. Additionally, the modules 165 may interact with each other via docking ports of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the modules 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses a plurality of sub-modules that are slidably received within the master module 178.

[0061] In various aspects, the imaging module 138 includes 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 configured with 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 embodiment, the disposable housing is removably coupled with a reusable controller, a light source module, and a camera module. The light source module and / or the camera module can be selectively selected depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for imaging of the scanned beam. Similarly, the light source module can be configured to deliver white light or a different light depending on the surgical procedure.

[0062] During a surgical procedure, it may be inefficient to remove a surgical device from the surgical field and replace it with another surgical device including a different camera or a different light source. Temporary loss of view of the surgical field may result in undesirable results. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or a camera module midstream during a surgical procedure without the need to remove the imaging device from the surgical field.

[0063] In one aspect, the imaging device comprises a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module that may be configured for snap-fit ​​engagement with the first channel. A second channel is configured to slidably receive a light source module that may be configured for snap-fit ​​engagement with the second channel. In another embodiment, the camera module and / or the light source module may be rotated into a final position within their corresponding channels. A threaded engagement may be employed instead of a snap-fit ​​engagement.

[0064] In various embodiments, multiple imaging devices are positioned at different locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between the imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from the different imaging devices.

[0065] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, issued Aug. 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is incorporated herein by reference in its entirety. Additionally, U.S. Patent No. 7,982,776, issued Jul. 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems may be integrated with the imaging module 138. Additionally, U.S. Patent Application Publication No. 2011 / 0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS," and U.S. Patent Application Publication No. 2014 / 0243597, published August 28, 2014, entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE," each of which is incorporated herein by reference in its entirety.

[0066] 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 rooms of a medical facility, or any room in a medical facility with specialized equipment for surgical procedures, to a cloud-based system (e.g., cloud 204, which may include a remote server 213 coupled to storage device 205). In one embodiment, 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 can further 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 switched. A passive surgical data network acts as a conduit for data, allowing data to go from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes the additional functionality of configuring each port in the network hub 207 or network switch 209 to allow traffic to pass through the monitored surgical data network. An intelligent surgical data network can 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.

[0067] Modular devices 1a-1n located in the operating room may be coupled to the modular communication hub 203. The network hub 207 and / or the network switch 209 may be coupled to the 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 the cloud-based computer 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 room may also be coupled to the network switch 209. The network switch 209 may be coupled to the network hub 207 and / or the network router 211 to connect 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.

[0068] 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 communications hub 203 may be housed in a modular control tower configured to receive multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. The modular communications hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various aspects, devices 1a-1n / 2a-2m may include various modules such as, for example, 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 communications 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 a modular communications hub 203 of a surgical data network 201.

[0069] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a-1n / 2a-2m to the cloud. Any one 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 a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. The term "cloud" may be used as a metaphor for the "internet," but the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "a type of internet-based computing," where various services such as servers, storage, and applications are delivered to a modular communications hub 203 and / or computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210 via the internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. The cloud computing services may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0070] By applying cloud computer data processing techniques to 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 can be used to observe tissue status and evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n / 2a-2m can be used to diagnostically inspect data including images of samples of body tissue to identify pathologies such as disease effects using cloud-based computing. This includes tissue and phenotypic localization and margin confirmation. At least some of the devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using techniques such as various sensors integrated with the imaging devices and overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n / 2a-2m, including image data, may be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve the outcome of the surgical procedure by determining whether further treatments can be pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and using a standardized approach can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.

[0071] In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via wired or wireless channels depending on the configuration of the devices 1a-1n with respect to the network hub. The network hub 207 may be implemented in one embodiment 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 room 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) for forwarding device data. Only one of the devices 1a-1n can send data at a time through the network hub 207. The network hub 207 does not have a routing table or intelligence on where to send the information and broadcasts all network data across each connection and to the remote server 213 (FIG. 9) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose security risks and cause bottlenecks.

[0072] In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within 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 room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and functions in full duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.

[0073] The network hub 207 and / or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for sending data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different networks located in different operating rooms of the same medical facility, or different operating rooms of different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

[0074] In one embodiment, the network hub 207 may be implemented as a USB hub that 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 more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information over wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.

[0075] In another embodiment, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band of 2.4-2.485 GHz) and to create a personal area network (PAN). In other aspects, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications 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 designated 3G, 4G, 5G, and beyond. The computing module may include multiple communications modules. For example, a first communications module may be dedicated to short-range wireless communications, such as Wi-Fi and Bluetooth, and a second communications module may be dedicated to long-range wireless communications, such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and the like.

[0076] The modular communications hub 203 can act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types known as frames. Frames carry data generated by the devices 1a-1n / 2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211 which forwards this data to cloud computing resources by using any number of wireless or wired communications standards or protocols described herein.

[0077] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 is generally easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.

[0078] 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 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210. As illustrated in the embodiment of FIG. 9, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 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 room devices are coupled to cloud computing resources and data storage via the modular control tower 236. The robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. The devices / instruments 235, visualization system 208, among others, may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.

[0079] FIG. 10 illustrates a surgical hub 206 comprising a number of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication hub 203, e.g., a network-connected device, and a computer system 210, e.g., for providing local processing, visualization, and imaging. As shown in FIG. 10, the modular communication hub 203 can be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 to 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 communication connections to cloud computing resources and a local display 217. Communication to the cloud 204 can be via either wired or wireless communication channels.

[0080] The surgical hub 206 uses the non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating field using either an ultrasound or laser-based non-contact measurement device. As described in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," section "Surgical Hub Spatial Awareness Within an Operating Room," which is incorporated by reference in its entirety, the ultrasound-based non-contact sensor module scans the operating room by transmitting bursts of ultrasound and receiving echoes as the bursts of ultrasound reflect off the exterior walls of the operating room, where the sensor module is configured to determine the size of the operating room and adjust the distance limit for Bluetooth pairing. The laser-based non-contact sensor module scans the operating room, for example, by transmitting laser light pulses, receiving laser light pulses that reflect off the exterior walls of the operating room, and comparing the phase of the transmitted pulses to the received pulses to determine the size of the operating room and adjust the distance limit for Bluetooth pairing.

[0081] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, a storage device 248, a memory 249, a non-volatile memory 250, and an input / output interface 251 via a system bus. The system bus may be any of several types of bus structure(s) including a memory bus or memory controller, a peripheral or external bus, and / or a local bus using any of a variety of bus architectures, including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), Micro-Channel 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.

[0082] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including, for example, 256KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a pre-fetch buffer to improve performance beyond 40 MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.

[0083] In one embodiment, the processor 244 may include a safety controller, including two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4 from 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 offering scalable performance, connectivity, and memory options.

[0084] System memory includes volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may 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. In addition, 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).

[0085] The computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage devices, including but not limited to devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage devices can include storage media, either independently or in combination with other storage media, including but not limited to optical disk drives, such as compact disc ROM drives (CD-ROM), compact disc recordable drives (CD-R Drives), compact disc rewritable drives (CD-RW Drives), or digital versatile disc ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of the disk storage devices to the system bus.

[0086] It should be appreciated that the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in a preferred operating environment. Such software includes an operating system. The operating system, which may be stored on disk storage, functions to control and allocate resources of the computer system. System applications take advantage of the operating system's management of resources through program modules and program data stored either in system memory or on disk storage. It should be appreciated that the various components described herein may be implemented with various operating systems or combinations of operating systems.

[0087] A user inputs commands or information into the computer system 210 through input device(s) coupled to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, gamepad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, webcam, and the like. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial port, parallel port, game port, and USB. Output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to the computer system and also to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters include, by way of example 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.

[0088] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other common network nodes, and typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown with the remote computer(s). The remote computer(s) are logically connected to the computer system through a network interface, which is then physically connected through 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 / IEEE802.3, Token Ring / IEEE802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and variations thereon, packet-switched networks, and Digital Subscriber Lines (DSL).

[0089] In various aspects, the computer system 210 of FIG. 10, the imaging module 238 of FIGS. 9-10, and / or the visualization system 208, and / or the processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) used to process digital images. The image processor may use parallel computing using single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0090] The communications connection(s) refers to the hardware / software used to connect the network interface to the bus. Although the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as modems, including ordinary telephone grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

[0091] In various aspects, the device / instrument 235 described with reference to Figures 9-10 may be implemented as an ultrasonic surgical instrument and a combination energy surgical instrument 7012 as described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, and 27A-27F. Thus, the ultrasonic / combination surgical instrument 7012 described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, and 27A-27F is configured to interface with the modular control tower 236 and the surgical hub 206. When connected to the surgical hub 206, the ultrasonic / combination surgical instrument 7012 described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, 27A-27F 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 any combination thereof. Additionally, when connected to the hub 206, the ultrasonic / combination surgical instrument 7012 described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, 27A-27F may utilize processing circuitry available on the hub local computer system 210.

[0092] FIG. 11 illustrates a functional block diagram of one embodiment of a USB network hub 300 device in accordance with at least one embodiment of the present disclosure. In the illustrated embodiment, the USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that provides an upstream USB transmit / receive port 302 and up to three downstream USB transmit / receive ports 304, 306, 308 that conform to the USB 2.0 standard. The upstream USB transmit / receive port 302 is a differential rooted data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transmit / receive ports 304, 306, 308 are differential data ports, with each port including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-DM3) output.

[0093] The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. A fully compliant USB transceiver is integrated into the circuitry of the upstream USB transmit / receive port 302 and all downstream USB transmit / receive ports 304, 306, 308. The downstream USB transmit / receive ports 304, 306, 308 support both full speed and low speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 to manage power.

[0094] The USB network hub 300 device includes a serial interface engine (SIE) 310. 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 understands signaling down to the transaction level. Functions it handles may include packet recognition, transaction reordering, detection / generation of SOP, EOP, RESET, and RESUME signals, 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-to-parallel / parallel-to-serial conversion. The SIE 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 for controlling communication between the upstream USB transmit / receive port 302 and the downstream USB transmit / receive ports 304, 306, 308 via port logic circuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic 328 for controlling commands from a serial EEPROM via a serial EEPROM interface 330.

[0095] In various aspects, the USB network hub 300 can connect up to 127 functions organized in up to six logical layers to a single computer. Additionally, 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. The USB network hub 300 may be configured to support four modes of power management: bus-powered hub with either individual or ganged port power management, and self-powered hub with either individual or ganged port power management. In one aspect, using a USB cable, the USB network hub 300, the upstream USB transmit / receive port 302 is plugged into a USB host controller, and the downstream USB transmit / receive ports 304, 306, 308 are exposed for connecting USB compatible devices, and so on.

[0096] Further details regarding the structure and function of surgical hubs and / or surgical hub networks can be found in U.S. Provisional Patent Application No. 62 / 659,900, entitled "METHOD OF HUB COMMUNICATION," filed April 19, 2018, which is incorporated by reference in its entirety.

[0097] Cloud system hardware and function modules FIG. 12 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. In one aspect, the computer-implemented interactive surgical system is configured to monitor and analyze data regarding the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and operating rooms or medical facilities. The computer-implemented interactive surgical system includes a cloud-based analysis system. Although the cloud-based analysis system is described as a surgical system, it is not necessarily limited to such and may be a cloud-based medical system. As shown in FIG. 12, the cloud-based analysis system includes a plurality of surgical instruments 7012 (which may be the same as or similar to the instruments 112), a plurality of surgical hubs 7006 (which may be the same as or similar to the hubs 106), and a surgical data network 7001 (which may be the same as or similar to the network 201) coupling the surgical hubs 7006 to a cloud 7004 (which may be the same as or similar to the cloud 204). Each of the plurality of surgical hubs 7006 is communicatively coupled to one or more surgical instruments 7012. The hub 7006 is also communicatively coupled to a cloud 7004 of computer-implemented interactive surgical systems via a 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 any other suitable computer network. The surgical hub 7006 coupled to the cloud 7004 may be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 is paired with the surgical hub 7006 for control and performance of various surgical procedures or operations described herein.

[0098] In addition, the surgical instrument 7012 may include a transceiver for data transmission to and from the corresponding surgical hub 7006 (which may also include a transceiver). The combination of the surgical instrument 7012 and the corresponding hub 7006 may indicate a particular location, such as an operating room within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 may store the location data. As shown in FIG. 12, the cloud 7004 includes a central server 7013 (which may be the same as or similar to the remote server 113 of FIG. 1 and / or the remote server 213 of FIG. 9), a hub application server 7002, a data analysis module 7034, and an input / output ("I / O") interface 7007. The central server 7013 of the cloud 7004 collectively manages the cloud computing system, which includes monitoring requests by the client surgical hubs 7006 and managing the processing power of the cloud 7004 to execute the requests. Each of the central servers 7013 includes one or more processors 7008 coupled to a suitable memory device 7010, which may include volatile memory such as random access memory (RAM) and non-volatile memory such as magnetic storage. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, actions, recommendations, and other operations described below. Additionally, the processor 7008 may execute the data analysis module 7034 independently of or in conjunction with a hub application executed independently by the hub 7006. The central servers 7013 also include an aggregated medical data database 2212, which may reside in the memory 2210.

[0099] Based on the connection to the various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from the various surgical instruments 7012 and the particular data generated by their corresponding hubs 7006. Such aggregated data may be stored in the aggregated medical database 7011 of the cloud 7004. Specifically, the cloud 7004 may advantageously perform data analysis and operations on the aggregated data to result in functionality that an individual hub 7006 cannot achieve by itself. To this end, as shown in FIG. 12, the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7007 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7007 may be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. The I / O interface 7007 may thus facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed upon request from the hubs 7006. These requests may be sent to the hub 7006 via the hub application. The I / O interface 7007 may include one or more high speed data ports, which may include a Universal Serial Bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 is configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests made by the hub application through the hub 7006 to control access to the aggregated medical data database 7011 and perform load balancing. The data analysis module 7034 is described in more detail with reference to FIG. 13.

[0100] The particular cloud computing system configuration described in this disclosure is specifically designed to address various problems that arise in the context of medical operations and procedures performed using medical devices such as surgical instruments 7012, 112. In particular, the surgical instruments 7012 may be digital surgical devices configured to interact with the cloud 7004 to implement techniques to improve surgical outcomes. The various surgical instruments 7012 and / or the surgical hub 7006 may include touch-controlled user interfaces such that a clinician may control aspects of the interaction between the surgical instruments 7012 and the cloud 7004. Other suitable user interfaces for control, such as an auditory controlled user interface, may also be used.

[0101] FIG. 13 is a block diagram illustrating a functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system includes a number of data analysis modules 7034 that may be executed by a processor 7008 of the cloud 7004 to provide data analysis solutions to problems specifically arising in the medical field. As shown in FIG. 13, the functionality of the cloud-based data analysis modules 7034 may be accessed in relation to the surgical hub 7006 via a hub application 7014 hosted by a hub application server 7002. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 defines a set of protocols and routines corresponding to the hub application 7014. In addition, the API 7016 manages the storage and retrieval of data in and from the aggregated medical data database 7011 for the operation of the application 7014. A cache 7018 is also coupled to the API 7016 for storing data (e.g., temporarily) and for more efficient retrieval of data used by the application 7014. 13 includes modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004, according to some aspects. In one aspect, a data analysis module is used to make certain recommendations based on an analysis of trends, outcomes, and other data.

[0102] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying salient features or configurations (e.g., trends), managing redundant data sets, and storing data in paired data sets that may be grouped by procedure, but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of the surgical instruments 7012 may include applying a binary classification, such as bleeding or non-bleeding events. More generally, the binary classification may be characterized as either a desired event (e.g., a successful surgical procedure) or an undesired event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may represent individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 may generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the aggregated medical data database 7011 to execute the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the aggregated medical data database 2212.

[0103] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 may determine optimal ordering points for surgical stapler instruments 7012 for a group of medical facilities based on corresponding projected demand for such instruments 7012. The resource optimization module 7020 could also evaluate resource usage or other operational configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the organized data aggregated from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 may be able to recommend to a medical facility (e.g., a medical service provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 may be able to suggest better supply chain parameters such as product reorder points, provide suggestions for different surgical instruments 7012, their use, or procedural steps to improve surgical outcomes, etc. The medical facility may receive such suggestions via the corresponding surgical hub 7006. More specific suggestions regarding parameters or configurations of various surgical instruments 7012 may also be provided. The hub 7006 and / or surgical instruments 7012 may each have a display screen that displays the data or suggestions provided by the cloud 7004.

[0104] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this connection, the suggestion module 7030 may be able to make suggestions using these other potential operating parameters based on resulting in a better surgical outcome, such as a better seal or less bleeding. For example, the suggestion module 7030 may send suggestions to the surgical hub 7006 regarding when to use a particular cartridge for a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large collections of raw data and provide focused suggestions (advantageously determined based on the aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may be able to analyze, evaluate, and / or aggregate geographic similarities between medical providers / facilities based on type of medical procedure, type of patient, number of patients, medical providers / facilities that use similar types of instruments, etc.

[0105] The control program update module 7026 may be configured to implement various surgical instrument 7012 suggestions when the corresponding control program is updated. For example, the patient outcome analysis module 7028 may be able to identify correlations linking certain control parameters with successful (or unsuccessful) outcomes. Such correlations may be addressed when an updated control program is transmitted to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012 transmitted via the corresponding hub 7006 may incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and suggestions module 7030 may be able to identify improved ways to use the instrument 7012 based on the aggregated performance data.

[0106] The cloud-based analysis 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 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and may be associated with an authorized cloud access level. For example, based on providing accurate credentials, the surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the aggregated medical data database 7011 of the cloud 7004 may include a database of credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined level of access to receive data analytics generated by the cloud 7004.

[0107] Additionally, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the 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 inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.

[0108] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a memory device of each of the surgical instruments 7012. The authorization and security module 7024 may 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 may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 to indicate that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This data transmission readiness may also be indicated by, for example, a light indicator on the instrument 7012. The cloud 7004 may also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 may send signals directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to the control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 may be used to implement system-wide solutions to address local or global issues 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 this group.

[0109] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and suggested changes (e.g., via the suggestions module 2030). Thus, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational actions or geographic locations. In this manner, the cloud 7004 may provide broader analysis and suggestions for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of suggestions on costs and effectiveness for a particular facility (for overall operations and / or various medical procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of ​​other facilities or any other comparable facilities.

[0110] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., severity, surprise, suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functions described above to improve the cloud-based analysis and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to the data analysis performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in a specific response from the cloud 7004 (corresponding to the level of urgency), such as elevation for rapid response, special handling, exclusion from the aggregated medical data database 7011, or other suitable response. Additionally, if necessary, the cloud 7004 may send a request (e.g., push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be required in situations where the cloud detects significant irregularities or outliers and the cloud is unable to determine the cause of the irregularity. The central server 7013 may be programmed to trigger this push message in certain critical situations, such as, for example, when data is determined to differ from expected values ​​by more than a predetermined threshold, or if security is deemed to be involved.

[0111] Further details regarding the cloud analytics system can be found in U.S. Provisional Patent Application No. 62 / 659,900, entitled "METHOD OF HUB COMMUNICATION," filed April 19, 2018, which is incorporated by reference in its entirety.

[0112] Situational Awareness Although an "intelligent" device that includes a control algorithm that responds to sensed data may be an improvement over a "dumb" device that operates without considering the sensed data, some sensed data may be incomplete or inconclusive when considered alone, i.e., without the context of the type of surgical procedure being performed or the type of tissue being operated on. Without knowing the procedure context (e.g., knowing the type of tissue being operated on or the type of procedure being performed), the control algorithm may inaccurately or suboptimally control the modular device when given sensed data that does not include the specific context. For example, the optimal method of the control algorithm to control the surgical instrument in response to a particular sensed parameter may vary according to the particular type of tissue being operated on. This is due to the fact that different tissue types have different properties (e.g., resistance to tearing) that cause them to respond differently to actions taken by the surgical instrument. Thus, it may be desirable for the surgical instrument to take different actions even when the same measurement is sensed for a particular parameter. As one specific example, the optimal way to control a surgical stapling and severing instrument in response to the instrument sensing an unexpectedly high force to close its end effector depends on whether the type of tissue is susceptible to tearing or resistant to this. For tissue susceptible to tearing, such as lung tissue, the instrument's control algorithm optimally ramps down the motor in response to an unexpectedly high force to close to avoid tearing the tissue. For tissue resistant to tearing, such as stomach tissue, the instrument's control algorithm optimally ramps up the motor in response to an unexpectedly high force to close to ensure that the end effector is properly clamped to the tissue. Without knowing whether lung tissue or stomach tissue is being clamped, the control algorithm may make suboptimal decisions.

[0113] One solution utilizes a surgical hub that includes a system configured to derive information about the surgical procedure to be 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 the received data and then control the modular devices paired with the surgical hub based on the inferred context of the surgical procedure. FIG. 14 shows a diagram of a situation-aware surgical system 5100 according to at least one embodiment of the present disclosure. In some examples, the data sources 5126 include, for example, the modular devices 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular devices themselves), a database 5122 (e.g., an EMR database including patient records), and patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor).

[0114] The surgical hub 5104, which may be similar in many respects to the hub 106, may be configured to derive contextual information related to the surgical procedure from the data based, for example, on a particular combination of received data or a particular order in which data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure 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 the received data may be referred to as "situational awareness." In one example, the surgical hub 5104 may incorporate a situational awareness system, which is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from the received data.

[0115] The situational awareness system of the surgical hub 5104 may be configured to derive the contextual information from the data received from the data sources 5126 in a variety of different ways. In one example, the situational awareness system includes a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitors 5124, and / or the modular devices 5102) with corresponding contextual information for the surgical procedure. In other words, the machine learning system may be trained to accurately derive the contextual information for the surgical procedure from the inputs provided. In another illustrative example, the situational awareness system may include a lookup table that stores pre-characterized contextual information for the surgical procedure in correspondence with one or more inputs (or ranges of inputs) that correspond to the contextual information. In response to a query with one or more inputs, the lookup table may return the corresponding contextual information for the situational awareness system to control the modular devices 5102. In one example, 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 example, the situational awareness system includes an additional machine learning system, lookup table, or other such system that generates or obtains one or more control adjustments for one or more modular devices 5102 when provided with the contextual information as an input.

[0116] A surgical hub 5104 incorporating a situational awareness system provides many benefits to the surgical system 5100. One benefit includes improved interpretation of sensed and collected data, which improves processing accuracy and / or use of the data during the course of a surgical procedure. To return to the previous example, the situational aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, when an unexpectedly high force is detected to close the end effector of the surgical instrument, the situational aware surgical hub 5104 can properly ramp up or down the motor of the surgical instrument to match the type of tissue.

[0117] As another example, the type of tissue being operated on can affect adjustments made to the compression speed and load threshold of the surgical stapling and severing instrument for a particular tissue gap measurement. The context-aware surgical hub 5104 can estimate whether the surgical procedure being performed is a thoracic or abdominal procedure, which allows the context-aware surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and severing instrument is pulmonary (in the case of thoracic surgery) or stomach (in the case of abdominal surgery). The surgical hub 5104 can then adjust the compression speed and load threshold of the surgical stapling and severing instrument appropriately for the type of tissue.

[0118] As yet another example, the type of body cavity being operated on during an insufflation procedure may affect the functionality of the smoke evacuator. The situationally aware surgical hub 5104 can determine if the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type. As the procedure type is typically performed within a particular body cavity, the surgical hub 5104 can control the smoke evacuator motor speed appropriately for the body cavity being operated on. Thus, the situationally aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.

[0119] As yet another example, the type of procedure being performed may affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. An arthroscopic procedure, for example, requires a higher energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is submerged in fluid. The situation-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on may affect the optimal energy level at which an ultrasonic surgical instrument or a RF electrosurgical instrument operates. The situation-aware surgical hub 5104 can determine what type of surgical procedure is being performed according to the expected tissue profile of the surgical procedure and then customize the energy level of the ultrasonic surgical instrument or the RF electrosurgical instrument, respectively. Additionally, the situationally aware surgical hub 5104 may be configured to adjust the energy levels of the ultrasonic or RF electrosurgical instruments over the course of a surgical procedure, rather than just on a procedure basis. The situationally aware surgical hub 5104 can determine which step of the surgical procedure is occurring or will occur thereafter, and then update the generator and / or the control algorithms of the ultrasonic or RF electrosurgical instruments to set the energy levels to a value appropriate for the tissue type expected according to the step of the surgical procedure.

[0120] As yet another example, data can be drawn from additional data sources 5126 to improve conclusions that the surgical hub 5104 draws from one data source 5126. The situation-aware surgical hub 5104 can augment data received from the modular devices 5102 with contextual information it builds on the surgical procedure from other data sources 5126. For example, the situation-aware surgical hub 5104 can be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the 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 may not be conclusive. Thus, in one example, the surgical hub 5104 can be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively coupled to the surgical hub 5104) to make a determination about the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take into account the physiological measurement data to provide additional context when analyzing the visualization data. The additional context can be useful in cases where the visualization data may not be conclusive or incomplete by itself.

[0121] Another benefit includes actively and automatically controlling the paired modular devices 5102 according to the particular step of the surgical procedure being performed to reduce the number of times a medical professional is required to interact with or control the surgical system 5100 during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 can actively activate a 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. By actively activating the energy source, the instrument can be ready for use as soon as the preceding step of the procedure is completed.

[0122] As another example, the situation-aware surgical hub 5104 can determine whether a current or subsequent step in a 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 see. The surgical hub 5104 can then actively change the displayed view (e.g., provided by a medical imaging device for the visualization system 108) accordingly, causing the display to automatically adjust throughout the surgical procedure.

[0123] As yet another example, the context-aware surgical hub 5104 can determine what step of a surgical procedure is being performed or will be performed later, and whether specific data or comparisons between data are required for that step of the surgical procedure. The surgical hub 5104 can be configured to automatically call up data screens based on the step of the surgical procedure being performed, without waiting for the surgeon to ask for specific information.

[0124] Another benefit includes checking for errors during the setup of a surgical procedure or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 can determine whether the operating room is properly or optimally set up for the surgical procedure being performed. The surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product location, or setup needs, and then compare the current operating room layout to a standard layout for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In one example, the surgical hub 5104 can be configured to compare a list of items for the procedure scanned by an appropriate scanner and / or a list of devices paired with the surgical hub 5104 to a recommended or expected manifest of items and / or devices for a given surgical procedure. If any discontinuities exist between the lists, the surgical hub 5104 can be configured to provide a warning indicating that a particular modular device 5102, patient monitor 5124, and / or other surgical item is missing. In one example, the surgical hub 5104 can be configured to determine the relative distance or position of the modular devices 5102 and the patient monitoring devices 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or expected layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide a warning indicating that the current layout of the surgical procedure deviates from the recommended layout.

[0125] As another example, the situation-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or otherwise deviating from an expected course of action during the course of a surgical procedure. For example, the surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from a memory) a corresponding list of steps or sequences of equipment use, 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 has determined is being performed. In one example, the surgical hub 5104 may be configured to provide a warning indicating that an unexpected action is being performed or an unexpected device is being utilized at a particular step in the surgical procedure.

[0126] Overall, the situational awareness system for the surgical hub 5104 improves the outcome of surgical procedures by adjusting surgical instruments (and other modular devices 5102) for the specific context of each surgical procedure (e.g., to accommodate different tissue types) and validating actions during a surgical procedure. The situational awareness system also improves the efficiency of the surgeon in performing a surgical procedure by automatically suggesting next steps, providing data, and adjusting displays and other modular devices 5102 within the surgical site according to the specific context of the procedure.

[0127] 15, there is shown a timeline 5200 illustrating the situational awareness of a hub, such as the surgical hub 106 or 206 (FIGS. 1-11). The timeline 5200 is an exemplary surgical procedure and the contextual information that the surgical hub 106, 206 can derive from data received from data sources at each step of the surgical procedure. The timeline 5200 illustrates typical steps that may be taken by nurses, surgeons, and other medical personnel during the course of a lung segmentectomy surgery, beginning with setting up the operating room and ending with transporting the patient to a post-op recovery room.

[0128] The situation-aware surgical hub 106, 206 receives data from data sources throughout the course of a surgical procedure, including data generated each time medical personnel utilize a modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 receives this data from the paired modular devices and other data sources to continually derive inferences (i.e., contextual information) regarding 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 can, for example, record data regarding the procedure to generate a report, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to a particular procedure step, adjust the modular device based on the context (e.g., activate a monitor, adjust the field of view (FOV) of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and any other such actions described above.

[0129] As a first step 5202 in this exemplary procedure, hospital personnel retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.

[0130] In a second step 5204, personnel scan the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies utilized in various types of procedures to verify that the mix of supplies is compatible with the thoracic procedure. Additionally, the surgical hub 106, 206 may also determine that the procedure is not a wedge procedure (either because the incoming supplies do not include certain supplies required for a thoracic wedge procedure or are not otherwise compatible with a thoracic wedge procedure).

[0131] In a third step 5206, medical personnel scan the patient's band via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 can then verify the patient's identity based on the scanned data.

[0132] In a fourth step 5208, the medical staff turns on the auxiliary devices. The auxiliary devices utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case, they include smoke evacuators, aspirators, and medical imaging devices. Once activated, the auxiliary equipment, which is a modular device, may automatically pair with the surgical hub 106, 206 located within a certain proximity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive contextual information regarding the surgical procedure by detecting the type of modular device that is paired 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 a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the type of modular devices that connect to the hub, the surgical hub 106, 206 may roughly deduce the particular procedure that the surgical team will be performing. Once the surgical hub 106, 206 knows what particular procedure is being performed, the surgical hub 106, 206 can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources (e.g., modular devices and patient monitoring devices) to estimate which steps of the surgical procedure the surgical team is performing.

[0133] In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices to the patient. The EKG electrodes and other patient monitoring devices may be paired with the surgical hub 106, 206. Once the surgical hub 106, 206 begins receiving data from the patient monitoring devices, the surgical hub 106, 206 confirms that the patient is in the operating room.

[0134] In a sixth step 5212, medical personnel induce anesthesia in the patient. The surgical hub 106, 206 can estimate that the patient is under anesthesia based on data from the modular devices and / or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Once the sixth step 5212 is completed, the pre-operative portion of the lung segmentectomy surgery is complete and the operative portion begins.

[0135] In a seventh step 5214, the patient's lung being operated on is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206 can, for example, infer that the patient's lung has been collapsed from ventilator data. Because the surgical hub 106, 206 can compare the detection of the patient's lung being collapsed to the expected steps of the procedure (which may be accessed or retrieved in advance), it can infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure.

[0136] In an eighth step 5216, a medical imaging device (e.g., a scope) is inserted and video feed 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 a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that the wedge procedure has already been discounted by the surgical hub 106, 206 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (FIG. 2) may be used to determine contextual information regarding the type of procedure being performed among many different methods, including by determining the angle at which the medical imaging device is oriented with respect to visualization of the patient's anatomy, by monitoring the number or medical imaging devices being used (i.e., activated and paired with the surgical hub 106, 206), and by monitoring the type of visualization device being used. For example, one technique for performing a VATS lobectomy places the camera above the diaphragm in the anterior inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmentectomy places the camera in an anterior intercostal position relative to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situational awareness system may be trained to recognize the location of the medical imaging device based on visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while 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 may be communicatively 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 determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.

[0137] At a ninth step 5218, the surgical team begins the dissection step of the procedure. Because the surgical hub 106, 206 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it can infer that the surgeon is in the process of dissecting and separating the patient's lungs. The surgical hub 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the previously discussed steps of the procedure have been completed) corresponds to the dissection step. In a particular example, the energy instrument can be an energy tool attached to a robotic arm of a robotic surgical system.

[0138] At a tenth step 5220, the surgical team proceeds to the ligation step of the procedure. Because the surgical hub 106, 206 receives data from the surgical stapling and severing instrument indicating that the instrument is being fired, the surgical hub 106, 206 can infer that the surgeon is ligating the artery and vein. As with the previous step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the step in the retrieved process. In a particular example, the surgical instrument may be a surgical tool attached to a robotic arm of a robotic surgical system.

[0139] In an eleventh step 5222, the segmental resection portion of the procedure is performed. The surgical hub 106, 206 can infer that the surgeon is transecting parenchymal tissue based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond to, for example, the size or type of staples fired by the instrument. Because different types of staples are applied to different types of tissue, the cartridge data can indicate the type of tissue being stapled and / or transected. In this case, the type of staples fired is applied to parenchymal tissue (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is being performed.

[0140] Then, at a twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 may 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, the RF or ultrasonic instrument utilized after the parenchymal tissue is transected corresponds to the node dissection step, which allows the surgical hub 106, 206 to make this inference. It is noted that the surgeon will periodically alternate between the surgical stapling / cutting instrument and the surgical energy (i.e., RF or ultrasonic) instrument depending on the particular step during the procedure, as different instruments are better suited for certain tasks. Thus, the particular sequence in which the stapling / cutting instrument and the surgical energy instrument are used may indicate which step of the procedure the surgeon is performing. Additionally, in certain instances, a robotic tool may be used for one or more steps during the surgical procedure, and / or a handheld surgical instrument may be used for one or more steps during the surgical procedure. The surgeon(s) can, for example, alternate between the robotic tool and the handheld surgical instrument and / or can use the devices simultaneously, for example. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure begins.

[0141] In a thirteenth step 5226, the patient's anesthesia is reversed. The surgical hub 106, 206 may estimate that the patient is emerging from anesthesia based on, for example, ventilator data (i.e., the patient's breathing rate begins to increase).

[0142] Finally, the fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Thus, the surgical hub 106, 206 can presume 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 this exemplary procedure description, based on data received from various data sources communicatively coupled to the surgical hub 106, 206, the surgical hub 106, 206 can determine or presume when each step of a given surgical procedure is occurring.

[0143] Situational awareness is further described in U.S. Provisional Patent Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated by reference in its entirety. In certain examples, the operation of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, may be controlled by the hub 106, 206 based on its situational awareness and / or feedback from its components and / or based on information from the cloud 104.

[0144] In one aspect, the modular device 5102 described below with reference to Figures 24-40 may be implemented as an ultrasonic surgical instrument and combined energy surgical instrument 7012 as described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, 27A-27F. Thus, the modular device 5102 implemented as an ultrasonic surgical instrument and combined energy surgical instrument 7012 as described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, 27A-27F is configured to operate as a data source 5126 and interact with a database 5122 and a patient monitoring device 5124. The modular device 5102, implemented as the ultrasonic surgical instrument and combined energy surgical instrument 7012 described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, and 27A-27F, is further configured to interact with the surgical hub 5104 to provide information (e.g., data and control) to the surgical hub 5104 and to receive information (e.g., data and control) from the surgical hub 5104.

[0145] Generator Hardware 16 is a circuit diagram of a robotic surgical instrument 700 configured to operate the surgical tools described herein, according to one embodiment of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of an closure tube, shaft rotation, and articulation using either single or multiple articulation drive couplings. In one embodiment, the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, or one or more articulation members, or combinations thereof. The surgical instrument 700 includes a control circuit 710 configured to control a motorized firing member, a closure member, a shaft member, or one or more articulation members, or combinations thereof.

[0146] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, a shaft 740, and one or more articulating members 742a, 742b via a number of motors 704a-704e. A position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Another sensor 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 may be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.

[0147] In one aspect, the control circuitry 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, the timer / counter 731 provides an output signal, such as an elapsed time or a digital count, to the control circuitry 710 to correlate the position of the closure member 714 determined by the position sensor 734 with the output of the timer / counter 731, such that the control circuitry 710 can determine the position of the closure member 714 at a particular time (t) relative to a starting position or time (t) when the closure member 714 is at a particular position relative to the starting position. The timer / counter 731 may be configured to measure elapsed time, count an external event, or measure the time of an external event.

[0148] In one aspect, the control circuitry 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuitry 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuitry 710 may be programmed to select a firing control program or a closing control program based on the tissue condition. The firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuitry 710 may be programmed to translate the displacement member at a slower speed and / or with less power. When thinner tissue is present, the control circuitry 710 may be programmed to translate the displacement member at a higher speed and / or with more power. The closing control program may control the closing force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the articulating members 742a, 742b.

[0149] In one aspect, the control circuitry 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 include 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 embodiments, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some embodiments, the motor controllers 708a-708e may be omitted, and the control circuitry 710 may directly generate the motor drive signals.

[0150] 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 the displacement member stroke. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program for a closed-loop configuration. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the sum of the pulse widths of the motor drive signals, 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 the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity.

[0151] In one aspect, the motors 704a-704e can receive power from an energy source 712. The energy source 712 can be a DC power source driven by a mains AC power source, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e can be mechanically coupled to respective moveable mechanical elements, such as the closure member 714, the clamp arm 716, the shaft 740, the joint 742a, and the joint 742b, via respective transmissions 706a-706e. The transmissions 706a-706e can include one or more gears or other coupling components for coupling the motors 704a-704e to the moveable mechanical elements. The position sensor 734 can sense the position of the closure member 714. The position sensor 734 can be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuitry 710 as the closure member 714 translates in the distal and proximal directions. The control circuitry 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some examples, the position sensor 734 may be omitted. If any of the motors 704a-704e are step motors, the control circuitry 710 may track the position of the closure member 714 by summing up the number and direction of steps the motor 704 is commanded to perform. The position sensor 734 may be located in the end effector 702 or in any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.

[0152] In one aspect, the control circuit 710 is configured to drive a firing member, such as the closure member 714 portion of the end effector 702. The control circuit 710 provides motor settings to the motor controller 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 closure member 714. The transmission 706a includes a movable mechanical element, such as a rotating element and a firing member, for controlling the movement of the closure member 714 in the distal and proximal directions along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly including a knife gear reduction set including a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal is indicative of the force required to fire or displace the closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 or the firing member along the firing stroke as a feedback signal to the control circuit 710. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the closure member 714 translates distally, the clamp arm 716 closes against the ultrasonic blade 718.

[0153] In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 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 a motor 704b. An 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 clamp arm 716. The transmission 706b includes a movable mechanical element, such as a rotating element and a closure member, for controlling the movement of the clamp arm 716 from an open position and a closed position. In one aspect, the motor 704b is coupled to a closure gear assembly including a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closure force feedback signal to the control circuit 710. The closure force feedback signal is indicative of the closure force applied to the clamp arm 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. An additional sensor 738 in the end effector 702 can provide a closure force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control 708b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.

[0154] 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 controller 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 includes a movable mechanical element, such as a rotating element, to control the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is coupled to a rotational transmission assembly including a tubular gear segment formed on (or attached to) the proximal end of the proximal closure tube to be operably engaged by a rotating gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal is indicative of the rotational 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. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.

[0155] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides motor settings to a motor controller 708d, which provides a drive signal to a motor 704d. An 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 includes a movable mechanical element, such as an articulation element, for controlling the ±65° articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut, which is rotatably journaled on a proximal end portion of the distal spine portion and rotatably driven by an articulation gear assembly on the proximal end portion of the distal spine portion. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal is indicative of the articulation force applied to the end effector 702. A sensor 738 , such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710 .

[0156] In another embodiment, the articulation function of the robotic surgical system 700 may include two articulation members, or linkages 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b may be driven antagonistically relative to the other linkage to provide resistive holding motion and load to the head when the head is not moving, and to provide articulation motion when the head is articulating. The articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Thus, as the head rotates, the mechanical efficiency of the push-pull linkage changes. This change in mechanical efficiency may be more pronounced with other articulation linkage drive systems.

[0157] In one aspect, one or more of the motors 704a-704e may comprise brushed DC motors with gearboxes and mechanical connections to the firing members, closure members, or articulation members. Another example includes electric motors 704a-704e operating movable mechanical elements such as displacement members, articulation connections, closure tubes, and shafts. External influences are the unmeasured and unpredictable influences of things such as tissue, surroundings, and friction on a physical system. Such external influences may be referred to as drags that act against one of the electric motors 704a-704e. External influences such as drags may cause the operation of a physical system to deviate from the desired operation of the physical system.

[0158] 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 provide an absolute positioning system in conjunction with the control circuit 710. 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 the Boulder algorithm, which is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.

[0159] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensor 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 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 sensor 738 may include one or more sensors. The sensor 738 may be positioned on the clamp arm 716 to determine the position of the tissue using a split electrode. The torque sensors 744a-744e may be configured to sense forces such as firing force, closure force, and / or articulation force, among others. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member in the rack and its position, (3) which portion of the ultrasonic blade 718 has tissue on it, and (4) the load and position on both articulation rods.

[0160] 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 strain in the clamp arm 716 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude with the magnitude of strain. The sensor 738 may comprise a pressure sensor configured to detect pressure created by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensor 738 may be configured to detect the impedance of a tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.

[0161] In one aspect, the sensor 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 sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device, such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include non-conductor-containing switches, ultrasonic switches, accelerometers, and inertial sensors, among others.

[0162] In one aspect, the sensor 738 may be configured to measure the force applied by the closure drive system to the clamp arm 716. For example, one or more sensors 738 may be located at an interaction point between a closure tube and the clamp arm 716 to detect a closure force applied by the closure tube to the clamp arm 716. The force applied to the clamp arm 716 may be representative of tissue compression experienced by a tissue section captured between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force applied by the closure drive system to the clamp arm 716. The one or more sensors 738 may be sampled in real time during the clamping operation by a processor of the control circuitry 710. The control circuitry 710 receives and analyzes the real time sample measurements to provide and time based information to assess the closure force applied to the clamp arm 716 in real time.

[0163] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current drawn by one of the motors 704a-e. 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 controller software. The displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be any one of any feedback controllers, including, but not limited to, a PID, state feedback, linear-quadratic (LQR), and / or adaptive controller. The robotic surgical instrument 700 can include a power supply to convert the signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force. Further details are disclosed in U.S. patent application Ser. No. 15 / 636,829, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," filed Jun. 29, 2017, which is incorporated by reference in its entirety.

[0164] 17 shows a circuit diagram of a surgical instrument 750 configured to control distal translation of a displacement member, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as a closure member 764. The surgical instrument 750 includes an end effector 752, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

[0165] The position, movement, displacement, and / or translation of a linear displacement member, such as the closure member 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because the closure member 764 is coupled to a longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and / or translation of the closure member 764 can be achieved by the position sensor 784 as described herein. The control circuitry 760 may be programmed to control the translation of a displacement member, such as the closure member 764. In some embodiments, the control circuitry 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, such as the closure member 764, in the manner described. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuitry 760 to correlate the position of the closure member 764 determined by the position sensor 784 with the output of the timer / counter 781 such that the control circuitry 760 can determine the position of the closure member 764 at a particular time (t) relative to a starting position. The timer / counter 781 may be configured to measure elapsed time, count external events, or measure the time of an external event.

[0166] The control circuitry 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include 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 speed 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 include 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 circuitry 760 may directly generate the motor drive signal 774.

[0167] The motor 754 can receive power from an energy source 762. The energy source 762 can be or can include a battery, a supercapacitor, or any other suitable energy source. The motor 754 can be mechanically coupled to the closure member 764 via a transmission 756. The transmission 756 can include one or more gears or other coupling components for coupling the motor 754 to the closure member 764. The position sensor 784 can sense the position of the closure member 764. The position sensor 784 can be or can include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 can include an encoder configured to provide a series of pulses to the control circuitry 760 as the closure member 764 translates in the distal and proximal directions. The control circuitry 760 can track the pulses to determine the position of the closure member 764. Other suitable position sensors can be used, including, for example, a proximity sensor. Other types of position sensors can provide other signals indicative of the movement of the closure member 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuitry 760 can track the position of the closure member 764 by summing the number and direction of steps the motor 754 is commanded to take. The position sensor 784 can be located in the end effector 752 or in any other portion of the instrument.

[0168] The control circuitry 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 various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors.

[0169] The one or more sensors 788 may comprise a strain gauge, such as a micro strain gauge, configured to measure the amount of strain in the clamp arm 766 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude with the amount of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure created by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect the impedance of a tissue portion located between the clamp arm 766 and the ultrasonic blade 768, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.

[0170] The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. For example, one or more sensors 788 may be located at an interaction point between a closure tube and the clamp arm 766 to detect a closure force applied to the clamp arm 766 by the closure tube. The force exerted on the clamp arm 766 may be representative of tissue compression experienced by a tissue section captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 766 by the closure drive system. The one or more sensors 788 may be sampled in real time during the clamping operation by a processor of the control circuitry 760. The control circuitry 760 receives and analyzes the real time sample measurements to provide and time based information to assess the closure force applied to the clamp arm 766 in real time.

[0171] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the closure member 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.

[0172] The control circuitry 760 may be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member may be actuated to move the closure member 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 may include a feedback controller, which may be any one of any feedback controllers, including, but not limited to, a PID, state feedback, LQR, and / or adaptive controller. The surgical instrument 750 may include a power supply to convert a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force.

[0173] The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting or closure member 764 by a brushed DC motor with a gearbox and mechanical connection to the articulation and / or knife system. Another example is an electric motor 754 that operates, for example, the displacement member and the articulation driver of an interchangeable shaft assembly. External influences are the unmeasured and unpredictable influences of things like tissue, surroundings and friction on the physical system. Such external influences are sometimes referred to as obstacles that act against the electric motor 754. External influences such as obstacles can cause the operation of the physical system to deviate from the desired operation of the physical system.

[0174] Various exemplary embodiments relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, a motor 754 may drive a displacement member in a distal and proximal direction along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766. A clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, for example, by pressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member in a distal direction along a longitudinal axis of the end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the displacement member translates distally, a closure member 764 with a cutting element positioned at its distal end can cut tissue between the ultrasonic blade 768 and the clamp arm 766 .

[0175] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as, for example, the closure member 764, 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 control program based on the tissue condition. The control program may describe the distal movement of the displacement member. Different control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or with less power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or with more power.

[0176] In some embodiments, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of the displacement member stroke. Based on the 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 the translation distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, the total pulse width of the 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 in a closed loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Further details are disclosed in U.S. patent application Ser. No. 15 / 720,852, filed Sep. 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," which is incorporated by reference in its entirety.

[0177] 18 shows a circuit diagram of a surgical instrument 750 configured to control distal translation of a displacement member, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as a closure member 764. The surgical instrument 750 includes an end effector 752, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

[0178] The position, movement, displacement, and / or translation of a linear displacement member, such as the closure member 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because the closure member 764 is coupled to a longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and / or translation of the closure member 764 can be achieved by the position sensor 784 as described herein. The control circuitry 760 may be programmed to control the translation of a displacement member, such as the closure member 764. In some embodiments, the control circuitry 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, such as the closure member 764, in the manner described. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuitry 760 to correlate the position of the closure member 764 determined by the position sensor 784 with the output of the timer / counter 781 such that the control circuitry 760 can determine the position of the closure member 764 at a particular time (t) relative to a starting position. The timer / counter 781 may be configured to measure elapsed time, count external events, or measure the time of an external event.

[0179] The control circuitry 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include 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 speed 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 include 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 circuitry 760 may directly generate the motor drive signal 774.

[0180] The motor 754 can receive power from an energy source 762. The energy source 762 can be or can include a battery, a supercapacitor, or any other suitable energy source. The motor 754 can be mechanically coupled to the closure member 764 via a transmission 756. The transmission 756 can include one or more gears or other coupling components for coupling the motor 754 to the closure member 764. The position sensor 784 can sense the position of the closure member 764. The position sensor 784 can be or can include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 can include an encoder configured to provide a series of pulses to the control circuitry 760 as the closure member 764 translates in the distal and proximal directions. The control circuitry 760 can track the pulses to determine the position of the closure member 764. Other suitable position sensors can be used, including, for example, a proximity sensor. Other types of position sensors can provide other signals indicative of the movement of the closure member 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuitry 760 can track the position of the closure member 764 by summing the number and direction of steps the motor 754 is commanded to take. The position sensor 784 can be located in the end effector 752 or in any other portion of the instrument.

[0181] The control circuitry 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 various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors.

[0182] The one or more sensors 788 may comprise a strain gauge, such as a micro strain gauge, configured to measure the amount of strain in the clamp arm 766 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude with the amount of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure created by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect the impedance of a tissue portion located between the clamp arm 766 and the ultrasonic blade 768, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.

[0183] The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. For example, one or more sensors 788 may be located at an interaction point between a closure tube and the clamp arm 766 to detect a closure force applied to the clamp arm 766 by the closure tube. The force exerted on the clamp arm 766 may be representative of tissue compression experienced by a tissue section captured between the clamp arm 766 and the ultrasonic blade 768. The one or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 766 by the closure drive system. The one or more sensors 788 may be sampled in real time during the clamping operation by a processor of the control circuitry 760. The control circuitry 760 receives and analyzes the real time sample measurements to provide and time based information to assess the closure force applied to the clamp arm 766 in real time.

[0184] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the closure member 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.

[0185] The control circuitry 760 may be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member may be actuated to move the closure member 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 may include a feedback controller, which may be any one of any feedback controllers, including, but not limited to, a PID, state feedback, LQR, and / or adaptive controller. The surgical instrument 750 may include a power supply to convert a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force.

[0186] The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting or closure member 764 by a brushed DC motor with a gearbox and mechanical connection to the articulation and / or knife system. Another example is an electric motor 754 that operates, for example, the displacement member and the articulation driver of an interchangeable shaft assembly. External influences are the unmeasured and unpredictable influences of things like tissue, surroundings and friction on the physical system. Such external influences are sometimes referred to as obstacles that act against the electric motor 754. External influences such as obstacles can cause the operation of the physical system to deviate from the desired operation of the physical system.

[0187] Various exemplary embodiments relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, a motor 754 may drive a displacement member in a distal and proximal direction along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766. A clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, for example, by pressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member in a distal direction along a longitudinal axis of the end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the displacement member translates distally, a closure member 764 with a cutting element positioned at its distal end can cut tissue between the ultrasonic blade 768 and the clamp arm 766 .

[0188] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as, for example, the closure member 764, 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 control program based on the tissue condition. The control program may describe the distal movement of the displacement member. Different control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or with less power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or with more power.

[0189] In some embodiments, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of the displacement member stroke. Based on the 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 the translation distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, the total pulse width of the 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 in a closed loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Further details are disclosed in U.S. patent application Ser. No. 15 / 720,852, filed Sep. 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," which is incorporated by reference in its entirety.

[0190] 18 is a schematic diagram of a surgical instrument 790 configured to control various functions, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as a closure member 764. The surgical instrument 790 includes an end effector 792 that may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that may be replaced by or work in conjunction with one or more RF electrodes 796 (shown in dashed lines). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 that is driven by an ultrasonic generator 771.

[0191] In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid-state switch, a Hall effect device, an MR device, a GMR device, a magnetometer, among others. In other implementations, the sensor 638 may be a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include a non-conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.

[0192] In one aspect, the position sensor 784 may be implemented as an absolute positioning system with a magnetic rotary absolute positioning system implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 784 may provide an absolute positioning system in conjunction with the control circuit 760. 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 Boulder algorithm, which is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.

[0193] In some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuitry 760 can track the position of the closure member 764 by summing the number and direction of steps the motor is commanded to take. The position sensor 784 can be located in the end effector 792 or in any other portion of the instrument.

[0194] The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 792. The sensors 788 may include one or more sensors.

[0195] An RF energy source 794 is coupled to the end effector 792 and is applied to an RF electrode 796 when the RF electrode 796 is provided within the end effector 792 in place of the ultrasonic blade 768 or when the RF electrode 796 is provided to operate in conjunction with the ultrasonic blade 768. For example, the ultrasonic blade may be made of a conductive metal and used as a return path for the electrosurgical RF current. A control circuit 760 controls the delivery of RF energy to the RF electrode 796.

[0196] Further details are disclosed in U.S. patent application Ser. No. 15 / 636,096, filed Jun. 28, 2017, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME," which is incorporated by reference in its entirety.

[0197] FIG. 19 shows an example of a generator 900, a form of generator configured to interface with an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub. The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone or in combination, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, which signals can be delivered individually or simultaneously to an end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory (not shown for clarity of disclosure) coupled to the processor 902. Digital information related to the waveforms is provided to the waveform generator 904, which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is provided to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient isolated side. A first signal of a first energy modality is provided between terminals labeled ENERGY1 and RETURN on the surgical instrument. A second signal of a second energy modality is coupled across a capacitor 910 and provided between terminals labeled ENERGY2 and RETURN on the surgical instrument. More than two energy modalities may be output, thus the subscript "n" indicates up to n ENERGY n It will be understood that n is a positive integer greater than 1.n ) may be provided without departing from the scope of the present disclosure.

[0198] A first voltage sense circuit 912 is coupled across the terminals labeled ENERGY1 and RETURN paths and measures the output voltage therebetween. A second voltage sense circuit 924 is coupled across the terminals labeled ENERGY2 and RETURN paths and measures the output voltage therebetween. A current sense circuit 914 is disposed in series with the RETURN section of the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient isolated side) of the power transformer 908 are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculations. Output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate output impedance, among other parameters. Input / output communication between the processor 902 and the patient isolation circuitry is provided through an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.

[0199] In one aspect, the impedance may be determined by the processor 902 by dividing the output of either the first voltage sense circuit 912 coupled across the terminals labeled ENERGY1 / RETURN or the second voltage sense circuit 924 coupled across the terminals labeled ENERGY2 / RETURN by the output of a current sense circuit 914 placed in series with the RETURN section of the secondary side of the power transformer 908. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY1 may be ultrasound energy and the second energy modality ENERGY2 may be RF energy. Yet, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. Also, while the example illustrated in FIG. 19 shows that a single return path (RETURN) can be provided to two or more energy modalities, in other embodiments, multiple return paths RETURN n However, each energy modality ENERGY n Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sense circuit 912 by the current sense circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sense circuit 924 by the current sense circuit 914.

[0200] As shown in FIG. 19, a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities, such as, for example, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy at high voltage and low current to drive an ultrasonic transducer using either monopolar or bipolar RF electrosurgical electrodes, at low voltage and high current to drive an RF electrode for tissue sealing, or in a coagulation waveform for spot coagulation. The output waveform from the generator 900 may be directed, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection to the generator 900 output of the ultrasonic transducer would preferably be located between the output labeled ENERGY1 and RETURN as shown in FIG. 18. In one embodiment, the RF bipolar electrode connection to the generator 900 output would preferably be located between the output labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be an active electrode (e.g., a pencil or other probe) to a suitable return pad connected to the ENERGY2 and RETURN outputs.

[0201] Further details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published March 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety.

[0202] The term "wireless" and its derivatives used throughout this application may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that may communicate data through the use of modulated electromagnetic radiation over a non-solid medium. This term does not imply that the associated devices do not include any wires, although in some aspects they may not be present. The communication modules may implement any of 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), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

[0203] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually a memory or some other data stream. The term is used herein to refer to a system that combines many dedicated "processors" or a central processor (central processing unit) in a computer system (especially a systems on a chip (SoC)).

[0204] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can include digital, analog, mixed-signal, and often high-frequency functions, all on a single substrate. An SoC integrates a microcontroller (or microprocessor) with modern peripherals such as a graphics processing unit (GPU), Wi-Fi module, or co-processor. An SoC may or may not include built-in memory.

[0205] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller may house one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM, and a small amount of RAM are often also included on the chip. Microcontrollers may be employed for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications that are composed of various separate chips.

[0206] As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with a peripheral device, or it may be the link between two parts of a computer or controller on an external device that manages the operation of (and connections with) that device.

[0207] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including, for example, 256KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance above 40MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.

[0208] In one aspect, the processor may include a safety controller, including two controller families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured 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 offering scalable performance, connectivity, and memory options.

[0209] Modular devices include modules that can be received in a surgical hub (e.g., as described in connection with FIG. 3 and FIG. 9 ) and surgical devices or instruments that can be connected to various modules to connect or pair with corresponding surgical hubs. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, aspirators, and displays. The modular devices described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on the surgical hub to which the particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can relate to the patient during surgery (e.g., tissue characteristics or injection pressure) or the modular device itself (e.g., advancing knife speed, motor current, or energy level). For example, a control algorithm for a surgical stapling and severing instrument may control the speed at which the instrument's motor drives the knife through tissue based on the resistance the knife encounters as it advances.

[0210] FIG 20 is a simplified block diagram of one embodiment of a generator 1100 for providing, among other advantages, the inductorless regulation described above. With reference to FIG 20, the generator 1100 may include a patient-isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolated stage 1520 and may include a tapped configuration (e.g., center-tapped or non-center-tapped configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to various surgical devices, such as, for example, an ultrasonic surgical device 1104 and an electrosurgical device 1106. In particular, the drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to the ultrasonic surgical device 1104, and the drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to the electrosurgical device 1106, where output 1600b corresponds to a center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620 having an output connected to the primary winding 1640 of the power transformer 1560. In certain embodiments, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic 1660 for providing a digital output to a digital-to-analog converter (DAC) 1680, which in turn provides a corresponding analog signal to the input of the power amplifier 1620. In certain embodiments, the programmable logic 1660 may include, for example, a field programmable gate array (FPGA). The programmable logic 1660 may control the input of the power amplifier 1620 via the DAC 1680, thereby controlling any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal appearing at the drive signal outputs 1600a, 1600b, 1600c.In certain aspects, and as described below, the programmable logic 1660, in conjunction with a processor (e.g., processor 1740, described below), can execute a number of digital signal processing (DSP)-based and / or other control algorithms to control parameters of the drive signal output by the generator 1100.

[0211] Power can be provided to the bus of the power amplifier 1620 by a switch mode regulator 1700. In a particular aspect, the switch mode regulator 1700 can include, for example, an adjustable buck regulator. As mentioned above, the non-isolated stage 1540 can further include a processor 1740, which in one aspect can include, for example, a DSP processor, such as an ADSP-21469 SHARC DSP available from Analog Devices, Norwood, Mass. In a particular aspect, the processor 1740 can control the operation of the switch mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. For example, in one aspect, the processor 1740 can receive as an input via the ADC 1760 the waveform envelope of a signal (e.g., an RF signal) to be amplified by the power amplifier 1620. The processor 1740 can then control the switch mode regulator 1700 (e.g., via a pulse width modulated (PWM) output) such that the rail voltages supplied to the power amplifier 1620 track the waveform envelope of the amplified signal. By dynamically modulating the rail voltages of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved compared to a fixed rail voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.

[0212] In certain aspects, the programmable logic 1660, in conjunction with the processor 1740, may execute a direct digital synthesizer (DDS) control scheme to control the waveform, frequency, and / or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic 1660 may execute a DDS control algorithm by recalling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be embedded in an FPGA. This control algorithm is particularly useful in ultrasonic applications where an ultrasonic transducer, such as the ultrasonic transducer 1120, may be driven by a well-defined sinusoidal current at its resonant frequency. Minimizing or reducing the total distortion of the operating branch current may correspondingly minimize or reduce undesirable resonant effects, since other frequencies may excite parasitic resonances. Because the waveform shape of the drive signal output by the generator 1100 may be affected by various distortion sources present in the output drive circuit (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal may be input to an algorithm, such as an error control algorithm executed by the processor 1740, which compensates for the distortion by appropriately pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated motional branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuit, may result in a motional branch drive signal having a desired waveform shape (e.g., sinusoidal) to optimally drive the ultrasonic transducer. Thus, in such an aspect, the LUT waveform samples represent not the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately generate the motional branch drive signal of the desired waveform when considering distortion effects.

[0213] The non-isolated stage 1540 may further include ADC 1780 and ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for sampling the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADC 1780, 1800 may be configured to sample at a high speed (e.g., 80 Msps) to allow for oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADC 1780, 1800 may allow for oversampling of the drive signal by approximately 200 times (depending on the drive frequency). In certain aspects, the sampling operation of the ADC 1780, 1800 may be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of high speed sampling in embodiments of the generator 1100 can enable, among other things, the calculation of complex currents flowing through the motional branches (which may be used in certain embodiments to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and highly accurate calculation of actual power consumption. The voltage and current feedback data output by the ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering, multiplexing) by the programmable logic 1660 and may be stored in a data memory, for subsequent retrieval, for example, by the processor 1740. As noted above, the voltage and current feedback data may be used as input to an algorithm to pre-distort or modify the LUT waveform samples on a dynamic and ongoing basis. In certain embodiments, this may require that each stored voltage and current feedback data pair be indexed or otherwise associated with the corresponding LUT sample output by the programmable logic 1660 as the voltage and current feedback data pair is acquired. Synchronizing the LUT samples with the voltage and current feedback data in this manner contributes to precise timing and stability of the predistortion algorithm.

[0214] In certain aspects, the voltage and current feedback data can be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, the voltage and current feedback data can be used to determine the impedance phase, e.g., the phase difference between the voltage drive signal and the current drive signal. The frequency of the drive signal can then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the measurement accuracy of the impedance phase. The determination of the phase impedance and frequency control signal can be performed, for example, by the processor 1740, with the frequency control signal provided as an input to a DDS control algorithm executed by the programmable logic 1660.

[0215] The impedance phase can be determined by Fourier analysis. In one embodiment, the generator voltage V g (t) Drive signal and generator current I g The phase difference between the (t) drive signal can be determined using a Fast Fourier Transform (FFT) or a Discrete Fourier Transform (DFT) as follows:

[0216]

number

[0217] Evaluating the Fourier transform at the frequency of the sine wave gives:

[0218]

number

[0219] Other approaches include weighted least squares estimation, Kalman filtering, and space vector based techniques. Substantially all of the processing in the FFT or DFT technique may be performed in the digital domain, for example using a two channel high speed ADC 1780, 1800. In one technique, digital signal samples of the voltage and current signals are Fourier transformed with an FFT or DFT. The phase angle φ at any time can be calculated by the following formula: φ=2πft+φ0

[0220] where φ is the phase angle, f is the frequency, t is the time, and φ0 is the phase at t=0.

[0221] Voltage V g (t) Signal and current I g Another technique for determining the phase difference between a (t) signal and a voltage V g (t) Signal and current I g For the (t) signal, the voltage signal V g Each negative to positive zero crossing of (t) triggers the start of a pulse, while the current signal I g Each negative to positive zero crossing of (t) triggers the end of a pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a measure of the phase difference. Additionally, positive to negative zero crossings can be used in a similar manner and the result averaged to reduce any effects of DC and harmonic content. In one implementation, the analog voltage V g (t) Signal and current I gThe (t) signal is converted to a digital signal that is high when the analog signal is positive and low when the analog signal is negative. High accuracy phase estimation requires a sharp transition between high and low. In one embodiment, a Schmitt trigger can be used in conjunction with an RC stabilization network to convert the analog signal to a digital signal. In other embodiments, an edge-triggered RS flip-flop and supporting circuitry may be used. In yet another embodiment, the zero-crossing technique may use an eXclusive OR (XOR) gate.

[0222] Other techniques for determining the phase difference between voltage and current signals include Lissajous figures and image monitoring, three-voltmeter method, crossed coil method, vector voltmeter and vector impedance methods, as well as phase standard instruments, phase-locked loops, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http: / / www.engnetbase.com> and the use of other techniques, such as those described in, which are incorporated herein by reference.

[0223] In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude setpoint can be directly specified or indirectly determined based on specified voltage amplitude and power setpoints. In certain aspects, control of the current amplitude can be performed by a control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm in the processor 1740. Variables controlled by the control algorithm to appropriately control the current amplitude of the drive signal can include, for example, scaling of LUT waveform samples stored in the programmable logic 1660 and / or the full-scale output voltage of the DAC 1680 (which provides an input to the power amplifier 1620) via the DAC 1860.

[0224] The non-isolated stage 1540 may further include a processor 1900 to provide, among other things, user interface (UI) functions. In one embodiment, the processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM926EJ-S core available from Atmel Corporation, San Jose, Calif. Examples of UI functions supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touch screen display), and communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and the programmable logic (e.g., via a serial peripheral interface (SPI) bus). While the processor 1900 may primarily support UI functions, it may also cooperate with the processor 1740 in certain embodiments to provide hazard mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and / or other input (e.g., touch screen input 2150, foot switch 1430 input, temperature sensor input 2160) and can disable the drive output of the generator 1100 if an erroneous condition is detected.

[0225] 21 illustrates a generator circuit 3500 split into multiple stages, with a first stage circuit 3504 in common with a second stage circuit 3506, according to at least one embodiment of the present disclosure. In one embodiment, a surgical instrument of a surgical system 1000 described herein may include a generator circuit 3500 split into multiple stages. For example, a surgical instrument of a surgical system 1000 may include a generator circuit 3500 split into at least two circuits, a first stage circuit 3504 and a second stage circuit 3506 of amplification that allow operation of radio frequency (RF) energy only, ultrasonic energy only, and / or a combination of RF and ultrasonic energy. A combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located in the handle assembly 3512 and a modular second stage circuit 3506 integral with the modular shaft assembly 3514. As discussed above in connection with the surgical instruments of the surgical system 1000 and throughout this description, the battery assembly 3510 and the shaft assembly 3514 are configured to mechanically and electrically communicate with the handle assembly 3512. The end effector assembly is configured to mechanically and electrically communicate with the shaft assembly 3514.

[0226] As shown in the embodiment of FIG. 21, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the control circuit 3200 described above. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420. As described above, the first stage drive circuit 3420 is configured to drive ultrasonic, radio frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 can drive any one of the second stage circuits 3506, such as the second stage ultrasonic drive circuit 3430, the second stage radio frequency (RF) current drive circuit 3432, and / or the second stage sensor drive circuit 3434. The common first stage drive circuit 3420 detects which second stage circuit 3506 is located within the shaft assembly 3514 when the shaft assembly 3514 is connected to the handle assembly 3512. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which one of the second stage circuits 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and / or second stage sensor drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 to provide the appropriate digital waveform to the second stage circuit 3506 to drive the appropriate load (e.g., ultrasonic, RF, or sensor). It will be appreciated that identification circuitry may be included in the various assemblies 3516 in the third stage circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Thus, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

[0227] 22 is a diagram of a surgical system 4000 representing one embodiment of the surgical system 1000 including a feedback system for use with any one of the surgical instruments of the surgical system 1000, which may include or implement many of the features described herein. The surgical system 4000 may include a generator 4002 coupled to a surgical instrument including an end effector 4006 that may be activated when a clinician manipulates a trigger 4010. In various embodiments, the end effector 4006 may include an ultrasonic blade for delivering ultrasonic vibrations to perform a surgical coagulation / cutting procedure on living tissue. In other embodiments, the end effector 4006 may include a conductive element coupled to a source of electrosurgical high frequency current energy to perform a surgical coagulation or cauterization procedure on living tissue, and either a mechanical knife or an ultrasonic blade with a sharp cutting edge to perform a cutting procedure on living tissue. When the trigger 4010 is actuated, the force sensor 4012 may generate a signal indicative of the amount of force being applied to the trigger 4010. In addition to or instead of the force sensor 4012, the surgical instrument can include a position sensor 4013 that can generate a signal indicative of the position of the trigger 4010 (e.g., how deeply the trigger has been depressed or otherwise actuated). In one aspect, the position sensor 4013 can be a sensor positioned with the outer tubular sheath or a reciprocating tubular actuating member located within the outer tubular sheath of the surgical instrument. In one aspect, the sensor can be a Hall effect sensor or any suitable transducer that changes its output voltage in response to a magnetic field. Hall effect sensors can be used for proximity switching, positioning, speed detection and current sensing applications. In one aspect, the Hall effect sensor operates as an analog converter and returns a voltage directly. With a known magnetic field, the distance from the Hall plate can be determined.

[0228] The control circuit 4008 can receive signals from the sensors 4012 and / or 4013. The control circuit 4008 can include any suitable analog or digital circuit components. The control circuit 4008 can further communicate with the generator 4002 and / or the transducer 4004 to modulate the power delivered to the end effector 4006 and / or the generator level or ultrasonic blade amplitude of the end effector 4006 based on the force applied to the trigger 4010 and / or the position of the trigger 4010 and / or the position of said outer tubular sheath relative to a reciprocating tubular actuating member located within the outer tubular sheath (e.g., as measured by a combination of a Hall effect sensor and a magnet). For example, the more force applied to the trigger 4010, the more power and / or the higher ultrasonic blade amplitude can be delivered to the end effector 4006. According to various aspects, the force sensor 4012 can be replaced by a multi-position switch.

[0229] According to various aspects, the end effector 4006 may include a clamp or clamping mechanism. When the trigger 4010 is initially actuated, the clamping mechanism may close, clamping tissue between the clamp arm and the end effector 4006. As the force applied to the trigger increases (e.g., as sensed by the force sensor 4012), the control circuit 4008 may increase the power delivered to the end effector 4006 by the transducer 4004 and / or the generator level or ultrasonic blade amplitude brought about the end effector 4006. In one aspect, the trigger position sensed by the position sensor 4013, or the clamp or clamp arm position sensed by the position sensor 4013 (e.g., with a Hall Effect sensor), may be used by the control circuit 4008 to set the power and / or amplitude of the end effector 4006. For example, as the trigger is moved further toward the fully actuated position or the clamp or clamp arm is moved further toward the ultrasonic blade (or end effector 4006), the power and / or amplitude of the end effector 4006 may be increased.

[0230] According to various aspects, the surgical instrument of the surgical system 4000 can also include one or more feedback devices to indicate the amount of power delivered to the end effector 4006. For example, the speaker 4014 can emit a signal indicative of the power of the end effector. According to various aspects, the speaker 4014 can emit a series of pulsed tones, the frequency of which indicates the power. In addition to or instead of the speaker 4014, the surgical instrument can include a visual display 4016. The visual display 4016 can indicate the power of the end effector according to any suitable manner. For example, the visual display 4016 can include a series of LEDs, where the power of the end effector is indicated by the number of illuminated LEDs. The speaker 4014 and / or the visual display 4016 can be driven by the control circuitry 4008. According to various aspects, the surgical instrument can include a ratchet device connected to the trigger 4010. As more force is applied to the trigger 4010, the ratchet device can generate an audible sound to provide an indirect indication of the end effector power. The surgical instrument can include other features that can enhance safety. For example, the control circuit 4008 can be configured to prevent power from being delivered to the end effector 4006 above a predetermined threshold. The control circuit 4008 can also provide a delay between the time a change in end effector power is indicated (e.g., by the speaker 4014 or visual display 4016) and the time the change in end effector power is delivered. In this way, the clinician can be given ample warning that the level of ultrasonic power delivered to the end effector 4006 is about to change.

[0231] In one aspect, the ultrasonic or radio frequency current generator of the surgical system 1000 may be configured to digitally generate the electrical signal waveform, desirably digitizing the waveform using a predetermined number of phase points stored in a look-up table. The phase points may be stored in a table defined in a memory, a field programmable gate array (FPGA), or any suitable non-volatile memory.

[0232] Advanced Energy Device Control Algorithm Various control algorithms for ultrasonic and combination energy surgical instruments (e.g., ultrasonic / monopolar surgical instruments, monopolar / bipolar surgical instruments, ultrasonic / bipolar surgical instruments, and other such combination energy devices) are described herein. For clarity, the surgical instrument is referred to in this section of the disclosure as surgical instrument 7012, although the disclosure in this section may also apply to the other surgical instruments referenced above, such as surgical instruments 112, 700.

[0233] In various aspects, the control algorithm of the surgical instrument 7012 may be configured to achieve a constant heat flux along the length of the ultrasonic blade of the surgical instrument 7012. The control algorithm may be applied by the control circuitry and / or the surgical hub. The control circuitry may execute a computer executable program / algorithm local to the surgical instrument 7012 or receive a suitable algorithm (e.g., an impedance rate algorithm) from the surgical hub and / or a cloud computing system. Alternatively, the surgical hub may execute the algorithm remotely to the surgical instrument 7012. A constant heat flux may advantageously improve the quality of tissue coagulation, cutting, or sealing. The surgical instrument 7012 may be an ultrasonic and bipolar or combined energy modality surgical instrument. The control algorithm may include determining or adjusting the clamping force in proportion to the progress of surgical coagulation of the tissue grasped by the surgical instrument 7012. Additionally, the control algorithm may include variably varying, such as increasing, the clamp arm pressure applied to the tissue pieces packed within the end effector to generate a constant heat flux along the blade length.

[0234] Specifically, the power of the electrosurgical energy delivered by the generator of the surgical instrument 7012, as well as the clamp arm pressure applied, can be adjusted or determined to achieve a predetermined heat flux. Additionally or alternatively, these can be adjusted to achieve a predetermined amount of power applied to the tissue. For example, the control algorithm can include varying the clamp arm pressure as well as varying the RF and ultrasonic power levels delivered by the generator to achieve a predefined heat flux or power applied to the tissue. The heat flux can be constant or near constant over the tissue welding time for a surgical procedure cycle. The variation implemented by the control algorithm can be based on at least one parameter, which can include, for example, tissue impedance, blade natural frequency, temperature, or some other parameter (e.g., tissue manipulation parameter). Additionally or alternatively, the variation of the clamp pressure and power level can be based on a heat flux controlled threshold. This heat flux controlled threshold can be dynamic such that the threshold is adjusted along the blade length based on the progression of the surgical cut and coagulation. This progression can be evaluated by a corresponding focal spot, which can indicate, for example, how well a fibrin clot is coagulating. Thus, a constant heat flux along the length of the blade can be created and the applied clamping force is proportional or corresponds to the solidification.

[0235] The control algorithm may also be configured to achieve a constant heat flux by adjusting the power over a series of successive impedance set points based on the time to achieve the set points to mimic impedance rise. In other words, as the generator of the surgical instrument 7012 progressively delivers power according to a predefined power curve (defining the relationship between the power delivered to the tissue and the tissue impedance), the control circuit may be configured to determine whether the tissue impedance reaches a particular amount at a particular time. Once the particular quality is reached, the generator may idle for a period of time and / or switch to a different power curve. If the particular quality is not reached, the generator may switch to a different power curve at that time or when the control circuit determines that the particular quality has not been reached or is unlikely to be reached. Additionally or alternatively, the control circuit may select a power curve based on a prediction that application of the selected power curve will cause the tissue impedance to reach a particular impedance level at a particular time in the surgical cycle.

[0236] The target or set tissue impedance point may depend on the time required to reach the next target point and / or the last set point. That is, for a series of tissue impedance points, each point may be determined based on its neighboring points, which may be either immediately before or after the target point. Other points in the series may also be used to determine the value of the target point. Each set point is defined as a tissue impedance target with an associated power level. For a series of impedance target points, the next tissue impedance target and power level may be determined as the delivery of power by the generator causes the tissue impedance to reach the target point. Subsequent impedance target points may be determined or adjusted based on the overall tissue impedance level at that moment in the surgical cycle and the time required to achieve the previous impedance target point. The set point may include a predetermined time, such as a dwell time, at the impedance target point before the control circuit determines the next adjustment.

[0237] In executing the control algorithm, the control circuitry and / or surgical hub may gradually close the end effector of the surgical instrument 7012 while applying a constant or near-constant clamping force or pressure to the grasped tissue along the length of the ultrasonic blade. That is, the control circuitry and / or surgical hub may adjust the end effector closure to account for changes in the clamping force applied to the tissue due to the progression of the surgical coagulation and / or cutting procedure. For example, as the grasped tissue is coagulated and cut at a proximal portion of the end effector, the corresponding proximal portion of the tissue may experience a greater applied clamping pressure due to the progression of the surgical coagulation / cutting. Thus, when the control circuitry and / or surgical hub senses or determines the progression of this coagulation / cutting operation (e.g., via a sealing or welding focus), it may adjust by increasing the clamping force applied to the distal section of the tissue. In this manner, each section of the grasped tissue may experience a uniform clamping pressure. As the location of the coagulation / cutting focus shifts along the length of the end effector, the applied clamping force may be further adjusted. Additionally or alternatively, the clamping arm (alternatively referred to as the first jaw) of the end effector may be curved to accentuate or amplify the clamping force.

[0238] Since the curved clamp arm will result in different clamping pressures being applied to the tissue, a control algorithm may be implemented to compensate for this deflection of the clamp arm. Thus, as the end effector gradually reaches its full closed stroke, the control circuitry and / or surgical hub may execute a control algorithm to compensate for this deflection in order to provide a constant or near constant clamping tissue pressure along the length of the blade (alternatively referred to as the second jaw of the end effector). Thus, the end effector may apply a relatively large clamping force to the distal portion of the end effector as tissue is being treated from the proximal to the distal direction. Additionally, the deflection of the clamp arm may cause a variation in heat flux along the length of the end effector. To address this, the control algorithm may include selectively energizing the surgical treatment electrodes (e.g., RF electrodes in the end effector) to compensate for or account for this variation. Specifically, the RF electrode can be divided into proximal and distal segments, and the control circuitry and / or surgical hub can control the generator to selectively energize the RF electrode segments appropriately to obtain a uniform and constant or near uniform and constant heat flux.

[0239] The control circuitry and / or surgical hub may be configured to execute a control algorithm to control energization of the segmented surgical treatment electrodes. For example, the electrodes may comprise two pairs of RF electrodes on each jaw of the end effector. The control circuitry may control the energization in conjunction with the progressive closure of the clamp arm / first jaw to achieve a constant current density along the end effector. Each of the two pairs of RF electrodes may be referred to as a proximal and distal set of electrodes, respectively, and may be energized as a set. The control circuitry may control the generator to energize the proximal and distal sets of electrodes sequentially such that an equal current density is generated or created in both the proximal and distal portions. In one aspect, the control circuitry and / or surgical hub may energize the proximal set of electrodes while causing the end effector to compress tissue with a first jaw pressure, resulting in a predetermined current density. When the measured tissue impedance (e.g., measured via a pressure, resistance, or other suitable sensor in the end effector) reaches or exceeds a predetermined threshold, the control circuitry and / or surgical hub may energize the distal set of electrodes and de-energize or cease application of power to the proximal set of electrodes. Simultaneously or substantially simultaneously, the clamping force applied by the clamp arm / first jaw may be increased to recreate a predetermined current density at the distal region where the distal set of electrodes is located. In this manner, the proximal and distal sets of the two electrodes may be energized or powered sequentially. Moreover, this sequential energization may occur in conjunction with variable application of clamping force. Additionally or alternatively, when the proximal set of electrodes delivers electrosurgical energy for treating tissue, the distal set of electrodes may simultaneously receive power from the generator at a lower power level for pre-heating. That is, the distal portion of the end effector may be pre-heated while the proximal portion is used to treat tissue. Similarly, the proximal portion of the end effector may also be pre-heated.

[0240] The surgical instrument 7012 may have a tissue (e.g., blood vessel) sealing mode in which a particular tissue impedance changes or rises in rate over time and a predictable coagulation time interval is targeted. During operation of the energy-based surgical instrument 7012, the tissue impedance may be selectively increased to "starve" the coagulation cycle. In other words, by applying electrosurgical energy according to a target tissue impedance point and dwell time, the progression of the coagulation cycle may be dynamically stopped or "starved" as needed to achieve a desired impedance change rate and coagulation time interval. In this manner, the generator may adjust power by ramping or cycling through different loads or power curves based on a target impedance set point with associated power levels and dwell times between switching between power levels or curves to obtain an overall coagulation time interval. The overall coagulation time may include a change in the impedance rise rate, as described in more detail below. In one aspect, an impedance rise rate, such as 50 ohms (Ω) per second, can be achieved by adjusting the dwell time at each target until a target time interval, such as 2 seconds (e.g., if applying the current power level or curve, otherwise increasing the impedance to 100Ω), or by increasing the number of targets and spacing them apart by specified increments, such as 50Ω increments, such that each power level or curve is applied until the next 50Ω target is reached.

[0241] Additionally, selectively achieving tissue impedance rise rates may be implemented to achieve predictable seal times as measured by surgical coagulation cycles. For example, the generator may apply power to the tissue according to a first power curve (e.g., defining a maximum power of 200 watts) to reach a target of 100Ω with four second pause time intervals. After reaching 100Ω and pausing for four seconds, the generator may achieve application of a series of power levels or curves. Each power level or curve may be determined and applied at an associated power level and pause time until the next target impedance point is reached, where the target impedance point is incrementally increased by 100Ω (i.e., each point is 100Ω greater than the previous one). By controlling the generator in this manner, at each target impedance point, the applied power level or curve may be altered according to the next target impedance point. The next impedance point may have an associated power level and pause time before the next impedance point is determined, which may be based on the overall tissue impedance level and time required to reach the target impedance point. In adjusting the impedance rise rate according to these dynamically determined target impedance points, predictable sealing times, such as a 7 second cycle time, can be achieved in the presently described embodiment.

[0242] The surgical instrument 7012 may be configured to deliver a combined electrosurgical energy, including ultrasonic and RF energy, to treatment tissue separated from a relatively hard or rigid substructure, such as a patient's bone. To determine when to apply this particular combination of electrosurgical energies, the sensor 788 may determine and monitor the natural or resonant frequency of the waveguide (and the blade on which it terminates). The waveguide natural frequency may be equivalent to an adjustment of the drive frequency created by the generator. Specifically, the sensor 788 may detect when the natural frequency experiences a wave or phase shift to determine when the end effector may impact a rigid substructure (e.g., bone, a relatively hard layer of soft tissue, etc.). When such an impact or contact is determined, the generator may be controlled to throttle both the ultrasonic blade amplitude and the RF power level. That is, the generator may reduce the transducer current used to vibrate the ultrasonic blade and the power delivered to the RF electrode. Thus, when the control circuitry and / or surgical hub detects bone or a gap in the soft tissue based on the ultrasonic resonant frequency, the surgical instrument 7012 can use ultrasonic energy to appropriately separate the tissue from harder underlying structures to supplement the heat generated by the application of RF energy. The control algorithms can also be configured to detect and throttle the application of electrosurgical energy upon detection of contact with a non-tissue object, such as when another instrument encounters an underlying clip, staple, or when the surgical instrument 7012 makes contact.

[0243] As mentioned above, the surgical instrument 7012 may be a combination surgical instrument, such as a combination monopolar / bipolar electrosurgical instrument, where the type of electrosurgical energy may be ultrasonic, RF, or any other suitable energy modality. In a monopolar modality, the patient being treated acts as a return path or electrical foundation (e.g., via a return pad on the patient's skin), while in a bipolar modality, the ultrasonic blade acts as a second pole for the delivery of the electrosurgical energy. A bipolar modality may generally be preferred for more controlled, localized application of electrosurgical energy. In this context, the control circuitry and / or surgical hub may execute a control algorithm to change the frequency of the electrosurgical monopolar energy to become non-therapeutic (outside of the therapeutic range) for monitoring aspects of the bipolar modality or system. Thus, in aspects where the surgical instrument 7012 functions as a bipolar tool, such as surgical shears, the performance of the control algorithm may provide improved neurosensing. Specifically, bipolar and monopolar energy modalities can be applied simultaneously or nearly simultaneously with monopolar energy delivered to the end effector at a non-therapeutic frequency as feedback to the bipolar energy delivery. For example, the generator can deliver a drive signal for nerve stimulation, such as a biphasic signal at 100-1000 Hertz (Hz) to stimulate a patient's nerve, where the monopolar energy circuit provides monopolar energy at a non-therapeutic frequency while the bipolar energy circuit provides bipolar energy in the range of 200 kilohertz (kHz) to 3 megahertz (MHz). In this manner, the non-therapeutic monopolar components can be used as feedback to the control circuitry and / or surgical hub to determine the proximity of the end effector to the patient's nerve. Using the determined nerve proximity, the surgical instrument can minimize inadvertent cutting of the nerve by the bipolar shears. Alternatively, the delivered bipolar energy can be feedback to the monopolar energy.

[0244] Additionally, the surgical instrument 7012 may adjust the application of bipolar electrosurgical energy based on changes in impedance resulting from the application of monopolar electrosurgical energy. Specifically, the control circuitry and / or surgical hub may execute a control algorithm that monitors the relative change in impedance from the monopolar energy such that a control setting for the bipolar energy is controlled. The sensor 788, control circuitry and / or surgical hub may detect or determine the impedance based on a signal sent through the monopolar energy circuit. For example, the impedance may be determined by dividing the output of the monopolar voltage sense circuit by the monopolar current sense circuit. The monopolar control setting may be a setting that defines how the monopolar energy is delivered to the end effector. Thus, a control algorithm may be executed to control the bipolar power using the monitored monopolar impedance, such as adjusting the bipolar power level based on the determined change in monopolar impedance. For example, given an applied clamp arm pressure of 14-17 pounds for the tip load, the generator can cycle from zero power to full power mode (e.g., 200 watts (W)) and use a monopolar to measure the relative impedance increase (e.g., to a particular threshold, such as 80 Ω) to control when to transition to a time-based control setting. That is, upon transition from 0 to 200 W, the determined change of 80 Ω can be used to trigger a change to a time-based bipolar power control setting that specifies applying a fixed amount of power, such as 100 W, for a predetermined period of time. Alternatively, the determined change of 80 Ω can cause a proportional step power reduction, such as a reduction in total power proportional to the increase in monopolar impedance.

[0245] The surgical instrument 7012 may also be a combination surgical instrument, such as a combination monopolar / ultrasonic electrosurgical instrument, in which the monopolar energy is used to sense or monitor a surgical procedure using an ultrasonic modality. In particular, the operating frequency of the monopolar energy may be altered to monitor aspects of the ultrasonic energy modality. For example, the monopolar energy may be initially output at a therapeutic frequency level and switched to a lower, non-therapeutic frequency and power level to obtain tissue impedance measurements that may be used to monitor ultrasonic energy delivery. Although the absolute value of the impedance may not be useful, the change in tissue impedance value may be compared to an expected change in tissue impedance resulting from an electrosurgical procedure to detect the tissue therapeutic effect of the delivered ultrasonic energy. In other words, when tissue is treated by ultrasonic energy, there may be an expected change in tissue impedance. The control circuitry and / or surgical hub may be configured to use a change in the frequency of the monopolar energy, such as by switching to a non-therapeutic frequency level, to determine whether the tissue effect caused by ultrasonic therapy is consistent with the expected change.

[0246] Changing the operating frequency of the monopolar energy modality to monitor the ultrasonic energy modality can also be accomplished by switching the drive frequency to a very high level, such as above 10 MHz, to enable tissue monitoring. In this manner, the change in monopolar frequency can be used to monitor the therapeutic effects on tissue resulting from other energy modalities, such as ultrasonic energy modalities, as described above. In some circumstances, undesirable parasitic impedances may result. However, the higher drive frequency of the monopolar energy modality can beneficially negate or minimize parasitic or stray capacitances due to the use of monopolar return pads (e.g., MEGADYNE™ MEGA SOFT™ reusable patient return electrodes). Nevertheless, the relatively high therapeutic monopolar frequency can operate effectively even at monopolar power set at a low level to detect tissue impedance. As described above, alternatively, the generator can drive the monopolar output at a lower frequency and sub-therapeutic current to sense the ultrasonic therapy and associated effects on the treated tissue. At lower frequencies, there may not be as many parasitic effects due to cable drape, length, etc., but sensing or monitoring of ultrasound energy modalities may be limited by the use of monopolar return pads.

[0247] At least a portion of the control algorithms disclosed herein may be executed by the surgical hub (either alone or in combination with the associated control circuitry of the surgical instrument), however, the functions of the control algorithms are described as being executed by the control circuitry for clarity. Also, for clarity, the control circuitry of the surgical instrument 7012 in this portion of the disclosure is labeled control circuitry 710, however, the control circuitry 710 may be the same as or similar to the control circuitry 760, 3200, 3502, 4008. The control circuitry 710 may be part of the generator 4002 itself (although referred to as generator 4002 for clarity, the generator 4002 may be the same as or similar to the generators 140, 145, 240, 721, 771, 900, 1100) or may be another part of the surgical instrument 7012 separate from the generator 4002. In various aspects, a surgical instrument 7012 (e.g., an ultrasonic surgical instrument) such as those described in Figures 23A-23B, 24A-24B, 25A-25B, 26A-26E, and 27A-27F is configured to operate with situational awareness in a hub environment, such as surgical hub 106 or 206 (Figures 1-11), as shown, for example, by timeline 5200.

[0248] 23A-23B are graphs 203500, 203520 including a graph 203500 of clamping force as a function of time and an associated graph 203520 showing the progression of the location of coagulation and cutting along the length of the blade as a function of time, according to at least one embodiment of the present disclosure. As shown in FIGS. 23A-23B, increasing the clamping force as the coagulation / cutting location (e.g., coagulation / cutting focal point) relative to the movement of the ultrasonic blade can result in better coupling of the tissue with the ultrasonic blade. The focal point can move from proximal to distal or distal to proximal, for example, depending on the direction of the surgical procedure. Additionally, the focal point can represent the progression of a fibrin clot for clotting, for example. The clamping arm of the surgical instrument 7012 can be offset, angled, or otherwise curved to accentuate or amplify the pressure experienced by the tissue resulting from the application of the clamping force. The surgical focus and total seal or weld time may be determined by the control circuit 710 based on a sensor signal (e.g., from sensor 788) indicative of a surgical parameter such as tissue impedance, specific frequency, temperature, or some suitable tissue parameter. The control circuit 710 may increase the clamp arm pressure based on the sensor signal. The change in clamp force as a function of surgical coagulation / cutting position may be controlled by the control circuit 710 in conjunction with the variation of the electrosurgical power level delivered by the generator to achieve a predetermined heat flux or power applied to the tissue.

[0249] The heat flux can be implemented by the control circuitry 710 as a heat flux control threshold, which can be the same or vary over the duration of a surgical procedure performed by the surgical instrument 7012, such as based on the progression of the surgical cutting / coagulation. For example, the control circuitry 710 can adjust the heat flux control threshold based on a determined coagulation focus, the progression of the focus, and / or the progression of the cutting. A given heat flux can beneficially improve the quality of a surgical procedure, such as a tissue seal formed. In FIG. 23A, the x-axis 203508 indicates time, such as time over the course of a surgical cycle, and the y-axis 203510 indicates the clamping force applied. Thus, from time t0 to time t 10The time to may define a surgical cycle for the surgical instrument 7012. The clamping force may be measured in suitable units, such as pounds (lbs). As shown in the graph 203500, the y-axis 203510 has notations of maximum and minimum clamping force levels.

[0250] The dashed line 203502 represents the force applied by the clamp arm over time, from a minimum force at time t0 to a minimum force at time t 10 The clamping force value or amount may be a function of the process of the tissue coagulation process, which may be the time it takes for the end effector to apply force from t0 to t 10 t6。 As shown by dashed line 203502, the applied clamping force increases as tissue coagulation / cutting action is sensed. The dashed line 203502 reaches a maximum force at a point near time t6, and the force increases at time t 10 The dashed and dotted line 203504 represents the tissue impedance measured over the surgical cycle. As can be seen in the graph 203500, the measured tissue impedance changes over a period of time t 0にFIG. 23A shows how this increase in tissue impedance line 203504 corresponds to an increase in applied clamping force line 203502. The increase in applied force may aid in cutting the tissue and help weld the denatured tissue as the surgical cycle is completed. The clamp arm may also be curved to accentuate the tissue pressure due to the increase in clamping force. Additionally, the end effector may close progressively providing a constant or near constant tissue clamping pressure along the length of the end effector or ultrasonic blade. The constant or near constant clamping pressure is shown by solid line 203506, which may correspond to the pressure applied to the leading edge of the end effector where surgical coagulation and cutting occurs. Thus, the solid line 203506 remains at a fairly constant level with minimal or no fluctuations.

[0251] 23B illustrates that the focal point of the surgical coagulation and cutting action on tissue moves along the length of the ultrasonic blade or second jaw 203524 (similar or the same as ultrasonic blade 718, 768 or other ultrasonic blades described above) over the course of a surgical cycle. As shown in FIG. 23B, the focal point moves from proximal to distal over time, but the focal point can also move from distal to proximal. The progression of the tissue coagulation / cutting focal point over a surgical cycle is determined by its advancement from time point t0 to time t 10788。 That is, each of the black dots 203522A, 203522B, 203522N corresponds to a time point in the surgical cycle and also represents the formation of a tissue seal and / or tissue treatment progress. For example, the black dots may represent a coagulation focus determined by the control circuit 710 based on a signal from the sensor 788. The sensor signal may be indicative of a surgical parameter such as tissue impedance, a natural frequency of the ultrasonic blade, temperature, or some other tissue parameter. Based on the sensor signal, the control circuit 710 may determine the progression of the tissue seal / weld / coagulation focus and further determine the tissue welding / sealing time of the surgical procedure performed by the surgical instrument 7012.

[0252] Additionally, the control circuit 710 may be configured to control the closure of the end effector while compensating for clamp arm deflection that may result from the curved shape of the end effector. For example, the control circuit 710 may mechanically adjust the force applied by the clamp arm to offset any unbalanced force applied based on the curvature of the clamp arm so that a constant or near-constant tissue pressure is provided along the length of the end effector. Additionally, the control circuit 710 may selectively energize different segments (e.g., proximal and distal) of an RF electrode, such as the RF electrode 796, to compensate for or adjust for variations in heat flux caused by clamp arm deflection, as described in more detail below. The control circuit 710 may be configured to determine the cutting / welding focal point based on one or more of the resonant frequency and electrical continuity feedback measurements. A constant heat flux along the length of the ultrasonic blade 203524 may also be achieved. For example, when tissue is coagulated and cut at proximal portions of the end effector, the electrosurgical power levels delivered are relatively high in these proximal sections. Thus, the control circuit 710 may execute a control algorithm to increase the clamping force at the distal section, which may result in a higher current density at the distal section to compensate for the relatively lower power level at the distal section. In this manner, the heat flux and pressure experienced by the tissue along the ultrasonic blade 203524 may be constant and / or consistent with the heat flux control threshold. The control circuit 710 may receive a sensor signal from the sensor 788 indicative of a surgical parameter. The surgical parameter may be tissue impedance, a natural frequency of the ultrasonic blade, a temperature, or a tissue parameter. A weld time for the surgical procedure may be determined by the control circuit 710 based on the sensor signal. The control circuit 710 may vary one or more of the clamp arm pressure applied by the clamp arm and the power level of the electrosurgical energy to maintain a predetermined heat flux or one or more of the power applied to the tissue packed within the end effector.

[0253] 24A-24B show examples of controlling the segments of an end effector electrode and the clamping force applied and electrosurgical energy delivered by the end effector, according to at least one embodiment of the present disclosure. FIG. 24A shows the end effector 203540 in an open configuration. The end effector 203540 can be the same as or similar to any suitable end effector described above, such as end effector 702, 752, 792, 4006, or some other suitable end effector. As shown in FIG. 24A, the end effector 203540 includes two jaws including a first jaw (e.g., clamp arm) 203542 and a second jaw / ultrasonic blade 203544 (the same as or similar to ultrasonic blade 203524). The clamp arm 203542 can be the same as or similar to any suitable clamp arm described above, such as clamp arm 716, 766, or some other suitable clamp arm. Each of the first and second jaws 203542, 203544 includes an electrosurgical electrode 203546A-203546D, 203548A-203548D, respectively. The electrosurgical electrodes 203546A-203546D, 203548A-203548D may be the same as or similar to an RF electrode, such as RF electrode 796 or any other suitable electrode described above. The electrosurgical electrodes 203546A-203546D, 203548A-203548D may each be divided into proximal and distal portions or segments. For example, the electrodes 203546A-203546B, 203548A-203548B may form a proximal electrode pair or segment on the first and second jaws 203542, 203544, respectively. Similarly, electrodes 203546C-203546D, 203546C-203546D may form a distal electrode pair or segment on the first and second jaws 203542, 203544, respectively. In this manner, electrodes 203546A-203546B, 203548A-203548B may be longitudinally segmented. Longitudinally segmented electrodes may generate a constant current density.

[0254] The control circuitry 710 can be configured to execute a control algorithm that controls the application of power by the generator 4002 to the segmented electrodes 203546A-B, 203548A-B in conjunction with controlling the progressive closure of the clamping arm 203542 to obtain a constant or near-constant current density throughout the end effector 203540. FIG. 24B shows an example of this. In FIG. 24B, the end effector 203560 applies different clamping pressures to the tissue 203570 based on the different clamping forces resulting from different end effector closure angles θ1, θ2. Specifically, the control circuitry 710 may control the end effector 203560 to compress the tissue 203570 to a first jaw pressure (which may be predetermined or dynamically determined) while controlling the generator 4002 to energize the proximal set of electrodes 203546A-203546B, 203548A-203548B to generate a first predetermined current density. The generator 4002 may deliver power to one of the proximal electrode pairs, individually, or to both pairs. Additionally, the generator 4002 may power the jaws of the end effector individually, such as by applying power only to the power electrode pair 203546A-203546B on the first jaw 203542 and powering them sequentially or in tandem. Thus, the control circuit 710 may energize the electrode segments 203546A-203546D, 203548A-203548D based on the progressive closing stroke of the clamp arm 203542.

[0255] A tissue impedance signal (or signals indicative of current and voltage) may be output by a sensor 788 (e.g., pressure, resistance, or other suitable sensor) and transmitted as feedback to the control circuit 10. When the control circuit 710 determines that the tissue impedance reaches a predetermined or dynamically determined threshold, the control circuit 710 controls the end effector 203560 and the generator 4002 to vary one or more of the clamping force and power level (e.g., to reach a constant heat flux and / or heat flux control threshold). Specifically, the end effector 203560 may be controlled to apply an increased jaw pressure that is higher than the first jaw pressure. At the same time or within the same time frame, the control circuit 710 controls the generator 4002 to power down the proximal electrode pair and instead deliver power to one or both of the distal electrode pairs individually. That is, the generator 4002 supplies power to one or more of the electrodes 203546C-203546D, the distal segments of the electrodes 203546C-203546D. In this manner, the same current density in the clamped tissue can be obtained for the distal electrode or portion of the end effector 203560 as for the proximal electrode or portion of the end effector 203560. The current density can be determined pre-determined or dynamically as appropriate. As shown in FIGS. 24A-24B, increasing the clamp load pressure on the tissue 203570 corresponds to an increase in the angle between the clamp arm / first jaw 203562 and the ultrasonic blade / second jaw 203564, decreasing from θ1 to θ2. Also, as shown in FIGS. 24A-24B, the first and second jaws 203562, 203564 pivot about a pivot point 203568 to perform the end effector closing stroke.

[0256] 25A-B are graphs 203580, 203600 illustrating control of energization or power delivery of electrosurgical electrodes 203546A-D, 203548A-D, according to at least one embodiment of the present disclosure. As described above, the control circuit 710 may be configured to execute a control algorithm to control the end effector 203560 and the generator 4002 to create or generate a constant current density. During treatment of a proximal portion of the end effector 203560, the control circuit 710 may control the end effector to compress tissue 203570 at the proximal portion to a first clamping pressure. At the same time or within the same time frame, the generator 4002 may deliver power only to the proximal electrode pairs 203546A-B, 203548A-B to surgically treat the proximal portion. Either or both of the electrodes in the first and second jaws 203562, 203564 can be energized such that either or both of the proximal first electrode pair 203546A-203546B and the proximal second electrode pair 203548A-203548B can be energized. After surgical manipulation of the proximal portion, the generator 4002 can deliver power to the distal electrodes 203546C-203546D, 203548C-203548D to manipulate a distal portion of the end effector 203560. Either or both of the electrodes in the first and second jaws 203562, 203564 may be energized, such that either or both of the distal first electrode pair 203546A-203546B and the distal second electrode pair 203548A-203548B may be energized. In this manner, the electrosurgical electrodes 203546A-203546D, 203548A-203548D may be energized sequentially by the generator 4002.

[0257] 25A illustrates delivering power to the proximal (referenced as electrode pair "a") and distal (referenced as electrode pair "b") electrodes as the clamp pressure experienced by the tissue 203570 increases in a corresponding manner. The x-axis 203582 of the graph 203580 illustrates time, such as in seconds, which may span the length of a surgical cycle. The y-axes 203584, 203585 respectively illustrate the power level as expressed as a percentage of maximum power (100%), and the clamp pressure (e.g., measured in pounds) experienced by the tissue 203570. Graph 203580 shows an arrangement of proximal electrode pairs "a" 203546A-203546B, 203548A-203548B that are activated to treat tissue for a first period of time shown on the x-axis 203582, followed by an arrangement of distal electrode pairs "b" 203546C-203546D, 203548C-203548D that are activated to treat tissue for a second period of time shown on the x-axis. The rectangular function of graph 203580 shows this sequential energization. The generator 4002 first powers electrode pair "a" 203546A-203546B, 203548A-203548B according to power level line 203586, deactivates "a", then powers electrode pair "b" 203546C-203546D, 203548C-203548D according to power level line 203588, and finally deactivates "b". At the same time or within the same time frame, the control circuit 710 is controlling the end effector 203560 to apply a clamping pressure at level P1 while electrode pair "a" is activated, and a clamping pressure at level P2 while electrode pair "b" is activated. This application of clamping pressure is represented by clamping pressure line 203590. Once the surgical procedure on the proximal and distal portions is complete, the generator 4002 stops delivering power and the end effector 203560 returns to the open configuration.

[0258] FIG. 25B illustrates the pre-heating of distal electrode pair "b" 203546C-203546D, 203548C-203548D. Thus, while the proximal portion of the end effector 203560 is being treated, the control circuitry 710 may also control the generator 4002 to pre-heat the distal portion. In other words, during the time spanning the activation of electrode pair "a" 203546A-203546B, 203548A-203548B, the generator 4002 may deliver power at a lower power level to distal electrode pair "b" 203546C-203546D, 203548C-203548D to facilitate surgical treatment of the distal portion after completion of the surgical treatment of the proximal portion. The graph 203600 illustrates this. The x-axis 203602 of the graph 203600 indicates time, such as in seconds, which may span the length of a surgical cycle. The y-axes 203604, 203605 respectively indicate power level as expressed as a percentage of maximum power (100%) and clamp pressure (e.g., measured in pounds) experienced by the tissue 203570. The power level line 203606 of the graph 203600 indicates the sequential activation of electrode pair "a", similar to the power level line 203586. The power level line 203608 indicates a similar activation of electrode pair "b", except that the generator 4002 may deliver power to distal electrode pair "b" 203546C-203546D, 203548C-203548D at a lower power level of 20% of the maximum power level (100%) applied at the peak of the rectangular function. This applied lower power level allows a distal portion of the end effector 203560 to be pre-heated prior to treatment. At the same time or within the same frame, the control circuit 710 controls the end effector 203560 to apply clamping pressure at levels P1 and P2, as represented by clamping pressure line 203610. The control circuit 710 can also control the generator 4002 in an opposite manner, such that a proximal portion of the end effector 203560 is pre-heated prior to treatment.

[0259] 26A-26E are a series of graphs 203620, 203640, 203660, 203680, 203700 illustrating adjustment of power levels to achieve predictable sealing times in accordance with at least one embodiment of the present disclosure. The x-axis 203622, 203642, 203662, 203682, 203702 illustrates tissue impedance, which may be measured in ohms (Ω). The y-axis 203624, 203644, 203664, 203684, 203704 illustrates the power level applied by the generator 4002. The graphs 203620, 203640, 203660, 203680, 203700 illustrate how a series of consecutive impedance points may be set to mimic an impedance rise that corresponds to a particular tissue coagulation time. By achieving a target impedance rise rate and predictable coagulation time interval for the surgical instrument (e.g., in vessel sealing mode), a safer or otherwise better tissue seal may be achieved. Each impedance point in the series may be set based on the next target power level and / or impedance, and the time in the surgical cycle required to reach the previous or other previously set impedance point. Upon reaching a particular impedance point, the control circuit 710 may determine the next set impedance point and associated power level to achieve and / or maintain the desired rise in tissue impedance. In particular, the control circuit 710 may be configured to control the rise in tissue impedance such that the impedance of the tissue 203570 changes according to an impedance versus time curve ("bathtub curve") resembling the shape of a "bathtub". The impedance versus time curve may be characterized by an initial drop in tissue impedance upon initial application of electrosurgical energy until stabilization (minimum point), followed by a rise in tissue impedance corresponding to desiccation of the tissue 203570. The overall or concurrent tissue impedance level relative to this impedance bathtub curve, as assessed by the sensor 788 and control circuit 710, may also be used to adjust the next set impedance point.

[0260] The power level associated with each impedance point may be determined based on the power level that achieves a subsequent impedance point that tracks a different impedance versus time curve compared to the default impedance bathtub curve. The different impedance curve may be less aggressive (but may be more aggressive) than the bathtub curve, for example. In this manner, a desired rise in impedance may be mimicked as each impedance point in the series is achieved and the associated power level for each is determined according to a desired impedance versus time curve. This rise in impedance may correspond to drying of the tissue 203570, except that the rise may be adjusted relative to the default bathtub curve such that an improved tissue seal is obtained. Additionally or alternatively, by dynamically determining the set impedance points and associated power levels, the control circuit 710 may perform a surgical procedure according to a predictable coagulation time interval. The associated power level determined for each set impedance point may be one or more power values. In particular, the associated power level may be determined according to a load curve or a power curve. The power curve may be, for example, a predetermined power curve stored in a memory of the surgical instrument 7012, or may be a power curve determined dynamically according to a mathematical model or equation (e.g., changes in variables used in an equation or together in another equation to determine power), or any other suitable means.

[0261] Thus, the impedance points may be dynamically determined or targeted to achieve selective impedance increases. As described above, by controlling the rate of rise of the impedance of the tissue 203570 in this manner, tissue coagulation may become more predictable and improved. There may also be a pause between adjacent impedance set points in the series. This pause between impedance points may "starve" the coagulation cycle. That is, during the pause, the generator 4002 may not deliver power to the end effector 203560 such that the impedance of the tissue 203570 does not change significantly during the pause. The graph 203620 may show a natural load or power curve (e.g., a curve representing power level as a function of tissue impedance) as shown by the plotted applied power line 203626. The applied power line 203620 also shows the pause. The natural power curve may be a desired impedance versus time curve that includes a desired rise in impedance that is dynamically achieved as the series of impedance points are set. Specifically, graph 203640 shows a first set impedance point in a series of consecutive impedance points.

[0262] The first set point occurs at 100 Ω, so that the generator 4002 delivers an associated power level that ramps up to a maximum power, such as 200 watts (W), to achieve 100 Ω. The associated power level can be determined according to applying a power curve stored in the memory of the surgical instrument 7012 corresponding to the surgical hub and / or cloud, applying a segment or specific portion of the power curve, or by referencing a desired natural power curve to determine an appropriate level. As seen in the graph 203640, the corresponding first power curve is applied as represented by the applied power line 203646 to incrementally mimic the natural power curve. The applied power line 203646 also indicates a dwell time. Thus, the desired rate of rise and the natural power curve can be used as a guide along with the elapsed time to determine the next impedance point and associated power level. The remainder of the first power curve or power level is generally represented by the dotted line 203648. Upon reaching the first set impedance point at 100 Ω, the generator 4002 can dwell for a suitable period of time. This pause time may be predetermined or may be determined contemporaneously by the control circuit 710 and may be useful to temporarily pause or delay the coagulation cycle. During the pause time, the control circuit 710 may evaluate the progress of tissue coagulation, which may be compared, for example, to a desired natural power curve. The pause time may be, for example, 4 seconds. After pausing for 4 seconds, the control circuit 710 may determine that the next set impedance point is 200Ω based on a reference to the last set point of 100Ω, an estimated next impedance point, and / or a desired natural power curve (e.g., total or simultaneous impedance level of the tissue 203570 relative to the natural power curve), etc.

[0263] The control circuit 710 may also determine that the corresponding power level is less than 200W according to a second power curve that gradually reduces the power level below 200W. This second power curve or power level may be different from the first power curve or power level. As with the first set impedance point, the generator 4002 may deliver power to mimic or follow a desired impedance rise rate and / or according to a natural power curve. That is, the generator 4002 may deliver power as expected to reach the second set impedance point at a desired time. The graph 203660 includes an applied power line 203666 that shows the application of this second associated power by the generator 4002 to reach 200Ω and a dwell time. The remainder of the second power curve or power level is generally represented by a dotted line 203668. Once the impedance reaches 200Ω, the control circuit 710 may determine an appropriate amount of dwell time. For example, the control circuit 710 may determine that the generator 4002 should pause for one second to stop tissue coagulation. The control circuit 710 may further set the next target impedance point to 300Ω once the impedance reaches 200Ω. As described above, 300Ω may be determined based on factors such as a reference to the last set point 200Ω, an estimated next impedance point, and / or a desired natural power curve. The associated third power curve or power level applied by the generator 4002 may be determined with reference to or according to a desired impedance rise rate and / or natural power curve, as described above. As shown in the graph 203680, the third power curve or power level may be used as a function of impedance to modify the relative rate of change of the power level. The remainder of the third power curve or power level is generally represented by the dotted line 203688.

[0264] After pausing for 1 second, the generator 4002 can deliver power according to a corresponding third power curve or power level until the next set impedance point of 300Ω is reached. This is illustrated by the graph 203680. In the graph 203680, the applied power line 203686 represents delivering power according to the third power curve or power level and the determined pause time. As above, the control circuit 710 can implement a predetermined or simultaneously determined pause time upon reaching 300Ω. Furthermore, the control circuit 710 can determine that the next impedance point to be set is 400Ω based on the various factors described above. Furthermore, the control circuit 710 can change / determine that the corresponding power level is a fourth power curve or power level(s). The generator 4002 can deliver power according to this fourth power curve or power level until the next impedance set point is reached, as represented by the applied power line 203706. The remainder of the second power curve or power levels are generally represented by the dotted line 203708. Once the tissue impedance reaches the 300Ω set point, the control circuit 710 may determine that the next set point is 400Ω, similar to the determination of the series of previous impedance points. Once 400Ω is reached, the control circuit 710 may determine that tissue coagulation is complete and therefore terminate the coagulation process. This is illustrated by the graph 203700. More or fewer set impedance points may be used as needed. Based on using these dynamically determined series of set impedance points and associated powers, the control circuit 710 may mimic a desired impedance rise to obtain a predictable coagulation time interval. The impedance points and pause times may be used to assist in determining the power curve, either "on the fly" or simultaneously determined. In other words, the generator 4002 may apply segments or portions of different power curves and / or power levels as needed. Although FIGS. 26A-26E show the use of pause times, in other aspects, pause times may not be used.26A-26E, a total dwell time of 7 seconds may be implemented during the surgical cycle with a 100Ω difference between adjacent set impedance points to achieve a desired impedance rise rate. Other desired rise rates can be achieved, for example, by changing the dwell time to 2 seconds, or by using a 50Ω difference between adjacent set impedance points.

[0265] Thus, the control circuitry 710 can execute an impedance rate algorithm that may be programmed into the memory of the surgical instrument 7012 or received by a surgical hub or cloud computing system. Specifically, the control circuitry 710 can receive a first tissue impedance point (e.g., a given first set impedance point), determine a first power level of electrosurgical energy corresponding to the first tissue impedance point, control the generator to deliver the electrosurgical energy at the first power level, determine a second tissue impedance point, adjust the first power level to a second power level of electrosurgical energy based on a time interval to reach the second tissue impedance point, and control the generator to deliver the electrosurgical energy at the second power level. More tissue impedance points in the series of impedance points can be determined or targeted to achieve selective impedance increase. For example, the control circuitry 710 can determine a third tissue impedance point and determine the second tissue impedance point based on the third tissue impedance point and the corresponding time interval to reach the first tissue impedance point. After the control circuit 710 controls the generator 4002 to deliver electrosurgical energy to reach the second impedance point, it may determine a third impedance point and an associated power level.

[0266] Dwell times may also be implemented. For example, the control circuit 710 may adjust from a first power level to a second power level and pause for a period of time before determining a third tissue impedance point. Also, for example, the control circuit may control the generator 4002 to apply power according to the following steps: applying a first power level to reach a first tissue impedance point, terminating application of the first power level for a first pause time, determining by the control circuit a second tissue impedance point, applying the second power level to reach the second tissue impedance point, terminating application of the second power level for a second pause time, determining by the control circuit a third tissue impedance point, and applying a third power level to reach the third tissue impedance point to achieve a target impedance rise rate. The generator may further terminate application of the third power level for a third pause time, determine a fourth tissue impedance point, and apply the fourth power level to reach the fourth tissue impedance point. As described above, setting a series of impedance points can be determined based on previous impedance points and the time to deliver electrosurgical energy to reach those points. Thus, the third and fourth impedance points can be determined based on the first and second impedance points and the time to reach them. The time to reach the impedance points (e.g., the first, second, and third points) can correspond to a predetermined coagulation time interval.

[0267] 27A-F are graphs and flow charts 203720, 203740, 203760, 203780, 203800, 203820 illustrating approaches for delivering energy according to a power curve, according to at least one embodiment of the present disclosure. Further details regarding such approaches can be found in U.S. Patent No. 9,737,355, entitled "CONTROLLING IMPEDANCE RISE IN ELECTROSURGICAL MEDICAL DEVICES," which is incorporated by reference in its entirety, and U.S. Patent Application Publication No. 20180036065, entitled "METHODS AND SYSTEMS FOR ADVANCED HARMONIC ENERGY," which is incorporated by reference in its entirety.

[0268] FIG. 27A illustrates one embodiment of a diagram 203720 showing exemplary power curves 203726, 203728, 203730. The diagram 203720 includes an impedance axis 203722 that shows increasing tissue impedance from left to right. The power y-axis 203724 shows increasing power from bottom to top. Each power curve 203726, 203728, 203730 may define a series of power levels on the power y-axis 203724, corresponding to a number of potential sensed tissue impedances on the impedance x-axis 203722. In general, the power curves may take different shapes, which are illustrated in FIG. 27A. The power curve 203726 has a stepped shape, while the power curves 203728, 203730 are shown as having curved shapes. It is understood that the power curves used by the various embodiments may take any usable continuous or non-continuous shape. The power delivery rate or aggressiveness of a power curve may be indicated by its location on the diagram 203720. For example, a power curve that delivers more power for a given tissue impedance may be considered to be more aggressive. Thus, between two power curves, the curve that is highest on the power axis 203724 may be the more aggressive. It is understood that some power curves may overlap.

[0269] The aggressiveness of the two power curves may be compared by any suitable method. For example, a first power curve may be considered to be more aggressive than a second power curve over a given range of potential tissue impedances if the first power curve has a higher delivered power corresponding to at least half of the range of potential tissue impedances. Also, for example, a first power curve may be considered to be more aggressive than a second power curve over a given range of potential tissue impedances if the area under the first curve over the range is greater than the area under the second curve over the range. Similarly, if the power curves are represented separately, a first power curve may be considered to be more aggressive than a second power curve over a given set of potential tissue impedances if the sum of the power values ​​of the first power curve over the set of potential tissue impedances is greater than the sum of the power values ​​of the second power curve over the set of potential tissue impedances.

[0270] Some embodiments of the surgical instrument 7012 include a positive temperature coefficient (PTC) material located between one or more of the electrodes of the jaws 203562, 203564. The PTC material may have an impedance profile that remains relatively low and relatively constant until a threshold or trigger temperature is reached at which the impedance of the PTC material may increase. In use, the PTC material may be placed in contact with tissue while power is applied. The trigger temperature of the PTC material may be selected such that it corresponds with a tissue temperature that indicates completion of welding or coagulation. Thus, once the welding or coagulation process is complete, the temperature of the PTC material may increase, which may cause a corresponding increase in the impedance of the PTC material. This additional series of impedance is in series with the tissue and may cause a decrease in the power actually delivered to the tissue 203570.

[0271] It is understood that during the coagulation or welding process, tissue impedance may generally increase. In some aspects, tissue impedance may exhibit a sudden increase in impedance, indicative of successful coagulation. This increase may be due to physiological changes in the tissue, the PTC material reaching a trigger threshold, etc. The amount of energy that may be required to produce a sudden impedance increase may be related to the thermal mass of the tissue 203570 being acted upon. The thermal mass of any given piece of tissue may in turn be related to the type and amount of tissue 203570 in the slice. The PTC material may be used to determine the welding time of the surgical procedure performed by the surgical instrument 7012. Monitoring of the PTC material or other sensors 788 in the end effector 203560 may also be performed by the control circuit 710 to determine the coagulation focus and the progress of the surgical procedure (e.g., cutting). Based on these determinations, the control circuit 710 may adjust the heat flux control threshold along the length of the ultrasonic blade 203564.

[0272] Various embodiments may use sudden increases in tissue impedance to select an appropriate power curve for a given tissue piece. For example, the generator 4012 may select and apply successively more aggressive power curves until the tissue impedance reaches an impedance threshold that indicates a sudden increase has occurred. For example, reaching the impedance threshold may indicate that coagulation is proceeding properly with the most recently applied power curve. The impedance threshold may be a tissue impedance value, a rate of change in tissue impedance, and / or a combination of impedance and rate of change. For example, the impedance threshold may be met when a certain impedance value and / or rate of change is observed. As described herein, according to various embodiments, different power curves may have different impedance thresholds.

[0273] FIG. 27B illustrates one embodiment of a process flow 203740 for applying one or more power curves to a tissue fragment 203570. Any suitable number of power curves may be used. The power curves may be applied sequentially in order of aggressiveness until one of the power curves raises the tissue to the impedance threshold. In step 203742, the generator 4002 may apply a first power curve. According to various embodiments, the first power curve may be selected to deliver power at a relatively low rate. For example, the first power curve may be selected to avoid tissue burning in the tissue fragments that are expected to be the smallest and most vulnerable.

[0274] The first power curve may be applied at the tissue 203570 in any suitable manner. For example, the generator 4002 may generate a drive signal that implements the first power curve. The power curve may be implemented by adjusting the power of the drive signal. The power of the drive signal may be adjusted in any suitable manner. For example, the voltage and / or current of the signal may be adjusted. Also, in various embodiments, the drive signal may be pulsed. For example, the generator 4002 may adjust the average power by changing the frequency, pulse width, duty cycle, etc. of the drive signal. The drive signal may be provided to electrodes of the first and second jaw members 203562, 203564.

[0275] While applying the first power curve, the generator 4002 may monitor the total energy delivered to the tissue 203570. The impedance of the tissue 203570 may be compared to the impedance threshold at one or more energy thresholds. There may be any suitable number of energy thresholds, which may be selected by any suitable method. For example, the energy thresholds may be selected to correspond to known points at which different tissue types achieve impedance thresholds. In step 203744, the generator 4002 may determine whether the total energy delivered to the tissue 203570 has met or exceeded the first energy threshold. If the total energy has not yet reached the first energy threshold, the generator 4002 may continue to provide the first power curve at 203742.

[0276] If the total energy reaches the first energy threshold, the generator 4002 may determine whether an impedance threshold has been reached (step 203746). As described above, the impedance threshold may be a predetermined percentage impedance change (e.g., increase), a predetermined impedance, or a combination of the two. Once the impedance threshold is reached, the generator 4002 may continue to apply the first power curve in step 203742. For example, reaching the impedance threshold of the first power curve may indicate that the aggressiveness of the first power curve is sufficient to produce a suitable coagulation or weld.

[0277] If the impedance threshold has not been reached in step 203746, the generator 4002 may increase to the next aggressive power curve in step 203748 and may apply the power curve as the current power curve in step 203742. In some embodiments, increasing to the next most aggressive power curve may include applying a multiplier to a less aggressive power curve, such as, for example, a previously implemented power curve. Upon reaching the next energy threshold in step 203744, the generator 4002 may also determine whether the impedance threshold has been reached in step 203746. If not, the generator 4002 may also increase to the next aggressive power curve in step 203748 and may provide this power curve in step 203742.

[0278] The process flow 203740 may continue until terminated. For example, the process flow 203740 may be terminated upon reaching the threshold at step 203746. Upon achieving the impedance threshold, the generator 4002 may apply the power curve at this point until coagulation or welding is complete. Also, for example, the process flow 203740 may terminate when all available power curves are exhausted. Any suitable number of power curves may be used. If the most aggressive power curve is unable to raise the tissue to the impedance threshold, the generator 4002 may continue to apply the most aggressive power curve until the process is otherwise terminated (e.g., by the clinician or upon reaching a final energy threshold).

[0279] According to various aspects, the process flow 203740 may continue until a termination threshold occurs. The termination threshold may indicate that coagulation and / or welding is complete. For example, the termination threshold may be based on one or more of tissue impedance, tissue temperature, tissue capacitance, tissue inductance, elapsed time, and the like. Upon termination, the surgical instrument 7012 and / or the surgical hub 5104 may generate an audible sound indicating termination. These may be single termination thresholds, or in some aspects, different power curves may have different termination thresholds. According to various aspects, different power curves may have different impedance thresholds. For example, the process flow 203740 may transition from a first power curve to a second power curve if the first power curve fails to raise the tissue to the first tissue impedance threshold, and may then transition from the second power curve to a third power curve if the second power curve fails to raise the tissue to the second impedance threshold. In some aspects, rather than sequentially proceeding between the power curves, the generator 4002 may skip one or more power curves. For example, if the tissue impedance at the end of a power curve exceeds a skip threshold, the generator 4002 may skip to a more aggressive power curve (e.g., a power curve that provides more energy for a given tissue impedance) instead of proceeding to the next power curve.

[0280] In some embodiments using a pulsed drive signal, the generator 4002 may apply one or more composite load curves to the drive signal, and ultimately to the tissue. The composite load curve, like other power curves described herein, may define the power level delivered to the tissue as a function of measured tissue properties. Additionally, the composite load curve may define pulse characteristics, such as pulse width, in relation to the measured tissue properties (e.g., impedance, applied current, applied voltage, temperature, reflectance, force applied to tissue, etc.).

[0281] FIG. 27C is a diagram 203760 illustrating power and impedance characteristics of one embodiment of a drive signal that may be provided by the generator 4002 during a first mode. In FIG. 27C, impedance is shown on the x-axis 203762 and power is shown on the y-axis 203764. During the first mode, the generator 4002 may be configured to deliver a first power threshold 203766 to the tissue while the tissue impedance is below the threshold impedance 203768 for the mode. If the tissue impedance exceeds the threshold impedance 203768 for the first mode, the generator 4002 may limit the delivered power to a second power threshold 203770. In various embodiments, the second power threshold 203770 may be less than the maximum power the generator 4002 is configured to deliver to the tissue. In this manner, the first mode may prepare the tissue 203570 for greater power application in a subsequent mode. The duration of application of the first mode may be any suitable value, including, for example, 1 second. It will be appreciated that the drive signal may be pulsed during application of the first mode. For example, the first mode may be applied as a single pulse lasting for the duration of the duration of application of the first mode, or in multiple short pulses. In aspects utilizing multiple pulses in the first mode, each pulse may meet the impedance determination limit of the drive signal power, as described.

[0282] FIG. 27D is a diagram 203780 illustrating power and impedance characteristics of one embodiment of a drive signal that may be provided by the generator 4002 during the second mode. In FIG. 27D, impedance is sho...

Claims

1. 1. A surgical system comprising: a surgical hub configured to receive the impedance rate algorithm transmitted from a cloud computing system and communicatively coupled to the cloud computing system; a surgical instrument communicatively coupled to the surgical hub, An end effector, an ultrasonic blade configured to ultrasonically vibrate against tissue; an end effector comprising: a clamp arm configured to pivot relative to the ultrasonic blade; an electrode configured to receive electrosurgical energy from a generator and apply the received electrosurgical energy to the end effector to weld tissue with the electrosurgical energy applied to the end effector based on the generator generating a drive signal; an ultrasonic transducer acoustically coupled to the ultrasonic blade, the ultrasonic transducer configured to ultrasonically vibrate the ultrasonic blade in response to the drive signal; a control circuit coupled to the end effector, the control circuit executing the impedance ratio algorithm to: establishing a first tissue impedance target point; determining a first power level of the electrosurgical energy corresponding to the first tissue impedance target point; controlling the generator to deliver the electrosurgical energy at the first power level; establishing a second tissue impedance target point; adjusting the first power level to a second power level of the electrosurgical energy such that the second tissue impedance target point is expected to be reached at a desired time; A surgical system configured to control the generator to deliver the electrosurgical energy at the second power level.

2. The control circuit executes the impedance ratio algorithm and further establishing a third tissue impedance target point; 2. The surgical system of claim 1, configured to set the second tissue impedance target point based on the third tissue impedance target point and a time required to reach the first tissue impedance target point.

3. 3. The surgical system of claim 2, wherein the control circuit is configured to execute the impedance rate algorithm to set the third tissue impedance target point and further determine a third power level of the electrosurgical energy corresponding to the third tissue impedance target point when controlling the generator to deliver the electrosurgical energy at the second power level to reach the second tissue impedance target point.

4. 4. The surgical system of claim 3, wherein the control circuitry is configured to execute the impedance rate algorithm to further adjust the third tissue impedance target point based on a tissue impedance level assessed by a sensor and the desired time to reach the second tissue impedance target point.

5. 3. The surgical system of claim 2, wherein the control circuitry is configured to execute the impedance rate algorithm to further determine a pause time before adjusting the first power level to the second power level of the electrosurgical energy and setting the third tissue impedance target point, and to control the generator to deliver the electrosurgical energy at the first power level during the pause time.

6. The surgical system of claim 1 , wherein the electrode comprises a plurality of longitudinally arranged electrode segments.

7. The surgical system of claim 6 , wherein the control circuitry is configured to execute the impedance rate algorithm to further energize the plurality of electrode segments based on a progressive closing stroke of the clamp arm.

8. The surgical system of claim 1, wherein the second power level is determined according to a curve representing power level as a function of tissue impedance stored in a memory of the surgical instrument.

9. The surgical system of claim 1, wherein the second power level is determined according to an impedance versus time curve stored in a memory of the surgical instrument.

10. The surgical system of claim 1, wherein the first tissue impedance target point and the second tissue impedance target point are set to mimic an impedance rise corresponding to a specific tissue coagulation time.

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