A powered stapling device configured to adjust the force, forward speed, and overall stroke of a cutting member based on sensed parameters of firing or clamping
The surgical stapling instrument dynamically adjusts torque and speed based on sensed parameters, addressing inefficiencies in existing systems by enhancing precision and safety in surgical procedures.
Patent Information
- Application Number
- JP2023121553
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-11-06
- Filing Date
- 2023-07-26
- Publication Date
- 2025-07-08
- Estimated Expiration
- 2038-11-14
AI Technical Summary
Existing surgical systems lack the ability to dynamically adjust the force, advancement speed, and overall stroke of cutting members based on sensed parameters during clamping or firing, leading to inefficiencies and potential complications in surgical procedures.
A surgical stapling instrument equipped with a motor and control circuit that senses parameters associated with clamping or firing to adjust torque and speed of the cutting member, allowing for precise control of the stapling process.
Enhances the precision and safety of surgical procedures by dynamically adjusting the stapling process based on real-time feedback, improving tissue handling and reducing complications.
Smart Images

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Abstract
Description
Technical Field
[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Application No. 16 / 182,240, filed on November 6, 2018, entitled "POWERED STAPLING DEVICE CONFIGURED TO ADJUST FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER BASED ON SENSED PARAMETER OF FIRING OR CLAMPING", the disclosure of which is hereby incorporated by reference in its entirety.
[0002] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62 / 729,185, filed on September 10, 2018, 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", the disclosure of which is hereby incorporated by reference in its entirety.
[0003] This application further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62 / 659,900, filed on June 30, 2018, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE", U.S. Provisional Application No. 62 / 692,748, filed on June 30, 2018, entitled "SMART ENERGY ARCHITECTURE", and U.S. Provisional Application No. 62 / 692,768, filed on June 30, 2018, entitled "SMART ENERGY DEVICES", the disclosures of each of which are hereby incorporated by reference in their entireties.
[0004] This application further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 692,747, filed on April 19, 2018, entitled "METHOD OF HUB COMMUNICATION", the entire disclosure of which is incorporated herein by reference in its entirety.
[0005] This application further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 650,898, filed on March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", U.S. Provisional Patent Application No. 62 / 650,887, filed on March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", U.S. Provisional Patent Application No. 62 / 650,882, filed on March 30, 2018, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", and U.S. Provisional Patent Application No. 62 / 650,877, filed on March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS", the entire disclosures of which are incorporated herein by reference in their entireties.
[0006] This application further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 640,417, filed on March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", and U.S. Provisional Patent Application No. 62 / 640,415, filed on March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR", the entire disclosures 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, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 611,340, filed December 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS"; and U.S. Provisional Patent Application No. 62 / 611,339, filed December 28, 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM", each disclosure of which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION
[0008] The present disclosure relates to various surgical systems. Surgical procedures are typically performed in an operating room or room within a medical facility such as a hospital, for example. A sterile field is typically created around the patient. The sterile field can include scrubbed team members wearing appropriate attire, as well as all equipment and fixtures within that area. Various surgical devices and systems are utilized to perform surgical procedures. SUMMARY OF THE INVENTION BRIEF DESCRIPTION OF THE DRAWINGS
[0009] In one aspect, the present disclosure provides a surgical stapling instrument that includes an end effector configured to clamp tissue, a cutting member, a motor coupled to the cutting member and configured to move the cutting member between a first position and a second position, and a control circuit coupled to the motor. The control circuit is configured to sense parameters associated with clamping of the end effector and control the motor to adjust the torque applied to the cutting member by the motor.
[0010] In another aspect, the present disclosure provides a surgical stapling instrument that includes an end effector configured to clamp tissue, a cutting member, a motor coupled to the cutting member and configured to move the cutting member between a first position and a second position, and a control circuit coupled to the motor, the control circuit being configured to sense parameters associated with the firing of the cutting member and to control the motor to adjust the torque applied to the cutting member by the motor.
[0011] In yet another aspect, the present disclosure provides a powered stapling device that includes a circular stapling head assembly, an anvil, a trocar coupled to the anvil and to a motor, the motor being configured to advance and retract the trocar, and a control circuit coupled to the motor, the control circuit being configured to determine the position of the trocar in one of a plurality of zones and to set an anvil closing speed based on the determined position of the trocar.
Brief Description of the Drawings
[0012] The various aspects described herein, both of the mechanisms and of the methods of operation, together with their further objects and advantages, will be best understood from the following description taken in conjunction with the accompanying drawings hereinafter.
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[0013] The applicant of the present application owns the following U.S. patent applications filed on November 6, 2018, each disclosure of which is incorporated herein by reference in its entirety. · U.S. Patent Application 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 No. 16 / 182,233 entitled "MODIFICATION OF SURGICAL SYSTEMS CONTROL PROGRAMS BASED ON MACHINE LEARNING", · U.S. Patent Application 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 No. 16 / 182,248 entitled "DETECTION AND ESCALATION OF SECURITY RESPONSES OF SURGICAL INSTRUMENTS TO INCREASING SEVERITY THREATS", · U.S. Patent Application No. 16 / 182,251 entitled "INTERACTIVE SURGICAL SYSTEM", · U.S. Patent Application No. 16 / 182,260 entitled "AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN SURGICAL NETWORKS", · U.S. Patent Application 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 No. 16 / 182,249, entitled "POWERED SURGICAL TOOL WITH PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING END EFFECTOR PARAMETER", · U.S. Patent Application No. 16 / 182,246, entitled "ADJUSTMENTS BASED ON AIRBORNE PARTICLE PROPERTIES", · U.S. Patent Application No. 16 / 182,256, entitled "ADJUSTMENT OF A SURGICAL DEVICE FUNCTION BASED ON SITUATIONAL AWARENESS", · U.S. Patent Application 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 No. 16 / 182,269 entitled "IMAGE CAPTURING OF THE AREAS OUTSIDE THE ABDOMEN TO IMPROVE PLACEMENT AND CONTROL OF A SURGICAL DEVICE IN USE", · U.S. Patent Application 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 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 No. 16 / 182,232 entitled "CONTROL OF A SURGICAL SYSTEM THROUGH A SURGICAL BARRIER", · U.S. Patent Application 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 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 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 No. 16 / 182,234 entitled "STAPLING DEVICE WITH BOTH COMPULSORY AND DISCRETIONARY LOCKOUTS BASED ON SENSED PARAMETERS", · U.S. Patent Application 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", and · U.S. Patent Application No. 16 / 182,238 entitled "ULTRASONIC ENERGY DEVICE WHICH VARIES PRESSURE APPLIED BY CLAMP ARM TO PROVIDE THRESHOLD CONTROL PRESSURE AT A CUT PROGRESSION LOCATION".
[0014] The applicant of the present application owns the following U.S. patent applications filed on September 10, 2018, each disclosure of which is incorporated herein by reference in its entirety. · 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", · U.S. Provisional Patent Application No. 62 / 729,177 entitled "AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION", · U.S. Provisional Patent Application 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".
[0015] The applicant of the present application owns the following U.S. patent applications filed on August 28, 2018, each disclosure of which is hereby incorporated by reference in its entirety: · U.S. Patent Application No. 16 / 115,214, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR", · U.S. Patent Application 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 No. 16 / 115,208 entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION", · U.S. Patent Application No. 16 / 115,220 entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE", · U.S. Patent Application No. 16 / 115,232 entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM", · U.S. Patent Application No. 16 / 115,239 entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT", · U.S. Patent Application No. 16 / 115,247 entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR", · U.S. Patent Application No. 16 / 115,211 entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS", · U.S. Patent Application No. 16 / 115,226 entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT", · U.S. Patent Application 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 No. 16 / 115,256, entitled "INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP", · U.S. Patent Application 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".
[0016] The applicant of the present application owns the following U.S. patent applications filed on August 23, 2018, each disclosure of which is incorporated herein by reference in its entirety. · 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".
[0017] The applicant of the present application owns the following U.S. patent applications filed on June 30, 2018, the entire disclosures of each of which are incorporated herein by reference. · 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".
[0018] The applicant of the present application owns the following U.S. patent applications filed on June 29, 2018, the entire disclosures of each of which are incorporated herein by reference. · U.S. Patent Application No. 16 / 024,090, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", · U.S. Patent Application No. 16 / 024,057, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS", · U.S. Patent Application No. 16 / 024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION", · U.S. Patent Application No. 16 / 024,075, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING", · U.S. Patent Application 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 No. 16 / 024,150 entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES", · U.S. Patent Application No. 16 / 024,160 entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY", · U.S. Patent Application No. 16 / 024,124 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE", · U.S. Patent Application No. 16 / 024,132 entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT", · U.S. Patent Application No. 16 / 024,141 entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY", · U.S. Patent Application No. 16 / 024,162 entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES", · U.S. Patent Application No. 16 / 024,066 entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL", · U.S. Patent Application No. 16 / 024,096 entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS", · U.S. Patent Application No. 16 / 024,116 entitled "SURGICAL EVACUATION FLOW PATHS", · U.S. Patent Application No. 16 / 024,149 entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL", · U.S. Patent Application 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 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".
[0019] The applicant of the present application owns the following U.S. Patent Provisional Applications filed on June 28, 2018, each disclosure of which is hereby incorporated by reference in its entirety: · U.S. Patent Provisional 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".
[0020] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on April 19, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Provisional Patent Application No. 62 / 659,900, entitled "METHOD OF HUB COMMUNICATION".
[0021] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on March 30, 2018, the entire disclosure of each of which is incorporated herein by reference. · U.S. Provisional Patent Application No. 62 / 650,898, filed on 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".
[0022] The applicant of the present application owns the following U.S. patent applications filed on March 29, 2018, each disclosure of which is incorporated herein by reference in its entirety. · U.S. Patent Application No. 15 / 940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES", · U.S. Patent Application 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 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 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 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 No. 15 / 940,645 entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT", · U.S. Patent Application 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 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 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 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 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".
[0023] The applicant of the present application owns the following U.S. Patent Provisional Applications filed on March 28, 2018, the entire disclosures of each of which are incorporated herein by reference. · U.S. Patent Provisional Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES", · U.S. Patent Provisional Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD", · U.S. Patent Provisional Application No. 62 / 649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS", · U.S. Patent Provisional Application No. 62 / 649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER", · U.S. Patent Provisional Application No. 62 / 649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS", · U.S. Patent Application No. 62 / 649,291, titled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT" · U.S. Patent Application No. 62 / 649,296, titled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES" · U.S. Patent Application No. 62 / 649,333, titled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER" · U.S. Patent Application No. 62 / 649,327, titled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES" · U.S. Patent Application No. 62 / 649,315, titled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK" · U.S. Patent Application No. 62 / 649,313, titled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES" · U.S. Patent Application No. 62 / 649,320, titled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS" · U.S. Patent Application No. 62 / 649,307, titled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and · U.S. Patent Application No. 62 / 649,323, titled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".
[0024] The applicant of the present application owns the following US patent provisional applications filed on March 8, 2018, each of which is incorporated herein by reference in its entirety. · US Provisional Patent Application No. 62 / 640,417 entitled "Temperature Control in Ultrasonic Device and Control System Therefor", and · US Provisional Patent Application No. 62 / 640,415 entitled "Estimating State of Ultrasonic End Effector and Control System Therefor".
[0025] The applicant of the present application owns the following US patent provisional applications filed on December 28, 2017, each of which is incorporated herein by reference in its entirety. · US Provisional Patent Application No. 62 / 611,341 entitled "Interactive Surgical Platform", · US Provisional Patent Application No. 62 / 611,340 entitled "Cloud-Based Medical Analytics", and · US Provisional Patent Application No. 62 / 611,339 entitled "Robot Assisted Surgical Platform".
[0026] Before describing various aspects of the surgical device and generator in detail, it should be noted that the exemplary embodiments are not limited to the details of the structure and arrangement of the components shown in the accompanying drawings and description in terms of their application or use. The exemplary embodiments may be implemented or incorporated in other aspects, variations, and modifications, and may be practiced or carried out in various ways. Further, unless otherwise specified, the terms and expressions used herein are selected for the purpose of explaining the exemplary embodiments for the convenience of the reader and are not intended to limit them. Further, it should be understood that one or more of the aspects, embodiments, and / or examples described below can be combined with any one or more of the other aspects, embodiments, and / or examples described below.
[0027] Surgical hub Referring to FIG. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., 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 that communicates with cloud 104 which may include a remote server 113. In one embodiment, as shown in FIG. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 that are configured to communicate with each other and / or with 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 greater than or equal to 1.
[0028] In various aspects, as described herein with reference to FIGS. 1-7, the intelligent instrument 112 may be implemented as a circular powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40). The intelligent instrument 112 (e.g., device 1 a -1 n ) is configured to operate within a surgical data network 201 as described with reference to FIG. 8.
[0029] FIG. 2 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 within an operating 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 operate at least one removably coupled surgical tool 117 while the surgeon views the surgical site through the surgeon's console 118 during minimally invasive incision of the patient's body. Images of the surgical site can be obtained by a medical imaging device 124, and the medical imaging device 124 can be operated by the patient-side cart 120 to orient the imaging device 124. The robot hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
[0030] Other types of robotic systems can be easily 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 Dec. 28, 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM", the disclosure of which is incorporated herein by reference in its entirety.
[0031] Various examples of cloud-based analytics implemented by the cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, filed Dec. 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS", the disclosure of which is incorporated herein by reference in its entirety.
[0032] In various aspects, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.
[0033] The optical components of the imaging device 124 may include one or more illumination light sources and / or one or more lenses. One or more illumination light sources may be directed to illuminate a portion of the surgical field. One or more image sensors can receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.
[0034] One or more illumination light sources can be configured to emit electromagnetic energy within the visible spectrum and the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is a portion of the electromagnetic spectrum that is visible to the human eye (i.e., detectable by the human eye) and is sometimes referred to as visible light, or simply light. A typical human eye responds to wavelengths of approximately 380 nm to approximately 750 nm in air.
[0035] The invisible spectrum (i.e., the non-emission spectrum) is a portion of the electromagnetic spectrum that is located below and above the visible spectrum (i.e., wavelengths less than approximately 380 nm and greater than approximately 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than approximately 750 nm are longer than the red visible spectrum and become invisible infrared (IR), microwaves, and radio electromagnetic radiation. Wavelengths less than approximately 380 nm are shorter than the violet spectrum and become invisible ultraviolet, X-rays, and gamma-ray electromagnetic radiation.
[0036] 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, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.
[0037] In one aspect, the imaging device uses multispectral monitoring to distinguish topography from underlying structures. Multispectral images capture image data within a specific wavelength range across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments sensitive to light from specific wavelengths, such as IR and ultraviolet light, beyond the visible light range. Spectral imaging methods can enable the extraction of additional information that cannot be captured by the human eye with its red, green, and blue receptors. The use of multispectral imaging methods is described in detail in the "Advanced Imaging Acquisition Module" of U.S. Patent Provisional Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", the disclosure of which is hereby incorporated by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical field to perform one or more of the above-described tests on the treated tissue after one surgical operation has been completed.
[0038] It is self-evident that strict sterilization of the operating room and surgical instruments is required during any surgical procedure. The strict hygiene and sterilization conditions required in the "surgical theater", i.e., the operating room or treatment room, require the highest level of sterility for all medical devices and instruments. Part of that sterilization process is the need to sterilize anything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field can be considered a specific area, such as within a tray or on a sterile towel, that is considered free of microorganisms, or the sterile field can be considered the area immediately surrounding the patient prepared for the surgical procedure. The sterile field can include scrubbed team members wearing appropriate clothing, as well as all equipment and fixtures within that area.
[0039] In various aspects, the visualization system 108 includes, as shown in FIG. 2, one or more imaging sensors strategically positioned with respect to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. For the various components of the visualization system 108, the disclosure is described in the "Advanced Imaging Acquisition Module" section of U.S. Patent Provisional Application No. 62 / 611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", the disclosure of which is hereby incorporated by reference in its entirety.
[0040] As shown in FIG. 2, the primary display 119 is disposed within the sterile field so as to be visible to the operator of the operating table 114. Additionally, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 that face away from each other. The visualization system 108 guided by the hub 106 is configured to utilize the displays 107, 109, and 119 to coordinate the flow of information to the operators inside and outside the sterile field. For example, the hub 106 can cause the visualization system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109 while maintaining a live video of the surgical site on the primary display 119. The snapshot on the non-sterile display 107 or 109 can enable, for example, a non-sterile operator to perform diagnostic steps related to the surgical procedure.
[0041] In one aspect, the hub 106 is also configured to send diagnostic input or feedback entered by a non-sterile operator located at the visualization tower 111 within the sterile field to the primary display 119 within the sterile area, where it can be viewed by the sterile operator of the operating table. In one embodiment, the input may be in the form of a modification 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.
[0042] Referring to FIG. 2, the surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 is also configured to regulate the flow of information to the display of the surgical instrument 112. For example, the flow of information is further described in U.S. Provisional Patent Application No. 62 / 611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by a non-sterile operator at the visualization tower 111 may be sent by the hub 106 to the surgical instrument display 115 within the sterile field, where the diagnostic inputs or feedback may be viewed by the operator of the surgical instrument 112. Examples of exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the section "Surgical Instrument Hardware" and in U.S. Provisional Patent Application No. 62 / 611,341, filed Dec. 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", the disclosure of which is incorporated herein by reference in its entirety.
[0043] Referring now to FIG. 3, the hub 106 is shown in communication with the visualization system 108, the robotic system 110, and the hand-held intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In certain aspects, as shown in FIG. 3, the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[0044] During a surgical procedure, the application of energy to tissue for sealing and / or cutting generally involves smoke evacuation, aspiration of excess fluid, and / or perfusion of tissue. Fluid, power, and / or data lines from different sources often become entangled during a surgical procedure. Valuable time can be lost in addressing this problem during a surgical procedure. To untangle the lines, it may be necessary to unplug 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 power, data, and fluid lines and reduces the frequency of such line entanglements.
[0045] 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 combined generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. The combined 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 combined generator module further includes a smoke evacuation component, at least one energy supply cable for connecting the combined generator module to a surgical instrument, at least one smoke evacuation component configured to discharge 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.
[0046] 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 perfusion module slidably receivable within the hub housing. In one aspect, the hub housing includes a fluid interface.
[0047] Certain surgical procedures may require applying more than one type of energy to tissue. One type of energy may be more beneficial for cutting tissue, while a different type of energy may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the modular housing 136 of a hub is configured to accommodate different generators and facilitate two-way communication between them. One advantage of the modular housing 136 of the hub is that it allows for the quick removal and / or replacement of various modules.
[0048] Aspects of the present disclosure present a modular surgical housing for use in surgical procedures involving the application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking station having a first docking port including first data and power contacts, wherein the first energy generator module is slidably moveable to electrically engage the power and data contacts, and wherein the first energy generator module is also slidably moveable to disengage from the electrical engagement with the first power and data contacts.
[0049] 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 that is different from the first energy, and a second docking station having a second docking port including second data and power contacts, wherein the second energy generator module is slidably moveable to electrically engage the power and data contacts, and wherein the second energy generator module is also slidably moveable to disengage from the electrical engagement with the second power and data contacts.
[0050] Furthermore, the modular surgical housing further includes a communication bus between a first docking port and a second docking port configured to facilitate communication between a first energy generator module and a second energy generator module.
[0051] Referring to FIGS. 3-7, aspects of the present disclosure are presented with respect to a modular housing 136 of a hub that enables modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The modular housing 136 of the hub further facilitates two-way communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 may be a generator module comprising integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 slidably insertable into the modular housing 136 of the hub. 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 comprise a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the modular housing 136 of the hub. The modular housing 136 of the hub may be configured to facilitate the insertion of multiple generators and two-way communication between the generators docked to the modular housing 136 such that the multiple generators function as a single generator.
[0052] In one aspect, the modular housing 136 of the hub comprises a modular power and communication backplane 149 with external and wireless communication headers to enable removable attachment of the modules 140, 126, 128 and two-way communication between them.
[0053] In one aspect, the modular housing 136 of the hub includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and a combined generator module 145 slidably receivable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combined generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the modular housing 136 of the hub when the combined generator module 145 is slid into position within the corresponding docking station 151 of the modular housing 136 of the hub. In one aspect, the combined generator module 145 includes, as shown in FIG. 5, bipolar, ultrasonic, and monopolar modules, and a smoke evacuation module integrated with a single housing unit 139.
[0054] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that conveys captured / recovered smoke and / or fluid away from the surgical site, for example, to the smoke evacuation module 126. The vacuum suction generated from the smoke evacuation module 126 can draw smoke into the opening of the utility conduit at the surgical site. The utility conduit connected to the fluid line may be in the form of a flexible tube that terminates at the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path that extends toward the smoke evacuation module 126 received within the hub housing 136.
[0055] In various aspects, the aspiration / irrigation module 128 is connected to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one example, the aspiration and suction fluid lines are in the form of flexible tubes that extend from the surgical site toward the aspiration / irrigation module 128. One or more drive systems may be configured to cause irrigation and aspiration of fluid to and from the surgical site.
[0056] In one aspect, a surgical tool includes a shaft having an end effector at its distal end, at least one energy treatment unit 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 extends through the shaft. Similarly, the irrigation tube can extend through the shaft and can have an inlet port proximate to the energy delivery means. The energy delivery means is configured to deliver ultrasonic and / or RF energy to the surgical site and is coupled to the generator module 140 by a cable that first extends through the shaft.
[0057] 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 the vacuum source can be housed within the aspiration / irrigation module 128. In one embodiment, the fluid source and / or the vacuum source can be housed within the hub housing 136 separately from the aspiration / irrigation module 128. In such an embodiment, the fluid interface can be configured to connect the aspiration / irrigation module 128 to the fluid source and / or the vacuum source.
[0058] In one aspect, the corresponding docking stations on the modular housings 136 of the modules 140, 126, 128 and / or the hub can include an alignment function configured to align the docking ports of the modules and engage these corresponding components within the docking stations of the modular housing 136 of the hub. For example, as shown in FIG. 4, the combined generator module 145 includes side brackets 155 configured to slidably engage corresponding brackets 156 of the corresponding docking station 151 of the modular housing 136 of the hub. The brackets cooperate to guide the docking port contacts of the combined generator module 145 into electrical engagement with the docking port contacts of the modular housing 136 of the hub.
[0059] In some embodiments, the drawers 151 of the modular housing 136 of the hub are the same size 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 and are each designed to accommodate a specific module.
[0060] Furthermore, to avoid inserting a module into a drawer with incompatible contacts, the contacts of a specific module may be keyed to engage the contacts of a specific drawer.
[0061] As shown in FIG. 4, the docking port 150 of one drawer 151 is 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 modular housing 136 of the hub. Alternatively or additionally, the docking ports 150 of the modular housing 136 of the hub may facilitate wireless two-way communication between the modules housed within the modular housing 136 of the hub. For example, any suitable wireless communication such as Air Titan - Bluetooth may be used.
[0062] FIG. 6 shows the individual power bus attachments of the plurality of lateral docking ports of a lateral modular housing 160 configured to receive a plurality of modules of a surgical hub 206. The lateral modular housing 160 is configured to receive and interconnect the modules 161 laterally. The modules 161 are slidably inserted into a docking station 162 of the lateral modular housing 160 that includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the modules 161 are arranged laterally within the lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically within the lateral modular housing.
[0063] FIG. 7 shows a vertical modular housing 164 configured to receive a plurality of modules 165 of a 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. The drawer 167 of the vertical modular housing 164 is arranged in the vertical direction, but in certain cases, the vertical modular housing 164 may include a laterally arranged drawer. Further, the modules 165 can interact with each other via the docking ports of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the module 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses a plurality of sub-modules slidably received within the master module 178.
[0064] In various aspects, the imaging module 138 includes a built-in video processor and a modular light source and is adapted to be used with various imaging devices. In one aspect, the imaging device is composed of a modular housing that can be assembled with a light source module and a camera module. The housing may be a disposable housing. In at least one embodiment, the disposable housing is removably coupled to a reusable controller, a light source module, and a camera module. The light source module and / or the camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for imaging a scanned beam. Similarly, the light source module can be configured to deliver white light or different light according to the surgical procedure.
[0065] During a surgical procedure, it can be inefficient to remove a surgical device from the surgical field and replace it with another surgical device that includes a different camera or a different light source. Temporarily losing the view of the surgical field can result in undesirable outcomes. The modular imaging device of the present disclosure is configured to allow for the 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.
[0066] In one aspect, the imaging device includes a tubular housing that includes a plurality of channels. The first channel is configured to slidably receive a camera module that can be configured to snap-fit engage with the first channel. The second channel is configured to slidably receive a light source module that can be configured to snap-fit engage with the second channel. In another example, the camera module and / or the light source module can be rotated to a final position within their corresponding channels. A screw engagement may be employed instead of the snap-fit engagement.
[0067] In various examples, a plurality of imaging devices are positioned at different locations within the surgical field to provide a plurality of 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 different imaging devices.
[0068] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, issued August 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is hereby incorporated by reference in its entirety. Further, U.S. Patent No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is hereby incorporated by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems can be integrated with the imaging module 138. Further, 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 hereby incorporated by reference in their entirety.
[0069] FIG. 8 shows a surgical data network 201 comprising a modular communication hub 203 arranged in one or more operating rooms of a medical facility or any room within a medical facility equipped with specialized equipment for surgical procedures, the modular communication hub 203 being configured to connect to a cloud-based system (e.g., cloud 204 which may include a remote server 213 connected to a storage device 205). In one aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 that communicates 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 functions as a conduit for data, enabling data to go from one device (or segment) to another device and to cloud computing resources. An intelligent surgical data network enables traffic to be monitored as it passes through the surgical data network and includes additional functionality that configures each port within 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.
[0070] The modular devices 1a to 1n arranged in the operating room may be connected to the modular communication hub 203. The network hub 207 and / or the network switch 209 may be connected to the network router 211 to connect the devices 1a to 1n to the cloud 204 or the local computer system 210. The data associated with the devices 1a to 1n may be transferred via the router to a cloud-based computer for remote data processing and operation. The data associated with the devices 1a to 1n may also be transferred to the local computer system 210 for local data processing and operation. The modular devices 2a to 2m located in the same operating room may also be connected to the network switch 209. The network switch 209 may be connected to the network hub 207 and / or the network router 211 to connect the devices 2a to 2m to the cloud 204. The data associated with the devices 2a to 2n may be transferred via the network router 211 to the cloud 204 for data processing and operation. The data associated with the devices 2a to 2m may also be transferred to the local computer system 210 for local data processing and operation.
[0071] It will be appreciated that the surgical data network 201 can be extended by interconnecting a plurality of network hubs 207 and / or a plurality of network switches 209 with a plurality of network routers 211. The modular communication hub 203 can be housed within a modular control tower configured to receive a plurality of devices 1a - 1n / 2a - 2m. The local computer system 210 may also be housed within the modular control tower. The modular communication 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 embodiments, the devices 1a - 1n / 2a - 2m can include, among other modular devices connectable to the modular communication hub 203 of the surgical data network 201, for example, an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, among other various modules.
[0072] 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 devices 1a - 1n / 2a - 2m to the cloud. Any one or all of the devices 1a - 1n / 2a - 2m connected 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 operation. It will be understood that cloud computing relies on shared computing resources rather than having a local server or personal device to handle software applications. The term "cloud" can be used as a metaphor for the "Internet", but this term is not so limited. Thus, the term "cloud computing" can be used herein to refer to "a type of Internet - based computing", in which case various services such as servers, storage devices, and applications are delivered to a modular communication hub 203 and / or a computer system 210 located at the surgical site (e.g., fixed, mobile, temporary, or an on - site operating room or space) and to devices connected to the modular communication hub 203 and / or the computer system 210 via the Internet. The cloud infrastructure can be maintained by a cloud service provider. In this context, the cloud service provider can be an entity that coordinates the use and control of the devices 1a - 1n / 2a - 2m located in one or more operating rooms. Cloud computing services can perform a number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage devices.
[0073] By applying cloud computer data processing technology to the data collected by devices 1a - 1n / 2a - 2m, the surgical data network provides improvements in surgical outcomes, cost reduction, and patient satisfaction. After tissue sealing and cutting procedures, at least some of devices 1a - 1n / 2a - 2m can be used to observe the tissue state to evaluate leakage or perfusion of the sealed tissue. At least some of devices 1a - 1n / 2a - 2m can be used to examine data including images of samples of body tissue for diagnostic purposes using cloud - based computing to identify medical conditions such as the effects of diseases. This includes tissue and phenotype localization and margin confirmation. At least some of devices 1a - 1n / 2a - 2m can be used to identify the anatomical structure of the body using techniques such as various sensors integrated with the imaging device and overlaying images captured by multiple imaging devices. The data collected by devices 1a - 1n / 2a - 2m, including image data, may be transferred to the cloud 204 or the local computer system 210 or both for data processing and operations including image processing and manipulation. The data can be analyzed to improve the results of surgical procedures by determining whether further treatments such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and application of precision robots can be performed on tissue - specific sites and conditions. Such data analysis may further employ prognostic analysis processing, and using a standardized approach can provide useful feedback either to confirm surgical treatment and surgeon behavior or to propose modifications to surgical treatment and surgeon behavior.
[0074] In one implementation, the operating room devices 1a to 1n may be connected to the modular communication hub 203 via a wired channel or a wireless channel according to the configuration of the devices 1a to 1n with respect to the network hub. The network hub 207 may be implemented as a local network broadcast device that functions on the physical layer of the Open System Interconnection (OSI) model in one aspect. The network hub provides connectivity to the devices 1a to 1n located within the same operating room network. The network hub 207 collects data in packet form and transmits them to the router in half-duplex mode. The network hub 207 does not store any media access control / Internet Protocol (MAC / IP) for transferring device data. Only one of the devices 1a to 1n can transmit data at a time via the network hub 207. The network hub 207 has no routing table or intelligence regarding the destination of information and broadcasts all network data across each connection and to the remote server 213 (FIG. 9) on the cloud 204. The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can pose a security risk and cause a bottleneck.
[0075] In another implementation, the operating room devices 2a to 2m may be connected to the network switch 209 via a wired channel or a wireless channel. 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 to 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. A plurality of devices 2a to 2m can transmit data simultaneously via the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a to 2m for data transfer.
[0076] The network hub 207 and / or the network switch 209 is connected to the 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 transmitting the data packets received from the network hub 207 and / or the network switch 211 to the cloud-based computer resources for further processing and manipulation of the data collected by any one or all of the devices 1a to 1n / 2a to 2m. The network router 211 may be used, for example, to connect two or more different networks located at different locations, such as different operating rooms in the same medical facility or different networks in different operating rooms of different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and functions in full-duplex mode. A plurality of devices can transmit data simultaneously. The network router 211 uses IP addresses for data transfer.
[0077] In one embodiment, the network hub 207 may be implemented as a USB hub that enables a plurality of USB devices to be connected to a host computer. The USB hub can expand a single USB port into several levels so that there are more ports available for connecting devices to the host system computer. The network hub 207 can include wired or wireless capabilities for receiving information via a wired channel or a wireless channel. In one aspect, a wireless USB short-range high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and the devices 2a-2m located in the operating room.
[0078] In other embodiments, the operating room devices 1a-1n / 2a-2m can exchange data over a short distance from fixed and mobile devices (using short-wavelength UHF radio waves in the ISM band of 2.4 - 2.485 GHz) and can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to construct a personal area network (PAN). In other aspects, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via a number of wireless or wired communication standards or protocols including, but not limited to, Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols designated for 3G, 4G, 5G, and beyond. The computing module may include a plurality of 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, Ev-DO, etc.
[0079] The modular communication hub 203 can function as a central connection for one or all of the operating room devices 1a - 1n / 2a - 2m and handles a data type known as a frame. The frame carries data generated by the devices 1a - 1n / 2a - 2m. When a frame is received by the modular communication hub 203, the frame is amplified and transmitted to the network router 211, which transfers this data to cloud computing resources by using a number of wireless or wired communication standards or protocols described herein.
[0080] The modular communication 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. Since the modular communication hub 203 is generally easy to install, configure, and maintain, the modular communication hub 203 is a good option for network - connecting the operating room devices 1a - 1n / 2a - 2m.
[0081] FIG. 9 shows a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar to the computer-implemented interactive surgical system 100 in many respects. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar to the surgical system 102 in many respects. 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 within the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210. As illustrated in the embodiment of FIG. 9, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator module 226, a suction / irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage devices via the modular control tower 236. A robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. Among other things, the device / instrument 235, visualization system 208 may be coupled to the modular control tower 236 via the wired or wireless communication standards or protocols described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., a monitor, screen) to display and overlay 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 the images and overlaid images.
[0082] FIG. 10 shows a surgical hub 206 comprising a plurality of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication hub 203, such as a network connection device, and a computer system 210 for providing, for example, local processing, visualization, and imaging. As shown in FIG. 10, the modular communication hub 203 is connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches within the modular communication hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to a processor to provide a communication connection to cloud computing resources and a local display 217. Communication to the cloud 204 can be performed via either a wired or wireless communication channel.
[0083] 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 surgical site using either an ultrasonic or laser-based non-contact measurement device. As described in the "Surgical Hub Spatial Awareness Within an Operating Room" section of U.S. Patent Provisional Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is hereby incorporated by reference in its entirety, the ultrasonic-based non-contact sensor module scans the operating room by transmitting ultrasonic bursts and receiving the echoes when the ultrasonic bursts are reflected off the outer walls of the operating room, where the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room, for example, by transmitting laser light pulses, receiving the laser light pulses reflected off the outer walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.
[0084] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is connected via a system bus to a communication module 247, a storage device 248, a memory 249, a non-volatile memory 250, and an input / output interface 251. The system bus may use any of a variety of bus architectures including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus, such as a 9-bit bus, an Industry Standard Architecture (ISA), a Micro-Charmel Architecture (MSA), an Extended ISA (EISA), an Intelligent Drive Electronics (IDE), a VESA Local Bus (VLB), a Peripheral Component Interconnect (PCI), a USB, an Advanced Graphics Port (AGP), a Personal Computer Memory Card International Association bus (PCMCIA), a Small Computer Systems Interface (SCSI), or any other proprietary bus, but is not limited to these.
[0085] Processor 244 may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex made by Texas Instruments. In one aspect, the processor may be, for example, an on-chip memory of 256KB single-cycle flash memory or other non-volatile memory with a maximum of 40MHz, whose details are available in the product datasheet, a prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle serial random access memory (SRAM), an internal read-only memory (ROM) with StellarisWare (registered trademark) software, 2KB 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, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, which may be the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.
[0086] In one aspect, processor 244 may include a safety controller that includes two controller families such as TMS570 and RM4x, also known by the trade name of Hercules ARM Cortex R4 made by Texas Instruments. The safety controller may be configured specifically for safety-critical applications of IEC61508 and ISO26262, among others, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options.
[0087] Examples of system memory include volatile memory and non-volatile memory. The basic input / output system (BIOS), which contains basic routines for transferring information between elements within a computer system during startup and the like, is stored in non-volatile memory. For example, non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. An example of volatile memory is random-access memory (RAM) that functions as an external cache memory. Further, RAM is available in many forms such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus RAM (DRRAM).
[0088] Computer system 210 also includes removable / non-removable volatile / non-volatile computer storage media, such as disk storage devices. Examples of disk storage devices include, but are not limited to, magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. Additionally, the disk storage device can include the storage medium, separately or in combination with other storage media, such as optical disk drives like compact disc ROM devices (CD-ROM), compact disc recordable drives (CD-R Drive), compact disc rewritable drives (CD-RW Drive), or digital versatile disc ROM drives (DVD-ROM), among others. A removable or non-removable interface may be used to facilitate connection of the disk storage device to the system bus.
[0089] It should be understood that computer system 210 includes software that functions as a medium between a user and basic computer resources, described in a suitable operating environment. Such software includes an operating system. The operating system, which can be stored on the disk storage device, functions to control and allocate the resources of the computer system. System applications utilize the resource management by the operating system through program modules and program data stored either in the system memory or on the disk storage device. It should be understood that the various components described herein can be implemented with various operating systems or combinations of operating systems.
[0090] The user inputs commands or information into the computer system 210 via an input device (s) connected to the I / O interface 251. Examples of input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, etc. These and other input devices are connected to the processor through the system bus via an interface port (s). Examples of interface port (s) include, for example, serial port, parallel port, game port, and USB. The output device (s) use some of the same type of ports as the input device (s). Thus, for example, a USB port may be used to provide input to the computer system and output information from the computer system to the output device. The output adapter is provided to indicate the presence of some output devices, such as a monitor, display, speaker, and printer, among others, that require a special adapter. Examples of output adapters include, by way of illustration and not limitation, video and sound cards that provide a connection means between the output device and the system bus. Note that other devices and / or systems of devices, such as remote computer (s), provide both input and output functions.
[0091] 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, for example, a personal computer, a server, a router, a network PC, a workstation, a microprocessor-based device, a peer device, or other common network nodes, and typically includes many or all of the elements described with respect to the computer system. For simplicity, only a memory storage device is shown with the remote computer(s). The remote computer(s) is logically connected to the computer system via a network interface and subsequently physically connected via a communication connection. The network interface includes communication networks such as local area networks (LANs) and wide area networks (WANs). Examples of LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, etc. Examples of WAN technologies include circuit-switched networks such as point-to-point links, Integrated Services Digital Network (ISDN) and its variations, packet-switched networks, and Digital Subscriber Line (DSL), but are not limited thereto.
[0092] In various aspects, the computer system 210 of FIG. 10, the imaging module 238 of FIGS. 9-10, and / or the visualization system 208, and / or the processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) used for the processing of digital images. The image processor can enhance speed and efficiency using parallel computing that uses single instruction multiple data (SIMD), or multiple instruction multiple data (MIMD) techniques. The digital image processing engine can perform various tasks. The image processor may be a system on a chip with a multi-core processor architecture.
[0093] Communication connection(s) refer to the hardware / software used to connect a network interface to a bus. For the sake of clarity of illustration, the communication connection is shown inside the computer system, but the communication connection may be external to the computer system 210. For illustrative purposes only, the hardware / software required for connection to a network interface includes modems such as ordinary telephone grade modems, cable modems, and DSL modems, ISDN adapters, and internal and external technologies such as Ethernet cards.
[0094] In various aspects, the apparatus / instrument 235 described with reference to FIGS. 9 - 10 can be implemented as the circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40). Thus, the circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40) are configured to be associated with the modular control tower 236 and the surgical hub 206. Once connected to the surgical hub 206, the circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40) are configured to be associated with the cloud 204, the server 213, other hub - connected instruments, the hub display 215, or the visualization system 209, or combinations thereof. Further, once connected to the hub 206, the circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40) may utilize the processing circuitry available within the hub local computer system 210.
[0095] FIG. 11 shows a functional block diagram of one aspect of a USB network hub 300 device according to at least one aspect of the present disclosure. In the illustrated aspect, 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 transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 that comply with the USB 2.0 standard. The upstream USB transceiver port 302 is a differential routed data port that includes a differential data plus (DP0) input paired with a differential data minus (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports where each port includes a differential data plus (DP1 - DP3) output paired with a differential data minus (DM1 - DM3) output.
[0096] 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 circuits 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 high-speed and low-speed devices by automatically setting the throughput rate according to the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus power mode or self-power mode and includes hub power logic 312 for managing power.
[0097] 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 protocols described in Chapter 8 of the USB specification. The SIE 310 typically understands signaling up to the transaction level. Functions it handles can include packet recognition, transaction rearrangement, detection / generation of SOP, EOP, RESET, and RESUME signals, clock / data separation, non-return-to-zero invert (NRZI) data encoding / decoding and bit stuffing, CRC generation and checking (for tokens and data), generation of packet ID (PID), and checking / decoding, and / or serial / parallel or parallel / serial conversion. The 310 receives a clock input 314 and is connected to a suspend / resume logic, a frame timer 316 circuit, and a hub repeater circuit 318 via port logic circuits 320, 322, 324 to control communication between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308. The SIE 310 is connected to a command decoder 326 via interface logic to control commands from a serial EEPROM via a serial EEPROM interface 330.
[0098] In various aspects, the USB network hub 300 can connect up to 127 functions configured within up to six logical layers to a single computer. Further, the USB network hub 300 can connect to all peripheral devices using four standardized wire cables that provide both communication and power distribution. The power configurations are bus power mode and self-power mode. The USB network hub 300 may be configured to support four modes of power management of a bus-powered hub with either individual port power management or linked port power management, and a self-powered hub with either individual port power management or linked port power management. In one aspect, using a USB cable and the USB network hub 300, the upstream USB transceiver port 302 is plugged into a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB-compatible devices, and so on.
[0099] Further details regarding the structure and function of the surgical hub and / or surgical hub network can be found in U.S. Patent Provisional Application No. 62 / 659,900, filed on April 19, 2018, entitled "METHOD OF HUB COMMUNICATION", which is hereby incorporated by reference in its entirety.
[0100] Cloud System Hardware and Functional 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, this computer-implemented interactive surgical system is configured to monitor and analyze data regarding the operation of various surgical systems including a surgical hub, surgical instruments, a robotic device, and an operating room or medical facility. The computer-implemented interactive surgical system includes a cloud-based analysis system. The cloud-based analysis system is described as a surgical system, but is not necessarily limited thereto and may be a cloud-based medical system. As shown in FIG. 12, the cloud-based analysis system includes a plurality of surgical instruments 7012 (which may be the same as or similar to instrument 112), a plurality of surgical hubs 7006 (which may be the same as or similar to hub 106), and a surgical data network 7001 (which may be the same as or similar to network 201) for coupling the surgical hubs 7006 to a cloud 7004 (which may be the same as or similar to 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 the cloud 7004 of the computer-implemented interactive surgical system via the network 7001. The cloud 7004 is a remote centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 12, access to the cloud 7004 is achieved via the network 7001, which can be the Internet or some other suitable computer network. The surgical hub 7006 coupled to the cloud 7004 can be regarded as the client side of the cloud computing system (i.e., the cloud-based analysis system). The surgical instruments 7012 are paired with the surgical hubs 7006 for the control and implementation of various surgical procedures or operations described herein.
[0101] In addition, the surgical instrument 7012 may include a transceiver (which may also include a transmitter and a receiver) for data transmission to and from a corresponding surgical hub 7006. The combination of the surgical instrument 7012 and the corresponding hub 7006 may indicate a specific location, such as an operating room within a medical facility (e.g., a hospital) for providing a medical operation. For example, the memory of the surgical hub 7006 may store location data. As shown in FIG. 12, the cloud 7004 includes a central server 7013, a hub application server 7002, a data analysis module 7034, and an input / output (I / O) interface 7007 (which may be the same as or similar to the remote server 113 in FIG. 1 and / or the remote server 213 in FIG. 9). The central server 7013 of the cloud 7004 collectively manages a cloud computing system, which includes monitoring requests by the client module 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 can include volatile memory such as random access memory (RAM) and non-volatile memory such as a magnetic storage device. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute the data analysis module 7034 for cloud-based data analysis, operations, proposals, and other operations described below. Further, the processor 7008 can execute the data analysis module 7034 independently of or in combination with a hub application independently executed by the hub 7006. The central server 7013 also includes an aggregated medical data database 2212 that can be resident in the memory 2210.
[0102] Based on the connection to various surgical hubs 7006 via network 7001, cloud 7004 can aggregate data from specific data generated by various surgical instruments 7012 and their corresponding hubs 7006. Such aggregated data may be stored in the aggregated medical database 7011 of cloud 7004. Specifically, cloud 7004 may advantageously perform data analysis and operations on the aggregated data to provide functions that individual hubs 7006 cannot achieve on their own. For this purpose, as shown in FIG. 12, cloud 7004 and surgical hub 7006 are communicatively coupled to transmit and receive information. I / O interface 7007 is connected to a plurality of surgical hubs 7006 via network 7001. In this way, I / O interface 7007 can be configured to transfer information between surgical hub 7006 and the aggregated medical data database 7012. Therefore, I / O interface 7007 can facilitate the read / write operations of the cloud-based analysis system. Such read / write operations may be performed in response to requests from hub 7006. These requests may be sent to hub 7006 via the hub application. I / O interface 7007 may include one or more high-speed data ports, such as a Universal Serial Bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting cloud 7004 to hub 7006. The hub application server 7002 of cloud 7004 is configured to host and supply shared functions to software applications (e.g., hub applications) executed by surgical hub 7006. For example, hub application server 7002 may manage requests made by the hub application by hub 7006, control access to the aggregated medical data database 7011, and perform load balancing. The data analysis module 7034 will be described in more detail with reference to FIG. 13.
[0103] The configuration of the specific cloud computing system described in this disclosure is designed to address various problems that arise in the context of medical operations and procedures performed using medical devices such as surgical instruments 7012, 112. In particular, the surgical instrument 7012 may be a digital surgical device configured to interact with the cloud 7004 to implement techniques for improving surgical outcomes. The various surgical instruments 7012 and / or surgical hubs 7006 may include a touch-controlled user interface so that a clinician may control the manner of interaction between the surgical instrument 7012 and the cloud 7004. Other suitable user interfaces for control, such as an auditorily controlled user interface, may also be used.
[0104] FIG. 13 is a block diagram showing the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system includes a plurality of data analysis modules 7034 that may be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions for problems specifically occurring in the medical field. As shown in FIG. 13, the functionality of the cloud-based data analysis module 7034 may be assisted via a hub application 7014 hosted by a hub application server 7002 that can be accessed with respect to a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may operate in cooperation to execute the data analysis module 7034. An application program interface (API) 7016 defines a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 manages the storage of data into and the reading of data from a database 7011 of aggregated medical data for the operation of the application 7014. A cache 7018 also stores data (e.g., temporarily) and is coupled to the API 7016 for more efficient retrieval of data used by the application 7014. The data analysis module 7034 of FIG. 13 includes modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program update 7026, patient outcome analysis 7028, recommendation 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004 in some aspects. In one aspect, the data analysis module is used for specific recommendations based on the analysis of trends, outcomes, and other data.
[0105] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata) including identification of significant features or patterns (e.g., trends), management of redundant data sets, and storage of data into paired data sets that can be grouped by surgery but do not necessarily match the actual surgical date and surgeon. In particular, the paired data sets generated from the operation of the surgical instrument 7012 may include applying a binary classification such as a bleeding or non-bleeding event. More generally, the binary classification may be characterized as either a desirable event (e.g., a successful surgical procedure) or an undesirable event (e.g., a misfire or misused surgical instrument 7012). The aggregated self-describing data may correspond to individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 can generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. For this purpose, the processor 7008 can 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.
[0106] The resource optimization module 7020 can be configured to analyze this aggregated data to determine the optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 may determine the optimal order points for surgical staplers 7012 for a group of medical facilities based on the corresponding predicted demand for such instruments 7012. The resource optimization module 7020 may also evaluate the resource usage or other operational configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the proposal module 7030 can be configured to analyze the compiled data aggregated from the data collection and aggregation module 7022 to provide proposals. For example, the proposal module 7030 may propose 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, for example, based on it having a higher error rate than expected. Additionally, the proposal module 7030 and / or the resource optimization module 7020 may propose better supply chain parameters such as product reorder points and provide proposals such as for different surgical instruments 7012, their use, or the procedural steps to improve surgical outcomes. The medical facility can receive such proposals via the corresponding surgical hub 7006. More specific proposals regarding the parameters or configurations of the various surgical instruments 7012 can also be provided. The hub 7006 and / or the surgical instrument 7012 may each optionally have a display screen for displaying data or proposals provided by the cloud 7004.
[0107] The patient outcome analysis module 7028 can analyze surgical results 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 proposal module 7030 may be able to propose using these other potential operating parameters based on resulting in better surgical outcomes, such as better sealing or less bleeding. For example, the proposal module 7030 can send a proposal to the surgical hub 7006 regarding when to use a particular cartridge with the corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze the large-scale collection of raw data while controlling for common variables and provide centralized proposals across multiple healthcare facilities (advantageously, determined based on aggregated data). For example, the cloud-based analysis system may be able to analyze, evaluate, and / or aggregate the type of medical procedure, type of patient, number of patients, and geographical similarities among healthcare providers / facilities that use similar types of instruments, etc., where the healthcare providers / facilities use similar types of instruments.
[0108] The control program update module 7026 may be able to configure to implement proposals for various surgical instruments 7012 when the corresponding control program is updated. For example, the patient outcome analysis module 7028 may be able to identify a correlation that links certain control parameters to successful (or failed) outcomes. Such a correlation may be addressed when the updated control program is sent to the surgical instrument 7012 via the control program update module 7026. The update to the instrument 7012 sent via the corresponding hub 7006 may incorporate the 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 the proposal module 7030 may be able to identify improved ways of using the instrument 7012 based on the aggregated performance data.
[0109] The cloud-based analysis system may include security functions implemented by the cloud 7004. These security functions may be managed by the authorization and security module 7024. Each surgical hub 7006 can have associated unique credential information such as a username, password, and other suitable security credential information. This credential information can be stored in the memory 7010 and may be associated with an authorized cloud access level. For example, based on providing accurate credential information, the surgical hub 7006 may be granted access to communicate with the cloud up to a certain range (e.g., may transmit or receive certain defined types of information). For this purpose, the aggregated medical data database 7011 of the cloud 7004 may include a database of credential information to verify the accuracy of the provided credential information. Different credential information may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analysis generated by the cloud 7004.
[0110] Furthermore, for security purposes, the cloud may maintain a database of the hubs 7006, instruments 7012, and other devices that may include a "blacklist" of prohibited devices. Specifically, a surgical hub 7006 listed on the blacklist may not be permitted to interact with the cloud, while a surgical instrument 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag an instrument 7012 based on incompatibility or other specified criteria. In this way, counterfeit medical devices and inappropriate reuse of such devices throughout the cloud-based analysis system can be identified and addressed.
[0111] Surgical instrument 7012 may transmit a wireless signal, using a wireless transceiver, that represents, for example, authorization information for access to a corresponding hub 7006 and cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization information can be stored in the respective memory device of surgical instrument 7012. An authorization and security module 7024 can determine whether the authorization information is accurate or forged. The authorization and security module 7024 may also dynamically generate authorization information for enhanced security. The qualification information may also be encrypted, such as by using hash-based encryption. When appropriate authorization is transmitted, surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately to cloud 7004, indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, cloud 7004 may transition to a state where it is capable of receiving medical data for storage in an aggregated medical data database 7011. This data transmission readiness may also be indicated, for example, by an optical indicator on instrument 7012. Cloud 7004 may also transmit a signal to surgical instrument 7012 to update their associated control programs. Cloud 7004 can transmit a signal directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) such that software updates to the control programs are only transmitted to appropriate surgical instruments 7012. Further, cloud 7004 may be used to implement a system-wide solution to address local or global issues based on selective data transmission and authorization information. For example, if a group of surgical instruments 7012 is identified as having a common manufacturing defect, cloud 7004 may change the authorization information corresponding to this group to implement an operational lockout for this group.
[0112] A cloud-based analytics system may be able to monitor multiple healthcare facilities (e.g., a healthcare facility such as a hospital) to determine improved practices and proposed changes (e.g., via the proposal module 2030). Thus, the processor 7008 of the cloud 7004 can analyze data associated with individual healthcare facilities, identify the facilities, and aggregate that data with other data associated with other healthcare facilities. The groups may be defined, for example, based on similar practices or geographical location. In this way, the cloud 7004 may provide a broad analysis and proposal for 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 a proposal regarding the cost and effectiveness for a particular facility (with respect to overall operations and / or various medical procedures). The cost and effectiveness associated with that particular facility may also be compared to the corresponding local zone of other facilities or any other equivalent facility.
[0113] The data classification and prioritization module 7032 may prioritize and classify data based on significance (e.g., the severity, unexpectedness, suspiciousness of a medical event associated with the data). This classification and prioritization may be used in conjunction with the functions of the other data analysis modules 7034 described herein to improve the cloud-based analysis and operations described herein. For example, the data classification and prioritization module 7032 can assign priorities to data analysis performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels can result in specific responses from the cloud 7004 (corresponding to levels of urgency), such as escalation for rapid response, special processing, exclusion from the aggregated medical data database 7011, or other suitable responses. Further, if necessary, the cloud 7004 can send requests (e.g., push messages) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message can result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be required in situations where the cloud detects significant irregularities or outliers and the cloud is unable to determine the cause of the irregularities. The central server 7013 may be programmed to trigger this push message in specific critical situations, such as when data is determined to deviate from predicted values beyond a predetermined threshold or when security is deemed to have been accessed illegally.
[0114] In various aspects, the surgical instrument(s) 7012 described above with reference to FIGS. 12 and 13 can be implemented as circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40). Accordingly, the circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40) are configured to be associated with a surgical hub 7006 and configured to be associated with a network 2001 so as to be associated with the cloud 7004. Accordingly, the processing power and data analysis module 7034 provided by the central server 7013 are configured to process information (e.g., data and control) from the circular powered stapling devices 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 33), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40). Further details regarding the cloud analysis system can be found in U.S. Provisional Patent Application No. 62 / 659,900, filed on Apr. 19, 2018, entitled "METHOD OF HUB COMMUNICATION", which is hereby incorporated by reference in its entirety.
[0115] Situation recognition An "intelligent" device that includes a control algorithm that responds to sensed data may be an improvement over a "dumb" device that operates without considering the sensed data. However, some sensed data may be incomplete or inconclusive when considered alone, i.e., without the context of the type of surgical procedure being performed or the type of tissue being operated on. Without knowing the procedure context (e.g., knowing the type of tissue being operated on or the type of procedure being performed), the control algorithm may inaccurately or sub-optimally control the modular device when provided with sensed data that does not include a specific context. For example, the optimal manner of controlling a surgical instrument in response to a particular sensed parameter may vary according to the specific type of tissue being operated on. This is due to the fact that different tissue types have different properties (e.g., resistance to tearing), which results in different responses to actions taken by the surgical instrument. Thus, even when the same measurement is sensed for a particular parameter, it may be desirable for the surgical instrument to take different actions. As one specific example, the optimal manner of controlling a surgical stapling and cutting instrument in response to the instrument sensing an unexpectedly high force to close its end effector may vary depending on whether the tissue type is susceptible to tearing or is resistant to it. In the case of tissue that is susceptible to tearing, such as lung tissue, the control algorithm for the instrument optimally ramps down the motor in response to the unexpectedly high force to close in order to avoid tearing the tissue. In the case of tissue that is resistant to tearing, such as stomach tissue, the control algorithm for the instrument optimally ramps up the motor in response to the unexpectedly high force to close in order to ensure that the end effector is properly clamped to the tissue. Without knowing whether lung tissue or stomach tissue is being clamped, the control algorithm may make sub-optimal decisions.
[0116] One solution utilizes a surgical hub that is configured to derive information regarding a surgical procedure based on data received from various data sources and then to control a paired modular device as appropriate. In other words, the surgical hub is configured to infer information regarding the surgical procedure from the received data and then to control a modular device 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 aspect of the present disclosure. In some examples, the data source 5126 can include, for example, a modular device 5102 (which can include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database including patient records), and a patient monitoring device 5124 (e.g., a blood pressure (BP) monitor and an electrocardiography (EKG) monitor).
[0117] The surgical hub 5104, which may be similar to the hub 106 in many respects, can be configured to derive context information regarding the surgical procedure from the data based on, for example, a particular combination(s) of the received data or the particular order in which data is received from the data source 5126. The context information inferred from the received data can include, for example, the type of surgical procedure being performed, a particular step of the surgical procedure that the surgeon is performing, the type of tissue being operated on, or the body cavity being treated. This ability of the surgical hub 5104 according to some aspects to derive or infer information related to the surgical procedure from the received data can be referred to as "situation awareness." In one example, the surgical hub 5104 can incorporate a situation awareness system that is hardware and / or programming associated with the surgical hub 5104 that derives context information related to the surgical procedure from the received data.
[0118] The situation recognition system of the surgical hub 5104 can be configured to derive context information from data received from various different data sources 5126. In one example, the situation recognition system correlates various inputs (e.g., data from the database 5122, the patient monitoring device 5124, and / or the modular device 5102) with corresponding context information regarding the surgical procedure, and includes a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data. In other words, the machine learning system can be trained to accurately derive context information regarding the surgical procedure from the provided inputs. In another exemplary example, the situation recognition system can include a look-up table that stores context information pre-characterized regarding the surgical procedure in correspondence with one or more inputs (or ranges of inputs) corresponding to the context information. In response to a query with one or more inputs, the look-up table can return the corresponding context information of the situation recognition system to control the modular device 5102. In one example, the context information received by the situation recognition system of the surgical hub 5104 is associated with a specific control adjustment or a set of control adjustments of one or more modular devices 5102. In another example, the situation recognition system includes a further machine learning system, a look-up table, or other such systems that generate or obtain one or more control adjustments of one or more modular devices 5102 when context information is provided as an input.
[0119] A surgical hub 5104 incorporating a situation awareness system provides many benefits to a surgical system 5100. One benefit includes improving the interpretation of sensed and collected data, which improves the processing accuracy and / or use of data during a surgical procedure. To return to a previous example, the situation awareness surgical hub 5104 can determine which type of tissue is being operated on, and thus, if an unexpectedly high force is detected to close the end effector of a surgical instrument, the situation awareness surgical hub 5104 can correctly ramp up or ramp down the motor of the surgical instrument according to the type of tissue.
[0120] As another example, the type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of a surgical stapling and cutting instrument for a particular tissue gap measurement. The situation awareness surgical hub 5104 can estimate whether the surgical procedure being performed is a thoracic procedure or an abdominal procedure, whereby the situation awareness surgical hub 5104 can determine whether the tissue clamped by the end effector of the surgical stapling and cutting instrument is a lung (in the case of thoracic surgery) or a stomach (in the case of abdominal surgery). The surgical hub 5104 can then appropriately adjust the compression speed and load threshold of the surgical stapling and cutting instrument according to the type of tissue.
[0121] As yet another example, the type of body cavity being operated on during an insufflation procedure can affect the function of a smoke evacuator. The situation awareness surgical hub 5104 can determine whether the surgical site is under pressure (by determining that the surgical procedure utilizes insufflation) and can determine the type of procedure. Since the type of procedure is generally performed within a particular body cavity, the surgical hub 5104 can appropriately control the motor speed of the smoke evacuator according to the body cavity being operated on. Thus, the situation awareness surgical hub 5104 can provide a certain amount of smoke evacuation for both thoracic and abdominal surgeries.
[0122] As yet another example, the type of procedure being performed can affect the energy level optimal for operating an ultrasonic surgical instrument or a radiofrequency (RF) electrosurgical instrument. An arthroscopic procedure, for example, requires a higher energy level because the end effector of an ultrasonic surgical instrument or an RF electrosurgical instrument is immersed in a fluid. The situational awareness surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., “energy level”) of the generator to compensate for the fluid-filled environment. In related fashion, the type of tissue being operated on can affect the energy level optimal for operating an ultrasonic surgical instrument or an RF electrosurgical instrument. The situational awareness surgical hub 5104 can determine which type of surgical procedure is being performed according to the expected tissue profile of the surgical procedure and then can customize the energy levels of the ultrasonic surgical instrument or the RF electrosurgical instrument, respectively. Further, the situational awareness surgical hub 5104 can be configured to adjust the energy levels of the ultrasonic surgical instrument or the RF electrosurgical instrument not only on a procedure basis but also over the course of the surgical procedure. The situational awareness surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed next and then update the control algorithms of the generator and / or the ultrasonic surgical instrument or the RF electrosurgical instrument to set the energy level to a value appropriate for the tissue type expected according to the steps of the surgical procedure.
[0123] As yet another example, data can be drawn from additional data sources 5126 to improve the conclusions drawn by the surgical hub 5104 from one data source 5126. The situation-aware surgical hub 5104 can enhance the data received from the modular device 5102 with context information constructed regarding a surgical procedure from other data sources 5126. For example, the situation-aware surgical operating hub 5104 can be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may not be conclusive. Thus, in one illustration, the surgical hub 5104 further compares a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively coupled 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 further be configured to make a determination regarding the integrity of a staple line or tissue weld. In other words, the situation-aware system of the surgical hub 5104 can provide additional context when analyzing visualization data in consideration of physiological measurement data. The additional context can be useful when the visualization data may not be conclusive or complete by itself.
[0124] As another benefit, actively and automatically controlling the paired modular devices 5102 according to the specific steps of the surgical procedure being performed to reduce the number of times medical personnel need to interact with or control the surgical system 5100 during the surgical procedure. For example, the situation-aware surgical hub 5104 can actively activate the generator to which the RF electrosurgical instrument is connected if it determines that a subsequent step of the procedure requires the use of the instrument. By actively activating the energy source, the instrument can be made ready for use as soon as the preceding step of the procedure is completed.
[0125] As another example, the situation awareness surgical hub 5104 can determine, according to the feature(s) at the surgical site where the surgeon is expected to look, whether the current or subsequent steps of the surgical procedure require different fields of view or degrees of magnification on the display. The surgical hub 5104 can then actively change the displayed field of view (e.g., supplied by the medical imaging device for the visualization system 108) accordingly, causing the display to automatically adjust over the surgical procedure.
[0126] As yet another example, the situation awareness surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed subsequently, and whether a particular data or comparison between data is required for that step of the surgical procedure. The surgical hub 5104 can be configured to automatically call up a data screen based on the step of the surgical procedure being performed, without waiting for the surgeon to request specific information.
[0127] Another benefit includes checking for errors during the setup of a surgical procedure or during the surgical procedure itself. For example, the situational awareness surgical hub 5104 can determine whether the operating room is properly or optimally set up for the surgical procedure being performed. The surgical hub 5104 can determine the type of surgical procedure being performed and obtain the corresponding checklist, product locations, or setup needs (e.g., from memory), and then be configured to compare the current operating room layout to the 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, for example, a list of items for a procedure scanned by a suitable scanner and / or a list of devices paired with the surgical hub 5104 to a proposed or expected manifest of items and / or devices for a given surgical procedure. If there are any discontinuities between the lists, the surgical hub 5104 can be configured to provide a warning indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In one example, the surgical hub 5104 can be configured to determine, for example, the relative distance or position of the modular device 5102 and the patient monitoring device 5124 by means of a proximity sensor. The surgical hub 5104 can compare the relative position of the devices to a proposed or expected layout for a particular surgical procedure. If there is a discontinuity 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 proposed layout.
[0128] As another example, the situation awareness surgical hub 5104 can determine whether a surgeon (or other healthcare provider) is making a mistake or otherwise deviating from the expected sequence of actions during a surgical procedure. For example, the surgical hub 5104 can determine the type of surgical procedure being performed, retrieve a corresponding list of steps or sequence of device use (e.g., from memory), and then compare the steps being taken during the surgical procedure, or the devices being used, to the expected steps or devices for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In one illustration, the surgical hub 5104 can be configured to provide a warning indicating that an unexpected action is being taken, or an unexpected device is being utilized, at a particular step in the surgical process.
[0129] Overall, the situation awareness system for the surgical hub 5104 improves the outcome of a surgical procedure by adjusting (e.g., adapting to different tissue types) surgical instruments (and other modular devices 5102) for the specific context of each surgical procedure and verifying actions during the surgical procedure. The situation awareness system also improves the efficiency of the surgeon during the performance of a surgical procedure by automatically suggesting the next step, providing data, and adjusting displays and other modular devices 5102 within the surgical field according to the specific context of the procedure.
[0130] In one aspect, as described below with reference to FIGS. 24-40, the modular device 5102 can be implemented as a circular powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40). Thus, the modular device 5102 implemented as the circular powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) operates as a data source 5126 and is configured to interact with the database 5122 and the patient monitoring device 5124. The modular device 5102 implemented as the circular powered stapling device 201800 (FIGS. 24-30), 201502 (FIGS. 31-33), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) is further configured to interact with the surgical hub 5104 to provide information (e.g., data and control) to the surgical hub 5104 and receive information (e.g., data and control) from the surgical hub 5104.
[0131] Referring now to FIG. 15, for example, a timeline 5200 showing the situation awareness of a hub such as the surgical hub 106 or 206 (FIGS. 1-11) is shown. The schedule 5200 is exemplary surgical procedures and context information that the surgical hubs 106, 206 can derive from data received from a data source at each step of the surgical procedure. The schedule 5200 shows the typical steps that will be taken by nurses, surgeons, and other healthcare providers during a lobectomy procedure that begins with setting up the operating room and ends with transferring the patient to the post-operative recovery room.
[0132] The situation awareness surgical hubs 106, 206 receive data from a data source that includes data generated each time a healthcare provider utilizes a modular device paired with the surgical hubs 106, 206 over the course of a surgical procedure. The surgical hubs 106, 206 receive this data from the paired modular devices and other data sources and can continuously derive an estimate (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 situation awareness system of the surgical hubs 106, 206 can, for example, record data regarding the procedure to generate a report, verify the steps being taken by the healthcare provider, provide data or prompts that may be relevant to a particular procedure step (e.g., via a display screen), 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 an RF electrosurgical instrument), and perform any other such operations as described above.
[0133] As a first step 5202 in this exemplary procedure, a hospital staff member reads the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hubs 106, 206 determine that the procedure to be performed is a chest procedure.
[0134] In a second step 5204, the staff member scans the incoming medical supplies for the procedure. The surgical hubs 106, 206 cross-reference the scanned supplies with a list of supplies utilized in various types of procedures and confirm that the mix of supplies corresponds to a chest procedure. Additionally, the surgical hubs 106, 206 can also determine that the procedure is not a wedge procedure (either because the incoming supplies do not include the specific supplies required for a chest wall wedge procedure or for some other reason do not correspond to a chest wall wedge procedure).
[0135] In the third step 5206, the healthcare provider scans the patient's band via a scanner communicably connected to the surgical hubs 106, 206. Subsequently, the surgical hubs 106, 206 can confirm the patient's identification information based on the scanned data.
[0136] In the fourth step 5208, the medical staff turns on the auxiliary devices. The auxiliary devices used can vary according to the type of surgical procedure and the techniques used by the surgeon. In this exemplary case, these include a smoke evacuator, an inhaler, and a medical imaging device. Once activated, the auxiliary devices, which are modular devices, can automatically pair with the surgical hubs 106, 206 located within a specific vicinity of the modular device as part of its initialization process. Subsequently, the surgical hubs 106, 206 can derive context information regarding the surgical procedure by detecting the type of modular device paired with it during this pre-operative or initialization stage. In this particular embodiment, the surgical hubs 106, 206 determine that the surgical procedure is a VATS surgery based on this specific combination of paired modular devices. Based on the combination of data from the patient's EMR, the list of medical supplies used in the surgery, and the type of modular device connected to the hub, the surgical hubs 106, 206 can generally estimate the specific procedure being performed by the surgical team. Once the surgical hubs 106, 206 know what specific procedure is being carried out, subsequently, the surgical hubs 106, 206 can read the steps of that procedure from memory or from the cloud and then cross-reference the data subsequently received from the connected data sources (e.g., modular devices and patient monitoring devices) to estimate which step of the surgical procedure the surgical team is executing.
[0137] In the fifth step 5210, the staff attaches EKG electrodes and other patient monitoring devices to the patient. The EKG electrodes and other patient monitoring devices can pair with the surgical hubs 106, 206. When the surgical hubs 106, 206 start receiving data from the patient monitoring devices, the surgical hubs 106, 206 confirm that the patient is in the operating room.
[0138] In the sixth step 5212, the healthcare provider induces anesthesia in the patient. The surgical hubs 106, 206 can estimate that the patient is under anesthesia based on data from modular devices and / or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or combinations thereof. When the sixth step 5212 is completed, the preoperative portion of the pneumonectomy is completed and the operative portion begins.
[0139] In the seventh step 5214, the lung of the patient being operated on is deflated (while ventilation is switched to the contralateral lung). The surgical hubs 106, 206 can estimate, for example, that the patient's lung has been deflated from ventilator data. Since the surgical hubs 106, 206 can compare the detection that the patient's lung has been deflated with the expected steps of the procedure (which can be accessed or read in advance), it can be estimated that the operative portion of the procedure has started, thereby determining that deflating the lung is the first surgical step in this particular procedure.
[0140] In the eighth step 5216, a medical imaging device (e.g., a scope) is inserted and the video footage from the medical imaging device is started. The surgical hubs 106, 206 receive medical imaging device data (i.e., video or image data) through the connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hubs 106, 206 can determine that the laparoscopic portion of the surgical procedure has started. Further, the surgical hubs 106, 206 can determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that wedge procedures have already been discounted by the surgical hubs 106, 206 based on the data received in the second step 5204 of the procedure). The data from the medical imaging device 124 (FIG. 2) is used to determine the type of procedure being performed from among a number of different ways including by determining the angle of the medical imaging device oriented with respect to the visualization of the patient's anatomical structure, by monitoring the number or medical imaging devices being used (i.e., activated and paired with the surgical hubs 106, 206), and by monitoring the type of visualization device being used. For example, one technique for performing a VATS lobectomy is to place the camera above the diaphragm at the anteroinferior corner of the patient's chest cavity, while one technique for performing a VATS segmentectomy is to place the camera at an anterior intercostal position with respect to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situation recognition system can be trained to recognize the position of the medical imaging device based on the visualization of the patient's anatomical structure. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmentectomy utilizes multiple cameras. As yet another example, one technique for performing a VATS segmentectomy utilizes an infrared light source (which can be communicably coupled to the surgical hub as part of the visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy.By tracking any or all of this data from the medical imaging device, the surgical hubs 106, 206 can determine the specific type of surgical procedure being performed and / or the techniques being used for a specific type of surgical procedure.
[0141] In the ninth step 5218, the surgical team begins the incision step of the procedure. The surgical hubs 106, 206 can presume that the surgeon is in the process of incising and separating the patient's lung because they receive data from an RF or ultrasonic generator indicating that an energy instrument is being fired. The surgical hubs 106, 206 can determine that the energy instrument being fired at this point in the process (i.e., after the previously considered steps of the procedure have been completed) corresponds to the incision step by cross-referencing the received data with the read steps of the surgical procedure. In a specific example, the energy instrument can be an energy tool attached to a robotic arm of a robotic surgical system.
[0142] In the tenth step 5220, the surgical team proceeds to the ligation step of the procedure. The surgical hubs 106, 206 can presume that the surgeon is ligating arteries and veins because they receive data from a surgical stapling and cutting instrument indicating that an instrument is being fired. Similar to the previous step, the surgical hubs 106, 206 can derive this presumption by cross-referencing the receipt of data from the surgical stapling and cutting instrument with the steps within the read process. In a specific example, the surgical instrument can be a surgical tool attached to a robotic arm of a robotic surgical system.
[0143] In the 11th step 5222, a regional resection of the treatment is performed. The surgical hubs 106, 206 can be estimated by the surgeon to be transecting the parenchymal tissue based on data from the surgical stapling and cutting instrument including data from its cartridge. The data of the cartridge can correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissues, the data of the cartridge can indicate the type of tissue being stapled and / or transected. In this case, the type of staples fired is used for parenchymal tissue (or other similar tissue types), whereby the surgical hubs 106, 206 can be estimated to be performing the regional resection of the treatment.
[0144] Subsequently, in the 12th step 5224, a nodulectomy step is performed. The surgical hubs 106, 206 can be estimated by the surgical team to be incising the nodule and performing a leak test based on data received from a generator indicating that an RF or ultrasonic instrument is being fired. In this particular treatment, the RF or ultrasonic instrument used after the parenchymal tissue has been transected corresponds to the nodulectomy step, which enables the surgical hubs 106, 206 to make this estimation. Since different instruments are better suited for specific tasks, it should be noted that the surgeon may periodically switch between the surgical stapling / cutting instrument and the surgical energy (i.e., RF or ultrasonic) instrument according to the specific steps during the treatment. Therefore, the specific order in which the stapling / cutting instrument and the surgical energy instrument are used can indicate which step of the treatment the surgeon is performing. Further, in certain examples, robotic tools can be used for one or more steps during the surgical treatment and / or handheld surgical instruments can be used for one or more steps during the surgical treatment. The surgeon(s) can, for example, alternate between the robotic tool and the handheld surgical instrument in sequence and / or, for example, use the devices simultaneously. When the 12th step 5224 is completed, the incision is closed and the postoperative part of the treatment begins.
[0145] In the 13th step 5226, the patient's anesthesia is reversed. The surgical hubs 106, 206 can be estimated, for example, based on ventilator data (i.e., when the patient's respiratory rate begins to increase), that the patient is starting to wake up from anesthesia.
[0146] Finally, the 14th step 5228 is for the healthcare provider to remove various patient monitoring devices from the patient. Thus, the surgical hubs 106, 206 can be estimated that the patient has been transferred to the recovery room when the hubs lose EKG, BP, and other data from the patient monitoring devices. As can be seen from the description of this exemplary procedure, based on the data received from various data sources communicably coupled to the surgical hubs 106, 206, the surgical hubs 106, 206 can determine or estimate when each step of a given surgical procedure is occurring.
[0147] In various aspects, the circular powered stapling devices 201800 (Figs. 24 - 30), 201502 (Figs. 31 - 33), 201532 (Figs. 34 - 35), 201610 (Figs. 36 - 40) are configured to operate in a situation - awareness state within a hub environment, such as by a timeline 5200 as shown, e.g., for the surgical hub 106 or 206 (Figs. 1 - 11). Situation awareness is further described in U.S. Patent Provisional Application No. 62 / 659,900, filed on April 19, 2018, entitled "METHOD OF HUB COMMUNICATION", which is hereby incorporated by reference in its entirety. In a particular example, for instance, the operation of a robotic surgical system, including various robotic surgical systems disclosed herein, can be controlled by the hubs 106, 206 based on its situation awareness and / or feedback from its components, and / or based on information from the cloud 104.
[0148] Hardware of Surgical Instruments FIG. 16 shows a logic diagram of a control system 470 for a surgical instrument or tool according to one or more aspects of the present disclosure. The system 470 includes a control circuit. The control circuit includes a microcontroller 461 that includes a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 is operably coupled to a longitudinally movable displacement member to drive a powered circular stapling device knife element, trocar, or anvil. A tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to a processor 462 that can be programmed or configured to determine the position of the longitudinally movable drive member and the position of the firing member, firing bar, or knife element. An additional motor may be provided to a tool driver interface to control knife firing, movement of a closure tube, rotation of a shaft, and articulation. A display 473 may display various operating states of the instrument and include touch screen functionality for data input. Information displayed on the display 473 can be overlaid with an image acquired via an endoscopic imaging module.
[0149] In one aspect, the microcontroller 461 may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex from Texas Instruments. In one aspect, the main microcontroller 461 may be, for example, an on-chip memory of up to 256KB single-cycle flash memory or other non-volatile memory with a maximum of 40MHz, the details of which are available in the product datasheet, a prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle SRAM, an internal ROM with StellarisWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and / or one or more 12-bit ADCs including 12 analog input channels, such as the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.
[0150] In one aspect, the microcontroller 461 may include a safety controller including two controller families such as TMS570 and RM4x, also known by the trade name of Hercules ARM Cortex R4 from Texas Instruments. The safety controller may be configured specifically for safety-critical applications of IEC61508 and ISO26262, among others, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options.
[0151] The microcontroller 461 may be programmed to perform various functions, such as precise control of the speed and position of the knife and articulation system. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and a mechanical coupling to the articulation or knife system. In one aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily replaced for use in a tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system is described in U.S. Patent Application Publication No. 2017 / 0296213, published on October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0152] The microcontroller 461 may be programmed to provide accurate control of the displacement member and the speed and position of the articulation system. The microcontroller 461 may be configured to calculate a response within the software of the microcontroller 461. The calculated response is compared with the measured response of the actual system to obtain an "observed" response, which is used for the determination of the actual feedback. The observed response is a suitably adjusted value that balances the smooth and continuous nature of the response by simulation with the response by measurement, which can detect external influences on the system.
[0153] In one aspect, the motor 482 may be controlled by a motor driver 492 and may be used by a surgical instrument or tool firing system. In various forms, the motor 482 may be, for example, a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In another arrangement, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including field-effect transistors (FETs). The motor 482 may be powered by a power supply assembly removably attached to the handle assembly or tool housing to supply control power to the surgical instrument or tool. The power supply assembly may include a battery including a number of battery cells connected in series that may be used as a power source to power the surgical instrument or tool. In certain situations, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be lithium-ion batteries that may be connectable to and separable from the power supply assembly.
[0154] The motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with an external N-channel power metal-oxide semiconductor field-effect transistor (MOSFET) designed particularly for inductive loads such as brushed DC motors. The driver 492 includes an inherent charge pump regulator, which provides full (>10V) gate drive to battery voltages up to 7V, enabling the A3941 to operate with a reduced gate drive up to 5.5V. A bootstrap capacitor may be used to provide the above battery supply voltage required for the N-channel MOSFET. The internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in a fast or slow decay mode using diodes or synchronous rectification. In the slow decay mode, current recirculation is possible by either the high-side FET or the low-side FET. The power FETs are protected from shoot-through by a register-adjustable dead time. The integrated diagnostics indicate low voltage, overtemperature, and power bridge anomalies and can be configured to protect the power MOSFETs under most short-circuit conditions. Other motor drivers can be easily substituted for use in the tracking system 480 with an absolute positioning system.
[0155] The tracking system 480 includes a controlled motor drive circuit arrangement with a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member having a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reduction assembly. In other aspects, the displacement member may represent a firing member adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing bar or knife, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member is used generically to refer to any movable member of a surgical instrument or tool, such as a drive member, a firing member, a firing bar, a knife, a trocar, or an anvil of a powered circular stapling device, or any element that can be displaced. In one aspect, the longitudinally movable drive member is coupled to the firing member, the firing bar, and the knife. Thus, the absolute positioning system can, in fact, track the linear displacement of the knife by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, the firing member, the firing bar, or the knife, or combinations thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor.Linear displacement sensors may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), slide potentiometers, magnetic sensing systems comprising a movable magnet and a series of Hall effect sensors arranged in a line, magnetic sensing systems comprising a fixed magnet and a series of Hall effect sensors arranged on a series of movable lines, optical detection systems comprising a movable light source and a series of light diodes or photodetectors arranged in a line, optical detection systems comprising a fixed light source and a series of light diodes or photodetectors arranged on a series of movable lines, or any combination thereof.
[0156] The electric motor 482 may include a rotary shaft that operably interfaces with a gear assembly that is mounted in meshing engagement with a set of drive teeth or a rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one revolution of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gear ring and sensor arrangement can be connected to the linear actuator by a rack and pinion arrangement or to the rotary actuator by spur gears or other connections. The power supply can supply power to the absolute positioning system and the output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member having a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reduction assembly. The displacement member represents a longitudinally movable firing member, firing bar, knife, or combination thereof.
[0157] One rotation of the sensor element associated with the position sensor 472 corresponds to the longitudinal linear displacement d1 of the displacement member, where d1 is the linear distance in the longitudinal direction that the displacement member moves from point "a" to point "b" after one rotation of the sensor element connected to the displacement member. The sensor arrangement may be connected via a gear reduction that results in the position sensor 472 completing one or more rotations relative to the full stroke of the displacement member. The position sensor 472 can complete multiple rotations relative to the full stroke of the displacement member.
[0158] To provide a unique position signal for two or more rotations of the position sensor 472, a series of switches (where n is an integer greater than 1) may be used either alone or in combination with a gear reduction. The state of the switches is fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1 + d2 +... dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor arrangement may comprise an analog rotational sensor such as a magnetic sensor, a potentiometer, etc., or an array of analog Hall effect elements that output a unique combination of position signals or values.
[0159] The position sensor 472 may comprise any number of magnetic sensing elements, such as a magnetic sensor classified, for example, based on whether it measures the total magnetic field or a vector component of the magnetic field. The technologies used to produce both types of magnetic sensors involve many aspects of physics and electronics. Technologies used for magnetic field sensing include, among others, search coils, flux gates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetic impedance, magnetostrictive / piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magneto-optics, and microelectromechanical systems-based magnetic sensors.
[0160] In one aspect, the position sensor 472 of the tracking system 480 comprising an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 472 cooperates with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low-voltage and low-power component, and includes four Hall effect elements in the area of the position sensor 472 located above the magnet. Further, a high-resolution ADC and a smart power management controller are provided on the chip. A coordinate rotation digital computer (CORDIC) processor, also known as the digit-by-digit method and Volder's algorithm, is provided to implement a concise and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, bit shifting, and table reference operations. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface such as a serial peripheral interface (SPI) interface. The position sensor 472 provides a resolution of 12 bits or 14 bits. The position sensor 472 may be an AS5055 chip provided in a small QFN16-pin 4×4×0.85 mm package.
[0161] Tracking system 480 with an absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, a state feedback, and an adaptive controller. The power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some aspects, examples of other sensors may include the sensor arrangements described in U.S. Patent No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM", which is hereby incorporated by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM", which is hereby incorporated by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT", which is hereby incorporated by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include a comparison and combination circuit to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, and inductive resistance to predict how the state and output of the physical system will be based on knowing the input.
[0162] The absolute positioning system provides the absolute position of the displacement member upon power-up of the instrument without having to retract or advance the displacement member to a reset (zero or home) position, as may be required by conventional rotary encoders that count the number of steps the motor 482 has simply traveled forward or backward to estimate the position of device actuators, drive bars, knives, etc.
[0163] For example, a sensor 474, such as a strain gauge or a micro strain gauge, is configured to measure one or more parameters of the end effector, such as the amplitude of the strain exerted on the anvil during a clamping operation, which can indicate, for example, the closing force applied to the anvil. The measured strain is converted into a digital signal and provided to the processor 462. Instead of, or in addition to, the sensor 474, a sensor 476, such as a load cell, for example, can measure the closing force applied to the anvil by the closing drive system. For example, a sensor 476, such as a load cell, can measure the firing force applied to the knife during the firing stroke of a surgical instrument or tool. The knife is configured to engage a wedge thread, which is configured to cam the staple driver upward to eject staples into deformable contact with the anvil. The knife also includes a sharp cutting edge that can be used to cut tissue when advancing the knife distally by a firing bar. Alternatively, a current sensor 478 can be used to measure the current draw by the motor 482. The force required to advance the firing member can correspond, for example, to the current drawn by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.
[0164] In one configuration, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. To measure the force exerted by the end effector on the tissue being treated, a strain gauge can be coupled to the end effector. A system for measuring the force applied to tissue grasped by the end effector includes, for example, a strain gauge sensor 474 such as a micro strain gauge configured to measure one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on the jaw members of the end effector during a clamping operation, which can indicate compression of the tissue. The measured strain is converted to a digital signal and provided to the processor 462 of the microcontroller 461. A load sensor 476 can measure, for example, the force used to operate a knife element to cut tissue captured between an anvil and a staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The measurements of the magnetic field sensor can also be converted to a digital signal and provided to the processor 462.
[0165] The measurements of tissue compression, tissue thickness, and / or the force required to close the end effector on the tissue, respectively measured by sensors 474, 476, can be used by the microcontroller 461 to characterize corresponding values of the selected position of the firing member and / or the velocity of the firing member. In one example, the memory 468 can store techniques, equations, and / or look-up tables that can be used by the microcontroller 461 during evaluation.
[0166] The control system 470 for a surgical instrument or tool may also include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 1-14. The control system 470 is used by powered circular stapling instruments 201800 (FIGS. 24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40) to control the aspects of the powered circular stapling instruments 201800, 201502, 201532, 201610. Aspects of the control system 470 are used by the powered circular stapling instruments 201800, 201502, 201532, 201610 to sense the positions of the anvil and tissue compression force from others by using 472, 474, 476, tracking system 480, and current sensor 478 to provide feedback to the controller 461.
[0167] FIG. 17 shows a control circuit 500 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. The control circuit 500 can be configured to implement the various processes described herein. The control circuit 500 can include a microcontroller comprising one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions for implementing the various processes described herein. The processor 502 can be any one of a number of single-core or multi-core processors known in the art. The memory circuit 504 can comprise volatile and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0168] FIG. 18 shows a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool. The combinational logic circuit 510 can be configured to implement the various processes described herein. The combinational logic circuit 510 can include a finite state machine that receives data associated with a surgical instrument or tool at input 514, processes the data by combinational logic 512, and provides an output 516.
[0169] FIG. 19 shows a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool. The sequential logic circuit 520 or combinational logic 522 can be configured to implement the various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, combinational logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 can store the current state of the finite state machine. In a particular example, the sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from input 526, process the data by combinational logic 522, and provide an output 528. In other aspects, the circuit may include a combination of a processor (e.g., processor 502 of FIG. 17) and a finite state machine that implements the various processes herein. In other aspects, the finite state machine can include a combination of a combinational logic circuit (e.g., combinational logic circuit 510 of FIG. 18) and the sequential logic circuit 520.
[0170] FIG. 20 shows a surgical instrument or tool 600 having a plurality of motors that can be activated to perform various functions. In a particular example, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In a particular example, the plurality of motors of the surgical instrument 600 can be individually activated to cause a firing motion, a closing motion, and / or an articulation motion in the end effector. The firing motion, the closing motion, and / or the articulation motion can be transmitted to the end effector, for example, via a shaft assembly. In one aspect, the surgical instrument 600 represents a handheld surgical instrument. In another aspect, the surgical instrument 600 represents a robotic surgical instrument. In other aspects, the surgical instrument 600 represents a combination of a handheld and a robotic surgical instrument. In various aspects, the surgical stapler 600 may represent a linear stapler or a circular stapler.
[0171] In a particular example, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604 configured to transmit the firing motion generated by the motor 602 to the end effector, specifically to displace a knife element. In a particular example, the firing motion generated by the motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by the end effector and / or advance the cutting edge of the knife element to cut the captured tissue. The knife element can be retracted by reversing the direction of the motor 602.
[0172] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably coupled to a closure motor drive assembly 605 configured to specifically displace a closure tube to close the anvil and transmit the closure motion generated by the motor 603 to the end effector to compress tissue between the anvil and the staple cartridge. By the closure motion, for example, the end effector can transition from an open configuration to an approaching configuration to capture tissue. The end effector can be transitioned to an open position by reversing the direction of the motor 603. In a circular stapler implementation, the motor 603 may be coupled to the trocar portion of the circular stapler portion of the powered stapling device. The motor 603 can be used to advance and retract the trocar.
[0173] In certain examples, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operably coupled to corresponding articulation motor drive assemblies 608a, 608b configured to transmit the articulation motion generated by the motors 606a, 606b to the end effector. In certain examples, by the articulation motion, for example, the end effector can articulate with respect to the shaft.
[0174] As described above, a surgical instrument or tool may include a plurality of motors configured to perform various independent functions. In a particular example, the plurality of motors of the surgical instrument or tool can be activated individually or separately to perform one or more functions while other motors remain stopped. For example, the joint movement motors 606a, 606b can be activated to move the end effector in joint movement while the firing motor 602 remains stopped. Alternatively, the firing motor 602 can be activated to fire a plurality of staples and / or advance the blade tip while the joint movement motors 606 are stopped. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to advance the closure tube and the knife element distally, as will be described in more detail below in this specification.
[0175] In a particular example, a surgical instrument or tool may include a common control module 610 that can be used with the plurality of motors of the surgical instrument or tool. In a particular example, the common control module 610 can correspond to one of the plurality of motors at a time. For example, the common control module 610 may be connectable and separable individually to the plurality of motors of the surgical instrument. In a particular example, the plurality of motors of the surgical instrument or tool may share one or more common control modules such as the common control module 610. In a particular example, the plurality of motors of the surgical instrument or tool can engage individually and selectively with the common control module 610. In a particular example, the common control module 610 can be selectively switched from cooperation with one of the plurality of motors of the surgical instrument or tool to cooperation with another of the plurality of motors of the surgical instrument or tool.
[0176] In at least one example, a common control module 610 can selectively switch between operably engaging with the articulation motors 606a, 606b and operably engaging with either the firing motor 602 or the closing motor 603. In at least one embodiment, as shown in FIG. 20, a switch 614 can move or transition between multiple positions and / or states. For example, in a first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602, and in a second position 617, the switch 614 may electrically couple the common control module 610 to the closing motor 603. In a third position 618a, the switch 614 may electrically couple the common control module 610 to the first articulation motor 606a, and in a fourth position 618b, the switch 614 may electrically couple the common control module 610 to the second articulation motor 606b. In a particular example, simultaneously, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b. In a particular example, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.
[0177] Each of the motors 602, 603, 606a, 606b may include a torque sensor for measuring the output torque on the motor's shaft. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaw or by a torque sensor of the motor that actuates the jaw.
[0178] In various examples, as shown in FIG. 20, the common control module 610 may include a motor driver 626 that may include one or more H-bridge FETs. The motor driver 626 may modulate the power transmitted from the power supply 628 to the motor connected to the common control module 610 based on an input from, for example, a microcontroller 620 (“controller”). In a particular example, as described above, the current drawn by the motor can be determined using the microcontroller 620 while the motor is connected to the common control module 610.
[0179] In a particular example, the microcontroller 620 may include a microprocessor 622 (“processor”) and one or more non-transitory computer-readable media or memory units 624 (“memory”). In a particular example, the memory 624 can store various program instructions that, when executed, can cause the processor 622 to perform the functions and / or calculations described herein. In a particular example, one or more of the memory units 624 may be connected to the processor 622, for example.
[0180] In a particular example, the power supply 628 may be used to supply power to, for example, the microcontroller 620. In a particular example, the power supply 628 may include a battery (or “battery pack” or “power pack”), such as a lithium-ion battery, for example. In a particular example, the battery pack may be configured to be removably attached to the handle to supply power to the surgical instrument 600. A number of battery cells connected in series may be used as the power supply 628. In a particular example, the power supply 628 may be, for example, replaceable and / or rechargeable.
[0181] In various examples, the processor 622 can control the motor driver 626 to control the position, rotation direction, and / or speed of a motor coupled to the common control module 610. In a particular example, the processor 622 can signal the motor driver 626 to stop and / or disable a motor coupled to the common control module 610. As used herein, the term "processor" is to be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a central processing unit (CPU) of a computer on one integrated circuit or on up to a few integrated circuits. A processor is a multipurpose programmable element that accepts digital data as input, processes that data according to instructions stored in memory, and provides results as output. Since it has internal memory, it is an example of sequential digital logic. A processor operates on numbers and symbols represented in the binary number system.
[0182] In one example, the processor 622 may be any single-core or multi-core processor, such as those known by the trade name of ARM Cortex made by Texas Instruments. In a specific example, the microcontroller 620 may be, for example, LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the LM4F230H5QR of Texas Instruments, among the functions readily available in the product datasheet, in particular, has on-chip memory of 256KB single-cycle flash memory or other non-volatile memory with a maximum of 40MHz, a prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle SRAM, an internal ROM with StellarisWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and one or more 12-bit ADCs with 12 analog input channels, and is an ARM Cortex-M4F processor core. Other microcontrollers may be easily substituted for use with the module 4410. Therefore, the present disclosure should not be limited to this context.
[0183] In a specific example, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that can be connected to the common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b. Such program instructions can cause the processor 622 to control the firing function, the closing function, and the articulation function according to the input from the algorithm or control program of the surgical instrument or tool.
[0184] In a particular example, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert processor 622 of program instructions to be used in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions related to the firing, closing, and articulation of the end effector. In a particular example, sensor 630 may comprise a position sensor that can be used, for example, to sense the position of switch 614. Thus, when processor 622 detects, for example, via sensor 630 that switch 614 is in the first position 616, it can use the program instructions associated with the firing of the knife of the end effector, and when processor 622 detects, for example, via sensor 630 that switch 614 is in the second position 617, it can use the program instructions associated with the closing of the anvil, and when processor 622 detects, for example, via sensor 630 that switch 614 is in the third position 618a or the fourth position 618b, it can use the program instructions associated with the articulation of the end effector.
[0185] Surgical instrument 600 may comprise a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 1-14. Surgical instrument 600 may be a powered circular stapling instrument 201800 (FIGS. 24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40).
[0186] FIG. 21 is a circuit diagram of a surgical instrument 700 configured to operate a surgical tool as described herein. The surgical instrument 700 may be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of a closure tube, rotation of a shaft, and articulation using any of a single or plurality of articulation drive linkages. In one aspect, 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. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, closure member, shaft member, or one or more articulation members. In one aspect, the surgical instrument 700 represents a hand-held surgical instrument. In another aspect, the surgical instrument 700 represents a robotic surgical instrument. In other aspects, the surgical instrument 700 represents a combination of a hand-held and robotic surgical instrument. In various aspects, the surgical stapler 700 may represent a linear stapler or a circular stapler.
[0187] In one aspect, the surgical instrument 700 includes a control circuit 710 configured to control an anvil 716 and a knife 714 (or cutting element including a sharp cutting edge) portion of an end effector 702, a removable staple cartridge 718, a shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704e. A position sensor 734 may be configured to provide position feedback of the knife 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. A timer / counter 731 provides timing and count information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.
[0188] In one aspect, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause 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 circuit 710 to correlate the position of the knife 714 determined by the position sensor 734 with the output of the timer / counter 731. As a result, the control circuit 710 can determine the position of the knife 714 at a specific time (t) relative to the start position or time (t) when the knife 714 is at a specific position relative to the start position. The timer / counter 731 may be configured to measure an elapsed time, count external events, or measure the time of external events.
[0189] In one aspect, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue states. The control circuit 710 may be programmed to directly or indirectly sense a tissue state, such as thickness, as described herein. The control circuit 710 may be programmed to select a firing control program or a closure control program based on the tissue state. The firing control program may be able to describe the distal movement of the displacement member. Various firing control programs can be selected to better handle various tissue states. For example, if thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a slower speed and / or with less power. If thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a faster speed and / or with more power. The closure control program may be able to control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the articulating movement members 742a, 742b.
[0190] In one aspect, the control circuit 710 may generate a motor setpoint signal. The motor setpoint signal may be provided to various motor controllers 708a - 708e. The motor controllers 708a - 708e may include one or more circuits configured to provide motor drive signals to motors 704a - 704e to drive the motors 704a - 704e as described herein. In some embodiments, the motors 704a - 704e may be brushed DC electric motors. For example, the speed of the motors 704a - 704e may be proportional to their respective motor drive signals. In some embodiments, the motors 704a - 704e may be brushless DC electric motors, and each motor drive signal may include a PWM signal provided to one or more stator windings of the motors 704a - 704e. Also, in some embodiments, the motor controllers 708a - 708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.
[0191] In one aspect, the control circuit 710 may first operate each of the motors 704a - 704e in an open - loop configuration during a first open - loop portion of the stroke of the displacement member. Based on the response of the surgical instrument 700 during the open - loop portion of the stroke, the control circuit 710 may select a firing control program in a closed - loop configuration. Examples of the response of the instrument may include the translational 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 total pulse width of the motor drive signal, etc. After the open - loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during 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 translational data describing the position of the displacement member to translate the displacement member at a constant speed.
[0192] In one aspect, motors 704a - 704e can receive power from an energy source 712. The energy source 712 may be a main AC power source, a battery, a supercapacitor, or a DC power source driven by any other suitable energy source. Motors 704a - 704e may be mechanically coupled via respective transmission devices 706a - 706e to individual movable mechanical elements such as knife 714, anvil 716, shaft 740, articulation movement 742a, and articulation movement 742b. Transmission devices 706a - 706e may include one or more gears or other connecting components for connecting motors 704a - 704e to the movable mechanical elements. A position sensor 734 may sense the position of the knife 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicating the position of the knife 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the knife 714 translates in the distal and proximal directions. The control circuit 710 may track the pulses to determine the position of the knife 714. For example, other suitable position sensors, including proximity sensors, may be used. Other types of position sensors can provide other signals indicative of the movement of the knife 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of motors 704a - 704e is a stepper motor, the control circuit 710 can track the position of the knife 714 by summing the number of steps and direction the motor 704 is instructed to perform. The position sensor 734 can be located within the end effector 702 or any other part of the instrument. Each output of motors 704a - 704e includes torque sensors 744a - 744e for sensing force and has an encoder for sensing rotation of the drive shaft.
[0193] In one aspect, the control circuit 710 is configured to drive a firing member such as the knife 714 portion of the end effector 702. The control circuit 710 provides a motor setpoint to the motor control unit 708a, and the motor control unit 708a 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 device 706a that is coupled to the knife 714. The transmission device 706a includes movable mechanical elements such as a rotating element and a firing member for controlling the movement of the knife 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 that includes 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 represents the force required to fire or displace the knife 714. A position sensor 734 may be configured to provide the control circuit 710 with the position of the knife 714 or the position of the firing member along the firing stroke as a feedback signal. The end effector 702 may include additional sensors 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor control unit 708a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to a stroke end position distal to the stroke start position. As the firing member translates distally, the knife 714, which includes a cutting element positioned at the distal end, advances distally to cut tissue located between the staple cartridge 718 and the anvil 716.
[0194] In one aspect, the control circuit 710 is configured to drive a closing member, such as the anvil 716 portion of the end effector 702. The control circuit 710 provides a motor setpoint to a motor control unit 708b that provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b that is coupled to the anvil 716. The transmission 706b includes movable mechanical elements, such as rotating elements and closing members, for controlling the movement of the anvil 716 from an open position and a closed position. In one aspect, the motor 704b is coupled to a closing gear assembly that includes a closing reduction gear set supported by meshing engagement with a closing spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716. A position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738 within the end effector 702 can provide the closing force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned opposite the staple cartridge 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control unit 708b. In response to the closing signal, the motor 704b advances the closing member to grip tissue between the clamp arm 716 and the staple cartridge 718.
[0195] In one aspect, the control circuit 710 is configured to rotate a shaft member, such as shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor setpoint to a motor control unit 708c that provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c that is coupled to the shaft 740. The transmission mechanism 706c includes a movable mechanical element, such as a rotating element, to control the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is coupled to a rotary transmission assembly including a tubular gear segment formed (or attached) on the proximal end of the proximal closure tube so as to be operably engaged by a rotary 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 represents the rotational force applied to the shaft 740. A position sensor 734 may be configured to provide the position of the closure member to the control circuit 710 as a feedback signal. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
[0196] In the implementation of the circular stapler, the transmission device 706c element is coupled to the trocar to advance or retract the trocar. In one aspect, the shaft 740 is part of a closed system that includes a trocar 201904 and a trocar actuator 201906, as will be discussed in more detail with reference to FIGS. 29A-29 below. Thus, the control circuit 710 controls the motor control circuit 708c to control the motor 704c to advance or retract the trocar. A torque sensor 744c is provided to measure the torque applied by the shaft of the motor 704c to the transmission component 706c used to advance and retract the trocar. The position sensor 734 may include various sensors for tracking the position of the trocar, anvil 716, or knife 714, or any combination thereof. Other sensors 738 may be used to measure various parameters including the position or velocity of the trocar, anvil 716, or knife 714, or any combination thereof. The torque sensor 744c, the position sensor 734, and the sensor 738 are coupled to the control circuit 710 as inputs to various processes for controlling the operation of the surgical instrument 700 in a desired manner.
[0197] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides motor setpoints to a motor control unit 708d that provides drive signals to a motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d that is coupled to an articulation member 742a. The transmission 706d includes movable mechanical elements such as articulation elements for controlling the ±65° articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably supported on the proximal end portion of the distal spine portion and is 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 an articulation encoder, may provide the control circuit 710 with the articulation position of the end effector 702.
[0198] In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members, or links 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robotic interface (rack) that is driven by two motors 708d, 708e. When an individual firing motor 704a is provided, each of the articulation links 742a, 742b can be driven antagonistically with respect to the other link to provide a resistance holding movement and load to the head when the head is not moving and to provide articulation when the head is articulating. The articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Thus, as the head rotates, the mechanical efficiency of the push-pull link changes. This change in mechanical efficiency can be more pronounced in the drive systems of other articulation links.
[0199] In one aspect, one or more of the motors 704a-704e may comprise a brushed DC motor with a gearbox and a mechanical coupling to a firing member, a closure member, or an articulating member. As another example, the electric motors 704a-704e may operate movable mechanical elements such as displacement members, articulating couplings, closure tubes, and shafts. External influences are unmeasured and unpredictable influences such as those of tissue, ambient bodies, and friction of physical systems. Such external influences may be referred to as a drag acting against one of the electric motors 704a-704e. External influences such as drag may cause the operation of the physical system to deviate from the desired operation of the physical system.
[0200] 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 the AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 can provide an absolute positioning system in conjunction with the control circuit 710. The position may be located above a magnet and may include a plurality of Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the volder algorithm, which implements a concise and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, bit shifting, and table reference operations.
[0201] In one aspect, control circuit 710 may communicate with one or more sensors 738. The sensors 738 are positioned on end effector 702 and may be adapted to operate with 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 include magnetic sensors, magnetic field sensors, strain gauges, load cells, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of end effector 702. The sensors 738 may include one or more sensors. The sensors 738 may be disposed on the deck of staple cartridge 718 to determine the position of tissue using split electrodes. Torque sensors 744a - 744e may be configured to sense forces such as, among other things, firing force, closing force, and / or articulation force. Thus, control circuit 710 can sense (1) the closing load experienced by the distal closure tube and its position, (2) the firing member in the rack and its position, (3) which part of staple cartridge 718 has tissue thereon, and (4) the loads and positions on both articulation rods.
[0202] In one aspect, one or more sensors 738 may include strain gauges such as micro strain gauges configured to measure the magnitude of strain in anvil 716 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 738 may include pressure sensors configured to detect the pressure generated by the presence of tissue compressed between anvil 716 and staple cartridge 718. The sensors 738 may be configured to detect the impedance of the tissue portion located between anvil 716 and staple cartridge 718, and this impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0203] In one aspect, the sensor 738 may be implemented as, among other things, one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magneto-resistive (MR) devices, giant magneto-resistive (GMR) devices, and magnetometers. In other implementations, the sensor 738 may be implemented as, among other things, a solid state switch that operates under the influence of light such as an optical sensor, an IR sensor, an ultraviolet sensor, etc. Further, 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, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.
[0204] In one aspect, the sensor 738 may be configured to measure the force exerted on the anvil 716 by the closure drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the anvil 716 to detect the closure force applied to the anvil 716 by the closure tube. The force exerted on the anvil 716 may represent the tissue compression experienced by the tissue portion captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be arranged at various points of interaction along the closure drive system to detect the closure force applied to the anvil 716 by the closure drive system. One or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. The control circuit 710 receives the real-time sample measurements, provides and analyzes time-based information, and evaluates in real time the closure force applied to the anvil 716.
[0205] In one aspect, a current sensor 736 can be used to measure the current drawn by each of motors 704a - 704e. The force required to advance any of the movable mechanical elements such as knife 714 corresponds to the current drawn by one of motors 704a - 704e. The force is converted into a digital signal and provided to control circuit 710. Control circuit 710 can be configured to simulate the response of the actual system of the instrument with the controller's software. The displacement member can be actuated to move the knife 714 within end effector 702 at or near a target velocity. Surgical instrument 700 can include a feedback controller, which can be one of any feedback controllers including, but not limited to, PID, state feedback, linear - quadratic (LQR), and / or adaptive controllers. Surgical instrument 700 can include a power source for converting a signal from the feedback controller into a physical input such as, for example, case voltage, PWM voltage, frequency - modulated voltage, current, torque, and / or force. Further details are disclosed in U.S. Patent Application No. 15 / 636,829, filed on June 29, 2017, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0206] Surgical instrument 700 may include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 1 - 14. Surgical instrument 700 may be a powered circular stapling instrument 201800 (FIGS. 24 - 30), 201502 (FIGS. 31 - 32), 201532 (FIGS. 34 - 35), 201610 (FIGS. 36 - 40).
[0207] FIG. 22 shows a block diagram of a surgical instrument 750 configured to control various functions. In one aspect, the surgical instrument 750 is programmed to control the distal translation of a displacement member such as a knife 764 or other suitable cutting element. The surgical instrument 750 includes an end effector 752 that may include an anvil 766, a knife 764 (including a sharp cutting edge), and a removable staple cartridge 768.
[0208] The position, movement, displacement, and / or translation of a linear displacement member such as the knife 764 can be measured by an absolute positioning system, sensor arrangement, and position sensor 784. Since the knife 764 is coupled to a longitudinally movable drive member, the position of the knife 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and / or translation of the knife 764 can be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of a displacement member such as the knife 764. In some embodiments, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for causing a processor or processors to execute instructions to control a displacement member, such as the knife 764, in the manner described. In one aspect, a timer / counter 781 provides an output signal, such as an elapsed time or digital count, to the control circuit 760 to correlate the position of the knife 764 determined by the position sensor 784 with the output of the timer / counter 781, such that the control circuit 760 can determine the position of the knife 764 at a particular time (t) relative to the starting position. The timer / counter 781 may be configured to measure an elapsed time, count external events, or measure the time of external events.
[0209] The control circuit 760 may generate a motor setpoint signal 772. The motor setpoint signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to drive the motor 754 by providing a motor drive signal 774 to the motor 754 as described herein. In some embodiments, 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 embodiments, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.
[0210] The motor 754 can 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 can be mechanically coupled to the knife 764 via a transmission device 756. The transmission device 756 may include one or more gears or other coupling components for coupling the motor 754 to the knife 764. In one aspect, the transmission device is coupled to a trocar actuator of a circular stapler to advance or retract the trocar. A position sensor 784 may sense the position of the knife 764, the trocar, or the anvil 766, or a combination thereof. The position sensor 784 may be, or may include, any type of sensor capable of generating position data indicative of the position of the knife 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the knife 764 translates distally and proximally. The control circuit 760 may track the pulses to determine the position of the knife 764. For example, other suitable position sensors, including proximity sensors, may be used. Other types of position sensors can provide other signals indicative of the movement of the knife 764. Also, in some embodiments, 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 knife 764 by summing the number and direction of steps instructed for the motor 754 to execute. The position sensor 784 can be located within the end effector 752 or any other part of the instrument.
[0211] In the implementation of the circular stapler, the transmission 756 elements may be connected to the trocar to advance or retract the trocar, connected to the knife 764 to advance or retract the knife 764, or connected to the anvil 766 to advance or retract the anvil 766. These functions may be implemented with a single motor using a suitable clutch mechanism, or, for example, as shown with reference to FIG. 21, may be implemented using separate motors. In one aspect, the transmission device 756 is part of a closed system including the trocar 201904 and the trocar actuator 201906, as will be discussed in more detail below with reference to FIGS. 29A-29C. Thus, the control circuit 760 controls the motor control circuit 758 to control the motor 754 to advance or retract the trocar. Similarly, the motor 754 may be configured to advance or retract the knife 764 and to advance or retract the anvil 766. A torque sensor may be provided to measure the torque applied by the shaft of the motor 754 to the transmission component 756 used to advance and retract the trocar, the knife 764, or the anvil 766, or a combination thereof. The position sensor 784 may include various sensors for tracking the position of the trocar, the knife 764, or the anvil 766, or any combination thereof. Other sensors 788 may be used to measure various parameters including the position or velocity of the trocar, the knife 764, or the anvil 766, or any combination thereof. The torque sensor, the position sensor 784, and the sensor 788 are coupled to the control circuit 760 as inputs to various processes for controlling the operation of the surgical instrument 750 in a desired manner.
[0212] The control circuit 760 can communicate with one or more sensors 788. The sensors 788 are positioned on the end effector 752 and can be 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 can include inductive sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, 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. In one aspect, the sensors 788 may be configured to determine the position of the trocar of a circular stapler.
[0213] One or more sensors 788 may include strain gauges such as micro strain gauges configured to measure the magnitude of strain in the anvil 766 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 788 may include pressure sensors configured to detect the pressure generated by the presence of tissue compressed between the anvil 766 and the staple cartridge 768. The sensors 788 may be configured to detect the impedance of a tissue portion located between the anvil 766 and the staple cartridge 768, and this impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0214] Sensor 788 may be configured to measure the force exerted on anvil 766 by a closure drive system. For example, one or more sensors 788 may be positioned at the point of interaction between the closure tube and anvil 766 to detect the closure force applied to anvil 766 by the closure tube. The force exerted on anvil 766 may represent the tissue compression experienced by the tissue portion captured between anvil 766 and staple cartridge 768. One or more sensors 788 may be positioned at various points of interaction along the closure drive system to detect the closure force applied to anvil 766 by the closure drive system. One or more sensors 788 may be sampled in real time by a processor of control circuit 760 during the clamping operation. Control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates in real time the closure force applied to anvil 766.
[0215] A current sensor 786 can be used to measure the current drawn by motor 754. The force required to advance knife 764 corresponds to the current drawn by motor 754. The force is converted into a digital signal and provided to control circuit 760.
[0216] Control circuit 760 may be configured to simulate the response of the actual system of the instrument with the controller software. The displacement member can be actuated to move knife 764 within end effector 752 at or near a target speed. Surgical instrument 750 can include a feedback controller, which can be one of any feedback controllers including, but not limited to, for example, PID, state feedback, LQR, and / or adaptive controllers. Surgical instrument 750 can include a power supply for converting the signal from the feedback controller into a physical input such as, for example, case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force.
[0217] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or knife 764 by a brushed DC motor with a gearbox and mechanical connections to the articulation and / or knife system. Another example is an electric motor 754 of a replaceable shaft assembly that operates, for example, a displacement member and an articulation driver. External influences are unmeasured and unpredictable influences such as tissue, the surrounding body, and friction on the physical system. Such external influences may be referred to as disturbances that act against the electric motor 754. External influences such as disturbances may cause the operation of the physical system to deviate from the desired operation of the physical system.
[0218] Various exemplary aspects are directed to a surgical instrument 750 having an end effector 752 with motor-driven surgical stapling and cutting means. For example, the motor 754 may drive a displacement member in a distal and proximal direction along the longitudinal axis of the end effector 752. The end effector 752 may include a pivotable anvil 766 and, when configured for use, a staple cartridge 768 disposed on the opposite side of the anvil 766. A clinician may grasp tissue between the anvil 766 and the staple cartridge 768 as described herein. When the instrument 750 is ready for use, the clinician may provide a firing signal, for example, by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member in a distal direction along the longitudinal axis of the end effector 752 from a proximal stroke start position to a stroke end position distal of the stroke start position. As the displacement member translates distally, a knife 764 having a cutting element positioned at its distal end can cut tissue between the staple cartridge 768 and the anvil 766.
[0219] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as knife 764, based on one or more tissue states. The control circuit 760 may be programmed to sense a tissue state, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a firing control program based on the tissue state. The firing control program may be capable of describing the distal movement of the displacement member. Various firing control programs may be selected to better handle various tissue states. For example, if 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. If thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a faster speed and / or with more power.
[0220] In some embodiments, the control circuit 760 may first operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's 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, for example, 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, and the like. 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 translational data describing the position of the displacement member to translate the displacement member at a constant speed. Further details are disclosed in U.S. Patent Application No. 15 / 720,852, filed September 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0221] The surgical instrument 750 may include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 1 to 14. The surgical instrument 750 may be a powered circular stapling instrument 201800 (FIGS. 24 to 30), 201502 (FIGS. 31 to 32), 201532 (FIGS. 34 to 35), 201610 (FIGS. 36 to 40).
[0222] FIG. 23 is a schematic diagram of a surgical instrument 790 configured to control various functions according to one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member such as a knife 764. The surgical instrument 790 may include an end effector 792 that includes an anvil 766, a knife 764, and a detachable staple cartridge 768 that can be exchanged with an RF cartridge 796 (shown in dashed lines).
[0223] Referring to FIGS. 21 to 23, in various aspects, the sensors 738, 788 may be implemented as, among other things, limit switches, electromechanical devices, solid-state switches, Hall effect devices, MR devices, GMR devices, magnetometers. In other implementations, the sensors 738, 788 may be, among other things, solid-state switches that operate under the influence of light such as optical sensors, IR sensors, ultraviolet sensors. Further, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensors 738, 788 may include, among other things, conductor-free switches, ultrasonic switches, accelerometers, and inertial sensors.
[0224] In one aspect, the position sensors 734, 784 may be implemented as an absolute positioning system comprising a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensors 734, 784, in association with the control circuit 760, can provide an absolute positioning system. The position is located above the magnet and may include a plurality of Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the border algorithm, which implements a concise and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, bit shifting, and table reference operations.
[0225] In one aspect, the knives 714, 764 may be implemented as knife members comprising a knife body operably supporting a tissue cutting blade thereon, and may further include an anvil engagement tab or feature and a channel engagement feature or foot. In one aspect, the staple cartridges 718, 768 may be implemented as standard (mechanical) surgical fastener cartridges, which may be linear staple cartridges or circular staple cartridges. In one aspect, the RF cartridge 796 (FIG. 23) may be implemented as an RF cartridge. These, and other sensor arrangements, are described in co-owned U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, titled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT", which is hereby incorporated by reference in its entirety.
[0226] The position, movement, displacement, and / or translation of a linear displacement member, such as a trocar, knife 714, 764, or anvil 716, 766, can be measured by an absolute positioning system, sensor arrangement, and position sensors 734, 784 represented as position sensors. Since the knives 714, 764 are connected to a longitudinally movable drive member, the position of the trocar, knife 714, 764, or anvil 716, 766 can be determined by measuring the position of the longitudinally movable drive member using the position sensors 734, 784. Thus, in the following description, the position, displacement, and / or translation of the knife 764, or anvil 716, 766 can be achieved by the position sensors 734, 784 described herein. The control circuits 710, 760 may be programmed to control the translation of displacement members, such as the knife 764, or anvil 716, 766, as described herein. In some embodiments, the control circuits 710, 760 may include one or more microcontrollers, microprocessors, or other suitable processors for causing a processor or processors to execute instructions to control displacement members, such as a trocar, knife 764, or anvil 716, 766, in the manner described. In one aspect, timers / counters 731, 781 provide output signals, such as elapsed time or digital count, to the control circuits 710, 760 to correlate the position of the trocar, knife 714, 764, or anvil 716, 766 determined by the position sensors 734, 784 with the output of the timers / counters 731, 781, such that the control circuits 710, 760 can determine the position of the trocar, knife 714, 764, or anvil 716, 766 at a particular time (t) relative to the starting position. The timers / counters 731, 781 can be configured to measure elapsed time, count external events, or measure the time of external events.
[0227] The control circuits 710, 760 may generate a motor setpoint signal 772. The motor setpoint signal 772 (for each motor when multiple motors are used) may be provided to the motor controllers 708a - e, 758. The motor controllers 708a - e, 758 may include one or more circuits configured to provide a motor drive signal 774 to the motors 704a - e, 754 to drive the motors 704a - e, 754, as described herein. In some embodiments, the motors 704a - e, 754 may be brushed DC power motors. For example, the speed of the motors 704a - e, 754 may be proportional to the motor drive signal 774. In some examples, the motors 704a - e, 754 may be brushless DC power motors, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motors 704a - e, 754. Also, in some embodiments, the motor controllers 708a - e, 758 may be omitted, and the control circuits 710, 760 may directly generate the motor drive signal 774.
[0228] Motors 704a - e, a battery, a supercapacitor, or any other suitable energy source. Motors 704a - e, 754 may be mechanically coupled to the trocar, knife 764, or anvils 716, 766 via transmission devices 706a - e, 756. Transmission devices 706a - e, 756 may include one or more gears or other coupling components for coupling motors 704a - e, 754 to the trocar, knife 764, or anvils 716, 766. Position sensors 734, 784 may sense the position of the trocar, knife 714, 764, or anvils 716, 766. Position sensors 734, 784 may be or include any type of sensor capable of generating position data indicating the position of the trocar, knife 764, or anvils 716, 766. In some examples, position sensors 734, 784 may include encoders configured to provide a series of pulses to control circuits 710, 760 as the trocar, knife 764, or anvils 716, 766 translate in the distal and proximal directions. Control circuits 710, 760 may track the pulses to determine the position of the trocar, knife 714, 764, or anvils 716, 766. For example, other suitable position sensors, including proximity sensors, may be used. Other types of position sensors may provide other signals indicative of the movement of the trocar, knife 764, or anvils 716, 766. Also, in some embodiments, position sensors 734, 784 may be omitted. If motors 704a - e, 754 are stepper motors, control circuits 710, 760 may track the position of the trocar, knife 714, 764, or anvils 716, 766 by totaling the number and direction of steps instructed for motors 704a - e, 754 to execute. Position sensors 734, 784 may be located within end effectors 702, 752, 792 or any other part of the instrument.
[0229] The control circuits 710, 760 can communicate with one or more sensors 738, 788. The sensors 738, 788 are positioned on the end effectors 702, 752, 792 and can be adapted to operate with the surgical instruments 700, 750, 790 to measure various derived parameters such as gap distance vs. time, tissue compression vs. time, and anvil strain vs. time. The sensors 738, 788 can include inductive sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effectors 702, 752, 792. The sensors 738, 788 can include one or more sensors.
[0230] One or more of the sensors 738, 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the anvils 716, 766 during the clamped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 738, 788 may include a pressure sensor configured to detect the pressure generated by the presence of tissue compressed between the anvils 716, 766 and the staple cartridges 718, 768. The sensors 738, 788 may be configured to detect the impedance of a tissue portion located between the anvils 716, 766 and the staple cartridges 718, 768, and this impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0231] Sensors 738, 788 can be configured to measure the forces exerted on anvils 716, 766 by a closure drive system. For example, one or more sensors 738, 788 can be at the interaction points between the closure tube and anvils 716, 766 to detect the closure force applied to anvils 716, 766 by the closure tube. The forces exerted on anvils 716, 766 can represent the tissue compression experienced by the tissue portion captured between anvils 716, 766 and staple cartridges 738, 768. One or more sensors 738, 788 can be positioned at various interaction points along the closure drive system to detect the closure force applied to anvils 716, 766 by the closure drive system. One or more sensors 738, 788 may be sampled in real time by the processor portions of control circuits 710, 760 during the clamping operation. Control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates in real time the closure force applied to anvils 716, 766.
[0232] Current sensors 736, 786 can be used to measure the current drawn by motors 704a - e, 754. The force required to advance the trocar, knife 714, 764, or anvils 716, 766 corresponds to the current drawn by motors 704a - e, 754. The force is converted into a digital signal and provided to control circuits 710, 760.
[0233] Referring to FIG. 23, RF energy source 794 is coupled to end effector 792 and is applied to RF cartridge 796 when RF cartridge 796 is loaded into end effector 792 in place of staple cartridge 768. Control circuit 760 controls the delivery of RF energy to RF cartridge 796.
[0234] Surgical instrument 790 may comprise a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 1-14. Surgical instrument 790 may be a powered circular stapling instrument 201800 (FIGS. 24-30), 201502 (FIGS. 31-32), 201532 (FIGS. 34-35), 201610 (FIGS. 36-40).
[0235] Further details are disclosed in U.S. Patent Application 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 hereby incorporated by reference in its entirety.
[0236] Powered Circular Stapling Surgical Instrument In some cases, it may be desirable to provide power control for a circular stapling instrument. The following examples only include illustrative versions of circular stapling instruments that can control both tissue clamping and cutting / stapling via a single rotational drive using a single motor. FIG. 24 shows an exemplary powered circular stapling instrument 201800. The instrument 201800 of this embodiment includes a stapling head assembly 201802, an anvil 201804, a shaft assembly 201806, a handle assembly 201808, and a rotary knob 201812. The stapling head assembly 201802 is selectively coupled to the anvil 201804. The stapling head assembly 201802 is operable to clamp tissue between the staple pocket and the staple forming pocket of the anvil 201804. The stapling head assembly 201802 includes a cylindrical knife operable to cut tissue captured between the stapling head assembly 201802 and the anvil 201804. The stapling head assembly 201802 drives staples through tissue captured between the stapling head assembly 201802 and the anvil 201804. The stapling instrument 201800 may be used to create a fixed anastomosis (e.g., end-to-end anastomosis) in a patient's gastrointestinal tract or other location. The outer tubular member 201810 is coupled to the actuator handle assembly 201808. The outer tubular member 201810 provides a mechanical ground between the stapling head assembly 201802 and the handle assembly 201808.
[0237] The staple head assembly 201802 is operable to clamp, cut, and staple tissue in response to a single rotational input communicated via the shaft assembly 201806. Thus, although the staple head assembly 201802 may include a translational clutch feature, a translational actuation input that linearly translates through the shaft assembly 201806 is not necessary for the staple head assembly 201802. Merely by way of example, at least a portion of the staple head assembly 201802 may be configured in accordance with at least some of the teachings of U.S. Patent Application No. 13 / 716,318, filed December 17, 2012, entitled "Motor Driven Rotary Input Circular Stapler with Modular End Effector," and U.S. Patent Publication No. 2014 / 0166728, published June 19, 2014, the disclosures of which are incorporated herein by reference. Other suitable configurations of the staple head assembly 201802 will be apparent to those skilled in the art in view of the teachings herein.
[0238] Shaft assembly 201806 couples handle assembly 201808 to staple head assembly 201802. Shaft assembly 201806 includes a single actuation feature, a rotary drive actuator 201814, as shown in FIG. 25. Drive actuator 201814 is operable to drive staple head assembly 201802 to clamp tissue, cut tissue, and staple tissue. Thus, linear actuation through shaft assembly 201806 is not necessary, but rotary drive actuator 201814 can translate longitudinally to shift between a tissue clamping mode and a tissue cutting / stapling mode. For example, drive actuator 201814 can translate from a first longitudinal position where rotation of drive actuator 201814 provides clamping of tissue in staple head assembly 201802 to a second longitudinal position where rotation of drive actuator 210814 provides cutting and stapling of tissue in staple head assembly 201802. Some versions of shaft assembly 201806 may include one or more flexible portions. Examples of shaft assemblies configured with flexible portions and incorporable into shaft assembly 201806 are disclosed in U.S. Patent Application No. 13 / 716,323, filed Dec. 17, 2012, entitled “Motor Driven Rotary Input Circular Stapler with Lockable Flexible Shaft,” and U.S. Patent Publication No. 2014 / 0166718, published Jun. 19, 2014, the disclosures of which are incorporated herein by reference. Alternatively, shaft assembly 201806 may be rigid along the length of shaft assembly 201806 or may have one or more flexible portions configured in some other manner.
[0239] The handle assembly 201808 is shown in FIGS. 25-27. The handle assembly 201808 includes a handle housing 201816, a motor housing 201818, a motor 201820, a battery 201822, a rotary knob 201812, and a firing ring 201826. The motor housing 201818 is positioned within the handle housing 201816. The handle housing 201816 includes ribs (201827, 201828, 201830, 201832) that extend inwardly into the handle housing 201816 to support the motor housing 201818 as shown in FIG. 26. The battery 201822 is positioned proximal to the motor 201820 within the motor housing 201818. The battery 201822 may be removed from the motor housing 201818 so that it can be replaced, discarded, or recharged. As best seen in FIG. 27, the battery 201822 includes electrical contacts 201834, 201836 that extend distally from the battery 201822. The motor 201820 includes electrical contacts 201838, 201840 that extend proximally from the motor 201820. The battery electrical contact 201836 and the motor electrical contact 201840 are connected via a conductive metal band 201842. A screw 201844 couples the band 201842 to the motor housing 201818 to secure the position of the band 201842 relative to the motor housing 201818. Thus, the band 201842 is configured to always connect the battery electrical contact 201836 and the motor electrical contact 201840.
[0240] As shown in FIG. 27, the battery electrical contact 201846 is connected to a conductive metal band 201848. The metal band 201848 is fixed to the motor housing 201818 via a conductive screw 201854. The motor electrical contact 201838 is connected to a conductive metal band 201852. The metal band 201852 is fixed to the motor housing 201818 via a conductive screw 201850. The motor housing 201818 is formed from an electrically insulating material (e.g., plastic) and includes annular contacts 201856, 201858 wound around the motor housing 201818. The screws 201850, 201854 are each connected to their respective annular contacts 201856, 201858 to electrically connect the battery electrical contact 201834 and the motor electrical contact 201838 to the annular contacts 201856, 201858, respectively.
[0241] Another conductive metal band 201860 is fixed to the handle housing 201816. Each end of the metal band 201860 forms respective spring contacts 201862, 201864. The motor housing 201818 translates proximally and / or distally relative to the handle housing 201816 to selectively connect and / or disconnect the spring contacts 201862, 201864 with the annular contacts 201856, 201858. Specifically, when the motor housing 201818 is in the distal position, the spring contact 201862 engages the annular contact 201856 and the spring contact 201864 engages the annular contact 201858 to connect the battery 201822 to the motor 201820 and supply power to the motor 201820. The spring contacts 201862, 201864 are part of the same conductive metal band 201860 and since the contacts 201836, 201840 are already connected via the band 201866, it should be understood that the engagement between the spring contacts 201862, 201864 and the annular contacts 201856, 201858 completes the circuit between the battery 201822 and the motor 201820. This positioning is used to provide the actuating action of the stapling head assembly 201802. When the motor housing 201818 is in the proximal position, the spring contacts 201862, 201864 are separated from the annular contacts 201856, 201858 so that the battery 201822 is separated from the motor 201820 and the motor 201820 does not receive power. This positioning is used to provide the manual actuating action of the stapling head assembly 201802. The annular shape of the annular contacts 201856, 201858 allows for proper contact between the spring contacts 201862, 201864 and the annular contacts 201856, 201858 regardless of the angular position of the motor housing 201818 within the handle housing 201816. In some versions, the band 201860 may include a break connected to an external switch so that the user can operate the external switch to complete the connection between the battery 201822 and the motor 201820 after the motor housing 201818 is in the distal position.
[0242] The proximal end of the motor housing 201818 is fixedly secured to the rotary knob 201812, as shown in FIG. 25. In one aspect, the rotary knob 201812 may be coupled to a motor to rotate the rotary knob 201812. The rotary knob 201812 projects proximally from the handle housing 201816 and includes a spline 201868 that extends distally from the rotary knob 201812. The handle housing 201816 includes corresponding teeth 201870 for selectively engaging the spline 201868. The rotary knob 201812 is pulled and / or pushed to translate the motor housing 201818 within the handle housing 201816. When the rotary knob 201812 is in the proximal position, the spline 201868 is disengaged from the handle housing 201816, such that the rotary knob 201812 and the motor housing 201818 are free to rotate relative to the handle housing 201816. This positioning is used to provide manual actuation of the staple head assembly 201802. When the rotary knob 201812 is in the distal position, the spline 201868 engages corresponding teeth 201870 within the handle housing 201816 to lock rotation of the rotary knob 201812 and the motor housing 201818 relative to the handle housing 201816. The spline 201868 and the teeth 201870 thus provide mechanical grounding for the motor housing 201818 relative to the handle housing 201816. This positioning is used to provide powered actuation of the staple head assembly 201802, as described in more detail below. The rotary knob 201812 is biased to the distal position by an elastic member 201872 within the handle housing 201816. Specifically, the elastic member 201872 extends distally from a rib 201828 of the handle housing 201816 to a first gear 201874, which is integrally fixed to the distal end of the motor housing 201818. When the rotary knob 201812 is in the proximal position, the elastic member 201872 compresses between the first gear 201874 and the rib 201828 to elastically bias the handle housing 201816 to the distal position.
[0243] The operation mode selection assembly is positioned distally of the motor housing 201818 within the handle housing 201816. As shown in FIGS. 28A-28B, the operation mode selection assembly includes a first gear 201874 and a second gear 201878, with the first gear 201874 coaxially and slidably disposed around the second gear 201878. The first gear 201874 includes square teeth aligned around the inner opening of the first gear 201874. The square teeth define an array of circumferentially spaced recesses. The second gear 201878 includes a shaft 201880, a spline 201876, and an annular flange 201882, as shown in FIGS. 28A-28B. The shaft 201880 has a distally presented opening. The distally presented opening is hexagonal and receives the proximal end 201896 of the driver actuator 201814, which is also hexagonal (FIG. 25). The shaft 201880 also has a proximally presented opening (not shown) that is semi-circular to complement and receive a drive shaft 201886 that extends distally from the motor 201820. Other suitable shapes and configurations of the shafts 201896, 201886 may be used to couple the second gear 201878 to the shafts 201896, 201886.
[0244] As shown in FIG. 28A, the spline 201876 of the second gear 201878 is positioned on the proximal end of the shaft 201880 and extends distally. The spline 201876 corresponds to the teeth of the first gear 201874, and thus the spline 201876 is configured to fit within the recesses defined between the teeth. A pair of annular flanges 201882 are positioned at the distal end of the shaft 201880 and extend outwardly to engage an annular rib 201884 that extends inwardly of the handle housing 201816, thereby fixing the longitudinal position of the second gear 201878 within the handle housing 201816. While the annular rib 201884 fixes the longitudinal position of the second gear 201878 within the handle housing 201816, the annular rib 201884 nevertheless allows the second gear 201878 to rotate relative to the handle housing 201816. Other suitable engagement features for fixing the second gear 201878 longitudinally will be apparent to those skilled in the art in view of the teachings herein.
[0245] As shown in FIGS. 28A-28B, the first gear 201874 is positioned around the second gear 201878. The first gear 201874 is fixedly coupled to the distal end of the motor housing 201818, such that the first gear 201874 translates and rotates integrally with the motor housing 201818. As shown in FIG. 28B, when the motor housing 201818 is in the proximal position, the motor 201820 and the first gear 201874 are also in the proximal position. In this position, the drive shaft 201886 of the motor 201820 is disengaged from the second gear 201878, and the teeth of the first gear 201874 engage the splines of the second gear 201878. Thus, when the rotary knob 201812 rotates, the motor housing 201818 and the first gear 201874 also rotate. This positioning provides for manual actuation of the staple head assembly 201802. Since the teeth of the first gear 201874 are engaged with the splines 201876, the rotary knob 201812 rotates the second gear 201878 relative to the motor housing 201818. As shown in FIG. 28A, when the motor housing 201818 is in the distal position, the motor 201820 and the first gear 201874 are also in the distal position. The motor 201820 is engaged with the second gear 201878 via shafts 201886, 201880. The first gear 201874 slides over the shaft 201880 of the second gear 201878 to disengage the splines 201876. Thus, rotation of the drive shaft 201886 of the motor 201820 rotates the second gear 201878. This positioning provides for powered actuation of the staple head assembly 201802. In other words, as shown in FIG. 28A, when the knob 201812 and the motor housing 201818 are in the distal position, the motor 201820 rotates the second gear 201878. As shown in FIG. 28B, when the knob 201812 and the motor housing 201818 are in the proximal position, the knob 201812 rotates the second gear 201878.
[0246] Returning to FIGS. 25-26 for reference, the distal end of the second gear 201878 is coupled to the driver actuator 201814, such that rotation of the second gear 201878 rotates the driver actuator 201814. Thus, when the second gear 201878 is rotated, the driver actuator 201814 is rotated to adjust the gap distance d between the anvil 201804 and the stapling head assembly 201802. The handle housing 201816 further includes a firing ring 201826 and a connecting member 201890. The connecting member 201890 is fixed around the recess 201892 of the driver actuator 201814 as shown in FIG. 25. Thus, the connecting member 201890 translates with the driver actuator 201814, but the driver actuator 201814 rotates freely within the connecting member 201890. The connecting member 201890 includes a protruding portion that extends outwardly to connect the connecting member 201890 to the firing ring 201826. The protruding portion of the connecting member 201890 extends through the slot 201894 of the housing assembly 201816 as shown in FIG. 25. The slot 201894 extends circumferentially around a portion of the handle assembly 201816. The firing ring 201826 is wrapped around the handle housing 201816 and is rotatable and translatable relative to the handle housing 201816 to manually drive the protruding portion of the connecting member 201890 through the slot 201894.
[0247] When the firing ring 201826 is in the distal position, the protrusion of the connecting member 201890 is positioned within the slot 201894 of the handle housing 201816. When the connecting member 201890 is positioned within the slot 201894, the connecting member 201890 couples the drive actuator 201814 to a feature within the staple head assembly 201802 that is operable to adjust the gap distance d between the anvil 201804 and the staple head assembly 201802. For example, when the connecting member 201890 rotates clockwise within the slot 201894, the gap distance d decreases to close the anvil 201804 relative to the staple head assembly 201802. When the connecting member 201890 rotates counterclockwise within the slot 201894, the gap distance d increases to open the anvil 201804 relative to the staple head assembly 201802. The elastic member 201888 is positioned proximal to the connecting member 201890 to bias the connecting member 201890 distally (FIG. 25). The connecting member 201890 of the firing ring 201826 can then be translated proximally through the slot. When the firing ring 201826 is in the proximal position, the protrusion of the connecting member 201890 is positioned within the slot. When the connecting member 201890 is positioned within the slot, the connecting member 201890 couples the drive actuator 201814 to a feature within the staple head assembly 201802 that drives the knife and staples in response to rotation of the drive actuator 201814. For example, when the connecting member 201890 rotates clockwise within the slot, the staple head assembly 201802 drives the knife and staples. The configuration of the slot prevents the connecting member 201890 from rotating counterclockwise. Other suitable connecting member 201890 rotation configurations will be apparent to those skilled in the art in view of the teachings herein.
[0248] As shown in FIG. 26, switch 201898 is positioned within handle housing 201816 and aligned with coupling member 201890. When the powered operation mode is selected, switch 201898 is configured to electrically connect motor 201820 and battery 201822 when switch 201898 is pressed, and switch 201898 is configured to electrically disconnect motor 201820 and battery 201822 when switch 201898 is not pressed. Coupling member 201890 is configured to engage and press switch 201898 when coupling member 201890 is rotated.
[0249] Referring next to FIGS. 29A-29C, in this embodiment, the instrument 201800 includes a closure system and a firing system. The closure system includes a trocar 201904, a trocar actuator 201906, and a rotation knob 201812 (FIG. 24). As previously discussed, the rotation knob 201812 may be coupled to a motor to rotate the rotation knob 201812 in a clockwise or counterclockwise direction. The anvil 201804 may be coupled to the distal end of the trocar 201904. The rotation knob 201812 translates the trocar 201904 longitudinally relative to the staple head assembly 201802, such that when the anvil 201804 is coupled to the trocar 201904, the anvil 201804 is translated to clamp tissue between the anvil 201804 and the staple head assembly 201804. The firing system includes a trigger, a trigger actuation assembly, a driver actuator 201908, and a staple driver 201910. The staple driver 201910 includes a cutting element such as a knife 201912 configured to cut tissue when the staple driver 201910 is actuated longitudinally. Additionally, staples 201902 are positioned distally of a plurality of staple driving members 201914 of the staple driver 201910, such that when the staple driver 201910 is actuated longitudinally, the staple driver 201910 also drives the staples 201902 distally. Thus, when the staple driver 201910 is actuated via the driver actuator 201908, the knife 201912 member 201914 cuts the tissue 201916 substantially simultaneously and drives the staples 201902 distally into the tissue relative to the staple head assembly 201802. Next, the components and functionality of the closure system and the firing system will be described in more detail.
[0250] As shown in FIGS. 29A-29C, anvil 201804 is selectively connectable to instrument 201800 to provide a surface against which staple 201902 can be bent to staple a substance housed between staple head assembly 201802 and anvil 201804. Anvil 201804 of the present embodiment is selectively connectable to a trocar or a distal pointed rod 201904 that extends distally with respect to staple head assembly 201802. Referring to FIGS. 29A-29C, anvil 201804 is selectively connectable via connection of the proximal shaft 201918 of anvil 201904 to the distal tip of trocar 201904. Anvil 201804 includes a generally circular anvil head 201920 and a proximal shaft 201918 that extends proximally from anvil head 201920. In the illustrated embodiment, proximal shaft 201918 includes a tubular member 201922 having an elastically biased retaining clip 201924 for selectively connecting anvil 201804 to trocar 201904, but this is merely optional, and it should be understood that other retaining features for connecting anvil 201804 to trocar 201904 may be used. For example, a C-clip, clamp, thread, pin, adhesive, etc. may be used to connect anvil 201804 to trocar 201904. Additionally, although anvil 201804 is described as being selectively connectable to trocar 201904, in some versions, proximal shaft 201918 may include a one-way connection feature, such that once anvil 201804 is attached, anvil 201804 cannot be removed from trocar 201904. Merely exemplary one-way features include, by way of example only, a one-way snap, collet, collar, tab, band, etc. Of course, still other configurations for connecting anvil 201804 to trocar 201904 will be apparent to those skilled in the art in view of the teachings herein. For example, trocar 201904 may alternatively be a hollow shaft, and proximal shaft 201918 may include a pointed rod insertable into this hollow shaft.
[0251] The anvil head 201920 of this embodiment includes a plurality of staple forming pockets 201936 formed in the proximal surface 201940 of the anvil head 201920. Thus, as shown in FIG. 29C, when the anvil 201804 is in the closed position and the staple 201902 is driven from the stapling head assembly 201802 into the staple forming pocket 201936, the legs 201938 of the staple 201902 are bent to form a completed staple.
[0252] It should be understood that in the case of the anvil 201804 as a separate component, the anvil 201804 may be inserted into and fixed to a portion of the tissue 201916 before being coupled to the stapling head assembly 201802. By way of example only, while the instrument 201800 is inserted into and fixed to the second tubular portion of the tissue 201916, the anvil 201804 may be inserted into and fixed to the first tubular portion of the tissue 201916. For example, the first tubular portion of the tissue 201916 may be sutured to or around a portion of the anvil 201804, and the second tubular portion of the tissue 201916 may be sutured to or around the trocar 201904.
[0253] As shown in FIG. 29A, the anvil 201804 is then coupled to the trocar 201904. The trocar 201904 of the present embodiment is shown in the most distal operative position. By coming to the position where the trocar 201904 extends in this way, a wider area where the tissue 201916 can be coupled can be provided before attaching the anvil 201804. In addition, by coming to the position where the trocar 20190400 extends, easier attachment of the anvil 201804 to the trocar 201904 can be provided. The trocar 201904 further includes a tapered distal tip. Such a tip can pierce the tissue and / or assist in the insertion of the anvil 201804 into the trocar 201904, but the tapered distal tip is merely optional. For example, in other versions, the trocar 201904 may have a blunt tip. Additionally, or alternatively, the trocar 201904 may include a magnetic portion (not shown) to which the anvil 201804 can be attached towards the trocar 201904. Of course, further configurations and arrangements for the anvil 201804 and the trocar 201904 will be apparent to those skilled in the art in view of the teachings of this specification.
[0254] When anvil 201804 is coupled to trocar 201904, the distance between the proximal face of anvil 201804 and the distal face of staple head assembly 201802 defines a gap distance d. Trocar 201904 of the present embodiment is longitudinally translatable relative to staple head assembly 201802 via adjustment knob 201812 (FIG. 24) positioned at the proximal end of actuator handle assembly 201808 (FIG. 24), as described in more detail below. Thus, when anvil 201804 is coupled to trocar 201904, the gap distance d is enlarged or reduced by rotation of adjustment knob 201812 by actuating anvil 201804 relative to staple head assembly 201802. For example, as shown successively in FIGS. 29A and 29B, anvil 201804 is shown to be actuated proximally relative to actuator handle assembly 201808 from an initial open position to a closed position, thereby shortening the gap distance d and the distance between the two portions of tissue 201916 to be joined. Once the gap distance d is within a predetermined range, staple head assembly 201802 is fired, as shown in FIG. 29C, and tissue 201916 between anvil 201804 and staple head assembly 201802 can be stapled and cut. Staple head assembly 201802 is operable to staple and cut tissue 201916 by actuation of a trigger of actuator handle assembly 201808, as described in more detail below.
[0255] Still referring to FIGS. 29A-29C, the user sutures a portion of the tissue 201916 around the tubular member 201944 such that the anvil head 201920 is positioned within a portion of the tissue 201916 to be stapled. When the tissue 201916 is attached to the anvil 201804, a retaining clip 201924 and a portion of the tubular member 201922 project outwardly from the tissue 201916 so that the user can connect the anvil 201804 to the trocar 201904. With the tissue 201916 connected to the trocar 201904 and / or another portion of the staple head assembly 201802, the user attaches the anvil 201804 to the trocar 201904 and actuates the anvil 201804 proximally toward the staple head assembly 201802 to reduce the gap distance d. Once the instrument 201800 is within the operating range, the user then staples the ends of the tissue 201916 together, thereby forming a substantially continuous tubular portion of the tissue 201916.
[0256] The staple head assembly 201802 of this embodiment is connected to the distal end of the shaft assembly 201806 and includes a slidable staple driver 201910 and a tubular casing 201926 that houses a plurality of staples 201902 included within a staple pocket 201928. The shaft assembly 201806 of this embodiment includes an outer tubular member 201942 and a driver actuator 201908. The staples 201902 and the staple pocket 201928 are arranged in a circular array around the tubular casing 201926. In this embodiment, the staples 201902 and the staple pocket 201928 are arranged in a pair of concentric annular rows consisting of the staples 201902 and the staple pocket 201928. The staple driver 201910 is operable to act longitudinally within the tubular casing 201926 in response to the rotation of the actuator handle assembly 201808 (FIG. 24). As shown in FIGS. 29A-29C, the staple driver 201910 includes a trocar opening 201930, a central recess 201932, and a plurality of members 201914 that are circumferentially arranged around the central recess 201932 and extend distally with respect to the shaft assembly 201806, and a flared cylindrical member. Each member 201914 is configured to contact and engage a corresponding one of the plurality of staples 201902 within the staple pocket 201928. Thus, when the staple driver 201910 moves distally with respect to the actuator handle assembly 201808, each member 201914 drives the corresponding staple 201902 from its staple pocket 201928 through a staple hole 201934 formed at the distal end of the tubular casing 201926. Since each member 201914 extends from the staple driver 201910, the plurality of staples 201902 are driven from the staple head assembly 201802 substantially simultaneously.When anvil 201804 is in the closed position, staple 201902 is driven into staple forming pocket 201936 to bend legs 201938 of staple 201902, thereby stapling material positioned between anvil 201804 and staple head assembly 201808. FIG. 30 shows staple 201902 driven by member 201914 into staple forming pocket 201928 of anvil 201804 to bend legs 201938 as an example.
[0257] Powered circular stapling instruments 201800, 201502, 201532, 201610 described herein with reference to FIGS. 24 - 30 may be controlled using any of the control circuits described in connection with FIGS. 16 - 23. For example, control system 470 described with reference to FIG. 16. Further, powered circular stapling instruments 201800, 201502, 201532, 201610 may be used in a hub and cloud environment as described in connection with FIGS. 1 - 15.
[0258] Circular stapler control algorithm In various aspects, the present disclosure provides a powered stapling device configured with a circular stapler control algorithm to adjust the force, forward speed, and overall stroke of a cutting member of the device based on at least one sensed parameter of firing or clamping. In another aspect, the cutting member of the device is operable independently from both firing and closing. In yet another aspect, the sensed parameter may be final inter - tissue gap, force during closing, tissue creep stabilization, or force during firing. In still another aspect, knife operation can be performed with either load control or stroke control having adjustable limits on control parameters. Both the maximum applicable force and the overall full stroke range can be adjusted. The controlled parameter may have secondary limits on non - control functions. In yet another aspect, the forward speed of the cutting member is adjustable to a predetermined speed based on the state of the device at the start of cutting.
[0259] Adjustment of cutting parameters In one aspect, a powered stapling device is configured to adjust the force, forward speed, and overall stroke of the cutting member of the device based on at least one sensed parameter of firing or clamping. In one aspect, the cutting member of the device is operable independently from both firing and closing. In another aspect, the sensed parameter includes the final inter-tissue gap, the force during closing, tissue creep stabilization, or the force during firing. In one aspect, knife actuation is configured to be performed with either load control or stroke control having adjustable limits on control parameters. For example, both the maximum applicable force and the overall full stroke range can be adjusted. The controlled parameter may have a secondary limit to a non-control function. In one aspect, the forward speed of the cutting member is adjustable to a predetermined speed based on the state of the device at the start of cutting.
[0260] Adjustment of closing speed or direction based on sensed attachment In various aspects, the closing speed or direction of the circular stapler, or a combination thereof, can be adjusted based on the sensed attachment relative to the fully attached state of the anvil. In one aspect, the present disclosure provides a digitally enabled circular stapler algorithm for determining a change in the closing speed of the anvil at a primary location of the trocar to ensure proper seating of the anvil on the trocar. FIG. 31 is a diagram 201500 of a powered stapling device 201502 and a graph 201504 showing the closing speed adjustment of the anvil 201514 portion of the powered stapling device 201502 at specific primary points along the retraction stroke of the trocar 201510, according to at least one aspect of the present disclosure. The powered stapling device 201502 is similar to the powered circular stapling instrument 201800 described herein with reference to FIGS. 24-30 and may be controlled using any of the control circuits described in connection with FIGS. 16-23 and may be used in a hub and cloud environment as described in connection with FIGS. 1-15. The anvil 201514 includes an anvil head 201515 and an anvil shank 201517. The trocar 201510 can be advanced and retracted in the direction indicated by arrow 201516. In one aspect, when the trocar 201510 is slightly but not fully attached to the anvil 201514, the closing speed of the anvil 210514 can be adjusted at specific primary points along the retraction stroke of the trocar 201510 to improve the final seating of the anvil 201514 on the trocar 201510.
[0261] The powered stapling device 201502 shown on the left side of FIG. 31 includes a circular stapling head assembly 201506 having a seating collar 201508 that receives a trocar 201510 therethrough. The trocar 201510 engages an anvil 201514 via a locking feature 201512. The trocar 210510 is movable in the direction indicated by arrow 201516 and, for example, advances and retracts. A cutting element, such as knife 201519, cuts tissue when the circular stapling head assembly 201506 is driven toward the anvil 201514. In one aspect, the closing speed of the anvil 201514 can be adjusted at specific key points along the retraction stroke of the anvil 201510 to improve the final seating of the anvil 201514 on the trocar 201510 when, for example, the trocar 210510 is slightly but not fully attached to the anvil 201514. Thus, the closing speed of the anvil 201514 can be varied at key locations to ensure proper seating. As described above with reference to FIGS. 24 - 30, the position or displacement of the trocar 210510 when advanced or retracted by a trocar actuator coupled to a motor may be detected by a plurality of proximity sensors disposed along the displacement path of the trocar 210510. In some aspects, the position or displacement of the trocar 210510 may be tracked using a tracking system 480 (FIG. 16) or position sensors 734, 784 (FIGS. 21, 23).
[0262] On the right side of FIG. 31, graph 201504 shows "δ trocar" along the vertical axis and "V" along the horizontal axis, according to at least one aspect of the present disclosure closureShows the closing speed of anvil 201514 as a function of the position of trocar 201510 at a particular key point labeled "mm / second". Anvil 201514 closing speed profile curve 201505 is plotted as a function of the position of trocar 201510. The closing speed of anvil 201514 is decelerated in a first zone 201518 to ensure proper attachment of trocar 210510 to anvil 201514, becomes faster in a second zone 201520 during closing, is decelerated again in a third zone 201522 to confirm the attachment, and can then be further decelerated in a fourth zone 201524 during application of a high closing load.
[0263] The closing speed adjustment of the anvil 201514 at specific key points along the retraction stroke of the trocar 201510 improves the final seating of the anvil 201514 on the trocar 201510 when the trocar is slightly but not fully attached. At the trocar 201510 position δ0, the anvil 201514 is in the fully open position 201521, and at the trocar 201510 position δ4, the anvil 201514 is in the fully closed position 201523. Between the fully open position 201521 δ0 and the fully closed position δ4 of the trocar 201510, the closing speed of the anvil 201514 is adjusted based on the position of the trocar 201510. For example, in a first zone 201518 where the trocar 201510 moves from the fully open position 201521 δ0 to a first trocar 201510 position δ1, the closing speed of the anvil 201514 is decelerated (0 to 2 mm / second) to ensure proper attachment of the anvil 201514 to the trocar 201510. When the trocar 201510 moves from δ1 to δ2, in a second zone 201520, the anvil 201514 is closed at a constant rapid closing speed (3 mm / second). When the trocar 201510 moves to the position of δ2 to δ3, in a third zone 201522, the closing speed of the anvil 201514 is decelerated to confirm full attachment of the anvil 201514 to the trocar 201510. Finally, when the trocar 201510 moves to the position of δ3 to δ4, in a fourth zone 201524, the closing speed of the anvil 201514 is decelerated again during high closing loads.
[0264] FIG. 32 is a cross-sectional view of the powered stapling device 201502 shown in FIG. 31 in a closed configuration, for example, with the circular stapling head assembly 201506 advancing toward the anvil 201514. As shown in FIG. 32, the circular stapling head assembly 201506 and the trocar 201510 are shown in an advanced configuration for grasping tissue within the tissue interstitial space 210511 defined between the anvil 201514 and the circular stapling head assembly 201506. As described herein, the trocar 201510 may be advanced or retracted, for example, by a motor coupled to a trocar actuator, as previously described with reference to FIGS. 24-30. The knife 201519 is used to cut tissue captured between the anvil 201514 and the trocar 201510. The knife 201519 is coupled to a motor configured to advance and retract the knife 201519. The control circuit is used to control the motor and to control the advance / retract speed of the trocar 201510 or the knife 201519 or a combination thereof.
[0265] FIG. 33 is a logical flow diagram of a process 201700 showing a control program or logical configuration for adjusting the closing speed of the anvil 201514 portion of the powered stapling device 201502 at specific key points along the retraction stroke of the trocar 201510, according to at least one aspect of the present disclosure. This process 201700 may be implemented in conjunction with any of the control circuits described with reference to FIGS. 16-23. This process 201700 may be implemented, for example, within a hub or cloud computing environment as described with reference to FIGS. 1-15.
[0266] Specifically, the process 201700 shown in FIG. 33 will be described with reference to the control circuit 760 of FIG. 22. The control circuit 760 determines 201702 the position of the trocar 201510 based on the information received from the position sensor 784. Alternatively, the position of the trocar 201510 may be determined based on the information received from the sensor 788 or the timer / counter 781 circuit or a combination thereof. Based on the position of the trocar 201510, the control circuit 760 determines the closing speed (V of the anvil 201514 as a function of the position of the trocar 201510 at a specific key point according to at least one aspect of the present disclosure. closurecontrols (mm / second). Thus, when the position of the trocar 201510 is within the first zone 201518 where the anvil 201514 is attached to the trocar 201510, the process 201700 continues along the yes (Y) branch, and the control circuit 760 sets the closing speed of the anvil 201514 to deceleration 201704 to ensure proper attachment of the trocar 210510 to the anvil 201514. Otherwise, the process 201700 continues along the no (N) branch. When the position of the trocar 201510 is within the second zone 201520, which is referred to as the rapid overall closing zone, the process 201700 continues along the yes (Y) branch, and the control circuit 760 sets the closing speed of the anvil 201514 to high speed 201706 to quickly close the anvil 201514. Otherwise, the process 201700 continues along the no (N) branch. When the position of the trocar 201510 is within the third zone 201522, which is referred to as the confirmation zone, the process continues along the yes (Y) branch, and the control circuit 760 sets the closing speed of the anvil 201514 to deceleration 201708 to confirm complete attachment of the anvil 201514 to the trocar 201510. Otherwise, the process 201700 continues along the no (N) branch. When the position of the trocar 201510 is within the fourth zone 201524, which is referred to as the high closing load zone, the process 201700 continues along the yes (Y) branch, and the control circuit 760 sets the closing speed of the anvil 201514 to a speed slower than the previous confirmation zone 201522 during the application of the high closing load 201710. When the anvil 201514 completely closes the trocar 201510 and captures the tissue therebetween, the control circuit 760 activates the knife 201519 to cut the tissue.
[0267] In one aspect, the present disclosure provides a digitally enabled circular stapler adaptation algorithm for determining multi-directional seating movement on a trocar and properly seating an anvil. FIG. 34 is a diagram 201530 of a powered stapling device 201532 and a graph 201534 showing detection of the closing speed of a trocar 201540 and an anvil 201544 according to at least one aspect of the present disclosure. The powered stapling device 201532 is similar to the powered circular stapling instrument 201800 described herein with reference to FIGS. 24-30 and may be controlled using any of the control circuits described in connection with FIGS. 16-23 and may be used in a hub and cloud environment as described in connection with FIGS. 1-15. The anvil 201544 includes an anvil head 201545 and an anvil shank 201547. The trocar 201540 can be advanced and retracted in the direction indicated by arrow 201546. In one aspect, if a loose tension from the trocar 201540 is detected on the anvil shank 201547, the powered stapling device 210530 may stop retracting or retract towards the open position 201541 or advance in the reverse direction until the seating instability of the anvil 201544 is resolved. If the anvil 201544 is completely disengaged, the powered stapling device 210530 can indicate to the user to attempt to reattach the anvil shank 201547 to the trocar 201540 and fully open 201541.
[0268] The powered stapling device 201532 shown on the left side of FIG. 34 includes a circular stapling head assembly 201536 having a seating collar 201538 that receives the trocar 201540 therethrough. The trocar 201540 engages the anvil 201544 via a locking feature 201542. The trocar 210540 is movable in the direction indicated by arrow 201546, e.g., advancing and retracting. A cutting element, such as knife 201548, cuts tissue when the circular stapling head assembly 201536 is driven towards the anvil 201544.
[0269] In one aspect, the closing speeds of the trocar 201540 and the anvil 201544 can be detected, and any discrepancy between the closing speeds of the two components can cause the trocar 201540 to automatically extend and then cause the trocar 201540 to retract in order to fully seat the anvil 201544 onto the trocar 201540. In one aspect, any discrepancy between the closing speeds of the trocar 201540 and the anvil 201544 is provided to a control circuit or a processor to operate a motor coupled to the trocar 201540 to cause the trocar 201540 to automatically extend and then retract again to fully seat the anvil 201544 onto the trocar 201540. If the anvil shank 201547 detects a loose pull from the trocar 201540, the smart power stapling device 201532 can be configured to stop retracting or, conversely, advance in the open direction until the instability in seating the anvil 201544 is resolved. When the anvil 201544 is fully disengaged, the user may be indicated to attempt to reattach the anvil shank 201547 to the trocar 201540 and may be fully opened. As shown in FIG. 34, if the detachment of the anvil 201544 is sensed before reconfirming the attachment of the anvil 201544, the control algorithm is configured to return the trocar 201540 toward the open position 201541 to reset the anvil 201544 and, when it is confirmed that the anvil 201544 is attached, can be processed as normal.
[0270] Accordingly, the system can be configured for multi-directional seating movement on the trocar 201540 to properly seat the anvil 201544. For example, if the anvil shank 201547 detects a loose pull from the trocar 201540, the smart power stapling device 201530 can be configured to stop retracting or, conversely, move forward in the open direction until the instability in seating the anvil 201544 is resolved. If the anvil 201544 is fully separated, the smart power stapling device 201532 can be configured to indicate to the user to attempt to reattach the anvil shank 201547 to the trocar 201540 and to fully open.
[0271] On the right side of FIG. 34, graph 201534 shows the position of trocar 201510 as a function of time at specific key points, labeled "δTrocar" along the vertical axis and "t" along the horizontal axis, according to at least one aspect of the present disclosure. Trocar 201540 position profile curve 201549 is plotted as a function of time (t). Referring to trocar 201540 position profile curve 201549, trocar 201540 moves from fully open position 201541 towards fully closed position 201543 over a first period 201556 at a rapid closing speed. During a second period 201558, trocar 201540 moves at a low speed to a confirmation zone 201547 where anvil lock feature 201542 engages seating collar 201538 to confirm proper engagement of anvil lock feature 201542 with seating collar 201538. In the illustrated embodiment, the start of detachment of anvil 201544 is sensed at time 201552. Upon sensing that anvil 201544 has been detached, trocar 201540 advances towards the open position and returns over a third period 201560. Trocar 201540 then moves slowly during a fourth period 201562 until it is determined or confirmed that anvil 201544 is attached to trocar 201540 at time 201554. Thereafter, trocar 201540 moves very slowly towards closed position 201543 under high tissue load before knife 201548 advances to cut tissue captured between anvil 201544 and circular staple head assembly 201536 during a fifth period 201564.
[0272] FIG. 35 is a logical flow diagram of a process 201720 showing a control program or logic configuration for detecting multi-directional seating movement on a trocar 201540 to drive an anvil 201544 to a proper seating, according to at least one aspect of the present disclosure. This process 201720 may be implemented using any control circuit described herein with reference to FIGS. 16-23. This process 201720 may be implemented, for example, within a hub or cloud computing environment described with reference to FIGS. 1-15.
[0273] Specifically, the process 201720 shown in FIG. 35 will be described with reference to the control circuit 760 of FIG. 22. The control circuit 760 determines 201722 the closing speed of the trocar 201540 based on the information received from the position sensor 784. The control circuit 760 then determines 201724 the closing speed of the anvil 201544 based on the information received from the position sensor 784. Alternatively, the closing speed of the trocar 201540 or the anvil 201544 may be determined based on the information received from the sensor 788 or the timer / counter 781 circuit or a combination thereof. The control circuit 760 compares 207126 the closing speeds of the trocar 201540 and the anvil 201544. If there is no discrepancy between the closing speeds of the trocar 201540 and the anvil 201544, the process 201720 continues along the no (N) branch and loops until there is a discrepancy between the closing speeds of the trocar 201540 and the anvil 201544. When there is a discrepancy between the closing speeds of the trocar 201540 and the anvil 201544, the process 201720 continues along the yes (Y) branch, and the control circuit 760 extends and retracts 207128 the trocar 201540 to reset the anvil 201544. Thereafter, the process 201720 checks 201130 the attachment of the trocar 201540 and the anvil 201544. If the attachment is confirmed, the process 201720 continues along the yes (Y) branch, and the control circuit 760 decelerates 207132 the closing speed of the trocar 201540 under tissue load. If the attachment is not confirmed, the process 201720 continues along the no (N) branch and loops until the attachment of the trocar 201540 to the anvil 201544 is confirmed. When the anvil 201544 is fully closed on the trocar 201540 and captures the tissue therebetween, the control circuit 760 activates the knife 201548 to cut the tissue.
[0274] Adjustment of Knife Speed / Endpoint Based on Tissue Parameters In various aspects, the circular stapler and knife speed of the endpoint can be adjusted based on the sensed toughness or thickness of the tissue between the anvil and the cartridge. Thus, the circular stapler control algorithm can be configured to detect tissue gap and firing force to adjust knife stroke and speed. In one aspect, the present disclosure provides a digitally enabled circular stapler adaptive algorithm for detecting tissue gap and firing force to adjust knife stroke and knife speed in accordance with at least one aspect of the present disclosure.
[0275] In general, FIGS. 36-38 illustrate a circular powered stapling device 201610, as well as an anvil 201612 (δ Anvil ) position and the clamp closure force (FTC) and knife 201616 (δ Knife ) position of the knife 201616 velocity (V K ) and Knife 201616 Force (F K 3A-3D depict a series of graphs illustrating the force vector of the anvil 201612, which is a tissue gap or reaction force vector. Using data sensed at different points along the length of the shank 201621, a control algorithm can generate a map of the tissue gap or reaction force vector of the anvil 201612 monitoring the high or low side as it is compressed on tissue. Upon firing, the system measures the force acting on the compression element 201620, which includes a force sensor, and adjusts it to act evenly along the force vector of the shank to provide an even and complete cut.
[0276] 36 is a partial schematic diagram of a circular powered stapling device 201610 showing an anvil 201612 closure on the left and an actuating knife 201616 on the right, in accordance with at least one embodiment of the present disclosure. A2 to fully closed position δ A0 The anvil 201612 is movable to the intermediate position δ A1represents the point where anvil 201612 contacts the tissue located between anvil 201612 and circular stapler 201614. One or more position sensors located along the length of anvil shank 201621 monitor the position of anvil 201612. In one aspect, the position sensor may be located within seating collar 201618. Compression element 201620 is in an intermediate position δ A1 As shown in A1 , to monitor the force applied to the tissue and detect the initial contact of anvil 201612 with the tissue, a force sensor such as a strain gauge may be provided, for example. The position sensor and the force sensor interface with any of the control circuits described herein with reference to FIGS. 16-23, which implement, for example, a circular stapler control algorithm. Circular powered stapling device 201610 is also in a fully retracted position δ A0 to a fully extended position δ A2 to achieve complete tissue cutting, and includes a movable cutting element such as knife 201616. The intermediate position δ A1 of knife 201616 represents the point where knife 201616 contacts compression element 201620, which is equipped with a strain gauge or other contact or proximity sensor.
[0277] Powered stapling device 201610 includes a motor, sensors, and a control circuit as described herein in connection with FIGS. 16-30. The motor is controlled by the control circuit to move anvil 201612 and knife 201616. One or more position sensors located on powered stapling device 201610 provide the positions of anvil 201612 and knife 201616 to the control circuit. Additional sensors such as force sensor 201620 also provide the tissue contact and force acting on anvil 201612 and knife 201616 to the control circuit. The control circuit uses the position of anvil 201612, the position of knife 201616, the initial tissue contact, or the force acting on anvil 201612 or knife 201616 to implement the circular stapler control algorithm described below in connection with FIG. 39.
[0278] Figure 37 is a graphical representation 201600 of anvil 201612 displacement (δ Anvil ) along the vertical axis as a function of the force (FTC) closing the clamp along the horizontal axis, according to at least one aspect of the present disclosure. The vertical line represents the FTC threshold 201606 indicating tissue toughness. To the left of the FTC threshold 201606 represents tissue with normal toughness, and to the right of the FTC threshold 201606 represents tissue with high toughness. When the anvil 201612 retreats from the fully open position δ A2 to the intermediate position δ A1 where the anvil 201612 first contacts the tissue, the FTC is substantially low (about 0). When the anvil 201612 continues to close towards the circular stapler 201614 beyond this point and subtracts the compressed tissue thickness from the fully retracted position δ A0 , the FTC is non-linear. Each tissue type from normal to high toughness will result in a different FTC curve. For example, the first FTC curve 201604 shown by the dashed line ranges from about 0 to about 100 lbs, and the maximum FTC is below the FTC threshold 201606. The second FTC curve 201602 shown by the solid line ranges from about 0 to about 200 lbs, and the maximum FTC exceeds the FTC threshold 201606. As previously discussed, the FTC is located within the compression element 201620 and is measured by a force sensor connected to the control circuit.
[0279] Figure 38 is a graphical representation 201630 of knife 201616 displacement (δ K ) along the vertical axis as a function of the speed (V K mm / sec) of the knife 201616 along the horizontal axis on the left side, and also as a function of the force (F Knife lbs) of the knife 201616 along the horizontal axis on the right side, according to at least one aspect of the present disclosure. On the left is a graphical representation 201632 of knife 201616 displacement (δ K ) along the vertical axis as a function of the speed (V Knife mm / sec) of the knife 201616 along the horizontal axis. On the right is a graphical representation of knife 201616 displacement (δ K ) along the vertical axis as a function of the force (F Knife) is the graphical representation 201634. The dashed lines 201638 and the curves 20142 in each of the graphical representations 201632 and 201634 represent a normal toughness tissue, and the solid lines 201636 and 201640 represent a tough tissue.
[0280] As shown by the normal tissue knife speed profile 201638, referring to the left graphical representation 201632 for normal tissue toughness, the initial speed of the knife 201616 for normal tissue toughness starts at, for example, just over 4 mm / sec at the initial knife position δ K0 At, for example, just over 4 mm / sec at the initial knife position δ. The knife 201616 continues at that speed until it reaches the knife position δ K1 Where the knife 201616 contacts the tissue, and the knife 201616 slows down as it cuts through the tissue until it reaches the knife position δ K2 Where the completion of the cut and the control circuit indicate to stop the motor and thus stop the knife 201616. As shown by the normal tissue knife force curve 201642, referring to the right graphical representation 201634 for normal tissue toughness, the force acting on the knife 201616 is 0 lbs at the initial knife position δ K0 And varies non-linearly until the knife 201616 reaches the knife position δ K2 Where the cut is completed.
[0281] As shown by the thick tissue knife speed profile 201636, referring to the left graphical representation 201632 for high tissue toughness, the initial speed of the knife 201616 for high tissue toughness starts at a second speed, for example, just over 3 mm / sec, which is lower than the first speed and less than the initial speed for normal tissue toughness at the initial knife position δ K0 At, and the knife 201616 continues until it reaches the knife position δ K1Continue at that speed until reaching. At this point, the speed of the knife 201616 begins to decelerate non-linearly when cutting tissue due to the short displacement of the knife 201616. The control circuit detects that the knife 201616 has contacted the tissue and, in response, indicates that the knife 201616 has completed cutting and the control circuit stops the motor, thus stopping the knife 201616 at position δ K2 Increase the speed of the motor to increase the speed of the knife 201616, for example, to the initial speed up to the knife 201616. This is shown as a speed spike 201644 to improve the cutting of tough tissue. Referring to the right graphical representation 201634 for high tissue toughness as shown by the thick tissue knife force curve 201640, the force acting on the knife 201616 is 0 lbs at the initial knife position δ K0 and changes non-linearly until the knife 201616 reaches the knife position δ K2 where cutting is completed. The comparison of the normal and high tissue knife force curves 201640, 201642 shows that by adding a speed spike 201644 immediately after tissue contact with the knife 201616 at a lower speed, the knife 201616 experiences a lower force when cutting tissue with higher toughness than when cutting tissue with normal toughness.
[0282] FIG. 39 is a logic flow diagram of a process 201720 showing a control program or logic configuration for detecting tissue gap and the force to be emitted to adjust the knife stroke and speed according to at least one aspect of the present disclosure. This process 201750 may be implemented in conjunction with any of the control circuits described with reference to FIGS. 16-23. This process 201750 may be implemented, for example, in a hub or cloud computing environment as described with reference to FIGS. 1-15.
[0283] Specifically, the process 201750 shown in FIG. 39 will be described with reference to the control circuit 760 of FIG. 22 and the circular powered stapling device 201610 shown in FIGS. 36 - 38. The control circuit 760 monitors 201752 the displacement of the anvil 201612 based on the position feedback received from the position sensor 784. As previously discussed, in one aspect, the position sensor 784 may be embedded in the shank 201612 of the anvil 201612. When the anvil 201612 is displaced, the control circuit 760 monitors 201754 the contact of the tissue positioned between the anvil 201612 and the circular stapler 201614 with the anvil 201612. In one aspect, the tissue contact may be provided by a force sensor embedded in the compression element 201620. The force sensor is represented as the sensor 788 element of the surgical instrument 790 shown in FIG. 22. The force sensor 788 is used to monitor 201756 the force to close the clamp (FTC), which is the closing force of the anvil 201612 on the tissue positioned between the anvil 201612 and the circular stapler 201614. The control circuit 760 compares 201758 the FTC with a predetermined threshold. When the FTC is below the predetermined threshold, the control circuit 760 sets the speed of the motor 754 to advance 201760 the knife 201616 using the normal tissue toughness speed profile 201638 as shown in FIG. 38. When the FTC exceeds the predetermined threshold, the control circuit 760 sets the speed of the motor 754 to advance 201762 the knife 201616 using the high tissue toughness speed profile 201636 with a speed spike 201644 as shown in FIG. 38.
[0284] FIG. 40 is a logical flow diagram of a process 201762 for advancing a knife 201616 under a high tissue toughness speed profile 201636 having a speed spike 201644 as shown in FIG. 38, according to at least one aspect of the present disclosure. This process 201762 may be implemented with any of the control circuits described with reference to FIGS. 16-23. This process 201750 may be implemented, for example, within a hub or cloud computing environment as described with reference to FIGS. 1-15.
[0285] Specifically, the process 201762 shown in FIG. 40 will be described with reference to the control circuit 760 of FIG. 22 and the circular powered stapling device 201610 shown in FIGS. 36-38. When high tissue toughness is detected, the control circuit 760 sets 201770 the initial speed of the knife 201616 to a lower knife speed relative to the knife speed used to cut normal tissue toughness. In one aspect, the slower knife speed in a state of high tissue toughness promotes a better cut. The control circuit 760 monitors 201772 when the knife 201616 contacts the tissue. As previously discussed, tissue contact may be detected by a force sensor embedded in the compression element 201620. As shown in FIG. 38, when the knife 201616 contacts the tissue, the knife 201616 naturally decelerates. Thus, when the control circuit 760 detects that the knife 201616 has contacted the tissue, tissue contact is detected, and the control circuit 760 increases 201774 the speed of the motor 754 to increase the speed of the knife 201616 that cuts the tissue. The control circuit 760 monitors 201776 the completion of the cut, maintains 201778 the speed of the motor 740 until the completion of the cut is detected, and then stops 201780 the motor 740.
[0286] Various aspects of the subject matter described herein are presented in the following numbered examples. Example 1. A surgical stapling instrument, comprising: an end effector configured to clamp tissue; a cutting member; a motor coupled to the cutting member, the motor being configured to move the cutting member between a first position and a second position; and a control circuit coupled to the motor, the control circuit being configured to sense a parameter associated with the clamping of the end effector and to control the motor to adjust the torque applied to the cutting member by the motor.
[0287] Example 2. The surgical stapling instrument according to Example 1, wherein the cutting member is operable independently of the end effector.
[0288] Example 3. The surgical stapling instrument according to any one of Examples 1 or 2, wherein the parameter includes an inter-tissue gap, a force during closing of the end effector, tissue creep stabilization, or a force during firing, or any combination thereof.
[0289] Example 4. The surgical stapling instrument according to any one of Examples 1 to 3, wherein the control circuit is configured to control the motor to drive the cutting member in either a load control mode or a stroke control mode according to an adjustable control parameter.
[0290] Example 5. The surgical stapling instrument according to any one of Examples 1 to 4, wherein the control circuit is configured to control the forward speed at which the motor drives the cutting member according to an initial state when the motor starts driving the cutting member from the first position.
[0291] Example 6. The surgical instrument according to any one of Examples 1 to 5, wherein the control circuit is configured to control the motor to adjust the speed at which the motor drives the cutting member.
[0292] Example 7. The surgical instrument according to any one of Examples 1 to 6, wherein the control circuit is configured to control the motor to adjust the distance by which the motor drives the cutting member according to a parameter.
[0293] Example 8. The surgical instrument according to any one of Examples 1 to 7, wherein the control circuit is configured to control the motor to adjust any combination of torque, speed, or distance.
[0294] Example 9. A surgical stapling instrument, comprising an end effector configured to clamp tissue, a cutting member, a motor coupled to the cutting member and configured to move the cutting member between a first position and a second position, and a control circuit coupled to the motor, the control circuit being configured to sense a parameter associated with the firing of the cutting member and to control the motor to adjust the torque applied to the cutting member by the motor.
[0295] Example 10. The surgical stapling instrument according to Example 9, wherein the cutting member is operable independently of the end effector.
[0296] Example 11. The surgical stapling instrument according to any one of Examples 9 or 10, wherein the parameter includes an inter-tissue gap, a force during closure of the end effector, tissue creep stabilization, or a force during firing, or any combination thereof.
[0297] Example 12. The surgical stapling instrument according to any one of Examples 9 to 11, wherein the control circuit is configured to control the motor to drive the cutting member in either a load control mode or a stroke control mode according to an adjustable control parameter.
[0298] Example 13. The surgical stapling instrument according to any one of Examples 9 to 12, wherein the control circuit is configured to control the forward speed at which the motor drives the cutting member according to the initial state when the motor starts driving the cutting member from the first position.
[0299] Example 14. The surgical instrument according to any one of Examples 9 to 13, wherein the control circuit is configured to control the motor to adjust the speed at which the motor drives the cutting member.
[0300] Example 15. The surgical instrument according to any one of Examples 9 to 14, wherein the control circuit is configured to control the motor to adjust the distance that the motor drives the cutting member according to a parameter.
[0301] Example 16. The surgical instrument according to any one of Examples 9 to 15, wherein the control circuit is configured to control the motor to adjust any combination of torque, speed, or distance.
[0302] Example 17. A powered stapling device, comprising a circular stapling head assembly, an anvil, a trocar connected to the anvil and connected to a motor, the trocar configured such that the motor advances and retracts the trocar, and a control circuit connected to the motor, the control circuit configured to determine the position of the trocar in one of a plurality of zones and set an anvil closing speed based on the determined position of the trocar.
[0303] Example 18. The powered stapling device according to Example 17, wherein the plurality of zones includes a first zone during attachment of the trocar to the anvil, a second zone during retraction of the trocar and closing of the anvil, a third zone during confirmation of attachment of the trocar to the anvil, and a fourth zone during application of a high closing load.
[0304] Example 19. The control circuit is configured to set the closing speed of the anvil to a first speed when the trocar is in a first zone to ensure proper attachment of the trocar to the anvil, set the closing speed of the anvil to a second speed greater than the first speed when the trocar is in a second position during retraction of the trocar and closing of the anvil, set the closing speed of the anvil to a third speed less than the second speed to confirm attachment of the trocar to the anvil, and set the closing speed of the anvil to a fourth speed less than the third speed when the trocar is in a fourth zone during application of a high closing load, a power stapling device according to any one of Examples 17 or 18.
[0305] Example 20. The control circuit is configured to determine the closing speed of the trocar, determine the closing speed of the anvil, compare the closing speed of the trocar and the closing speed of the anvil to determine the difference between the closing speed of the trocar and the closing speed of the anvil, and when the difference exceeds a predetermined value, extend and retract the trocar to reset the anvil, a power stapling device according to any one of Examples 17 to 19.
[0306] Example 21. The control circuit is configured to confirm attachment of the trocar to the anvil and decelerate the closing speed of the trocar during tissue loading, a power stapling device according to any one of Examples 17 to 20.
[0307] Example 22. The power stapling device further comprises a knife connected to the motor and a sensor positioned on the anvil, the sensor being configured to detect tissue contact and the force applied to the anvil, the sensor being connected to the anvil, and the control circuit being configured to monitor anvil displacement, monitor tissue contact with the anvil, monitor the force for closing the anvil, compare the force for closing with a predetermined threshold value, and when the force for closing is less than the predetermined threshold value, set a first initial knife speed and advance the knife with a first speed profile suitable for cutting normal tissue toughness, or when the force for closing is greater than or equal to the predetermined threshold value, set a second initial knife speed and advance the knife with a second speed profile suitable for cutting high tissue toughness, as described in any one of Examples 17 to 21.
[0308] Example 23. To advance the knife with the second speed profile, the control circuit is further configured to set the second initial knife speed to a speed less ...
Claims
1. A powered stapling device, comprising: a circular stapling head assembly; an anvil; a trocar coupled to the anvil and to a motor, the motor being configured to advance and retract the trocar; a control circuit coupled to the motor, the control circuit being configured to: determine the position of the trocar in one of a plurality of zones; and set a closing speed of the anvil based on the determined position of the trocar; wherein the plurality of zones include: a first zone during attachment of the trocar to the anvil; a second zone during retraction of the trocar and closing of the anvil; a third zone during verification of attachment of the trocar to the anvil; and a fourth zone during application of a high closing load; wherein the control circuit is configured to: set the closing speed of the anvil to a first speed when the trocar is in the first zone to ensure proper attachment of the trocar to the anvil; set the closing speed of the anvil to a second speed greater than the first speed when the trocar is in the second zone during retraction of the trocar and closing of the anvil; set the closing speed of the anvil to a third speed less than the second speed to verify attachment of the trocar to the anvil; and set the closing speed of the anvil to a fourth speed less than the third speed when the trocar is in the fourth zone during application of a high closing load.
2. A powered stapling device, comprising: a circular stapling head assembly; an anvil; a trocar coupled to the anvil and to a motor, the motor being configured to advance and retract the trocar; a control circuit coupled to the motor, the control circuit being configured to: determine the position of the trocar in one of a plurality of zones; and set a closing speed of the anvil based on the determined position of the trocar; wherein the control circuit is configured to: determine a closing speed of the trocar; Determining the closing speed of the anvil; Comparing the closing speed of the trocar with the closing speed of the anvil to determine the difference between the closing speed of the trocar and the closing speed of the anvil; When the difference is greater than a predetermined value, further configured to extend and retract the trocar and reset the anvil, a powered stapling device. **Claim 3**: A powered stapling device, A circular stapling head assembly; An anvil; A trocar connected to the anvil and connected to a motor, the motor being configured to advance and retract the trocar, the trocar; A control circuit connected to the motor, Determining the position of the trocar in one of a plurality of zones; Configured to set the closing speed of the anvil based on the determined position of the trocar, a control circuit, comprising: The control circuit is further configured to confirm the attachment of the trocar to the anvil and decelerate the closing speed of the trocar during tissue loading, a powered stapling device. **Claim 4**: A powered stapling device, A circular stapling head assembly; An anvil; A trocar connected to the anvil and connected to a motor, the motor being configured to advance and retract the trocar, the trocar; A control circuit connected to the motor, Determining the position of the trocar in one of a plurality of zones; Configured to set the closing speed of the anvil based on the determined position of the trocar, a control circuit, A knife connected to the motor; A sensor disposed on the anvil, comprising: The sensor is configured to detect tissue contact and the force applied to the anvil, the sensor is connected to the anvil, and the control circuit is Monitoring anvil displacement; Monitoring tissue contact with the anvil; Monitoring the force for closing the anvil; Comparing the force for closing with a predetermined threshold value; When the force for closing is less than the predetermined threshold, set a first initial knife speed and advance the knife with a first speed profile suitable for cutting normal tissue toughness, or When the force for closing is greater than or equal to the predetermined threshold, set a second initial knife speed and advance the knife with a second speed profile suitable for cutting high tissue toughness, and is further configured to perform the above, a powered stapling device. **Claim 5** To advance the knife with the second speed profile, the control circuit sets the second initial knife speed to a speed less than the first initial knife speed; monitors knife contact with the tissue; when tissue contact is detected, increases the motor speed to increase the knife speed; monitors completion of cutting; when completion of cutting is detected, further configured to stop the motor, the powered stapling device according to claim 4.
Citation Information
Patent Citations
electric surgical instrument
JP2009539420A