Systems and methods for operating room management
Patent Information
- Application Number
- EP2024801983
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-11-02
- Filing Date
- 2024-10-10
- Publication Date
- 2026-09-09
AI Technical Summary
Operating rooms face inefficiencies due to sub-optimal management of human resources, instrumentation, and time, leading to increased costs and potential surgical site infections.
A system comprising cameras, sensors, processing stations, and machine learning software to optimize operating room management by improving resource allocation, instrument tracking, and real-time analytics.
The system enhances operating room efficiency by reducing idle time for surgeons, optimizing instrument usage, and improving sterility maintenance, thereby decreasing costs and infection risks.
Smart Images

Figure IB2024059933_08052025_PF_FP_ABST
Abstract
Description
SYSTEMS AND METHODS FOR OPERATING ROOM MANAGEMENTPRIORITY APPLICATION
[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 547,112, filed on November 2, 2023, the disclosure of which is hereby incorporated by reference herein in its entirety.FIELD
[0002] The disclosure relates to the digital health field. For example, in certain embodiments, the disclosure is directed to systems with software and hardware components, for example, hardware components in the operating room and hospital, and software that can run on computers and / or mobile devices, for example, in the cloud. In certain embodiments, the systems and methods described herein have software and machine learning algorithm components.BACKGROUND
[0003] Increasing healthcare costs are a known problem in modem societies and hospitalization-related costs are big part of that. ORs (Operating Rooms) are among the most important elements of the hospital and ambulatory settings and usually are responsible for significant part of hospital revenue generation.
[0004] There are several problems that can be observed in the modem OR. The OR management is often done in a sub-optimal way. This is reflected by low total OR utilization (e.g., measured by percentage of effective OR use over predefined period of time), long turnover time between the cases (i.e. time to clean-up the room, prepare it and patient for the next case and synchronization between these activities), and low percentage of on-time surgery starts (including day's first surgery).
[0005] Human resources attributed to the OR are not always efficiently used. Overqualified HCWs (Healthcare Workers) can be forced to do simple tasks, e.g., scrub nurses cleaning, surgeon preparing instrumentation or even washing the patient, which prevents them from more adequate utilization of their skills.
[0006] The devices, especially the sterile instrumentation, often are not efficiently used. It is demonstrated that in many cases, complete instrumentation trays containing dozens of instruments are opened to use just one or none of them (17% of cases). This requires re-sterilization of complete tray for the next case which corresponds to a high cost (around 300 USD). There is a significant number of trays delivered with missing or broken instrumentation (respectively 10.5% and 5.9%). In one study involving just 2 neurosurgical procedures to estimate potential institutional savings due to better instrumentation management, up to $2.8 million a year through a 70% reduction in instrument processing through sterile supply has been recorded. Most OR practitioners would agree that a significant proportion of instruments included in certain surgical trays are consistently unused.
[0007] There is a significant time loss during surgery linked to use of instrumentation. In one study the surgeon was idle in nonoperative time attributable to instrumentation in 14 (29%) of the cases, which averaged surgeon idle waiting time of 8 minutes, 57 seconds, or 9.1% of total operative time. This leads to high inefficiencies, knowing that price of a minute in the operating room costs almost 40 USD, giving 360 USD additional cost per surgery.
[0008] Many problems linked to instrumentation and OR time come from the fact that OR staff has insufficient training. It is demonstrated that average OR personnel turnover is high and amounts to 10.7%. This leads to high training and productivity-loss cost knowing that in certain specializations at least 6 months of hands-on training is required to be considered and effective team member.
[0009] OR staff is responsible for maintaining aseptic technique. Particularly, scrub nurse is in charge of identifying any events that could lead to a loss of sterility (e.g., touching or approaching non-sterile surfaces, accidental drops etc.). Taking into account amount of scrub tasks, and restrained observation capability (e.g., field of visibility), complete observation is not possible. This might contribute to increase in total amount of SSI (Surgical Site Infections), which stays high even in developed countries (up to 11% for certain procedures).
[0010] Increased amount of technology and instrumentation leads to increased usage errors and procedural inefficiencies because OR staff may not know how to use the devices. An example instrumentation set for common knee revision surgery can contain 8 trays with 300+ instruments, most of them requiring assembly, and sometimes distributed over different trays. Increased use of digital user interfaces adds another layer of complexity. This leads to situations in which surgery cannot be conducted without specialized industry representative guiding whole OR team. This adds to surgery costs and organizational difficulties.
[0011] Some problems with instrumentation could be solved at the design and development stage. Unfortunately, industry players often do not have access to actual instrument utilization data coming from the field.
[0012] Thus, many operating rooms (ORs) are not economically managed due to sub- optimal human, hardware, time and training allocations. Accordingly, there is a need for improved systems for OR management.SUMMARY
[0013] The systems and methods described herein assist an operating room (OR) team during all surgery stages, assist with OR management, and / or enable surgeon- and surgeryspecific trainings, analytics and intelligence for administrators and provides optimization algorithms to decrease OR costs. In certain embodiments, the systems and methods described herein comprise an operating room (OR) hardware module with cameras and sensors, processing stations, cloud, terminals and associated machine learning (ML) software.
[0014] In some aspects, the present disclosure is directed to a system for management of an operating room, the system comprising: one or more cameras for receiving visual input from the operating room; optionally, one or more sensors for receiving additional input from the operating room, the one or more sensors based on one or more of the following: Wi-Fi, Bluetooth, ZigBee, Thread, radio frequency identification (RFID), ultra-wide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision; optionally, one or more audio input / output (I / O) devices (e.g., microphones and / or speakers) for receiving audio input from the operating room and / or for producing audio output to one or more users; one or more displays (e.g., screen, holographic display, or other display) (e.g., a display of an augmented reality (AR), virtual reality (VR), and / or mixed reality (MR) device) for presenting visual output data [e.g., via a graphical user interface and / or presented as an overlay (e.g., via an AR / VR / MR device)] to one or more users; a processor of a computing device for receiving and processing input data (e.g., the visual input received from the one or more cameras, and / or the additional input received from the one or more sensors, and / or the audio input received from the one or more audio I / O devices) from the operating room; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules, said outputdata rendered for presentation to at least one of the one or more users on the one or more displays.
[0015] In some aspects, the present disclosure is directed to a system for management of an operating room, the system comprising: one or more input devices, the one or more input devices comprising (i) one or more cameras for receiving visual input from the operating room, (ii) one or more sensors for receiving additional input from the operating room, and / or (iii) one or more audio input / output (I / O) devices for receiving audio input from the operating room (e.g., and also for producing audio output to one or more users); one or more output devices, the one or more output devices comprising: one or more displays for presenting visual output data, (ii) one or more projectors for projecting directionally-controlled light onto one or more objects in the operating room, and / or (iii) one or more audio input / output (I / O) devices for producing audio output (e.g., and optionally also for receiving audio input from the operating room) to one or more users; a processor of a computing device for receiving and processing input data (e.g., the visual input received from the one or more cameras, and / or the additional input received from the one or more sensors, and / or the audio input received from the one or more audio I / O devices) from the operating room; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules in order to perform one or more functions that assist one or more users (e.g., in the operating room).
[0016] In certain embodiments, the system further comprises a projector for projecting directionally-controlled light (e.g., laser light, a spotlight, or other light) onto one or more objects in the operating room, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to spatially locate said one or more objects and cause the projector to illuminate said one or more objects as a visual aid for the one or more users in the operating room.
[0017] In certain embodiments, the projector is a physical (real world) projector for projecting directionally-controlled light onto the one or more (physical) objects in real space. In certain embodiments, the projector is a virtual projector (e.g., software) for projecting directionally-controlled light via an augmented reality (AR) display onto the one or more objects in the operating room as viewed by a user wearing an AR headset, where the projectionof light is “onto” the object in the figurative sense since that is how said projection appears to the user wearing the headset.
[0018] In certain embodiments, the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules in order to perform one or more functions, said output data rendered for presentation to at least one of the one or more users on the one or more displays in service of said one or more functions, wherein said one or more functions comprises at least one member selected from the group consisting of: person identification (e.g., identify who is who in the operating room); stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage); predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal); instrument identification (e.g., identify which instruments are used and / or prepared and / or handled); speech recognition and synthesis (e.g., interpret conversation and produce speech response); human emotion recognition (e.g., recognize emotions of one or more users in the operating room); event detection (e.g., detect selected events in the operating room); spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room); context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non- sterile and / or mobile / fixed); video streaming (e.g., stream video to and / or from the operating room); situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge); specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant); and personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).
[0019] In certain embodiments, the one or more functions comprises instrument identification, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR or VR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more of the one or more displays. In certain embodiments, the instrument identification is part of a process performed by a system algorithm, e.g., one or more of the usecases described herein, e.g., scrub assistance (e.g., Scrub Nurse), training, and / or instrument tray optimization.
[0020] In certain embodiments, the one or more functions comprises context segmentation, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical warning presented via the display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual). For example, in certain embodiments, context segmentation comprises identifying and / or classifying surfaces (e.g., as sterile or non-sterile) and objects (e.g., as mobile or fixed), and the one or more functions comprises performing context segmentation as part of an event detection (e.g., detection of potential loss of sterility).
[0021] In certain embodiments, the one or more functions comprises stage and / or task identification, wherein the processor determines (i) an identification of a current stage of a surgical procedure and / or (ii) an identification of what stage will follow or will likely follow the current stage, and wherein the output data rendered for presentation to at least one of the one or more users comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.
[0022] In some aspects, the present disclosure is directed to a method for management of an operating room, the method comprising: receiving, by a processor of a computing device, input data from the operating room and producing visual and / or audio output data via one or more machine learning modules, said output data rendered for presentation to a user on a display, wherein the input data comprises one or more of (i)-(iii) as follows: (i) visual input from the operating room detected by one or more cameras; (ii) input from one or more sensors selected from the group consisting of the following: Wi-Fi, Bluetooth, ZigBee, Thread, radio frequency identification (RFID), ultra-wide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision; and (iii) audio input from one or more audio input / output (I / O) devices in the operating room.In some aspects, the present disclosure is directed to a method for management of an operating room, the method comprising: receiving, by a processor of a computing device, input data from the operating room and producing visual and / or audio output data via one or more machine learning modules (e.g., said output data rendered for presentation to a user on a display), wherein the input data comprises one or more of (i)-(iii) as follows: (i) visual input from theoperating room detected by one or more cameras; (ii) input from one or more sensors (e.g., selected from the group consisting of the following: Wi-Fi, Bluetooth, Thread, ZigBee, radio frequency identification (RFID), ultra-wide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision); and (iii) audio input from one or more audio input / output (I / O) (e.g., microphone (s)) devices in the operating room.
[0023] In certain embodiments, the method comprises producing visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions selected from the group consisting of: person identification (e.g., identify who is who in the operating room); stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage); predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal); instrument identification (e.g., identify which instruments are used and / or prepared and / or handled); speech recognition and synthesis (e.g., interpret conversation and produce speech response); human emotion recognition (e.g., recognize emotions of one or more users in the operating room); event detection (e.g., detect selected events in the operating room); spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room); context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed); video streaming (e.g., stream video to and / or from the operating room); situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge); specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant); and personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).
[0024] In certain embodiments, the one or more functions comprises instrument identification, and wherein the output data comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR, VR, or MR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more displays.
[0025] In certain embodiments, the one or more functions comprises context segmentation, and wherein the output data comprises a graphical warning presented via adisplay or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual). For example, in certain embodiments, context segmentation comprises identifying and / or classifying surfaces (e.g., as sterile or non-sterile) and objects (e.g., as mobile or fixed), and the one or more functions comprises performing context segmentation as part of an event detection (e.g., detection of potential loss of sterility).
[0026] In certain embodiments, the one or more functions comprises (i) identifying, by the processor of the computing device, a current stage of a surgical procedure and / or (ii) identifying, by the processor of the computing device, what stage will follow or will likely follow the current stage, and wherein the output data comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.
[0027] Any two or more of the features described in this specification, including in this summary section, may be combined to form implementations of the disclosure, whether specifically expressly described as a separate combination in this specification or not.BRIEF DESCRIPTION OF THE DRAWINGS
[0028] The foregoing and other objects, aspects, features, and advantages of the present disclosure will become more apparent and better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:
[0029] FIG. 1 is a schematic diagram of system operating room (OR) elements and setup, according to some illustrative embodiments.
[0030] FIG. 2 is a screenshot of a graphical user interface displaying information shown on the OR Screen, according to some illustrative embodiments.
[0031] FIG. 3 is a schematic diagram depicting a computing network and computing devices integrated with the system, according to some illustrative embodiments.
[0032] FIG. 4 is a schematic diagram depicting example stages and tasks performed by the system, according to some illustrative embodiments.
[0033] FIG. 5 depicts an automatic instrument recognition task performed by the system, according to some illustrative embodiments.
[0034] FIG. 6 is a screenshot of a graphical user interface showing an example warning linked to potential sterility loss due to touching of non-sterile surface (here, a non-protected OR light), according to some illustrative embodiments.
[0035] FIG. 7 depicts an automatic spatial localization task using bounding boxes, performed by the system, according to some illustrative embodiments. Note several regions corresponding to the same object (e.g., the Surgeon) and localization of surgical instruments (here, scissors).
[0036] FIG. 8 depicts an automatic context segmentation performed by the system, according to some illustrative embodiments.
[0037] FIG. 9 is a screenshot of a graphical user interface showing an example of the instrument learning function, according to some illustrative embodiments.
[0038] FIG. 10 is a screenshot of a graphical user interface showing an example instrument table layouts learning function, according to some illustrative embodiments.
[0039] FIG. 11 is a screenshot of a graphical user interface showing an example for training of instrumentation-task assignment, according to some illustrative embodiments.
[0040] FIG. 12 is a screenshot of a graphical user interface showing an example employee dashboard showing OR / Surgery performance, training compliance, and task assessment, according to some illustrative embodiments.
[0041] FIG. 13 is a schematic diagram illustrating Scrub Nurse use cases facilitated by the system, according to some illustrative embodiments.
[0042] FIG. 14 is a screenshot of a graphical user interface showing example assistance shown during surgery, according to some illustrative embodiments.
[0043] FIG. 15 depicts a graphical user interface showing a VR / AR / MR overlay depicting an OR Staff member showing an instrument to the system to request assistance in its identification and / or use, with the automatically determined identification shown in the overlay, along with a probability that said determination is accurate, according to some illustrative embodiments.
[0044] FIG. 16 is a screenshot of a graphical user interface showing assistance that is presented based on a detected instrument, surgery stage, staff exchange, or other trigger, according to some illustrative embodiments.
[0045] FIG. 17 is a schematic diagram illustrating Surgeon use cases facilitated by the system, according to some illustrative embodiments.
[0046] FIG. 18 is a screenshot of a graphical user interface presented on a mobile device, the screenshot showing a follow-up visible on a Surgeon Terminal in a Surgeon use case, according to some illustrative embodiments.
[0047] FIG. 19 is a schematic diagram illustrating Nurse use cases facilitated by the system, according to some illustrative embodiments.
[0048] FIG. 20 is a screenshot of a graphical user interface presented on a mobile device, the screenshot showing a Nurse Request Equipment use case visible on a Nurse Terminal in a Nurse use case, according to some illustrative embodiments.
[0049] FIG. 21 is a schematic diagram illustrating OR Manager use cases facilitated by the system, according to some illustrative embodiments.
[0050] FIG. 22 is a screenshot of a graphical user interface depicting an instrument optimization use case, according to some illustrative embodiments.
[0051] FIG. 23 is a schematic diagram illustrating Administrator use cases facilitated by the system, according to some illustrative embodiments.
[0052] FIGs. 24A-24C are schematic diagrams illustrating components of a VR headset with eye tracking capability, for use in the systems and methods described herein, according to illustrative embodiments of the present disclosure.
[0053] FIG. 25 is a schematic diagram illustrating a network environment for use in providing systems, methods, and architectures as described herein, according to some illustrative embodiments.
[0054] FIG. 26 is a schematic diagram illustrating a computing device and a mobile computing device that can be used in the systems and methods described herein, according to some illustrative embodiments.
[0055] Features and advantages of the present disclosure will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout. In the drawings, like reference numbers generally indicate identical, functionally similar, and / or structurally similar elements.DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS
[0056] It is contemplated that systems, architectures, devices, methods, and processes of the present disclosure encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and / or modification of the systems, architectures, devices, methods, and processes described herein may be performed, as contemplated by this description.
[0057] Throughout the description, where articles, devices, systems, and architectures are described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are articles, devices, systems, and architectures of the present disclosure that consist essentially of, or consist of, the recited components, and that there are processes and methods according to the present disclosure that consist essentially of, or consist of, the recited processing steps.
[0058] It should be understood that the order of steps or order for performing certain action is immaterial so long as operability is maintained. Moreover, two or more steps or actions may be conducted simultaneously.
[0059] The mention herein of any publication, for example, in the Background section, is not an admission that the publication serves as prior art with respect to any of the claims presented herein. The Background section is presented for purposes of clarity and is not meant as a description of prior art with respect to any claim.
[0060] Documents referenced herein are incorporated herein by reference. Where there is any discrepancy in the meaning of a particular term, the meaning provided in the Detailed Description section is controlling.
[0061] Headers are provided for the convenience of the reader - the presence and / or placement of a header is not intended to limit the scope of the subject matter described herein.
[0062] In certain embodiments, the systems and methods described herein can be used in hospitals, ambulatory centers, teaching centers, schools, and / or other institutions or stakeholders in the healthcare system . In some illustrative embodiments, the system has elements shown in FIG. 1.
[0063] FIG. 1 is a schematic drawing of system OR elements and set-up. The OR Module includes Visual Input, Audio input / output (I / O), and Projector and Additional Sensors. The Processing Station can be present in the OR, connected to OR Screen, and / or can provide a Cloud Link. Additional devices can be integrated with the system, for example, an AR / VR / MR (augmented reality, virtual reality, and / or mixed reality) Headset and smart Instrument Tables and Trays.
[0064] In FIG. 1, there are the following users:• Surgeon, in sterile clothing, operating on a patient (not shown) laying on the OR table,• Scrub Nurse, in sterile clothing, handling the sterile instrumentation, and• Nurse (sometimes called "Circulating Nurse"), bring the equipment in and out and performing various other mainly assistive tasks.
[0065] Other system users, not shown in FIG. 1, are as follows:• OR Manager• Administrator
[0066] In certain embodiments, there are zero, one, or more users of each of the above categories.
[0067] In the OR there are several instrument and equipment trays. These are usually sterile. The trays might be open or closed. The trays are used as storage for the Scrub Nurse. The instruments that are frequently or soon-to-be used, are stored on the Scrub Instrument Table. The Scrub Nurse is handling instruments, implants, liquids and other materials and handing them to the surgeon as the surgery advances.
[0068] In FIG. 1, the System has an OR Module that has several elements. These elements might be grouped together on one platform, e.g., suspended under the ceiling, standing on a tripod, cart, extending from the wall, or other arrangements. The elements might be all or partially separated, e.g., cameras separated in OR comers for better visibility, speakers and microphones separated, etc. Each of these elements might have its own stand, suspension, etc. These modules, or single elements might be attached or integrated into existing OR equipment, e.g., lights, bed, tables, and the like. There can be wearable, head-mounted cameras or integrated with other equipment, e.g., AR (Augmented Reality) headset.
[0069] Visual Input consists of one or more cameras. These cameras might be assembled in various configuration as described above, fixed, or handheld or wearable, integrated in OR equipment. These cameras might be electronically or manually controlled for their pan / tilt or zoom. Certain or all of the cameras might use wide angle objectives or 360° views. Resolution of the cameras, and their color depth, as well as any additional sensors (e.g., thermography, infrared or ultraviolet vision) can be adapted to the application. For example, the camera might have 4K or 1080P resolution, frame rate of 30 fps, and / or zoom up to 30x.
[0070] In certain embodiments, the system comprises a Projector. The Projector is a device that attracts user attention to one or more items, places or persons in the OR. For example, the Projector can be a video projector, one or more controllable in light size and strength and direction spotlights, one or more similarly controlled laser pointing devices, or others. There can be one or multiple projectors assembled together or placed separately to increase or improve indication coverage. In certain embodiments, Projection is done usingwearable means, e.g., AR or VR (Virtual Reality) headset, table rear projection or lightning or integrated screen technology with or without touch capabilities, holographic projection, projection on overlay transparent or semi-transparent materials or glass or others.
[0071] Audio I / O (Input / Output) is used to capture and produce sound in the OR. To capture the sound, one or more microphones are placed in one or more places. They can be attached to the OR module, walls, on tripods, integrated in other devices (e.g., AR / VR headset), and / or wearable. Microphones can be omnidirectional, directional, capacitor or dynamic, single ones or assembled in arrays, e.g., in order to identify the direction of the sound or help with signal processing (e.g., echo removal, clarity improve, noise subtraction). Audio output produces the sound that can be heard by one or more stakeholders. This can be done with usage of one or more speakers, headsets, or others. Speakers can be single units or assembled in arrays to improve characteristics of sound. They can be directional or assembled on a pan / tilt device to direct sound to specific person. They can be headphones. They can provide other functions, for example, noise removal, voice clarity improvement, and / or others.
[0072] There are Additional Sensors that can be used by the system in the operating room. For example, these can be based on Wi-Fi, Bluetooth, ZigBee, Thread, Radio Frequency Identification (RFID), Ultra-Wide Band (UWB), Inertial Measurement Unit (IMU), Visible Uight Communication (VUC), Infrared (IR), Ultrasonic, Geomagnetic, Uight Detection and Ranging (UiDAR), and / or Computer Vision systems. The Sensors can be used for various tasks including SUAM (Simultaneous Uocalization and Mapping), segmentation, recognition, additional inputs into machine learning models, and others.
[0073] In certain embodiments, the Processing Station is a computer device that can do a part of data processing, connectivity or run specific computer programs. It may be located directly in the operating room, anywhere else in the hospital or integrated in the Cloud. It might be assigned to an operating room or serve several operating rooms at the same time. It may be directly connected to the OR Module in the operating room, via proxy, using network, wireless or others. For example, it can be cable connected to the OR Screen (e.g., using HDMI connection), connected to the OR Module using network connection (e.g. Ethernet) over which communication with all elements of the OR Module is established. Communication involves obtaining audio and video streams, sending audio streams back together with control signals for pan / tilt / zoom of cameras and controlling the projectors. Processing Station might be cable or wireless connected to AR Headsets in the OR. Processing Station might be connected to hospital EAN (Local Area Network) for integration with the hospital digital systems (e.g.,PACS Picture Archiving and Communication System, EHR Electronic Health Record System, any hospital management of follow-up system). In certain embodiments, the Processing station is connected to a WAN (Wide Area Network) for connection to the Cloud.
[0074] The OR Screen is used to present information in the OR (see FIG. 2). This can be a standard screen attached to the wall, hanging from a ceiling, a screen on a cart, a transparent screen, a virtual screen (e.g., a projection, e.g., a holographic projection), or other. There can be one or more screens to improve the visibility. They can be displaying the same information or controlled separately, e.g., based on user position, field of view, attention. The OR Screen might be AR / VR headsets.
[0075] FIG. 2 is a screenshot of a graphical user interface displaying information shown on the OR Screen, according to some illustrative embodiments. Note, the selection tab on the to (“Preparation” tab is selected), information canvas covering most of the screen (green area) and dashboard on the right showing key surgery information.
[0076] In the OR, surgical devices, instruments and implants are placed on the Instrument Table. This can be a standard table, capable of receiving projection from the projector, a table with rear lighting coming, e.g., from an integrated and controllable screen, a table integrating controlled laser pointing devices or other. It might have a separate one or more cameras for acquiring images from the table or specific OR view.
[0077] Instrument trays can be placed on the separate tables. These can be standard tables, tables with integrated cameras or projection capabilities or others.
[0078] Instruments, devices, implants, medical equipment, liquids, and the like, that are are used in the OR are referred to, herein, collectively, as Instruments.
[0079] FIG. 3 is a schematic diagram depicting a computing network and computing devices integrated with the system, according to some illustrative embodiments. In FIG. 3, computer devices working with the system are shown. The Cloud is connected to processing stations, terminals, viewing stations, and data centers. In certain embodiments, the architecture of connection might be different, and not build around the star scheme. For example, viewing stations or terminals can be connected to processing station, hospital network can be connected to the Cloud, processing station can be integrated in the Cloud, and similarly for data centers, and the like. The connection can be done using any network protocol, serial interfaces, wired or wireless, specific connection buses, or others.
[0080] The Cloud refers to servers that are accessed over the Internet, and the software and databases that run on those servers. The Cloud runs computer software and algorithms forreceiving, analyzing and processing data from the processing station. These can be relatively high level data that requires minimal analysis, or low-level which involves significant amount of processing before being ready for further analysis. For example, data anonymization can be done on the Processing Station before leaving hospital LAN network, or it can be done on the Cloud. Similarly, person tracking and detection can be done on the Processing Station or base data (e.g., images) can be sent to the Cloud for processing and tracking and detection done there. Cloud provides connection to Viewing Stations, Terminals and Data Centers. These connections can be specific, providing specialized APIs and pre-processed data, and / or generic, requiring connecting devices to further process data and visualization by themselves. There can be one or several instances of the Cloud for optimizing calculation power, data storage and security. The Cloud might have a scalable processing and data storage capacities to be able to adapt to System's needs on-the-fly or in a configurable manner.
[0081] Any of the devices can be inside the hospital network, e.g., on hospital LAN, or in an outside network, e.g., WAN, in a highly secure environment (e.g., behind firewalls) or in public networks depending on security, user requirements and usability. Network tunnels, VPNs, NAT, VLANs and other technologies can be used for obtaining specific results (e.g., increase in security, speed, reliability and others).
[0082] Viewing Stations enable users to interact with the system, analyze data and configure parameters in an optimized setting. For example, this can be a computer station with a screen and internet connection. This can be a standard PC, PC with a touchscreen, all-in-one computer. Required function can be achieved via web browser and a web app running in the Cloud. Alternative Viewing Stations can be mobile devices, tablets, laptops, thin clients, AR and VR systems, or connected wearables. The function can be achieved by dedicated applications connecting directly to various system elements, remote applications or web apps running on other devices or virtual systems. Viewing Stations might be user-specific (e.g., OR Manager, Surgeon etc) or generic, configurable, or provided as-is.
[0083] In certain embodiments, the systems and methods described herein include Terminals. Terminals are devices which enable users to interact with the system, communicate with the system or other users, analyze data, and configure parameters in an optimized setting. For example, this can be a mobile device, belonging to the user or provided by the hospital, running an app and providing functionalities. Example functionalities could be messages, requests, status updates, checklists, knowledge base access and schedules described in Sections below. Alternatively, the Terminal might be a wearable device, e.g., a smartwatch or ARheadset or headphones, providing relevant information in most adequate way (text, sound, video) when required. Terminals might be user-specific (e.g., OR Manager, Surgeon etc) or generic, configurable, or provided as-is.
[0084] In certain embodiments, the Viewing Stations and Terminal are the same device.
[0085] Company Data Centers are computers, servers and other devices that connect to the cloud for further information processing and data storage. These can be data centers used for further product improvements, telemetry, debugging, communication, standard or OTA (Over-The-Air) updates and others. They can obtain raw or preprocessed data (e.g., anonymized) for further analysis, processing, and service. Company Data Centers can interface with the system via Cloud or directly with any possible architecture.
[0086] Hospital Network and Devices are any other devices that are not part of the system but can be important and useful for its function. For example, Hospital Network and Devices may include PACS, EHR servers and gateways, imaging devices, robotics, inventory management and ERP systems, CRM systems, HR systems, and / or others.System functions
[0087] In certain embodiments, the illustrative System uses functions shown in Table 1 below to implement use cases. These functions are described in more detail in the Sections that follow. “X” denotes a link between the indicated use case and function: (1) Assist with devices and instrumentation, (2) Obtain help, (3) Detect events, (4) Communicate, (5) Assist with surgery preparation, (6) Get trained, (7) Get notified, (8) Request equipment, (9) Get analytics, (10) Follow-up, (11) Learn, (12) Simulate load, (13) Manage schedule, (14) Manage team, (15) Manage trainings, and (16) Optimize instrumentation. Table 2 provides a brief description of each function / use case from Table 1.Table 1: Example use case-to-function allocation.Table 2: Brief Description of use case-to-functions.Personnel assessment Skills, capabilities, history, style and other parameters attached to a system userPerson identification
[0088] Person identification is an important function used by the System for assistance, event detection, measurements and statistics, context understanding, and others. The goal of identification is to uniquely identify a person (e.g., Dr. Dee Fault) and his / her function (Surgeon, Nurse, Scrub, Sales Representative, and others).
[0089] There are several ways in which person identification can be achieved. Various machine learning and neural network based algorithms can be used for this task. For example, any of the geometric approaches focusing on distinguishing features or the photo-metric statistical methods used to extract values from an image can be used. Also, feature-based approaches (focused on facial landmarks and analyzes their spatial parameters and correlation to other features) or holistic models (holistic methods view the human face as a whole unit) can be used. Concrete examples of such methods are as follows:• Convolutional Neural Network (CNN): a widely used neural network architecture for use in deep learning;• Eigenfaces: used to determine face variance in image datasets;• Fisherfaces: one of the most popular algorithms in face recognition;• Kernel Methods: o PCA (Principal Component Analysis) o SVM (Support Vector Machine);• Haar Cascades: object detection method on images;• Three-Dimensional Recognition: facial recognition method based on comparing a 3D facial scan to the database patterns;• Skin Texture Analysis;• Thermal Cameras: Thermal face recognition models are based on the unique temperature patterns of a human face;• ANFIS: adaptive neuro-fuzzy interference system, neural network with fuzzy elements;• Local Binary Patterns Histograms (LBPH); and• Proprietary solutions: o FaceNet: face recognition system FaceNet, developed by Google researchers in 2015. is based on face recounition benchmark datasets:o NEC: The solution developed by the Japanese technology company NEC allows accurate identification of people while recognizing age changes; and o Megvii (Face++): coming from Chinese technology company Megvii.
[0090] Many of these algorithms are based on a sequence involving face detection in an image, video, or real-time stream, calculation of a mathematical model of a face, and comparing the model to training sets or databases to identify or verify a person. The algorithms can be combined in various configurations, for each step of this process to achieve optimal results.
[0091] Training, validation, and test data for the algorithms might come from biometric pictures, labelled pictures from real settings, self-made pictures and recordings, assisted pictures and recordings, and others.
[0092] The algorithms and methods should be reliable enough to work in different lightning condition, facial expressions, surgical masks, hoods and other common OR equipment. For example, thermal imaging can enhance recognition reliability.
[0093] Another way to identify person is by using any type of fiducial, which can be easier identified by a specific technology. Example fiducials would be RFID tag, visible codes (e.g., QR codes or bar codes), color-coding of clothes (e.g. surgical / scrub cups), visible tags, optical tracking markers (e.g. reflective spheres), and / or electro -magnetic fiducials (which do not require a direct line of sight with a camera / sensor (e.g., detector)). Additionally, the tags can be used to measure persons position in the operating room.
[0094] Another way to identify a person is to deduce his / her role from the context. As such context, a person’s spatial location, behavior, tasks, and the like can be used. There are many methods for classification that can be used for this purpose. For example, Convolution Neural Networks or SVM could be used as shallow classifiers. Alternatively, deep learning classifiers can be used. Examples of other model architectures that could be used are: Recurrent Neural Networks (RNNs), Long Short-Term Memory (LSTM) networks, Generative Adversarial Networks (GANs), Deep Belief Networks (DBNs) and others.
[0095] Other exemplary ways to identify a person could be based on personal characteristics, e.g., voice, gait, movement pattern, thermovision-based patterns, characteristic elements (glasses, shoes etc.), Bluetooth devices (mobile phone, wearables), and others.
[0096] The methods can be used separately, in combination or sequence. Results can be combined using Kalman filter or other methods.Stage and task identification
[0097] The goal of this function is to identify surgery stage (e.g., patient preparation, implant placement, patient closure) and specific task (e.g., incision, bone cutting, bleeding management, suturing etc.), as depicted in FIG. 4. FIG. 4 is a schematic diagram depicting an activity diagram for the system, according to some illustrative embodiments. Note the alternative flow in stage “Access” depending on the bleeding. The stages and tasks might come from pre-defined lists or be constructed from scratch or evolve over time. The system uses various information to perform this function: visual inputs, audio I / O, outputs from other algorithms (e.g., instrument identification), and / or others. Current stage and task can be extracted from different information: persons present and their positions, instruments used, spoken language, noise signature, history of case, comparison to other cases, and / or others.Predictive analytics
[0098] The goal of this function is to enable a wide range of assistive tasks and optimizations in the operating room. These may include predicting which instrument can be used next, what is likely to happen and who and how should be notified about it, what equipment is going to be used and whether it is available in the operating room, what are important features for learning, how the load on the operating room is going to vary over time, which schedule is the most optimal according to predefined metrics, which instruments are going to be used most and how to optimize their tables and trays or the instruments themselves taking that into account, how the surgery will move on and when / who is going to be required to intervene, and others.
[0099] In order to make predictions, the model needs to be trained first. Data for training comes from various capabilities of the OR Module: visual input, audio I / O, sensor input, and / or the like. Also, input data for training this model might come from other system functions and modes, e.g., instrument identification, event detection, spatial localization, stage and task detection, past schedules and goals, efficiency of previous predictions, and others. Data can be manually introduced, too, for example, for initial guess parameters, to correct irregularities or introduce exceptional situations. Once the model is trained, it can be used for predictions by inputting relevant data.
[0100] In an illustrative example, the instrumentation prediction model can be trained first using real-time data coming from the surgery. The input dataset would be constructed using surgery stage and task data, identified instrumentation, person identification andlocalization data. This data set could come from 50 or more surgeries and be constantly increased as the system is being used. The data set should be divided into training (used to train the model), testing (used to tune the hyperparameters of the model, such as the learning rate and the number of hidden layers, to prevent overfitting), and validation sets (used to evaluate the performance of the model on unseen data and to estimate its generalization ability). After sufficiently efficient validation (e.g., prediction level of confidence 95% or more), the system could be used for predicting instruments that are going to be used next, with level of probability attached, that is later used in various use cases (e.g. use case Assist with instrumentation and devices)' .
[0101] A similar approach could be used for predicting coming events (loss function more dependent on expected events), equipment use (comparison of the equipment in the OR vs. expected equipment use and generation of relevant equipment requests), and follow-up (determining which stages are going to be next, with timeline information attached, and informing various user about it, e.g. letting the surgeon know when patient will be ready for him to begin).
[0102] For schedule predictions, the training data could be past experiences about estimated / planned OR use, effective use, planned and effective personnel and equipment use, presence of parallel events (e.g., other rooms use, vacation periods etc.), trends, equipment changes, personnel availability and training, and others. This model can be used in an interactive mode to allow OR Manager for choosing best planning (ref. use cases Manage schedule, Manage team).
[0103] There are several models and algorithms that can be used for this function. These can be single class prediction models (e.g., will the sterility loss event happen or not), multiple class predictions, probability prediction for certain events or their classes to appear, and regression models for output quantities (e.g. how long will current surgery stage take). There are several example algorithms that can be used for that purpose, for example, Logistic Regression, k-Nearest Neighbors, Decision Trees, Support Vector Machine, Naive Bayes, Logistic Regression or others.Instrument identification
[0104] This function identifies instruments as they are handled: brought to the OR, prepared, used, cleaned, disassembled, and others. This is a challenging task becauseinstrument vision is often incomplete (e.g., due to occlusions), surface can be covered with blood or particles, instruments can have many parts, have apparent wear, and the like.
[0105] Instrument identification can be interpreted as a classification task (see, for example, FIG. 5). FIG. 5 depicts an automatic instrument recognition task performed by the system, according to some illustrative embodiments. In certain embodiments, FIG. 5 is a graphical user interface (GUI) that is a VR / AR / MR overlay showing identified instruments to the wearer of a VR / AR / MR headset. Note instrument labels, bounding boxes, and recognition confidence level. Note that warnings for lower confidence levels are possible and could be resolved for example by providing user input or waiting for additional data.
[0106] To obtain training data, 3D renderings of instrument models can be used. These models are automatically labelled with the correct instrument they were generated from. Viewpoints can be randomly assigned or a standard set of viewpoints that are mostly used in the OR (e.g., top view for ceiling-mounted Visual input). From these viewpoints, a large set of 2D images can be generated and used as training, test, and validation sets. The renders can further simulate real-world examples by changing lighting, texture (e.g., material use), adding stains, and others. Alternatively, sets can come from real -world images, labelled completely or partially. For example, an OR team member could show the instrument to one or multiple cameras, and / or move it in the space until the system informs the user that the instrument has been acquired. Then user could define the label for the instrument and from this moment on, the instrument could be available for identification.
[0107] 3D renderings of instruments can come from instrument design files, be recreated manually, or acquired by specialized personnel or hospital employees using 3D scanners and other means.
[0108] Instrument identification can be used to recognize all the instruments that are handled, lay on tables or come in instrument trays to perform a complete inventory of devices used.
[0109] Instrument identification can also be used to identify instrument use over time, broken parts or failures. This could be achieved by learning of instrument performance over time (e.g., in conjunction with instrument-relevant events), changes in its visual appearance (e.g. de -colorization, parts missing or deformed), usage tracking, or others.Speech recognition and synthesis
[0110] Speech recognition and synthesis are used to obtain additional sources of information in the OR and simplify interaction with the system. It can be used in conjunction with instrument identification (e.g. to help to identify used instrument or its failure based on exchanges in the OR), to detect user intent, input user request (e.g. for help with an instrument, to notify team member, to request equipment), to detect user intent and equipment during surgery preparation stage, used as an input for constructing user training case (e.g. surgeon asks for instrument X, trainee should be able to quickly identify which instrument is it), analytics of what, when and how is said in the OR, enable precise surgery follow-up (e.g. better stages identification based on what is said and how), and others.
[0111] Input to speech recognition comes from OR Module Audio I / O, Terminals, or Viewing Stations equipment. This can be specialized equipment or standard consumer-class.
[0112] There are many algorithms for speech recognition. They are usually based on one of the following approaches: acoustic phonetic, pattern recognition, or artificial intelligence. Approaches might be combined to achieve better results and other approaches are possible. A speech signal is preprocessed, for example, it is normalized, voice activity is detected, and noise reduced. In the next stage, features are extracted. For example, prosodic features using pitch and duration, spectral features using LPC and Formants, and voice quality features using jitter and Teager Energy Operator features. Then, features are selected and reduced for example using principal component analysis and classified, for example using k- Nearest Neighbor.
[0113] Speaker recognition is an important part of the system. The goal of the recognition is to distinguish an individual based on his voice / text sample from the group of known individuals. There are several parameters that enable such recognition, for example pitch, tone, accent, and other pertinent features. Various deep learning-based models such as CNNs, RNNs, and their combinations can be used in several subtasks of speech and speaker identification, including verification, identification, diarization, and robust recognition. For example, a new user might be asked during registration to the system to record few voice samples, read example text or react to visible clues. Such samples might be used for training, validation and testing of the model that is then used in the OR. Such models can be further improved with OR-acquired data, for example, by cross section of identification coming from other means, e.g., visual.Emotion recognition
[0114] The emotion recognition function is important for assessment of how well the OR team works together, identifications of potential problems with teams composition, training, equipment or emotional compatibility. The emotion recognition system identifies the existence of a user’s varied emotions by extracting and classifying the prominent features from available signals. In the case of the OR, two main signals are visual (e.g., facial) and audio (e.g. speech).
[0115] In certain embodiments, the System may define a set of pre-defined emotions that will be matched with data. For example, these pre-defined emotions could be: Happy, Surprise, Neutral, Sad and Angry. Furthermore, the system may detect various levels of user focus on a task.
[0116] In the case of emotion recognition based on facial expressions, the following algorithm could be used. In the training phase, user facial images need to be pre-processed first, for example to remove noise, scale, mask and convert to grayscale. Next, a feature extraction algorithm could be used. This could be LBP, Gabor, HOG or others. Afterwards, a final feature vector is created using concatenation. To remove unwanted features, dimensional reduction can be used. In the end, one of the classification algorithms such as SVM, RF, and kNN can be used to classify the AUs (Action Units).
[0117] In the case of emotion recognition based on speech, a classifier, or a supervised learning construct, programmed to perceive any emotions in new speech signals is needed. For example, a categorical emotional model can be built to classify emotions from a predefined set above. Then the database of input data needs to be built. For example, this could be a natural database coming from recordings in the OR (e.g., linked with events in the OR, e.g. sterility loss), it can be elicited when specific user behavior is provoked or asked to act. Then, the system pre-processes speech signals using framing, normalization and voice activity detection. Specific voice features can be extracted using Prosodic, Spectral, Voice Quality or Teager- Energy Operator models. The final classification might be done based on traditional or deep learning classifiers. Examples of classifiers include Gaussian Mixture Model, Hidden Markov Model, Artificial Neural Network, and Support Vector Machines. Some other traditional classification techniques involve k-Nearest Neighbor (kNN), Decision Trees, Naive, Bayes Classifiers, Deep Belief Networks (DBN), Deep Boltzmann Machine (DBM), Restricted Boltzmann Machine (RBM), Recurrent Neural Networks (RNN), Long Short-Term Memory (LSTM) and Convolutional Neural Networks (CNN).
[0118] For example, during user registration, the System might ask the user to act a pre-defined emotions set. Also, some of the emotions might be provoked by showing specific content (e.g., surprising videos or pictures), e.g., with appropriate warnings provided beforehand and any required consent requested and voluntarily given. This initial database could be used fortraining the system which should be further improved by constant observation in the operating room and cross-linking between events, facial and speech emotions.Event detection
[0119] There are several types of events that are important for OR stakeholders. A first type of event is linked to contamination risk for the patient or personnel. Examples are incorrect room preparations (e.g. missing sterile drapes), incorrect instrumentation handling (e.g. assembly of instruments, like powered devices, where non-sterile battery needs to be inserted into sterile cover), incorrect aseptic technique when putting on sterile clothes, filling- up liquids (often done in tandem by the Scrub and Circulating Nurse), accidental touching of non-sterile surfaces by sterile equipment (see, for example, FIG. 6), passing too close to sterile equipment (generally 1 m or more is considered safe), instruments falling on the ground, and others. A second group of events is more linked to general patient safety and well accepted practice, for example, instrument and sponge count, avoiding excessive patient pressure, and the like. Other types of events that are important for safety are correct instruments assembly (especially for precise instruments used e.g., in stereotactic neurosurgery), correct handling (e.g. avoiding hits or excessive pressure on delicate instruments like measurement probes), avoiding accidental hitting of optical / electro-magnetic navigation arrays, and others.
[0120] The System can detect events using Visual and / or Audio I / O inputs. Other system internal functions, for example, spatial localization, can be used for this task, too. As a part of training phase, for each selected event type (e.g., touching of non-sterile surface, hitting navigation array etc.), s sequence of sensor streams (audio, video and others) is obtained. Additional sensors might be used for s specific purpose, e.g., optical tracking for navigation arrays, thermography for liquids, high quality video for surgical supplies count, and the like. The sensor stream series might be precisely labelled (e.g., each frame) or coarsely labelled (e.g. happening within 1 min). With this data, models and algorithms are trained, tested, and / or verified. Example algorithms used for event detection could be convolution neural networks CNNs (ID or more), histogram of oriented gradients (HOG), histogram of flow (HOF), motionboundary histograms (MBH), dense trajectories, a long short-term memory (LSTM) model and others.
[0121] Once the model trained, it can further improve its own functioning automatically or with user feedback. For example, if an event happens, the OR team could inform the system (e.g., by saying "sterility loss", ref. Speech recognition function), and the system can use it to further improve its algorithms.
[0122] Operating rooms are complicated environments that may make training machine learning modules to (e.g., accurately) perform certain functions, such as machine vision tasks, and / or produce (e.g., accurate) audio and / or visual output difficult. For example, it may be difficult for a machine learning module to determine which portions of data are relevant and which are irrelevant in particularly complicated datasets, like visual and / or sensor data from an operating room. Moreover, it may be difficult to obtain appropriate training data for specialized settings, like operating rooms. Such data may not be readily available and the ability to collect additional data may be limited (e.g., by infrastructure and / or for legal or regulatory reasons). In an operating room, there are subject matter experts, such as surgeons and nurses, that can easily identify when certain events (e.g., actions) occur but such persons may not be able to observe all occurrences of such events. Moreover, it would be time consuming for such a person to manually annotate visual data after the fact and therefore obtaining training data in such a manner is likely impractical. However, a person could easily provide annotations for other (e.g., visual) input using audio that is contemporaneously recorded without disrupting workflow [e.g., of an operating room (e.g., without disrupting a surgery)] . For example, a user may speak in a manner that can be captured by a microphone in an operating room as one or more events are occurring to provide audio-derived annotations to visual data (e.g., video recordings) of the event(s) for use in training a machine learning module. A machine-learning module may be trained (e.g., fine-tuned) using a combination of visual and / or sensor data and corresponding audio data (e.g., where the audio data provide annotations for the visual data), for example in addition to a (e.g., more general) pre-training. Such training may be used for event detection and / or stage and / or task identification. Alternatively or in addition, a machine learning module may be trained using data specific to a particular operating room. Operating rooms may have wide variation that makes general training less preferable or less accurate.Spatial localization
[0123] A goal of spatial localization is to identify three-dimensional (3D) positions of people, their clothes, instruments, and equipment in the operating room. For example, identifying where the person and its clothes are, together with information about surrounding equipment, can help with identifying if a sterility loss event happened due to touching of non- sterile surface. Identifying the position of the OR instruments can help with their assembly by showing how to assembly parts that are currently used and where to place them for quicker reuse. Frequency, position, and speed of manipulation can be used for analytics and identifying how well are instruments used and assessing risk related to their use. Positions of people and instruments can be used to better identify surgery stage (e.g., an assistant with retractors and scalpels ready during patient opening stage). Information about people positions and / or instruments use can be used in user training and assessment. For example, the best location for people and equipment can be identified in most effective surgeries (e.g., the shortest ones with correct outcomes) and subsequently used to train nurses, surgeons and OR team. Similarly, the best positions of equipment and instrumentation can be used in the surgery preparation stage to guide OR staff.
[0124] For example, the 3D scene / model of the OR can be automatically created in real time using LiDAR or machine vision technology (see, for example, FIG. 7). Based on this, spatial transformation (e.g., translation and rotation, e.g., represented by a homogenous transform matrix) of scene elements can be identified (e.g., people, clothes, equipment, instrumentation). This can be achieved by on-the-fly registration of fixed or dynamic scene models using affine, scalable, warping, or other registration method. For example, an ICP (Iterative Closes Point) algorithm, Hom transformation, or other algorithm can be used for this purpose. The algorithms may adapt existing or develop new equipment models based on sensor information. For example, an instrument model can be created based on 3D scene information. For adjustable instruments, their models can be automatically updated for detecting the status the instruments are in.
[0125] For people position measurement, the localization technique can be based on skeletal approximation. In this approach, a virtual skeleton is associated with or assigned to each person. Based on visual information, RFID tags, IMUs (Inertial Measurement Units), position, and configuration of a person is calculated. Alternatively, a person’s position can be extracted directly from one or multiple video streams, especially taken from different angles, using standard or machine-learning based algorithms.
[0126] There are alternative methods for tracking instruments and people positions in the OR. These could be visual tracking, using stereo camera systems and reflective or LEDbased fiducials assembled in markers attached to people and devices, electro-magnetic systems, sound and ultrasonic-based techniques, infrared technologies, visible light communications, radiofrequency based navigation, cellular, Wi-Fi, Thread, and ZigBee based technologies. There are proximity-based technologies where position is assessed based on localization in reference to predefined base position, for example, using automatic ID systems, RFID tags, or Bluetooth. Also, the position can be assessed based on visible markers, for example QR codes, processed by one or more cameras and video streams. Other methods for estimating people / human positions and postures involve various computer vision and deep neural network algorithms, CNNs or LSTMs. For example, 3D meshes of human bodies can be extracted from single images and the tracked over time using video streams. Example algorithms involve Human Mesh Recovery, PHALP (Predicting Human Appearance, Location and Pose for tracking), ViT (Vision Transformer) and ViTPose and others.Context segmentation
[0127] Context segmentation is used for determining the nature of an object, person, surface, and the like. For example, sterile surfaces and clothes need to be distinguished from non-sterile, mobile equipment (e.g., instrument tables and trays) from fixed equipment (e.g. OR table attached to the floor), surgical instruments from other devices, certain disposables (e.g. countable items: sponges, rubber bands etc.) from reusables, and the like (see FIG. 8). In certain embodiments, FIG. 8 depicts a graphical user interface showing a VR / AR / MR overlay of an automatic context segmentation performed by the system. This overlay identifies selected devices (instrument table, drapes), their classes (sterile), and people (here, surgeon).
[0128] Information about context segmentation can be used to assist with devices and surgery preparation (e.g., by indicating correct places to prepare instrumentation, tables, and trays), to detect events (e.g., determining which element is sterile and which is not at this concrete surgery stage), for the analytics (use of space, human resources and devices across surgery, OR, institution, or the like, determining improvement points), to follow-up on surgery advancement (presence of specific devices or people in the OR), training (e.g., by indicating how to organize space), and others.
[0129] Context segmentation can be implemented in various ways. For example, the system can be taught to recognize the context. This can be done using various machine learningalgorithms, trained using labelled training (e.g., video streams with segmented elements), verification, and training sets. This can be done using, for example, machine learning classification algorithms. Another option is to use distinguishing features to mark specific classes of objects. For example, sterile surfaces are usually covered with a specific color drape in the OR. Another option is by tracking the object and recognizing its class from type and history of its use (e.g., items taken out from sterilization trays are sterile, e.g., see the Section on Spatial localization). A combination of various methods can be used to increase coverage or reliability of the system. In such case, a Kalman filter can be used to consider different measurement and analysis streams.
[0130] Certain elements can change their context in the course of use. For example, a sterile surface can become considered as non-sterile at the end of surgery, during clean-up, and after patient close (e.g., see the Section on Stage and task identification).Video streaming
[0131] By video streaming, a stream of video, audio, or data (e.g., haptic data) or any combination of these is understood. This streaming capacity can be achieved using any of the appropriate OR Module devices, e.g., Visual Input, Audio I / O, and / or Additional Sensors. The stream can be processed using algorithms. For example, audio can be processed to improve voice clarity (e.g., by using compressors, limiter, equalizers and others). For example, video can be processed to anonymize persons, patients and remove sensitive information. This can be achieved using automatic algorithms, based on machine learning and standard approaches, that identify such information in the stream and proceed with its removal or coverage.
[0132] Video streaming can be used for communication with other interested parties. For example, the surgeon can communicate with other specialists to share knowledge and assist with difficult case resolution. The video snippets can be used to document a particular situation in the OR, e.g., sterility loss due to touching non-sterile device, and reused for team information or training. Repetitive situations can be case-matched and used for training, analytics, or documentation. For the Follow-up use case, being able to see in real time the stream, or its parts, from the OR can be very useful. Video recordings can be used for documenting best practices later shown during the training stage.Situation and person learning
[0133] Situation and person learning means gathering knowledge about how specific tasks in the OR are achieved with a focus on process, people, equipment, and timeline. For example, this could involve defining what is the principal process for the specific surgeon (e.g., Dr. Dee Fault) to conduct specific surgery (e.g. femur osteotomy). It would contain a sequence of tasks (e.g., incision, measurement, initial cut, measurement, second cut, and the like), with alternative flows (e.g., bone fissure detection), time lengths, instruments involved, people involved, information consulted, outcome impact, and the like.
[0134] This information could be used in the surgery preparation stage by making sure that all the required instrumentation and devices are ready. Situation and person learning is important for preparing and getting a surgeon- / surgery- / OR- / equipment-specific customized training. It can be used to proactively request equipment that is going to be used (ref. use case Request equipment). Another potential use involves simulating OR load using actual case models and help with OR schedule management (ref. OR Manager use cases).
[0135] Learning could be implemented building on outputs from other System algorithms, for example, the following: Person identification, Stage and task identification, Instrument identification, Event detection, Spatial localization, Context segmentation and others. Data from these algorithms can be related together to create training, validation and testing datasets. These datasets can be used for training machine learning algorithms. These algorithms could involve CNNs, RNNs, LSTM networks, GAN networks, Principal Component Analysis, Support Vector Machines, and others.Generate specific training
[0136] The goal of this function is to generate a surgeon- / surgery- / OR- / equipment- specific customized training for concerned stakeholder(s) (e.g., Nurse, Scrub, Surgical Physician Assistant, Surgeon, or the like). This function may use input information from other modules, for example, those described in Situation and person learning Section.
[0137] An example generated training could start with learning relevant instrument names (see FIG. 9). FIG. 9 is a screenshot of a graphical user interface showing an example of the instrument learning function, according to some illustrative embodiments, where the user is presented with various instruments and needs to correctly assign their names. The generated training could be achieved by showing instruments to the users and asking to choose right name, e.g., from the list or to say it aloud. Next, the user could be presented with real-lifedemonstration of instruments assembly, excerpts from surgery (see the Section Video streaming) or pages or materials adapted from the instrumentation manuals. Based on learning, real life information from other elements of the system, and past trainings, the most challenging assemblies and sequences could be focused on, e.g., by increasing the number and complexity of exercises. Similarly, instruments’ disassembly and cleaning could be shown. The user could train this part by interacting with phantom models shown on screen, via an AR / VR / MR headset, generic tracked devices, haptic devices, joysticks, or real models.
[0138] The most optimal scrub table layouts could be shown to the user (see FIG. 10). FIG. 10 is a screenshot of a graphical user interface showing an example instrument table layouts learning function, according to some illustrative embodiments. Trainee is presented with various instruments and probability of their use at this surgery stage. Based on this, she / he designs most adequate table layout. An example or most optimal layout is used for reference. Layouts could come from other system models, for example, Learning, to optimize the speed and frequency of instrument preparation.
[0139] Next, the user could learn which stages and tasks are part of the surgery (see FIG. 4 and FIG. 11). FIG. 11 is a screenshot of a graphical user interface showing an example for training of instrumentation-task assignment, according to some illustrative embodiments. The user can be presented with still images, video streams, overlays, and others, from actual surgery. The learning of stages and tasks that are part of the surgery could be divided into several levels: stages (e.g., opening, cutting, implant placement), subtasks (incision, bleeding control, tissue separation), and tasks (cut through skin, prepare electrosurgical device, and the like). These levels could be connected in processes, for example, the main process which is used or favorable in most of the cases, and alternatives, together with their triggers (e.g., excessive bleeding mitigation due to unintentional artery cut). These processes could be taught to the trainee by step-by-step explanation, intermittent evaluations, art of memory techniques, visuals, and others. This part of the training could be constructed bottom-up by learning the lower-level tasks first, as building blocks that are used later to construct stages and as a whole surgery.
[0140] Evaluations could be done progressively across the training to assess effectiveness of its stages, and in the end, to assess global effectiveness and personal improvement. Also, by having direct feedback from the OR, the system could automatically assess the user improvement and based on that, adjust the training. Such adjustments could be used more horizontally, where learnings from one trainee are applied to the other. The systemcould, by itself, detect which is the best method for learning, e.g., by automatizing A / B learning technique where to two matched or representative sets of users two alternative methods of training are presented and their efficacy assessed.
[0141] Each stage of the training could be divided into a generic part, applicable to many surgeries, and specific parts that are more surgeon- / OR- / equipment-specific. For example, the trainee might learn that in most cases surgeon Dr. Dee Fault skips through certain parts while other surgeons do it differently.Personnel assessment
[0142] The goal of this stage is to assess how well a person fits with different tasks he / she can be assigned to, define improvement areas, and help with team and schedule management. This information could be used to obtain specific, person-related analytics and insights, could be used for learning and pro-actively predicting course of action in the OR, simulating load and managing schedule to have the most efficient resource utilization, to compose the best performing teams, and to manage personal trainings.
[0143] Personnel assessment could be achieved by analyzing personal behavior from the operating room and outcome from System algorithms. For example, the information on speed and correctness of preparation, instrument waiting time, events frequency, presence and type of tasks performed could be used (see relevant Sections describing these functions and use cases).
[0144] Personal progress and assessment during training sessions and trend tracking through surgeries could be used for the assessment, as well.
[0145] The information can be assembled in personal dashboards with drill down possibility to underlying data, video snippets showing specific behavior, and recorded events (see FIG. 12). FIG. 12 is a screenshot of a graphical user interface showing an example employee dashboard showing OR / Surgery performance, training compliance, and task assessment, according to some illustrative embodiments. From the difference of required and actual task assessment, a training program can be suggested and schedule adapted (see adequate buttons). The dashboard can be compared to other data, e.g., institution average and best scores, other institutions, or the like.System Use Cases
[0146] In the use case diagrams below, users are shown with a schematic person design, use cases in rounded boxes, participating system elements in rectangles, and connection / participation using lines. The examples below are illustrative - other configurations are possible. For example, it is possible that other equipment is used in the process, other actors are involved, and different underlying functions enabling the use case are performed. For example, a sales representative from industry can help with certain surgery stages, new use cases can be built on a top of existing functionalities, and functionalities can be reconfigured or arranged differently to realize use case.Scrub Nurse
[0147] Illustrative Scrub Nurse Use Cases enabled by the System are shown in FIG. 13. FIG. 13 is a schematic diagram illustrating Scrub Nurse use cases facilitated by the system, according to some illustrative embodiments. The illustrative “Assist with device and instrumentation” use case performed by the system helps the Scrub Nurse to prepare and organize for the most efficient instrumentation handling (see FIG. 14). FIG. 14 is a screenshot of a graphical user interface showing example assistance shown during surgery, according to some illustrative embodiments. The following items are noted in the screenshot of FIG. 14: ( 1 ) the system identified possible improvement in instrument table layout and suggests it to the user together with example reference layout; and (2) the system identified an instrument missing, which has high probability of usage in coming instances, stages and tasks.
[0148] A goal of the Scrub Nurse Use Cases is to reduce to minimum the Surgeon’s waiting time for the instrument, implant, device, or any other equipment (called, collectively, instruments). This is achieved thanks to System awareness of current surgery stage and task. This information, using the Predictive analytics, is used to identify which stage will follow and which instruments are going to be used. Instrument and equipment identification is used to assess if relevant instruments are already prepared. Each instrument can have a probability use score attached to better judge priorities. In order to communicate this information to Scrub, Projector and Audio I / O can be used. For example, Projector might highlight the instrument with laser pointer, with rear projection or with spotlight, might show the instrument on the OR Screen, highlight through AR Headset, announce through speaker, or the like. Additionally, instrument table set-up to optimize instrument handling time might be communicated to thescrub. Such set-up could be calculated based on probability of instrument use, instrument size, assembly, and the like. For communication, any projection means or OR Screen might be used.
[0149] A goal of the "Obtain help” use case is to provide immediate help to the scrub concerning instrument assembly and use. Many instruments, from various manufacturers and systems, are being used in the operating room and it is increasingly complex to retain how they are meant to be operated. The System, based on current surgery stage and task, as well as instruments shown by the nurse (e.g., handheld towards Visual Input), shows instruction or help for assembly and instrument use (see FIG. 15 and FIG. 16). This information can be shown with Projector, OR Screen, AR Headset or others. The Scrub or other user can further interact with system asking questions and giving speech feedback or instructions. For example., they might ask for clarity on a particular step, show assembly animation, or view from a different angle. The help contents might be provided by instrumentation manufacturer, company providing the System or by OR Staff themselves.
[0150] FIG. 15 depicts a graphical user interface showing a VR / AR / MR overlay depicting an OR Staff member showing an instrument to the system to request assistance in its identification and / or use, with the automatically determined identification shown in the overlay, along with a probability that said determination is accurate, according to some illustrative embodiments. FIG. 16 is a screenshot of a graphical user interface showing assistance that is presented based on a detected instrument, surgery stage, staff exchange, or other trigger, according to some illustrative embodiments. Example assistance shows what needs to be done for instrument exchange and assembly. Still pictures, descriptions, short videos, animations, or the like, can be used.
[0151] The Detect events use case helps with detection of surgery-important events. These could be potential sterility loss due to incorrect aseptic technique (e.g., touching of non- sterile surface), incorrect instrument assembly, unintentional hits of the navigation markers (fiducials attached to patient anatomy to enable tracking), and others. This is achieved thanks to spatial localization of persons and objects linked with context segmentation (sterile / non- sterile) and stage and task identification (e.g., at the end of the surgery all the instruments can be safely scrapped by a non-sterile person). After detection, some events need to be communicated to the OR Staff (e.g., sterility loss). This could be done via OR Screen, projector, sound alarm, or others. After obtaining staff attention, the event can be shown (e.g., the moment when sterile clothing accidentally touched non-sterile wall) for the OR Staff todecide on handling the issue. It should be possible to acknowledge certain events. Events should be logged for further analysis.
[0152] The Communicate use case enables OR Staff to simply communicate between each other or with external people. This can be a simple voice communication, or more advanced including video streams or better situation awareness (e.g., depending on surgery stage, person triggering the communication etc.). This information can be used to better define to whom the communication is targeted and what is being asked.
[0153] The Assist with surgery preparation use case is activated before the surgery with a goal to ensure that all required equipment is available in the OR. This uses past experiences, especially events where surgeon or staff had to wait for specific device, to construct dynamic, surgeon and case-specific list of equipment. This equipment presence can be automatically detected or users might be asked to check and confirm.
[0154] The Get trained use case enables transfer of user and situation-specific knowledge to the trainee. Training is procedure- and surgeon- specific as well as adapted to the trainee (nurse, scrub, particular person). It uses past experiences, events, instruments and equipment, timing information, video and audio streams, target audience, and the like to generate training goals and training content. Training can be viewed on Viewing Station in a series of learning and training materials. Final result assessment can be provided to assess candidate and training effectiveness. Additionally, this effectiveness can be assessed during follow-up cases in the OR. The training can be done on Terminal, Viewing Station, or a specific training device. A specific training device could be a flat-lying touchscreen with PC, AR (Augmented Reality) or VR (Virtual Reality) devices (or MR mixed reality devices), haptic devices, holographic devices and projectors, laser projectors, joysticks, haptic devices, phantom devices, wearables, IMUs (Inertial Measurement Unit) devices, training instrument sets, and others.
[0155] The Follow-up use case enables users to be up to date with operating room events. For example, it allows OR Staff to concentrate on other activities or take rest until relevant stage in the OR is achieved and when their presence is required.
[0156] The Request equipment use cases are requests for a Nurse to bring equipment to the OR, emergency assistance requests, automatic reactions to events (e.g., instrument sterility is compromised and new instrument needs to brought in the room). Notifications can be shown on Terminals or Viewing Stations. This function is enabled by automatic stage and task identification and its outcomes can be automatically assessed (e.g. has required actionhappened on time) and used for future improvements. Request equipment is used based on user trigger or automatically ask for bringing specific equipment to the OR. The goal is to always have required instrumentation and equipment in the OR. Requests can be generated automatically based on surgery stage and current inventory in the OR (e.g., automatically assessed), previous learning, events, and the like. Requests can be user-triggered, for example simple voice command, for example, “Ask the nurse to bring new scalpels” could be directly text coded “Surgeon X requests new scalpels in block number Y” and sent to relevant person’s terminal (here Nurse Terminal).Surgeon
[0157] Surgeon use cases enabled by the System are shown in FIG. 17.
[0158] The Get analytics use case allows the surgeon to assess his and his team’s performance. For example, this would be reviewed in an office setting, on a Viewing Station. Based on intra-operative data, the surgeon could review several graphs and indicators, for example: effective OR, effective OR time vs. planned time, preparation time, instrumentation waiting time, ambiance / mood in the OR, event statistics (detected events, number of them, and the like), surgery stages statistics, personnel statistics (who, where, when, etc.), trends, costs, and others . Surgeon could have a possibility to compare his data to a wider pool of data coming from other surgeons in the same institution, other hospitals, other geographies and worldwide.
[0159] The Surgeon Follow-up, Request equipment and Detect events use cases are similar to the ones described in previous Sections. These use cases should be adapted to the surgeon. For example, surgeon is interested in other events then scrub nurse, as usually he comes into the operating room at a later stage then the Scrub. Similarly, as much as aseptic technique events are of prime interest for the scrub, surgeon is mainly interested in more procedure-relevant, direct patient impact events. For example, this includes errors with manipulating surgical tracking and navigation equipment, hitting patient measurement markers attached to anatomy (described above) and others.
[0160] The use case Follow up enables real-time follow-up of the surgeries (see FIG. 18). The follow-up is done automatically or semi-automatically with some user participation. Fellow-up information can be communicated using scales, advancement graphs, textual messages, logs, event reports, comparison to statistical results, goals, and the like, in order to keep all the stakeholders up to date. Expected duration of each stage, based on previous experiences and learning, can be indicated. Follow-up can be done on Terminal, ViewingStation or other device. This use case can be linked to Get notified, for example to include alarms, reminders and others.
[0161] FIG. 18 is a screenshot of a graphical user interface presented on a mobile device, the screenshot showing a follow-up visible on a Surgeon Terminal in a Surgeon use case, according to some illustrative embodiments. The user has a clear view of current surgery stage, can consult video stream, and call OR staff. He has a clear overview of when his involvement begins and can plan accordingly. Alarms can be set for predefined stages, here, one minute before expected cutting.
[0162] The use case Learn is happening in the background and concerns the System rather than the surgeon. The System constantly gathers data about persons, equipment, instruments, events, exchanges, visual and audio, mood, timing, spatial, and others. This data is later used for analytics, obtaining intelligence, predictive simulations, training, and others.Circulating Nurse
[0163] Circulating Nurse, or Nurse, use cases enabled by the System are shown in FIG. 19. Circulating Nurse use cases Assist with surgery preparation, Detect events, Get notified, and Request equipment are similar to use cases described in previous Sections. These use cases should be adapted to the specific needs and role of the Nurse. For example, she can bring equipment based on the request from the OR (see FIG. 20). She can receive messages, voice or video calls on her terminal. The messages can be automatically acknowledged and checked when requested equipment is in the OR. The Nurse participates actively in surgery preparation. In this use case, she can directly receive information about what needs to be prepared and where particular attention needs to be paid, on her terminal or OR Screen. As mentioned in previous Sections, surgery preparation is based on dynamic lists that adapt over time to surgery type, surgeon, personnel and others.
[0164] FIG. 20 is a screenshot of a graphical user interface presented on a mobile device, the screenshot showing a Nurse Request Equipment use case visible on a Nurse Terminal in a Nurse use case, according to some illustrative embodiments. It shows overview of what is requested in each OR, together with an estimation of when it is going to be used. Color-coding, alarms, and ordering can be used to communicate priority. Expected equipment, together with attached probability, can be foreseen by the System based on previous experiences, surgery execution and detected events.
[0165] The OR Manage use cases enabled by the System are shown in FIG. 21. OR Manger use cases Follow-up, Get notified are similar to the use cases described in previous Sections. These use cases should be adapted to specific OR Manager needs, for example, by showing data of interest for him (e.g., whole team performance, OR global workload, and the like), notifications about specific events, and others.
[0166] Use case Simulate load allows OR Manager to simulate OR load for predefined future period of time (e.g., week, month, quarter, and the like). By the load, many factors are considered like OR effective use, probability of delays, readiness, personnel adequacy, expected timings, spare capacity, and others. This use case allows user to effectively simulate impact of various parameters like personnel changes, equipment, new treatments, new approaches, training needs, and the like. Data for simulation, especially for new areas for particular institution, can come from other institutions, physicians, settings, previous history, and others. This use case is an effective support for decision making from both clinical and health economics point of view.
[0167] Use case Manage schedule makes use of the Simulate load and other information to help OR schedule management. It is a known problem that OR schedule management has important challenges due to many non-obvious impact factors (patient, surgeon, OR team, equipment etc.) that are hard to consider. By integration of simulation factor and pertinent learning from previous experiences with the team, equipment and location, more precise and better corresponding to reality schedules can be constructed. Also, schedule management can take different time constraints into consideration (e.g., surgeon wants to operate between 7h and 16h, nurse without long over-hours, anesthesia in yet different time slots and administration 24h a day).
[0168] Use case Manage team allows team effectiveness assessment in the light of current and future tasks, schedule, changes, and the like. It gives a comparison between required and best skills and the available ones. It allows to identify team gaps in quantity and / or training. It allows to assess impact for personnel changes and training. The implementation can be achieved, for example, using a heatmap representation with required / available skills, timeline, and workload updated in real time depending on schedule changes, suggested team and shift allocations, suggested trainings to optimize team adequacy, and others. It allows observation of trends in personal development over time.
[0169] In order to Manage trainings, OR Manager can assign specific training to the user. In order to choose the best training, personal assessment of the user can be consulted,compared to the rest of the team (see FIG. 12 and use case Manage team) and schedule (use case Manage schedule) and training availability (use case Get trained).
[0170] Use case Optimize instrumentation addresses important problem described in earlier Sections and linked to the fact that even if just one instrument is used, the complete tray needs to be re-sterilized. In this use case, a design of a new sterilization tray can be achieved which based on the surgeon, surgery, OR team and past experiences can optimize instrumentation trays that minimize the sterilization costs per case (see FIG. 22). For example, the system might suggest tray composition that consists of instruments that are used in 90% of the cases and second tray in remaining 10%. Thus, in most of the cases, only one case will be opened and sterilized, resulting in important cost savings. The scope of the instrumentation (one surgery vs. many, one surgeon vs. multiple, and the like) can be defined to allow an institution to define its own tradeoffs (e.g., universality - cost, complexity of operations - specialization, and the like). The System can suggest complete tray configuration and allow user individual changes to further tune tray composition. These changes might be attached to a score, e.g., probability of use, to allow user assessment of the impact of changes. Relevant documentation of tray composition can be exported and communicated with cleaning and sterilization departments. Also, simulated tray layouts can be made for the target composition. There exist universal sterilization trays that could be used, specific tray could be provided by the manufacturer or adaptation or complete trays produced by the hospital using, e.g., additive manufacturing.
[0171] FIG. 22 is a screenshot of a graphical user interface depicting an instrument optimization use case, according to some illustrative embodiments. It is surgeon- (Dr. Dee Fault) and surgery- (here TKA) specific. It shows current instrument trays disposition and results of an analysis coming actual cases. Based on this data, the System proposes optimized tray disposition which minimizes sterilization costs (each opened tray needs to resterilized for next case, even if no instruments are taken out). The System can also determine and display an estimation of savings to visualize impact.Administrator
[0172] Administrator use cases enabled by the System are shown in FIG. 23. Administrator use cases Follow-up, Get notified are similar to the use cases described in previous Sections. These use cases should be adapted to specific Administrator needs, forexample, by displaying data of interest for him (e.g., by OR, complete institution, global workload, and the like), notifications about specific events, and others.
[0173] The Get analytics use case allows Administrator to assess his institutions and its members performance. For example, this would be reviewed in an office setting, on a Viewing Station. Based on data, Administrator could review several graphs and indicators, for example: effective OR, effective OR time vs. planned time, preparation time, instrumentation waiting time, ambiance / mood in the OR, event statistics (detected events, number of them, and the like), surgery stages statistics, personnel statistics (who, where, when, etc.), trends, costs analysis, and others. Administrator could have a possibility to compare his data to a wider pool of data coming from other units in the same institution, other hospitals, other geographies, and worldwide.Industry
[0174] Collected data about the OR and instrumentation use statistics can be of important value for industry, hospitals, and administrators. For example, usage statistics can serve as important usability information, events log for risk management, cost analysis for health economics, and the like. This data in raw, pre-processed, or synthesized form can be provided to these institutions.
[0175] Currently, many surgeries receive assistance from industry which provides Sales Representatives available in the Ors to help Surgeon and OR staff. The cost impact is often reflected in high price of instruments or implants or sometimes invoiced separately. The System may remove the need for such assistance by providing use cases Assist with devices and instrumentation and Assist with surgery preparation, and others. Industry may provide different pricing options to institutions wanting to preserve Sales Representatives and those willing to pass to the functionalities provided by the System.VR / AR / MR devices for use with the System
[0176] Commercially available virtual reality (VR), augmented reality (AR), and / or mixed reality (MR) systems feature head-worn and / or face-worn hardware, as well as eyetracking software, and may be used as components of the systems and methods described herein. For example, the following is a description of an illustrative VR headset system for use in various embodiments described herein. As used herein, the terms “headset”, “VR headset”, “AR headset”, or “MR headset” refer broadly to such head- or face-worn systems thatimplement virtual reality, augmented reality, and / or mixed reality functionality. For example, in certain embodiments, the commercial VR / AR headset system has eye-tracking capability.
[0177] An example of a professional-grade VR / AR headset system with eye tracking capability that can be used with the systems and methods described herein is the VIVE Pro Eye Office VR system, manufactured by HTC Corporation (headquartered in Xindian, New Taipei, Taiwan), as described at https: / / business.vive.com / us / product / vive-pro-eye-office / and in U.S. Patent No. 10,990,170, entitled, “Eye tracking method, electronic device, and non-transitory computer readable storage medium,” and in U.S. Patent No. 10,705,604, entitled, “Eye tracking apparatus and light source control method thereof,” the disclosure of each of which is incorporated herein by reference in its entirety. Another example of a virtual-, augmented-, and / or mixed-reality device that includes eye tracking capability and may be used with the systems and methods described herein is the Varjo Aero manufactured by Varjo Technologies Oy (Helsinki, FI). A Varjo Aero may be used to track eye movement of a user while rendering and displaying one or more screens, graphics, and / or widgets to the user, for example for object identification and / or tracking for the user.
[0178] Virtual-, augmented-, and / or mixed-reality devices (e.g., VR headsets) may be used in various embodiments described herein, for example to provide a mechanism with which to show a user where in a setting an object is located and / or to track an object in a setting for a user (e.g., for object detection, e.g., real-time object detection). Commercially-available virtual reality (VR), augmented reality (AR), and / or mixed reality (MR) systems feature head-worn and / or face-worn hardware, as well as eye-tracking software, and may be used as components of the systems and methods described herein. As used herein, the terms “headset” or “VR headset” refer broadly to such head- or face-worn systems that implement virtual reality, augmented reality, and / or mixed reality functionality. A virtual-, augmented-, and / or mixed- reality device (e.g., VR headset) may include eye tracking capability. Eye tracking capability may be used to track movement of one or both eyes of a user, for example in order to properly (e.g., spatially) render one or more graphics and / or widgets to a user to indicate where an object is, for - 41 -xamplee using a bounding box, overlay (e.g., semi-translucent coloring) over the object, or other graphic or widget. An virtual-, augmented-, and / or mixed-reality devices (e.g., headsets) may be used to perform one or more machine vision tasks for a user (e.g., to provide indications of where objects are and / or track objects in a setting, such as, for example, surgical or medical tools in a healthcare setting, such as an operating room) as disclosed herein. A virtual-, augmented-, and / or mixed-reality device (e.g., VR headset) may be a consumer gradedevice. A virtual-, augmented-, and / or mixed-reality device (e.g., VR headset) may be a professional grade device.
[0179] An example of a professional-grade VR headset system with eye tracking capability that can be used with the systems and methods described herein is the VIVE Pro Eye Office VR system, manufactured by HTC Corporation (headquartered in Xindian, New Taipei, Taiwan), as described at https: / / business.vive.com / us / product / vive-pro-eye-office / and in U.S. Patent No. 10,990,170, entitled, “Eye tracking method, electronic device, and non-transitory computer readable storage medium,” and in U.S. Patent No. 10,705,604, entitled, “Eye tracking apparatus and light source control method thereof,” the disclosure of each of which is incorporated herein by reference in its entirety. Another example of a virtual-, augmented-, and / or mixed-reality device that includes eye tracking capability and may be used with the systems and methods described herein is the Varjo Aero manufactured by Varjo Technologies Oy (Helsinki, FI). A Varjo Aero may be used to track eye movement of a user while rendering and displaying one or more screens, graphics, and / or widgets to the user, for example for object identification and / or tracking for the user.
[0180] Fig. 24A shows an illustrative system 2400 that can perform methods described herein. The illustrative system 2400 includes a memory 2402 on which instructions are stored that, when executed by processor 2404, perform one or more methods described herein. Optionally, the system 2400 can include a VR headset 2410, for example from which a first and second data stream corresponding to a gaze direction and gaze origin are sent to, and received by, the processor 2404 for use in executing instructions stored on the memory 2402.
[0181] Fig. 24B shows a detailed block diagram of components that may be included in the VR headset 2410, for example if the VR headset 2410 is a VIVE Pro Eye Office VR system. The components may include one or more of (i) a camera 2412 for tracking an eye of a user; (ii) one or more illumination sources LSI, LS2, . . . LSN for illuminating an eye of the user to provide signal to the camera 2412 in order to track the eye; (iii) one or more optics 2416, such as lenses, reflectors, or other light guiding components, for guiding light that has interacted with the eye (e.g., reflected from the eye) to the camera 2412; (iv) a display 420 for displaying images to the user; (v) one or more headset processors 2414 for processing data from camera 2412, for the display 420, or from and / or for other components in the VR headset 2410; and (vi) one or more adjustment and / or head support mechanisms 422 for physically adjusting (e.g., orienting and / or aligning) the VR headset on a user (e.g., relative to an eye of the user and / or for comfort during use). Generally, the VR headset 2410 is a wearableapparatus that may be worn over one or both eyes of a user at a time. For example, the VIVE Pro Eye Office VR system is worn over both eyes but other VR headsets that can be used may have a “monocle” style that is worn over one eye at a time. The display 420 may also be used to provide one or more graphics and / or widgets (e.g., simulated images) to the user.
[0182] The processor 2404 that executes instructions may be one of the headset processors 2414. The memory 2402 and the processor 2404 may be housed in the VR headset 2410 or may be separately housed, for example in a server or other computing device that is in communication (e.g., wireless communication) with the VR headset 2410. The one or more headset processors 2414 may be used to send data stream(s) to the processor 2402, for example wirelessly.
[0183] The VR headset 2410 may also include one or more adjustment and / or head support mechanisms 422. Adjustment mechanisms 422 may include one or more mechanical mechanisms, such as knobs, straps, dials, or the like. The adjustment mechanisms 422 may be used to adjust the horizontal and / or vertical position of the headset (e.g., a component thereof, such as the display 420) relative to the head of a user. For example, the VIVE Pro Eye Office VR system includes mechanism(s) to adjust the interpupillary distance (IPD) to the particular user using the system by an “IPD knob.” IPD adjustment may involve first determining a physical IPD measurement, for example manually by the user or with assistance from another person. As another example, the VIVE Pro Eye Office VR system includes a lens distance adjustment button that can be pressed to allow a user to adjust the distance of the lens further or closer to his or her face. Such an adjustment may be used to account for user anatomy or other factors, such as glasses or other sight aids. A user may be prompted to make adjustment of one or more of the adjustment mechanism(s) 422 based on a virtual alignment aid to determine whether the VR headset 2410 is properly aligned and / or oriented.
[0184] Various head support mechanisms may be used to “mount” a VR headset on a user’s head in order to secure the VR headset and / or assist in providing user comfort during use. Head support mechanisms 422 may include one or more physical structure(s) such as strap(s), mount(s), brace(s), padding, or the like. The physical structure(s) may be adjustable (e.g., a hook and loop fastener or elastic strap) or compliant (e.g., foam padding) or both (e.g., an adjustable strap with padding). For example, the VIVE Pro Eye Office VR system includes a replaceable face cushion that provides compliant support around a user’s eyes for comfort as well as a head pad, adjustment dial, and center strap that collectively secure the system to a user’s head with the adjustment dial being part of the head pad that sits on the back of the headand center strap that runs over the top of the head. The adjustment dial can adjust the tension of the center strap and the center strap also has a hook and loop fastener for easy mounting and dismounting from the head.
[0185] Additional details about certain illustrative adjustment and / or head support mechanisms that can be included in an embodiment of a VR headset, such as the VR headset 2410 shown in Figs. 4A-4C, are provided in the VIVE Pro Eye User guide for the VIVE Pro Eye Office VR system. Other adjustment and / or head support schemes can be used. Furthermore, in certain embodiments, a particular mechanism (e.g., structure) may serve as both an adjustment mechanism and a head support mechanism. For example, a strap may be used to secure a VR headset to a wearer and may also be used to adjust a physical position of the VR headset to the wearer’s eyes.
[0186] Fig. 24C shows a schematic of how the illustrative VR headset 2410 can be used to track an eye 2401 of a user. Illumination sources (light sources) LSI, LS2, . . . , LSN provide light to the eye 2401. Light is received by reflector 2416 from the eye 2401 after illumination and reflected toward the camera 2412 where it is detected and the processed using a headset processor 2414 that is part of a controller, which refers to lookup table 2418. Optionally, the display 420 simultaneously displays image(s) to the user, for example to prompt eye movement or a particular focus of the user in order to orient or track the eye 2401. One or more optics 2416 (e.g., lenses) may be used to focus or otherwise guide light from the display 420 to the user. The display 420 may be considered a portion of one or more optics 2416, for example a “lens” of the VR headset 2410 may include the display 420 (or portion thereof).
[0187] In the illustrative VR headset 2410, the illumination sources LS 1 , LS2, . . . , LSN project a plurality of light beams to the eye 2401 on a target zone. The light reflection device 2416 receives and reflects the display image IMG of the eye 2401 to the camera 2412. The controller with headset processor 2414 is coupled to the camera 2412 and the illumination sources LSI, LS2, ... , LSN. A headset processor 2414 receives the display image IMG and analyzes the contrast ratio of the display image IMG. The headset processor 2414 additionally generates the command signal DS through a result of the analysis, and controls the turning on or turning off states of each of the illumination sources LSI, LS2, ... , LSN through the command signal DS. The lookup table 2418 is configured to store the relationship between the turning on / tuming off states of the illumination sources LSI, LS2, ... , LSN and the field of view information of the eyeball. The lookup table 2418 may be implemented as a memory of any suitable form, which will be apparent to those of skill in the art. The lookup table 2418 maybe external to the controller with the headset processor 2414 and coupled to the controller. Alternatively, the lookup table 2418 may also be embedded in the controller with the headset processor 2414. Further details of additional embodiments of how such a lookup table 2418 and controller may be used to control components of a VR headset 2410 to track the eye 2401 of a user (e.g., patient) can be found in U.S. Patent No. 10,705,604.
[0188] A virtual-, augmented-, and / or mixed-reality device may include one or more cameras that capture real time images (e.g., in a video feed) of at least a portion of a field of view of a user. In this way, a virtual-, augmented-, and / or mixed-reality device can provide images to a machine vision module (e.g., included in the device or communicatively coupled thereto) in order for the module (e.g., a machine learning model therein) to use the images as input to perform one or more machine vision tasks (e.g., detection, identification, and / or tracking of one or more objects) (e.g., object detection). Output of the module (e.g., from the model) may be rendered and displayed to a user by a virtual-, augmented-, and / or mixed-reality device. A machine vision module may take output from a machine learning model (e.g., object identity and / or position) and process it, for example generating one or more graphics and / or widgets.
[0189] A virtual-, augmented-, and / or mixed-reality device may be or include a headset or be or include another display (e.g., be or include a window through which a user views a scene in the user’s field of view) (e.g., a head-up display). For example, in certain settings, a user will naturally be looking through a transparent window, such as for example a fume hood in a research or laboratory setting or a protective window on a piece of construction equipment (e.g., a crane or front loader). A virtual-, augmented-, and / or mixed-reality device may include or be integrated with such transparent windows.
[0190] Illustrative embodiments of systems and methods disclosed herein were described above with reference to computations performed locally by a computing device, for example included in a VR headset with eye tracking capability. However, computations performed over a network are also contemplated, for example as described with respect to Figs. 25-26. Methods of the present disclosure, or portions thereof, may be performed using a processor. The processor may be a part of a computing device and / or computing system.Software, Computer System, and Network Environment
[0191] Certain embodiments described herein make use of computer algorithms in the form of software instructions executed by a computer processor. In certain embodiments, thesoftware instructions include a machine learning module, also referred to herein as artificial intelligence software. As used herein, a machine learning module refers to a computer implemented process (e.g., a software function) that implements one or more specific machine learning algorithms, such as an artificial neural network (ANN), a convolutional neural network (CNN), random forest, decision trees, support vector machines, and the like, in order to determine, for a given input, one or more output values. In certain embodiments, the input comprises numerical data, tagged data, and / or functional relationships. In certain embodiments, the input comprises image data and / or alphanumeric data which can include 2D and / or 3D datasets, numbers, words, phrases, or lengthier strings, for example. In certain embodiments, the one or more output values comprise image data (e.g. 2D and / or 3D datasets) and / or values representing numeric values, words, phrases, or other alphanumeric strings. In certain embodiments, the input comprises alphanumeric data which can include numbers, words, phrases, or lengthier strings, for example. In certain embodiments, the one or more output values comprise values representing numeric values, words, phrases, or other alphanumeric strings. In certain embodiments, the machine learning module may include natural language processing (NLP) to allow it to automatically analyze an input alphanumeric string(s) to determine output values classifying a content of the text (e.g., an intent), e.g., as in natural language understanding (NLU). For example, a machine learning module may receive as input a textual string (e.g., entered by a human user, for example) and generate various outputs. For example, the machine learning module may automatically analyze the input alphanumeric string(s) to determine output values classifying a content of the text (e.g., an intent), e.g., as in natural language understanding (NLU). In certain embodiments, a textual string is analyzed to generate and / or retrieve an output alphanumeric string.
[0192] In certain embodiments, machine learning modules implementing machine learning techniques are trained, for example, using datasets that include categories of data described herein. Such training may be used to determine various parameters of machine learning algorithms implemented by a machine learning module, such as weights associated with layers in neural networks. In certain embodiments, once a machine learning module is trained, e.g., to accomplish a specific task such as identifying certain output strings, values of determined parameters are fixed and the (e.g., unchanging, static) machine learning module is used to process new data (e.g., different from the training data) and accomplish its trained task without further updates to its parameters (e.g., the machine learning module does not receive feedback and / or updates). In certain embodiments, machine learning modules may receivefeedback, e.g., based on user review of accuracy, and such feedback may be used as additional training data, to dynamically update the machine learning module. In certain embodiments, two or more machine learning modules may be combined and implemented as a single module and / or a single software application. In certain embodiments, two or more machine learning modules may also be implemented separately, e.g., as separate software applications. A machine learning module may be software and / or hardware. For example, a machine learning module may be implemented entirely as software, or certain functions of an ANN module (e.g., CNN) may be carried out via specialized hardware (e.g., via an application specific integrated circuit (ASIC)). A machine-learning module may be pre-trained and / or trained during use (e.g., on the fly).
[0193] In certain embodiments, machine learning modules implementing machine learning techniques may be composed of individual nodes (e.g. units, neurons). A node may receive a set of inputs that may include at least a portion of a given input data for the machine learning module and / or at least one output of another node. A node may have at least one parameter to apply and / or a set of instructions to perform (e.g., mathematical functions to execute) over the set of inputs. In certain embodiments, node instructions may include a step to provide various relative importance to the set of inputs using various parameters, such as weights. The weights may be applied by performing scalar multiplication (e.g., or other mathematical function) between a set of inputs values and the parameters, resulting in a set of weighted inputs. In certain embodiments, a node may have a transfer function to combine the set of weighted inputs into one output value. A transfer function may be implemented by a summation of all the weighted inputs and the addition of an offset (e.g., bias) value. In certain embodiments, a node may have an activation function to introduce non-linearity into the output value. Non-limiting examples of the activation function include Rectified Linear Activation (ReLu), logistic (e.g., sigmoid), hyperbolic tangent (tanh), and softmax. In certain embodiments, a node may have a capability of remembering previous states (e.g., recurrent nodes). Previous states may be applied to the input and output values using a set of learning parameters.
[0194] In certain embodiments, the machine learning module comprises a deep learning architecture composed of nodes organized into layers. For example, a layer is a set of nodes that receives data input (e.g., weighted or non-weighted input), transforms it (e.g., by carrying out instructions, e.g., applying a set of functions e.g., linear and / or non-linear functions), and passes transformed values as output (e.g., to the next layer). In certain embodiments, the setof nodes in a particular layer may share the same parameters and instructions without interacting with each other. A machine learning module may be composed of at least one layer (e.g., ordered). Examples of types of layers include convolutional layers (e.g., layers with a kernel, a matrix of parameters that is slid across an input to be multiplied with multiple input values to reduce them to a single output value); fully connected (FC) layers (e.g. all nodes are connected to all outputs of the previous layer); recurrent layers, long / short term memory (LSTM) layers, gated recurrent unit (GRU) layers (e.g., nodes with the various abilities to memorize and apply their previous inputs and / or outputs); batch normalization (BN) layers (e.g., layers that normalize a set of outputs from another layer, allowing for more independent learning of individual layers); activation layers (e.g., layers with nodes that only contain an activation function); and / or (un)pooling layers [e.g., layers that reduce (increase) dimensions of an input by summarizing (splitting) input values in defined patches).
[0195] In certain embodiments, the performance of a machine learning module may be characterized by its ability to produce an output data with specific accuracy. To achieve specific accuracy, a training process is performed to find optimal parameters, such as weights, for each node in each layer of the machine learning module. In certain embodiments, the training process of a machine learning module may involve using output data to calculate an objective function (e.g., cost function, loss function, error function) that needs to be optimized (e.g., minimized, maximized). For example, a machine learning objective function may be a combination of a loss function and regularization parameter. The loss function is related to how well the output is able to predict the input. The loss function may take various forms, like mean squared error, mean absolute error, binary cross-entropy, categorical cross-entropy, for example. The regularization term may be needed to prevent overfitting and improve generalization of the training process. Examples of regularization techniques include LI Regularization or Lasso Regression, L2 Regularization or Ridge Regression, and Dropout (e.g., dropping layer outputs at random during training process).
[0196] In certain embodiments, objective function optimization of a machine learning module may involve finding at least one (e.g., all) of the present global optima (e.g., as opposed to local optima). In certain embodiments, the algorithm for objective function optimization follows principles of mathematical optimization for a multi-variable function and relies on achieving specific accuracy of the process. Examples of objective function optimization algorithms include gradient descent, nonlinear conjugate gradient, random search, Levenberg- Marquardt algorithm, limited-memory Broyden-Fietcher-Goldfarb-Shanno algorithm, patternsearch, basin hopping method, Krylov method, Adam method, genetic algorithm, particle swarm optimization, surrogate optimization, and simulated annealing.
[0197] In certain embodiments, the machine learning modules comprises one or more image-based segmentation neural networks. Illustrative examples of segmentation neural networks include, for instance, Deep Image Matting (DIM), semantic segmentation methods (U-Net, DeepLab Series), Mask R-CNN, Chroma Keying and / or Luminance Keying CNNs, RefmeNet, and MODNet.
[0198] In certain embodiments, the machine learning modules comprise one of more generative Al modules. Rather than depending on use of predetermined weights and rules, generative Al leverages complex neural networks and algorithms to understand patterns and produce output that mimic human creativity. Examples of generative Al modules include image synthesis models (e.g., DALL-E3, DALL-E2, Imagen 3 in Gemini, Craiyon, and the like) and text generation models (e.g., ChatGPT, GPT-4, and the like).
[0199] As shown in FIG. 25, an implementation of a network environment 2500 for use in providing systems, methods, and architectures as described herein is shown and described. In brief overview, referring now to FIG. 25, a block diagram of an illustrative cloud computing environment 2500 is shown and described. The cloud computing environment 2500 may include one or more resource providers 2502a, 2502b, 2502c (collectively, 2502). Each resource provider 2502 may include computing resources. In some implementations, computing resources may include any hardware and / or software used to process data. For example, computing resources may include hardware and / or software capable of executing algorithms, computer programs, and / or computer applications. In some implementations, illustrative computing resources may include application servers and / or databases with storage and retrieval capabilities. Each resource provider 2502 may be connected to any other resource provider 2502 in the cloud computing environment 2500. In some implementations, the resource providers 2502 may be connected over a computer network 2508. Each resource provider 2502 may be connected to one or more computing device 2504a, 2504b, 2504c (collectively, 2504), over the computer network 2508.
[0200] The cloud computing environment 2500 may include a resource manager 2506. The resource manager 2506 may be connected to the resource providers 2502 and the computing devices 2504 over the computer network 2508. In some implementations, the resource manager 2506 may facilitate the provision of computing resources by one or more resource providers 2502 to one or more computing devices 2504. The resource manager 2506may receive a request for a computing resource from a particular computing device 2504. The resource manager 2506 may identify one or more resource providers 2502 capable of providing the computing resource requested by the computing device 2504. The resource manager 2506 may select a resource provider 2502 to provide the computing resource. The resource manager 2506 may facilitate a connection between the resource provider 2502 and a particular computing device 2504. In some implementations, the resource manager 2506 may establish a connection between a particular resource provider 2502 and a particular computing device 2504. In some implementations, the resource manager 2506 may redirect a particular computing device 2504 to a particular resource provider 2502 with the requested computing resource.
[0201] FIG. 26 shows an example of a computing device 2600 and a mobile computing device 2650 that can be used in the methods and systems described in this disclosure. The computing device 2600 is intended to represent various forms of digital computers, such as laptops, desktops, workstations, personal digital assistants, servers, blade servers, mainframes, and other appropriate computers. The mobile computing device 2650 is intended to represent various forms of mobile devices, such as personal digital assistants, cellular telephones, smartphones, and other similar computing devices. The components shown here, their connections and relationships, and their functions, are meant to be examples only, and are not meant to be limiting.
[0202] The computing device 2600 includes a processor 2602, a memory 2604, a storage device 2606, a high-speed interface 2608 connecting to the memory 2604 and multiple high-speed expansion ports 2610, and a low-speed interface 2612 connecting to a low-speed expansion port 2614 and the storage device 2606. Each of the processor 2602, the memory 2604, the storage device 2606, the high-speed interface 2608, the high-speed expansion ports 2610, and the low-speed interface 2612, are interconnected using various busses, and may be mounted on a common motherboard or in other manners as appropriate. The processor 2602 can process instructions for execution within the computing device 2600, including instructions stored in the memory 2604 or on the storage device 2606 to display graphical information for a GUI on an external input / output device, such as a display 2616 coupled to the high-speed interface 2608. In other implementations, multiple processors and / or multiple buses may be used, as appropriate, along with multiple memories and types of memory. Also, multiple computing devices may be connected, with each device providing portions of the necessary operations (e.g., as a server bank, a group of blade servers, or a multi-processor system). Also,multiple computing devices may be connected, with each device providing portions of the necessary operations (e.g., as a server bank, a group of blade servers, or a multi-processor system). Thus, as the term is used herein, where a plurality of functions are described as being performed by “a processor”, this encompasses embodiments wherein the plurality of functions are performed by any number of processors (e.g., one or more processors) of any number of computing devices (e.g., one or more computing devices). Furthermore, where a function is described as being performed by “a processor”, this encompasses embodiments wherein the function is performed by any number of processors (e.g., one or more processors) of any number of computing devices (e.g., one or more computing devices) (e.g., in a distributed computing system).
[0203] The memory 2604 stores information within the computing device 2600. In some implementations, the memory 2604 is a volatile memory unit or units. In some implementations, the memory 2604 is a non-volatile memory unit or units. The memory 2604 may also be another form of computer-readable medium, such as a magnetic or optical disk.
[0204] The storage device 2606 is capable of providing mass storage for the computing device 2600. In some implementations, the storage device 2606 may be or contain a computer- readable medium, such as a hard disk device, an optical disk device, a flash memory or other similar solid state memory device, or an array of devices, including devices in a storage area network or other configurations. Instructions can be stored in an information carrier. The instructions, when executed by one or more processing devices (for example, processor 2602), perform one or more methods, such as those described above. The instructions can also be stored by one or more storage devices such as computer- or machine -readable mediums (for example, the memory 2604, the storage device 2606, or memory on the processor 2602).
[0205] The high-speed interface 2608 manages bandwidth-intensive operations for the computing device 2600, while the low-speed interface 2612 manages lower bandwidthintensive operations. Such allocation of functions is an example only. In some implementations, the high-speed interface 2608 is coupled to the memory 2604, the display 2616 (e.g., through a graphics processor or accelerator), and to the high-speed expansion ports 2610, which may accept various expansion cards (not shown). In the implementation, the low- speed interface 2612 is coupled to the storage device 2606 and the low-speed expansion port 2614. The low-speed expansion port 2614, which may include various communication ports (e.g., USB, Bluetooth®, Ethernet, wireless Ethernet) may be coupled to one or moreinput / output devices, such as a keyboard, a pointing device, a scanner, or a networking device such as a switch or router, e.g., through a network adapter.
[0206] The computing device 2600 may be implemented in a number of different forms, as shown in the figure. For example, it may be implemented as a standard server 2620, or multiple times in a group of such servers. In addition, it may be implemented in a personal computer such as a laptop computer 2622. It may also be implemented as part of a rack server system 2624. Alternatively, components from the computing device 2600 may be combined with other components in a mobile device (not shown), such as a mobile computing device 2650. Each of such devices may contain one or more of the computing device 2600 and the mobile computing device 2650, and an entire system may be made up of multiple computing devices communicating with each other.
[0207] The mobile computing device 2650 includes a processor 2652, a memory 2664, an input / output device such as a display 2654, a communication interface 2666, and a transceiver 2668, among other components. The mobile computing device 2650 may also be provided with a storage device, such as a micro-drive or other device, to provide additional storage. Each of the processor 2652, the memory 2664, the display 2654, the communication interface 2666, and the transceiver 2668, are interconnected using various buses, and several of the components may be mounted on a common motherboard or in other manners as appropriate.
[0208] The processor 2652 can execute instructions within the mobile computing device 2650, including instructions stored in the memory 2664. The processor 2652 may be implemented as a chipset of chips that include separate and multiple analog and digital processors. The processor 2652 may provide, for example, for coordination of the other components of the mobile computing device 2650, such as control of user interfaces, applications run by the mobile computing device 2650, and wireless communication by the mobile computing device 2650.
[0209] The processor 2652 may communicate with a user through a control interface 2658 and a display interface 2656 coupled to the display 2654. The display 2654 may be, for example, a TFT (Thin-Film-Transistor Liquid Crystal Display) display or an OLED (Organic Light Emitting Diode) display, or other appropriate display technology. The display interface 2656 may comprise appropriate circuitry for driving the display 2654 to present graphical and other information to a user. The control interface 2658 may receive commands from a user and convert them for submission to the processor 2652. In addition, an external interface 2662may provide communication with the processor 2652, so as to enable near area communication of the mobile computing device 2650 with other devices. The external interface 2662 may provide, for example, for wired communication in some implementations, or for wireless communication in other implementations, and multiple interfaces may also be used.
[0210] The memory 2664 stores information within the mobile computing device 2650. The memory 2664 can be implemented as one or more of a computer-readable medium or media, a volatile memory unit or units, or a non-volatile memory unit or units. An expansion memory 2674 may also be provided and connected to the mobile computing device 2650 through an expansion interface 2672, which may include, for example, a SIMM (Single In Line Memory Module) card interface. The expansion memory 2674 may provide extra storage space for the mobile computing device 2650, or may also store applications or other information for the mobile computing device 2650. Specifically, the expansion memory 2674 may include instructions to carry out or supplement the processes described above, and may include secure information also. Thus, for example, the expansion memory 2674 may be provided as a security module for the mobile computing device 2650, and may be programmed with instructions that permit secure use of the mobile computing device 2650. In addition, secure applications may be provided via the SIMM cards, along with additional information, such as placing identifying information on the SIMM card in a non-hackable manner.
[0211] The memory may include, for example, flash memory and / or NVRAM memory (non-volatile random access memory), as discussed below. In some implementations, instructions are stored in an information carrier and, when executed by one or more processing devices (for example, processor 2652), perform one or more methods, such as those described above. The instructions can also be stored by one or more storage devices, such as one or more computer- or machine-readable mediums (for example, the memory 2664, the expansion memory 2674, or memory on the processor 2652). In some implementations, the instructions can be received in a propagated signal, for example, over the transceiver 2668 or the external interface 2662.
[0212] The mobile computing device 2650 may communicate wirelessly through the communication interface 2666, which may include digital signal processing circuitry where necessary. The communication interface 2666 may provide for communications under various modes or protocols, such as GSM voice calls (Global System for Mobile communications), SMS (Short Message Service), EMS (Enhanced Messaging Service), or MMS messaging (Multimedia Messaging Service), CDMA (code division multiple access), TDMA (timedivision multiple access), PDC (Personal Digital Cellular), WCDMA (Wideband Code Division Multiple Access), CDMA2000, or GPRS (General Packet Radio Service), among others. Such communication may occur, for example, through the transceiver 2668 using a radio-frequency. In addition, short-range communication may occur, such as using a Bluetooth®, Wi-Fi™, or other such transceiver (not shown). In addition, a GPS (Global Positioning System) receiver module 2670 may provide additional navigation- and location- related wireless data to the mobile computing device 2650, which may be used as appropriate by applications running on the mobile computing device 2650.
[0213] The mobile computing device 2650 may also communicate audibly using an audio codec 2660, which may receive spoken information from a user and convert it to usable digital information. The audio codec 2660 may likewise generate audible sound for a user, such as through a speaker, e.g., in a handset of the mobile computing device 2650. Such sound may include sound from voice telephone calls, may include recorded sound (e.g., voice messages, music files, etc.) and may also include sound generated by applications operating on the mobile computing device 2650.
[0214] The mobile computing device 2650 may be implemented in a number of different forms, as shown in the figure. For example, it may be implemented as a cellular telephone 2680. It may also be implemented as part of a smart-phone 2682, personal digital assistant, or other similar mobile device.
[0215] Various implementations of the systems and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and / or combinations thereof. These various implementations can include implementation in one or more computer programs that are executable and / or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
[0216] These computer programs (also known as programs, software, software applications or code) include machine instructions for a programmable processor, and can be implemented in a high-level procedural and / or object-oriented programming language, and / or in assembly / machine language. As used herein, the terms machine-readable medium and computer-readable medium refer to any computer program product, apparatus and / or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used toprovide machine instructions and / or data to a programmable processor, including a machine- readable medium that receives machine instructions as a machine-readable signal. The term machine-readable signal refers to any signal used to provide machine instructions and / or data to a programmable processor.
[0217] To provide for interaction with a user, the systems and techniques described here can be implemented on a computer having a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user and a keyboard and a pointing device (e.g., a mouse or a trackball) by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form, including acoustic, speech, or tactile input.
[0218] The systems and techniques described here can be implemented in a computing system that includes a back end component (e.g., as a data server), or that includes a middleware component (e.g., an application server), or that includes a front end component (e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the systems and techniques described here), or any combination of such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication (e.g., a communication network). Examples of communication networks include a local area network (LAN), a wide area network (WAN), and the Internet.
[0219] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other.
[0220] In some implementations, certain modules described herein can be separated, combined, or incorporated into single or combined modules. Any modules depicted in the figures are not intended to limit the systems described herein to the software architectures shown therein.
[0221] Without limitation to the foregoing description, the following is an enumerated list of non-limiting exemplary embodiments included in the present disclosure. Those of ordinary skill in the art will appreciate that one or more features discussed above may beincluded with or incorporated into any of the following numbered embodiments to form additional embodiments.1. A system for management of an operating room, the system comprising: one or more cameras for receiving visual input from the operating room; one or more displays (e.g., screen, holographic display, or other display) (e.g., a display of an augmented reality (AR), virtual reality (VR), and / or mixed reality (MR) device) for presenting visual output data [e.g., via a graphical user interface and / or presented as an overlay (e.g., via an AR / VR / MR device)] to one or more users; a processor of a computing device for receiving and processing input data (e.g., the visual input received from the one or more cameras, and / or the additional input received from the one or more sensors, and / or the audio input received from the one or more audio I / O devices) from the operating room; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules, said output data comprising data rendered for presentation to at least one of the one or more users on the one or more displays.2. The system of embodiment 1, comprising one or more sensors for receiving additional input from the operating room, wherein the at least a portion of the input data received from the operating room comprises at least a portion of the additional input.3. The system of embodiment 2, wherein the one or more sensors are based on one or more of the following: Wi-Fi, Bluetooth, ZigBee, radio frequency identification (RFID), ultrawide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision.4. The system of any one of embodiments 1-3, comprising one or more audio input / output (I / O) devices (e.g., microphones and / or speakers) for receiving audio input from the operating room and / or for producing audio output to one or more users, wherein the at least a portion of the input data received from the operating room comprises at least a portion of the additionalinput and / or wherein the visual and / or audio output data comprises the audio output from the one or more audio I / O devices.5. The system of any one of embodiments 1-4, further comprising a projector for projecting directionally-controlled light (e.g., laser light, a spotlight, or other light) onto one or more objects in the operating room, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to spatially locate said one or more objects and cause the projector to illuminate said one or more objects as a visual aid for the one or more users in the operating room.6. A system for management of an operating room, the system comprising: one or more input devices, the one or more input devices comprising (i) one or more cameras for receiving visual input from the operating room, (ii) one or more sensors for receiving additional input from the operating room, and / or (iii) one or more audio input / output (I / O) devices for receiving audio input from the operating room (e.g., and also for producing audio output to one or more users); one or more output devices, the one or more output devices comprising: one or more displays for presenting visual output data, (ii) one or more projectors for projecting directionally-controlled light onto one or more objects in the operating room, and / or (iii) one or more audio input / output (I / O) devices for producing audio output (e.g., and optionally also for receiving audio input from the operating room) to one or more users; a processor of a computing device for receiving and processing input data (e.g., the visual input received from the one or more cameras, and / or the additional input received from the one or more sensors, and / or the audio input received from the one or more audio I / O devices) from the operating room; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules in order to perform one or more functions that assist one or more users (e.g., in the operating room).7. The system of any one of embodiments 1-6, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received fromthe operating room to produce the visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions.8. The system of any one of embodiments 1-7, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce the visual and / or audio output data via the one or more machine learning modules for performing one or more functions.9. The system of any one of embodiments 1-8, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to perform one or more functions using the one or more machine learning modules.10. The system of any one of embodiments 7-9, wherein at least a portion of said output data is rendered for presentation to at least one of the one or more users on the one or more displays in service of said one or more functions.11. The system of any one of embodiments 7-10, wherein the one or more functions comprise person identification (e.g., identify who is who in the operating room) [e.g., differentiating between persons based on function (e.g., scrub nurse from surgeon) (e.g., using semantic segmentation)] .12. The system of any one of embodiments 6-11, wherein the one or more functions comprise stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage).13. The system of any one of embodiments 6-12, wherein the one or more functions comprise predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal).14. The system of any one of embodiments 6-13, wherein the one or more functions comprise instrument identification (e.g., identify which instruments are used and / or prepared and / or handled).15. The system of any one of embodiments 6-14, wherein the one or more functions comprise speech recognition and synthesis (e.g., interpret conversation and produce speech response).16. The system of any one of embodiments 6-15, wherein the one or more functions comprise human emotion recognition (e.g., recognize emotions of one or more users in the operating room).17. The system of any one of embodiments 6-16, wherein the one or more functions comprise event detection (e.g., detect selected events in the operating room).18. The system of any one of embodiments 6-17, wherein the one or more functions comprise spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room).19. The system of any one of embodiments 6-18, wherein the one or more functions comprise context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed);20. The system of any one of embodiments 6-19, wherein the one or more functions comprise video streaming (e.g., stream video to and / or from the operating room).21. The system of any one of embodiments 6-20, wherein the one or more functions comprise situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge).22. The system of any one of embodiments 6-21, wherein the one or more functions comprise specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant).23. The system of any one of embodiments 6-22, wherein the one or more functions comprise personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).24. The system of any one of embodiments 6-23, wherein the one or more functions comprises instrument identification, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR or VR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more of the one or more displays.25. The system of any one of embodiments 6-24, wherein the one or more functions comprises context segmentation, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical warning presented via the display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual).26. The system of any one of embodiments 6-25, wherein the one or more functions comprises stage and / or task identification, wherein the processor determines (i) an identification of a current stage of a surgical procedure and / or (ii) an identification of what stage will follow or will likely follow the current stage, and wherein the output data rendered for presentation to at least one of the one or more users comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.27. The system of any one of embodiments 1-26, comprising one or more thermal cameras for receiving thermal imaging input from the operating room (e.g., wherein the at least a portion of the input data received from the operating room comprises at least a portion of the additional input).28. The system of embodiment 27, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the thermal imaging input to producevisual and / or audio output data via the one or more machine learning modules identifying one or more persons in the operating room (e.g., wherein the one or more persons are obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or an obfuscated body (e.g., obfuscated by a gown or drape)] .29. The system of any one of embodiments 1-28, comprising one or more sensors and / or one or more cameras operable to detect one or more fiducials in the operating room [e.g., comprising one or more RFID tags, one or more visible codes (e.g., QR codes or bar codes), one or more color-coding of clothes (e.g. surgical / scrub cups), one or more visible tags, one or more optical tracking markers (e.g. reflective spheres), and / or one or more electro-magnetic fiducials) disposed on one or more persons.30. The system of embodiment 29, wherein the instructions, when executed by the processor, cause the processor to produce visual and / or audio output data identifying the one or more persons in the operating room via the one or more machine learning modules based on data from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons are visually obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or a visually obfuscated body (e.g., obfuscated by a gown or drape)] (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor).31. The system of embodiment 29 or embodiment 30, wherein the instructions, when executed by the processor, cause the processor to determine a position of the one or more persons in the operating room (e.g., via the one or more machine learning modules) based on data received from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor) (e.g., using skeletal approximation).32. The system of any one of embodiments 1-31, wherein the instructions, when executed by the processor, are operable to determine identity and / or position of one or more persons in the operating room (e.g., via the one or more machine learning modules) using a combination of (e.g., in sequence) (e.g., combined using a Kalman filter) facial recognition, 3D mesh based identification and / or tracking, fiducial-based identification and / or positioning, contextualidentification and / or positioning (e.g., based on a person’s spatial location, behavior, and / or tasks), thermal imaging, one or more personal characteristics (e.g., voice, gait, movement, characteristic elements), and wireless identification and / or positioning (e.g., Bluetooth location or other near-field communication) (e.g., (e.g., using skeletal approximation).33. The system of any one of embodiments 1-32, wherein the instructions, when executed by the processor, are operable to determine identity and / or position of one or more persons in the operating room using a combination of audio and visual identification and / or positioning (e.g., based on data received from one or more cameras and one or more audio input / output devices (e.g., microphones and / or speakers)) (e.g., using skeletal approximation).34. The system of any one of embodiments 1-33, wherein the instructions, when executed by the processor, cause the processor to produce visual and / or audio output data for stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage) via the one or more machine learning modules based on instrument identification for one or more instruments in the operating room performed with the one or more machine learning modules.35. The system of any one of embodiments 1-34, wherein the instructions, when executed by the processor, cause the processor to identify a current stage and / or task of a surgery via the one or more machine learning modules based on persons present and / or their positions, instruments used, spoken language, noise signature, history of current case, and / or comparison to other cases reflected in the input data (e.g., as determined with the one or more machine learning modules) (e.g., and produce corresponding visual and / or audio output data).36. The system of any one of embodiments 1-35, wherein the one or more machine learning modules have been trained using real-time data coming from surgery in the operating room (e.g., surgery stage and task data, identified instrumentation, person identification and / or localization data).37. The system of any one of embodiments 1-36, wherein the visual and / or output data correspond to (e.g., comprise) a VR / AR / MR overlay [e.g., wherein the instructions, whenexecuted by the processor, cause the processor to render (e.g., and display) the VR / AR / MR overlay] .38. The system of embodiment 37, wherein the VR / AR / MR overlay identifies instruments to the wearer of a VR / AR / MR headset (e.g., using labels, bounding boxes, and / or recognition confidence level).39. The system of embodiment 37 or embodiment 38, wherein the VR / AR / MR overlay comprises a warning for a low confidence level for identification of an instrument.40. The system of embodiment 39, wherein the instructions, when executed by the processor, cause the processor to receive input (e.g., audio input) from a user and resolve the low confidence level based on the received input (e.g., an audio indication of what the instrument is).41. The system of any one of embodiments 1-40, wherein the one or more machine learning modules are operable to learn (i) instrument performance over time (e.g., in conjunction with instrument-relevant events), (ii) changes in instrument visual appearance (e.g., de-colorization, parts missing or deformed), and / or (iii) usage tracking and to provide the audio and / or visual output data based on the learning.42. The system of embodiment 41 , wherein the audio and / or visual output data corresponds to an identification of an instrument over time, a broken part, or failure of an instrument.43. The system of any one of embodiments 1 -42, wherein the one or more machine learning modules are operable to recognize speech of one or more persons and produce the audio and / or visual output data based on said recognized speech.44. The system of embodiment 43, wherein the one or more machine learning modules have been trained to recognize speech based on a natural database of recordings from an operating room.45. The system of embodiment 44, wherein the recordings comprise recordings linked with events in the operating room (e.g., sterility loss).46. The system of any one of embodiments 1 -45 , wherein the one or more machine learning modules have been trained using data specific to the operating room (e.g., audio and / or visual data gathered during use of the operating room) (e.g., in addition to a general pre-training on data from other operating rooms) (e.g., thereby being tailoring to the specific operating room in which the system is deployed) (e.g., data corresponding to where surgeon or staff had to wait for specific device, e.g., such that the one or more machine learning modules are operable to construct dynamic, surgeon and case-specific list of equipment).47. The system of any one of embodiments 1-46, wherein the audio and / or visual output data are indicative of a safety event.48. The system of embodiment 47, wherein the safety event comprises a contamination risk (e.g., for a patient and / or one or more users) (e.g., an audio and / or visual warning).49. The system of embodiment 47 or embodiment 48, wherein the instructions, when executed by the processor, cause the processor to produce the audio and / or visual output data via the one or more machine learning modules based on a determination made using the input data that there has been incorrect room preparation (e.g. missing sterile drape(s)), incorrect instrumentation handling (e.g. assembly of instruments, like powered devices, where non- sterile battery needs to be inserted into sterile cover), incorrect aseptic technique when putting on sterile clothes, filling-up liquids, accidental touching of non-sterile surfaces by sterile equipment, passing too close to sterile equipment, or one or more instruments falling on the ground.50. The system of any one of embodiments 1-49, wherein the one or more machine learning modules have been trained using visual input from one or more cameras and / or one or more sensors combined with corresponding audio input [e.g., audio-derived annotations (e.g., labels)] (e.g., for event detection and / or stage and / or task identification) [e.g., indicative of a safety event (e.g., a user auditorily indicating “sterility loss”)] (e.g., by showing instruments toone or more users and prompting the one or more users to choose a name, e.g., from a list or to say it aloud).51. The system of any one of embodiments 1-50, wherein the one or more machine learning modules are operable to perform on-the-fly registration (e.g., of fixed or dynamic scene elements).52. The system of any one of embodiments 1-51, wherein the audio and / or visual output data are indicative of position of instruments in the operating room that are to be assembled and / or how to assemble said instruments.53. The system of any one of embodiments 1-52, wherein the audio and / or visual output data are indicative of where to place instruments for quicker reuse.54. The system of any one of embodiments 1-53, wherein the audio and / or visual output data are indicative of a sterility loss and the instructions, when executed by the processor, cause the processor to produce the audio and / or visual output data via the one or more machine learning modules based on position of one or more persons and clothes of the one or more persons together with information about surrounding equipment when the one or more machine learning modules determine that a non-sterile surface was touched thereby.55. The system of any one of embodiments 1-54, wherein the one or more machine learning modules are operable to perform contextual segmentation of sterile and non-sterile elements (e.g., surfaces and clothes) (e.g., based on color) [e.g., based on relative position and / or history (e.g., instruments taken from a sterilization tray are sterile)].56. The system of any one of embodiments 1-55, wherein the one or more machine learning modules are operable to perform contextual segmentation of fixed elements (e.g., attached table(s)) and mobile elements (e.g., instruments and trays).57. The system of any one of embodiments 1-56, wherein the one or more machine learning modules are operable to perform contextual segmentation of disposables [e.g. countable items (e.g., sponges, rubber bands)] and reusables.58. The system of any one of embodiments 1-57, wherein the instructions, when executed by the processor, cause the processor via the one or more machine learning modules, based on the input data, to produce an optimized layout for instruments in the operating room and the audio and / or visual output data comprises an indication of the layout.59. The system of any one of embodiments 1-58, wherein the one or more machine learning modules have been trained based on user interaction with phantom models shown on a display via an AR / VR / MR headset, a generic tracked device, a haptic device, a joystick, and / or a real model.60. The system of any one of embodiments 1-59, wherein the instructions, when executed by the processor, cause the processor to output via the one or more machine learning modules information on speed and correctness of preparation, instrument waiting time, events frequency, presence and type of tasks performed or a combination thereof in order to analyze personal behavior from the operating room based on the input data.61. The system of any one of embodiments 1-60, wherein the instructions, when executed by the processor, cause the processor to output via the one or more machine learning modules information on effectiveness, effective OR time vs. planned time, preparation time, instrumentation waiting time, ambiance / mood in the OR, event statistics (e.g., detected events and / or number of them), surgery stages statistics, personnel statistics, trends, costs, or a combination thereof in order to analyze personal behavior from the operating room based on the input data.62. The system of any one of embodiments 1-61, wherein the instructions, when executed by the processor, cause the processor to output via the one or more machine learning modules information on one or more direct patient impact events (e.g., errors with manipulating surgical tracking and navigation equipment and / or hitting patient measurement markers attached to anatomy) based on the input data.63. The system of any one of embodiments 1-62, wherein the audio and / or visual output data are indicative of instruments to be used in a next stage.64. The system of any one of embodiments 1-63, wherein the audio and / or visual output data are indicative of what needs to be done for instrument exchange and assembly.65. The system of any one of embodiments 1 -64, wherein the one or more machine learning modules are operable to determine whether needed equipment is present in the operating room based on a user request (e.g., an auditory request) and the input data and the audio and / or visual output data confirm presence or absence of the equipment.66. A method for management of an operating room, the method comprising: receiving, by a processor of a computing device, input data from the operating room and producing visual and / or audio output data via one or more machine learning modules, said output data rendered for presentation to a user on a display, wherein the input data comprises one or more of (i)-(iii) as follows:(i) visual input from the operating room detected by one or more cameras;(ii) input from one or more sensors selected from the group consisting of the following: Wi-Fi, Bluetooth, ZigBee, radio frequency identification (RFID), ultra-wide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision; and(iii) audio input from one or more audio input / output (I / O) devices in the operating room.67. A method for management of an operating room, the method comprising: receiving, by a processor of a computing device, input data from the operating room and producing visual and / or audio output data via one or more machine learning modules (e.g., said output data rendered for presentation to a user on a display), wherein the input data comprises one or more of (i)-(iii) as follows:(i) visual input from the operating room detected by one or more cameras;(ii) input from one or more sensors (e.g., selected from the group consisting of the following: Wi-Fi, Bluetooth, Thread, ZigBee, radio frequency identification (RFID), ultrawide band (UWB), inertial measurement unit (IMU), visible light communication (VUC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (UiDAR), and computer vision); and(iii) audio input from one or more audio input / output (I / O) (e.g., microphone (s)) devices in the operating room.68. The method of embodiment 66 or embodiment 67, comprising producing visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions selected from the group consisting of: person identification (e.g., identify who is who in the operating room); stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage); predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal); instrument identification (e.g., identify which instruments are used and / or prepared and / or handled); speech recognition and synthesis (e.g., interpret conversation and produce speech response); human emotion recognition (e.g., recognize emotions of one or more users in the operating room); event detection (e.g., detect selected events in the operating room); spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room); context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed); video streaming (e.g., stream video to and / or from the operating room); situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge); specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant); and personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).69. The method of embodiment 68, wherein the one or more functions comprises instrument identification, and wherein the output data comprises a graphical overlay (e.g.,bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR, VR, or MR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more displays.70. The method of embodiment 68, wherein the one or more functions comprises context segmentation, and wherein the output data comprises a graphical warning presented via a display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual).71. The method of embodiment 68, wherein the one or more functions comprises (i) identifying, by the processor of the computing device, a current stage of a surgical procedure and / or (ii) identifying, by the processor of the computing device, what stage will follow or will likely follow the current stage, and wherein the output data comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.72. The method of any one of embodiments 66-71, comprising producing the visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions.73. The method of any one of embodiments 66-72, comprising producing the visual and / or audio output data via the one or more machine learning modules for performing one or more functions.74. The method of any one of embodiments 66-73, comprising using at least a portion of the input data received from the operating room to perform one or more functions using the one or more machine learning modules.75. The method of any one of embodiments 72-74, wherein at least a portion of said output data is rendered for presentation to at least one of the one or more users on the one or more displays in service of said one or more functions.76. The method of any one of embodiments 72-75, wherein the one or more functions comprise person identification (e.g., identify who is who in the operating room) [e.g., differentiating between persons based on function (e.g., scrub nurse from surgeon) (e.g., using semantic segmentation)] .77. The method of any one of embodiments 72-76, wherein the one or more functions comprise stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage).78. The method of any one of embodiments 72-77, wherein the one or more functions comprise predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal).79. The method of any one of embodiments 72-78, wherein the one or more functions comprise instrument identification (e.g., identify which instruments are used and / or prepared and / or handled).80. The method of any one of embodiments 72-79, wherein the one or more functions comprise speech recognition and synthesis (e.g., interpret conversation and produce speech response).81. The method of any one of embodiments 72-80, wherein the one or more functions comprise human emotion recognition (e.g., recognize emotions of one or more users in the operating room).82. The method of any one of embodiments 72-81, wherein the one or more functions comprise event detection (e.g., detect selected events in the operating room).83. The method of any one of embodiments 72-82, wherein the one or more functions comprise spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room).84. The method of any one of embodiments 72-83, wherein the one or more functions comprise context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed);85. The method of any one of embodiments 72-84, wherein the one or more functions comprise video streaming (e.g., stream video to and / or from the operating room).86. The method of any one of embodiments 72-85, wherein the one or more functions comprise situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge).87. The method of any one of embodiments 72-86, wherein the one or more functions comprise specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant).88. The method of any one of embodiments 72-87, wherein the one or more functions comprise personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).89. The method of any one of embodiments 72-88, wherein the one or more functions comprises instrument identification, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR or VR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more of the one or more displays.90. The method of any one of embodiments 72-89, wherein the one or more functions comprises context segmentation, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical warning presented via the display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual).91. The method of any one of embodiments 72-90, wherein the one or more functions comprises stage and / or task identification, and the stage and / or task identification comprises (i) an identification of a current stage of a surgical procedure and / or (ii) an identification of what stage will follow or will likely follow the current stage, and wherein the output data rendered for presentation to at least one of the one or more users comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.92. The method of any one of embodiments 66-91, comprising obtaining thermal imaging input from one or more thermal imaging cameras in the operating room and using at least a portion of the thermal imaging input to produce visual and / or audio output data via the one or more machine learning modules identifying one or more persons in the operating room (e.g., wherein the one or more persons are obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or an obfuscated body (e.g., obfuscated by a gown or drape)].93. The method of any one of embodiments 1-28, comprising detecting one or more fiducials in the operating room with one or more sensors and / or one or more cameras operable to [e.g., comprising one or more RFID tags, one or more visible codes (e.g., QR codes or bar codes), one or more color-coding of clothes (e.g. surgical / scrub cups), one or more visible tags, one or more optical tracking markers (e.g. reflective spheres), and / or one or more electromagnetic fiducials) disposed on one or more persons.94 The method of embodiment 93, comprising producing visual and / or audio output data identifying the one or more persons in the operating room via the one or more machine learning modules based on data from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons are visually obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or a visually obfuscated body (e.g., obfuscated by a gown or drape)] (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor).95. The method of embodiment 93 or embodiment 94, comprising determining a position of the one or more persons in the operating room (e.g., via the one or more machine learningmodules) based on data received from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor) (e.g., using skeletal approximation).96. The method of any one of embodiments 66-95, comprising determining identity and / or position of one or more persons in the operating room (e.g., via the one or more machine learning modules) using a combination of (e.g., in sequence) (e.g., combined using a Kalman fdter) facial recognition, 3D mesh based identification and / or tracking, fiducial-based identification and / or positioning, contextual identification and / or positioning (e.g., based on a person’s spatial location, behavior, and / or tasks), thermal imaging, one or more personal characteristics (e.g., voice, gait, movement, characteristic elements), and wireless identification and / or positioning (e.g., Bluetooth location or other near-field communication) (e.g., (e.g., using skeletal approximation).97. The method of any one of embodiments 66-96, comprising determining identity and / or position of one or more persons in the operating room using a combination of audio and visual identification and / or positioning (e.g., based on data received from one or more cameras and one or more audio input / output devices (e.g., microphones and / or speakers)) (e.g., using skeletal approximation).98. The method of any one of embodiments 66-97, comprising producing visual and / or audio output data for stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage) via the one or more machine learning modules based on instrument identification for one or more instruments in the operating room performed with the one or more machine learning modules.99. The method of any one of embodiments 66-98, comprising identifying a current stage and / or task of a surgery via the one or more machine learning modules based on persons present and / or their positions, instruments used, spoken language, noise signature, history of current case, and / or comparison to other cases reflected in the input data (e.g., as determined with the one or more machine learning modules) (e.g., and produce corresponding visual and / or audio output data).100. The method of any one of embodiments 66-99, wherein the one or more machine learning modules have been trained using real-time data coming from surgery in the operating room (e.g., surgery stage and task data, identified instrumentation, person identification and / or localization data).101. The method of any one of embodiments 66-100, wherein the visual and / or output data correspond to (e.g., comprise) a VR / AR / MR overlay [e.g., wherein the method comprises rendering (e.g., and displaying) the VR / AR / MR overlay to a user (e.g., on a VR / AR / MR headset)] .102. The method of embodiment 101, wherein the VR / AR / MR overlay identifies instruments to the wearer of a VR / AR / MR headset (e.g., using labels, bounding boxes, and / or recognition confidence level).103. The method of embodiment 101 or embodiment 102, wherein the VR / AR / MR overlay comprises a warning for a low confidence level for identification of an instrument.104. The method of embodiment 103, comprising receiving input (e.g., audio input) from a user and resolving the low confidence level based on the received input (e.g., an audio indication of what the instrument is).105. The method of any one of embodiments 66-104, comprising training the one or more machine learning modules to learn (i) instrument performance over time (e.g., in conjunction with instrument-relevant events), (ii) changes in instrument visual appearance (e.g., decolorization, parts missing or deformed), and / or (iii) usage tracking and to provide the audio and / or visual output data based on the learning.106. The method of embodiment 105, wherein the audio and / or visual output data corresponds to an identification of an instrument over time, a broken part, or failure of an instrument.107. The method of any one of embodiments 66-106, comprising recognizing speech of one or more persons using the one or more machine learning modules that has been received usingan audio I / O device in the operating room and producing the audio and / or visual output data based on said recognized speech.108. The method of embodiment 107, wherein the one or more machine learning modules have been trained to recognize speech based on a natural database of recordings from an operating room.109. The method of embodiment 108, wherein the recordings comprise recordings linked with events in the operating room (e.g., sterility loss).110. The method of any one of embodiments 66-109, wherein the one or more machine learning modules have been trained (e.g., wherein the method comprises training the one or more machine learning modules) using data specific to the operating room (e.g., audio and / or visual data gathered during use of the operating room) (e.g., in addition to a general pre-training on data from other operating rooms) (e.g., thereby being tailoring to the specific operating room in which the method is deployed) (e.g., data corresponding to where surgeon or staff had to wait for specific device, e.g., such that the one or more machine learning modules are operable to construct dynamic, surgeon and case-specific list of equipment).111. The method of any one of embodiments 66- 110, wherein the audio and / or visual output data indicate a safety event.112. The method of embodiment 111, wherein the safety event comprises a contamination risk (e.g., for a patient and / or one or more users) (e.g., an audio and / or visual warning).113. The method of embodiment 111 or embodiment 112, comprising determining, via the one or more machine learning modules, using the input data that there has been incorrect room preparation (e.g. missing sterile drape(s)), incorrect instrumentation handling (e.g. assembly of instruments, like powered devices, where non-sterile battery needs to be inserted into sterile cover), incorrect aseptic technique when putting on sterile clothes, filling-up liquids, accidental touching of non-sterile surfaces by sterile equipment, passing too close to sterile equipment, or one or more instruments falling on the ground.113. The method of any one of embodiments 66-112, wherein the one or more machine learning modules have been trained (e.g., wherein the method comprises training the one or more machine learning modules) using visual input from one or more cameras and / or one or more sensors combined with corresponding audio input [e.g., audio-derived annotations (e.g., labels)] (e.g., for event detection and / or stage and / or task identification) [e.g., indicative of a safety event (e.g., a user auditorily indicating “sterility loss”)] (e.g., by showing instruments to one or more users and prompting the one or more users to choose a name, e.g., from a list or to say it aloud).114. The method of any one of embodiments 66-113, wherein the one or more machine learning modules perform on-the-fly registration (e.g., of fixed or dynamic scene elements).115. The method of any one of embodiments 66-114, wherein the audio and / or visual output data indicate position of instruments in the operating room that are to be assembled and / or how to assemble said instruments.116. The method of any one of embodiments 66-115, wherein the audio and / or visual output data indicate where to place instruments for quicker reuse.117. The method of any one of embodiments 66-116, wherein the audio and / or visual output data indicate a sterility loss and the method comprises producing the audio and / or visual output data via the one or more machine learning modules based on position of one or more persons and clothes of the one or more persons together with information about surrounding equipment when the one or more machine learning modules determine that a non-sterile surface was touched thereby.118. The method of any one of embodiments 66-117, comprising performing contextual segmentation of sterile and non-sterile elements with the one or more machine learning modules (e.g., surfaces and clothes) (e.g., based on color) [e.g., based on relative position and / or history (e.g., instruments taken from a sterilization tray are sterile)].119. The method of any one of embodiments 66-118, comprising performing contextual segmentation of fixed elements with the one or more machine learning modules (e.g., attached table(s)) and mobile elements (e.g., instruments and trays).120. The method of any one of embodiments 66-119, comprising performing contextual segmentation of disposables [e.g. countable items (e.g., sponges, rubber bands)] and reusables with the one or more machine learning modules.121. The method of any one of embodiments 66-120, comprising producing, by the one or more machine learning modules, based on the input data, an optimized layout for instruments in the operating room and the audio and / or visual output data comprises an indication of the layout.122. The method of any one of embodiments 66-121, wherein the one or more machine learning modules have been trained (e.g., wherein the method comprises training the one or more machine learning modules) based on user interaction with phantom models shown on a display via an AR / VR / MR headset, a generic tracked device, a haptic device, a joystick, and / or a real model.123. The method of any one of embodiments 66-122, comprising outputting via the one or more machine learning modules, based on the input data, information on speed and correctness of preparation, instrument waiting time, events frequency, presence and type of tasks performed or a combination thereof in order to analyze personal behavior from the operating room.124. The method of any one of embodiments 66-123, comprising outputting via the one or more machine learning modules, based on the input data, information on effectiveness, effective OR time vs. planned time, preparation time, instrumentation waiting time, ambiance / mood in the OR, event statistics (e.g., detected events and / or number of them), surgery stages statistics, personnel statistics, trends, costs, or a combination thereof in order to analyze personal behavior from the operating room.125. The method of any one of embodiments 66-124, comprising outputting via the one or more machine learning modules information on one or more direct patient impact events (e.g., errors with manipulating surgical tracking and navigation equipment and / or hitting patient measurement markers attached to anatomy) based on the input data.126. The method of any one of embodiments 66-125, wherein the audio and / or visual output data indicate instruments to be used in a next stage.127. The method of any one of embodiments 66-126, wherein the audio and / or visual output data indicate what needs to be done for instrument exchange and assembly.128. The method of any one of embodiments 66-127, comprising determining, via the one or more machine learning modules, whether needed equipment is present in the operating room based on a user request (e.g., an auditory request) for confirmation and the input data and the audio and / or visual output data confirm presence or absence of the equipment.
[0222] Elements of different implementations described herein may be combined to form other implementations not specifically set forth above. Elements may be left out of the processes, computer programs, databases, etc. described herein without adversely affecting their operation. In addition, the logic flows depicted in the figures do not require the particular order shown, or sequential order, to achieve desirable results. Various separate elements may be combined into one or more individual elements to perform the functions described herein.
[0223] Certain embodiments of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those embodiments, but rather the intention is that additions and modifications to what was expressly described in the present disclosure are also included within the scope of the disclosure. Moreover, it is to be understood that the features of the various embodiments described in the present disclosure were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express, without departing from the spirit and scope of the disclosure. The disclosure has been described in detail with particular reference to certain embodiments thereof, but it will be understood that variations and modifications can be effected within the spirit and scope of the claimed invention.
Claims
What is claimed is:
1. A system for management of an operating room, the system comprising: one or more cameras for receiving visual input from the operating room; one or more displays (e.g., screen, holographic display, or other display) (e.g., a display of an augmented reality (AR), virtual reality (VR), and / or mixed reality (MR) device) for presenting visual output data [e.g., via a graphical user interface and / or presented as an overlay (e.g., via an AR / VR / MR device)] to one or more users; a processor of a computing device for receiving and processing input data (e.g., the visual input received from the one or more cameras, and / or the additional input received from the one or more sensors, and / or the audio input received from the one or more audio I / O devices) from the operating room; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules, said output data comprising data rendered for presentation to at least one of the one or more users on the one or more displays.
2. The system of claim 1, comprising one or more sensors for receiving additional input from the operating room, wherein the at least a portion of the input data received from the operating room comprises at least a portion of the additional input.
3. The system of claim 2, wherein the one or more sensors are based on one or more of the following: Wi-Fi, Bluetooth, ZigBee, radio frequency identification (RFID), ultra-wide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision.
4. The system of any one of claims 1-3, comprising one or more audio input / output (I / O) devices (e.g., microphones and / or speakers) for receiving audio input from the operating room and / or for producing audio output to one or more users, wherein the at least a portion of the input data received from the operating room comprises at least a portion of the additional input and / or wherein the visual and / or audio output data comprises the audio output from the one or more audio I / O devices.
5. The system of any one of claims 1-4, further comprising a projector for projecting directionally-controlled light (e.g., laser light, a spotlight, or other light) onto one or more objects in the operating room, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to spatially locate said one or more objects and cause the projector to illuminate said one or more objects as a visual aid for the one or more users in the operating room.
6. A system for management of an operating room, the system comprising: one or more input devices, the one or more input devices comprising (i) one or more cameras for receiving visual input from the operating room, (ii) one or more sensors for receiving additional input from the operating room, and / or (iii) one or more audio input / output (I / O) devices for receiving audio input from the operating room (e.g., and also for producing audio output to one or more users); one or more output devices, the one or more output devices comprising: one or more displays for presenting visual output data, (ii) one or more projectors for projecting directionally-controlled light onto one or more objects in the operating room, and / or (iii) one or more audio input / output (I / O) devices for producing audio output (e.g., and optionally also for receiving audio input from the operating room) to one or more users; a processor of a computing device for receiving and processing input data (e.g., the visual input received from the one or more cameras, and / or the additional input received from the one or more sensors, and / or the audio input received from the one or more audio I / O devices) from the operating room; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce visual and / or audio output data via one or more machine learning modules in order to perform one or more functions that assist one or more users (e.g., in the operating room).
7. The system of any one of claims 1-6, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce the visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions.
8. The system of any one of claims 1-7, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to produce the visual and / or audio output data via the one or more machine learning modules for performing one or more functions.
9. The system of any one of claims 1-8, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the input data received from the operating room to perform one or more functions using the one or more machine learning modules.
10. The system of any one of claims 7-9, wherein at least a portion of said output data is rendered for presentation to at least one of the one or more users on the one or more displays in service of said one or more functions.
11. The system of any one of claims 7-10, wherein the one or more functions comprise person identification (e.g., identify who is who in the operating room) [e.g., differentiating between persons based on function (e.g., scrub nurse from surgeon) (e.g., using semantic segmentation)] .
12. The system of any one of claims 6-11, wherein the one or more functions comprise stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage).
13. The system of any one of claims 6-12, wherein the one or more functions comprise predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal).
14. The system of any one of claims 6-13, wherein the one or more functions comprise instrument identification (e.g., identify which instruments are used and / or prepared and / or handled).
15. The system of any one of claims 6-14, wherein the one or more functions comprise speech recognition and synthesis (e.g., interpret conversation and produce speech response).
16. The system of any one of claims 6-15, wherein the one or more functions comprise human emotion recognition (e.g., recognize emotions of one or more users in the operating room).
17. The system of any one of claims 6-16, wherein the one or more functions comprise event detection (e.g., detect selected events in the operating room).
18. The system of any one of claims 6-17, wherein the one or more functions comprise spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room).
19. The system of any one of claims 6-18, wherein the one or more functions comprise context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed);20. The system of any one of claims 6-19, wherein the one or more functions comprise video streaming (e.g., stream video to and / or from the operating room).
21. The system of any one of claims 6-20, wherein the one or more functions comprise situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge).
22. The system of any one of claims 6-21, wherein the one or more functions comprise specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant).
23. The system of any one of claims 6-22, wherein the one or more functions comprise personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).
24. The system of any one of claims 6-23, wherein the one or more functions comprises instrument identification, and wherein the output data rendered for presentation to at least oneofthe one ormore users comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR or VR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more of the one or more displays.
25. The system of any one of claims 6-24, wherein the one or more functions comprises context segmentation, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical warning presented via the display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual).
26. The system of any one of claims 6-25, wherein the one or more functions comprises stage and / or task identification, wherein the processor determines (i) an identification of a current stage of a surgical procedure and / or (ii) an identification of what stage will follow or will likely follow the current stage, and wherein the output data rendered for presentation to at least one of the one or more users comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.
27. The system of any one of claims 1-26, comprising one or more thermal cameras for receiving thermal imaging input from the operating room (e.g., wherein the at least a portion of the input data received from the operating room comprises at least a portion of the additional input).
28. The system of claim 27, wherein the instructions, when executed by the processor, cause the processor to use at least a portion of the thermal imaging input to produce visual and / or audio output data via the one or more machine learning modules identifying one or more persons in the operating room (e.g., wherein the one ormore persons are obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or an obfuscated body (e.g., obfuscated by a gown or drape)] .
29. The system of any one of claims 1-28, comprising one or more sensors and / or one or more cameras operable to detect one or more fiducials in the operating room [e.g., comprising one or more RFID tags, one or more visible codes (e.g., QR codes or bar codes), one or more color-coding of clothes (e.g. surgical / scrub cups), one or more visible tags, one or more optical tracking markers (e.g. reflective spheres), and / or one or more electro-magnetic fiducials) disposed on one or more persons.
30. The system of claim 29, wherein the instructions, when executed by the processor, cause the processor to produce visual and / or audio output data identifying the one or more persons in the operating room via the one or more machine learning modules based on data from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons are visually obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or a visually obfuscated body (e.g., obfuscated by a gown or drape)] (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor).
31. The system of claim 29 or claim 30, wherein the instructions, when executed by the processor, cause the processor to determine a position of the one or more persons in the operating room (e.g., via the one or more machine learning modules) based on data received from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor) (e.g., using skeletal approximation).
32. The system of any one of claims 1-31, wherein the instructions, when executed by the processor, are operable to determine identity and / or position of one or more persons in the operating room (e.g., via the one or more machine learning modules) using a combination of (e.g., in sequence) (e.g., combined using a Kalman filter) facial recognition, 3D mesh based identification and / or tracking, fiducial-based identification and / or positioning, contextual identification and / or positioning (e.g., based on a person’s spatial location, behavior, and / or tasks), thermal imaging, one or more personal characteristics (e.g., voice, gait, movement, characteristic elements), and wireless identification and / or positioning (e.g., Bluetooth location or other near-field communication) (e.g., (e.g., using skeletal approximation).
33. The system of any one of claims 1-32, wherein the instructions, when executed by the processor, are operable to determine identity and / or position of one or more persons in the operating room using a combination of audio and visual identification and / or positioning (e.g., based on data received from one or more cameras and one or more audio input / output devices (e.g., microphones and / or speakers)) (e.g., using skeletal approximation).
34. The system of any one of claims 1-33, wherein the instructions, when executed by the processor, cause the processor to produce visual and / or audio output data for stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage) via the one or more machine learning modules based on instrument identification for one or more instruments in the operating room performed with the one or more machine learning modules.
35. The system of any one of claims 1-34, wherein the instructions, when executed by the processor, cause the processor to identify a current stage and / or task of a surgery via the one or more machine learning modules based on persons present and / or their positions, instruments used, spoken language, noise signature, history of current case, and / or comparison to other cases reflected in the input data (e.g., as determined with the one or more machine learning modules) (e.g., and produce corresponding visual and / or audio output data).
36. The system of any one of claims 1-35, wherein the one or more machine learning modules have been trained using real-time data coming from surgery in the operating room (e.g., surgery stage and task data, identified instrumentation, person identification and / or localization data).
37. The system of any one of claims 1-36, wherein the visual and / or output data correspond to (e.g., comprise) a VR / AR / MR overlay [e.g., wherein the instructions, when executed by the processor, cause the processor to render (e.g., and display) the VR / AR / MR overlay] .
38. The system of claim 37, wherein the VR / AR / MR overlay identifies instruments to the wearer of a VR / AR / MR headset (e.g., using labels, bounding boxes, and / or recognition confidence level).
39. The system of claim 37 or claim 38, wherein the VR / AR / MR overlay comprises a warning for a low confidence level for identification of an instrument.
40. The system of claim 39, wherein the instructions, when executed by the processor, cause the processor to receive input (e.g., audio input) from a user and resolve the low confidence level based on the received input (e.g., an audio indication of what the instrument is).
41. The system of any one of claims 1-40, wherein the one or more machine learning modules are operable to learn (i) instrument performance over time (e.g., in conjunction with instrument-relevant events), (ii) changes in instrument visual appearance (e.g., de-colorization, parts missing or deformed), and / or (iii) usage tracking and to provide the audio and / or visual output data based on the learning.
42. The system of claim 41, wherein the audio and / or visual output data corresponds to an identification of an instrument over time, a broken part, or failure of an instrument.
43. The system of any one of claims 1-42, wherein the one or more machine learning modules are operable to recognize speech of one or more persons and produce the audio and / or visual output data based on said recognized speech.
44. The system of claim 43, wherein the one or more machine learning modules have been trained to recognize speech based on a natural database of recordings from an operating room.
45. The system of claim 44, wherein the recordings comprise recordings linked with events in the operating room (e.g., sterility loss).
46. The system of any one of claims 1-45, wherein the one or more machine learning modules have been trained using data specific to the operating room (e.g., audio and / or visual data gathered during use of the operating room) (e.g., in addition to a general pre-training on data from other operating rooms) (e.g., thereby being tailoring to the specific operating room in which the system is deployed) (e.g., data corresponding to where surgeon or staff had to waitfor specific device, e.g., such that the one or more machine learning modules are operable to construct dynamic, surgeon and case-specific list of equipment).
47. The system of any one of claims 1-46, wherein the audio and / or visual output data are indicative of a safety event.
48. The system of claim 47, wherein the safety event comprises a contamination risk (e.g., for a patient and / or one or more users) (e.g., an audio and / or visual warning).
49. The system of claim 47 or claim 48, wherein the instructions, when executed by the processor, cause the processor to produce the audio and / or visual output data via the one or more machine learning modules based on a determination made using the input data that there has been incorrect room preparation (e.g. missing sterile drape(s)), incorrect instrumentation handling (e.g. assembly of instruments, like powered devices, where non-sterile battery needs to be inserted into sterile cover), incorrect aseptic technique when putting on sterile clothes, filling-up liquids, accidental touching of non-sterile surfaces by sterile equipment, passing too close to sterile equipment, or one or more instruments falling on the ground.
50. The system of any one of claims 1-49, wherein the one or more machine learning modules have been trained using visual input from one or more cameras and / or one or more sensors combined with corresponding audio input [e.g., audio-derived annotations (e.g., labels)] (e.g., for event detection and / or stage and / or task identification) [e.g., indicative of a safety event (e.g., a user auditorily indicating “sterility loss”)] (e.g., by showing instruments to one or more users and prompting the one or more users to choose a name, e.g., from a list or to say it aloud).
51. The system of any one of claims 1-50, wherein the one or more machine learning modules are operable to perform on-the-fly registration (e.g., of fixed or dynamic scene elements).
52. The system of any one of claims 1-51, wherein the audio and / or visual output data are indicative of position of instruments in the operating room that are to be assembled and / or how to assemble said instruments.
53. The system of any one of claims 1-52, wherein the audio and / or visual output data are indicative of where to place instruments for quicker reuse.
54. The system of any one of claims 1-53, wherein the audio and / or visual output data are indicative of a sterility loss and the instructions, when executed by the processor, cause the processor to produce the audio and / or visual output data via the one or more machine learning modules based on position of one or more persons and clothes of the one or more persons together with information about surrounding equipment when the one or more machine learning modules determine that a non-sterile surface was touched thereby.
55. The system of any one of claims 1-54, wherein the one or more machine learning modules are operable to perform contextual segmentation of sterile and non-sterile elements (e.g., surfaces and clothes) (e.g., based on color) [e.g., based on relative position and / or history (e.g., instruments taken from a sterilization tray are sterile)].
56. The system of any one of claims 1-55, wherein the one or more machine learning modules are operable to perform contextual segmentation of fixed elements (e.g., attached table(s)) and mobile elements (e.g., instruments and trays).
57. The system of any one of claims 1-56, wherein the one or more machine learning modules are operable to perform contextual segmentation of disposables [e.g. countable items (e.g., sponges, rubber bands)] and reusables.
58. The system of any one of claims 1-57, wherein the instructions, when executed by the processor, cause the processor via the one or more machine learning modules, based on the input data, to produce an optimized layout for instruments in the operating room and the audio and / or visual output data comprises an indication of the layout.
59. The system of any one of claims 1-58, wherein the one or more machine learning modules have been trained based on user interaction with phantom models shown on a display via an AR / VR / MR headset, a generic tracked device, a haptic device, a joystick, and / or a real model.
60. The system of any one of claims 1-59, wherein the instructions, when executed by the processor, cause the processor to output via the one or more machine learning modules information on speed and correctness of preparation, instrument waiting time, events frequency, presence and type of tasks performed or a combination thereof in order to analyze personal behavior from the operating room based on the input data.
61. The system of any one of claims 1-60, wherein the instructions, when executed by the processor, cause the processor to output via the one or more machine learning modules information on effectiveness, effective OR time vs. planned time, preparation time, instrumentation waiting time, ambiance / mood in the OR, event statistics (e.g., detected events and / or number of them), surgery stages statistics, personnel statistics, trends, costs, or a combination thereof in order to analyze personal behavior from the operating room based on the input data.
62. The system of any one of claims 1-61, wherein the instructions, when executed by the processor, cause the processor to output via the one or more machine learning modules information on one or more direct patient impact events (e.g., errors with manipulating surgical tracking and navigation equipment and / or hitting patient measurement markers attached to anatomy) based on the input data.
63. The system of any one of claims 1-62, wherein the audio and / or visual output data are indicative of instruments to be used in a next stage.
64. The system of any one of claims 1-63, wherein the audio and / or visual output data are indicative of what needs to be done for instrument exchange and assembly.
65. The system of any one of claims 1-64, wherein the one or more machine learning modules are operable to determine whether needed equipment is present in the operating room based on a user request (e.g., an auditory request) and the input data and the audio and / or visual output data confirm presence or absence of the equipment.
66. A method for management of an operating room, the method comprising:receiving, by a processor of a computing device, input data from the operating room and producing visual and / or audio output data via one or more machine learning modules, said output data rendered for presentation to a user on a display, wherein the input data comprises one or more of (i)-(iii) as follows:(i) visual input from the operating room detected by one or more cameras;(ii) input from one or more sensors selected from the group consisting of the following: Wi-Fi, Bluetooth, ZigBee, radio frequency identification (RFID), ultra-wide band (UWB), inertial measurement unit (IMU), visible light communication (VLC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (LiDAR), and computer vision; and(iii) audio input from one or more audio input / output (I / O) devices in the operating room.
67. A method for management of an operating room, the method comprising: receiving, by a processor of a computing device, input data from the operating room and producing visual and / or audio output data via one or more machine learning modules (e.g., said output data rendered for presentation to a user on a display), wherein the input data comprises one or more of (i)-(iii) as follows:(i) visual input from the operating room detected by one or more cameras;(ii) input from one or more sensors (e.g., selected from the group consisting of the following: Wi-Fi, Bluetooth, Thread, ZigBee, radio frequency identification (RFID), ultrawide band (UWB), inertial measurement unit (IMU), visible light communication (VUC), infrared (IR), ultrasonic, geomagnetic, light detection and ranging (UiDAR), and computer vision); and(iii) audio input from one or more audio input / output (I / O) (e.g., microphone (s)) devices in the operating room.
68. The method of claim 66 or claim 67, comprising producing visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions selected from the group consisting of: person identification (e.g., identify who is who in the operating room); stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage);predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal); instrument identification (e.g., identify which instruments are used and / or prepared and / or handled); speech recognition and synthesis (e.g., interpret conversation and produce speech response); human emotion recognition (e.g., recognize emotions of one or more users in the operating room); event detection (e.g., detect selected events in the operating room); spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room); context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed); video streaming (e.g., stream video to and / or from the operating room); situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge); specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant); and personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).
69. The method of claim 68, wherein the one or more functions comprises instrument identification, and wherein the output data comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR, VR, or MR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more displays.
70. The method of claim 68, wherein the one or more functions comprises context segmentation, and wherein the output data comprises a graphical warning presented via a display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual).
71. The method of claim 68, wherein the one or more functions comprises (i) identifying, by the processor of the computing device, a current stage of a surgical procedure and / or (ii) identifying, by the processor of the computing device, what stage will follow or will likely follow the current stage, and wherein the output data comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.
72. The method of any one of claims 66-71, comprising producing the visual and / or audio output data via the one or more machine learning modules in order to perform one or more functions.
73. The method of any one of claims 66-72, comprising producing the visual and / or audio output data via the one or more machine learning modules for performing one or more functions.
74. The method of any one of claims 66-73, comprising using at least a portion of the input data received from the operating room to perform one or more functions using the one or more machine learning modules.
75. The method of any one of claims 72-74, wherein at least a portion of said output data is rendered for presentation to at least one of the one or more users on the one or more displays in service of said one or more functions.
76. The method of any one of claims 72-75, wherein the one or more functions comprise person identification (e.g., identify who is who in the operating room) [e.g., differentiating between persons based on function (e.g., scrub nurse from surgeon) (e.g., using semantic segmentation)] .
77. The method of any one of claims 72-76, wherein the one or more functions comprise stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage).
78. The method of any one of claims 72-77, wherein the one or more functions comprise predictive analytics (e.g., based on past experiences, predict a likely next action and / or a next goal).
79. The method of any one of claims 72-78, wherein the one or more functions comprise instrument identification (e.g., identify which instruments are used and / or prepared and / or handled).
80. The method of any one of claims 72-79, wherein the one or more functions comprise speech recognition and synthesis (e.g., interpret conversation and produce speech response).
81. The method of any one of claims 72-80, wherein the one or more functions comprise human emotion recognition (e.g., recognize emotions of one or more users in the operating room).
82. The method of any one of claims 72-81, wherein the one or more functions comprise event detection (e.g., detect selected events in the operating room).
83. The method of any one of claims 72-82, wherein the one or more functions comprise spatial localization (e.g., spatially localize person(s) and / or equipment in the operating room).
84. The method of any one of claims 72-83, wherein the one or more functions comprise context segmentation (e.g., identify and / or tag people and / or equipment in the operating room, e.g., identify such as sterile / non-sterile and / or mobile / fixed);85. The method of any one of claims 72-84, wherein the one or more functions comprise video streaming (e.g., stream video to and / or from the operating room).
86. The method of any one of claims 72-85, wherein the one or more functions comprise situation and person learning (e.g., automatically gather person and / or situation and / or time specific knowledge).
87. The method of any one of claims 72-86, wherein the one or more functions comprise specific training generation (e.g., generate training specific to a particular surgeon and / or procedure(s) customized for one or more particular users, e.g., a scrub, nurse, sales representative, and / or assistant).
88. The method of any one of claims 72-87, wherein the one or more functions comprise personnel assessment (e.g., assess skills, capabilities, history, and / or style associated with one or more particular system users).
89. The method of any one of claims 72-88, wherein the one or more functions comprises instrument identification, and wherein the output data rendered for presentation to at least one ofthe one ormore users comprises a graphical overlay (e.g., bounding box) rendered in relation to an identified instrument (e.g., as viewed via an AR or VR display) to graphically annotate (e.g., outline, highlight, denote with text, and / or graphically present a determined probability said identification is accurate) the identified instrument to the at least one of the one or more users via one or more of the one or more displays.
90. The method of any one of claims 72-89, wherein the one or more functions comprises context segmentation, and wherein the output data rendered for presentation to at least one of the one or more users comprises a graphical warning presented via the display or an audible warning presented via an audio output device, said warning indicating a potential loss of sterility (e.g., due to touching of a non-sterile instrument by an individual).
91. The method of any one of claims 72-90, wherein the one or more functions comprises stage and / or task identification, and the stage and / or task identification comprises (i) an identification of a current stage of a surgical procedure and / or (ii) an identification of what stage will follow or will likely follow the current stage, and wherein the output data rendered for presentation to at least one of the one or more users comprises illumination by the projector of one or more instruments that are likely to be used in the current stage and / or the next stage of the surgical procedure.
92. The method of any one of claims 66-91, comprising obtaining thermal imaging input from one or more thermal imaging cameras in the operating room and using at least a portionof the thermal imaging input to produce visual and / or audio output data via the one or more machine learning modules identifying one or more persons in the operating room (e.g., wherein the one or more persons are obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or an obfuscated body (e.g., obfuscated by a gown or drape)].
93. The method of any one of claims 1-28, comprising detecting one or more fiducials in the operating room with one or more sensors and / or one or more cameras operable to [e.g., comprising one or more RFID tags, one or more visible codes (e.g., QR codes or bar codes), one or more color-coding of clothes (e.g. surgical / scrub cups), one or more visible tags, one or more optical tracking markers (e.g. reflective spheres), and / or one or more electro-magnetic fiducials) disposed on one or more persons.94 The method of claim 93, comprising producing visual and / or audio output data identifying the one or more persons in the operating room via the one or more machine learning modules based on data from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons are visually obfuscated [e.g., have an obfuscated face (e.g., obfuscated by a mask) and / or a visually obfuscated body (e.g., obfuscated by a gown or drape)] (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor).
95. The method of claim 93 or claim 94, comprising determining a position of the one or more persons in the operating room (e.g., via the one or more machine learning modules) based on data received from the one or more sensors and / or one or more cameras corresponding to the one or more fiducials (e.g., wherein the one or more persons do not have a direct line of sight with any camera or sensor) (e.g., using skeletal approximation).
96. The method of any one of claims 66-95, comprising determining identity and / or position of one or more persons in the operating room (e.g., via the one or more machine learning modules) using a combination of (e.g., in sequence) (e.g., combined using a Kalman filter) facial recognition, 3D mesh based identification and / or tracking, fiducial-based identification and / or positioning, contextual identification and / or positioning (e.g., based on a person’s spatial location, behavior, and / or tasks), thermal imaging, one or more personal characteristics (e.g., voice, gait, movement, characteristic elements), and wireless identificationand / or positioning (e.g., Bluetooth location or other near-field communication) (e.g., (e.g., using skeletal approximation).
97. The method of any one of claims 66-96, comprising determining identity and / or position of one or more persons in the operating room using a combination of audio and visual identification and / or positioning (e.g., based on data received from one or more cameras and one or more audio input / output devices (e.g., microphones and / or speakers)) (e.g., using skeletal approximation).
98. The method of any one of claims 66-97, comprising producing visual and / or audio output data for stage and / or task identification (e.g., identify a current stage of a surgical procedure and / or identify what stage will follow or will likely follow the current stage) via the one or more machine learning modules based on instrument identification for one or more instruments in the operating room performed with the one or more machine learning modules.
99. The method of any one of claims 66-98, comprising identifying a current stage and / or task of a surgery via the one or more machine learning modules based on persons present and / or their positions, instruments used, spoken language, noise signature, history of current case, and / or comparison to other cases reflected in the input data (e.g., as determined with the one or more machine learning modules) (e.g., and produce corresponding visual and / or audio output data).
100. The method of any one of claims 66-99, wherein the one or more machine learning modules have been trained using real-time data coming from surgery in the operating room (e.g., surgery stage and task data, identified instrumentation, person identification and / or localization data).
101. The method of any one of claims 66-100, wherein the visual and / or output data correspond to (e.g., comprise) a VR / AR / MR overlay [e.g., wherein the method comprises rendering (e.g., and displaying) the VR / AR / MR overlay to a user (e.g., on a VR / AR / MR headset)] .
102. The method of claim 101, wherein the VR / AR / MR overlay identifies instruments to the wearer of a VR / AR / MR headset (e.g., using labels, bounding boxes, and / or recognition confidence level).
103. The method of claim 101 or claim 102, wherein the VR / AR / MR overlay comprises a warning for a low confidence level for identification of an instrument.
104. The method of claim 103, comprising receiving input (e.g., audio input) from a user and resolving the low confidence level based on the received input (e.g., an audio indication of what the instrument is).
105. The method of any one of claims 66-104, comprising training the one or more machine learning modules to learn (i) instrument performance over time (e.g., in conjunction with instrument-relevant events), (ii) changes in instrument visual appearance (e.g., de-colorization, parts missing or deformed), and / or (iii) usage tracking and to provide the audio and / or visual output data based on the learning.
106. The method of claim 105, wherein the audio and / or visual output data corresponds to an identification of an instrument over time, a broken part, or failure of an instrument.
107. The method of any one of claims 66-106, comprising recognizing speech of one or more persons using the one or more machine learning modules that has been received using an audio I / O device in the operating room and producing the audio and / or visual output data based on said recognized speech.
108. The method of claim 107, wherein the one or more machine learning modules have been trained to recognize speech based on a natural database of recordings from an operating room.
109. The method of claim 108, wherein the recordings comprise recordings linked with events in the operating room (e.g., sterility loss).
110. The method of any one of claims 66-109, wherein the one or more machine learning modules have been trained (e.g., wherein the method comprises training the one or more machine learning modules) using data specific to the operating room (e.g., audio and / or visual data gathered during use of the operating room) (e.g., in addition to a general pre-training on data from other operating rooms) (e.g., thereby being tailoring to the specific operating room in which the method is deployed) (e.g., data corresponding to where surgeon or staff had to wait for specific device, e.g., such that the one or more machine learning modules are operable to construct dynamic, surgeon and case-specific list of equipment).
111. The method of any one of claims 66-110, wherein the audio and / or visual output data indicate a safety event.
112. The method of claim 111, wherein the safety event comprises a contamination risk (e.g., for a patient and / or one or more users) (e.g., an audio and / or visual warning).
113. The method of any one of claims 66-112, wherein the one or more machine learning modules have been trained (e.g., wherein the method comprises training the one or more machine learning modules) using visual input from one or more cameras and / or one or more sensors combined with corresponding audio input [e.g., audio-derived annotations (e.g., labels)] (e.g., for event detection and / or stage and / or task identification) [e.g., indicative of a safety event (e.g., a user auditorily indicating “sterility loss”)] (e.g., by showing instruments to one or more users and prompting the one or more users to choose a name, e.g., from a list or to say it aloud).
114. The method of any one of claims 66-113, wherein the one or more machine learning modules perform on-the-fly registration (e.g., of fixed or dynamic scene elements).
115. The method of any one of claims 66-114, wherein the audio and / or visual output data indicate position of instruments in the operating room that are to be assembled and / or how to assemble said instruments.RECTIFIED SHEET (RULE 91 ) ISA / EP116. The method of any one of claims 66-115, wherein the audio and / or visual output data indicate where to place instruments for quicker reuse.
117. The method of any one of claims 66-116, wherein the audio and / or visual output data indicate a sterility loss and the method comprises producing the audio and / or visual output data via the one or more machine learning modules based on position of one or more persons and clothes of the one or more persons together with information about surrounding equipment when the one or more machine learning modules determine that a non-sterile surface was touched thereby.
118. The method of any one of claims 66-117, comprising performing contextual segmentation of sterile and non-sterile elements with the one or more machine learning modules (e.g., surfaces and clothes) (e.g., based on color) [e.g., based on relative position and / or history (e.g., instruments taken from a sterilization tray are sterile)].
119. The method of any one of claims 66-118, comprising performing contextual segmentation of fixed elements with the one or more machine learning modules (e.g., attached table(s)) and mobile elements (e.g., instruments and trays).
120. The method of any one of claims 66-119, comprising performing contextual segmentation of disposables [e.g. countable items (e.g., sponges, rubber bands)] and reusables with the one or more machine learning modules.
121. The method of any one of claims 66-120, comprising producing, by the one or more machine learning modules, based on the input data, an optimized layout for instruments in the operating room and the audio and / or visual output data comprises an indication of the layout.
122. The method of any one of claims 66-121, wherein the one or more machine learning modules have been trained (e.g., wherein the method comprises training the one or more machine learning modules) based on user interaction with phantom models shown on a display via an AR / VR / MR headset, a generic tracked device, a haptic device, a joystick, and / or a real model.RECTIFIED SHEET (RULE 91 ) ISA / EP123. The method of any one of claims 66-122, comprising outputting via the one or more machine learning modules, based on the input data, information on speed and correctness of preparation, instrument waiting time, events frequency, presence and type of tasks performed or a combination thereof in order to analyze personal behavior from the operating room.
124. The method of any one of claims 66-123, comprising outputting via the one or more machine learning modules, based on the input data, information on effectiveness, effective OR time vs. planned time, preparation time, instrumentation waiting time, ambiance / mood in the OR, event statistics (e.g., detected events and / or number of them), surgery stages statistics, personnel statistics, trends, costs, or a combination thereof in order to analyze personal behavior from the operating room.
125. The method of any one of claims 66-124, comprising outputting via the one or more machine learning modules information on one or more direct patient impact events (e.g., errors with manipulating surgical tracking and navigation equipment and / or hitting patient measurement markers attached to anatomy) based on the input data.
126. The method of any one of claims 66-125, wherein the audio and / or visual output data indicate instruments to be used in a next stage.
127. The method of any one of claims 66-126, wherein the audio and / or visual output data indicate what needs to be done for instrument exchange and assembly.
128. The method of any one of claims 66-127, comprising determining, via the one or more machine learning modules, whether needed equipment is present in the operating room based on a user request (e.g., an auditory request) for confirmation and the input data and the audio and / or visual output data confirm presence or absence of the equipment.
129. The method of claim 111 or claim 112, comprising determining, via the one or more machine learning modules, using the input data that there has been incorrect room preparationRECTIFIED SHEET (RULE 91 ) ISA / EP(e.g. missing sterile drape(s)), incorrect instrumentation handling (e.g. assembly of instruments, like powered devices, where non-sterile battery needs to be inserted into sterile cover), incorrect aseptic technique when putting on sterile clothes, filling-up liquids, accidental touching of non- sterile surfaces by sterile equipment, passing too close to sterile equipment, or one or more instruments falling on the ground.RECTIFIED SHEET (RULE 91 ) ISA / EP