A system and method for tracking a portion of users as an alternative to non-monitoring devices.
The system enhances surgical environments with augmented reality by tracking staff and instruments, addressing the lack of integrated sensory feedback in existing surgical technologies to improve precision and efficiency.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-04-11
- Publication Date
- 2026-07-06
AI Technical Summary
Existing surgical procedures lack an effective way to provide an augmented reality interactive experience that enhances real-world surgical environments with computer-generated sensory information across multiple modalities, including vision, hearing, touch, proprioception, and smell, which is crucial for improving surgical precision and efficiency.
A system comprising a camera system, unique identifiers, active sensors, and a surgical hub that tracks surgical staff members and instruments, allowing for the display of virtual elements on augmented reality devices to enhance the surgical field with contextual data and sensory feedback.
Enables real-time tracking and augmentation of surgical environments, providing enhanced visual, auditory, tactile, and olfactory feedback to improve surgical precision and team coordination during procedures.
Smart Images

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Abstract
Description
Technical Field
[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 174,674, filed on April 14, 2021, entitled "HEADS UP DISPLAY", and U.S. Provisional Patent Application No. 63 / 284,326, filed on November 30, 2021, entitled "INTRAOPERATIVE DISPLAY FOR SURGICAL SYSTEMS", under 35 U.S.C. § 119(e). The entire disclosure of each of these applications is hereby incorporated by reference in its entirety.
Background Art
[0002] The present disclosure relates to devices, systems, and methods for providing an augmented reality interactive experience during a surgical procedure. During a surgical procedure, it would be desirable to provide an augmented reality interactive experience of the real - world environment in which objects existing in the real world are enhanced by overlaying computer - generated perceptual information across multiple sensory modalities, including, at times, vision, hearing, touch, proprioception, and smell. In the context of the present disclosure, images of the surgical field and surgical instruments and other objects appearing in the surgical field are enhanced by overlaying computer - generated visual, auditory, tactile, proprioceptive, olfactory, or other sensory information onto the real - world images of the surgical field and the instruments or other objects appearing in the surgical field. The images may be streamed in real - time or may be still images.
[0003] Real-world surgical instruments include a variety of surgical devices, including energy, staplers, or combinations of energy and staplers. Energy-based medical devices include, but are not limited to, radio frequency (RF) based unipolar and bipolar electrosurgical instruments, ultrasonic surgical instruments, combinations of RF electrosurgical instruments and ultrasonic instruments, and combinations of RF electrosurgical staplers and mechanical staplers. Surgical stapler devices are surgical instruments used to cut and staple tissue in a variety of surgical procedures, including obesity, thoracic, colorectal, obstetric and gynecological, urological, and general surgery. [Overview of the project] [Means for solving the problem]
[0004] In various examples, the Disclosure includes a camera system, a unique identifier corresponding to a first surgical staff member, which includes a visual indicator located on the outer surface of an article worn by an operating room personnel, the unique identifier being visible to the camera system, an active sensor corresponding to a first surgical staff member, which captures active tracking data, and a surgical hub communicably connected to the camera system and the active sensor, the surgical hub comprising memory and a control circuit, the control circuit being to receive context data from an external source, the context data including the position of a hand for a surgical instrument used in a surgical procedure, and the first A surgical system is provided, configured to: receive passive tracking data from a camera system associated with a surgical staff member; receive active tracking data from an active sensor associated with a first surgical staff member; determine that the surgical staff member is using a first surgical instrument that is not tracked by a surgical hub; compare the passive tracking data and active tracking data with the hand position for a surgical instrument used in a surgical procedure; determine a specific surgical instrument corresponding to the passive tracking data and context data; and display a virtual element on an augmented reality device, wherein the virtual element includes a virtual representation of a specific surgical instrument.
[0005] In various examples, the Disclosure relates to a method for tracking the movement of operating room personnel, wherein a surgical hub receives contextual data from an external source, the contextual data includes the position of the hand for surgical instruments used in a surgical procedure, the surgical hub identifies a first unique identifier associated with a first surgical staff member and a second unique identifier associated with a second surgical staff member, the surgical hub receives passive tracking data from camera systems associated with the first and second surgical staff members, the passive tracking data is determined by a reference marker, and the surgical hub, The present invention provides a method comprising: receiving active tracking data from active sensors associated with a first surgical staff member and a second surgical staff member; determining, by a surgical hub, that the first or second surgical staff member is using a first surgical instrument that is not being tracked by the surgical hub; comparing passive tracking data and active tracking data with the hand position for a surgical instrument used in a surgical procedure; determining, by a surgical hub, a specific surgical instrument corresponding to the passive tracking data and contextual data; and transmitting virtual elements to be displayed on an augmented reality device. [Brief explanation of the drawing]
[0006] The various embodiments described herein with respect to both configuration and operation methods, along with their further purposes and advantages, can be best understood by referring to the following description in conjunction with the accompanying drawings. [Figure 1] This is a block diagram of a computer-implemented interactive surgical system according to one aspect of the present disclosure. [Figure 2] This is a diagram of a surgical system used to perform surgical procedures in an operating room, according to one aspect of the present disclosure. [Figure 3] One aspect of the present disclosure is a visualization system, a robotic system, and a surgical hub paired with an intelligent instrument. [Figure 4]This figure shows a surgical data network, according to one aspect of the present disclosure, which includes a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to the cloud. [Figure 5] This figure shows a computer-implemented interactive surgical system according to one aspect of the present disclosure. [Figure 6] This figure shows a surgical hub, including a plurality of modules connected to a modular control tower, according to one aspect of the present disclosure. [Figure 7] This figure shows an augmented reality (AR) system, according to one aspect of the present disclosure, which includes an intermediate signal coupler located in the communication path between an imaging module and a surgical hub display. [Figure 8] This figure shows an augmented reality (AR) system, according to one aspect of the present disclosure, which includes an intermediate signal coupler located in the communication path between an imaging module and a surgical hub display. [Figure 9] This figure shows an augmented reality (AR) device worn by a surgeon to communicate data to a surgical hub, according to one aspect of the present disclosure. [Figure 10] This figure shows a system for augmenting surgical instrument information using an augmented reality display, according to one aspect of the present disclosure. [Figure 11] This figure shows a timeline of a situational awareness surgical procedure according to one aspect of the present disclosure. [Figure 12] This is a diagram of an exemplary OR configuration with a passive tracking camera system according to one aspect of the present disclosure. [Figure 13] This figure shows a surgical hub configured to determine the position of a surgical instrument based on the wrist angle of a surgical staff member, according to one aspect of the present disclosure. [Figure 14] This figure shows a passive tracking system comprising one or more cameras configured to uniquely identify and distinguish surgical personnel in an operating room, according to one aspect of the present disclosure. [Figure 15]This figure shows the initialization sequence in a passive tracking system according to one aspect of the present disclosure. [Figure 16] This figure shows a directional pattern that may be used to distinguish between left and right appendages or to assist a passive tracking camera when detecting movement, according to one aspect of the present disclosure. [Figure 17] This figure shows an identification code on the dorsal side of a surgical glove, as detected by thermal imaging or an infrared (IR) camera, according to one aspect of the present disclosure. [Figure 18] This figure shows identification codes on both the dorsal and palmar sides of a surgical glove according to one aspect of the present disclosure. [Figure 19] This figure shows identification QR codes assigned to each finger of a surgical staff member, according to one aspect of the present disclosure. [Figure 20] This figure shows a wrist-mounted camera configured to monitor and track the movement of a single employee's fingers and wrist, according to one aspect of the present disclosure. [Figure 21] This figure shows an active surgical glove according to one aspect of the present disclosure, comprising a reference marker on each finger, a plurality of embedded strain gauges, and a gyroscope connected to a control circuit. [Figure 22] This figure shows a single strain gauge sensor associated with the fingertip, according to one aspect of the present disclosure. [Figure 23] This figure shows a flexible circuit printed on a sterile material, such as latex, nitrile, or other sterile material used in surgical gloves, according to one aspect of the present disclosure. [Figure 24] This figure shows a flexible circuit that may be used to connect a strain gauge to a control circuit, according to one aspect of the present disclosure. [Figure 25] This figure shows an active reference marker connected to a control circuit, printed directly onto a sterile material, according to one aspect of the present disclosure. [Figure 26]A diagram showing a piezoelectric ceramic power cell that can be used to harvest energy from movement and power a control circuit, strain gauges, gyroscopes, accelerometers, and / or active reference markers according to one aspect of the present disclosure. [Figure 27] A diagram showing an active sensor glove having a detachable housing that includes a control circuit housing and a gyroscope according to one aspect of the present disclosure. [Figure 28] A diagram showing a detachable active sensor harness that includes a plurality of embedded strain gauge sensors communicatively coupled to a control circuit using flexible wires within a housing according to one aspect of the present disclosure. [Figure 29] A diagram showing an active sensor harness removed from a hand according to one aspect of the present disclosure. [Figure 30] A diagram showing a graphic representation of the handoff of a surgical instrument between a first surgeon and a second surgeon according to one aspect of the present disclosure. [Figure 31] A diagram of the musculoskeletal diagram of a human hand according to one aspect of the present disclosure. [Figure 32] A diagram showing the front and back sides of the right arm according to one aspect of the present disclosure. [Figure 33] A diagram showing a pair of wrist-mounted sensors communicatively coupled to a surgical hub according to one aspect of the present disclosure. [Figure 34] A diagram showing a plurality of MMG sensors directly attached to the muscles of the forearm according to one aspect of the present disclosure. [Figure 35] A diagram showing a flexible wireless sensor coupled to a flexible adhesive medium that adheres directly to the skin according to one aspect of the present disclosure. [Figure 36] A diagram showing a graphical plot of five EMG channels corresponding to the movement of four fingers and the thumb in a hand according to one aspect of the present disclosure. [Figure 37] A graphical plot of MMG signals corresponding to the movement and position of a hand according to one aspect of the present disclosure. [Figure 38]This figure shows a model according to one aspect of the present disclosure that correlates the amplitude value of maximum muscle contraction measured in Vrms with the percentage of maximum voluntary contraction (%MCV). [Figure 39] This figure shows an active sensor sleeve comprising a plurality of active sensors for measuring MMG signals and / or EMG signals, according to one aspect of the present disclosure. [Figure 40] This figure shows three linear regression models for analyzing EMG signals to evaluate muscle fatigue over time, according to one aspect of the present disclosure. [Figure 41] This is a logical diagram of a method for tracking the movement of operating room staff according to one aspect of the present disclosure.
[0007] Throughout the drawings, corresponding reference numerals indicate corresponding parts. The examples described herein illustrate various disclosed embodiments in one form, and such examples should not be construed as limiting the scope. [Modes for carrying out the invention]
[0008] The applicant of this application owns the following concurrently filed U.S. patent applications, the entirety of which is incorporated herein by reference: • U.S. Patent Application entitled "METHOD FOR INTRAOPERATIVE DISPLAY FOR SURGICAL SYSTEMS"; Agent Reference Number END9352USNP1 / 210120-1M • U.S. Patent Application entitled "Utilization of surgical data values and situational awareness to control the overlay in surgical field view"; Agent reference number END9352USNP2 / 210120-2 U.S. Patent Application entitled "SELECTIVE AND ADJUSTABLE MIXED REALITY OVERLAY IN SURGICAL FIELD VIEW"; Agent Reference Number END9352USNP3 / 210120-3 • U.S. Patent Application entitled "RISK BASED PRIORITIZATION OF DISPLAY ASPECTS IN SURGICAL FIELD VIEW"; Agent Reference Number END9352USNP4 / 210120-4 • U.S. Patent Application entitled "SYSTEMS AND METHODS FOR CONTROLLING SURGICAL DATA OVERLAY"; Agent Reference Number END9352USNP5 / 210120-5 U.S. Patent Application entitled "SYSTEMS AND METHODS FOR CHANGING DISPLAY OVERLAY OF SURGICAL FIELD VIEW BASED ON TRIGGERING EVENTS"; Agent Reference Number END9352USNP6 / 210120-6 • U.S. Patent Application entitled "CUSTOMIZATION OF OVERLAID DATA AND CONFIGURATION"; Agent Reference Number END9352USNP7 / 210120-7 U.S. Patent Application entitled "INDICATION OF THE COUPLE PAIR OF REMOTE CONTROLS WITH REMOTE DEVICES FUNCTIONS"; Agent Reference Number END9352USNP8 / 210120-8 U.S. Patent Application entitled "Cooperative Overlays of Interacting Instruments Which Resurface in Both Overlays Being Effected"; Agent Reference Number END9352USNP9 / 210120-9 U.S. Patent Application entitled "ANTICIPATION OF INTERACTIVE UTILIZATION OF COMMON DATA OVERLAYS BY DIFFERENT USERS"; Agent Reference Number END9352USNP10 / 210120-10 U.S. Patent Application entitled "MIXING DIRECTLY VISUALIZED WITH RENDERED ELEMENTS TO DISPLAY BLENDED ELEMENTS AND ACTIONS HAPPENING ON-SCREEN AND OFF-SCREEN"; Agent Reference Number END9352USNP11 / 210120-11 U.S. Patent Application entitled "UTILIZING CONTEXTUAL PARAMETERS OF ONE OR MORE SURGICAL DEVICES TO PREDICT A FREQUENCY INTERVAL FOR DISPLAYING SURGICAL INFORMATION"; Agent Reference Number END9352USNP13 / 210120-13 U.S. Patent Application entitled "Cooperation Among Multiple Display Systems to Provide a Healthcare User Customized Information"; Agent Reference Number END9352USNP14 / 210120-14 • U.S. Patent Application entitled "INTRAOPERATIVE DISPLAY FOR SURGICAL SYSTEMS"; Agent Reference Number END9352USNP15 / 210120-15 • U.S. Patent Application entitled "ADAPTATION AND ADJUSTABILITY OR OVERLAID INSTRUMENT INFORMATION FOR SURGICAL SYSTEMS"; Agent Reference Number END9352USNP16 / 210120-16, and, U.S. Patent Application entitled "MIXED REALITY FEEDBACK SYSTEMS THAT COOPERATE TO INCREASE EFFICIENT PERCEPTION OF COMPLEX DATA FEEDS"; Agent reference number END9352USNP17 / 210120-17.
[0009] The applicant of this application owns the following U.S. patent applications, the entirety of which is incorporated herein by reference: U.S. Patent Application No. 16 / 209,423 (currently U.S. Patent Publication No. 2019 / 0200981-A1) entitled "METHOD OF COMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS", • U.S. Patent Application No. 16 / 209,453, entitled "METHOD FOR CONTROLLING SMART ENERGY DEVICES" (currently published as U.S. Patent Application Publication No. 2019 / 0201046-A1).
[0010] Before describing in detail the various embodiments of surgical devices and generators, it should be noted that the illustrative embodiments are not limited in their application or use to the details of the structure and arrangement of the components illustrated in the accompanying drawings and descriptions. The illustrative embodiments may be implemented or incorporated into other embodiments, variations, and modifications, and may be carried out or performed in various ways. Furthermore, unless otherwise specified, the terms and expressions used herein have been selected for the purpose of illustrating the illustrative embodiments for the convenience of the reader and are not intended to limit them. Furthermore, it should be understood that one or more embodiments, expressions of embodiments, and / or embodiments described below may be combined with any one or more other embodiments, expressions of embodiments, and / or embodiments described below.
[0011] Various embodiments apply to on-screen displays for surgical systems for various energy and surgical stapler-based medical devices. Energy-based medical devices include, but are not limited to, radio frequency (RF)-based unipolar and bipolar electrosurgical instruments, ultrasonic surgical instruments, combinations of RF electrosurgical instruments and ultrasonic instruments, and combinations of RF electrosurgical staplers and mechanical staplers. Surgical stapler devices include surgical staplers combined with electrosurgical devices and / or ultrasonic devices. Embodiments of ultrasonic surgical devices may be configured, for example, to transversely incise and / or coagulate tissue during surgical procedures. Embodiments of electrosurgical devices may be configured, for example, to transversely incise, coagulate, seal, weld and / or dry tissue during surgical procedures. Embodiments of surgical stapler devices may be configured to transversely incise and staple tissue during surgical procedures, and in some embodiments, surgical stapler devices may be configured to deliver RF energy to tissue during surgical procedures. Electrosurgical devices are configured to deliver therapeutic and / or non-therapeutic RF energy to tissue. Elements of surgical staplers, electrosurgical devices, and ultrasound devices can be used in combination within a single surgical instrument.
[0012] In various embodiments, the Disclosure provides the OR team with on-screen displays of real-time information during surgical procedures. According to various embodiments of the Disclosure, many novel and unique on-screen displays are provided for displaying various visual information feedback to the OR team on screen. According to the Disclosure, the visual information may include one or more of various visual media, with or without sound. Generally, the visual information includes still photographs, moving photographs, video or audio recordings, graphic art, visual aids, models, displays, visual representation services, and support processes. The visual information may be communicated on any number of display options, such as, for example, a primary OR screen, the energy or surgical stapler device itself, a tablet, augmented reality glasses, etc.
[0013] In various embodiments, this disclosure provides a list of many potential options for communicating visual information to an OR team in real time without overwhelming the OR team with too much visual information. For example, in various embodiments, this disclosure provides on-screen displays of visual information that enable a surgeon, or other members of the OR team, to selectively activate on-screen displays, such as icons surrounding screen options, to manage the rich visual information. One or a combination of factors may be used to determine the active display, and these may include, among other things, the energy-based (e.g., electrosurgery, ultrasound) or machine-based (e.g., stapler) surgical device in use, the estimated risk associated with a given display, the surgeon's level of experience, and the surgeon's choice. In other embodiments, the visual information may include rich data overlaid or superimposed on the surgical field to manage the visual information. In various embodiments described below, this includes superimposed images that require video analysis and tracking to properly overlay the data. Visual information data thus communicated can provide additional useful visual information to the OR team in a more concise and understandable way, in contrast to static icons.
[0014] In various embodiments, the Disclosure provides techniques for selectively activating on-screen displays, such as icons surrounding a screen, to manage visual information during a surgical procedure. In other embodiments, the Disclosure provides techniques for determining an active display using one or a combination of factors. In various embodiments, the techniques provided by the Disclosure may include, among other things, selecting an energy-based or machine-based surgical device to be used as the active display, estimating the risks associated with a given display, and utilizing the experience level of the surgeon or OR team making the selection.
[0015] In other embodiments, the techniques described herein may include overlaying or superimposing rich data onto the surgical field for the purpose of managing visual information. Several display arrangements described herein involve overlaying various visual representations of surgical data onto a live stream of the surgical field. As used herein, the term overlay includes translucent overlays, partial overlays, and / or moving overlays. Graphical overlays may take the form of transparent graphics, translucent graphics, or opaque graphics, or combinations of transparent, translucent, and opaque elements or effects. Furthermore, overlays may be placed on, or at least partially on or near, objects in the surgical field, such as end effectors and / or important surgical structures. A particular display arrangement may include changes in one or more display elements of the overlay, including changes in color, size, shape, display time, display location, display frequency, highlighting, or combinations thereof, based on changes in display priority values. Graphical overlays are rendered on an active display monitor to quickly and efficiently communicate critical information to the OR team.
[0016] In other embodiments, the technology provided by the Disclosure may include superimposing images that require video analysis and tracking in order to appropriately overlay visual information data. In other embodiments, the technology provided by the Disclosure may include communicating rich visual information, as opposed to simple static icons, to provide additional visual information to the OR team in a more concise and easily understandable manner. In other embodiments, the visual overlay may be used in combination with auditory and / or somatosensory overlays, e.g., thermal, chemical, and mechanical devices, and combinations thereof.
[0017] The following description generally pertains to devices, systems, and methods for providing augmented reality (AR) interactive experiences during surgical procedures. In this context, images of the surgical field and surgical instruments and other objects appearing in the surgical field are enhanced by overlaying computer-generated visual, auditory, tactile, somatosensory, olfactory, or other sensory information onto the real-world images of the surgical field, instruments, and / or other objects appearing in the surgical field. The images may be streamed in real time or they may be still images. Augmented reality is a technique for rendering and displaying virtual or "augmented" virtual objects, data, or visual effects that are overlaid on a real environment. The real environment may include the surgical field. Virtual objects overlaid on a real environment may be represented at fixed or set positions relative to one or more aspects of the real environment. In non-limiting examples, if a real-world object moves out of the field of view of the real environment, the virtual object fixed to the real-world object also moves out of the field of view of augmented reality.
[0018] Some of the display arrangements described herein involve overlaying various visual representations of surgical data onto a live stream of the surgical field. As used herein, the term overlay includes translucent overlays, partial overlays, and / or moving overlays. Furthermore, overlays may be placed on, or at least partially on or near, objects in the surgical field, such as end effectors and / or important surgical structures. A particular display arrangement may include changes in one or more display elements of the overlay, including changes in color, size, shape, display time, display location, display frequency, highlighting, or combinations thereof, based on a change in display priority value.
[0019] As described herein, AR is an extended version of the real physical world achieved through the use of digital visual elements, sounds, or other sensory stimuli delivered via technology. Virtual reality (VR) is a computer-generated environment with scenes and objects that appear real, making the user feel immersed in them. This environment is perceived through a device known as a virtual reality headset or helmet. While both mixed reality (MR) and AR are considered immersive technologies, they are not the same. MR is an extension of mixed reality that allows real and virtual elements to interact within an environment. AR often adds digital elements to a live view by using a camera, while an MR experience combines elements of both AR and VR, where real-world and digital objects interact.
[0020] In an AR environment, one or more computer-generated virtual objects may be displayed alongside one or more real-world (i.e., so-called "real-world") elements. For example, real-time images or videos of the surrounding environment may be displayed on a computer screen display along with one or more overlay virtual objects. Such virtual objects can provide supplementary information about the environment or, in general, enhance the user's perception and engagement with the environment. Conversely, real-time images or videos of the surrounding environment can, in addition or alternatively, enhance the user's engagement with the virtual objects displayed on the display.
[0021] Apparatus, systems, and methods in the context of this disclosure enhance images received from one or more imaging devices during surgical procedures. Imaging devices may include various scopes used during non-invasive and minimally invasive surgical procedures, AR devices, and / or cameras that provide images during incisional surgical procedures. Images may be streamed in real time or still images. Apparatus, systems, and methods provide an augmented reality interactive experience by enhancing images of a real-world surgical environment by overlaying representations of virtual objects or data and / or real objects onto the real-world surgical environment. The augmented reality experience may be viewed on a display and / or AR device that allows the user to view virtual objects overlaid on the real-world surgical environment. The display may be located in the operating room or located away from the operating room. The AR device is worn on the head of a surgeon or other operating room personnel and typically includes two stereoscopic display lenses or screens, one for each eye of the user. Natural light can pass through the two transparent or translucent display lenses so that aspects of the real environment are visible, while projecting light to make virtual objects visible to the user of the AR device.
[0022] Two or more displays and AR devices may be used in conjunction with a first display or AR device that controls one or more additional displays or AR devices in a system having defined roles. For example, when activating a display or AR device, the user may select a role (e.g., a surgeon, surgical assistant, nurse, etc. during a surgical procedure), and the display or AR device may display information related to that role. For example, a surgical assistant may have the display show virtual representations of instruments that the surgeon needs to use for the next step in the surgical procedure. The surgeon's focus on the current step may differ from the information displayed by the surgical assistant.
[0023] While many known on-screen displays and alerts exist, this disclosure provides many novel and unique augmented reality interactive experiences during surgical procedures. Such augmented reality interactive experiences include visual, auditory, tactile, somatosensory, olfactory, or other sensory feedback information to the surgical team inside or outside the operating room. Virtual feedback information overlaid on the real-world surgical environment may be provided to the operating room (OR) team, including, but not limited to, personnel within the OR, such as the surgical surgeon, surgical assistants, scrub wearers, anesthesiologists, and circulating nurses. The virtual feedback information can be communicated on any number of display options, such as primary OR screen displays, AR devices, energy or surgical staplers, tablets, augmented reality glasses, and other devices.
[0024] Figure 1 shows a computer-implemented interactive surgical system 1 comprising one or more surgical systems 2 and a cloud-based system 4. The cloud-based system 4 may include a remote server 13 connected to remote storage 5. Each surgical system 2 comprises at least one surgical hub 6 that communicates with the cloud 4. For example, a surgical system 2 may comprise a visualization system 8, a robotic system 10, and a handheld intelligent surgical instrument 12, each configured to communicate with each other and / or with the hub 6. In some embodiments, a surgical system 2 may comprise M hubs 6, N visualization systems 8, O robotic systems 10, and P handheld intelligent surgical instruments 12, where M, N, O, and P are integers of 1 or more. The computer-implemented interactive surgical system 1 may be configured to provide an augmented reality interactive experience during surgical procedures, as described herein.
[0025] Figure 2 shows an example of a surgical system 2 for performing a surgical procedure on a patient lying on an operating table 14 in a surgical operating room 16. A robotic system 10 is used as part of the surgical system 2 in the surgical procedure. The robotic system 10 includes a surgeon's console 18, a patient-side cart 20 (surgical robot), and a surgical robot hub 22. The patient-side cart 20 allows the surgeon to operate at least one detachably connected surgical tool 17 through a minimally invasive incision in the patient's body while viewing the surgical site through the surgeon's console 18 or an augmented reality (AR) device 66 worn by the surgeon. Images of the surgical site during the minimally invasive procedure (e.g., still or live images streamed in real time) can be acquired by a medical imaging device 24. The patient-side cart 20 can operate the imaging device 24 to orient it. Images of the incision surgical procedure can be acquired by a medical imaging device 96. The robot hub 22 processes images of the surgical site for subsequent display on the surgeon's console 18, or on an AR device 66 worn by the surgeon or another person in the surgical room 16.
[0026] The optical components of the imaging device 24, 96, or AR device 66 may include one or more illumination sources and / or one or more lenses. One or more illumination sources may be directed to illuminate a portion of the surgical field. One or more image sensors may receive light reflected or refracted from tissues and instruments in the surgical field.
[0027] In various embodiments, the imaging device 24 is configured for use in minimally invasive surgical procedures. Examples of imaging devices suitable for use with this disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopies, colonoscopes, cystoscopes, duodenoscopes, intestinaloscopes, gastroscopy (gastroscopy), endoscopes, laryngoscopes, nasopharyngolaryngoscopes, sigmoidoscopy, thoracoscopy, and ureteroscopes. In various embodiments, the imaging device 96 is configured for use in incisional (invasive) surgical procedures.
[0028] In various embodiments, the visualization system 8 comprises one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing devices, one or more storage arrays, and one or more displays. In one embodiment, the visualization system 8 includes interfaces for HL7, PACS, and EMR. In one embodiment, the imaging device 24 may employ multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within a specific wavelength range in the electromagnetic spectrum. Wavelengths are separated by filters or by instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging can extract information invisible to the human eye. Multispectral monitoring allows the surgical field to be repositioned after the surgical task for performing tests on the treated tissue is completed.
[0029] Figure 2 shows a primary display 19 positioned in the sterile field for the operator on the operating table 14 to see. The visualization tower 11 includes a first non-sterile display 7 and a second non-sterile display 9 positioned outside the sterile field and facing opposite directions from each other. The visualization system 8, guided by the hub 6, is configured to utilize displays 7, 9, and 19 to coordinate the flow of information to operators inside and outside the sterile field. For example, the hub 6 can cause the visualization system 8 to display AR images of the surgical site recorded by imaging devices 24 and 96 through the non-sterile displays 7, 9, or AR device 66, while maintaining live video of the surgical site on the primary display 19 or AR device 66. The non-sterile displays 7 and 9 can, for example, enable non-sterile operators to perform diagnostic steps related to the surgical procedure.
[0030] Figure 3 shows a hub 6 that communicates with a visualization system 8, a robotic system 10, and handheld intelligent surgical instruments 12. Hub 6 includes a hub display 35, an imaging module 38, a generator module 40, a communication module 30, a processor module 32, a storage array 34, and an operating room mapping module 33. Hub 6 further includes a smoke extraction module 26 and / or a suction / irrigation module 28. In various embodiments, the imaging module 38 includes an AR device 66, and the processor module 32 includes an integrated video processor and an augmented reality modeler (e.g., as shown in Figure 10). Modular light sources can be adapted for use with various imaging devices. In various examples, multiple imaging devices can be positioned at different locations in the surgical field to provide multiple views (e.g., non-invasive, minimally invasive, invasive, or incisional surgical procedures). The imaging module 38 can be configured to switch between imaging devices to provide the optimal view. In various embodiments, the imaging module 38 can be configured to integrate images from different imaging devices and provide an augmented reality interactive experience during surgical procedures as described herein.
[0031] Figure 4 shows a surgical data network 51 including a modular communication hub 53 configured to connect modular devices located in one or more operating rooms / surgery sites of a medical facility to a cloud-based system. The cloud 54 may include a remote server 63 (Figure 5) connected to a storage device 55. The modular communication hub 53 includes a network hub 57 and / or a network switch 59 that communicate with a network router 61. The modular communication hub 53 is connected to a local computer system 60 for data processing. The operating room modular devices 1a-1n may be connected to the modular communication hub 53. The network hub 57 and / or the network switch 59 are connected to the network router 61 so that devices 1a-1n can connect to the cloud 54 or the local computer system 60. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. The operating room devices 1a-1n may be connected to the modular communication hub 53 via a wired channel or a wireless channel. The surgical data network environment 51 may be employed, as described herein, to provide an augmented reality interactive experience during a surgical procedure, in particular to provide augmented images of the surgical field to one or more remote displays 58.
[0032] Figure 5 shows a computer-implemented interactive surgical system 50. The computer-implemented interactive surgical system 50 is similar in many respects to the computer-implemented interactive surgical system 1. The computer-implemented interactive surgical system 50 includes one or more surgical systems 52 that are similar in many respects to surgical system 2. Each surgical system 52 includes at least one surgical hub 56 that communicates with a cloud 54 which may include a remote server 63. In one embodiment, the computer-implemented interactive surgical system 50 includes a modular control tower 23 connected to a plurality of surgical site devices, such as intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in Figure 6, the modular control tower 23 includes a modular communication hub 53 connected to a computer system 60.
[0033] Returning to Figure 5, the modular control tower 23 is connected to an imaging module 38 connected to an endoscope 98, a generator module 27 connected to an energy device 99, a fume exhaust module 76, a suction / irrigation module 78, a communication module 13, a processor module 15, a storage array 16, and optionally smart devices / instruments 21 and sensor modules 29 connected to a display 39. Surgical site devices are connected to cloud computing resources such as a server 63, data storage 55, and a display 58 via the modular control tower 23. The robot hub 72 may also be connected to the modular control tower 23, as well as the server 63, data storage 55, and display 58. In particular, the devices / instruments 21 and the visualization system 58 may be connected to the modular control tower 23 via wired or wireless communication standards or protocols as described herein. The modular control tower 23 may be connected to a hub display 65 (e.g., a monitor, screen) to display received augmented images, including overlaid virtual objects on the real surgical world, received from the imaging module 38, device / instrument display 39, and / or other visualization systems 58. The hub display 65 may also display data received from devices connected to the modular control tower 23, along with the images and overlay images.
[0034] Figure 6 shows a surgical hub 56 including multiple modules connected to a modular control tower 23. The modular control tower 23 includes a modular communication hub 53, such as a network connectivity device, and a computer system 60 for local processing, visualization, and imaging of augmented surgical information. The modular communication hub 53 is connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communication hub 53, and data associated with the modules may be transferred to the computer system 60, cloud computing resources, or both. Each of the network hubs / switches 57 / 59 within the modular communication hub 53 may include three downstream ports and one upstream port. The upstream network hubs / switches 57, 59 are connected to the processor 31 to provide communication connectivity to cloud computing resources and local displays 67. Communication to the cloud 54 can be done via either a wired communication channel or a wireless communication channel.
[0035] The computer system 60 includes a processor 31 and a network interface 37. The processor 31 is connected via a system bus to a communication module 41, storage 45, memory 46, non-volatile memory 47, and an input / output interface 48. The system bus may be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus, using various available bus architectures.
[0036] The processor 31 may include an augmented reality modeler (e.g., as shown in Figure 10) and may be implemented as a single-core or multi-core processor, such as one known by the trademark name ARM Cortex by Texas Instruments. In one embodiment, the processor may be, for example, the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes on-chip memory of 256KB single-cycle flash memory or other non-volatile memory with a maximum frequency of 40MHz, a prefetch buffer for improving performance beyond 40MHz, 32KB single-cycle serial random access memory (SRAM), internal read-only memory (ROM) with StellarisWare® software, 2KB electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels. Further details are available in the product datasheet.
[0037] System memory includes volatile and non-volatile memory. The Basic Input / Output System (BIOS), which contains basic routines for transferring information between elements within the computer system during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory may include random access memory (RAM), which functions as external cache memory. Furthermore, RAM is available in many forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync-link DRAM (SLDRAM), and direct rhombus RAM (DRRAM).
[0038] The computer system 60 also includes removable / non-removable volatile / non-volatile computer storage media, such as disk storage. Examples of disk storage devices include, but are not limited to, magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, the disk storage device may include the above-mentioned storage media independently or in combination with other storage media. Examples of other storage media include, but are not limited to, optical disk drives such as compact disk ROM devices (CD-ROMs), compact disk recordable drives (CD-R drives), compact disk rewritable drives (CD-RW drives), or digital multi-purpose disk ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of the disk storage device to the system bus.
[0039] In various embodiments, the computer system 60 in Figure 6, the imaging module 38 in Figures 4 to 6, and / or the visualization system 58, and / or the processor module 15 may include an image processor, an image processing engine, an image processing unit (GPU), a media processor, or any dedicated digital signal processor (DSP) used for processing digital images. The image processor can increase speed and efficiency using parallel computing with single-instruction multiple data (SIMD) or multiple-instruction multiple data (MIMD) techniques. The digital image processing engine can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.
[0040] Figure 7 shows an augmented reality system 263 that includes an intermediate signal coupler 64 located in the communication path between the imaging module 38 and the surgical hub display 67. The signal coupler 64 combines audio and / or image data received from the imaging module 38 and / or the AR device 66. The surgical hub 56 receives the combined data from the coupler 64, overlays the provided data onto the display 67, and displays the overlaid data. The imaging device 68 may be a digital video camera, and the audio device 69 may be a microphone. The signal coupler 64 may include a wireless head-up display adapter for coupling to the AR device 66 located in the communication path of the display 67 to a console that enables the surgical hub 56 to overlay data onto the display 67.
[0041] Figure 8 shows an augmented reality (AR) system including an intermediate signal coupler positioned in the communication path between the imaging module and the surgical hub display. Figure 8 shows an AR device 66 worn by the surgeon 73 to communicate data to the surgical hub 56. Peripheral information of the AR device 66 does not include active images. Rather, peripheral information includes only signals that do not have the same requirements for device settings or refresh rate. The interaction may extend the surgeon 73's information based on links with preoperative computed tomography (CT) or other data linked within the surgical hub 56. The AR device 66 can identify structures and, for example, ask whether an instrument is touching a nerve, blood vessel, or adhesion. The AR device 66 may include processing in the surgical hub 56 used to provide preoperative scan data, optical views, tissue examination characteristics acquired throughout the procedure, and / or answers. The surgeon 73 may write notes on the AR device 66 so that they are stored in the hub storage 45 along with patient data for later use in reporting or follow-up.
[0042] The AR device 66, worn by the surgeon 73, links to the surgical hub 56 using auditory and visual information to avoid the need for overlays, and allows customization of information displayed around the periphery of the field of view. The AR device 66 provides signals from devices (e.g., instruments) and answers queries regarding location information linked with video to identify device settings or quadrants or locations. The AR device 66 has voice control and voice feedback from the AR device 66. The AR device 66 can interact with other systems in the operating room and can have available feedback and interaction wherever the surgeon 73 looks. For example, the AR device 66 may receive voice or gesture start commands and queries from the surgeon, and the AR device 66 may provide feedback in the form of one or more modalities, including voice, visual, or haptic touch.
[0043] Figure 9 shows a surgeon 73 and a patient 74 wearing AR devices 66, and may include a camera 96 in the operating room 75. The AR device 66 worn by the surgeon 73 may be used to present virtual objects overlaid on a real-time image of the surgical field to the surgeon 73 through an augmented reality display 89 or through a hub-connected display 67. The real-time image may include parts of surgical instruments 77. The virtual objects may not be visible to others in the operating room 75 (e.g., surgical assistants or nurses), but they may also wear AR devices 66. Even if another person is viewing the operating room 75 using an AR device 66, that person may not be able to see the virtual objects, or may be able to see the virtual objects in augmented reality shared with the surgeon 73, or may be able to see modified versions of the virtual objects (e.g., according to customization specific to the surgeon 73), or may see different virtual objects.
[0044] Virtual objects and / or data may be configured to appear on a portion of the surgical instrument 77 or within the surgical field captured by the imaging module 38, the imaging device 68 during minimally invasive surgical procedures, and / or the camera 96 during incisional surgical procedures. In the illustrated example, the imaging module 38 is a laparoscopic camera that provides live images of the surgical area during minimally invasive surgical procedures. The AR system may present virtual objects fixed to real objects regardless of the viewpoint of one or more viewers of the AR system (e.g., the surgeon 73). For example, virtual objects may be visible to viewers of the AR system inside the operating room 75, but not visible to viewers of the AR system outside the operating room 75. Virtual objects may be displayed to viewers outside the operating room 75 when a viewer enters the operating room 75. Augmented images may be displayed on the surgical hub display 67 or the augmented reality display 89.
[0045] The AR device 66 may include one or more screens or lenses, such as a single screen or two screens (e.g., one for each user's eye). The screens may allow light to pass through them so that aspects of the real environment are visible while virtual objects are being displayed. Virtual objects may become visible to the surgeon 73 by projecting light. Virtual objects may appear to have some degree of transparency or may be opaque (i.e., blocking aspects of the real environment).
[0046] An AR system may be visible to one or more viewers and may include differences between views available to one or more viewers, while maintaining some common aspects between views. For example, a heads-up display may change between two views, but virtual objects and / or data may be fixed to real objects or areas in both views. Aspects such as the color, lighting, or other changes of an object may occur between views without changing the fixed position of at least one virtual object.
[0047] Users can view virtual objects and / or data presented within the AR system as opaque or with a certain level of transparency. For example, a user can interact with a virtual object by moving it from a first position to a second position. For instance, a user may move an object with their own hand. This may be done virtually in the AR system by determining that the hand has moved to a position adjacent to or adjacent to the object (using one or more cameras, which may be mounted on the AR device 66, such as AR device camera 79 or a separate camera 96, and which may be static or controlled to move) and moving the object accordingly. The virtual form may include a virtual representation of a real-world object, or it may include visual effects such as lighting effects. The AR system may include rules to govern the behavior of the virtual object, such as exposing the virtual object to gravity or friction, or it may include other predefined rules that negate real-world physical constraints (e.g., floating objects, perpetual motion, etc.). The AR device 66 may include a camera 79 (which should not be confused with a separate camera 96). The AR device camera 79 or camera 96 may include an infrared camera, an infrared filter, a visible light filter, multiple cameras, a depth camera, etc. The AR device 66 may project virtual items onto a representation of the real environment that the user can see.
[0048] The AR device 66 may be used, for example, in an operating room 75 during a surgical procedure performed on a patient 74 by a surgeon 73. The AR device 66 may project or display virtual objects, such as virtual objects during the surgical procedure, to extend the surgeon's vision. The surgeon 73 may view the virtual objects using the AR device 66, a remote controller for the AR device 66, or interact with the virtual objects by using his hands to “interact” with the virtual objects or gestures recognized by the camera 79 of the AR device 66, for example. The virtual objects can extend surgical tools, such as surgical instruments 77. For example, the virtual object may appear to be connected to the surgical instrument 77 (to the surgeon 73 viewing the virtual object through the AR device 66), or to remain at a fixed distance from the surgical instrument 77. In another example, the virtual object may be used to guide the surgical instrument 77 and may appear to be fixed to the patient 74. In certain examples, the virtual object may react to the movement of other virtual or real-world objects in the surgical field. For example, a virtual object may be modified when a surgeon is manipulating a surgical instrument in close proximity to the virtual object.
[0049] The augmented reality display system imaging device 38 captures real images of the surgical area during the surgical procedure. The augmented reality displays 89 and 67 present an overlay of the operating modes of the surgical instrument 77 onto the real images of the surgical area. The surgical instrument 77 includes a communication circuit 231 for communicating operating mode and functional data from the surgical instrument 77 to the AR device 66 via a communication circuit 233 on the AR device 66. The surgical instrument 77 and the AR device 66 are shown in RF wireless communication between circuits 231 and 233, as indicated by arrows B and C, but other communication technologies (e.g., wired, ultrasonic, infrared, etc.) may be employed. The overlay relates to the operating modes of the surgical instrument 77 that are actively visualized. The overlay combines the modes of tissue interaction in the surgical area with functional data from the surgical instrument 77. The processor portion of the AR device 66 is configured to receive operating mode and functional data from the surgical instrument 77, determine overlays related to the operation of the surgical instrument 77, and combine the tissue characteristics within the surgical area with the functional data from the surgical instrument 77. The augmented images display alerts regarding device performance considerations, non-conformity use, and incomplete capture. Non-conformity use includes out-of-range tissue conditions and tissue improperly balanced within the jaws of the end effector. Additional augmented images provide indications of incidental events, including indications of tissue tension and foreign body detection. Other augmented images display device status overlays and instrument indications.
[0050] Figure 10 shows a system 83 for augmenting images of the surgical field with information using an AR display 89, according to at least one aspect of the present disclosure. The system 83 may be used to perform the techniques described below, for example, by using a processor 85. The system 83 includes one aspect of an AR device 66 that can communicate with a database 93. The AR device 66 includes a processor 85, memory 87, an AR display 89, and a camera 79. The AR device 66 may also include a sensor 90, a speaker 91, and / or a haptic controller 92. The database 93 may include image storage 94 or preoperative planning storage 95.
[0051] The processor 85 of the AR device 66 includes an augmented reality modeler 86. The augmented reality modeler 86 may be used by the processor 85 to create an augmented reality environment. For example, the augmented reality modeler 86 may receive images of instruments in the surgical field from a camera 79 or sensor 90, etc., and create an augmented reality environment that fits within the displayed image of the surgical field. In another example, physical objects and / or data may be overlaid on the surgical field and / or surgical instrument images, and the augmented reality modeler 86 may use the physical objects and data to present an augmented reality display of virtual objects and / or data within the augmented reality environment. For example, the augmented reality modeler 86 may use or detect instruments at the patient's surgical site and present virtual objects and / or data on the surgical instruments, and / or images of the surgical site in the surgical field captured by the camera 79. The AR display 89 may display the AR environment overlaid on the real environment. The display 89 can use the AR device 66, which is located in a fixed position, etc., within the AR environment, to show virtual objects and / or data.
[0052] The AR device 66 may include sensors 90 such as infrared sensors. The camera 79 or sensor 90 may be used to detect movements such as gestures by a surgeon or other user, which may be interpreted by the processor 85 as attempted or intended interactions by the user with a virtual target. The processor 85 can identify objects in the real environment by processing information received using the camera 79, for example. In other embodiments, sensor 90 may be a tactile sensor, audible sensor, chemical sensor, or thermal sensor to generate corresponding signals that can be combined with various data feeds to create an augmented environment. Sensor 90 may include binaural audio sensors (spatial sound), inertial measurement (accelerometer, gyroscope, magnetometer) sensors, environmental sensors, depth camera sensors, hand and eye-tracking sensors, and voice command recognition capabilities.
[0053] The AR display 89 may, for example, during a surgical procedure, allow the surgical field to be viewed through the AR display 89, while presenting virtual features within the surgical field that correspond to physical features hidden by the patient's anatomical features. The virtual features may have a virtual position or orientation that corresponds to a first physical position or orientation of the physical features. In one example, the virtual position or orientation of the virtual features may include an offset from the first physical position or orientation of the physical features. The offset may include a predetermined distance from the augmented reality display, a relative distance from the augmented reality display to the anatomical features, and so on.
[0054] In one example, the AR device 66 may be an individual AR device. In one embodiment, the AR device 66 may be a HoloLens 2 AR device manufactured by Microsoft in Redmond, Washington. This AR device 66 includes a visor with lenses and binaural audio features (spatial sound), inertial measurements (accelerometer, gyroscope, magnetometer), environmental sensors, a depth camera, a video camera, hand and eye tracking, and voice command recognition capabilities. It provides a high-resolution, improved field of view by using mirrors to orient waveguides in front of the wearer's eyes. The image can be magnified by changing the angle of the mirrors. It also provides eye tracking to recognize the user and adjust the lens width for a particular user.
[0055] In another example, AR device 66 could be the Snapchat Spectacles 3 AR device. This AR device offers the ability to capture paired images, recreate 3D depth mapping, add virtual effects, and play 3D videos. The AR device includes two HD cameras for capturing 3D photos and videos at 60fps, while four built-in microphones record immersive high-fidelity audio. Images from both cameras are combined to construct a geometric map of the real world around the user, providing a new sense of depth perception. Photos and videos can be wirelessly synchronized to an external display device.
[0056] In yet another example, AR device 66 could be Google's Glass 2 AR device. This AR device provides inertial measurement (accelerometer, gyroscope, magnetometer) information overlaid on the lens (outside the field of view) to supplement the information.
[0057] In another example, AR device 66 could be an Echo Frames AR device from Amazon. This AR device does not have a camera / display. The microphone and speaker are linked to Alexa. This AR device has fewer features than a head-up display.
[0058] In yet another example, AR device 66 could be the Focals AR device by North (Google). This AR device provides a notification pusher / smartwatch analog, inertial measurement, screen overlays for information (weather, calendar, messages), and voice control (Alexa) integration. This AR device also provides basic head-up display functionality.
[0059] In another example, AR device 66 could be an Nreal AR device. This AR device includes spatial sound, two ambient cameras, a photographic camera, an IMU (accelerometer, gyroscope), an ambient light sensor, and proximity sensor functions. Nebula projects application information onto the lens.
[0060] In various other examples, the AR device 66 may be any one of the following commercially available AR devices, namely Magic Leap 1, Epson Moverio, Vuzix Blade AR, ZenFone AR, Microsoft AR glasses prototype, or EyeTap, which create light collinear with the ambient light directly onto the retina. A beam splitter makes the same visible light available to a computer, for example, to process and overlay information. The AR visualization system may include a HUD, contact lenses, glasses, virtual reality (VR) headset, virtual retinal display, intraoperative display, and / or smart contact lenses (bionic lenses).
[0061] The multi-user interface for the AR device 66 includes a virtual retinal display such as a raster display that draws directly onto the retina rather than on a screen in front of the eyes, a smart TV, a smartphone, and / or a spatial display such as the Sony Spatial Display System.
[0062] Other AR technologies may include, for example, AR capture devices and software applications, AR creation devices and software applications, and AR cloud devices and software applications. AR capture devices and software applications include, for example, the Apple Polycam app and Ubiquity 6 (Mirrorworld using the Display.land app), which allow users to scan and acquire 3D images of the real world (to create 3D models). AR creation devices and software applications include, for example, Adobe Aero, Vuforia, ARToolKit, Google ARCore, Apple ARKit, MAXST, Aurasma, Zappar, and Blippar. AR cloud devices and software applications include, for example, Facebook, Google (world geometry, object recognition, predictive data), Amazon AR Cloud (commerce), Microsoft Azure, Samsung Project Whare, Niantic, and Magic Leap.
[0063] Situational awareness is the ability of several embodiments of a surgical system to determine or infer information related to a surgical procedure from data received from a database and / or instruments. This information may include the type of procedure being performed, the type of tissue being operated on, or the body cavity being treated. Based on contextual information relating to a surgical procedure, the surgical system can be improved, for example, by controlling modular devices connected to it (e.g., robotic arms and / or robotic surgical tools) and providing contextualized information or suggestions to the surgeon during the course of the surgical procedure.
[0064] Figure 11 shows a timeline of a situation-aware surgical procedure. Figure 11 shows an exemplary surgical procedure timeline 5200 and contextual information that the surgical hub 5104 can derive from data received from data source 5126 at each step of the surgical procedure. Timeline 5200 shows typical steps that nurses, surgeons, and other healthcare workers might take during a lung segmentectomy procedure, which begins with setting up the operating room and ends with transferring the patient to the postoperative recovery room. Throughout the course of the surgical procedure, the situation-aware surgical hub 5104 receives data from data source 5126, including data generated each time healthcare workers use the modular device 5102 paired with the surgical hub 5104. By receiving this data from the paired modular device 5102 and other data sources 5126, the surgical hub 5104 can continuously derive estimations (i.e., contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being performed at any given time. The situational awareness system of the surgical hub 5104 can, for example, record data relating to a procedure to generate a report, verify the steps being taken by a healthcare professional, provide data or prompts that may be relevant to a particular procedure step (e.g., via a display screen), adjust the modular device 5102 based on context (e.g., activate a monitor, adjust the FOV of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument), and perform any other such actions as described above.
[0065] In the first step 5202, hospital staff retrieve the patient's EMR from the hospital's EMR database. Based on the patient data selected in the EMR, the surgical hub 5104 determines that the procedure to be performed is a thoracic surgery.
[0066] In the second 5204, staff scan incoming medical supplies for a procedure. The surgical hub 5104 cross-references the scanned supplies with a list of supplies used in various types of procedures to confirm that the mixture of supplies corresponds to a thoracic procedure. Furthermore, the surgical hub 5104 can also determine that the procedure is not a wedge resection (because the incoming supplies either do not contain specific supplies required for a thoracic wedge resection or are otherwise not corresponding to a thoracic wedge resection).
[0067] In the third 5206, a healthcare worker scans the patient band via a scanner 5128 that is communicably connected to a surgical hub 5104. The surgical hub 5104 can then verify the patient's identity based on the scanned data.
[0068] In the fourth part of 5208, a medical professional turns on the assistive device. The assistive devices used may vary depending on the type of surgical procedure and the techniques used by the surgeon, but in this exemplary case, they include a fume exhauster, an air insulator, and a medical imaging device. Once activated, the assistive device, which is a modular device 5102, can automatically pair with a surgical hub 5104 located within a specific vicinity of the modular device 5102 as part of its initialization process. The surgical hub 5104 can then derive contextual information about the surgical procedure by detecting the type of modular device 5102 paired with it during this pre-operative or initialization phase. In this particular embodiment, the surgical hub 5104 determines that the surgical procedure is a VATS surgery based on this particular combination of paired modular devices 5102. Based on the combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the type of modular device 5102 connected to the hub, the surgical hub 5104 can roughly estimate the specific procedure performed by the surgical team. Once the surgical hub 5104 knows what particular procedure is being performed, it can then read the steps of that procedure from memory or the cloud, and then cross-reference the data subsequently received from connected data sources 5126 (e.g., modular device 5102 and patient monitoring device 5124) to estimate which steps of the surgical procedure the surgical team is performing.
[0069] In step 5210, the staff attaches the EKG electrode and other patient monitoring devices 5124 to the patient. The EKG electrode and other patient monitoring devices 5124 can be paired with the surgical hub 5104. Once the surgical hub 5104 begins receiving data from the patient monitoring devices 5124, the surgical hub 5104 confirms that the patient is in the operating room.
[0070] In step 6, 5212, medical personnel induce anesthesia in the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from modular devices 5102 and / or patient monitoring devices 5124, including, for example, EKG data, blood pressure data, ventilator data or a combination thereof. Once step 6, 5212 is completed, the preoperative portion of the lung segmentectomy is complete and the surgical portion commences.
[0071] In section 7 of 5214, the lung of the patient being operated on collapses (while ventilation is switched to the contralateral lung). The surgical hub 5104 can infer from the ventilator data that the patient's lung has collapsed. The surgical hub 5104 can compare the detection of the patient's lung collapse with the expected steps of the procedure (which can be accessed or read in advance), so it can infer that the surgical portion of the procedure has begun and determine that collapsing the lung is the first surgical step in this particular procedure.
[0072] In step 85216, a medical imaging device 5108 (e.g., a scope) is inserted, and video footage from the medical imaging device is initiated. The surgical hub 5104 receives medical imaging device data (i.e., still image data or real-time live-streaming video) through its connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 5104 can determine that the laparoscopic portion of the surgical procedure has commenced. Furthermore, the surgical hub 5104 can determine that the particular procedure being performed is a segmentectomy, as opposed to a lobectomy (note that wedge resection has not been taken into consideration by the surgical hub 5104 based on the data received in the second step 5204 of the procedure). Using data from the medical imaging device 124 (Figure 2), contextual information regarding the type of procedure being performed can be determined in various ways, for example, by determining the angle of the medical imaging device directed towards the visualization of the patient's anatomical structure, by monitoring the number of medical imaging devices being used (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being used.
[0073] For example, one technique for performing VATS lobectomy positions the camera above the diaphragm in the anteroinferior corner of the patient's thoracic cavity, while another technique for performing VATS segmentectomy positions the camera in an anterior intercostal position relative to the segmental fissure. The situational awareness system can be trained, for example, using pattern recognition or machine learning techniques, to recognize the position of the medical imaging device according to the visualization of the patient's anatomical structure. As another example, one technique for performing VATS lobectomy utilizes a single medical imaging device, while another technique for performing VATS segmentectomy utilizes multiple cameras. As yet another example, one technique for performing VATS segmentectomy utilizes an infrared light source (which can be communicably connected to a surgical hub as part of the visualization system) to visualize the segmental fissure, which is not used in VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the specific type of surgical procedure being performed and / or the technique being used for that specific type of surgical procedure.
[0074] In Section 9, 5218, the surgical team initiates the incision step of the procedure. The surgical hub 5104 receives data from an RF or ultrasound generator indicating that an energy instrument is being emitted, and can therefore infer that the surgeon is in the process of incising and separating the patient's lung. The surgical hub 5104 can cross-reference the received data with the read-out steps of the surgical procedure to determine that the energy instrument being emitted at this point in the process (i.e., after the completion of the procedure steps described above) corresponds to the incision step.
[0075] In the tenth step 5220, the surgical team proceeds to the ligation step of the procedure. The surgical hub 5104 receives data from the surgical stapling and cutting instruments indicating that instruments are being fired, and can therefore infer that the surgeon is ligating arteries and veins. As in the previous step, the surgical hub 5104 can derive this inference by cross-referencing the data received from the surgical stapling and cutting instruments with the steps in the read-out process.
[0076] In the eleventh step 5222, the segmental resection portion of the procedure is performed. The surgical hub 5104 estimates that the surgeon has transversely incised parenchymal tissue, based on data from surgical instruments, including data from a staple cartridge. Cartridge data may correspond, for example, to the size or type of staples fired by the instrument. Cartridge data may indicate the type of tissue being stapled and / or transversely incised, for different types of staples used for different types of tissue. The type of staples fired is used for parenchymal tissue or other similar tissue types, and the surgical hub 5104 can estimate that a segmental resection procedure has been performed.
[0077] Next, in the twelfth step 5224, the nodule incision step is performed. Based on the data received from the generator indicating that an RF or ultrasonic instrument is being emitted, the surgical hub 5104 can infer that the surgical team is incising the nodule and performing a leak test. In this particular procedure, the RF or ultrasonic instrument used after the parenchymal tissue has been transversely incised corresponds to the nodule incision step, thereby enabling the surgical hub 5104 to make this inference. Note that the surgeon will periodically switch between surgical stapling / cutting instruments and surgical energy (i.e., RF or ultrasonic) instruments depending on the specific step in the procedure, as different instruments are better suited to specific tasks. Thus, the specific sequence in which stapling / cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Once the twelfth step 5224 is completed, the incision is closed and the postoperative portion of the procedure begins.
[0078] In the 13th step 5226, the patient is de-anesthetized. The surgical hub 5104 can estimate that the patient is waking up from anesthesia, for example, based on ventilator data (i.e., the patient's respiratory rate begins to increase).
[0079] Finally, in the 14th step 5228, the healthcare worker removes the various patient monitoring devices 5124 from the patient. Thus, the surgical hub 5104 can infer that the patient has been transferred to the recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices 5124. Based on the data received from various data sources 5126 that are communicably connected to the surgical hub 5104, the surgical hub 5104 can determine or infer when each step of a given surgical procedure is occurring.
[0080] As shown in the first step 5202 of the timeline 5200 shown in Figure 11, in addition to using patient data from the EMR database(s) to estimate the type of surgical procedure to be performed, the patient data can also be used by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular device 5102.
[0081] In light of the foregoing descriptions of augmented reality (AR), mixed reality, and image overlay technologies, this disclosure may be configured to render and display augmented reality content on an AR headset, an external display, or a combination of one or more devices. In addition, the external display may be configured to provide a split-screen view that displays the AR content and an unaugmented live feed of the surgical field.
[0082] This disclosure describes an operating room (OR) personnel tracking system configured to extrapolate the movement, location, orientation, and context of one or more active OR personnel to determine a specific surgical procedure in progress, surgical instruments being used by the OR personnel, and / or the expected movement of the OR personnel. The system may be further configured to render virtual elements as augmented reality (AR) content, including expected locations of surgical instruments, recommendations, guidance, warnings, and surgical site information. The AR content is integrated in real time with a live feed of the surgical site to assist OR personnel in intraoperative surgical procedures.
[0083] Figure 12 shows an exemplary OR16000 configuration with a passive tracking camera system according to at least one aspect of the present disclosure. In various implementations, the surgical hub 16001 can communicate via a communication protocol (e.g., Bluetooth) to one or more cameras 16002, surgical instruments 16010, displays 16006, overhead lights 16008, and other surgical devices within the OR16000. Camera 16002 can be oriented to capture images and / or videos of surgical personnel 16003 and / or surgical instruments 16010 (or other surgical devices) within the OR16000 during the course of a surgical procedure. Captured images may include still images or moving images (i.e., videos). Images of surgical personnel 16003 and / or surgical instruments 16002 can be captured at various angles and magnifications, using various filters, etc. In one implementation, camera 16002 is positioned within the OR 16000 to allow for the collective visualization of each surgical staff member 16003 performing a surgical procedure. Thus, the surgical hub 16001 can receive captured image and / or video data from camera 16002 to visually analyze the surgical staff member 16003 and / or surgical instruments 16010 during the surgical procedure. The image and / or video data can be processed using various machine vision, image processing, object recognition, and optical tracking techniques to track the features, characteristics, actions, and movements of the surgical staff member 16003 and / or surgical instruments 16010.
[0084] The surgical hub 16001 (Figure 12) can be configured to determine the position of a surgical instrument 16010 based on the wrist angle of the surgical staff member 16003, as shown in Figure 13. In this particular implementation, the angle of the individual's wrist 16016 is defined as the angle α between the longitudinal axis 16014 of the surgical instrument 16010 held by the surgeon and the longitudinal axis 16012 of the individual's hand (i.e., the proximal-to-distal axis). In other implementations, the wrist angle can be defined, for example, as the angle between the individual's hand and forearm. The surgical hub 16001 can use the wrist angle α to track the movement of the surgical staff member 16003, along with the movement 16004 of the other hand of the surgical staff member 16003.
[0085] Figure 14 shows a passive tracking system 16005 comprising one or more cameras 16002 configured to uniquely identify and distinguish surgical staff such as surgeon A, surgeon B, nurse A, nurse B, anesthesiologist, technician, etc. The passive tracking system 16005 can distinguish between different surgical staff using several different visual identifiers on surgical gloves 16018, including patterns, colors, inks, codes (e.g., barcodes or QR codes), or combinations of multiple identifiers. In one embodiment, each surgical staff member in the operating room has a different color or pattern 16020a to 16020n on the glove 16018 that uniquely corresponds to the surgical staff member's identification information. The color of the surgical glove 16018 is detectable only by the camera 16002 and is shown in color on the display 16006.
[0086] Figure 15 shows the initialization sequence in the passive tracking system 16005. In one embodiment, the surgical staff's gloves may include identifiers or codes 16022a, 16022b. Codes 16022a, 16022b may be scanned or identified by camera 16002 and transmitted to surgical hub 16001 (Figure 12) to associate identification glove colors or patterns 16020a-16020n (shown in Figure 14), staff identification information, and left and right hands. The surgical hub 16001 records the identification information associated with codes 16022a, 16022b and may associate that information with surgical procedures, operating rooms, patients, or other surgical analyses. Each surgical staff member may be required to initialize their gloves 16018 when entering the operating room or before surgery. The gloves 16018 are displayed and identified on display 16006.
[0087] Identification features on the glove 16018 may be printed directly onto the glove 16018, providing a sterile surface that is visible or invisible in the visible light spectrum. In various embodiments, the identification pattern may comprise invisible ink, optical reference markers, photosensitive tags printed directly onto the glove, or retroreflective material. In one embodiment, certain colors, patterns, or codes may be found to be distracting, and therefore, it may be preferable that the identification pattern be invisible in the visible light spectrum.
[0088] Figure 16 shows a directional pattern 16040 that may be used to distinguish between left and right attachments or to help the passive tracking camera 16002 detect movement. Different directional patterns 16040 may be associated with different personnel and may be printed on gloves, wristbands, and / or forearm bands to help the passive tracking camera 16002 detect movement.
[0089] Figure 17 shows an identification code 16022 on the dorsal side of a surgical glove 16018, which is detected by a thermal imaging or infrared (IR) camera 16002. The code 16022 may be printed on the underside of the surgical glove 16018 using a thermally conductive material that allows for heat transfer from the surgical staff in a specific pattern. In addition, the color or pattern may be visible to the surgical staff to ensure that they have matching pairs of gloves. In another embodiment, each glove 16018 is unique and associated with a staff member by an initialization sequence. The initialization sequence does not require the gloves to be kept in pairs and may be pulled from a box of disposable gloves, such as conventional latex gloves.
[0090] In another embodiment, Figure 18 shows identification codes 16022a and 16022b on both the dorsal and palmar sides of a surgical glove 16018. Printing identification codes on both sides of the glove 16018 allows personnel to initialize their gloves 16018 more quickly during the initialization sequence, increasing the likelihood that one of the passive tracking cameras 16002 (Figures 14-15) can see identification codes 16022a and 16022b.
[0091] Some tracking analyses may require more granular identification of hand movements, including precise movement of each finger of the staff member. In one example, a surgical hub 16001 (Figure 12) can track the handover of surgical instruments from one surgeon to another based on the tracked finger movements of surgical staff. Figure 19 shows identification QR codes 16022a, 16022b assigned to each finger 16024a-j of a surgical staff glove 16018.
[0092] During surgical procedures, multiple surgical personnel may crowd around the surgical site in close proximity, potentially obstructing the view of one or more of the passive tracking cameras 16002 (Figures 14-15). To mitigate this problem, a surgical hub 16001 (Figure 12) can use one or more cameras 16002 in a network configuration to track identifiers throughout the operating room. Figure 20 shows wrist-mounted cameras 16026a, 16026b, and 16016n configured to monitor and track the movement of a single staff member's fingers and wrist. The wrist-mounted cameras 16026a-n are communicably connected to the surgical hub via a wired or wireless medium and can transmit data in continuous or periodic data dumps. The wrist-mounted cameras 16026a-n are equipped with a sterile, adjustable strap 16028 that accommodates multiple cameras 16026a-n along the wrist of a surgical staff member. Wrist-mounted cameras 16026a-n can map hand and finger movements based on multiple nodes 16030 corresponding to the joints of the hand. Wrist-mounted cameras 16026a-n may be used with conventional surgical gloves or with an IR printed grid to assist camera 16002 in tracking the movement of nodes 16030. However, even with wrist-mounted cameras 16026a-n, there may be cases where certain particle size measurements cannot be seen or identified. The identifiers or nodes 16030 are obscured by biological material and are therefore difficult or impossible for camera 16002 to see. In some situations, the passive camera 16002 can still see the identifiers when they are printed with IR visible ink.
[0093] However, the passive tracking camera 16002 (Figures 14-15) alone may not have sufficient resolution to capture the detailed and granular hand movements 16004 (Figure 13) required to measure certain parameters such as force or finger strain. In addition, the camera 16002 may be visually obstructed and its ability to recognize certain movements 16004 necessary to identify surgical instruments 16010 (Figure 12), procedures, or other movements being targeted may be impaired. In this disclosure, various active tracking systems are suitable for measuring and detecting different levels of accuracy and reliability that may be imperceptible to passive tracking cameras. In one embodiment, a gyroscope or accelerometer (Figures 21-22) may be positioned on the back (dorsal side) of a surgical glove that can detect the angle of the hand as the hand pivots and rotates. The surgical glove may further be equipped with strain gauges (Figures 21-22) on the fingers of the glove to track the movement of the surgical staff's fingers and supplement the passive tracking data. Active sensors such as gyroscopes and strain gauges provide additional data points, enabling the surgical hub to manage multiple user interactions within the same surgical space with greater precision. In addition, data collected by these active sensors can be used to better quantify the interaction between surgical personnel and surgical devices. The surgical hub 16001 (Figure 12) may be configured to receive active signals, passive signals, or a combination of both active and passive signals.
[0094] In various embodiments, active sensors may be used to provide additional resolution (orientation and finger positioning) to a passive tracking system when multiple users are operating different aspects of a single device. For example, during a complex endoscopic procedure, one surgeon may manage scope stabilization and visualization while another surgeon operates a tool through the work channel. It is common for multiple pairs of hands to be in contact with the scope handle, and passive systems may not be able to associate actions performed by one pair of hands with the corresponding user. By adding active systems such as finger strain gauges or glove gyroscopes, the surgical hub can identify which surgeon's hand is supplying or holding the tool, and which surgeon's hand is stabilizing the scope, because different finger shapes and hand orientations are required to perform each task. Finger shapes and hand orientations can be characterized in depth to improve the accuracy of predicting which user is performing a particular task or operating a particular device while multiple users or devices are in the same visual space.
[0095] Figure 21 shows an active surgical glove 16118 comprising a reference marker on each of the fingers 16124, a plurality of embedded strain gauge sensors 16132, and a gyroscope 16136 connected to a control circuit 16140. The reference marker 16124 is used by a passive tracking camera that tracks finger movement. The control circuit 16140 receives strain gauge measurements from each of the strain gauge sensors 16132 via flexible wires 16134, as well as gyroscope data. The gyroscope may be embedded in a circuit or housing connected to the control circuit 16140. The control circuit 16140 may transfer active sensor data to a surgical hub 16001 (Figure 12) via a wireless communication protocol or a physical I / O communication port. The control circuit 16140 may be configured to transmit data in real time via a wireless communication protocol such as Bluetooth. In various embodiments, the control circuit 16140 may dynamically adjust the transmission rate to manage power.
[0096] The control circuit 16140 has an active identifier 16122 such as a QR code (registered trademark), an RFID sensor, or other wireless communication, which allows personnel to associate their identification information with active tracking data. In addition, the surgical hub associates a reference marker 16124 with the user during the initialization sequence.
[0097] In various embodiments, the surgical hub uses passive tracking data to calibrate active sensors on the glove to the surrounding environment, thereby enabling the sensors within the glove to recognize the hand's position in space regardless of visual obstruction. For example, at the start of each surgery, a calibration sequence (Figures 14-15) can be performed to synchronize the sensors within the glove with the surrounding environment, including other users in the room, in addition to critical areas (patient bed, Mayo stand, etc.). Each surgical staff member may scan a unique identifier within the glove (e.g., QR code®, NFC, active RFID, passive RFID, etc.) that uniquely corresponds to the user and sensors within the system. During the calibration sequence, all users hold their hands in various orientations within the field of view of the passive tracking system (e.g., camera 16002 in Figures 14-15), and the unique identification markers on the glove allow the visual system to identify the relative position of each user's glove. Throughout the procedure, when the hand is obstructed by a device, blood, or moves in or out of the field of view, active sensors such as accelerometers and gyroscopes can be used to track the position and orientation of each user's hand.
[0098] Figure 22 shows a single strain gauge sensor 16132 associated with the fingertip. In various embodiments, the active sensor surgical glove may include at least one strain gauge sensor 16132 per finger, and strain gauge sensors 16132 may be included at each joint of the hand. Due to the size of the strain gauge sensors 16132, they may be embedded in a flexible sterile material with little or no size perceptible to the surgeon. It will be understood that the surgical glove does not interfere with the natural tactile feedback provided by conventional latex, nitrile, or other sterile materials used in surgical gloves.
[0099] Figures 23 and 24 show a flexible circuit 16135 that may be used to connect a strain gauge sensor 16132 to a control circuit. Figure 23 shows a flexible circuit printed on a sterile flexible material 16138, such as latex, nitrile, or other sterile materials used in surgical gloves. After use, gloves may be sterilized after a predetermined number of use cycles or may be disposable. Reusable gloves may be sterilized using heat or a disinfectant such as alcohol, provided that the sterilization process does not destroy the glove material or damage the printed active sensor circuit.
[0100] Figure 25 shows an active reference marker 16144 connected to a control circuit 16140 and printed directly onto a sterile flexible material 16138. This allows for the strategic placement of strain gauge sensors 16132 and reference markers on the surgical glove to track and locate finger and hand movements.
[0101] Figure 26 shows a piezoelectric ceramic power cell 16146 that can be used to acquire energy from motion and power control circuits, strain gauges, gyroscopes, accelerometers, and / or active reference markers. The active sensor glove may comprise multiple piezoelectric ceramic power cells 16146 that convert low-frequency motion (movement of fingers or wrist) into energy stored in a power source (e.g., a battery or capacitor). The power cell 16146 includes a flexible ceramic layer that captures the vibrations of motion as mechanical energy. The stretched power cell 16146a stretches when the sterile flexible material 16138 of the glove stretches, and the flexible ceramic layer 16148 is released and vibrates with the movement of the hand. The stretched power cell 16146a is in an excited state and returns to an unstretched, static power cell 16146b when the sterile flexible material 16138 contracts. The change results in vibrations in the flexible ceramic layer 16148, generating a small-amplitude voltage response that can be captured within the energy storage device.
[0102] Figure 27 shows an active sensor glove 16118 having a removable housing 16150 that houses a control circuit 16140 and a gyroscope 16136. The housing 16150 is a waterproof enclosure for protecting electrical components such as the control circuit, gyroscope, accelerometer, and power supply such as a rechargeable battery or supercapacitor. The housing 16150 is physically connected to the active sensor glove 16118 at connection point 16142. Connection point 16142 allows power and data to pass between the housing and the active sensor on the glove 16118. After surgical procedures, the removable housing is detached from connection point 16142, thereby allowing the glove 16118 to be sterilized and the housing 16150 to be connected to an external power supply to charge the internal power supply.
[0103] In another embodiment, the active sensor is detachable from the passive glove 16018 having a reference sensor 16024. Figure 28 shows a detachable active sensor harness 16252 comprising multiple embedded strain gauge sensors 16232 communicated to a control circuit 16240 by flexible wires 16234 within a housing 16250. Figure 29 shows the active sensor harness 16252 removed from the hand. After a surgical procedure, the surgical staff can remove the active sensor harness 16252 and sterilize it for subsequent use, and discard the glove 16018. As shown in Figures 28-29, the passive glove 16018 includes a detachable finger / glove strap 16254.
[0104] In various embodiments, strain gauge sensors 16132, 16232 provide additional data for tracking the handover of surgical instruments between a first surgeon and a second surgeon. Tracking the handover helps a medical facility monitor the device after the handover and ensure that the correct user is controlling the device. Figure 30 shows a graphical representation of the handover of surgical instruments 16300 between a first surgeon and a second surgeon. Surgeon A begins to hand over the surgical instrument to surgeon B, and surgeon B reaches for the device and grasps it 16302. Both the active and passive tracking systems determine that the surgical instrument has been handed over from surgeon A to surgeon B.
[0105] In another example, surgeon A begins to hand a surgical instrument to surgeon B. However, surgeon B begins to grasp the instrument, but before the handover is complete, surgeon A pulls the instrument back. Surgeon A sees some bleeding that needs to be cauterized, and grasps the instrument again. The passive tracking system tracks surgeon A's hand and surgical instrument as it moves closer to surgeon B to initiate the handover, recognizes that surgeon B has made contact with the device, and suggests that the handover is complete. Using the passive tracking system alone could result in losing track of the instrument because surgeon B did not "initiate" the handover, but the device is receding with surgeon A's hand. Because the active tracking system is related to an open or grasped hand, it can detect finger position, and an additional level of confirmation can be ensured that the device is only assigned to a "grasping" user when it is outside the transfer zone.
[0106] Active tracking using EMG and MMG signals This disclosure further describes active tracking of one or more surgical personnel by monitoring myophonography (MMG) and / or electromyography (EMG) signals generated by the muscles and tendons of the personnel's hands, wrists, and forearms. EMG sensors measure the electrical currents generated by muscles during contraction in response to neuromuscular activity. MMG sensors measure changes in mechanical energy observed on the surface of muscles. MMG sensors may be used alternatively or in addition with EMG sensors. MMG signals may have a higher signal-to-noise ratio than EMG signals, enabling more granular muscle activity measurements. EMG and MMG sensors may be placed on the hands, wrists, and forearms to measure muscle movement, either in place of or in conjunction with a passive tracking system. A surgical hub may further synchronize passive and active data.
[0107] Figure 31 shows a musculoskeletal diagram of the human hand. The posterior or dorsal side of the hand 16402 shows the extensor tendons 16406, and the anterior or palmar side of the hand 16404 shows the flexor tendons 16408. The extensor tendons 16406 and flexor tendons 16408 are complementary tendons that control the movement and force of each finger of the hand. Each finger is actuated by individual extensor tendons 16406 and flexor tendons 16408 that extend from the respective finger through the wrist to the muscles of the forearm. The brain sends nerve signals to the muscles of the forearm to generate hand movement.
[0108] Figure 32 shows the anterior 16410 and posterior 16412 of the right arm. The brain sends electrical signals to the muscles of the forearm, controlling the movement and force of each finger on each hand. Therefore, the movement and force of a particular finger can be determined by measuring the signals generated by the extensor and flexor tendons.
[0109] Figure 33 shows a pair of wrist-mounted sensors 16502 communicatively connected to a surgical hub 16001 (Figure 12). The sensors 16502 are configured to monitor EMG and / or MMG signals generated by the extensor and flexor tendons as they pass through the flexor and extensor retinaculum.
[0110] In another embodiment, the active sensor may be directly attached to the control muscles of the forearm. Figure 34 shows a plurality of MMG sensors 16502 directly attached to the muscles of the forearm. The sensors are positioned according to the corresponding flexor and extensor tendons of the fingers.
[0111] In another embodiment, the active sensor may be a wireless sensor 16602 that adheres directly to the skin. Figure 35 shows a flexible wireless sensor 16602 connected to a flexible adhesive medium 16604 that adheres directly to the skin 16606. The wireless sensor 16602 may be placed on the muscle to measure EMG or MMG signals, or it may be used by a passive tracking system to monitor specific movements of the employee. The wireless sensor 16602 may be communicatively connected to a surgical hub to transmit active tracking data wirelessly. Multiple wireless sensors 16602 may be on an adhesive sheet, and all sensors are registered in the identification information of a particular employee.
[0112] Figure 36 shows a graphical plot 16620 of five EMG channels corresponding to the movement of four fingers and the thumb in the hand. The surgical hub can receive EMG signals and plot the results so that the movement can be analyzed. Each channel corresponds to one sensor and one finger, but may capture movement from other fingers. The surgical hub plots the data to isolate and classify the movement and magnitude of specific fingers 16610-16618. The surgical hub may indicate periods of movement and periods of no movement.
[0113] Figure 37 shows a graphical plot 16640 of MMG signals corresponding to hand movement and position. Since MMG signal resolution depends on proximity to the muscle, accurate placement of the MMG sensor is crucial. The graphical plot 16640 includes eight channels corresponding to different muscles for activating coordinated movement.
[0114] Figure 38 shows Model 16660, which correlates the amplitude value of maximum muscle contraction measured in Vrms with the percentage of maximum voluntary contraction (%MCV). In one embodiment, a linear regression model may be used to correlate the MMG signal with the force applied by a specific finger or combination of fingers.
[0115] Figure 39 shows an active sensor sleeve 16800 comprising multiple active sensors 16802 for measuring MMG and / or EMG signals. The sensor sleeve 16800 includes an elastic mating material 16804 configured to fit snugly around the forearm of a surgical staff member. The active sensors 16802 correspond to different muscle movements in the forearm and indicate the overall movement, motion, and force of the fingers and hand. The sensors may be connected to elastically deformable conduit wires that extend and contrast with the sleeve material 16804. The sensor sleeve 16800 may be configured in different size ranges to accommodate different forearm sizes and ensure proper sensor positioning. The sleeve comprises a control circuit 16808 and a power supply 16806. The control circuit may be configured to store active data during the surgical procedure and transmit the data to the surgical hub at the end, or to transmit the data to the surgical hub in real time. The sleeve further comprises multiple active beacons 16810 indicating real-time position and the surgical staff member. In addition, the sensor may include a thermocouple 16812, a pressure transducer 16814, and an impedance electrode 16816.
[0116] Figure 40 shows three linear regression models that analyze EMG signals to assess muscle fatigue over time. Plots 16902, 16904, and 16906 correspond to different surgeons. The linear fit gradient correlates with the rate of muscle fatigue over time. The active signal can be used to assess the skill or surgical procedure of individual surgeons. In this example, plot 16904 shows a smaller gradient for surgeon B, indicating that surgeon B experienced less muscle fatigue at the same interval as surgeons A and C. In addition, EMG signals can also be used to plot muscle stress over the duration of a surgical procedure.
[0117] Figure 41 is a logical diagram of a method 17210 for tracking the movement of operating room personnel according to one aspect of the present disclosure. Referring here to Figures 12, 14, and 15, according to method 17210, a surgical hub 16001 receives context data from an external source (17212). The context data includes the position of the hand for surgical instruments used in a surgical procedure. The surgical hub 16001 identifies a first unique identifier associated with a first surgical staff member 16003 and a second unique identifier associated with a second surgical staff member 16003 (17214). The surgical hub 16001 receives passive tracking data from camera systems 16002 associated with the first and second surgical staff members 16003 (17216). The passive tracking data is determined by reference markers. The surgical hub 16001 receives active tracking data from active sensors associated with the first surgical staff member 16003 and the second surgical staff member 16003 (17218). The surgical hub 16001 determines that the first surgical staff member 16003 or the second surgical staff member 16003 is using the first surgical instrument 16010 that is not being tracked by the surgical hub 16001 (17220). The surgical hub 16001 compares the passive tracking data and active tracking data with the hand position of the surgical instrument 16010 used in the surgical procedure (17222). The surgical hub 16001 determines the specific surgical instrument 16010 corresponding to the passive tracking data and context data (17224). The surgical hub 16001 transmits virtual elements displayed on the augmented reality device 66 (Figures 1 to 10) (17226).
[0118] Accordingly, this disclosure provides methods, systems, and devices for distinguishing multiple surgical personnel who are in close proximity, working with the same tools, overlapping within the same spatial area, and / or are obscured from the direct line of sight of a passive tracking camera.
[0119] Various additional aspects of the subject matter described herein are illustrated in the following numbered examples.
[0120] Example 1: A surgical system comprising a camera system, a unique identifier corresponding to a first surgical staff member, including a visual indicator located on the outer surface of an article worn by an operating room personnel, wherein the unique identifier is visible to the camera system, an active sensor corresponding to a first surgical staff member, which captures active tracking data, and a surgical hub communicably connected to the camera system and the active sensor, the surgical hub comprising memory and a control circuit, wherein the control circuit receives context data from an external source, the context data including the position of the hand for surgical instruments used in a surgical procedure. A surgical system configured to: receive passive tracking data from a camera system associated with a first surgical staff member; receive active tracking data from an active sensor associated with the first surgical staff member; determine that the surgical staff member is using a first surgical instrument that is not tracked by a surgical hub; compare the passive tracking data and active tracking data with the hand position for a surgical instrument used in a surgical procedure; determine a specific surgical instrument corresponding to the passive tracking data and context data; and display a virtual element on an augmented reality device, wherein the virtual element includes a virtual representation of a specific surgical instrument.
[0121] Example 2: The surgical system described in Example 1, wherein the article includes surgical gloves.
[0122] Example 3: The surgical system according to Example 2, wherein the active sensor is embedded in a surgical glove and is configured to measure the location, force, or proximity, or a combination thereof, to the structural elements of each finger of a first surgical worker located within the surgical glove.
[0123] Example 4: The surgical system according to Example 3, wherein the active sensor is communicatively connected to the control circuit using an elastically deformable conductor.
[0124] Example 5: The surgical system described in Example 4, wherein the elastically deformable conductor is printed on a surgical glove.
[0125] Example 6: A surgical system according to any one of Examples 1 to 5, wherein the first article comprises a tracking sleeve worn on the forearm of a first surgical staff member, and an active sensor is embedded within the tracking sleeve, and the active sensor is configured to measure an active movement signal corresponding to the movement of the first person.
[0126] Example 7: The surgical system according to Example 6, wherein the active motion signal includes a myocardiogram (MMG) signal and an electromyogram (EMG) signal.
[0127] Example 8: The surgical system according to Example 6, wherein the second article comprises a passive tracking surgical glove, and the passive tracking data is captured based on the movement of the passive tracking glove and associated based on active tracking data captured from a tracking sleeve.
[0128] Example 9: A surgical system according to any one of Examples 1 to 8, wherein the unique identifier includes a unique identifier for each finger of the first surgical staff member.
[0129] Example 10: A surgical system according to any one of Examples 1 to 9, wherein the unique identifier includes a first unique identifier for the left hand of the first surgical staff member and a second unique identifier for the right hand of the first surgical staff member.
[0130] Example 11: A surgical system from any one of Examples 1 to 10, wherein the control circuit is further configured to determine a user input initiated by a first surgical staff member, corresponding to an initiation sequence that registers a unique identifier in the identification information of the first surgical staff member.
[0131] Example 12: A method for tracking the movement of operating room personnel, comprising: receiving context data from an external source via a surgical hub, wherein the context data includes the position of the hand for surgical instruments used in a surgical procedure; identifying a first unique identifier associated with a first surgical staff member and a second unique identifier associated with a second surgical staff member via the surgical hub; receiving passive tracking data from camera systems associated with the first and second surgical staff members via the surgical hub, wherein the passive tracking data is determined by a reference marker; and the surgical hub, A method comprising: receiving active tracking data from active sensors associated with one surgical staff member and a second surgical staff member; determining by a surgical hub that the first or second surgical staff member is using a first surgical instrument that is not being tracked by the surgical hub; comparing passive tracking data and active tracking data with the hand position for a surgical instrument used in a surgical procedure; determining a specific surgical instrument corresponding to the passive tracking data and contextual data; and transmitting virtual elements to be displayed on an augmented reality device by the surgical hub.
[0132] Example 13: The method according to Example 12, wherein the active sensor includes at least one strain gauge corresponding to each finger of the first and second surgical staff.
[0133] Example 14: The method according to Example 13, further comprising: determining with the surgical hub that a first surgical staff member is holding a first surgical instrument; determining with the surgical hub that the handover of the first surgical instrument has begun based on a change in the gripping positions of the first and second surgical staff members; determining with the surgical hub that a second surgical staff member has begun to grasp the first surgical instrument; and determining with the surgical hub that the handover of the surgical instrument from the first surgical staff member to the second surgical staff member has been completed.
[0134] Example 15: The method according to any one of Examples 12-14, wherein the more unique identifier comprises at least a unique color, pattern, texture, or quick response (QR) code, or a combination thereof, and the unique identifier is scanned as part of an initiation sequence to register the unique identifier in the identification information of a first surgical staff member.
[0135] Example 16: The method according to any one of Examples 12-15, wherein the reference marker is tracked with a light source outside the visible spectrum.
[0136] Example 17: The method according to Example 16, wherein the reference marker is embedded in a surgical glove.
[0137] Example 18: The method according to Example 16, wherein the light source is part of a wrist-mounted camera.
[0138] Example 19: The method according to any one of Examples 12 to 18, wherein the active sensor is embedded in a surgical glove and the active sensor is communicatively connected to a control circuit on the surgical glove.
[0139] Example 20:20. The method according to Example 19, wherein the control circuit is enclosed in a removable housing.
[0140] Example 21: The method according to Example 19, wherein the active sensor and control circuit receive power from a piezoelectric ceramic power cell.
[0141] While several forms have been shown and described, it is not the applicant's intention to limit or restrict the attached claims to such details. Many modifications, variations, alterations, substitutions, combinations, and equivalents of these forms can be implemented and will be conceived by those skilled in the art without departing from the scope of this disclosure. Furthermore, the structure of each element related to the described form can be alternatively described as a means for providing the function performed by that element. Also, while materials are disclosed with respect to specific components, other materials may be used. Therefore, it should be understood that the above description and the attached claims are intended to cover all such modifications, combinations, and variations as being included within the scope of the disclosed forms. The attached claims are intended to cover all such modifications, variations, alterations, substitutions, alterations, and equivalents.
[0142] The detailed descriptions above have described various forms of apparatus and / or processes using block diagrams, flowcharts and / or embodiments. To the extent that such block diagrams, flowcharts and / or embodiments include one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation included in such block diagrams, flowcharts and / or embodiments can be implemented individually and / or collectively by various hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will understand that some or all of the forms disclosed herein can be equivalently implemented on integrated circuits as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or substantially any combination thereof, and that designing circuits and / or writing software and / or firmware code falls within the scope of the skills of those skilled in the art in light of this disclosure. Furthermore, as will be understood by those skilled in the art, the mechanisms of the subject matter described herein can be distributed in various forms as one or more program products, and the specific forms of the subject matter described herein are applicable regardless of the particular type of signal carrier medium used to actually carry out the distribution.
[0143] Instructions used to program logic to implement various disclosed embodiments may be stored in system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Furthermore, instructions may be distributed over a network or by other computer-readable media. Thus, machine-readable media may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but are not limited to floppy diskettes, optical disks, compact disks, read-only memory (CD-ROMs), and magneto-optical disks, read-only memory (ROMs), random access memory (RAMs), erasable programmable read-only memory (EPROMs), electrically erasable programmable read-only memory (EEPROMs), magnetic or optical cards, flash memory, or tangible machine-readable storage used for transmitting information over the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, non-temporary computer-readable media may include any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
[0144] When used in any aspect of this specification, the term “control circuit” can mean, for example, hardwired circuits, programmable circuits (e.g., computer processors, processing units, processors, microcontrollers, microcontroller units, controllers, digital signal processors (DSPs), programmable logic devices (PLDs), programmable logic arrays (PLAs), or field-programmable gate arrays (FPGAs) including one or more individual instruction processing cores), state-machine circuits, firmware that stores instructions executed by programmable circuits, and any combination thereof. Control circuits can be embodied collectively or individually as circuits that form part of a larger system, such as an integrated circuit (IC), an application-specific integrated circuit (ASIC), a system-on-a-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, or a smartphone. Accordingly, as used herein, “control circuit” includes, but is not limited to, an electrical circuit having at least one separate electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application-specific integrated circuit, an electrical circuit forming a general-purpose computing device configured by a computer program (e.g., a general-purpose computer configured by a computer program that performs at least partially the processes and / or devices described herein, or a microprocessor configured by a computer program that performs at least partially the processes and / or devices described herein), an electrical circuit forming a memory device (e.g., in the form of random access memory), and / or an electrical circuit forming a communication device (e.g., a modem, a communication switch, or an optical-electric installation). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog form, digital form, or some combination thereof.
[0145] When used in any aspect of this specification, the term “logic” may mean an application, software, firmware, and / or circuit configured to perform any of the operations described above. Software may be embodied as software packages, code, instructions, instruction sets, and / or data recorded on a non-temporary computer-readable storage medium. Firmware may be embodied as code, instructions, or instruction sets, and / or hardcoded (e.g., non-volatile) data in a memory device.
[0146] When used in any aspect of this specification, the terms “component,” “system,” “module,” etc., may refer to a control circuit, a computer-related entity, hardware, a combination of hardware and software, software, or running software.
[0147] Where used in any aspect of this specification, “algorithm” means a self-consistent sequence of steps leading to a desired result, and “step” means the manipulation of physical quantities and / or logical states that can take the form of electrical or magnetic signals, which are not necessarily required but can be stored, transferred, combined, compared, and otherwise manipulated. These signals are commonly referred to as bits, values, elements, symbols, characters, terms, numbers, etc. These and similar terms may be associated with appropriate physical quantities, or simply are convenient labels applied to these quantities and / or states.
[0148] A packet-switched network is one example of a network. Communication devices can communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol is the Ethernet communication protocol, which can enable communication using the Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the "IEEE 802.3 Standard" published in December 2008 by the Institute of Electrical and Electronics Engineers (IEEE), and / or later versions of the Ethernet standard. Alternatively or additionally, communication devices can communicate with each other using the X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with standards published by the International Telecommunication Union - Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, communication devices can communicate with each other using the Frame Relay communication protocol. The Frame Relay communication protocol conforms to or may be compatible with standards published by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, transceivers may communicate with each other using the Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol conforms to or may be compatible with the ATM standard and / or later versions of this standard, published by the ATM Forum in August 2001 under the title "ATM-MPLS Network Interworking 2.0". Naturally, different and / or later developed connection-oriented network communication protocols are equally construed herein.
[0149] Unless otherwise explicitly stated, as is evident from the foregoing disclosures, any use of terms such as “processing,” “computing,” “calculating,” “determining,” and “displaying” throughout the foregoing disclosures should be understood to refer to the actions and processes of a computer system or similar electronic computing device that manipulate and convert data represented as physical (electronic) quantities in the registers and memory of a computer system into other data similarly represented as physical quantities in the memory or registers of a computer system or other such information storage, transmission, or display device.
[0150] One or more components may be referred to herein as “configured to,” “configurable to,” “operable / operative to,” “adapted / adaptable,” “able to,” “conformable / conformed to,” and so on. Those skilled in the art will understand that “configured to” generally encompasses active components and / or inactive components and / or standby components, unless the context should interpret it otherwise.
[0151] The terms “proximal” and “distal” are used herein in reference to the clinician operating the handle portion of a surgical instrument. “Proximal” refers to the part closest to the clinician, and “distal” refers to the part further away from the clinician. For convenience and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein in reference to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be restrictive and / or absolute.
[0152] Those skilled in the art will generally understand that the terms used herein, and especially in the appended claims (e.g., the text of the appended claims), are generally intended to be "open" terms (for example, the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," and the term "includes" should be interpreted as "includes but is not limited to"). Furthermore, those skilled in the art will understand that if a particular number is intended in an introduced claim recitation, such intent is clearly stated in the claim, and if such statement is not present, such intent does not exist. For example, to aid understanding, subsequent appended claims may include the introductory phrases "at least one" and "one or more" to introduce the claim recitation. However, the use of such phrases should not be interpreted as suggesting that any particular claim containing such introduced claim description is limited to claims containing only one such description, even if the same claim contains an introductory phrase such as "one or more" or "at least one" and the indefinite article "a" or "an" (for example, "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"). The same applies when introducing a claim description using a definite article.
[0153] In addition, even if a specific number is explicitly stated in the introduced claim, it will be recognized by those skilled in the art that such a statement should typically be interpreted as meaning at least the number stated (for example, if there is a statement that is simply “two descriptions” without any other modifiers, it generally means at least two descriptions, or two or more descriptions). Furthermore, when a notation similar to “at least one of A, B, and C, etc.” is used, such a notation is generally intended to be understood in a way that those skilled in the art will understand (for example, “a system having at least one of A, B, and C” is not limited to systems having only A, only B, only C, both A and B, both A and C, both B and C and / or all of A, B and C, etc.). When expressions similar to "at least one of A, B, or C" are used, such expressions are generally intended to be understood in a way that a person skilled in the art would understand (for example, "a system having at least one of A, B, or C" is not limited to systems having only A, only B, only C, both A and B, both A and C, both B and C and / or all of A, B and C). Furthermore, a person skilled in the art will understand that typically any disjunctive word and / or phrase representing two or more selective terms should be understood, whether in the specification, claims, or drawings, as intended to include the possibility of including one of those terms, any of those terms, or both of those terms, unless the context requires a different interpretation. For example, the phrase "A or B" will typically be understood to include the possibility of "A" or "B" or "A and B".
[0154] With respect to the attached claims, those skilled in the art will understand that the operations cited herein may generally be performed in any order. Furthermore, while various operations are shown in sequence(s), it should be understood that the operations may be performed in any order other than those shown, or simultaneously. Examples of such alternative orderings may include repetition, alternation, interruption, reordering, augmentation, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context should imply otherwise. Moreover, terms such as “responsive to,” “related to,” or other past tense adjectives are generally not intended to exclude such variations, unless the context should imply otherwise.
[0155] It is worth noting that any reference to “one aspect,” “aspect,” “example,” or “example” means that the specific feature, structure, or characteristic described in relation to that aspect is included in at least one aspect. Therefore, the phrases “in one aspect,” “in aspect,” “example,” and “example” found in various places throughout this specification do not necessarily all refer to the same aspect. Furthermore, specific features, structures, or characteristics can be combined in any preferred manner in one or more aspects.
[0156] Any patent application, patent, non-patent publication, or other disclosure material referenced herein and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated material does not conflict with this Specified. Disclosures expressly stated herein, both in themselves and to the extent required, shall supersede any conflicting statements incorporated herein by reference. Any material, or any part thereof, that is referred to as being incorporated herein by reference but conflicts with current definitions, views, or other disclosures contained herein shall be incorporated only to the extent that there is no conflict between the incorporated material and the current disclosures.
[0157] In summary, the numerous benefits that can be obtained as a result of using the concepts described herein have been described. The above descriptions of one or more forms are presented for illustrative and explanatory purposes only. They are not intended to be comprehensive or to be limited to the exact forms disclosed. Modifications or variations are possible in light of the above teachings. One or more forms have been selected and described to illustrate the principle and practical applications, thereby enabling a person skilled in the art to utilize the various forms, along with various modifications, for specific conceivable uses. The claims presented herein are intended to define the overall scope.
[0158] [Implementation Method] (1) A surgical system, Camera system and, A unique identifier corresponding to a first surgical staff member, comprising a visual indicator located on the outer surface of an article worn by an operating room personnel, wherein the unique identifier is visible to the camera system, An active sensor corresponding to the first surgical staff member, which captures active tracking data, A surgical hub, which is communicatively connected to the camera system and the active sensor, comprises a memory and a control circuit, wherein the control circuit is Receiving context data from an external source, wherein the context data includes the position of the hand for surgical instruments used in a surgical procedure. Receiving passive tracking data from the camera system associated with the first surgical staff member, Receiving active tracking data from the active sensor associated with the first surgical staff member, Determining that the surgical staff member is using a first surgical instrument that is not tracked by the surgical hub, The passive tracking data and the active tracking data are compared with the position of the hand for surgical instruments used in surgical procedures. To determine a specific surgical instrument corresponding to the passive tracking data and the context data, A surgical system configured to display virtual elements on an augmented reality device, wherein the virtual elements include a virtual representation of a particular surgical instrument. (2) The surgical system according to Embodiment 1, wherein the article includes a surgical glove. (3) The surgical system according to Embodiment 2, wherein the active sensor is embedded in the surgical glove and is configured to measure the location, force, or proximity, or a combination thereof, to the structural elements of each finger of the first surgical worker located within the surgical glove. (4) The surgical system according to Embodiment 3, wherein the active sensor is communicated to the control circuit using an elastically deformable conductor. (5) The surgical system according to Embodiment 4, wherein the elastically deformable conductor is printed on the surgical glove.
[0159] (6) The surgical system according to Embodiment 1, wherein the first article includes a tracking sleeve worn on the forearm of the first surgical staff member, the active sensor being embedded in the tracking sleeve, and the active sensor being configured to measure an active movement signal corresponding to the movement of the first person. (7) The surgical system according to Embodiment 6, wherein the active movement signal includes a myocardiogram (MMG) signal and an electromyogram (EMG) signal. (8) The surgical system according to Embodiment 6, wherein the second article includes a passive tracking surgical glove, the passive tracking data being captured based on the movement of the passive tracking glove and associated based on the active tracking data captured from the tracking sleeve. (9) The surgical system according to Embodiment 1, wherein the unique identifier includes a unique identifier for each finger of the first surgical staff member. (10) The surgical system according to Embodiment 1, wherein the unique identifier includes a first unique identifier for the left hand of the first surgical staff member and a second unique identifier for the right hand of the first surgical staff member.
[0160] (11) The control circuit is, The surgical system according to Embodiment 1, further configured to determine user input initiated by the first surgical staff member, corresponding to a start sequence for registering the unique identifier in the identification information of the first surgical staff member. (12) A method for tracking the movement of operating room staff, The surgical hub receives contextual data from an external source, wherein the contextual data includes the position of the hand for surgical instruments used in a surgical procedure. The surgical hub identifies a first unique identifier associated with a first surgical staff member and a second unique identifier associated with a second surgical staff member. The surgical hub receives passive tracking data from camera systems associated with the first and second surgical personnel, wherein the passive tracking data is determined by a reference marker. The surgical hub receives active tracking data from active sensors associated with the first and second surgical personnel, The surgical hub determines that the first surgical staff member or the second surgical staff member is using a first surgical instrument that is not tracked by the surgical hub, The surgical hub compares the passive tracking data and the active tracking data with the hand position for surgical instruments used in surgical procedures. The surgical hub determines a specific surgical instrument corresponding to the passive tracking data and the context data, A method comprising transmitting virtual elements displayed on an augmented reality device via the surgical hub. (13) The method according to embodiment 12, wherein the active sensor includes at least one strain gauge corresponding to each finger of the first and second surgical staff. (14) The surgical hub determines that the first surgical staff member is holding the first surgical instrument, The surgical hub determines, based on the change in the gripping position of the first surgical staff member and the second surgical staff member, that the handover of the first surgical instrument has begun. The surgical hub determines that the second surgical staff member has begun to grasp the first surgical instrument, The method according to Embodiment 13, further comprising determining that the surgical hub has completed the handover of the surgical instrument from the first surgical staff member to the second surgical staff member. (15) The method according to Embodiment 12, wherein the unique identifier comprises at least a unique color, pattern, texture, or quick response (QR) code, or a combination thereof, and the unique identifier is scanned as part of an initiation sequence for registering the unique identifier in the identification information of the first surgical staff member.
[0161] (16) The method according to embodiment 12, wherein the reference marker is tracked by a light source outside the visible spectrum. (17) The method according to embodiment 16, wherein the reference marker is embedded in a surgical glove. (18) The method according to embodiment 16, wherein the light source is part of a wrist-mounted camera. (19) The method according to Embodiment 12, wherein the active sensor is embedded in a surgical glove and the active sensor is communicatively connected to a control circuit on the surgical glove. (20) The method according to embodiment 19, wherein the control circuit is enclosed in a removable housing.
[0162] (21) The method according to embodiment 19, wherein the active sensor and the control circuit receive power from a piezoelectric ceramic power cell.
Claims
1. A surgical system, Camera system and, A unique identifier corresponding to a surgical staff member, comprising a visual indicator located on the outer surface of an article worn on the hand by the surgical staff member, wherein the unique identifier is visible to the camera system, An active sensor corresponding to the surgical staff member, which captures active tracking data measuring the shape of each finger and the orientation of the hand of the surgical staff member, A surgical hub, which is communicatively connected to the camera system and the active sensor, comprises a memory and a control circuit, wherein the control circuit is Receiving context data from an external source, wherein the context data includes the position of the hand and the shape of each finger for gripping surgical instruments used in a surgical procedure, and the orientation of the hand. The camera system receives passive tracking data that tracks the position of the surgical staff member's hand, Receiving the active tracking data from the active sensor associated with the surgical staff member, The passive tracking data and the active tracking data are compared with the context data. Based on the above comparison, a specific surgical instrument corresponding to the context data is determined, A surgical system configured to display virtual elements on an augmented reality device, wherein the virtual elements include a virtual representation of a particular surgical instrument.
2. The surgical system according to claim 1, wherein the article includes a surgical glove.
3. The surgical system according to claim 2, wherein the active sensor is embedded in the surgical glove and is configured to measure the location, force, or proximity, or a combination thereof, to the structural elements of each finger of the surgical worker located within the surgical glove.
4. The surgical system according to claim 3, wherein the active sensor is communicated to the control circuit using an elastically deformable conductor.
5. The surgical system according to claim 4, wherein the elastically deformable conductor is printed on the surgical glove.
6. The surgical system according to claim 1, wherein the first article includes a tracking sleeve worn on the forearm of the surgical staff member, the active sensor being embedded in the tracking sleeve, and the active sensor being configured to measure an active movement signal corresponding to the movement of the surgical staff member.
7. The surgical system according to claim 6, wherein the active movement signal includes a myogram (MMG) signal and an electromyogram (EMG) signal.
8. The surgical system according to claim 6, wherein the second article comprises a passive tracking surgical glove, the passive tracking data being captured based on the movement of the passive tracking surgical glove and associated based on the active tracking data captured from the tracking sleeve.
9. The surgical system according to claim 1, wherein the unique identifier includes a unique identifier for each finger of the surgical staff member.
10. The surgical system according to claim 1, wherein the unique identifier includes a first unique identifier for the left hand of the surgical staff member and a second unique identifier for the right hand of the surgical staff member.
11. The aforementioned control circuit is The surgical system according to claim 1, further configured to determine a user input initiated by the surgical staff member that corresponds to a start sequence for registering the unique identifier in the surgical staff member's identification information.
12. A method for tracking the movements of operating room staff, The surgical hub receives contextual data from an external source, the contextual data including the position of the hand and the shape of each finger for gripping surgical instruments used in a surgical procedure, and the orientation of the hand. The surgical hub uses a camera to identify a first unique identifier associated with a first surgical staff member and a second unique identifier associated with a second surgical staff member, based on a unique identifier which is a visual indicator located on the outer surface of an article worn by a surgical staff member. The surgical hub receives passive tracking data from the camera system, tracking the position of the surgical staff member's hand, wherein the passive tracking data is determined by the first unique identifier and the second unique identifier. The surgical hub receives active tracking data from active sensors associated with the first and second surgical personnel, measuring the shape of each finger and the orientation of the hands of the first and second surgical personnel. The surgical hub compares the passive tracking data and the active tracking data with the context data. The surgical hub determines, based on the comparison, a specific surgical instrument corresponding to the context data, A method comprising transmitting virtual elements displayed on an augmented reality device via the surgical hub.
13. The method according to claim 12, wherein the active sensor includes at least one strain gauge corresponding to each finger of the first and second surgical staff.
14. The surgical hub determines that the first surgical staff member is holding the surgical instrument, The surgical hub determines that the handover of the surgical instrument has begun based on the change in the gripping position of the first and second surgical personnel, The surgical hub determines that the second surgical staff member has begun to grasp the surgical instrument, The method according to claim 13, further comprising determining that the surgical hub has completed the handover of the surgical instrument from the first surgical staff member to the second surgical staff member.
15. The method according to claim 12, wherein the unique identifier comprises at least a unique color, pattern, texture, or quick response (QR) code, or a combination thereof, and the unique identifier is scanned as part of an initiation sequence for registering the unique identifier in the identification information of the first surgical staff member.
16. The method according to claim 12, wherein the reference marker is tracked by a light source outside the visible spectrum.
17. The method according to claim 16, wherein the reference marker is embedded in a surgical glove.
18. The method according to claim 16, wherein the light source is part of a wrist-mounted camera.
19. The method according to claim 12, wherein the active sensor is embedded in a surgical glove, and the active sensor is communicatively connected to a control circuit on the surgical glove.
20. The method according to claim 19, wherein the control circuit is enclosed in a removable housing.
21. The method according to claim 19, wherein the active sensor and the control circuit receive power from a piezoelectric ceramic power cell.
Citation Information
Patent Citations
Systems and methods for data capture in an operating room
JP2019500921A
System for developing one or more patient-specific spinal implants
JP2020518311A
Interactive systems and methods for real-time laparoscopic navigation
US20150265369A1
Sensor Embedded Wearable Technology Glove
US20160174897A1