Surgical instruments

Abstract

An ultrasonic surgical instrument is provided. [Solution] The device comprises an end effector 203220 having an ultrasonic blade 203226 configured to ultrasonically vibrate in contact with tissue and a clamp arm 203224 configured to pivot relative to the ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade and configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from a generator, and a control circuit coupled to the end effector, wherein at least one of the ultrasonic blade and the clamp arm is configured to compress, deform, deflect, or bend.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Nonprovisional Patent Application No. 16 / 182,238, filed November 6, 2018, entitled "ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION LOCATION," the entire disclosure of which is incorporated herein by reference.

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional 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 entire disclosure of which is incorporated herein by reference.

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

[0004] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 62 / 659,900, filed April 19, 2018, entitled “METHOD OF HUB COMMUNICATION,” the entire disclosure of which is incorporated herein by reference.

[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 entireties. [Background technology]

[0008] The present disclosure relates to various surgical systems. Surgical procedures are typically performed in an operating room or surgery suite within a medical facility, such as a hospital. Typically, a sterile field is created 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 aspect of the present disclosure. [Diagram 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present disclosure. [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 a smoke evacuation component 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 aspect 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 schematic diagram of a robotic surgical instrument configured to manipulate a surgical tool described herein, in accordance with at least one embodiment 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 schematic diagram of a surgical instrument configured to control various functions, according to at least one aspect of the present disclosure. [Figure 19] 1 illustrates an example of a generator, according to at least one embodiment 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 aspect of a surgical instrument with a feedback system for use with the surgical instrument, according to one aspect of the present disclosure. [Figure 23A] 1 is a graph including a graph of clamping force as a function of time and an associated coagulation / cutting focus graph, 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 coagulation / cutting focus graph, according to at least one embodiment of the present disclosure. [Figure 24A] 1 is a graph including a graph of clamping force as a function of distance from a distal tip of an end effector and a graph of blade displacement as a function of distance from the distal tip, in accordance with at least one embodiment of the present disclosure. [Figure 24B]1 is a graph including a graph of clamping force as a function of distance from a distal tip of an end effector and a graph of blade displacement as a function of distance from the distal tip, in accordance with at least one embodiment of the present disclosure. [Diagram 25] 11 is a graph of clamping force distribution as a function of various sections along the length of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 26] 13 is a graph of a blade displacement profile as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 27A] FIG. 13 is a cross-sectional view of an end effector illustrating a closing stroke of the end effector, in accordance with at least one embodiment of the present disclosure. [Figure 27B] FIG. 13 is a cross-sectional view of an end effector illustrating a closing stroke of the end effector, in accordance with at least one embodiment of the present disclosure. [Figure 27C] FIG. 13 is a cross-sectional view of an end effector illustrating a closing stroke of the end effector, in accordance with at least one embodiment of the present disclosure. [Figure 28A] 27A-27C are graphs of clamping force applied between a blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 28B] 27A-27C are graphs of clamping force applied between a blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 28C] 27A-27C are graphs of clamping force applied between a blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 29A] FIG. 13 is a cross-sectional view of an end effector showing a proximal start closed stroke configuration, according to at least one embodiment of the present disclosure. [Figure 29B]FIG. 13 is a cross-sectional view of an end effector showing a proximal start closed stroke configuration, according to at least one embodiment of the present disclosure. [Figure 29C] FIG. 13 is a cross-sectional view of an end effector showing a proximal start closed stroke configuration, according to at least one embodiment of the present disclosure. [Figure 30A] FIG. 13 is a cross-sectional view of an end effector illustrating a distal start closed stroke configuration and illustrating associated part stresses, in accordance with at least one embodiment of the present disclosure. [Figure 30B] FIG. 13 is a cross-sectional view of an end effector illustrating a distal start closed stroke configuration and illustrating associated part stresses, in accordance with at least one embodiment of the present disclosure. [Figure 30C] FIG. 13 is a cross-sectional view of an end effector illustrating a distal start closed stroke configuration and illustrating associated part stresses, in accordance with at least one embodiment of the present disclosure. [Figure 30D] FIG. 13 is a cross-sectional view of an end effector illustrating a distal start closed stroke configuration and illustrating associated part stresses, in accordance with at least one embodiment of the present disclosure. [Figure 31A] 30A-30D are graphs of clamping force applied between an ultrasonic blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure, corresponding to the cross-sectional views of FIGS. [Figure 31B] 30A-30D are graphs of clamping force applied between an ultrasonic blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure, corresponding to the cross-sectional views of FIGS. [Figure 31C] 30A-30D are graphs of clamping force applied between an ultrasonic blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure, corresponding to the cross-sectional views of FIGS. [Figure 31D] 30A-30D are graphs of clamping force applied between an ultrasonic blade and a clamp arm as a function of distance from a distal tip of an end effector, in accordance with at least one embodiment of the present disclosure, corresponding to the cross-sectional views of FIGS. [Diagram 32] 1A-E are cross-sectional views of an end effector illustrating a distal start closed stroke configuration and showing associated part stresses, according to 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 Serial No. 16 / 182,235, 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.”

[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 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. 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 is noted that the illustrated examples 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 examples may be implemented 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 examples, and not for the purpose of limiting them. Furthermore, it is to be understood that one or more of the aspects, embodiment of the aspects, and / or examples described below can be combined with any one or more of the other aspects, embodiment of the aspects, and / or examples 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., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one example, as shown in FIG. 1, the surgical systems 102 include a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and / or with the hub 106. In some aspects, the 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 surgical instruments and combination energy surgical instruments 7012, as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E. As shown in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E, an intelligent instrument 112 (e.g., devices 1a-1n), such as an ultrasonic / combination surgical instrument 7012, is 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 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. Images of the surgical site can be obtained by a medical imaging device 124, which can be manipulated and directed by the patient side cart 120. The robotic hub 122 can be used to process images of the surgical site and then display the processed images to the surgeon through 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, filed December 28, 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM," the disclosure of which is incorporated herein by reference in its entirety.

[0028] Various examples of cloud-based analytical methods implemented 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 entire disclosure of which is incorporated herein by reference.

[0029] In various embodiments, the imager 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 a portion 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 called 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 is sometimes called 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 less than about 380 nm and greater than about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, which are invisible infrared (IR), microwave, and wireless electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, which are 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, cystoscopes, 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 from across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments that can sense specific wavelengths of light, 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 entire disclosure of which is incorporated herein by reference. Multispectral monitoring can be a useful tool to reposition the surgical field after one surgical procedure is completed in order 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 field", i.e., the operating room or procedure room, require the utmost sterility of all medical devices and equipment. Part of the sterilization process described above includes 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 is 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, and 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, one or more image processing units, one or more storage arrays, and one or more displays, as shown in Figure 2. 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 entire disclosure of which is incorporated herein by reference.

[0037] As shown in FIG. 2, the primary display 119 is positioned within the sterile field so as to be visible to an operator positioned at the operating table 114. Additionally, a visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. A visualization system 108 guided by the hub 106 is configured to use 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 image 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 a 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 at the visualization tower 111 in the sterile field to a primary display 119 in the sterile field for viewing by a sterile operator located 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, coordination of information flow 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 can be sent by the hub 106 to the surgical instrument display 115 in the sterile field, where the diagnostic input or feedback can be viewed by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the "Surgical Instrument Hardware" section of U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference.

[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 fluids, 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 during a surgical procedure to address this issue. 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 the lines.

[0042] Aspects of the present disclosure present a surgical hub for use in a surgical procedure involving the 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 contacts 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 the 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. An embodiment of the present disclosure presents a solution in which the modular housing 136 of the hub is configured to house various 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 with respect 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 that is slidably receiveable in the docking station 151 of the surgical hub housing 136. The rear side of the combination generator module 145 includes a docking port 152 having power and data contacts that is configured to engage with a corresponding docking port 150 having 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 a bipolar, ultrasonic, and monopolar module and a smoke evacuation module integrated together in 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 example, the aspiration and suction fluid lines are in the form of flexible tubing that extends from the surgical site toward 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 and 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 example, 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 example, a 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's modular housing 136 may include alignment features configured to align the docking ports of the modules into engagement with their counterparts in the docking stations of the hub's modular housing 136. For example, as shown in FIG. 4, the combination generator module 145 includes a side bracket 155 configured to slidably engage with a corresponding bracket 156 of the corresponding docking station 151 of the hub's 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's modular housing 136.

[0056] In some embodiments, 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 embodiments, the drawers 151 are different sizes, each designed to accommodate a particular module.

[0057] Additionally, keying features may be provided to engage contacts on a particular module with contacts on a particular drawer to prevent insertion of the module into a drawer with incompatible contacts.

[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 two-way 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 two-way 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 lateral modular housing 160 configured to receive multiple modules of surgical hub 206. Lateral modular housing 160 is configured to laterally receive and interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of lateral modular housing 160 that include a backplane for interconnecting modules 161. As shown in FIG. 6, modules 161 are arranged laterally within lateral modular housing 160. Alternatively, modules 161 may be arranged vertically within 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 drawer 167 of the vertical modular housing 164 is vertically arranged, in certain cases the vertical modular housing 164 may include a horizontally arranged drawer. Additionally, the modules 165 may interact with each other via a docking port of the vertical modular housing 164. In the example 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 example, 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 beam scanning imaging. Similarly, the light source module can be configured to deliver white light or 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 for 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 can be configured for snap-fit ​​engagement with the first channel. A second channel is configured to slidably receive a light source module that can be configured for snap-fit ​​engagement with the second channel. In another example, the camera module and / or the light source module can be rotated into a final position within their corresponding channels. A threaded engagement may be employed instead of a snap-fit ​​engagement.

[0064] In various examples, multiple imaging devices are placed at various 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," are each incorporated herein by reference in their 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 aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communication hub 203 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 device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port in the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[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 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 can 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 sharing computing resources rather than having local servers or personal devices to handle software applications. Although the term "cloud" may be used as a metaphor for the "internet," 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 via the internet to the modular communication hub 203 and / or computer system 210 located in the operating room (e.g., a fixed, mobile, temporary or on-site operating room or space) and to devices connected to the modular communication hub 203 and / or computer system 210. 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 the 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 the 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 the sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of samples of body tissue, to identify pathologies, such as the effects of disease, using cloud-based computing. Such data includes tissue localization and margin confirmation, as well as phenotypes. At least some of the devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with the imaging devices and techniques such as 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 may 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 the surgical procedure and surgeon's 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 relative to the network hub. The network hub 207 may be implemented in one aspect as a local network broadcast device that operates on the physical layer of the Open Systems 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 media access control / Internet Protocol (MAC / Internet Protocol, IP) for forwarding any 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, but 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 for connecting 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 at different locations, such as different networks located in different operating rooms in the same medical facility or different operating rooms in 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 example, 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 via 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 example, 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 another aspect, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via a number of 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 any other wireless and wired protocols designated as Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as 3G, 4G, 5G and beyond. The computing module may include multiple communication modules, for example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[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 as 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 example 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 robotic 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 as 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 multiple 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 a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room 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," which is incorporated herein by reference in its entirety, in which a sensor module is configured to determine the size of the operating room and adjust the distance limit for Bluetooth pairing, an 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. The laser-based non-contact sensor module scans the operating room, for example, by transmitting laser light pulses, receives the laser light pulses that reflect off the exterior walls of the operating room, and compares the phase of the transmitted pulses with 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 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 bus or external bus, and / or a local bus using any of a variety of bus architectures, including, but not limited to, 9-bit bus, Industry Standard Architecture (ISA), MicroChannel Architecture (MSA), Enhanced 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 System Interface (SCSI), or any other proprietary bus.

[0082] The 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 embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. The processor core includes on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a pre-fetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB 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) analogs, 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, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limiting applications to provide advanced integrated safety mechanisms 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), SyncLink 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. Disk storage includes, but is 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, disk storage can include the above storage media, either independently or in combination with other storage media. Other storage media include, but are not limited to, optical disk drives, such as compact disk ROM drives (CD-ROM), compact disk recordable drives (CD-R drives), compact disk rewriteable drives (CD-RW drives), or digital versatile disk ROM drives (DVD-ROM). Removable or non-removable interfaces may be used to facilitate connection of 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 can 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, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, 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 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 only 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 devices, peer devices, or other common network nodes, but typically include many or all of the elements described with respect to a computer system. For simplicity, only one memory storage device is 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 / IEEE 802.3, Token Ring / IEEE 802.5, 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 thereof, packet-switched networks, and Digital Subscriber Lines (DSL).

[0089] In various aspects, the computer system 210 of FIG. 10, the imaging module 238 and / or the visualization system 208 and / or the processor module 232 of FIGS. 9-10 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 regular telephone grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.

[0091] In various aspects, the device / instrument 235 described herein with reference to Figures 9-10 may be implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012, as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E. Thus, the ultrasonic / combination surgical instrument 7012 as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E is configured to interface with the modular control tower 236 and the surgical hub 206. When an ultrasonic / combination surgical instrument 7012 such as those depicted in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E is connected to the surgical hub 206, the ultrasonic / combination surgical instrument 7012 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 an ultrasonic / combination surgical instrument 7012 such as those depicted in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E is connected to the hub 206, it may utilize processing circuitry available in 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 transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed and low speed devices by automatically setting the ramp-up speed 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 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in Chapter 8 of the USB specification. The SIE 310 typically 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 inverted (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. 310 receives a clock input 314 and is coupled to suspend / resume logic and frame timer 316 circuitry and hub repeater circuitry 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 port power management or ganged port power management, and self-powered hub with either individual port power management or ganged port power management. In one aspect, using a USB cable, the USB network hub 300, the upstream USB 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, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," 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 related to 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 in general. 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), which couples 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). The surgical instruments 7012 are 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 the data analysis module 7034 to perform 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 server 7013 also includes 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 an aggregated medical database 7011 of the cloud 7004. In particular, the cloud 7004 may advantageously perform data analysis and calculations on the aggregated data to gain insights and / or perform functions that an individual hub 7006 cannot accomplish 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 database 7011 of aggregated medical data. The I / O interface 7007 may thus facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed in response to requests from the hub 7006. These requests may be sent to the hub 7006 via a 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 serve sharing 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 database 7011 of aggregated medical data 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 surgeries 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 the performance of surgical procedures. 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 analytics system includes a number of data analytics modules 7034 that may be executed by a processor 7008 of the cloud 7004 to provide data analytics solutions to problems specifically arising in the medical field. As shown in FIG. 13, the functionality of the cloud-based data analytics modules 7034 may be supported via a hub application 7014 that may be hosted by a hub application server 7002 and accessed on the surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analytics 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 a database 7011 of aggregated medical data 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 a module for resource optimization 7020, a module for data collection and aggregation 7022, a module for authorization and security 7024, a module for control program updates 7026, a module for patient outcome analysis 7028, a module for recommendations 7030, and a module for 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, the data analysis modules are used for specific recommendations based on 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 tied 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 whether an event is a bleeding event or a non-bleeding event. More generally, the binary classification may be characterized as either a desired event (e.g., a successful surgical procedure) or an undesirable event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may 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 base the optimal ordering points of surgical staplers 7012 for a group of medical facilities on corresponding predicted demand by such instruments 7012. The resource optimization module 7020 may 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 aggregated organized data 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. In addition, 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 such as different surgical instruments 7012, their usage 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 recommendation module 7030 may be able to use these other potential operating parameters to make suggestions based on resulting in a better surgical outcome, such as a better seal or less bleeding. For example, the recommendation module 7030 may send recommendations to the surgical hub 7006 regarding when a particular cartridge should be used with a corresponding stapled surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large collections of raw data and provide focused recommendations (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 data based on type of medical procedure, type of patient, number of patients, geographic similarity between medical providers / facilities using similar types of instruments that no one medical facility can analyze independently on its own, 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 processed 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., may only 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 cannot be allowed 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 full functionality 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 can also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 can send signals that are 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 can be used to implement system-wide solutions, addressing 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) and determining improved practices and suggested changes accordingly (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 in a group. A group may be defined, for example, based on similar operational actions or geographic location. In this manner, the cloud 7004 may provide analysis and suggestions across a group 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 healthcare 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 the 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 (corresponding to the level of urgency) from the cloud 7004, or other suitable response, including escalation for a rapid response, special handling, exclusion from the aggregated medical data database 7011, etc. Additionally, if necessary, the cloud 7004 may send a request (e.g., a 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, which may be to request supporting or additional data. This push message may be required in situations where the cloud detects a significant irregularity or outlier 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 when security is deemed to be involved.

[0111] In various aspects, the surgical instrument(s) 7012 described herein with reference to Figures 12 and 13 may be implemented as ultrasonic surgical instruments and combination energy surgical instruments 7012 as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E. Thus, an ultrasonic surgical instrument 7012 such as that described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E is configured to interface with a surgical hub 7006 and with a network 2001, which is configured to interface with a cloud 7004. Thus, the processing power provided by the central server 7013 and data analysis module 7034 is configured to process information (e.g., data and control) from combinations of ultrasonic surgical instruments and energy surgical instruments 7012 as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E.

[0112] Further details regarding the cloud analytics system can be found 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.

[0113] Situational Awareness Although an "intelligent" device that includes a control algorithm responsive 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 control the modular device inaccurately or suboptimally when given sensed data that does not include the specific context. For example, the optimal method for a control algorithm to control a 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 tissue type is susceptible to tearing or resistant to this. For tissue that is 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 that is 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 on the tissue. Without knowing whether lung tissue or stomach tissue is being clamped, the control algorithm may make a suboptimal decision.

[0114] One solution utilizes a surgical hub that includes a system configured to derive information about a currently occurring surgical procedure 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).

[0115] While the surgical hub 5104 may be similar in many respects to the hub 106, such a surgical hub 5104 may be configured to derive contextual information related to the surgical procedure from the data, for example, based 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.

[0116] The situational awareness system of the surgical hub 5104 may be configured to derive the contextual information in a variety of different ways from the data received from the data source 5126. 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 monitor 5124, and / or the modular device 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 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 interrogation with one or more inputs, the lookup table may return corresponding contextual information for the situational awareness system to control the modular device 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 additional machine learning systems, lookup tables, or other such systems that generate or obtain one or more control adjustments for one or more modular devices 5102 when provided with context information as input.

[0117] 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. Returning 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.

[0118] 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.

[0119] 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 a procedure type is generally 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.

[0120] 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 if 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 and then customize the energy level of the ultrasonic surgical instrument or the RF electrosurgical instrument, respectively, according to the expected tissue profile of the surgical procedure. Additionally, the situationally aware surgical hub 5104 may be configured to adjust the energy levels of the ultrasonic surgical instrument or RF electrosurgical instrument over the course of a surgical procedure, rather than just adjusting on a procedure-by-procedure basis. The situationally aware surgical hub 5104 can determine which step of the surgical procedure is occurring or will occur afterwards, and then update the generator and / or the control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy levels to a value appropriate for the expected tissue type as the step of the surgical procedure progresses.

[0121] As yet another example, the surgical hub 5104 may draw data from additional data sources 5126 to improve conclusions the surgical hub 5104 draws from one data source 5126. The situation-aware surgical hub 5104 may augment data received from the modular device 5102 with contextual information it builds on the surgical procedure from other data sources 5126. For example, the situation-aware surgical hub 5104 may 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 may 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.

[0122] Another benefit includes proactively 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 the surgical procedure. For example, the situation-aware surgical hub 5104 can proactively activate the generator to which the RF electrosurgical instrument is connected if it determines that a subsequent step of the procedure will require the use of the instrument. By proactively activating the energy source, the instrument can be ready for use as soon as the previous step of the procedure is completed.

[0123] As another example, the situation-aware surgical hub 5104 can determine whether a current or subsequent step in the surgical procedure requires a different view or degree of magnification on the display according to the feature(s) at the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively 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.

[0124] As yet another example, the context-aware surgical hub 5104 can determine which step of a surgical procedure is being performed or will be performed subsequently, 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 request specific information.

[0125] Another benefit includes checking for errors during the setup or 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 upcoming surgical procedure. The surgical hub 5104 can be configured to determine the type of surgical procedure currently 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 a preferred scanner and / or a list of devices paired with the surgical hub 5104 to a recommended or expected inventory of items and / or devices for a given surgical procedure. 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 if there is any discontinuity between the lists. 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 any discontinuities exist 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.

[0126] 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 can 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 can 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.

[0127] The situational awareness system for the surgical hub 5104 improves the outcome of the surgical procedure overall by adjusting the 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 the surgical procedure. The situational awareness system also improves the efficiency of the surgeon in performing the 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.

[0128] 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 illustrates an exemplary surgical procedure and the contextual information that the surgical hub 106, 206 may derive from data received from data sources at each step of the surgical procedure. The timeline 5200 illustrates the typical steps that nurses, surgeons, and other medical personnel may take during the course of a lung segmentectomy surgery, beginning with setting up the operating room and ending with transporting the patient to a post-operative recovery room.

[0129] 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 use 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, and can continually derive inferences (i.e., context 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, etc.), and any other such actions described above.

[0130] 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.

[0131] 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 combination of supplies is compatible with a 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 the specific supplies required for a thoracic wedge procedure or are not otherwise compatible with a thoracic wedge procedure).

[0132] 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.

[0133] 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. When the auxiliary device is activated, the auxiliary device, 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 the combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the type of modular devices connecting to the hub, the surgical hub 106, 206 may roughly deduce the particular procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what particular procedure is being performed, it 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 deduce which steps of the surgical procedure the surgical team is performing.

[0134] 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.

[0135] In a sixth step 5212, medical personnel anesthetize the patient. The surgical hub 106, 206 may 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.

[0136] 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 read in advance), it can infer that the surgical portion of the procedure has already begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure.

[0137] 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 can determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 can determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that a wedge procedure has already been determined not to be a possibility 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 in many different ways to determine contextual information regarding the type of procedure being performed. For example, it may be used to determine the angle at which the medical imaging device is oriented relative to the visualization of the patient's anatomy, monitor the number of medical imaging devices being used (i.e., activated and paired with the surgical hub 106, 206), and monitor 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 intercostal position anterior to the segmental fissure. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the location of the medical imaging device based on the 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 uses 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 used in a VATS lobectomy.By tracking any or all of this data from the medical imaging devices, 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.

[0138] At a ninth step 5218, the surgical team begins the cutting 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 presume that the surgeon is in the process of cutting and mobilizing 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 steps of the procedure described above have been completed) corresponds to the cutting step. In a particular example, the energy instrument can be an energy tool attached to a robotic arm of a robotic surgical system.

[0139] 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, it can infer that the surgeon is currently 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.

[0140] 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 utilized for 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 utilized for 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.

[0141] Then, at a twelfth step 5224, a node dissection step is performed. Based on the data received from the generator indicating that an RF or ultrasonic instrument is being fired, the surgical hub 106, 206 may infer that the surgical team is dissecting the node and performing a leak test. For this particular procedure, the RF or ultrasonic instrument used after the parenchymal tissue is transected corresponds to the node dissection step, thereby enabling the surgical hub 106, 206 to make the above 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 using robotic tools and handheld surgical instruments and / or use the devices simultaneously. Once the twelfth step 5224 is completed, the incisions are closed and the post-operative portion of the procedure begins.

[0142] In a thirteenth step 5226, the patient is brought out of anesthesia. The surgical hub 106, 206 may estimate that the patient is coming out of anesthesia based on, for example, ventilator data (i.e., the patient's breathing rate begins to increase).

[0143] Finally, a 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 estimate when each step of a given surgical procedure is occurring.

[0144] 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.

[0145] In one aspect, as described below with reference to Figures 24-40, the modular device 5102 is implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012, as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E. Thus, as shown in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E, the modular device 5102 implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012 is configured to operate as a data source 5126 and interact with a database 5122 and a patient monitoring device 5124. As depicted in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E, the modular device 5102 implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012 is further configured to interact with the surgical hub 5104 to provide information (e.g., data and control) to the surgical hub 5104 and receive information (e.g., data and control) from the surgical hub 5104.

[0146] In one aspect, as described below with reference to Figures 24-40, the modular device 5102 is implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012, as described in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E. Thus, as shown in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E, the modular device 5102 implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012 is configured to operate as a data source 5126 and interact with a database 5122 and a patient monitoring device 5124. As depicted in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E, the modular device 5102 implemented as an ultrasonic surgical instrument and combination energy surgical instrument 7012 is further configured to interact with the surgical hub 5104 to provide information (e.g., data and control) to the surgical hub 5104 and receive information (e.g., data and control) from the surgical hub 5104.

[0147] Generator Hardware 16 is a schematic diagram of a robotic surgical instrument 700 configured to manipulate a surgical tool 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 joints. 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.

[0148] 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.

[0149] In one aspect, the control circuitry 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more 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. As a result, 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.

[0150] 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.

[0151] In one aspect, the control circuitry 710 can generate motor set point signals. The motor set point signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may comprise one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the respective motor drive signals. In some examples, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some examples, the motor controllers 708a-708e may be omitted, and the control circuitry 710 may directly generate the motor drive signals.

[0152] 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.

[0153] 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 transmission mechanisms 706a-706e. The transmission mechanisms 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 distally and proximally. 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.

[0154] 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 a motor set point to the motor control 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission mechanism 706a, which is coupled to the closure member 714. The transmission mechanism 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 may provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal 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.

[0155] In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708b, which provides a drive signal to 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 mechanism 706b, which is coupled to the clamp arm 716. The transmission mechanism 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.

[0156] 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 the motor control 708c, which provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission mechanism 706c, which is coupled to the shaft 740. The transmission mechanism 706c includes a movable mechanical element, such as a rotating element, for controlling 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 mechanism 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 rotational 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 representative 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.

[0157] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission mechanism 706d that is coupled to the articulation member 742a. ​​The transmission mechanism 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 represents the articulation force applied to the end effector 702. A sensor 738, such as a articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.

[0158] 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 linkages 742a, 742b may be driven antagonistically with respect to the other linkage to provide a resistive holding motion and load to the head when the head is not moving, and to provide an articulation motion when the head is articulating. The articulation members 742a, 742b are attached to the head at a defined radius as the head rotates. Thus, the mechanical advantage of the push-pull linkage changes as the head rotates. This change in mechanical advantage may be more pronounced with other articulation linkage drive systems.

[0159] In one aspect, one or more of the motors 704a-704e may comprise a gearbox and a brushed DC motor with a mechanical link to a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e operating movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are 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.

[0160] 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 circuitry 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 implements simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting and table lookup operations.

[0161] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 may be disposed 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 sensors 738 may comprise magnetic sensors, magnetic field sensors, strain gauges, load cells, pressure sensors, force sensors, torque 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 702. The sensors 738 may include one or more sensors. The sensors 738 may be disposed on the clamp arm 716 to determine the position of the tissue using split electrodes. 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.

[0162] 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.

[0163] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (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.

[0164] In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on 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 the closure force exerted by the closure tube on the clamp arm 716. The force exerted on the clamp arm 716 may be representative of tissue compression experienced by a tissue slice captured between the clamp arm 716 and the ultrasonic blade 718. The one or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force exerted by the closure drive system on the clamp arm 716. The one or more sensors 738 may be sampled by a processor of the control circuit 710 in real time during the clamping operation. The control circuit 710 receives the real time sample measurements to provide and analyze time based information to assess the closure force exerted on the clamp arm 716 in real time.

[0165] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the 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.

[0166] 17 shows a schematic 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.

[0167] 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 examples, the control circuitry 760 may comprise one or more microcontrollers, microprocessors or other suitable processors to execute instructions that cause the one or more processors to control the displacement member, e.g., 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. As a result, the control circuit 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 time external events.

[0168] 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.

[0169] The motor 754 may receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission mechanism 756. The transmission mechanism 756 may include one or more gears or other coupling components for coupling the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or may 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 may 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 may track the pulses to determine the position of the closure member 764. 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 764. Also, in some examples, 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.

[0170] The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 may be disposed 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 can include one or more sensors.

[0171] 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.

[0172] 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 the closure force exerted by the closure tube on the clamp arm 766. 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 exerted by the closure drive system on the clamp arm 766. The one or more sensors 788 may be sampled by a processor of the control circuitry 760 in real time during the clamping operation. The control circuitry 760 receives the real time sample measurements to provide and analyze time based information to assess the closure force exerted on the clamp arm 766 in real time.

[0173] 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.

[0174] The control circuitry 760 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 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 can include a feedback controller, which can 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 can 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.

[0175] 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 unmeasured and unpredictable influences of things like tissue, surroundings and friction on the physical system. Such external influences may be referred to as obstacles that act against the electric motor 754. External influences such as obstacles may cause the operation of the physical system to deviate from the desired operation of the physical system.

[0176] 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 an ultrasonic blade 768 that is positioned opposite the clamp arm 766 when configured for use. 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 .

[0177] In various examples, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as 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.

[0178] In some examples, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of 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.

[0179] 18 shows a schematic 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.

[0180] 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 examples, the control circuitry 760 may comprise one or more microcontrollers, microprocessors or other suitable processors to execute instructions that cause the processor or processors to control the displacement member, e.g., 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. As a result, the control circuit 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 time external events.

[0181] 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.

[0182] The motor 754 may receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission mechanism 756. The transmission mechanism 756 may include one or more gears or other coupling components for coupling the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or may 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 may 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 may track the pulses to determine the position of the closure member 764. 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 764. Also, in some examples, 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.

[0183] The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 may be disposed 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 can include one or more sensors.

[0184] 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.

[0185] 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 exerted by the closure tube on the clamp arm 766. 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 exerted by the closure drive system on the clamp arm 766. The one or more sensors 788 may be sampled by a processor of the control circuitry 760 in real time during the clamping operation. The control circuitry 760 receives the real time sample measurements to provide and analyze time based information to assess the closure force exerted on the clamp arm 766 in real time.

[0186] 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.

[0187] The control circuitry 760 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 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 can include a feedback controller, which can 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 can 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.

[0188] 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 unmeasured and unpredictable influences of things like tissue, surroundings and friction on the physical system. Such external influences may be referred to as obstacles that act against the electric motor 754. External influences such as obstacles may cause the operation of the physical system to deviate from the desired operation of the physical system.

[0189] 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 .

[0190] In various examples, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as 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.

[0191] In some examples, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of 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.

[0192] 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 replace or operate 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.

[0193] 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.

[0194] 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 be interfaced with the control circuit 760 to provide an absolute positioning system. The position may include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and 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.

[0195] In some examples, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 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.

[0196] The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 may be disposed 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 can include one or more sensors.

[0197] 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.

[0198] 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.

[0199] 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.

[0200] 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 on the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If a different return path is 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 circuit is provided via an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.

[0201] 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 impedance of the tissue may be measured by dividing the output of the second voltage sense circuit 924 by the current sense circuit 914.

[0202] As shown in FIG. 19, the generator 900, which includes at least one output port, may include a power transformer 908 with 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 with either monopolar or bipolar RF electrosurgical electrodes, at high voltage and low current to drive an ultrasonic transducer, 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 of the ultrasonic transducer to the output of the generator 900 would preferably be located between the output labeled ENERGY1 and RETURN as shown in FIG. 18. In one example, the connection of the RF bipolar electrode to the output of the generator 900 would preferably be located between the output labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be the active electrode (e.g., pencil or other probe) to the ENERGY2 output and a suitable return pad connected to the RETURN output.

[0203] 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.

[0204] As used throughout this description, the term "wireless" and its derivatives 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.

[0205] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually 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) within a computer system, especially a system on a chip (SoC).

[0206] 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.

[0207] 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 and a small amount of RAM in the form of ferroelectric RAM, NOR flash or OTP ROM 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 made up of various separate chips.

[0208] As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with a peripheral device. It may also 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.

[0209] 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 embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. The processor core includes on-chip memory of 256KB of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance beyond 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) analogs, 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.

[0210] 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 limiting applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity and memory options.

[0211] 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 be related to the patient during surgery (e.g., tissue characteristics or insufflation pressure) or related to the modular device itself (e.g., advancing knife speed, motor current, or energy level). For example, the control algorithm of 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 offered by the knife as it advances.

[0212] 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) and defines drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to various surgical devices, such as, for example, the ultrasonic surgical device 1104 and the 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 device 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 device 1660 may include, for example, a field programmable gate array (FPGA). The programmable logic device 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 device 1660, in conjunction with a processor (e.g., processor 1740, described below), can execute a number of digital signal processing (DSP)-based control algorithms and / or other control algorithms to control parameters of the drive signal output by the generator 1100.

[0213] 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 that the processor 1740 receives 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) being 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.

[0214] In certain aspects, the programmable logic device 1660, together 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 device 1660 may execute a DDS control algorithm by calling up 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. Undesirable resonant effects may be minimized or reduced because other frequencies may excite parasitic resonances, and correspondingly, the total distortion of the operating branch current is minimized or reduced. 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, to appropriately pre-distort or modify the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real time) to compensate for the distortion. 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 through 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.

[0215] 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 by the programmable logic device 1660 and processed (e.g., FIFO buffering, multiplexing), 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 device 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.

[0216] 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 being provided as an input to a DDS control algorithm executed by the programmable logic device 1660.

[0217] The impedance phase may be determined by Fourier analysis. In one aspect, the phase difference between the generator voltage Vg(t) and generator current Ig(t) drive signals may be determined using a Fast Fourier Transform (FFT) or Discrete Fourier Transform (DFT) as follows:

[0218]

number

[0219] Evaluating the Fourier transform at the frequency of the sine wave gives:

[0220]

number

[0221] 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

[0222] where φ is the phase angle, f is the frequency, t is the time, and φ0 is the phase at t=0.

[0223] Another technique for determining the phase difference between the voltage Vg(t) and current Ig(t) signals is the zero-crossing method, which produces highly accurate results. For voltage Vg(t) and current Ig(t) signals with the same frequency, each negative-to-positive zero crossing of the voltage signal Vg(t) triggers the start of a pulse, while each negative-to-positive zero crossing of the current signal Ig(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 measurement of the phase difference. Additionally, positive-to-negative zero crossings can also be used in a similar manner, and any effects of DC and harmonic content can be reduced when the results are averaged. In one implementation, the analog voltage Vg(t) and current Ig(t) signals are converted to a high digital signal when the analog signal is positive and a low digital signal when the analog signal is negative. High accuracy phase estimation requires sharp transitions 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 another embodiment, 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.

[0224] Other techniques for determining the phase difference between voltage and current signals include Lissajous figures and image monitoring, methods such as the three-voltmeter method, the crossed coil method, the vector voltmeter and the vector impedance method, as well as phase standard instruments, phase-locked loops and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http: / / www.engnetbase.com> and other techniques such as those described in, incorporated herein by reference.

[0225] In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point can be directly specified or indirectly determined based on specified voltage amplitude and power set points. 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 device 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.

[0226] 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 device (e.g., via a serial peripheral interface (SPI) bus). Although 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 inputs (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.

[0227] 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 allows 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 throughout this description in connection with the surgical instruments of the surgical system 1000, 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.

[0228] As shown in the example 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.

[0229] 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, which may be activated upon a clinician's manipulation of 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 radio frequency current energy to perform a surgical coagulation or cauterization procedure on living tissue, and either a mechanical knife or an ultrasonic blade having a sharp cutting edge to perform a cutting procedure on living tissue. When the trigger 4010 is actuated, the force sensor 4012 can 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 is 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.

[0230] 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 communicate with the generator 4002 and / or the transducer 4004 and modulate the generator level or ultrasonic blade amplitude of the end effector 4006 and / or the position of the trigger 4010 and / or the position of the outer tubular sheath (e.g., as measured by a combination of a Hall effect sensor and a magnet) based on the power delivered to the end effector 4006 and / or the force applied to the trigger 4010 and / or the position of the outer tubular sheath (e.g., as measured by a combination of a Hall effect sensor and a magnet) relative to a reciprocating tubular actuating member positioned within the outer tubular sheath. 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.

[0231] 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 to clamp 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 to 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.

[0232] 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 LEDs illuminated. 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.

[0233] 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.

[0234] Advanced energy device control algorithm Various control algorithms for ultrasonic and 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 will be referred to as the surgical instrument 7012 in this section of the disclosure, although the disclosure in this section may also apply to the other surgical instruments referred to above as surgical instruments 112, 700, etc.

[0235] In various aspects, the control algorithm of the ultrasonic surgical instrument 7012 may be configured to apply a variable clamp arm pressure throughout the cycle time or tissue coagulation / cutting process of the surgical procedure to generate a constant pressure profile from proximal to distal. A constant pressure profile means that each portion of tissue held within the end effector of the surgical instrument 7012 along the proximal to distal end of the end effector experiences the same or substantially the same pressure resulting from the force applied by the end effector clamp arm. This may advantageously result in better coagulation of the surgically cut tissue. The control algorithm may be applied by the control circuitry and / or the surgical hub. A constant pressure profile from proximal to distal may involve applying a control algorithm to vary the pressure applied by the clamp arm to provide a threshold control pressure at a cutting progression position. The cutting progression position may be represented by the progression of a corresponding welding / coagulation focus as determined by the control circuitry and / or the surgical hub. Thus, the pressure may vary based on the focus. The threshold control pressure may be a constant pressure that is applied to tissue regardless of the amount of end effector activation, i.e., the pressure applied does not change (or at least does not change significantly) despite changes in the spread of the tissue load of the end effector.

[0236] A piece or portion of tissue may be loaded into the end effector for a surgical procedure, such as by initially loading the tissue at the distal end of the end effector. In this manner, contact may occur initially at a distal point of the end effector. One or more distal portions of the ultrasonic blade and clamp arm may grasp the tissue at this distal point. The initial pressure applied by the clamp arm may be determined or adjusted (e.g., from a default pressure level) by the control circuitry and / or surgical hub based on the size of the tissue piece being initially grasped, which corresponds to the amount of blade utilized at the start (initial tissue load of the end effector). After surgically cutting the tissue, surgical coagulation / sealing may be performed by the surgical instrument 7012, such as by ultrasonic vibration of the ultrasonic blade and / or delivery of an RF electrical signal waveform output from the generator to the RF electrode. In the coagulation process, the progression of the weld may be used to adjust the applied clamp pressure. Specifically, the pressure of the clamp arm may be adjusted as the cutting / welding focal point shifts along the blade throughout the progression of the weld.

[0237] To better grip the tissue at the distal point, one or more of the blade and clamp arm can be biased or offset to create a preferential initial contact point at the distal end. The remaining portion of the clamp arm can then be loaded broadly from distal to proximal. In other words, in this distal start closed stroke configuration, the offset ultrasonic blade can deflect to fully close against the tissue and clamp arm at the end effector distal end, followed by further deflection in the proximal direction. The deflection of the blade and clamp arm can be approximately equal or balanced relative to one another. The distal start closed stroke configuration is described in more detail below. The clamp arm pressure can also be varied from the initial pressure by the control circuitry and / or surgical hub based on how much the end effector is loaded with tissue and the progress of the weld. The clamp arm pressure can also be varied based on measured tissue impedance (e.g., via a pressure, resistance or other suitable sensor 788 in the end effector). Additionally, depending on which energy modality or modalities are selected for the surgical instrument 7012, the power level of one or more of the RF and ultrasonic energy delivered to the end effector can also be varied based on the measured tissue impedance. In addition to RF and ultrasonic energy, other types of electrosurgical energy can also be used.

[0238] As discussed above, tissue loading may begin at the tip or distal end of the end effector such that initial contact between the ultrasonic blade and the clamp arm is at the tip. The surgical hub and / or control circuitry may be configured to vary the pressure applied by the clamp arm based on the degree of blade utilization, which may be determined via a position sensor 784 (referred to as position sensor 784 in this portion of the disclosure, but as discussed above, position sensor 784 may also be referred to as position sensor 734, 4013, etc.). Specifically, the application of clamp pressure may be controlled such that no pressure is applied in portions of the end effector where the clamp arm and ultrasonic blade do not include tissue. In other words, the application of clamp pressure may be tailored to portions of the end effector where tissue is located between the ultrasonic blade and the clamp arm. This may advantageously reduce the temperature and heat present in the ultrasonic blade following activation of the generator of the surgical instrument 7012. Furthermore, when the generator delivers energy to the end effector, portions of the end effector where no tissue is located experience a relatively lower force, thereby reducing the energy delivered to those portions, thus reducing the peak temperature and heat of the ultrasonic blade after the generator is activated.

[0239] This targeted application of force by the clamp arm can be accomplished based on motorized or manual closure control, a first closure from the tip of the end effector, and feedback provided to the control circuitry and / or surgical hub. The feedback can include thermally induced changes in resonant frequency and electrical continuity (or discontinuity). The feedback can be received by the control circuitry via a circuit including the ultrasonic blade and the clamp arm / ultrasonic blade interface (e.g., clamp tissue pad). A change or shift in the resonant frequency of the transducer can be used as feedback to determine the extent of tissue loading. In this manner, feedback can be used to adjust the applied clamp pressure. Additionally, the control circuitry can control the motor of the surgical instrument to perform a closure stroke such that the end effector closes at a point distal to the most proximal point of the grasped tissue. In this manner, a gap can be maintained between the clamp arm and the ultrasonic blade at a point proximal to the most proximal point of the grasped tissue.

[0240] The sensor 788 of the surgical instrument 7012 (referred to in this portion of the disclosure as sensor 788, but may also refer to sensor 738 or other sensors mentioned above) may provide an end effector closure signal as an input to the control circuit. Using this input, the control circuit may determine the current closure position of the end effector. When the control circuit determines that the end effector is closed at a tip portion (e.g., the distal tip or the proximal tip) or any other sub-portion of the length of the end effector (e.g., the distal half of the end effector), the control circuit may reduce the displacement of the ultrasonic blade. To this end, the power provided to the ultrasonic transducer may be reduced. This reduction in displacement may beneficially prevent or reduce excessive wear of the clamp arm tissue pad at the distal tip. This excessive wear is generally caused by a large distal force or high pressure at the distal tip (corresponding to a distal start closed stroke configuration) and the inherent larger distal displacement amount corresponding to the displacement profile associated with the ultrasonic blade.

[0241] Generally, when tissue does not fully occupy the space between the jaws of the end effector, reducing the surface area of ​​the clamp arm that is compressed against the blade reduces wasteful transmission of electrosurgical energy (including, for example, ultrasonic and RF energy) to the clamp arm and / or tissue pad. In other words, adjusting the clamp arm pressure allows relatively more electrosurgical energy to be directed at the tissue and not unnecessarily transmitted to other portions of the end effector. Because the pressure applied by the clamp arm is controlled based on the spread of tissue fill, a constant pressure can be applied to the tissue regardless of how much of the end effector is in an active state. The pressure may be further adjusted based on the progress of the surgical coagulation / cutting procedure with the surgical instrument 7012.

[0242] Additionally, the feedback circuit, including the ultrasonic blade and clamp pad, may also include a sensor 788 for sensing the impedance of tissue located between the clamp arm and the ultrasonic blade. In this case, the ultrasonic blade and its associated waveguide terminating in the blade may function as part of the return path of the feedback circuit. The sensed impedance may indicate the state of the coagulation / cutting cycle; that is, for example, comparing the tissue impedance to a threshold value may indicate the progress of the welding of the tissue, such as the progress of the welding / coagulation focus. The focus may indicate, for example, how well a fibrin clot is formed for coagulation. In this manner, the detected tissue impedance may enable the control circuit and / or the surgical hub to adjust the power provided to the ultrasonic transducer and the force applied by the clamp arm.

[0243] At least a portion of the control algorithm(s) disclosed herein may be executed by the surgical hub (either alone or in conjunction with the associated control circuitry of the surgical instrument), however, the functions of the control algorithm are described as being executed by the control circuitry, but for clarity of explanation only. Also, for clarity of explanation, 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 (which for clarity of explanation is referred to as generator 4002, but which may be the same as or similar to 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, the surgical instrument 7012 (e.g., an ultrasonic surgical instrument) depicted in Figures 23A-23B, 24A-24B, 25-26, 27A-27C, 28A-28C, 29A-29C, 30A-30D, 31A-31D, and 32A-32E is configured to operate with situational awareness within a hub environment, such as surgical hub 106 or 206 (Figures 1-11), as described in timeline 5200.

[0244] 23A-B are graphs 203000, 203020 including graphs of clamping force and associated coagulation / cutting focus as a function of time, according to at least one embodiment of the present disclosure. In FIG. 23A, the y-axis 203010 shows force and the x-axis 203008 shows time. The dashed line 203002 represents the force applied by the clamp arm over time, from a minimum force at time t0 to a minimum force at time t0. 10 The application of force by the clamp arm is tracked from an initial time t0 to a maximum force at time t 10The time over may define a surgical cycle of the surgical instrument 7012. The dashed and dotted line 203004 represents the measured tissue impedance over the surgical cycle. As can be seen in the graph 203000, the measured tissue impedance decreases from an initial level at time t0 to a lowest point at time t3, confirming the drop in impedance (the so-called "bathtub" portion of the impedance curve) that occurs from the start of the surgical procedure. After time t3, the tissue impedance line 203004 rises as the tissue being treated begins to dry. This drying results in an increase in tissue impedance. FIG. 23A shows how this increase in tissue impedance line 203004 corresponds to an increase in applied force line 203002. The increase in applied force may aid in cutting the tissue as well as welding the denatured tissue as the surgical cycle is completed.

[0245] Specifically, the control circuitry 710 may execute a control algorithm to provide a constant pressure profile from proximal to distal. By providing such a threshold control pressure, the tissue seal formed during the coagulation phase may advantageously be more uniform and reliable. Thus, the solid line 203006, which shows a measurement of the pressure applied to the tissue in the end effector, remains the same or nearly constant throughout the entire surgical cycle. The tissue pressure line 203006 may correspond to the pressure applied to the leading edge of the end effector where the surgical coagulation and cutting occurs. The clamping force may be a function of the progression of the tissue coagulation process. This relationship may be used to provide a constant tissue pressure. Thus, the tissue may be coagulated and cut at the proximal portion of the end effector, but an increase in the clamping force at the distal section results in better binding of the tissue to the distal section of the ultrasonic blade. In this way, each section of tissue (spanning from the proximal to the distal section of the end effector) may experience the same or nearly similar pressure. As the tissue weld progresses, the control circuitry may control the clamp arm to progress to closure, which is illustrated by graph 203000. The clamp arm may also be deflected towards the ultrasonic waveguide that terminates in the ultrasonic blade.

[0246] FIG. 23B illustrates that the focal point of the surgical coagulation and cutting action on tissue shifts along the length of the ultrasonic blade 203026 (similar or the same as ultrasonic blade 718, 768, or other ultrasonic blades described above) through the course of a surgical cycle. As shown in FIG. 23B, the focal point shifts from proximal to distal over time, but the focal point can also shift from distal to proximal. The former possibility corresponds to a proximal start closed stroke configuration, and the latter corresponds to a distal start closed stroke configuration. As described above, the control circuit 710 may be configured to determine the cutting / welding focal point based on one or more of the feedback measurements of resonant frequency and electrical continuity. The graph 203020 also illustrates a clamp arm 203022 (similar or the same as clamp arm 716, 766, or other clamp arms described above). The clamp arm 203022 may include a clamp tissue pad 203024, which may be formed from TEFLON® or some other suitable low friction material. The pad 203024 is mounted to cooperate with the blade 203026 such that pivoting movement of the clamp arm 203022 can position the clamp pad 203024 in a substantially parallel relationship with and in contact with the ultrasonic blade 203026. With this configuration, a piece of tissue to be clamped can be grasped between the tissue pad 203024 and the ultrasonic blade 203026. The tissue pad 203024 may include a sawtooth-like configuration including a plurality of axially spaced apart and proximally extending grasping teeth to improve grasping of tissue in cooperation with the ultrasonic blade 203026. The control circuit 710 can control the clamp arm 203022 between an open position and a closed position, including various intermediate positions therebetween. The control circuit 710 can vary the pressure applied by the clamp arm 203022 based on a shift of the weld focal point along the ultrasonic blade 203026 or the spread of tissue loaded into the end effector. The x-axis 203028 of the graph 203020 represents the same surgical cycle as the x-axis 203008.

[0247] 24A-24B are graphs 203040, 203060 according to at least one embodiment of the present disclosure, including a graph 203040 of clamping force as a function of distance from the distal tip of the end effector, and a graph 203060 of blade displacement as a function of distance from the distal tip. FIG. 24A illustrates how the clamping pressure between the ultrasonic blade 203026 and the clamp arm 203022 varies as a function of distance from the distal tip relative to the tissue. Specifically, the graph 203040 includes a number of clamping pressure curves 203042A-203042D that illustrate how the control circuit 710 can adjust the applied clamping pressure depending on the position of the tissue. To this end, the control circuit 710 may determine a closed position of one or more of the ultrasonic blade 203026 and the clamp arm 203022. The x-axis 203044, 203064 indicates the distance from the distal tip of the end effector, and the y-axis 203046, 203066 indicates the applied clamping force. In the proximal start closed stroke configuration of FIG. 24A, the applied clamping pressure rolls distally during the closing motion such that the closing stroke is fully clamped at the distal tip. In other words, the clamping pressure may be greatest at a minimum distance from the distal tip. Large amplitudes of clamping pressure may be required to surgically manipulate tissue, such as to manipulate vascular structures, as desired.

[0248] 24B shows the corresponding displacement profile of the ultrasonic blade 203026 as a function of distance from the tip of the end effector. In the graph 203060, the x-axis 203064 again indicates distance from the distal tip, and the y-axis 203066 indicates the magnitude of the displacement of the ultrasonic blade 203026. Relatedly, the zero point on the x-axis corresponds to the anti-node 203062, and the maximum point corresponds to the node 203068 of the ultrasonic blade 203026. The anti-node 203062 can be defined as a local absolute maximum where the displacement or vibration of the ultrasonic blade 203026 is at a local maximum. The node 203068 can be defined as a local absolute minimum where the displacement or vibration of the ultrasonic blade 203026 is at a local minimum. In general, the distance between adjacent nodes and anti-nodes can be ¼ wavelength of the drive or resonant frequency of the ultrasonic blade 203026. As shown by graph 203060, at anti-node 203062, the occurrence of the maximum positive range of ultrasonic vibration of the ultrasonic blade 203026 overlaps with a maximum distance from the distal tip. This also occurs at the next anti-node, which corresponds to the maximum negative range of ultrasonic vibration, but is not shown in FIG. 24B. At a minimum distance from the distal tip (node ​​203068), the ultrasonic vibration is at a minimum, completely clamping or gripping the tissue between the ultrasonic blade 203026 and the clamp arm 203022. This change in ultrasonic displacement as a function of distance from the tip is represented by displacement line 203070.

[0249] In contrast to a proximal initiated closing stroke configuration, the present disclosure may contemplate a distal initiated closing stroke configuration that helps close the distal tip of the end effector first, ultimately advantageously achieving thermal relief. Thermal relief may occur by configuring the control circuit 710 to control the clamp pressure according to the spread of tissue loaded into the end effector. Specifically, pressure may be provided only at the intersection of the ultrasonic blade 203026 and the clamp arm 203022 where they grasp tissue between them. By preventing or reducing pressure at portions of the end effector where no tissue is present, peak temperatures and residual heat following energy delivery from the generator 4002 are reduced. In this manner, relatively more energy is transferred to the tissue rather than to the conductive clamp arm tissue pad 203024. The clamp pad 203024 may be formed of molded carbon filled polytetrafluoroethylene or any other suitable material and may be secured to the underside of the clamp arm 203022 as described in U.S. Patent No. 2017 / 0164997, issued June 15, 2017, entitled "METHOD OF TREATING TISSUE USING END EFFECTOR WITH ULTRASONIC AND ELECTROSURGICAL FEATURES," which is incorporated by reference in its entirety.

[0250] The clamping tissue pad 203024 may also be electrically conductive based on the use of conductive fillers (e.g., carbon, carbon nanotubes, metal particles, etc.). Current can flow through the surgical instrument 7012 from the ultrasonic blade 203026 to the tissue pad 203024 via an isolated electrical circuit, allowing therapeutic or sub-therapeutic levels of RF energy to be applied by the end effector (e.g., via the RF electrode 796) to the tissue. When the surgical instrument 7012 includes an RF electrode 796, the control circuit 710 can be configured to adjust one or more of the power level of the RF energy and the power level of the electrosurgical energy based on the determined tissue impedance. Further details regarding conductive pads can be found in U.S. Patent No. 9,764,164, issued September 19, 2017, entitled "ULTRASONIC SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety. Other aspects of the combination of bipolar RF and ultrasonic architectures of the surgical instrument 7012 are described in U.S. Patent No. 9,017,326, issued April 28, 2015, entitled "IMPEDANCE MONITORING APPARATUS, SYSTEM, AND METHOD FOR ULTRASONIC SURGICAL INSTRUMENTS," U.S. Patent No. 10,022,568, issued July 17, 2018, entitled "DEVICES AND TECHNIQUES FOR CUTTING AND COAGULATING TISSUE," and U.S. Patent Application Publication No. 2017 / 0164997, published June 15, 2017, entitled "METHOD OF TREATING TISSUE USING END EFFECTOR WITH ULTRASONIC AND ELECTROSURGICAL FEATURES," which are incorporated by reference in their entireties herein.

[0251] For thermal mitigation and energy efficiency, the control circuit 710 may control the motor of the surgical instrument 7012 to regulate the closing of the clamp arm 203022 and / or the movement of the ultrasonic blade 203026. To this end, only a portion of the full length of the end effector may be used to grasp and treat tissue. For example, only the distal end of the end effector may be initially proximate the tissue piece followed by gradually more tissue loading in the proximal direction. In this distal start closing stroke configuration, the clamp arm 203022 and / or ultrasonic blade 203026 gradually deform to fully compress in contact with the tissue while maintaining a small gap between the clamp arm 203022 and ultrasonic blade 203026 in the portion of the end effector not containing tissue, while the force applied by the clamp arm increases until a full closing stroke threshold is reached. When the full closing stroke of the end effector is achieved, the clamp tissue pad 203024 may contact the full length of the tissue treatment portion of the ultrasonic blade 203026. In this manner, the control circuitry can be configured to close the end effector at the distal end of the end effector before closing the non-distal portion of the end effector. The pressure profile of the tissue treatment or end effect portion of the ultrasonic blade 203026 is described in more detail below.

[0252] An offset, beveled, or otherwise curved ultrasonic blade 203026 can help facilitate initial closure of the distal tip of the clamp arm 203022. A more detailed description of closing the distal tip of the end effector first (distal initiated closing stroke configuration) and the offset ultrasonic blade 203026 may be found in U.S. Pat. No. 8,444,663, issued May 21, 2013, entitled "ULTRASONIC SURGICAL SHEARS AND TISSUE PAD FOR THE SAME," U.S. Pat. No. 10,004,527, issued June 26, 2018, entitled "ULTRASONIC SURGICAL INSTRUMENT WITH STAGED CLAMPING," U.S. Patent Application Publication No. 2018 / 0153574, published June 7, 2018, entitled "HEADPIECE AND BLADE CONFIGURATIONS FOR ULTRASONIC SURGICAL INSTRUMENT," and U.S. Pat. No. 2018 / 0153574, entitled "ULTRASONIC SURGICAL INSTRUMENT HAVING OFFSET BLADES," issued Jan. 18, 2018, and U.S. Patent Application Publication No. 2018 / 0014848, entitled "ULTRASONIC SURGICAL INSTRUMENTS HAVING OFFSET BLADES," issued Jan. 18, 2018, all of which are incorporated herein by reference. As discussed above, the ultrasonic blade 203026 and / or the clamp arm 203022 may be flexible such that the control circuit 710 causes the ultrasonic blade 203026 and / or the clamp arm 203022 to deform as the applied clamping force increases. FIGS. 32A-E illustrate how such deformations may occur as tissue treatment progresses. Generally, the end effector should be in a fully closed state prior to application of electrosurgical energy. Also, a first deflection of the offset ultrasonic blade may correspond to a second deflection of the offset clamp arm.The first and second deflections described above may be shaped according to a closing pressure profile implemented by the control circuit 710 to provide a relatively large pressure at a proximal portion of the end effector.

[0253] The control circuit 710 may use feedback to control the end effector for thermal mitigation, as described above. For example, the control circuit 710 may monitor the resonant frequency of the ultrasonic blade 203026. The generator 4002 may include a tuning inductor to tune the capacitance to a certain resonant frequency so that substantially all of the generator current output flows into the motional branch. The motional branch current defines the impedance and phase magnitude according to the drive voltage. Thus, the current output of the generator 4002 represents the motional branch current, thereby enabling the generator 4002 to maintain its drive output at the resonant frequency of the ultrasonic transducer. The control circuit 710 may monitor the drive signal of the generator 4002, which correlates to the resonant frequency. The generator 4002 may deliver electrosurgical energy to the end effector to weld tissue based on generating the drive signal. As the surgical cycle progresses, the resonant frequency changes due to changes in the material stiffness of the tissue. Secondly, as the electrosurgical energy is delivered, the rapid accumulation of thermal energy within the ultrasonic blade 203026 causes a change in the stiffness of the material.

[0254] The control circuit 710 is configured to evaluate this dynamic thermal response via a change in frequency or a frequency slope (e.g., a first derivative of the frequency or frequency change with respect to time), for example, based on a comparison to a frequency threshold parameter value. Additionally or alternatively, the control circuit 710 can compare the change in resonant frequency to an initial frequency value determined at the beginning of activation of the electrosurgical energy, which may be recorded in the memory of the surgical instrument 7012. Based on the electrical signal generated by the generator 4002, the control circuit 710 can determine and compare the frequency slope or frequency change to a corresponding threshold value. Specifically, the control circuit 710 may determine when (i) the frequency slope is above an associated threshold parameter value, and (ii) when the frequency change is greater than a trough for the frequency. Greater than a frequency trough means, for example, that the decrease in frequency does not exceed a predetermined threshold drop relative to the determined initial frequency value. Based on one or more of these determinations, if frequency monitoring conditions (i), (ii) are met, the control circuit 710 may control (e.g., via a motor) the ultrasonic blade 203026 and / or the clamp arm 203022 to reduce the closing force / stroke. Thus, the control circuit 710 may determine a resonant frequency measurement indicative of a thermally induced change in resonant frequency to calculate the tissue welding / sealing focus.

[0255] In this manner, the control circuit 710 "reduces" the applied clamping force or pressure to beneficially minimize delivery of thermal energy to the clamp pad 203024 at locations proximal to the proximal extent of the grasped tissue. Further details regarding resonant frequency monitoring can be found in U.S. Patent No. 8,512,365, entitled "SURGICAL INSTRUMENTS," issued August 20, 2013, and U.S. Patent No. 9,788,851, entitled "SURGICAL INSTRUMENT WITH TISSUE DENSITY SENSING," issued October 17, 2017, both of which are incorporated herein by reference in their entirety. Additionally, the control circuit 710 can be programmed to follow set limits that define the tolerance within which the control circuit 710 can reduce the closing force or stroke. Set limits can be determined to prevent tissue from slipping or otherwise escaping from the grasp of the end effector. In addition, the surgical instrument 7012 may be designed to provide user feedback, such as visual, audible, tactile, kinesthetic, vibrational, or some other feedback to the user indicating the current closure status. For example, user feedback (e.g., a light emitting diode, a graphical user interface, a buzzer, a computer generated sound, a handle vibration, etc.) may indicate when the end effector closes at a point more proximal than the proximal extent of the grasped tissue. In situations where a user selects an override setting to override the automatic closure control mechanism of the surgical instrument 7012, this user feedback may be particularly useful in informing the user of the closure status.

[0256] As another example of feedback, the control circuit 710 can monitor the electrical impedance of the surgical instrument 7012. In various aspects, the surgical instrument 7012 may conduct an electrical current between the ultrasonic blade 203026 and the clamp arm tissue pad 203024 to deliver electrosurgical energy. By monitoring this current (or lack thereof), tissue impedance or transducer impedance based on the drive signal of the end effector sensor 788 and / or the generator 4002, the control circuit 710 may determine the amount of tissue loaded in the end effector. Specifically, the control circuit 710 may be programmed to detect and maintain the impedance of the circuit including the blade 203026 and the clamp arm tissue pad 203024 above a predetermined threshold. This maintained impedance may correspond to or approximately correspond to an electrical short. An electrical short, therefore, means that there is an electrical discontinuity between the ultrasonic blade 203026 and the clamp arm tissue pad 203024. Thus, minimal thermal energy is delivered to the portion of the clamp arm tissue pad 203024 that is located proximal to the proximal extent of the grasped tissue. To achieve this desired lack of electrical continuity, the control circuit 710 can implement a reduction in closure force or stroke, as described above. In this manner, the control circuit 710 can determine an electrical continuity measurement for calculating the tissue weld / seal focus.

[0257] On the other hand, when the end effector is not fully closed, the feedback received by the control circuit 710 can be used to reduce the output of the generator 4002. The output of the generator 4002 can be ultrasonic and / or bipolar RF electrosurgical energy depending on the energy modality configuration of the surgical instrument 7012. By reducing the ultrasonic displacement of the ultrasonic blade 203026 and / or the RF power conducted through the RF electrode 796, the control circuit 710 can prevent or reduce instances where relatively high power densities occur at the distal tip of the end effector. This is especially true considering that the ultrasonic vibrations of the ultrasonic blade 203026 are generally relatively high at the distal tip. In either case, avoiding these high power densities can advantageously stop or reduce excessive wear or deterioration of the clamp arm tissue pad 203024. The acoustic drive impedance of the ultrasonic blade 203026 can also be used to assess the jaw closure status. Additionally or alternatively, a closure switch on the surgical instrument 7012, such as a closure switch on the handle, can indicate when the clamp arm 203022 and / or ultrasonic blade 203026 are closed, as described, for example, in U.S. Patent No. 9,724,118, issued August 8, 2017, entitled "TECHNIQUES FOR CUTTING AND COAGULATING TISSUE FOR ULTRASONIC SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety. The position sensor 734 or motor current can also be used to determine the jaw closure status.

[0258] FIG. 25 is a graph 203080 of clamping force distribution as a function of various sections along the length of an end effector, according to at least one embodiment of the present disclosure. The x-axis 203082 shows sections along the length of the end effector, including section numbers 1-5. The y-axis 203084 shows the pressure gradient measured in suitable units ranging from 1-4. The units may be, for example, pounds (lbs). Section 1 represents the most distal portion of the end effector, while section 4 represents the most proximal portion. The measured force may be determined by the control circuit 710 based on a sensor 788, such as a pressure sensor. The pressure output signals of the pressure sensors 788 used to generate the graph 203080 are averaged or summed to smooth the clamping pressure line 203086. In other words, peaks and valleys in the pressure line 203086 that may result from irregularities in the pad 203024 (e.g., teeth in the clamp pad 203024) or that may result from irregularities in the sensor 788 are softened or smoothed in the graph 203080. As shown by the graph 203080, the force distribution at the proximal half of the end effector is relatively higher than the force distribution at the distal half of the end effector. In other words, the pressure profile ratio of the end effector is lower than a value of 1.

[0259] The pressure profile ratio can be defined as the total pressure applied to the distal portion divided by the total pressure applied to the proximal portion of the end effector. Thus, a pressure profile ratio greater than 1 indicates that the end effector is distally loaded, and a pressure profile ratio less than 1 indicates that the end effector is proximally loaded. An end effector that is distally loaded may have more accumulated pressure on the distal half, while an end effector that is proximally loaded will have more accumulated pressure on the proximal half. As shown by graph 203080, the end effector is proximally loaded as measured by pressure sensor 788. A proximally loaded state can be assessed as such when there are locations within the end effector that do not contain tissue. One such example can be seen in FIG. 32A. The relatively high force applied to the proximal portion of the end effector may result from a greater degree of curvature or offset between the ultrasonic blade 203026 and the clamp arm 203022 at the distal portion than at the proximal portion. Loading the proximal side of the end effector may be desirable because the ultrasonic blade 203026 may generally ultrasonically vibrate to a greater degree toward the distal portion. That is, the displacement of the ultrasonic blade 203026 may be greater at the distal portion of the end effector than at the proximal portion. A relatively high clamping pressure applied to the proximal portion may advantageously ensure a more uniform application of electrosurgical energy to tissue, thereby achieving a more reliable cutting / coagulation surgical procedure.

[0260] FIG. 26 is a graph 203100 of a blade displacement profile as a function of distance from a distal tip of an end effector, according to at least one embodiment of the present disclosure. The x-axis 203102 indicates the distance from the distal tip of the end effector, which is shown on the graph 203100 in millimeters (mm). The y-axis 203104 indicates the normalized velocity (on a scale ranging from 0 to 1) of the ultrasonic blade 203026. When normalized, the velocity profile shown in the graph 203100 is adjacent or overlapping with the displacement profile of the ultrasonic blade 203026. In addition, the drive resonant frequency 203108 of the ultrasonic blade 203026 defines the effective wavelength of the displacement or velocity profile. As shown in FIG. 26, the drive resonant frequency 203108 is 55.5 kilohertz (kHz), although other suitable resonant frequency values ​​are possible. The drive resonant frequency 203108 is a factor of the material, geometry and thermal conditions of the surgical instrument 7012. Also shown in Figure 26 is the tissue treatment boundary 203110 of the end effector. The tissue treatment boundary 203110 indicates the length of the tissue treatment (e.g., cutting and coagulation) portion of the end effector and is approximately 15 mm from the distal tip of the graph 203100. The velocity distance line 203106 represents the change in normalized velocity as a function of distance from the distal tip.

[0261] Stated another way, the tissue treatment portion spans 15 mm from the distal tip of the end effector as measured in the proximal direction. The velocity and / or displacement profile as depicted in graph 203100 shows that the velocity and / or displacement of the ultrasonic blade 203026 is maximum at the distal tip and decreases to a minimum as the distance from the distal tip increases to a maximum value. Thus, as shown in FIG. 25, preferentially distributing the clamping force toward the proximal portion of the end effector can enable more uniform power application along the length of the end effector. Power application is a function of the friction coefficient, velocity, and applied force or pressure. Thus, as described above, matching a relatively high distal velocity with a relatively low distal pressure and a relatively low proximal velocity with a relatively high proximal pressure can result in a more uniform cutting of tissue as determined with respect to time. When the end effector is fully closed such that the full closed stroke has been reached, the resulting pressure or force profile is half or a quarter higher proximal to the end effector, so the graph 203080 shows how the ratio of the pressure or force profiles is less than 1. Also, the amount of deflection of the ultrasonic blade 203026 and the amount of deflection of the clamp arm 203022 may be equal or matched over the course of the closing stroke of the end effector.

[0262] 27A-C are cross-sectional views of an end effector 203120 illustrating a closing stroke of the end effector, according to at least one embodiment of the present disclosure. The closing stroke progression illustrated in FIGS. 27A-C illustrates a proximal start configuration closing stroke. In FIG. 27A, the end effector 203120 (which may be the same as or similar to the end effectors described above, including end effectors 702, 752, 792, 4006) is in a more open position than the end effector in FIGS. 27B-C. The clamp arm 203122 includes a clamp arm tissue pad 203124, which may be the same as or similar to pad 203024. In FIG. 27A, the clamp arm 203122 is spaced away from the ultrasonic blade 203126 such that the clamp arm tissue pad 203124 first begins to abut or touch the blade at a proximal-most portion of the clamp arm tissue pad 203124. The clamp arm 203122 is inclined or angled upwardly relative to a horizontal axis defined by the end effector 203120. Thus, the opening between the clamp arm 203122 and the ultrasonic blade 203126 increases in a distal direction, away from the pivot point 203128. The clamp arm 203122 and ultrasonic blade 203126 may pivot about the pivot point 203128.

[0263] Although FIG. 27A does not show tissue grasped by the end effector 203120, in operation tissue is disposed within the end effector 203120 and during tissue treatment in FIG. 27A, the end effector 203120 may compress tissue that is at the proximal-most side of the extent of the pad 203124. In FIG. 27B, the clamp arm 203122 is further along the closing stroke of the end effector 203120. Thus, most or all of the proximal portion of the end effector is in a closed position. Thus, FIG. 27B shows that the proximal-most side of the extent of the pad 203124 is in contact with the ultrasonic blade 203126, while the portion of the pad 203124 just distal to the proximal-most side of the extent is also nearly closed or in contact with the ultrasonic blade 203126. Again, the gap between the clamp arm 203122 and the ultrasonic blade 203126 increases distally away from the pivot point 203128. FIG. 27C shows the fully closed position of the end effector 203120. In FIG. 27C, the entire extent of the clamp arm 203122 and pad 203124 are in contact with the ultrasonic blade 203126 to achieve a full closing stroke. Thus, clamping pressure is applied to all portions of the end effector 203120 as reflected in FIG. 28C. The progression of closure of the proximal start configuration as shown in FIGS. 27A-C shows how the clamping pressure or force rolls distally.

[0264] 28A-28C are graphs 203140, 203160, 203180 of clamping force applied between a blade and a clamp arm as a function of distance from a distal tip of an end effector 203120, corresponding to the cross-sectional views of FIGS. 27A-27C, respectively, in accordance with at least one embodiment of the present disclosure. The applied clamping pressure or force plotted in graphs 203140, 203160, 203180 can be measured by pressure sensor 788. In graphs 203140, 203160, 203180, the x-axis 203144, 203164, 203184 indicates distance from the distal tip of the end effector 203120. The y-axes 203146, 203166, 203186 show the clamp arm pressure or force applied between the clamp arm 203122 and the ultrasonic blade 203126. The applied clamp force lines 203142, 203162, 203184 show the clamp pressure as a function of distance from the distal tip of the end effector 203120. As discussed above, the applied clamp pressure first begins at the proximal-most extent of the clamp arm tissue pad 203124 adjacent the pivot point 203128. This is supported by FIG. 28A. In FIG. 28B, the clamp pressure begins to extend in the distal direction. Thus, the applied clamp force line 203162 begins at a point to the left of the applied clamp force line 203142. Additionally, the clamp pressure at the proximal-most extent of the clamp arm tissue pad 20312 is greater in FIG. 28B than in FIG. 28A. That is, the amplitude at the rightmost portion of applied clamping force line 203162 is greater than the corresponding amplitude of applied clamping force line 203142.

[0265] In FIG. 28C, the applied clamping force line 203182 begins at a point further to the left than the applied clamping force line 203162. In fact, clamping pressure is applied at all points on the x-axis 203184. The clamping pressure at the most proximal end of the clamp arm tissue pad 20312 spread is greater in FIG. 28C than in either FIG. 28B or FIG. 28A. The graph 203180 in FIG. 28C illustrates the applied pressure at a fully closed stroke or position of the end effector 203120. In a fully closed state of the end effector 203120, it may be desirable for the control circuit 710 to implement computer executable logic or rules that ensure the end effector 203120 reaches a fully closed stroke before application of energy by the generator 4002. As discussed above, a fully closed stroke is achieved when the end effector 203120 closes along its entire available length. By delivering electrosurgical energy to the tissue only after achieving a fully closed position, a better tissue seal may be performed. Specifically, homeostasis may be maximized or improved based on the fully closed stroke laterally displacing the inner layer and approximating the outer layer of tissue so that the layers may be brought together during delivery of electrosurgical energy. That is, optimal vessel sealing may occur when the inner muscle layer of the vessel is separated and moves away from the adventitial layer prior to application of electrosurgical energy. The outer tissue layer may form a more reliable tissue weld or seal (e.g., vascular adventitia, serosal covering, etc.).

[0266] One example of such a rule executed by the control circuitry 710 is that when a user activates a large vessel or advanced hemostasis mode of the surgical instrument 7012, the control circuitry 710 verifies that the end effector 203120 has reached a full closed stroke. This verification may occur, for example, via a handle closed switch or full switch of the surgical instrument 7012. If the closed switch is not in the closed position, this indicates that the end effector 203120 is not fully closed. As a result, the surgical instrument 7012 may generate a warning, such as an audible beep or visual warning, an audible warning, a tactile warning, a kinematic warning, a vibratory warning, or some other suitable warning. In some aspects, the surgical instrument 7012 may have mechanical components to control the application of a relatively high clamping force to displace vascular structures (e.g., approximating the adventitia) and a relatively low clamping force for energy delivery. Further details regarding the manipulation of such rules and vascular structures to cut and seal tissue can be found in U.S. Patent No. 8,779,648, entitled "ULTRASONIC DEVICE FOR CUTTING AND COAGULATING WITH STEPPED OUTPUT," issued July 15, 2014, U.S. Patent No. 9,241,728, entitled "SURGICAL INSTRUMENT WITH MULTIPLE CLAMPING MECHANISMS," issued January 26, 2016, and U.S. Patent No. 9,743,947, entitled "END EFFECTOR WITH A CLAMP ARM ASSEMBLY AND BLADE," issued August 29, 2017, all of which are incorporated herein by reference in their entireties.

[0267] 29A-C are cross-sectional views of an end effector 203200 illustrating a proximal start closed stroke configuration, according to at least one embodiment of the present disclosure. As shown in FIG. 29A, the end effector 203200 starts in an open position in which the clamp arm 203202 and the ultrasonic blade 203206 define a relatively large gap between one another. The clamp arm 203202 includes a clamp arm tissue pad 203204, which may be the same as or similar to pads 203024, 203124. In FIG. 29B, the clamp arm 203202 has been pivoted inwardly about a pivot point 203208 such that a proximal portion of the clamp arm tissue pad 203204 contacts tissue (not shown) located on the pad 203204. In other words, the end effector 203200 closes proximally first to apply full clamping pressure only to the proximal portion of the grasped tissue, and the clamping force progressively rolls or expands distally. As the end effector 203000 reaches the fully closed stroke shown in FIG. 29C, a more clamping pressure is gradually applied distally. In FIG. 29C, a fully closed pressure profile or force distribution is achieved at the fully closed position of the end effector 203000. As discussed above, for example, a relatively greater clamping pressure can be applied to the proximal portion of the end effector of the ultrasonic blade 203026 given the relatively lower proximal velocity of the ultrasonic blade 203026.

[0268] 30A-30D are cross-sectional views of the end effector 203220 illustrating a distal start closed stroke configuration and illustrating associated part stresses, according to at least one embodiment of the present disclosure. In the distal start closed stroke configuration, the end effector 203220 closes first at the distal tip, as illustrated in FIG. 30A and described above. Thus, the control circuitry is configured to control the closure of the clamp arm 203224 by pivoting the clamp arm 203224 to generate a point of initial contact between the ultrasonic blade 203226 and the clamp arm 203224 at the distal end of the end effector 203220. In FIG. 30A, the distal tip of the clamp arm 203224 is in contact with the ultrasonic blade 203226. In this manner, the clamp arm tissue pad 203224 of the clamp arm 203224 is compressed against the tissue grasped at the distal portion. Unlike Figures 29A-29C, the applied clamping pressure in Figures 30A-30D has rolled toward the proximal direction. Also, the ultrasonic blade 203226 may be curved, angled, or otherwise offset to allow for closing at the distal tip first. Figure 30B shows the end effector 203220 beginning to apply greater clamping pressure to the clamp arm tissue pad 203224 as it moves proximally. Thus, the outline 203228 shows the associated part stresses in response to this increased bending of the clamp arm 203224. Figure 30C shows the application of clamping pressure continues to progress such that the majority of the tissue treatment portion of the end effector 203220 is in a fully compressed position. The tissue treatment portion may refer to the portion of the end effector that includes the clamp arm tissue pad 203224. 30A-30D, in the proximal portion of the end effector 203220, the pad 203224 does not extend all the way to the intersection of the clamp arm 203224 and the ultrasonic blade 203226. Based on this configuration, the end effector has a slight proximal gap 203230, which can be beneficial for heat mitigation as discussed above.

[0269] In FIG. 30D, the end effector 203220 has achieved a fully closed stroke while advantageously maintaining the proximal gap 203230. As the end effector 203220 progressively approaches the fully closed position, one or more of the clamp arm 203224 and ultrasonic blade 203226 progressively realize greater local stresses resulting from increased applied bending forces. Thus, the local stresses progressively increase corresponding to the transition from FIG. 30A, 30C, 30C to FIG. 30D. As a result, in FIG. 30D, a maximum occurrence of local stress occurs at the contour 203228. As shown in FIG. 30A-30D and moving in the proximal direction, a greater portion of the end effector 203220 closes and a greater portion of the clamp arm tissue pad 203224 is active. 30D, the entire available surface area of ​​the pad 203224 is used to compress against the grasped tissue and ultrasonic blade 203226, while the portion of the end effector 203220 proximal to the proximal extent of the pad 203224 and the grasped tissue defines the proximal gap 203230. The pad 203224 may terminate at the most distal end of the extent of the proximal gap 203230, but may extend into the proximal gap 203230. Even when the pad 203224 extends in this manner, the clamp arm 203222 is recessed to assist in defining the proximal gap 203230. At the proximal gap 203230, less electrosurgical energy is delivered, which can advantageously reduce the temperature and heat present in the ultrasonic blade 203226 after activating energy delivery by the generator 4002. The control circuit 710 may be configured to effect a matching or corresponding deflection of the clamp arm 203224 and the ultrasonic blade 203226 such that each of the clamp arm 203224 and the ultrasonic blade 203226 deforms, deflects or bends as they transition from the configuration of FIG.

[0270] Additionally, the applied clamp pressure and the displacement and velocity of the ultrasonic blade 203226 may be controlled as the closing stroke progresses. For example, when the end effector 203220 is closed only at the distal tip or only at a nearly distal portion (e.g., FIGS. 30A-30B), the displacement and / or velocity of the ultrasonic blade 203226 may be reduced to prevent excessive wear or deterioration of the pad 203224. Thus, ultrasonic vibrations may be reduced when the end effector 203220 is not fully closed. As discussed above, the displacement may be relatively large at the distal tip portion, and thus, a reduced amount of blade displacement may be desirable for a distal start closing configuration of the end effector 203220. Additionally, the control circuit 710 may be configured to control the closing of one or more of the clamp arm 203222 and the ultrasonic blade 203226 to vary the applied pressure to provide a threshold control pressure based on a cutting progression position (e.g., a corresponding weld focal point). For example, as the end effector 203220 progresses from the state of FIG. 30A to the state of FIG. 30D, the surgical cutting or coagulation focal point may shift along the length of the ultrasonic blade 203226, which may be used to adjust the clamping pressure applied. The shift may be in the proximal or distal direction, for example, depending on the closing stroke configuration selected. For example, if the focal point is at a central portion of the distal half of the end effector 203220, a relatively greater pressure may be applied to that central portion, while a relatively lesser pressure may be applied to locations distal to the central portion.

[0271] In addition to or alternatively to adjusting clamping arm force based on cutting / coagulation focus, the control circuit 710 may generally apply a relatively small distal pressure and a larger proximal force to accommodate the displacement or velocity profile of the ultrasonic blade 203226. As described above, the displacement or velocity of the ultrasonic blade 203226 is relatively large at the distal portions, so the applied force may be smaller at those portions compared to the proximal portions. The ultrasonic blade 203226 may be made of a suitable material, such as titanium metal or alloy. More specifically, the titanium alloy may be a grade 5 alpha / beta titanium alloy, such as Ti-6Al-4V, or some other suitable metal. The clamping arm 203224 may also be made of a suitable material, such as stainless steel, more specifically, precipitation hardened 17-4 stainless steel. The clamp arm tissue pad 203224 may also be electrically conductive based on conductive fillers (e.g., carbon, carbon nanotubes, metal particles) so that the surgical instrument 7012 can conduct electrical current from the ultrasonic blade 203226 to the pad 203224 via an isolated electrical conduit after the end effector 203220 is fully closed. In this manner, electrosurgical energy, such as therapeutic or sub-therapeutic RF, can be delivered to the grasped tissue.

[0272] 31A-31D are graphs 203240, 203260, 203280, 203300 of clamping force applied between an ultrasonic blade 203226 and a clamp arm 203224 as a function of distance from a distal tip of an end effector 203220, corresponding to the cross-sectional views of FIGS. 30A-30D, respectively, in accordance with at least one embodiment of the present disclosure. Graphs 203240, 203260, 203280, 203300 include legends 203250, 203270, 203290, 203310, respectively, having different dot patterns that represent the degree of associated force due to, for example, compression between the ultrasonic blade 203226 and the clamp arm 203224. The pressure contour 203308 is plotted along with the corresponding blade models 203252, 203272, 203292, 203312, which are general depictions of the length of the ultrasonic blade 203226. The pressure contour 203308 may indicate the amount and location of component stresses applied versus distance away from the distal tip of the end effector 203220. The dashed lines 203254, 203274, 203294, 203314 indicate the proximal end of the tissue effecting portion of the end effector 203220 (e.g., the proximal end of the pad 203224). As can be seen in FIGS. 31A-31D, the pressure contour 203308 begins at the distal tip of the end effector 203220 and transitions proximally towards the dashed lines 203254, 203274, 203294, 203314. In the graphs 203240, 203260, 203280, 203300, the x-axis 203244, 203264, 203284, 203304 indicates the distance from the distal tip of the end effector 203220.

[0273] The y-axis 203246, 203266, 203286, 203306 show the applied clamping force resulting from contact between the ultrasonic blade 203226 and the clamp arm 203224. The applied force is represented by applied force lines 203242, 203262, 203282, 203302. In FIG. 14A, the applied clamping force occurs only at the distal tip, which corresponds to the distal tip of the distal start closed stroke configuration being closed first. The application of the clamping force gradually shifts proximally from the state of FIG. 31A to the state of FIG. 31D, as shown by the change in the applied force lines 203242, 203262, 203282, 203302. Additionally, the amplitude of the applied clamping force also gradually increases from the state of FIG. 31A to the state of FIG. 31D. Graphs 203240, 203260, 203280, 203300 may display a similar clamping force progression as shown in FIGS. 28A-C, except that the two series of graphs progress in opposite directions. Nevertheless, the distributed force or pressure profile shown in graph 203300 may closely resemble that of graph 203180. That is, FIGS. 31A-D show the applied pressure transitioning in a proximal direction, while FIGS. 28A-C show the pressure transitioning in a distal direction. However, the force profile when the full closure stroke is achieved will be the same or similar regardless of the closure stroke configuration selected. In FIGS. 31A-D, the component stresses of the closure stroke are represented by indicators 203248, 203268, 203288, 203308. Additionally, the position sensor 784 or other sensors 788 can be used to detect the position of the vessel along the length of the ultrasonic blade 203226 for the grasped tissue. This detection can be used to adjust the closing stroke in real time to target the vessel to apply maximum force to the top of the vessel. This detection can also be used to avoid applying power to portions of the end effector 203220 that are not in contact with tissue. This can be useful for thermal mitigation.

[0274] 32A-32E are cross-sectional views of an end effector 203340 illustrating a distal start closing stroke configuration and showing associated part stresses, according to at least one embodiment of the present disclosure. As seen in FIGS. 32A-32E, the ultrasonic blade 203346 is curved and deformable such that at the full closing stroke, the curvature of the ultrasonic blade 203346 flattens or bottoms out, as shown in FIGS. 32D-32E. Thus, the axis of the ultrasonic blade 203346 is offset. The ultrasonic blade 203346 and the clamp arm 203342 pivot about a pivot point 203348. The clamp arm 203342 includes a clamp arm tissue pad 203344. FIGS. 32A-32E show the progression of a distal tip first closure against tissue 203350 for application of electrosurgical energy through the pad 203344. 32B, the distal tip of the curved ultrasonic blade 203346 contacts the distal tip of the clamp arm 203342 based on pivoting one or more of the ultrasonic blade 203346 and the clamp arm 203342 toward one another. The ultrasonic blade 203346 and the clamp arm 203342 may move approximately equal distances toward one another for the duration of the closing stroke. The end effector 203340 may be compressed against the proximal-most of the spread of tissue 203350 at this point. The control circuitry 710 may be configured to determine the initial clamping pressure to be applied based on the size of the tissue 203350 initially loaded into the end effector 203340.

[0275] As seen in Figures 32B-32C, the deflection of the curved ultrasonic blade 203346 continues, rolling in the proximal direction. At the same time, more of the tissue 203350 is grasped. The deflection may include lowering the curvature of the ultrasonic blade 203346 to a base value by incrementally reducing the instantaneous curvature of the curved ultrasonic blade 203346. In Figure 32D, the curvature of the ultrasonic blade 203346 reaches a full base value such that the end effector 203340 is fully closed (i.e., reaches a full closed stroke). The portion of the grasped tissue 203350 is fully compressed against the ultrasonic blade 203346 and the clamp arm 203342 in the fully closed position, and electrosurgical energy can be delivered through the pad 203344 for cutting and coagulation. The distal to proximal extent of the grasped tissue within the end effector 203340 defines a tissue contact area. This tissue contact area may generate a significant amount of heat. In the event that the heat is moderated or reduced rather than fully bottomed out, the end effector 203340 maintains the deflection of the ultrasonic blade 203346 proximal to the proximal-most portion of the tissue contact area. This is illustrated in FIGS. 32A-32E. Thus, the control circuit 7012 may maintain a gap between the ultrasonic blade 203346 and the clamp arm 203342 at a point proximal to the proximal end of the tissue. Compared to the fully closed position illustrated in FIG. 32D, the portion of the pad 203344 not treating tissue (the portion of the pad 203344 proximal to the proximal-most portion of the tissue contact area) receives less thermal energy. As a result, the peak temperature and heat present in the ultrasonic blade 203346 following application of electrosurgical energy is reduced.

[0276] The ultrasonic blade 203346 is also shown with blade models 203352, 203372, 203392, 203412 showing the progression of the clamping force along the length of the end effector 203340. The first dashed line 203356 represents the distal tip and the second dashed line 203358 represents the proximal end of the end effector 203340. The second dashed line 203358 may also represent the proximal-most portion of the spread of the tissue 203350 or where the tissue 203350 stops. In the blade model 203352, no force is applied to the ultrasonic blade 203346. In the blade model 203372, the distal tip of the ultrasonic blade 203346 contacts the corresponding portion of the clamp arm 203342 and some force is applied to the distal portion of the ultrasonic blade 203346. The areas of greater applied force may be indicated by the darker shading of the pressure contours 203376, 203396, 203416. Thus, the relatively greater force represented by the pressure contour 203376 is applied to the distal tip in the blade model 203372. In the blade model 203392, the end effector 203340 is partially closed more proximally, so the pressure contour 203396 extends over a greater length of the end effector 203340. The pressure contour 203396 may vary depending on the location of the cutting / welding focus to provide a constant threshold pressure to the tissue 203350. In the blade model 203392, the end effector 203340 is fully closed and the applied clamping force has already completed moving proximally during the closing movement. Thus, the pressure contour 203396 extends over a greater length and terminates at a second dashed line 203358. EXAMPLES

[0277] Various aspects of the subject matter described herein are illustrated in the following numbered examples. Example 1: A surgical instrument includes an end effector, an ultrasonic transducer, and a control circuit, the control circuit coupled to the end effector. The end effector includes an ultrasonic blade configured to ultrasonically vibrate against tissue, and a clamp arm configured to pivot relative to the ultrasonic blade. The ultrasonic transducer is acoustically coupled to the ultrasonic blade. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from a generator. The end effector is configured to receive electrosurgical energy from...

Claims

1. 1. A surgical instrument comprising: an end effector including an ultrasonic blade configured to ultrasonically vibrate against tissue and a clamp arm configured to pivot relative to the ultrasonic blade; an ultrasonic transducer acoustically coupled to the ultrasonic blade and configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal from a generator; a control circuit coupled to the end effector; the clamp arm is configured to deform, deflect, or bend; the ultrasonic blade has a first abutment portion capable of directly abutting against the clamp arm, and the clamp arm has a second abutment portion capable of directly abutting against the ultrasonic blade; When the clamp arm is in an open position relative to the ultrasonic blade, the control circuit pivots the clamp arm so that initially, only the distal end of the first abutment portion of the ultrasonic blade and the distal end of the second abutment portion of the clamp arm can directly abut against each other, and then the direct abutment area of ​​the ultrasonic blade and the clamp arm gradually expands to the proximal side of the first abutment portion of the ultrasonic blade and the proximal side of the second abutment portion of the clamp arm, until the end effector is in a fully closed position where the entire first abutment portion of the ultrasonic blade and the entire second abutment portion of the clamp arm can directly abut against each other; At least one of a portion of the ultrasonic blade proximal to the first abutment portion and a portion of the clamp arm proximal to the second abutment portion is recessed, and a proximal gap is defined in which the ultrasonic blade and the clamp arm do not directly abut against each other even when the end effector is in the fully closed position; The control circuit is configured to reduce the ultrasonic vibration of the ultrasonic blade when the end effector is not in the fully closed position, by reducing the output of the ultrasonic transducer itself, compared to when the end effector is in the fully closed position, of the surgical instrument.

2. The surgical instrument of claim 1 , further comprising a radio frequency (RF) electrode configured to deliver radio frequency (RF) energy to tissue.

3. The surgical instrument of claim 2, wherein the control circuit is configured to adjust a power level of the radio frequency (RF) energy based on tissue impedance.

4. The surgical instrument of claim 1 , wherein the clamp arm includes a clamp arm tissue pad, the clamp arm tissue pad being compressible.

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