Use and technology analysis of surgeon / staff performance against baseline to optimize device utilization and performance for both current and future procedures
A computer system integrated with surgical devices and cameras analyzes surgeon and staff performance to optimize surgical procedures by comparing against baseline data, enhancing efficiency and adherence to optimal practices.
Patent Information
- Application Number
- JP2023215696
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-11-06
- Filing Date
- 2023-12-21
- Publication Date
- 2025-12-09
- Estimated Expiration
- 2038-11-14
AI Technical Summary
Existing surgical systems lack effective methods to optimize device utilization and performance by analyzing surgeon and staff performance against a baseline, leading to inefficiencies and potential deviations from optimal surgical procedures.
A computer system communicatively coupled to surgical devices and cameras that tracks physical characteristics of individuals, determines surgical contexts, and compares these characteristics to baseline data to identify deviations, enabling real-time adjustments and optimizations.
Enhances surgical efficiency by providing real-time feedback and adjustments to ensure adherence to optimal surgical practices, improving device performance and procedural outcomes.
Smart Images

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Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Nonprovisional Patent Application No. 16 / 182,255, filed November 6, 2018, entitled "USAGE AND TECHNIQUE ANALYSIS OF SURGEON / STAFF PERFORMANCE AGAINST A BASELINE TO OPTIMIZE DEVICE UTILIZATION AND PERFORMANCE FOR BOTH CURRENT AND FUTURE PROCEDURE," the entire disclosure of which is incorporated herein by reference.
[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 729,191, filed September 10, 2018, entitled "SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION," the disclosure of which is incorporated herein by reference in its entirety.
[0003] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 692,747, filed June 30, 2018, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE," U.S. Provisional Patent Application No. 62 / 692,748, filed June 30, 2018, entitled "SMART ENERGY ARCHITECTURE," and U.S. Provisional Patent Application No. 62 / 692,768, filed June 30, 2018, entitled "SMART ENERGY DEVICES," the disclosures of each of which are incorporated herein by reference in their entirety.
[0004] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," the disclosure of which is incorporated herein by reference in its entirety.
[0005] This application further relates to U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," U.S. Provisional Patent Application No. 62 / 650,887, filed March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," U.S. Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and U.S. Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND INTERACTIVE SURGICAL PLATFORM," the disclosures of each of which are incorporated herein by reference in their entirety under 35 U.S.C. §119(e). This application claims priority to U.S. Provisional Patent Application No. 62 / 650,877, filed March 30, 2018, entitled "CONTROLS."
[0006] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and U.S. Provisional Patent Application No. 62 / 640,415, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR," the disclosures of each of which are incorporated herein by reference in their entirety.
[0007] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017; and U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety. [Background technology]
[0008] The present disclosure relates to various surgical systems. Surgical procedures are typically performed in an operating room or room within a medical facility, such as a hospital. A sterile field is typically formed around the patient. The sterile field may include cleansed team members wearing appropriate clothing, as well as all equipment and fixtures within the area. Various surgical devices and systems are utilized in performing the surgical procedure. Summary of the Invention [Means for solving the problem]
[0009] In one general aspect, a computer system is configured to be communicatively coupled to a surgical device and a camera, the computer system comprising a processor and a memory coupled to the processor, the memory storing instructions that, when executed by the processor, cause the computer system to receive pre- and post-operative data from the surgical device, determine a surgical context based at least in part on the pre- and post-operative data, receive images of an individual via the camera, determine physical characteristics of the individual from the images, obtain baseline physical characteristics corresponding to the surgical context, and determine whether the physical characteristics of the individual deviate from the baseline physical characteristics.
[0010] In another general aspect, there is a computer-implemented method for tracking physical characteristics of an individual, the method including: receiving, by a computer system, pre- and post-operative data from a surgical device; determining, by the computer system, a surgical context based at least in part on the pre- and post-operative data; receiving, by the computer system, images of the individual via a camera communicatively coupled to the computer system; determining, by the computer system, physical characteristics of the individual from the images; obtaining, by the computer system, baseline physical characteristics corresponding to the surgical context; and determining, by the computer system, whether the physical characteristics of the individual deviate from the baseline physical characteristics.
[0011] In yet another general aspect, a computer system is configured to be communicatively coupled to a surgical device and a camera, the computer system comprising: a processor; and a memory coupled to the processor. The memory stores instructions, when executed by the processor, that cause the computer system to receive pre- and post-operative data from the surgical device, determine a surgical context based at least in part on the pre- and post-operative data, receive images of the individual via the camera, determine physical characteristics of the individual from the images, transmit data identifying the physical characteristics and the surgical context to a remote computer system, the remote computer system determining baseline physical characteristics corresponding to the surgical context and the physical characteristics responsive to data aggregated from multiple computer systems coupled to the remote computer system, and receive from the remote computer system whether the physical characteristics of the individual deviate from the baseline physical characteristics. [Brief explanation of the drawings]
[0012] The various aspects described herein, both as to organization and method of operation, together with further objects and advantages thereof, can best be understood by reference to the following description taken in conjunction with the accompanying drawings in which: [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 2] 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. [Figure 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. [Figure 4] FIG. 12 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, according to at least one aspect of the present disclosure. [Figure 5] FIG. 1 is a perspective view of a combination generator module including bipolar, ultrasonic, and monopolar contacts and smoke evacuation components according to at least one embodiment of the present disclosure. [Figure 6] 10 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a vertical modular housing configured to receive multiple modules, according to at least one embodiment of the present disclosure. [Figure 8] 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. [Figure 9] 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates a surgical hub with multiple modules connected to a modular control tower, according to at least one embodiment of the present disclosure. [Figure 11]1 illustrates one embodiment of a Universal Serial Bus (USB) network hub device in accordance with at least one embodiment of the present disclosure. [Figure 12] FIG. 1 is a block diagram of a cloud computing system comprising a plurality of smart surgical instruments connected to a surgical hub that can connect to a cloud component of the cloud computing system in accordance with at least one aspect of the present disclosure. [Figure 13] 1 is a functional module architecture of a cloud computing system in accordance with at least one aspect of the present disclosure. [Figure 14] 1 shows a diagram of a context-aware surgical system according to at least one aspect of the present disclosure. [Figure 15] 10 is a timeline illustrating situational awareness of a surgical hub, according to at least one aspect of the present disclosure. [Figure 16] FIG. 1 is a diagram of an operating room (OR) setting, according to at least one embodiment of the present disclosure. [Figure 17] FIG. 10 is a logic flow diagram of a process for visually assessing surgical staff members in accordance with at least one aspect of the present disclosure. [Figure 18] 1A-1C illustrate a series of models of surgical staff members during the course of a surgical procedure, in accordance with at least one aspect of the present disclosure. [Figure 19] 19 is a graph illustrating measured postures of the surgical staff member shown in FIG. 18 over time, in accordance with at least one embodiment of the present disclosure. [Figure 20] 1 is a depiction of a surgeon holding a surgical instrument, according to at least one embodiment of the present disclosure. [Figure 21] 10 is a scatter plot of wrist angle versus surgical outcome, in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0013] The applicant of this application owns the following U.S. patent applications, filed November 6, 2018, the disclosures of which are incorporated herein by reference in their 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 / 182,269, entitled "Image Capturing of the Areas Outside the Abdomen to Improve Placement and Control of a Surgical Device in Use"; U.S. patent application Ser. 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 / 182,240, entitled "POWERED STAPLING DEVICE CONFIGURED TO ADJUST FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER BASED ON SENSED PARAMETER OF FIRING OR CLAMPING"; 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 this application owns the following U.S. patent applications, filed September 10, 2018, the disclosures of which are incorporated herein by reference in their 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 this application owns the following U.S. patent applications, filed August 28, 2018, the disclosures of each of which are incorporated herein by reference in their 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 a Pad-Lless 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 this application owns the following U.S. patent applications, filed August 23, 2018, the disclosures of which are incorporated herein by reference in their 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 this application owns the following U.S. patent applications, filed June 30, 2018, the disclosures of which are incorporated herein by reference in their entirety: · 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 this application owns the following U.S. patent applications, filed June 29, 2018, the disclosures of which are incorporated herein by reference in their entirety: 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 this application owns the following U.S. provisional patent applications, filed June 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES"; U.S. Provisional Patent Application No. 62 / 691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS"; · U.S. Provisional Patent Application No. 62 / 691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; · U.S. Provisional Patent Application No. 62 / 691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL"; U.S. Provisional Patent Application No. 62 / 691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and · U.S. Provisional Patent Application No. 62 / 691,251, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS."
[0020] The applicant of this application owns the following U.S. provisional patent applications, filed April 19, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 659,900, entitled "METHOD OF HUB COMMUNICATION."
[0021] The applicant of this application owns the following U.S. provisional patent applications, filed March 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS"; · U.S. Provisional Patent Application No. 62 / 650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES"; U.S. Provisional Patent Application No. 62 / 650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and · U.S. Provisional Patent Application No. 62 / 650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS."
[0022] The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of which are incorporated herein by reference in their 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 MACILITY 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 this application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; · U.S. Provisional Patent Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; · U.S. Provisional Patent Application No. 62 / 649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS"; · U.S. Provisional Patent Application No. 62 / 649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"; · U.S. Provisional Patent Application No. 62 / 649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS"; U.S. Provisional Patent Application No. 62 / 649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT"; · U.S. Provisional Patent Application No. 62 / 649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; U.S. Provisional Patent Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; U.S. Provisional Patent Application No. 62 / 649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; · U.S. Provisional Patent Application No. 62 / 649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; U.S. Provisional Patent Application No. 62 / 649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES"; · U.S. Provisional Patent Application No. 62 / 649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Provisional Patent Application No. 62 / 649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and · U.S. Provisional Patent Application No. 62 / 649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS."
[0024] The applicant of this application owns the following U.S. provisional patent applications, filed March 8, 2018, the disclosures of which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 62 / 640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and · U.S. Provisional Patent Application No. 62 / 640,415, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR."
[0025] The applicant of this application owns the following U.S. provisional patent applications, filed December 28, 2017, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. U.S. Provisional Patent Application No. 62 / 611,341 entitled "INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," and · U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM."
[0026] Before describing various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied in or incorporated into other aspects, variations, and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise specified, the terms and phrases used herein have been chosen for the convenience of the reader for the purpose of describing the illustrative embodiments, and not for the purpose of limiting them. Furthermore, it should be understood that one or more of the aspects, embodiment(s), and / or embodiments described below can be combined with any one or more of the other aspects, embodiment(s), and / or embodiments described below.
[0027] Surgical Hub 1 , a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 connected to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one embodiment, as shown in FIG. 1 , the surgical systems 102 include a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and / or with the hub 106. In some aspects, the surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to 1.
[0028] FIG. 2 illustrates an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in a surgical suite 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 during minimally invasive incisions in the patient's body while the surgeon views the surgical site via the surgeon's console 118. Images of the surgical site can be acquired by a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
[0029] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.
[0030] Various examples of cloud-based analytics performed by the cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.
[0031] In various embodiments, the image capture device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.
[0032] The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.
[0033] The one or more illumination sources can be configured to emit electromagnetic energy within the visible and invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminescence spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., can be detected by) the human eye and is sometimes referred to as visible light, or simply light. The typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.
[0034] The invisible spectrum (i.e., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum cannot be detected by the human eye. Wavelengths above about 750 nm are longer than the red visible spectrum and constitute invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum and constitute invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.
[0035] In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.
[0036] In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths of light, including frequencies beyond the visible light range, e.g., IR and UV light. Spectral imaging can enable the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is described in detail in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring can be a useful tool for repositioning the surgical field after a surgical procedure is completed to perform one or more of the above-mentioned tests on the treated tissue.
[0037] It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical equipment. The strict hygiene and sterilization conditions required in the "surgical theater," i.e., operating room or procedure room, require the utmost sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field can be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field can be considered the area immediately surrounding the patient who has been prepared for the surgical procedure. The sterile field can include cleaned team members in appropriate clothing, as well as all supplies and fixtures within the area.
[0038] In various embodiments, visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIGURE 2. In one embodiment, visualization system 108 includes HL7, PACS, and EMR interfaces. The various components of visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.
[0039] As shown in FIG. 2 , primary display 119 is positioned within the sterile field so as to be visible to the operator of operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 includes first non-sterile display 107 and second non-sterile display 109 facing away from each other. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 can cause visualization system 108 to maintain a live video of the surgical site on primary display 119 while displaying snapshots of the surgical site captured by imager 124 on non-sterile displays 107 or 109. The snapshots on non-sterile displays 107 or 109 can, for example, enable the non-sterile operator to perform diagnostic steps related to the surgical procedure.
[0040] In one aspect, the hub 106 is also configured to send diagnostic input or feedback entered by a non-sterile operator located in the sterile field at the visualization tower 111 to the primary display 119 in the sterile field for viewing by the sterile operator at the operating table. In one example, the input may be in the form of a correction to a snapshot displayed on the non-sterile display 107 or 109 that can be sent by the hub 106 to the primary display 119.
[0041] 2 , a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 is also configured to coordinate information flow to the display of the surgical instrument 112. Coordinated information flow is further described in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 may be sent by the hub 106 to the surgical instrument display 115 within the sterile field, where the diagnostic input or feedback may be viewed by the operator of the surgical instrument 112. Examples of exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the section entitled "Surgical Instrument Hardware" and in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the disclosure of which is incorporated herein by reference in its entirety.
[0042] 3, hub 106 is shown in communication with visualization system 108, robotic system 110, and handheld intelligent surgical instrument 112. Hub 106 includes a hub display 135, an imaging module 138, a generator module 140 (which may include a monopolar generator 142, a bipolar generator 144, and / or an ultrasonic generator 143), a communications module 130, a processor module 132, and a storage array 134. In certain embodiments, as shown in FIG. 3, hub 106 further includes a smoke evacuation module 126, a suction / irrigation module 128, and / or an OR mapping module 133.
[0043] During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly accompanied by smoke evacuation, aspiration of excess fluid, and / or irrigation of the tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular housing 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line tangling.
[0044] Aspects of the present disclosure present a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module further includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
[0045] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received within the hub housing. In one aspect, the hub housing comprises a fluid interface.
[0046] Certain surgical procedures may require the application of more than one energy type to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular housing 136 is configured to house different generators and facilitate bidirectional communication between them. One advantage of the hub's modular housing 136 is that it allows for quick removal and / or replacement of various modules.
[0047] Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving the application of energy to tissue, the modular surgical housing including a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including first data and power contacts, the first energy generator module slidably movable into electrical engagement with the power and data contacts and the first energy generator module slidably movable out of electrical engagement with the first power and data contacts.
[0048] Further to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts and the second energy generator module is slidably movable out of electrical engagement with the second power and data contacts.
[0049] Additionally, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.
[0050] 3-7, aspects of the present disclosure are presented relating to a hub modular housing 136 that allows for modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The hub modular housing 136 further facilitates bidirectional communication between the modules 140, 126, and 128. As shown in FIG. 5, the generator module 140 may be a generator module that includes integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 that is slidably insertable into the hub modular housing 136. As shown in FIG. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular housing 136. The hub modular housing 136 may be configured to facilitate the insertion of multiple generators and bidirectional communication between the generators docked to the hub modular housing 136 so that the multiple generators function as a single generator.
[0051] In one aspect, the hub's modular housing 136 includes a modular power and communication backplane 149 with external and wireless communication headers to allow removable attachment of the modules 140, 126, 128 and bidirectional communication therebetween.
[0052] In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. Figure 4 shows a partial perspective view of the surgical hub housing 136 and a combination generator module 145 slidably receiveable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combination generator module 145 is configured to engage the corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into position within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic, and monopolar modules and a smoke evacuation module integrated together with a single housing unit 139, as shown in Figure 5.
[0053] In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured / collected smoke and / or fluid away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw the smoke into openings in utility conduits at the surgical site. Utility conduits connected to the fluid lines may be in the form of flexible tubing that terminates at the smoke evacuation module 126. The utility conduits and fluid lines define a fluid pathway that extends toward the smoke evacuation module 126, which is received within the hub housing 136.
[0054] In various aspects, the aspiration / irrigation module 128 is coupled to a surgical tool that includes aspiration and suction fluid lines. In one embodiment, the aspiration and suction fluid lines are in the form of flexible tubing that extends from the surgical site toward the aspiration / irrigation module 128. One or more drive systems can be configured to drive the irrigation and suction of fluids to and from the surgical site.
[0055] In one aspect, the 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 the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and have an inlet port proximate to the energy delivery instrument. The energy delivery instrument is configured to deliver ultrasonic and / or RF energy to the surgical site and is initially connected to the generator module 140 by a cable extending through the shaft.
[0056] The irrigation tubing can be in fluid communication with a fluid source, and the suction tubing can be in fluid communication with a vacuum source. The fluid source and / or vacuum source can be housed within aspiration / irrigation module 128. In one example, the fluid source and / or vacuum source can be housed within hub housing 136 separate from aspiration / irrigation module 128. In such an example, a fluid interface can be configured to connect aspiration / irrigation module 128 to the fluid source and / or vacuum source.
[0057] In one aspect, the modules 140, 126, 128 and / or their corresponding docking stations on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules into engagement with their counterparts in the docking stations of the hub modular housing 136. For example, as shown in FIG. 4 , the combination generator module 145 includes side brackets 155 configured to slidably engage with corresponding brackets 156 of the corresponding docking stations 151 of the hub modular housing 136. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136.
[0058] In some embodiments, the drawers 151 of the hub's modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In other embodiments, the drawers 151 are different sizes, each designed to accommodate a particular module.
[0059] Additionally, to prevent inserting a module into a drawer with incompatible contacts, the contacts on a particular module may be keyed to engage with the contacts on a particular drawer.
[0060] 4, the docking port 150 of one drawer 151 can be connected to the docking port 150 of another drawer 151 via a communication link 157 to facilitate two-way communication between modules housed within the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 can facilitate wireless two-way communication between modules housed within the hub modular housing 136. Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.
[0061] FIG. 6 illustrates individual power bus attachments of multiple lateral docking ports of lateral modular housing 160 configured to receive multiple modules of surgical hub 206. Lateral modular housing 160 is configured to laterally receive and interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of lateral modular housing 160, which include a backplane for interconnecting modules 161. As shown in FIG. 6, modules 161 are arranged laterally within lateral modular housing 160. Alternatively, modules 161 may be arranged vertically within lateral modular housing.
[0062] FIG. 7 illustrates a vertical modular housing 164 configured to receive multiple 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, which includes a backplane for interconnecting the modules 165. While the drawer 167 of the vertical modular housing 164 is vertically oriented, in certain cases the vertical modular housing 164 may include a horizontally oriented drawer. Additionally, the modules 165 may interact with each other via docking ports in the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the modules 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses multiple sub-modules that are slidably received within the master module 178.
[0063] In various aspects, the imaging module 138 includes a built-in video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is configured with a modular housing that can be assembled with a light source module and a camera module. The housing may be a disposable housing. In at least one embodiment, the disposable housing is removably coupled to a reusable controller, light source module, and camera module. The light source module and / or camera module can be selectively selected depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for imaging of a scanned beam. Similarly, the light source module can be configured to deliver white light or a different light depending on the surgical procedure.
[0064] During a surgical procedure, it can be inefficient to remove a surgical device from the surgical field and replace it with another surgical device containing a different camera or a different light source. Temporarily losing view of the surgical field can have undesirable consequences. The modular imaging device of the present disclosure is configured to allow for replacement of a light source module or camera module midstream during a surgical procedure without having to remove the imaging device from the surgical field.
[0065] In one aspect, the imaging device comprises a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module that can be configured for snap-fit engagement with the first channel. A second channel is configured to slidably receive a light source module that can be configured for snap-fit engagement with the second channel. In another embodiment, the camera module and / or the light source module can be rotated to a final position within their corresponding channels. A threaded engagement can be employed instead of a snap-fit engagement.
[0066] In various embodiments, multiple imaging devices are positioned at different locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between the imaging devices to provide the optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from the different imaging devices.
[0067] 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 incorporated herein by reference in its entirety. Additionally, U.S. Patent No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems may be integrated with imaging module 138. Additionally, U.S. Patent Application Publication No. 2011 / 0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS," and U.S. Patent Application Publication No. 2014 / 0243597, published August 28, 2014, entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE," each of which is incorporated herein by reference in its entirety.
[0068] FIG. 8 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms in a medical facility, or any room within a medical facility equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 connected to storage device 205). In one embodiment, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can further connect to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a data connector, allowing data to be transmitted from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes additional functionality, configuring each port in the network hub 207 or network switch 209 to allow traffic to pass through the monitored surgical data network. An intelligent surgical data network can be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0069] Modular devices 1a-1n located in an operating room can be connected to a modular communication hub 203. A network hub 207 and / or a network switch 209 can be connected to a network router 211 to connect the devices 1a-1n to the cloud 204 or a local computer system 210. Data associated with the devices 1a-1n can be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with the devices 1a-1n can also be transferred to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room can also be connected to the network switch 209. The network switch 209 can be connected to the network hub 207 and / or a network router 211 to connect the devices 2a-2m to the cloud 204. Data associated with the devices 2a-2n can be transferred to the cloud 204 via the network router 211 for data processing and manipulation. Data associated with the devices 2a-2m can also be transferred to the local computer system 210 for local data processing and manipulation.
[0070] It will be appreciated that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. The modular communications hub 203 can be housed within a modular control tower configured to receive multiple devices 1a-1n / 2a-2m. A local computer system 210 can also be housed in the modular control tower. The modular communications hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various embodiments, devices 1a-1n / 2a-2m may include various modules such as, for example, an imaging module 138 connected to an endoscope, a generator module 140 connected to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communications module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and / or a non-contact sensor module, among other modular devices that may be connected to a modular communications hub 203 of a surgical data network 201.
[0071] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m 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 manipulation. It will be understood that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" can be used as a metaphor for the "Internet," the term is not so limited. Thus, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing." In this case, various services, such as servers, storage, and applications, are delivered to a modular communications hub 203 and / or computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and further via the Internet to devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure can be maintained by a cloud service provider. In this regard, the cloud service provider can be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. The cloud computing service can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0072] By applying cloud computer data processing technology to data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. Using cloud-based computing, at least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of bodily tissue samples, to identify pathologies, such as the effects of disease. This includes tissue and phenotypic localization and margin confirmation. At least some of the devices 1a-1n / 2a-2m can be used to identify bodily anatomical structures using various sensors integrated with the imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n / 2a-2m, including image data, can be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve the outcome of the surgical procedure by determining whether further treatments can be performed, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and using a standardized approach can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.
[0073] In one implementation, operating room devices 1a-1n may connect to modular communications hub 203 via wired or wireless channels, depending on the configuration of devices 1a-1n relative to the network hub. Network hub 207, in one implementation, may be implemented as a local network broadcasting device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub provides connectivity to devices 1a-1n located within the same operating room network. Network hub 207 collects data in the form of packets and sends them to a router in half-duplex mode. Network hub 207 does not store any media access control / Internet Protocol (MAC / IP) information for transporting device data. Only one of devices 1a-1n can transmit data through network hub 207 at a time. Network hub 207 does not have a routing table or intelligence regarding where to send information; it broadcasts all network data across each connection and to a remote server 213 (FIG. 9) on cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.
[0074] In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired or wireless channel. The network switch 209 functions at the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and functions in full-duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.
[0075] The network hub 207 and / or the network switch 209 are connected to a network router 211 for connection to the cloud 204. The network router 211 functions at the network layer of the OSI model. The network router 211 provides a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.
[0076] In one embodiment, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.
[0077] In another embodiment, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band of 2.4-2.485 GHz) and to create a personal area network (PAN). In other aspects, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long-Term Evolution (LTE), and EV-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and beyond. The computing module may include multiple communications modules. For example, a first communications module may be dedicated to short-range wireless communications such as Wi-Fi and Bluetooth, and a second communications module may be dedicated to long-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and EV-DO.
[0078] The modular communications hub 203 can act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types known as frames. Frames carry data generated by the devices 1a-1n / 2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using any number of wireless or wired communications standards or protocols described herein.
[0079] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 is generally easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.
[0080] FIG. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 connected to the computer system 210. As illustrated in the embodiment of FIG. 9 , modular control tower 236 is connected to imaging module 238 connected to endoscope 239, generator module 240 connected to energy device 241, smoke evacuation module 226, suction / irrigation module 228, communications module 230, processor module 232, storage array 234, smart device / instrument 235 optionally connected to display 237, and non-contact sensor module 242. Operating room equipment is connected to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Device / instrument 235, visualization system 208, among other devices, may connect to modular control tower 236 via wired or wireless communication standards or protocols described herein. Modular control tower 236 may also connect to hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.
[0081] FIG. 10 illustrates a surgical hub 206 comprising multiple modules connected to a modular control tower 236. The modular control tower 236 comprises a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for providing local processing, visualization, and imaging. As shown in FIG. 10, the modular communications hubs 203 can be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches in the modular communications hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to a processor to provide communications connectivity to cloud computing resources and a local display 217. Communications to the cloud 204 can occur via either wired or wireless communication channels.
[0082] 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 ultrasound or laser-based non-contact measurement device. As described in the section titled "Surgical Hub Spatial Awareness Within an Operating Room" in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety, an ultrasound-based non-contact sensor module scans the operating room by transmitting bursts of ultrasound and receiving echoes when the bursts of ultrasound reflect off the exterior walls of the operating room, where the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. A laser-based non-contact sensor module scans the operating room by, for example, transmitting laser light pulses, receiving laser light pulses that reflect off the exterior walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.
[0083] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is connected to a communication module 247, a storage device 248, a memory 249, a non-volatile memory 250, and an input / output interface 251 via a system bus. The system bus may be any of several types of bus structure(s), including a memory bus or memory controller, a peripheral or external bus, and / or a local bus using any of a variety of bus architectures, including, but not limited to, a 9-bit bus, an Industrial Standard Architecture (ISA), a Micro-Channel 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.
[0084] Processor 244 may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including, for example, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product datasheet.
[0085] In one aspect, processor 244 may include a safety controller, including two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options.
[0086] System memory includes both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random-access memory (RAM), which acts as external cache memory. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate (DDR SDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and direct Rambus RAM (DRRAM).
[0087] The computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage devices. Disk storage devices include, but are not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage devices can include storage media either independently or in combination with other storage media, including, but not limited to, optical disk drives such as compact disc ROM drives (CD-ROMs), compact disc recordable drives (CD-R drives), compact disc rewritable drives (CD-RW drives), or digital versatile disc ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of the disk storage devices to the system bus.
[0088] It should be understood that computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software includes an operating system. The operating system, which may be stored on disk storage, functions to control and allocate resources of the computer system. System applications leverage the operating system's resource management through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.
[0089] A user inputs commands or information into the computer system 210 through input device(s) connected to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, or touchpad; keyboards; microphones; joysticks; gamepads; satellite dishes; scanners; TV tuner cards; digital cameras; digital video cameras; and webcams. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. Output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate the existence of some output devices, such as monitors, displays, speakers, and printers, among other output devices, that require special adapters. Output adapters include, by way of example and not limitation, video and sound cards, which provide a means of connection between an output device and the system bus. It should be noted that other devices and / or systems of devices, such as remote computer(s), provide both input and output capabilities.
[0090] 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) may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other common network nodes, and typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown with the remote computer(s). The remote computer(s) are logically connected to the computer system through a network interface, which is then physically connected via a communications connection. The network interface encompasses communications networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variants, packet-switched networks, and Digital Subscriber Lines (DSL).
[0091] In various embodiments, 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 specialized digital signal processor (DSP) used to process digital images. The image processor may employ parallel computing using single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.
[0092] The communications connection(s) refer to the hardware / software used to connect the network interface to the bus. While the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as modems, including regular telephone-grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.
[0093] FIG. 11 shows a functional block diagram of one embodiment of a USB network hub 300 device in accordance with at least one embodiment of the present disclosure. In the illustrated embodiment, the USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that conforms to the USB 2.0 standard and provides an upstream USB transmit / receive port 302 and up to three downstream USB transmit / receive ports 304, 306, and 308. The upstream USB transmit / receive port 302 is a differential routed data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transmit / receive ports 304, 306, and 308 are differential data ports, each including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-DM3) output.
[0094] The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. Fully compliant USB transceivers are integrated into the circuitry of the upstream USB transmit / receive port 302 and all downstream USB transmit / receive ports 304, 306, and 308. The downstream USB transmit / receive ports 304, 306, and 308 support both full-speed and low-speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 for managing power.
[0095] The USB network hub 300 device includes a serial interface engine (SIE) 310. The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in Chapter 8 of the USB Specification. The SIE 310 typically understands signaling down to the transaction level. Functions it handles may include packet recognition, transaction reordering, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, non-return-to-zero invert (NRZI) data encoding / decoding and bit stuffing, CRC generation and checking (token and data), packet ID (PID) generation and checking / decoding, and / or serial-to-parallel / parallel-to-serial conversion. 310 receives a clock input 314 and is connected via port logic circuits 320, 322, 324 to a suspend / resume logic and frame timer 316 circuit and a hub repeater circuit 318 for controlling communication between the upstream USB transmit / receive port 302 and the downstream USB transmit / receive ports 304, 306, 308. The SIE 310 is connected via interface logic 328 to a command decoder 326 for controlling commands from a serial EEPROM via a serial EEPROM interface 330.
[0096] In various embodiments, the USB network hub 300 can connect 127 functions organized into up to six logical layers (hierarchies) to a single computer. Furthermore, the USB network hub 300 can connect to all peripheral devices using a standardized four-wire cable that provides both communication and power distribution. Power configurations include bus-powered mode and self-powered mode. The USB network hub 300 may be configured to support four modes of power management: a bus-powered hub with either individual or ganged port power management, and a self-powered hub with either individual or ganged port power management. In one embodiment, using a USB cable, the USB network hub 300, the upstream USB transmit / receive port 302 is plugged into a USB host controller, and the downstream USB transmit / receive ports 304, 306, and 308 are exposed for connecting USB-compatible devices.
[0097] Further details regarding the structure and function of surgical hubs and / or surgical hub networks can be found in U.S. Provisional Patent Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety.
[0098] Cloud system hardware and functional modules FIG. 12 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one aspect, the computer-implemented interactive surgical system is configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and an operating room or medical facility. The computer-implemented interactive surgical system includes a cloud-based analysis system. While the cloud-based analysis system is described as a surgical system, it is not necessarily limited to such and may also 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) 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 connected to one or more surgical instruments 7012. The hub 7006 is also communicatively connected to a cloud 7004 of computer-implemented interactive surgical systems via a network 7001. The cloud 7004 is a remote, centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 12 , access to the cloud 7004 is achieved via the network 7001, which may be the Internet or some other suitable computer network. The surgical hub 7006, coupled to the cloud 7004, can be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 is paired with the surgical hub 7006 for control and performance of the various surgical procedures or operations described herein.
[0099] Additionally, the surgical instrument 7012 may include a transceiver for data transmission to and from a corresponding surgical hub 7006 (which may also include a transceiver). The combination of the surgical instrument 7012 and the corresponding hub 7006 may indicate a specific location, such as an operating room within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 may store the location data. As shown in FIG. 12 , the cloud 7004 includes a central server 7013 (which may be the same as or similar to the remote server 113 of FIG. 1 and / or the remote server 213 of FIG. 9 ), a hub application server 7002, a data analysis module 7034, and an input / output (“I / O”) interface 7007. The central server 7013 of the cloud 7004 collectively manages the cloud computing system, which includes monitoring requests by the client modules 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 connected to a suitable memory device 7010, which may include volatile memory such as random access memory (RAM) and non-volatile memory such as magnetic storage. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, actions, recommendations, and other operations described below. Further, the processor 7008 may execute the data analysis module 7034 independently of or in conjunction with a hub application executed independently by the hub 7006. The central server 7013 also includes an aggregated medical data database 2212, which may reside in the memory 2210.
[0100] Based on its connection to the various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from the various surgical instruments 7012 and the particular data generated by their corresponding hubs 7006. Such aggregated data may be stored in the cloud 7004's aggregated medical data database 7011. Specifically, the cloud 7004 may advantageously perform data analysis and operations on the aggregated data to yield functionality that individual hubs 7006 cannot achieve on their own. To this end, as shown in FIG. 12 , the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7007 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7007 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Thus, the I / O interface 7007 can facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed upon request from the hubs 7006. These requests may be sent to the hub 7006 via the hub application. The I / O interface 7007 may include one or more high-speed data ports, which may include a universal serial bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 is configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests made by the hub application, control access to the aggregated medical data database 7011, and perform load balancing. The data analysis module 7034 is described in further detail with reference to FIG. 13 .
[0101] The particular cloud computing system configurations described in this disclosure are specifically designed to address various problems that arise in the context of medical operations and procedures performed using medical devices, such as surgical instruments 7012, 112. In particular, the surgical instruments 7012 may be digital surgical devices configured to interact with the cloud 7004 to implement techniques for improving surgical outcomes. The various surgical instruments 7012 and / or the surgical hub 7006 may include touch-controlled user interfaces such that a clinician may control aspects of the interaction between the surgical instruments 7012 and the cloud 7004. Other suitable user interfaces for control, such as an auditory-controlled user interface, may also be used.
[0102] FIG. 13 is a block diagram illustrating 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 multiple data analysis modules 7034 that can be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions to problems specifically arising in the medical field. As shown in FIG. 13 , the functionality of the cloud-based data analysis modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002, which may be accessed in connection with a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 defines a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 manages the storage and retrieval of data in a database 7011 of aggregated medical data for operation of the applications 7014. A cache 7018 is also coupled to the API 7016 for storing data (e.g., temporarily) and for more efficient retrieval of data used by the applications 7014. 13 includes modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004, according to some aspects. In one aspect, a data analysis module is used to make specific recommendations based on an analysis of trends, outcomes, and other data.
[0103] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying notable features or configurations (e.g., trends), managing redundant data sets, and storing data in paired data sets that may be grouped by procedure but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of the surgical 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 desired event (e.g., a successful surgical procedure) or an undesired event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may represent individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 can generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the aggregated medical data database 7011 to execute the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the aggregated medical data database 2212.
[0104] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 may determine optimal ordering points for surgical staplers 7012 for a group of medical facilities based on the corresponding predicted demand for such instruments 7012. The resource optimization module 7020 could also evaluate resource usage or other operating configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the organized data aggregated from the data collection and aggregation module 7022 and provide recommendations. For example, the recommendation module 7030 may be able to recommend to a medical facility (e.g., a healthcare provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 may be able to suggest better supply chain parameters such as product reorder points, provide suggestions for different surgical instruments 7012, their use, or procedural steps that would improve surgical outcomes, etc. The medical facility may receive such suggestions via the corresponding surgical hub 7006. More specific suggestions regarding the parameters or configurations of various surgical instruments 7012 may also be provided. The hub 7006 and / or surgical instruments 7012 may each have a display screen that displays the data or suggestions provided by the cloud 7004.
[0105] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this connection, the recommendation module 7030 may be able to use these other potential operating parameters to make suggestions based on resulting in a better surgical outcome, such as a better seal or less bleeding. For example, the recommendation module 7030 may send recommendations to the surgical hub 7006 regarding when to use a particular cartridge for a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large collections of raw data and provide centralized recommendations (advantageously determined based on the aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may be able to analyze, evaluate, and / or aggregate geographic similarities between medical providers / facilities, such as type of medical procedure, type of patient, number of patients, providers / facilities that use similar types of instruments, etc.
[0106] The control program update module 7026 may be configured to implement various surgical instrument 7012 suggestions when the corresponding control program is updated. For example, the patient outcome analysis module 7028 may be able to identify correlations linking particular control parameters with successful (or unsuccessful) outcomes. Such correlations may be addressed when an updated control program is sent to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012 sent via the corresponding hub 7006 may incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and the suggestions module 7030 may be able to identify improved ways to use the instrument 7012 based on the aggregated performance data.
[0107] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and may be associated with an authorized cloud access level. For example, based on providing accurate credentials, the surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the aggregated medical data database 7011 of the cloud 7004 may include a database of credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analyses generated by the cloud 7004.
[0108] Additionally, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a “blacklist” of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be allowed to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.
[0109] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and the cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a respective memory device of the surgical instrument 7012. The authorization and security module 7024 may determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This readiness to transmit data may be indicated, for example, by a light indicator on the instrument 7012. The cloud 7004 may also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 may send signals directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 may be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 are identified as having a common manufacturing defect, the cloud 7004 may change the authorization credentials corresponding to this group to implement an operational lockout for this group.
[0110] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and proposed changes (e.g., via the recommendations module 2030). Accordingly, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational behavior or geographic location. In this manner, the cloud 7004 may provide broader analysis and recommendations for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of recommendations on cost and effectiveness for a particular facility (for overall operations and / or various healthcare procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of other facilities or any other comparable facilities.
[0111] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., the severity, surprise, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functionality described above to improve the cloud-based analyses and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in a particular response from the cloud 7004 (corresponding to the level of urgency), such as an elevation for rapid response, special handling, exclusion from the aggregated medical data database 7011, or other suitable response. Furthermore, if necessary, the cloud 7004 may send a request (e.g., a push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be required in situations where the cloud detects a significant irregularity or outlier and the cloud is unable to determine the cause of the irregularity. The central server 7013 may be programmed to trigger this push message in certain critical situations, such as when data is determined to differ from expected values by more than a predetermined threshold, or when security is deemed to be involved.
[0112] Further details regarding cloud analytics systems can be found in U.S. Provisional Patent Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety.
[0113] Situational Awareness While “intelligent” devices that include control algorithms responsive to sensed data may be an improvement over “dumb” devices that operate without considering the sensed data, some sensed data may be incomplete or inconclusive when considered alone, i.e., without the context of the type of surgical procedure being performed or the type of tissue being operated on. Without knowing the procedure context (e.g., knowing the type of tissue being operated on or the type of procedure being performed), the control algorithm may inaccurately or suboptimally control the modular device when given sensed data that does not include the specific context. For example, the optimal method for a control algorithm to control a surgical instrument in response to a particular sensed parameter may vary according to the particular type of tissue being operated on. This is due to the fact that different tissue types have different properties (e.g., resistance to tearing) that cause them to respond differently to actions taken by the surgical instrument. Therefore, it may be desirable for the surgical instrument to take different actions even when the same measured value is sensed for a particular parameter. As one specific example, the optimal way to control a surgical stapling and severing instrument in response to sensing an unexpectedly high force to close its end effector depends on whether the tissue type is susceptible to tearing or resistant to it. For tissue that is susceptible to tearing, such as lung tissue, the instrument's control algorithm optimally ramps down the motor in response to an unexpectedly high force to close to avoid tearing the tissue. For tissue that is resistant to tearing, such as stomach tissue, the instrument's control algorithm optimally ramps up the motor in response to an unexpectedly high force to close to ensure that the end effector is properly clamped to the tissue. Without knowing whether lung tissue or stomach tissue is being clamped, the control algorithm may make suboptimal decisions.
[0114] One solution utilizes a surgical hub that includes a system configured to derive information about the surgical procedure to be performed based on data received from various data sources and then control paired modular devices accordingly. In other words, the surgical hub is configured to infer information about the surgical procedure from the received data and then control the modular devices paired with the surgical hub based on the inferred context of the surgical procedure. FIG. 14 shows a diagram of a context-aware surgical system 5100 in accordance with at least one aspect of the present disclosure. In some examples, the data sources 5126 include, for example, the modular device 5102 (which may 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 patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor).
[0115] The surgical hub 5104, which may be similar in many respects to the hub 106, may be configured to derive contextual information regarding the surgical procedure from the data based, for example, on a particular combination of received data or a particular order in which data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step in the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity that is the subject of the procedure. This ability, by some aspects of the surgical hub 5104, to derive or infer information related to the surgical procedure from the received data may be referred to as “situational awareness.” In one example, the surgical hub 5104 may incorporate a situational awareness system, which is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from the received data.
[0116] The situational awareness system of the surgical hub 5104 can be configured to derive contextual information from data received from the data sources 5126 in a variety of different ways. In one example, the situational awareness system includes a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitor 5124, and / or the modular device 5102) with corresponding contextual information related to the surgical procedure. In other words, the machine learning system can be trained to accurately derive contextual information related to the surgical procedure from provided inputs. In another illustrative example, the situational awareness system can include a lookup table that stores pre-characterized contextual information related to the surgical procedure in correspondence with one or more inputs (or ranges of inputs) that correspond to the contextual information. In response to querying with one or more inputs, the lookup table can return corresponding contextual information for the situational awareness system to control the modular device 5102. In one example, the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another example, the situational awareness system includes an additional machine learning system, lookup table, or other such system that generates or obtains one or more control adjustments for one or more modular devices 5102 when provided with the contextual information as input.
[0117] A surgical hub 5104 incorporating a situational awareness system provides many benefits to the surgical system 5100. One benefit includes improved interpretation of sensed and collected data, which improves processing accuracy and / or use of the data during the course of a surgical procedure. To return to the previous example, the situational aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, if an unexpectedly high force is detected to close the end effector of the surgical instrument, the situational aware surgical hub 5104 can properly ramp up or down the motor of the surgical instrument to match the type of tissue.
[0118] As another example, the type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of the surgical stapling and severing instrument for a particular tissue gap measurement. The context-aware surgical hub 5104 can infer whether the surgical procedure being performed is a thoracic or abdominal procedure, which allows the context-aware surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and severing instrument is pulmonary (in the case of thoracic surgery) or stomach (in the case of abdominal surgery). The surgical hub 5104 can then adjust the compression speed and load threshold of the surgical stapling and severing instrument appropriately for the tissue type.
[0119] As yet another example, the type of body cavity being operated on during an insufflation procedure can affect the function of the smoke evacuator. The context-aware surgical hub 5104 can determine if the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type. Because procedure types are generally performed within specific body cavities, the surgical hub 5104 can control the smoke evacuator motor speed appropriately for the body cavity being operated on. Thus, the context-aware surgical hub 5104 can provide consistent smoke evacuation for both thoracic and abdominal procedures.
[0120] As yet another example, the type of procedure being performed may affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. Arthroscopic procedures, for example, require higher energy levels because the end effectors of the ultrasonic surgical instrument or RF electrosurgical instrument are immersed in fluid. The context-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on may affect the optimal energy level at which an ultrasonic surgical instrument or RF electrosurgical instrument operates. The context-aware 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 customize the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument, respectively. Additionally, the situation-aware surgical hub 5104 can be configured to adjust the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than just on a procedure-by-procedure basis. The situation-aware surgical hub 5104 can determine which step of the surgical procedure is occurring or will occur afterwards and then update the generator and / or the control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level to a value appropriate for the expected tissue type according to the step of the surgical procedure.
[0121] As yet another example, data can be drawn from additional data sources 5126 to improve conclusions the surgical hub 5104 draws from one data source 5126. The situation-aware surgical hub 5104 can augment data received from the modular device 5102 with contextual information it builds about the surgical procedure from other data sources 5126. For example, the situation-aware surgical hub 5104 can be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Thus, in one example, the surgical hub 5104 can be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 (FIG. 2) communicatively connected to the surgical hub 5104) to make a determination about the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.
[0122] Another benefit includes actively and automatically controlling the paired modular devices 5102 according to the particular step of the surgical procedure being performed to reduce the number of times a medical professional is required to interact with or control the surgical system 5100 during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 can actively activate a generator to which an RF electrosurgical instrument is connected if it determines that a subsequent step of the procedure requires the use of the instrument. By actively activating the energy source, the instrument can be ready for use as soon as the previous step of the procedure is completed.
[0123] As another example, the situation-aware surgical hub 5104 can determine whether a current or subsequent step in a surgical procedure requires a different view or degree of magnification on the display according to the feature(s) at the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively change the displayed view (e.g., provided by a medical imaging device for the visualization system 108) accordingly, causing the display to automatically adjust throughout the surgical procedure.
[0124] As yet another example, the context-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed subsequently, and whether specific data or comparisons between data are required for that step of the surgical procedure. The surgical hub 5104 can be configured to automatically call up data screens based on the step of the surgical procedure being performed, without waiting for the surgeon to ask for specific information.
[0125] Another benefit includes checking for errors during the setup of a surgical procedure or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 can determine whether the operating room is properly or optimally set up for the surgical procedure being performed. The surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product locations, or setup needs, and then compare the current operating room layout to a standard layout for the type of surgical procedure the surgical hub 5104 has determined is being performed. In one example, the surgical hub 5104 can be configured to compare a list of items for the procedure, scanned by a suitable scanner, and / or a list of devices paired with the surgical hub 5104, to a recommended or expected manifest of items and / or devices for a given surgical procedure. If any discontinuities exist between the lists, the surgical hub 5104 can be configured to provide a warning indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In one example, the surgical hub 5104 can be configured to determine the relative distance or position of the modular device 5102 and the patient monitoring device 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or expected layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide a warning indicating that the current layout of the surgical procedure deviates from the recommended layout.
[0126] As another example, the context-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or otherwise deviating from an expected course of action during the course of a surgical procedure. For example, the surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of steps or sequences of equipment use, and then compare the steps being taken, or the equipment being used, during the course of the surgical procedure with the expected steps or equipment for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In one example, the surgical hub 5104 can be configured to provide a warning indicating that an unexpected action is being taken or an unexpected device is being utilized at a particular step in the surgical procedure.
[0127] Overall, the situational awareness system for the surgical hub 5104 improves the outcome of surgical procedures by adjusting surgical instruments (and other modular devices 5102) for the specific context of each surgical procedure (e.g., to accommodate different tissue types) and validating actions during the surgical procedure. The situational awareness system also improves the efficiency of the surgeon in performing surgical procedures by automatically suggesting next steps, providing data, and adjusting displays and other modular devices 5102 within the surgical field according to the specific context of the procedure.
[0128] 15, a timeline 5200 illustrating the situational awareness of a hub, such as surgical hub 106 or 206 (FIGS. 1-11), is shown. Timeline 5200 illustrates an exemplary surgical procedure and the contextual information that surgical hub 106, 206 can derive from data received from data sources at each step of the surgical procedure. Timeline 5200 illustrates typical steps that may be taken by nurses, surgeons, and other medical personnel during the course of a lung segmentectomy surgery, beginning with setting up the operating room and concluding with transporting the patient to a post-operative recovery room.
[0129] The situation-aware surgical hub 106, 206 receives data from data sources throughout the course of a surgical procedure, including data generated each time medical personnel utilize a modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 receives this data from the paired modular devices and other data sources and can continuously derive inferences (i.e., contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time. The situation-aware system of the surgical hub 106, 206 can, for example, record data about the procedure to generate a report, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to a particular procedure step, adjust the modular device based on the context (e.g., activate a monitor, adjust the field of view (FOV) of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and any other such actions described above.
[0130] As a first step 5202 in this exemplary procedure, hospital personnel retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.
[0131] In a second step 5204, personnel scan the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies utilized in various types of procedures to verify that the mix of supplies is compatible with the thoracic procedure. Additionally, the surgical hub 106, 206 may also determine that the procedure is not a wedge procedure (either because the incoming supplies do not include the specific supplies required for a thoracic wedge procedure or are otherwise not compatible with a thoracic wedge procedure).
[0132] In a third step 5206, medical personnel scan the patient's band via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 can then verify the patient's identity based on the scanned data.
[0133] In a fourth step 5208, the medical staff turns on the auxiliary devices. The auxiliary devices utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case, they include a smoke evacuator, an aspirator, and a medical imaging device. Once activated, the auxiliary equipment, which is a modular device, may automatically pair with the surgical hub 106, 206 located within a specific proximity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive contextual information about the surgical procedure by detecting the type of modular device paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the types of modular devices connected to the hub, the surgical hub 106, 206 may roughly deduce the specific procedure the surgical team will perform. Once the surgical hub 106, 206 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources (e.g., modular devices and patient monitoring devices) to estimate which steps of the surgical procedure the surgical team is performing.
[0134] In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices to the patient. The EKG electrodes and other patient monitoring devices may be paired with the surgical hub 106, 206. When the surgical hub 106, 206 begins receiving data from the patient monitoring devices, the surgical hub 106, 206 confirms that the patient is in the operating room.
[0135] In a sixth step 5212, medical personnel induce anesthesia in the patient. The surgical hub 106, 206 can estimate that the patient is under anesthesia based on data from the modular devices and / or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Once the sixth step 5212 is complete, the pre-operative portion of the lung segmentectomy surgery is complete and the operative portion begins.
[0136] In a seventh step 5214, the patient's lung being operated on is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206 can, for example, infer that the patient's lung has been collapsed from ventilator data. The surgical hub 106, 206 can compare the detection of the patient's lung being collapsed to the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure.
[0137] In an eighth step 5216, a medical imaging device (e.g., a scope) is inserted and video feed from the medical imaging device is initiated. The surgical hub 106, 206 receives medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 106, 206 can determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 can determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that the wedge procedure was already discounted by the surgical hub 106, 206 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (FIG. 2) can be used to determine contextual information about the type of procedure being performed among many different methods, including by determining the angle at which the medical imaging device is oriented with respect to visualization of the patient's anatomy, by monitoring the number or medical imaging devices being used (i.e., activated and paired with the surgical hub 106, 206), and by monitoring the type of visualization device being used. For example, one technique for performing a VATS lobectomy positions the camera above the diaphragm in the anterior-inferior corner of the patient's chest cavity, while one technique for performing a VATS segmentectomy positions the camera in an anterior intercostal position relative to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situational awareness system can be trained to recognize the location of the medical imaging device based on visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmentectomy utilizes multiple cameras. As yet another example, one technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively connected 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 devices, the surgical hub 106, 206 can determine the particular type of surgical procedure being performed and / or the techniques being used for the particular type of surgical procedure.
[0138] In a ninth step 5218, the surgical team begins the dissection step of the procedure. Because the surgical hub 106, 206 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it can infer that the surgeon is in the process of dissecting and separating the patient's lungs. The surgical hub 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the previously discussed steps of the procedure have been completed) corresponds to the dissection step. In a particular example, the energy instrument may be an energy tool attached to a robotic arm of a robotic surgical system.
[0139] At a tenth step 5220, the surgical team proceeds to the ligation step of the procedure. Because the surgical hub 106, 206 receives data from the surgical stapling and severing instrument indicating that the instrument is being fired, it can infer that the surgeon is ligating the arteries and veins. As with the previous step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the steps in the retrieved process. In a particular example, the surgical instrument may be a surgical tool attached to a robotic arm of a robotic surgical system.
[0140] In an eleventh step 5222, the segmental resection portion of the procedure is performed. The surgical hub 106, 206 can infer that the surgeon is transecting parenchymal tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data can correspond, for example, to the size or type of staples fired by the instrument. Because different types of staples are applied to different types of tissue, the cartridge data can indicate the type of tissue being stapled and / or transected. In this case, the type of staples fired is applied to parenchymal tissue (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is being performed.
[0141] Subsequently, in a twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 can infer that the surgical team is dissecting nodes and performing a leak test based on data received from the generator indicating that an RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasonic instrument utilized after the parenchymal tissue is transected corresponds to the node dissection step, which enables the surgical hub 106, 206 to make this inference. Note that the surgeon will periodically alternate between a surgical stapling / severing instrument and a surgical energy (i.e., RF or ultrasonic) instrument depending on the particular step during the procedure, as different instruments are better suited for specific tasks. Thus, the particular sequence in which the stapling / severing instrument and the surgical energy instrument are used can indicate which step of the procedure the surgeon is performing. Furthermore, in certain instances, a robotic tool may be used for one or more steps during the surgical procedure, and / or a handheld surgical instrument may be used for one or more steps during the surgical procedure. The surgeon(s) can, for example, alternate between the robotic tool and the handheld surgical instrument and / or can use the devices simultaneously, for example. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure begins.
[0142] In a thirteenth step 5226, the patient's anesthesia is reversed. The surgical hub 106, 206 may estimate that the patient is emerging from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase).
[0143] Finally, the fourteenth step 5228 is for medical personnel to remove the various patient monitoring devices from the patient. Thus, the surgical hub 106, 206 can presume that the patient is being transported to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices. As can be seen from this exemplary procedure description, based on data received from various data sources communicatively coupled to the surgical hub 106, 206, the surgical hub 106, 206 can determine or presume when each step of a given surgical procedure is occurring.
[0144] Situational awareness is further described in U.S. Provisional Patent Application No. 62 / 659,900, filed April 19, 2018, entitled "METHOD OF HUB COMMUNICATION," which is incorporated herein by reference in its entirety. In certain examples, the operation of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, can be controlled by the hub 106, 206 based on its situational awareness and / or feedback from its components and / or based on information from the cloud 104.
[0145] Surgical staff evaluation In some aspects, the computer systems described herein are programmed to evaluate surgical staff during the course of a surgical procedure (e.g., how to use a surgical instrument) and propose recommendations to improve the surgical staff member's technique or actions. In one aspect, a computer system described herein ( FIGS. 1-11 ), such as the surgical hubs 106, 206, can be programmed to analyze the surgeon's and / or other surgical staff member's technique, physical characteristics, and / or performance against a baseline. Additionally, the computer system can be programmed to provide notifications or prompts indicating when the surgical staff deviates from the baseline so that the surgical staff can modify their actions and optimize their performance or technique. In some aspects, notifications can include warnings that the surgical staff is not utilizing proper technique (which may further include recommendations for corrective actions the surgical staff can take to address their technique), suggestions for alternative surgical products, statistics regarding correlations between procedural variables (e.g., time taken to complete a procedure) and monitored surgical staff physical characteristics, inter-surgeon comparisons, etc. In various aspects, notifications or recommendations can be provided either in real time (e.g., in the operating room during the surgical procedure) or in a post-procedure report. Thus, the computer system can be programmed to automatically analyze and compare staff member technique and instrumentation technique.
[0146] 16 is a diagram of an exemplary OR setting, according to at least one embodiment of the present disclosure. In various implementations, the surgical hub 211801 can connect via a communication protocol (e.g., Bluetooth) to various one or more cameras 211802, surgical instruments 211810, displays 211806, and other surgical devices within the OR 211800, as described above in the surgical hub section. The camera 211802 can be directed to capture images and / or video of the surgical staff member 211803 during the course of the surgical procedure. Thus, the surgical hub 211801 can receive the captured image and / or video data from the camera 211802 to visually analyze the technique or physical characteristics of the surgical staff member 211803 during the surgical procedure.
[0147] Figure 17 is a logic flow diagram of a process 211000 for visually assessing a surgical staff member in accordance with at least one aspect of the present disclosure. In the following description of process 211000, please also refer to Figures 10 and 16. Process 211000 may be performed by a processor or control circuitry of a computer system, such as processor 244 of surgical hub 206 shown in Figure 10. Thus, process 211000 may be embodied as a set of computer-executable instructions stored in memory 249 that, when executed by processor 244, cause the computer system (e.g., surgical hub 211801) to perform the described steps.
[0148] As described above under the section on surgical hubs, a computer system such as the surgical hub 211801 can be connected to or paired with various surgical devices, such as surgical instruments, generators, smoke evacuators, displays, etc. Through its connections to these surgical devices, the surgical hub 211801 can receive arrays of pre- and post-operative data from these paired surgical devices while the devices are being used during a surgical procedure. Additionally, as described above under the section on situational awareness, the surgical hub 211801 can determine the context of the surgical procedure being performed (e.g., the type of procedure being performed or the step of the procedure) based at least in part on the pre- and post-operative data received from these connected surgical devices. Thus, the processor 244 executing the process 211000 receives 211002 pre- and post-operative data from the surgical device(s) connected or paired with the surgical hub 211801 and utilizes situational awareness to determine 211004 the surgical context based at least in part on the received pre- and post-operative data. The surgical context determined by the surgical hub 211801 through situational awareness can be utilized to inform the assessment of surgical staff performing the surgical procedure.
[0149] Thus, the processor 244 captures 211006 an image(s) of the surgical staff performing the surgical procedure, for example, via a camera 211802 positioned within the OR 211800. The captured image(s) may include still images or moving images (i.e., video). The images of the surgical staff may be captured at various angles and magnifications, may utilize different filters, etc. In one implementation, the camera 211802 is positioned within the OR 211800 such that each surgical staff member performing the procedure may be collectively visualized.
[0150] Thus, the processor 244 determines 211008 body characteristics of one or more surgical staff members from the captured image(s). For example, the body characteristics may include posture, as discussed in connection with FIGS. 18-19, or wrist angle, as discussed in connection with FIGS. 20-21. In other implementations, the body characteristics may include the position, orientation, angle, or rotation of the individual's head, shoulders, torso, elbows, legs, hips, etc. The body characteristics may be determined 211008 utilizing various machine vision, image processing, object recognition, and optical tracking techniques. In one aspect, the body characteristics may be determined 211008 by processing the captured image to detect edges of objects in the image and comparing the detected image to a template of the body part being evaluated. Once the body part being evaluated is recognized, its position, orientation, and other characteristics may be tracked by comparing the movement of the tracked body part to the known position of the camera 211802. In another aspect, body characteristics can be determined 211008 utilizing a marker-based optical system (e.g., active markers embedded within the uniforms of surgical staff members emit electromagnetic radiation or other signals that can be received by a camera 211802 or other sensor connected to the surgical hub 211801). By tracking the movement of the markers relative to the camera 211802, the processor 244 can thus determine the corresponding position and orientation of the body part.
[0151] Thus, processor 244 evaluates 211010 the determined physical characteristics of the surgical staff member against a baseline. In one aspect, the baseline can correspond to the surgical context determined through situational awareness. Processor 244 can, for example, obtain baselines for various physical characteristics from a memory (e.g., memory 249 shown in FIG. 10 ) according to a given surgical context. The baseline can include values or ranges of values for particular physical characteristics tracked during a particular surgical context. The types of physical characteristics evaluated in different surgical contexts can be the same or unique to each particular surgical context.
[0152] In one aspect, the processor 244 can provide feedback to surgical staff members in real time during a surgical procedure. Real-time feedback can include graphical notifications or recommendations displayed on the display 211806 within the OR 211800, audio feedback emitted by the surgical hub 211801 or surgical instruments 211810, etc. Additionally, feedback can include suggestions that trocar port placement be shifted, that surgical instruments be moved from one trocar port to another, that the positioning of the operated patient be adjusted (e.g., the table angle be increased or rotated), and other such suggestions to improve access to the surgical site and minimize non-ideal surgical techniques presented by the surgical staff. In another aspect, the processor 244 can provide post-operative feedback to the surgical staff members. Post-operative feedback can include graphical overlays or notifications displayed on a video captured of the procedure that can be reviewed by the surgical staff for learning purposes, a post-operative report indicating the time or specific surgical steps the surgical staff deviated from the baseline, etc. Any visually identifiable physical characteristic (or combination of physical characteristics) can be used as the basis for suggesting improvements to the techniques exhibited by the surgical staff.
[0153] In one aspect, one or more steps of process 211000 can be performed by a second or remote computer system, such as a cloud computing system described under the Cloud System Hardware and Functional Modules section. For example, the surgical hub 211801 can receive 211002 pre- and post-operative data from connected surgical devices, determine 211004 a surgical context based at least in part on the pre- and post-operative data, and capture 211006 or receive images of the surgical staff member 211803 via camera 211802 and determine 211008 physical characteristics of the surgical staff member 211803, as described above. However, in this aspect, instead of performing the evaluation on the surgical hub 211801, the surgical hub 211801 can instead transmit data regarding the physical characteristics and the determined surgical context to a second computer system, such as a cloud computing system. The cloud computing system can then perform the evaluation by determining whether the determined physical characteristics deviate from a baseline physical characteristic corresponding to the surgical context. In some aspects, the baseline physical characteristics can be determined or calculated from data aggregated from all surgical hubs 211801 communicatively connected to the cloud computing system, thereby allowing the cloud computing system to compare the techniques of surgical staff members 211803 across multiple medical facilities. Accordingly, the cloud computing system can transmit the results of the comparison between the physical characteristics determined by the surgical hub 211801 and the corresponding baseline stored on or determined by the cloud computing system. Upon receiving the results, the surgical hub 211801 can then take appropriate action (e.g., displaying a notification if the technique of the surgical staff member 211803 deviates from the baseline, as described above).In other aspects, one or more additional or different steps of process 211000 may be performed by other computing systems communicatively coupled to the first computing system. Such connected computer systems may, in some aspects, be embodied as a distributed computing system.
[0154] 18-19 illustrate a hypothetical implementation of process 211000 shown in FIG. 17 in which the physical characteristic being evaluated is the posture of a surgical staff member. FIG. 18 illustrates a series of models 211050a, 211050b, 211050c, 211050d of a surgical staff member 211052 during the course of a surgical procedure, in accordance with at least one embodiment of the present disclosure. Correspondingly, FIG. 19 is a graph 211100 illustrating the measured posture of the surgical staff member shown in FIG. 18 over time, in accordance with at least one embodiment of the present disclosure. FIGS. 16-17 should also be referenced in the description of FIGS. 18-19 below. Thus, a surgical hub 211801 executing process 211000 can analyze the posture of a surgical staff member and provide recommendations if the staff member's posture deviates from a baseline. Poor, unexpected, or otherwise improper posture can indicate, for example, that a surgeon is fatigued, having difficulty with a particular surgical procedure, utilizing surgical instruments incorrectly, mispositioning surgical instruments, or acting in a potentially unsafe manner that may create hazards. Thus, monitoring the posture of surgical staff members during the course of a surgical procedure and providing notification when staff members deviate from a baseline posture can be beneficial to alert users who are unaware of their unsafe behavior so they can take corrective action or enable other individuals to take corrective action (e.g., replacing the fatigued staff member with a new individual).
[0155] 19, the vertical axis 211102 of the graph 211100 represents the posture of the individual, and the horizontal axis 211104 represents time. The first model 211050a of FIG. 18 corresponds to time t1 of FIG. 19 during the surgical procedure, the second model 211050b corresponds to time t2, the third model 211050c corresponds to time t3, and the fourth model 211050d corresponds to time t4. In parallel, FIGS. 18 and 19 show that the posture of the individual being assessed gradually deviates from the baseline position(s) during the course of the surgical procedure.
[0156] In one aspect, the posture of an individual assessed by a computer system can be quantified as a metric corresponding to the deviation in the position of one or more locations on the individual's body from a corresponding initial or threshold position. For example, FIG. 18 shows the change in an individual's head position 211054, shoulder position 211056, and hip position 211058 over time, modeled by a first line 211055, a second line 211057, and a third line 211059, respectively. In one aspect utilizing a marker-based optical system, the surgeon's uniformity can have markers located at one or more of these locations that can be tracked by the optical system, for example. In one aspect utilizing a markerless optical system, the optical system can be configured to identify a surgical staff member and optically track the location and movement of one or more body parts or body locations of the identified surgical staff member. Additionally, head, shoulder, and hip positions 211054, 211056, 211058 can be compared to a baseline head position 211060, a baseline shoulder position 211062, and a baseline hip position 211064, respectively. The baseline positions 211060, 211062, 211064 can correspond to the initial position of the respective body part (i.e., the position at time t0 in FIG. 19 ) or can be predetermined thresholds against which the body part's position is compared. In one aspect, the posture metric (as represented by the vertical axis 211102 of graph 211100) can be equal to the distance between one of the body positions 211054, 211056, 211058 and its corresponding baseline position 211060, 211062, 211064. In another aspect, the posture metric may be equal to the cumulative distance between two or more of the body positions 211054, 211056, 211058 and their corresponding baseline positions 211060, 211062, 211064. A first line 211108 in the graph 211100 represents raw posture metric values over time, and a second line 211106 represents normalized posture metric values over time.In various aspects, the process 211000 can evaluate 211010 whether a physical characteristic (in this case, posture) deviates from a baseline according to raw or mathematically manipulated (e.g., normalized) data.
[0157] In one aspect, the surgical hub 211801 executing the process 211000 can compare the calculated posture metric to one or more thresholds and then take various actions accordingly. In the illustrated implementation, the surgical hub 211801 compares the posture metric to a first threshold 211110 and a second threshold 211112. If the normalized posture metric represented by the second line 211106 exceeds the first threshold 211110, the surgical hub 211801 can be configured to provide a first notification or warning to surgical staff within the OR 211800 indicating a potential risk with a particular personal morphology. Furthermore, if the normalized posture metric represented by the second line 211106 exceeds the second threshold 211112, the surgical hub 211801 can be configured to provide a second notification or warning to a user within the OR 211800 indicating a high risk with a particular personal morphology. For example, at time t4, the assessed surgical staff member posture metric represented by the fourth model 211050d exceeds the first threshold 211110, and therefore the surgical hub 211801 can be configured to provide a first or early warning to the surgical staff.
[0158] 20-21 illustrate a hypothetical implementation of the process 211000 shown in FIG. 17 in which the physical characteristic being evaluated is a surgical staff member's wrist angle. FIG. 20 is a depiction of a surgeon holding a surgical instrument 211654, in accordance with at least one embodiment of the present disclosure. Correspondingly, FIG. 21 is a scatter plot 211700 of wrist angle versus surgical outcome, in accordance with at least one embodiment of the present disclosure. FIGS. 16-17 should also be referenced in the description of FIGS. 20-21 below. Thus, a surgical hub 211801 executing the process 211000 can analyze the wrist angle of a surgical staff member's hand holding a surgical instrument 211654 and provide recommendations if the staff member's wrist angle deviates from a baseline. Improperly holding a surgical instrument, as evidenced by an extreme wrist angle relative to the surgical instrument, can indicate, for example, that the surgeon is utilizing the surgical instrument incorrectly, positioning the surgical instrument incorrectly, utilizing the incorrect surgical instrument for the particular procedure, or otherwise acting in a potentially unsafe manner that may create hazards.
[0159] In this particular implementation, the angle of an individual's wrist 211650 is defined as the angle α between the longitudinal axis 211656 of the surgical instrument 211654 held by the surgeon and the longitudinal axis 211652 (i.e., the proximal-to-distal axis) of the individual's hand. In other implementations, the wrist angle may be defined, for example, as the angle between the individual's hand and forearm. In the scatter plot 211700 of FIG. 21 , the vertical axis 211702 represents the wrist angle α, and the horizontal axis 211704 represents the procedure outcome. The portions of the horizontal axis 211704 to the right and left of the vertical axis 211702 may correspond to, for example, positive and negative procedure outcomes, respectively. A variety of different procedure outcomes can be compared to the surgeon's wrist angle α, such as whether a particular procedure step or firing of the surgical instrument 211654 resulted in excessive bleeding, the occurrence of surgical rework, etc. Furthermore, the procedural outcome may be quantified in a variety of different ways depending on the particular type of procedural outcome being compared to the surgeon's wrist angle α. For example, if the procedural outcome involves bleeding after a particular firing of the surgical instrument 211654, the horizontal axis 211704 may represent the extent or amount of blood along the incision line from the firing of the surgical instrument 211654. Furthermore, the wrist angle α of each plotted point in the scatter plot 211700 may represent the wrist angle α at a particular moment in the surgical procedure, the average wrist angle α during a particular step in the surgical procedure, the overall average wrist angle during the surgical procedure, etc. Furthermore, whether the wrist angle α corresponds to the average wrist angle α or the wrist angle α at a particular moment may correspond to the type of procedural outcome being compared to the wrist angle α. For example, if the procedural outcome represented by the horizontal axis 211704 is the amount of bleeding from the firing of the surgical instrument 211654, the vertical axis 211702 may represent the wrist angle α at the moment the surgical instrument 211654 is fired. As another example, if the procedural outcome represented by the horizontal axis 211704 is the occurrence of re-actions for a particular procedure type, then the vertical axis 211702 may represent the average wrist angle α during the surgical procedure.
[0160] In one aspect, the surgical hub 211801 executing the process 211000 can compare the calculated wrist angle α to one or more thresholds and then take various actions. In the illustrated implementation, the surgical hub 211801 determines whether the surgeon's wrist angle α is within a first zone, graphically represented by a first threshold 211708a and a second threshold 211708b within the second zone, a second zone, graphically represented by a third threshold 211706a and a fourth threshold 211706b, or outside the second zone. If the wrist angle α measured by the surgical hub 211801 falls between the first threshold 221708a and the second threshold 221708b during the course of a surgical procedure, the surgical hub 211801 can be configured to determine that the wrist angle α is within acceptable parameters and take no action. If the surgeon's wrist angle α falls between the first threshold 221708a, second threshold 221708b and the third threshold 221706a, fourth threshold 221706b, the surgical hub 211801 is configured to provide a first notification or warning to surgical staff within OR 211800 indicating a potential risk of a particular personal morphology. Additionally, if the surgeon's wrist angle α falls outside the third threshold 221706a and fourth threshold 221706b, the surgical hub 211801 can be configured to provide a second notification or warning to a user within OR 211800 indicating a high risk of a particular personal morphology.
[0161] In some aspects, various thresholds or baselines to which monitored physical characteristics are compared can be empirically determined. The surgical hub 211801 and / or cloud computing system described under the Cloud System Hardware and Functional Modules section can capture data related to various physical characteristics of surgical staff members from a sample population of surgical procedures for analysis. In one aspect, the computer system can correlate those physical characteristics with various surgical outcomes and then set thresholds or baselines according to the particular physical characteristics of the surgeon or other surgical staff members that are most highly correlated with successful surgical outcomes. Thus, the surgical hub 211801 executing the process 211000 can provide notifications or alerts when surgical staff members deviate from best practices. In another aspect, the computer system can set thresholds or baselines according to the physical characteristics that are most often present within the sample population. Thus, the surgical hub 211801 executing the process 211000 can provide notifications or alerts when surgical staff members deviate from most common practices. 21 , the first threshold 211708a, the second threshold 211708b can be set to correspond to the most common wrist angles α exhibited by surgeons when performing a particular surgical procedure (i.e., the densest portions of the scatter plot 211700). Thus, when the surgical hub 211801 executing the process 211000 determines that the surgeon's wrist angle α deviates from the empirically determined baseline defined by the first threshold 211708a, the second threshold 211708b, the surgical hub 211801 can provide a notification to the surgical staff or take other action, as described above.
[0162] In one aspect, the physical characteristics tracked by the surgical hub 211801 may be differentiated according to product type. Accordingly, the surgical hub 211801 may be configured to notify surgical staff members when particular physical characteristics being tracked correspond to different product types. For example, the surgical hub 211801 may be configured to notify a surgeon when the surgeon's arm and / or wrist posture deviates from the baseline for the particular surgical instrument currently being utilized, indicating that a different surgical instrument would be more appropriate.
[0163] In one aspect, the surgical hub 211801 can be configured to compare the external orientation of the surgical instrument 211810 with the internal access orientation of its end effector. The external orientation of the surgical instrument 211810 can be determined via the camera 211802 and optical system described above. The internal orientation of the end effector of the surgical instrument 211810 can be determined via an endoscope or another scope utilized to visualize the surgical site. By comparing the external and internal orientations of the surgical instrument 211810, the surgical hub 211801 can determine whether a different type of surgical instrument 211810 is more appropriate. For example, the surgical hub 211801 can be configured to provide a notification to surgical staff if the external orientation of the surgical instrument 211810 deviates from the internal orientation of the end effector of the surgical instrument 211810 by more than a threshold degree.
[0164] In short, a computer system such as the Surgical Hub 211801 can be configured to provide recommendations to surgical staff members (e.g., surgeons) when their technique begins to deviate from best or common practice. In some aspects, the computer system can be configured to only provide notifications or feedback when an individual repeatedly exhibits suboptimal behavior during the course of a given surgical procedure. Notifications provided by the computer system can suggest, for example, that the surgical staff member adjust their technique to align with the optimal technique for the procedure type, utilize more appropriate equipment, etc.
[0165] In one aspect, the computer system (e.g., the surgical hub 211801) may be configured to allow surgical staff members to compare their skills to themselves, rather than to a baseline established by a sampled population or pre-programmed into the computer system. In other words, the baseline to which the computer system compares the surgical staff members may be the surgical staff members' previous performance in a particular surgical procedure type or previous instances of utilizing a particular type of surgical instrument. Such an aspect may be useful for allowing surgeons to track improvements in surgical skills during a literature test of a new surgical product. Thus, the surgical hub 211801 may be configured to evaluate the product during a test period and provide highlights of the product's use during a given period. In one aspect, the surgical hub 211801 may be programmed to be particularly sensitive to deviations between the surgical staff members' performance and the corresponding baseline, thereby allowing the surgical hub 211801 to reinforce proper technique for using a surgical device as the test period is underway. In one aspect, the surgical hub 211801 can be configured to record the use of a new surgical product and compare and contrast the use of the new product with the use of a previous baseline product. The surgical hub 211801 can further provide a post-analysis review to highlight recorded similarities and differences between the surgeon's tracked physical characteristics when using two different products. Additionally, the surgical hub 211801 may allow the surgeon to compare a population of procedures between the new surgical product and the old surgical product. Recommendations provided by the surgical hub 211801 can include, for example, a comparison video demonstrating the use of the new product.
[0166] In one aspect, the computer system (e.g., Surgical Hub 211801) can be configured to allow surgical staff members to directly compare their technique with other surgeons, rather than to a baseline established by a sampled population or pre-programmed into the computer system.
[0167] In one aspect, a computer system (e.g., the surgical hub 211801) can be configured to analyze trends in surgical device use as a surgeon becomes more experienced at performing a particular surgical procedure (or performing surgical procedures generally) or using new surgical instruments. For example, the computer system can identify movements, behaviors, and other physical characteristics that change dramatically as a surgeon becomes more experienced. Thus, the computer system can recognize when a surgeon is exhibiting suboptimal technique early in the surgeon's learning curve and can provide recommendations for an optimal approach before the suboptimal technique becomes ingrained in the surgeon. [Example]
[0168] Various aspects of the subject matter described herein are illustrated in the following numbered examples.
[0169] Example 1. A computer system configured to be communicatively connected to a surgical device and a camera. The computer system includes a processor and a memory coupled to the processor. The memory stores instructions that, when executed by the processor, cause the computer system to receive pre- and post-operative data from the surgical device, determine a surgical context based at least in part on the pre- and post-operative data, receive images of an individual via the camera, determine physical characteristics of the individual from the images, obtain baseline physical characteristics corresponding to the surgical context, and determine whether the physical characteristics of the individual deviate from the baseline physical characteristics.
[0170] Example 2. The computer system of example 1, wherein the physical characteristics include a posture of the individual.
[0171] Example 3. The computer system of example 2, wherein the pose of the individual corresponds to at least one body part position and deviation from a reference position.
[0172] Example 4. The computer system of example 1, wherein the physical characteristic comprises an orientation of the individual's wrist.
[0173] Example 5. The computer system of example 4, wherein the orientation of the individual's wrist corresponds to an angle between the individual's wrist and a surgical instrument held by the individual.
[0174] Example 6. The computer system of any one of Examples 1-5, wherein the baseline physical characteristics include instances of physical characteristics previously recorded for the individual.
[0175] Example 7. The computer system of any one of Examples 1-6, wherein the memory further stores instructions that, when executed by the processor, cause the computer system to provide a notification depending on whether the physical characteristic deviates from a baseline physical characteristic.
[0176] Example 8. The computer system of example 7, wherein the computer system provides notifications during a surgical procedure as pre- and post-operative data is received.
[0177] Example 9. A computer-implemented method for tracking physical characteristics of an individual. The method includes receiving, by a computer system, pre- and post-operative data from a surgical device, determining, by the computer system, a surgical context based at least in part on the pre- and post-operative data, receiving, by the computer system, images of the individual via a camera communicatively connected to the computer system, determining, by the computer system, physical characteristics of the individual from the images, obtaining, by the computer system, baseline physical characteristics corresponding to the surgical context, and determining, by the computer system, whether the physical characteristics of the individual deviate from the baseline physical characteristics.
[0178] Example 10. The computer-implemented method of example 9, wherein the body characteristics include a posture of the individual.
[0179] Example 11. The computer-implemented method of example 10, wherein the pose of the individual corresponds to at least one body part position and deviation from a reference position.
[0180] Example 12. The computer-implemented method of example 9, wherein the physical characteristics include an orientation of the individual's wrist.
[0181] Example 13. The computer-implemented method of example 12, wherein the orientation of the individual's wrist corresponds to an angle between the individual's wrist and a surgical instrument held by the individual.
[0182] Example 14. The computer-implemented method of any one of Examples 9-13, wherein the baseline physical characteristics include instances of physical characteristics previously recorded for the individual.
[0183] Example 15. The computer-implemented method of any one of Examples 9-14, further comprising: providing, by the computer system, a notification on the display depending on whether the physical characteristic deviates from the baseline physical characteristic.
[0184] Example 16. A computer system configured to be communicatively connected to a surgical device and a camera. The computer system comprises a processor and a memory coupled to the processor. The memory stores instructions that, when executed by the processor, cause the computer system to: receive pre- and post-operative data from the surgical device; determine a surgical context based at least in part on the pre- and post-operative data; receive images of the individual via the camera; determine physical characteristics of the individual from the images; transmit data identifying the physical characteristics and the surgical context to a remote computer system, wherein the remote computer system determines baseline physical characteristics corresponding to the surgical context and the physical characteristics in response to data aggregated from multiple computer systems coupled to the remote computer system; and receive from the remote computer system whether the physical characteristics of the individual deviate from the baseline physical characteristics.
[0185] Example 17. The computer system of Example 16, wherein the remote computer system comprises a cloud computing system.
[0186] Example 18. The computer system of example 16 or 17, wherein the physical characteristics include the individual's posture.
[0187] Example 19. The computer system of example 18, wherein the posture of the individual corresponds to at least one body part position and deviation from a reference position.
[0188] Example 20. The computer system of example 16 or 17, wherein the physical characteristics include an orientation of the individual's wrist.
[0189] Example 21 The computer system of example 20, wherein the orientation of the individual's wrist corresponds to an angle between the individual's wrist and a surgical instrument held by the individual.
[0190] While several embodiments have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments may be realized and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can alternatively be described as a means for providing the function performed by that element. Also, although materials are disclosed with respect to particular components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as fall within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.
[0191] The above detailed description has set forth various forms of apparatus and / or processes via block diagrams, flowcharts, and / or examples. To the extent that such block diagrams, flowcharts, and / or examples include one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation included in such block diagrams, flowcharts, and / or examples can be implemented individually and / or collectively using various types of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will understand that all or part of some aspects of the embodiments disclosed herein may be equivalently implemented on an integrated circuit, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or substantially any combination thereof, and that designing circuitry and / or writing software and / or firmware code is within the skill of those skilled in the art in light of this disclosure. Furthermore, those skilled in the art will understand that the subject mechanisms described herein can be distributed in a variety of forms as one or more program products, and that the illustrative embodiments of the subject matter described herein apply regardless of the particular type of signal-bearing medium used to actually effect the distribution.
[0192] The instructions used to program logic to perform the various disclosed aspects can be stored in system memory, such as dynamic random access memory (DRAM), cache, flash memory, or other storage device. Additionally, the instructions can be distributed over a network or by other computer-readable media. A machine-readable medium may therefore include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including, but not limited to, floppy diskettes, optical disks, compact disks, read-only memories (CD-ROMs), magneto-optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memories, or tangible machine-readable storage devices used to transmit information over the Internet via electrical, optical, acoustical, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Accordingly, non-transitory computer-readable media includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
[0193] The term “control circuitry,” as used in any aspect of the present specification, may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), or a field programmable gate array (FPGA)), a state machine circuit, firmware that stores instructions executed by the programmable circuit, and any combination thereof. Control circuitry, collectively or individually, may be embodied as circuitry that forms part of a larger system, such as, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), a system-on-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, a "control circuit" includes, but is not limited to, an electrical circuit having at least one discrete electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application-specific integrated circuit, an electrical circuit forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that at least partially executes the processes and / or apparatus described herein, or a microprocessor configured by a computer program that at least partially executes the processes and / or apparatus described herein), an electrical circuit forming a memory device (e.g., a form of random access memory), and / or an electrical circuit forming a communications device (e.g., a modem, a communications switch, or an opto-electrical device). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.
[0194] As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions, or instruction sets and / or hard-coded (e.g., non-volatile) data in a memory device.
[0195] As used in any aspect of this specification, the terms "component," "system," "module," etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.
[0196] As used in any aspect of this specification, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, and the "steps" refer to the manipulation of physical quantities and / or logical states, which may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms can be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.
[0197] The network may include a packet-switched network. The communication devices may communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include an Ethernet communication protocol, which may enable communication using the Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE), entitled "IEEE 802.3 Standard," December 2008, and / or later versions of this standard. Alternatively or additionally, the communication devices may communicate with each other using the X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published by the ATM Forum in August 2001 entitled "ATM-MPLS Network Interworking 2.0" and / or later versions of this standard.Of course, different and / or later-developed connection-oriented network communication protocols are equally contemplated herein.
[0198] Unless expressly specified otherwise, as will be apparent from the foregoing disclosure, discussions throughout the foregoing disclosure using terms such as "processing," "calculating," "computing," "determining," "displaying," and the like will be understood to refer to the operations and processing of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the computer system's registers and memory into other data similarly represented as physical quantities in the computer system's memory or registers or such information storage, transmission, or display device.
[0199] One or more components may be referred to herein as being "configured to," "configurable to," "operable / operative to," "adaptable," "capable to," "conformable / conformed to," etc. Those skilled in the art will understand that "configured to" may generally encompass active and / or inactive and / or standby components, unless the context requires otherwise.
[0200] The terms "proximal" and "distal" are used herein with reference to a clinician manipulating the handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0201] Those skilled in the art will understand that the terms used herein generally, and in the appended claims in particular (e.g., the body of the appended claims), are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.). Furthermore, those skilled in the art will understand that where a specific number is intended in an introduced claim recitation, such intention will be clearly recited in the claim; and, in the absence of such recitation, no such intention exists. For example, as an aid to understanding, the appended claims below may include the introductory phrases “at least one” and “one or more” to introduce the claim recitation. However, the use of such phrases should not be construed as suggesting that when a claim is introduced by the indefinite article "a" or "an," any particular claim containing such introduced claim language is limited to claims containing only one such recitation, even if the same claim contains an introductory phrase such as "one or more" or "at least one" and the indefinite article "a" or "an" (e.g., "a" and / or "an" should normally be construed to mean "at least one" or "one or more"). The same applies when a definite article is used to introduce a claim.
[0202] Furthermore, even when a specific number is explicitly stated in an introduced claim, those skilled in the art will recognize that such a statement should typically be interpreted to mean at least the recited number (e.g., a statement simply stating "two items," without any other modifiers, generally means at least two items, or two or more items). Furthermore, when notation similar to "at least one of A, B, and C, etc." is used, such syntax is generally intended in the sense that one skilled in the art would understand the notation (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). When notation similar to "at least one of A, B, or C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art would understand the notation (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). Furthermore, one of ordinary skill in the art will understand that any disjunctive word and / or phrase that typically represents two or more alternative terms should be understood, whether in the specification, claims, or drawings, to contemplate the possibility of including one of those terms, either of those terms, or both of those terms, unless the context requires otherwise. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B."
[0203] With respect to the appended claims, those skilled in the art will understand that the recited operations herein generally can be performed in any order. Also, while flow diagrams of various operations are shown in sequence(s), it should be understood that various operations may occur in orders other than those illustrated, or may occur simultaneously. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. Furthermore, terms such as "responsive to," "related to," or other past-tense adjectives are generally not intended to exclude such variations, unless the context requires otherwise.
[0204] It is worth noting that any reference to "one embodiment," "embodiment," "exemplary," "one illustrative embodiment," etc. means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," "exemplary," and "in one illustrative embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0205] Any patent application, patent, non-patent publication, or other disclosure material referenced herein and / or listed in any Application Data Sheet is incorporated herein by reference to the extent the incorporated material is not inconsistent with this specification. As such, and to the extent necessary, the disclosure material explicitly set forth herein shall supersede any conflicting statements incorporated herein by reference. Any content, or portions thereof, that conflicts with current definitions, opinions, or other disclosure material set forth herein shall be incorporated herein by reference, but only to the extent that there is no conflict between the referenced content and the current disclosure material.
[0206] In summary, many benefits have been described that result from using the concepts described herein. The foregoing description of one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to be limited to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments have been selected and described to illustrate the principles and practical applications, thereby enabling those skilled in the art to utilize various embodiments, with various modifications, as suitable for the particular use contemplated. It is intended that the claims presented herewith define the overall scope.
[0207] [Embodiment] (1) A computer system configured to be communicatively connected to a surgical device and a camera, comprising: a processor; a memory coupled to the processor, the memory being configured to, when executed by the processor, cause the computer system to: receiving pre- and post-operative data from the surgical device; determining a surgical context based at least in part on the pre- and post-operative data; receiving an image of an individual via the camera; determining a physical characteristic of the individual from the image; obtaining baseline physical characteristics corresponding to the surgical context; and determining whether the physical characteristic of the individual deviates from the baseline physical characteristic. (2) The computer system of claim 1, wherein the physical characteristics include the individual's posture. (3) The computer system of embodiment 2, wherein the posture of the individual corresponds to at least one body part position and deviation from a reference position. (4) The computer system of claim 1, wherein the physical characteristics include the orientation of the individual's wrist. (5) The computer system of embodiment 4, wherein the orientation of the individual's wrist corresponds to an angle between the individual's wrist and a surgical instrument held by the individual.
[0208] (6) The computer system of embodiment 1, wherein the baseline physical characteristics include previously recorded instances of the physical characteristics for the individual. (7) The computer system of embodiment 1, wherein the memory further stores instructions that, when executed by the processor, cause the computer system to provide a notification depending on whether the physical characteristic deviates from the baseline physical characteristic. (8) The computer system of embodiment 7, wherein the computer system provides the notification during a surgical procedure in which the pre- and post-operative data is received. (9) A computer-implemented method for tracking physical characteristics of an individual, comprising: receiving, by a computer system, pre- and post-operative data from the surgical device; determining, by the computer system, a surgical context based at least in part on the pre- and post-operative data; receiving, by the computer system, an image of the individual via a camera communicatively connected to the computer system; determining, with the computer system, physical characteristics of the individual from the image; acquiring, by the computer system, baseline body characteristics corresponding to the surgical context; and determining, by the computer system, whether the physical characteristic of the individual deviates from the baseline physical characteristic. (10) The computer-implemented method of claim 9, wherein the physical characteristics include the posture of the individual.
[0209] (11) A computer-implemented method as described in embodiment 10, wherein the posture of the individual corresponds to at least one body part position and deviation from a reference position. (12) The computer-implemented method of claim 9, wherein the physical characteristics include the orientation of the individual's wrist. (13) The computer-implemented method of claim 12, wherein the orientation of the wrist of the individual corresponds to an angle between the wrist of the individual and a surgical instrument held by the individual. (14) The computer-implemented method of embodiment 9, wherein the baseline physical characteristics include previously recorded instances of the physical characteristics for the individual. (15) The computer-implemented method of embodiment 9, further comprising providing, by the computer system, a notification on a display depending on whether the physical characteristic deviates from the baseline physical characteristic.
[0210] (16) A computer system configured to be communicatively connected to a surgical device and a camera, comprising: a processor; a memory coupled to the processor, the memory being configured to, when executed by the processor, cause the computer system to: receiving pre- and post-operative data from the surgical device; determining a surgical context based at least in part on the pre- and post-operative data; receiving an image of an individual via the camera; determining a physical characteristic of the individual from the image; transmitting data identifying the physical characteristics and the surgical context to a remote computer system; the remote computer system determines baseline body characteristics corresponding to the surgical context and the body characteristics in response to data aggregated from a plurality of computer systems connected to the remote computer system; and receiving from the remote computer system whether the physical characteristic of the individual deviates from the baseline physical characteristic. (17) The computer system of embodiment 16, wherein the remote computer system comprises a cloud computing system. (18) The computer system of embodiment 16, wherein the physical characteristics include the posture of the individual. (19) The computer system of embodiment 18, wherein the posture of the individual corresponds to at least one body part position and deviation from a reference position. (20) The computer system of embodiment 16, wherein the physical characteristics include a wrist orientation of the individual.
[0211] (21) The computer system of claim 20, wherein the orientation of the wrist of the individual corresponds to an angle between the wrist of the individual and a surgical instrument held by the individual.
Claims
1. 1. A computer system configured to be communicatively connected to a surgical device including a surgical instrument and a camera, the computer system comprising: a processor; a memory coupled to the processor, the memory being configured to, when executed by the processor, cause the computer system to: receiving, via said camera, an image of a surgical staff member performing a surgical procedure; determining the wrist angle of the surgical staff member from the image; retrieving from the memory two wrist angle thresholds corresponding to the surgical instrument held by the surgical staff; determining whether the angle of the wrist of the surgical staff member falls outside a range defined by the two wrist angle thresholds; The angle of the wrist of the surgical staff corresponds to an angle between a longitudinal axis of the surgical staff's hand and a longitudinal axis of the surgical staff's forearm.
2. The computer system of claim 1 , wherein the two wrist angle thresholds include instances of the wrist angle previously recorded for the surgical staff.
3. 2. The computer system of claim 1, wherein the memory further stores instructions that, when executed by the processor, cause the computer system to provide a notification depending on whether the angle of the wrist deviates from the range defined by the two wrist angle thresholds.
4. 1. A computer-implemented method for tracking wrist angles of surgical staff performing a surgical procedure, comprising: receiving, by a computer implemented therein, images of the surgical staff via a camera communicatively coupled to the computer; determining, by the computer, the angle of the wrist of the surgical staff member from the image; obtaining, by the computer, from a memory included in the computer, two wrist angle thresholds corresponding to a surgical instrument held by the surgical staff; determining, by the computer, whether the angle of the wrist of the surgical staff member falls outside a range defined by the two wrist angle thresholds; A computer-implemented method wherein the angle of the wrist of the surgical staff corresponds to an angle between a longitudinal axis of the surgical staff's hand and a longitudinal axis of the surgical staff's forearm.
5. The computer-implemented method of claim 4 , wherein the two wrist angle thresholds include instances of the wrist angle previously recorded for the surgical staff.
6. 5. The computer-implemented method of claim 4, further comprising providing, by the computer, a notification on a display depending on whether the angle of the wrist deviates from the range defined by the two wrist angle thresholds.
7. 1. A computer system configured to be communicatively connected to a surgical device including a surgical instrument and a camera, the computer system comprising: a processor; a memory coupled to the processor, the memory being configured to, when executed by the processor, cause the computer system to: receiving, via said camera, an image of a surgical staff member performing a surgical procedure; determining the wrist angle of the surgical staff member from the image; transmitting the angle of the wrist to a remote computer system; the remote computer system determines, in response to data aggregated from a plurality of computer systems connected to the remote computer system, two wrist angle thresholds corresponding to the surgical instrument held by the surgical staff; receiving from the remote computer system whether the angle of the wrist of the surgical staff deviates from a range defined by the two wrist angle thresholds; The angle of the wrist of the surgical staff corresponds to an angle between a longitudinal axis of the surgical staff's hand and a longitudinal axis of the surgical staff's forearm.
8. The computer system of claim 7 , wherein the remote computer system comprises a cloud computing system.
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