Classifications

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Definitions

• the present disclosure relates generally to surgical devices, systems, and methods using multi-source imaging.
• Surgical systems often incorporate an imaging system, which can allow medical practitioners to view a surgical site and/or one or more portions thereof on one or more displays, e.g, a monitor, a computer tablet screen, etc.
• the display(s) can be local and/or remote to a surgical theater.
• the imaging system can include a scope with a camera that views the surgical site and transmits the view to the one or more displays viewable by medical practitioner(s).
• Imaging systems can be limited by the information that they are able to recognize and/or convey to the medical practitioner(s). For example, certain concealed structures, physical contours, and/or dimensions within a three-dimensional space may be unrecognizable intraoperatively by certain imaging systems. For another example, certain imaging systems may be incapable of communicating and/or conveying certain information to the medical practitioner(s) intraoperatively.
• a surgical method in one embodiment includes gathering, with a first imaging device, first images of a surgical site during performance of a surgical procedure, gathering, with a second imaging device, second images of the surgical site during the performance of the surgical procedure, analyzing, with a controller, the first images and the second images to identify and define boundaries of connective soft tissue planes, relating, with the controller, the identified and defined boundaries of the connective soft tissue planes to an anatomic structure and a role of the tissue, and causing, with the controller, a display device to show information related to the tissue and to show at least one of the first images and the second images overlaid with the identified and defined boundaries of the connective soft tissue planes and thereby define a location and orientation of the connective soft tissue planes.
• the anatomic structure and the role of the tissue can include at least one of tissue planes, tissue composition, tumor location, tumor margin identification, adhesions, vascularization, and tissue fragility.
• the information related to the tissue can include at least one of a type of the tissue, collagen composition of the tissue, organized versus remodeled disorganized fiber orientation of the tissue, viability of the tissue, and health of the tissue.
• the first imaging device can include a structured light emitter configured to emit a structured light pattern on a surface of the anatomic structure, a spectral light emitter configured to emit spectral light in a plurality of wavelengths capable of penetrating the anatomic structure and reaching an embedded structure located below the surface of the anatomic structure, and an image sensor configured to detect reflected structured light pattern, reflected spectral light, and reflected visible light
• the method can further include constructing, with the controller, a three-dimensional (3D) digital representation of the anatomic structure from the reflected structured light pattern detected by the image sensor, and the controller can use the 3D digital representation in identifying and defining the boundaries of the connective soft tissue planes.
• the first imaging device can include a flexible scoping device, and the second imaging device can includes a rigid scoping device.
• the first imaging device can include a bronchoscope
• the anatomic structure can include a lung
• the method can further include advancing the bronchoscope into the lung
• the tissue can include bronchial tissue
• the embedded structure can include a tumor
• the location and orientation of the connective soft tissue planes can enable identification of tumor location and orientation in the lung.
• the first imaging device can gather the first images using a wavelength outside a spectrum of visible light so as to allow visualization of the embedded structure from outside the anatomic structure
• the wavelength outside the spectrum of visible light can include an ultrasound wavelength or an infrared wavelength
• the second imaging device can gather the second images using a wavelength within the spectrum of visible light so as to allow visualization of the surface of the anatomic structure.
• the method can further include delivering a contrast agent to the anatomic structure, the first imaging device can visualize the contrast agent within the anatomic structure, and the second imaging device cannot visualize the contrast agent within the anatomic structure.
• the first and second imaging devices can be releasably coupled to and controlled by a robotic surgical system
• a surgical hub can include the controller.
• a robotic surgical system can include the controller and the display device, and the first and second imaging devices can each be releasably coupled to and controlled by the robotic surgical system.
• a surgical system in one embodiment includes a first imaging device configured to gather first images of a surgical site during performance of a surgical procedure, a second imaging device configured to gather second images of the surgical site during the performance of the surgical procedure, and a controller configured to analyze the first images and the second images to identify and define boundaries of connective soft tissue planes, relate the identified and defined boundaries of the connective soft tissue planes to an anatomic structure and a role of the tissue, and cause a display device to show information related to the tissue and to show at least one of the first images and the second images overlaid with the identified and defined boundaries of the connective soft tissue planes and thereby define a location and orientation of the connective soft tissue planes.
• the anatomic structure and the role of the tissue can include at least one of tissue planes, tissue composition, tumor location, tumor margin identification, adhesions, vascularization, and tissue fragility.
• the information related to the tissue can include at least one of a type of the tissue, collagen composition of the tissue, organized versus remodeled disorganized fiber orientation of the tissue, viability of the tissue, and health of the tissue.
• the first imaging device can include a structured light emitter configured to emit a structured light pattern on a surface of the anatomic structure, a spectral light emitter configured to emit spectral light in a plurality of wavelengths capable of penetrating the anatomic structure and reaching an embedded structure located below the surface of the anatomic structure, and an image sensor configured to detect reflected structured light pattern, reflected spectral light, and reflected visible light, the controller can be configured to construct a three-dimensional (3D) digital representation of the anatomic structure from the reflected structured light pattern detected by the image sensor, and the controller can be configured to use the 3D digital representation in identifying and defining the boundaries of the connective soft tissue planes.
• a structured light emitter configured to emit a structured light pattern on a surface of the anatomic structure
• a spectral light emitter configured to emit spectral light in a plurality of wavelengths capable of penetrating the anatomic structure and reaching an embedded structure located below the surface of the anatomic structure
• an image sensor configured to detect reflected structured
• the first imaging device can include a flexible scoping device
• the second imaging device can includes a rigid scoping device.
• the anatomic structure can include a lung
• the first imaging device can include a bronchoscope configured to be advanced into the lung
• the tissue can include bronchial tissue
• the embedded structure can include a tumor
• the location and orientation of the connective soft tissue planes can enable identification of tumor location and orientation in the lung.
• the first imaging device can be configured to gather the first images using a wavelength outside a spectrum of visible light so as to allow visualization of the embedded structure from outside the anatomic structure
• the wavelength outside the spectrum of visible light can include an ultrasound wavelength or an infrared wavelength
• the second imaging device can be configured to gather the second images using a wavelength within the spectrum of visible light so as to allow visualization of the surface of the anatomic structure.
• the system can further include a contrast agent configured to be delivered to the anatomic structure, the first imaging device can be configured to visualize the contrast agent within the anatomic structure, and the second imaging device cannot visualize the contrast agent within the anatomic structure.
• the first and second imaging devices can each be configured to be releasably coupled to and controlled by a robotic surgical system, and a surgical hub can include the controller.
• the system can further include the display device, a robotic surgical system can include the controller and the display device, and the first and second imaging devices can each be configured to be releasably coupled to and controlled by the robotic surgical system.
• Figure 1 is a schematic view of one embodiment of a surgical visualization system
• Figure 2 is a schematic view of triangularization between a surgical device, an imaging device, and a critical structure of Figure 1;
• Figure 3 is a schematic view of another embodiment of a surgical visualization system
• Figure 4 is a schematic view of one embodiment of a control system for a surgical visualization system
• Figure 5 is a schematic view of one embodiment of a control circuit of a control system for a surgical visualization system
• Figure 6 is a schematic view of one embodiment of a combinational logic circuit of a surgical visualization system
• Figure 7 is a schematic view of one embodiment of a sequential logic circuit of a surgical visualization system
• Figure 8 is a schematic view of yet another embodiment of a surgical visualization system
• Figure 9 is a schematic view of another embodiment of a control system for a surgical visualization system.
• Figure 10 is a graph showing wavelength versus absorption coefficient for various biological materials
• Figure 11 is a schematic view of one embodiment of a spectral emitter visualizing a surgical site
• Figure 12 is a graph depicting illustrative hyperspectral identifying signatures to differentiate a ureter from obscurants
• Figure 13 is a graph depicting illustrative hyperspectral identifying signatures to differentiate an artery from obscurants
• Figure 14 is a graph depicting illustrative hyperspectral identifying signatures to differentiate a nerve from obscurants;
• Figure 15 is a schematic view of one embodiment of a near infrared (NIR) time-of-flight measurement system being utilized intraoperatively;
• NIR near infrared
• Figure 16 shows a time-of-flight timing diagram for the system of Figure 15;
• FIG. 17 is a schematic view of another embodiment of a near infrared (NIR) time-of-flight measurement system being utilized intraoperatively;
• NIR near infrared
• Figure 18 is a schematic view of one embodiment of a computer-implemented interactive surgical system
• Figure 19 is a schematic view of one embodiment a surgical system being used to perform a surgical procedure in an operating room
• Figure 20 is a schematic view of one embodiment of a surgical system including a smart surgical instrument and a surgical hub;
• Figure 21 is a flowchart showing a method of controlling the smart surgical instrument of Figure 20;
• Figure 22 is a schematic view of a colon illustrating major resections of the colon
• Figure 22A is a perspective partial cross-sectional view of one embodiment of a duodenal mucosal resurfacing procedure
• Figure 23 is a CT image showing an intersegmental plane between three tissue segments
• Figure 24 is a CT image showing an intersegmental plane between two of the tissue segments of Figure 23;
• Figure 25 is a schematic view of a display
• Figure 26 is an enhanced CT image of a lung
• Figure 27 is a schematic front view of lung airways
• Figure 28 is a schematic right side view of one embodiment of a path of advancement of a scope in a lung
• Figure 29 is a schematic front view of the path of advancement of the scope of Figure 28;
• Figure 30 is a schematic partially cross-sectional view of the scope of Figure 28 in the lung.
• Figure 31 is a flowchart showing one embodiment of a method of using primary and secondary imaging systems.
• Figure 32 is a schematic view of one embodiment of a display showing an on-the-fly adaptation of vascular CT with real-time local scanning.
• like-named components of the embodiments generally have similar features, and thus within a particular embodiment each feature of each like-named component is not necessarily fully elaborated upon.
• linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods.
• a person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape.
• a dimension or other measurement may not be a precise value but nevertheless be considered to be at about that value due to any number of factors such as manufacturing tolerances and sensitivity of measurement equipment. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the size and shape of components with which the systems and devices will be used.
• a surgical visualization system is configured to leverage “digital surgery” to obtain additional information about a patient’s anatomy and/or a surgical procedure.
• the surgical visualization system is further configured to convey data to one or more medical practitioners in a helpful manner.
• Various aspects of the present disclosure provide improved visualization of the patient’s anatomy and/or the surgical procedure, and/or use visualization to provide improved control of a surgical tool (also referred to herein as a “surgical device” or a “surgical instrument”).
• Digital surgery can embrace robotic systems, advanced imaging, advanced instrumentation, artificial intelligence, machine learning, data analytics for performance tracking and benchmarking, connectivity both inside and outside of the operating room (OR), and more.
• various surgical visualization systems described herein can be used in combination with a robotic surgical system, surgical visualization systems are not limited to use with a robotic surgical system.
• surgical visualization using a surgical visualization system can occur without robotics and/or with limited and/or optional robotic assistance.
• digital surgery can occur without robotics and/or with limited and/or optional robotic assistance.
• a surgical system that incorporates a surgical visualization system may enable smart dissection in order to identify and avoid critical structures.
• Critical structures include anatomical structures such as a ureter, an artery such as a superior mesenteric artery, a vein such as a portal vein, a nerve such as a phrenic nerve, and/or a tumor, among other anatomical structures.
• a critical structure can be a foreign structure in the anatomical field, such as a surgical device, a surgical fastener, a clip, a tack, a bougie, a band, a plate, and other foreign structures.
• Critical structures can be determined on a patient-by-patient and/or a procedure-by- procedure basis.
• Smart dissection technology may provide, for example, improved intraoperative guidance for dissection and/or may enable smarter decisions with critical anatomy detection and avoidance technology.
• a surgical system incorporating a surgical visualization system may enable smart anastomosis technologies that provide more consistent anastomoses at optimal location(s) with improved workflow.
• Cancer localization technologies may be improved with a surgical visualization platform. For example, cancer localization technologies can identify and track a cancer location, orientation, and its margins. In certain instances, the cancer localization technologies may compensate for movement of a surgical instrument, a patient, and/or the patient’s anatomy during a surgical procedure in order to provide guidance back to the point of interest for medical practitioner(s).
• a surgical visualization system may provide improved tissue characterization and/or lymph node diagnostics and mapping.
• tissue characterization technologies may characterize tissue type and health without the need for physical haptics, especially when dissecting and/or placing stapling devices within the tissue.
• Certain tissue characterization technologies may be utilized without ionizing radiation and/or contrast agents.
• lymph node diagnostics and mapping a surgical visualization platform may, for example, preoperatively locate, map, and ideally diagnose the lymph system and/or lymph nodes involved in cancerous diagnosis and staging.
• information available to a medical practitioner via the “naked eye” and/or an imaging system may provide an incomplete view of the surgical site.
• certain structures such as structures embedded or buried within an organ, can be at least partially concealed or hidden from view.
• certain dimensions and/or relative distances can be difficult to ascertain with existing sensor systems and/or difficult for the “naked eye” to perceive.
• certain structures can move pre-operatively (e.g, before a surgical procedure but after a preoperative scan) and/or intraoperatively. In such instances, the medical practitioner can be unable to accurately determine the location of a critical structure intraoperatively.
• a medical practitioner When the position of a critical structure is uncertain and/or when the proximity between the critical structure and a surgical tool is unknown, a medical practitioner’s decision-making process can be inhibited. For example, a medical practitioner may avoid certain areas in order to avoid inadvertent dissection of a critical structure; however, the avoided area may be unnecessarily large and/or at least partially misplaced. Due to uncertainty and/or overly/excessive exercises in caution, the medical practitioner may not access certain desired regions.
• excess caution may cause a medical practitioner to leave a portion of a tumor and/or other undesirable tissue in an effort to avoid a critical structure even if the critical structure is not in the particular area and/or would not be negatively impacted by the medical practitioner working in that particular area.
• surgical results can be improved with increased knowledge and/or certainty, which can allow a surgeon to be more accurate and, in certain instances, less conservative/more aggressive with respect to particular anatomical areas.
• a surgical visualization system can allow for intraoperative identification and avoidance of critical structures.
• the surgical visualization system may thus enable enhanced intraoperative decision making and improved surgical outcomes.
• the surgical visualization system can provide advanced visualization capabilities beyond what a medical practitioner sees with the “naked eye” and/or beyond what an imaging system can recognize and/or convey to the medical practitioner.
• the surgical visualization system can augment and enhance what a medical practitioner is able to know prior to tissue treatment (e.g., dissection, etc.) and, thus, may improve outcomes in various instances. As a result, the medical practitioner can confidently maintain momentum throughout the surgical procedure knowing that the surgical visualization system is tracking a critical structure, which may be approached during dissection, for example.
• the surgical visualization system can provide an indication to the medical practitioner in sufficient time for the medical practitioner to pause and/or slow down the surgical procedure and evaluate the proximity to the critical structure to prevent inadvertent damage thereto.
• the surgical visualization system can provide an ideal, optimized, and/or customizable amount of information to the medical practitioner to allow the medical practitioner to move confidently and/or quickly through tissue while avoiding inadvertent damage to healthy tissue and/or critical structure(s) and, thus, to minimize the risk of harm resulting from the surgical procedure.
• a surgical visualization system can include a first light emitter configured to emit a plurality of spectral waves, a second light emitter configured to emit a light pattern, and a receiver, or sensor, configured to detect visible light, molecular responses to the spectral waves (spectral imaging), and/or the light pattern.
• the surgical visualization system can also include an imaging system and a control circuit in signal communication with the receiver and the imaging system. Based on output from the receiver, the control circuit can determine a geometric surface map, e.g, three-dimensional surface topography, of the visible surfaces at the surgical site and a distance with respect to the surgical site, such as a distance to an at least partially concealed structure.
• the imaging system can convey the geometric surface map and the distance to a medical practitioner.
• an augmented view of the surgical site provided to the medical practitioner can provide a representation of the concealed structure within the relevant context of the surgical site.
• the imaging system can virtually augment the concealed structure on the geometric surface map of the concealing and/or obstructing tissue similar to a line drawn on the ground to indicate a utility line below the surface.
• the imaging system can convey the proximity of a surgical tool to the visible and obstructing tissue and/or to the at least partially concealed structure and/or a depth of the concealed structure below the visible surface of the obstructing tissue.
• the visualization system can determine a distance with respect to the augmented line on the surface of the visible tissue and convey the distance to the imaging system.
• the visible spectrum sometimes referred to as the optical spectrum or luminous spectrum, is that portion of the electromagnetic spectrum that is visible to (e.g, can be detected by) the human eye and may be referred to as “visible light” or simply “light.”
• a typical human eye will respond to wavelengths in air that are from about 380 nm to about 750 nm.
• the invisible spectrum (e.g, the non-luminous spectrum) is that portion of the electromagnetic spectrum that lies below and above the visible spectrum. The invisible spectrum is not detectable by the human eye.
• Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma ray electromagnetic radiation.
• Figure 1 illustrates one embodiment of a surgical visualization system 100.
• the surgical visualization system 100 is configured to create a visual representation of a critical structure 101 within an anatomical field.
• the critical structure 101 can include a single critical structure or a plurality of critical structures.
• the critical structure 101 can be any of a variety of structures, such as an anatomical structure, e.g, a ureter, an artery such as a superior mesenteric artery, a vein such as a portal vein, a nerve such as a phrenic nerve, a vessel, a tumor, or other anatomical structure, or a foreign structure, e.g, a surgical device, a surgical fastener, a surgical clip, a surgical tack, a bougie, a surgical band, a surgical plate, or other foreign structure.
• the critical structure 101 can be identified on a patient-by-patient and/or a procedure-by- procedure basis.
• the critical structure 101 can be embedded in tissue 103.
• the tissue 103 can be any of a variety of tissues, such as fat, connective tissue, adhesions, and/or organs.
• the critical structure 101 may be positioned below a surface 105 of the tissue 103.
• the tissue 103 conceals the critical structure 101 from the medical practitioner’s “naked eye” view.
• the tissue 103 also obscures the critical structure 101 from the view of an imaging device 120 of the surgical visualization system 100. Instead of being fully obscured, the critical structure 101 can be partially obscured from the view of the medical practitioner and/or the imaging device 120.
• the surgical visualization system 100 can be used for clinical analysis and/or medical intervention.
• the surgical visualization system 100 can be used intraoperatively to provide real-time information to the medical practitioner during a surgical procedure, such as real-time information regarding proximity data, dimensions, and/or distances.
• information may not be precisely real time but nevertheless be considered to be real time for any of a variety of reasons, such as time delay induced by data transmission, time delay induced by data processing, and/or sensitivity of measurement equipment.
• the surgical visualization system 100 is configured for intraoperative identification of critical structure(s) and/or to facilitate the avoidance of the critical structure(s) 101 by a surgical device.
• a medical practitioner can avoid maneuvering a surgical device around the critical structure 101 and/or a region in a predefined proximity of the critical structure 101 during a surgical procedure.
• a medical practitioner can avoid dissection of and/or near the critical structure 101, thereby helping to prevent damage to the critical structure 101 and/or helping to prevent a surgical device being used by the medical practitioner from being damaged by the critical structure 101.
• the surgical visualization system 100 is configured to incorporate tissue identification and geometric surface mapping in combination with the surgical visualization system’s distance sensor system 104. In combination, these features of the surgical visualization system 100 can determine a position of a critical structure 101 within the anatomical field and/or the proximity of a surgical device 102 to the surface 105 of visible tissue 103 and/or to the critical structure 101. Moreover, the surgical visualization system 100 includes an imaging system that includes the imaging device 120 configured to provide real-time views of the surgical site.
• the imaging device 120 can include, for example, a spectral camera (e.g, a hyperspectral camera, multispectral camera, or selective spectral camera), which is configured to detect reflected spectral waveforms and generate a spectral cube of images based on the molecular response to the different wavelengths. Views from the imaging device 120 can be provided in real time to a medical practitioner, such as on a display (e.g., a monitor, a computer tablet screen, etc.). The displayed views can be augmented with additional information based on the tissue identification, landscape mapping, and the distance sensor system 104.
• a spectral camera e.g, a hyperspectral camera, multispectral camera, or selective spectral camera
• Views from the imaging device 120 can be provided in real time to a medical practitioner, such as on a display (e.g., a monitor, a computer tablet screen, etc.).
• the displayed views can be augmented with additional information based on the tissue identification, landscape mapping, and the distance sensor system
• the surgical visualization system 100 includes a plurality of subsystems — an imaging subsystem, a surface mapping subsystem, a tissue identification subsystem, and/or a distance determining subsystem. These subsystems can cooperate to intra-operatively provide advanced data synthesis and integrated information to the medical practitioner.
• the imaging device 120 can be configured to detect visible light, spectral light waves (visible or invisible), and a structured light pattern (visible or invisible).
• Examples of the imaging device 120 includes scopes, e.g, an endoscope, an arthroscope, an angioscope, a bronchoscope, a choledochoscope, a colonoscope, a cytoscope, a duodenoscope, an enteroscope, an esophagogastro- duodenoscope (gastroscope), a laryngoscope, a nasopharyngo-neproscope, a sigmoidoscope, a thoracoscope, an ureteroscope, or an exoscope. Scopes can be particularly useful in minimally invasive surgical procedures. In open surgery applications, the imaging device 120 may not include a scope.
• the tissue identification subsystem can be achieved with a spectral imaging system.
• the spectral imaging system can rely on imaging such as hyperspectral imaging, multispectral imaging, or selective spectral imaging.
• Embodiments of hyperspectral imaging of tissue are further described in U.S. Pat. No. 9,274,047 entitled “System And Method For Gross Anatomic Pathology Using Hyperspectral Imaging” issued March 1, 2016, which is hereby incorporated by reference in its entirety.
• the surface mapping subsystem can be achieved with a light pattern system.
• Various surface mapping techniques using a light pattern (or structured light) for surface mapping can be utilized in the surgical visualization systems described herein.
• Structured light is the process of projecting a known pattern (often a grid or horizontal bars) on to a surface.
• invisible (or imperceptible) structured light can be utilized, in which the structured light is used without interfering with other computer vision tasks for which the projected pattern may be confusing.
• infrared light or extremely fast frame rates of visible light that alternate between two exact opposite patterns can be utilized to prevent interference.
• Embodiments of surface mapping and a surgical system including a light source and a projector for projecting a light pattern are further described in U.S. Pat. Pub.
• the distance determining system can be incorporated into the surface mapping system.
• structured light can be utilized to generate a three-dimensional (3D) virtual model of the visible surface 105 and determine various distances with respect to the visible surface 105.
• the distance determining system can rely on time-of-flight measurements to determine one or more distances to the identified tissue (or other structures) at the surgical site.
• the surgical visualization system 100 also includes a surgical device 102.
• the surgical device 102 can be any suitable surgical device. Examples of the surgical device 102 includes a surgical dissector, a surgical stapler, a surgical grasper, a clip applier, a smoke evacuator, a surgical energy device (e.g., mono-polar probes, bi-polar probes, ablation probes, an ultrasound device, an ultrasonic end effector, etc.), etc.
• the surgical device 102 includes an end effector having opposing jaws that extend from a distal end of a shaft of the surgical device 102 and that are configured to engage tissue therebetween.
• the surgical visualization system 100 can be configured to identify the critical structure 101 and a proximity of the surgical device 102 to the critical structure 101.
• the imaging device 120 of the surgical visualization system 100 is configured to detect light at various wavelengths, such as visible light, spectral light waves (visible or invisible), and a structured light pattern (visible or invisible).
• the imaging device 120 can include a plurality of lenses, sensors, and/or receivers for detecting the different signals.
• the imaging device 120 can be a hyperspectral, multispectral, or selective spectral camera, as described herein.
• the imaging device 120 can include a waveform sensor 122 (such as a spectral image sensor, detector, and/or three-dimensional camera lens).
• the imaging device 120 can include a right-side lens and a left-side lens used together to record two two-dimensional images at the same time and, thus, generate a 3D image of the surgical site, render a three-dimensional image of the surgical site, and/or determine one or more distances at the surgical site.
• the imaging device 120 can be configured to receive images indicative of the topography of the visible tissue and the identification and position of hidden critical structures, as further described herein.
• a field of view of the imaging device 120 can overlap with a pattern of light (structured light) on the surface 105 of the tissue 103, as shown in Figure 1.
• the surgical visualization system 100 can be incorporated into a robotic surgical system 110.
• the robotic surgical system 110 can have a variety of configurations, as discussed herein.
• the robotic surgical system 110 includes a first robotic arm 112 and a second robotic arm 114.
• the robotic arms 112, 114 each include rigid structural members 116 and joints 118, which can include servomotor controls.
• the first robotic arm 112 is configured to maneuver the surgical device 102
• the second robotic arm 114 is configured to maneuver the imaging device 120.
• a robotic control unit of the robotic surgical system 110 is configured to issue control motions to the first and second robotic arms 112, 114, which can affect the surgical device 102 and the imaging device 120, respectively.
• one or more of the robotic arms 112, 114 can be separate from the main robotic system 110 used in the surgical procedure.
• at least one of the robotic arms 112, 114 can be positioned and registered to a particular coordinate system without a servomotor control.
• a closed-loop control system and/or a plurality of sensors for the robotic arms 112, 114 can control and/or register the position of the robotic arm(s) 112, 114 relative to the particular coordinate system.
• the position of the surgical device 102 and the imaging device 120 can be registered relative to a particular coordinate system.
• robotic surgical systems include the OttavaTM robotic-assisted surgery system (Johnson & Johnson of New Brunswick, NJ), da Vinci® surgical systems (Intuitive Surgical, Inc. of Sunnyvale, CA), the HugoTM robotic-assisted surgery system (Medtronic PLC of Minneapolis, MN), the Versius® surgical robotic system (CMR Surgical Ltd of Cambridge, UK), and the Monarch® platform (Auris Health, Inc. of Redwood City, CA).
• Embodiments of various robotic surgical systems and using robotic surgical systems are further described in U.S. Pat. Pub. No. 2018/0177556 entitled “Flexible Instrument Insertion Using An Adaptive Force Threshold” filed Dec. 28, 2016, U.S. Pat. Pub. No.
• the surgical visualization system 100 also includes an emitter 106.
• the emitter 106 is configured to emit a pattern of light, such as stripes, grid lines, and/or dots, to enable the determination of the topography or landscape of the surface 105.
• projected light arrays 130 can be used for three-dimensional scanning and registration on the surface 105.
• the projected light arrays 130 can be emitted from the emitter 106 located on the surgical device 102 and/or one of the robotic arms 112, 114 and/or the imaging device 120.
• the projected light array 130 is employed by the surgical visualization system 100 to determine the shape defined by the surface 105 of the tissue 103 and/or motion of the surface 105 intraoperatively.
• the imaging device 120 is configured to detect the projected light arrays 130 reflected from the surface 105 to determine the topography of the surface 105 and various distances with respect to the surface 105.
• the imaging device 120 can include an optical waveform emitter 123, such as by being mounted on or otherwise attached on the imaging device 120.
• the optical waveform emitter 123 is configured to emit electromagnetic radiation 124 (near-infrared (NIR) photons) that can penetrate the surface 105 of the tissue 103 and reach the critical structure 101.
• the imaging device 120 and the optical waveform emitter 123 can be positionable by the robotic arm 114.
• the optical waveform emitter 123 is mounted on or otherwise on the imaging device 120 but in other embodiments can be positioned on a separate surgical device from the imaging device 120.
• a corresponding waveform sensor 122 (e.g, an image sensor, spectrometer, or vibrational sensor) of the imaging device 120 is configured to detect the effect of the electromagnetic radiation received by the waveform sensor 122.
• the wavelengths of the electromagnetic radiation 124 emitted by the optical waveform emitter 123 are configured to enable the identification of the type of anatomical and/or physical structure, such as the critical structure 101.
• the identification of the critical structure 101 can be accomplished through spectral analysis, photo-acoustics, and/or ultrasound, for example.
• the wavelengths of the electromagnetic radiation 124 can be variable.
• the waveform sensor 122 and optical waveform emitter 123 can be inclusive of a multispectral imaging system and/or a selective spectral imaging system, for example. In other instances, the waveform sensor 122 and optical waveform emitter 123 can be inclusive of a photoacoustic imaging system, for example.
• the distance sensor system 104 of the surgical visualization system 100 is configured to determine one or more distances at the surgical site.
• the distance sensor system 104 can be a time-of-flight distance sensor system that includes an emitter, such as the emitter 106 as in this illustrated embodiment, and that includes a receiver 108. In other instances, the time-of-flight emitter can be separate from the structured light emitter.
• the emitter 106 can include a very tiny laser source, and the receiver 108 can include a matching sensor.
• the distance sensor system 104 is configured to detect the “time of flight,” or how long the laser light emitted by the emitter 106 has taken to bounce back to the sensor portion of the receiver 108. Use of a very narrow light source in the emitter 106 enables the distance sensor system 104 to determining the distance to the surface 105 of the tissue 103 directly in front of the distance sensor system 104.
• the receiver 108 of the distance sensor system 104 is positioned on the surgical device 102 in this illustrated embodiment, but in other embodiments the receiver 108 can be mounted on a separate surgical device instead of the surgical device 102.
• the receiver 108 can be mounted on a cannula or trocar through which the surgical device 102 extends to reach the surgical site.
• the receiver 108 for the distance sensor system 104 can be mounted on a separate robotically-controlled arm of the robotic system 110 (e.g., on the second robotic arm 114) than the first robotic arm 112 to which the surgical device 102 is coupled, can be mounted on a movable arm that is operated by another robot, or be mounted to an operating room (OR) table or fixture.
• the imaging device 120 includes the receiver 108 to allow for determining the distance from the emitter 106 to the surface 105 of the tissue 103 using a line between the emitter 106 on the surgical device 102 and the imaging device 120.
• a distance d e can be triangulated based on known positions of the emitter 106 (on the surgical device 102) and the receiver 108 (on the imaging device 120) of the distance sensor system 104.
• the 3D position of the receiver 108 can be known and/or registered to the robot coordinate plane intraoperatively.
• the position of the emitter 106 of the distance sensor system 104 can be controlled by the first robotic arm 112, and the position of the receiver 108 of the distance sensor system 104 can be controlled by the second robotic arm 114.
• the surgical visualization system 100 can be utilized apart from a robotic system. In such instances, the distance sensor system 104 can be independent of the robotic system.
• distance d e is emitter-to- tissue distance from the emitter 106 to the surface 105 of the tissue 103
• distance d t is device-to-tissue distance from a distal end of the surgical device 102 to the surface 105 of the tissue 103.
• the distance sensor system 104 is configured to determine the emitter-to-tissue distance d e .
• the device-to-tissue distance d t is obtainable from the known position of the emitter 106 on the surgical device 102, e.g, on a shaft thereof proximal to the surgical device’s distal end, relative to the distal end of the surgical device 102.
• the device- to-tissue distance d t can be determined from the emitter-to-tissue distance d c .
• the shaft of the surgical device 102 can include one or more articulation joints and can be articulatable with respect to the emitter 106 and jaws at the distal end of the surgical device 102.
• the articulation configuration can include a multi-joint vertebrae-like structure, for example.
• a 3D camera can be utilized to triangulate one or more distances to the surface 105.
• distance d w is camera-to-critical structure distance from the optical waveform emitter 123 located on the imaging device 120 to the surface of the critical structure 101
• distance dA is a depth of the critical structure 101 below the surface 105 of the tissue 103 (e.g, the distance between the portion of the surface 105 closest to the surgical device 102 and the critical structure 101).
• the time-of-flight of the optical waveforms emitted from the optical waveform emitter 123 located on the imaging device 120 are configured to determine the camera-to-critical structure distance d w .
• the depth dA of the critical structure 101 relative to the surface 105 of the tissue 103 can be determined by triangulating from the camera-to-critical structure distance d w and known positions of the emitter 106 on the surgical device 102 and the optical waveform emitter 123 on the imaging device 120 (and, thus, the known distance d x therebetween) to determine distance d y , which is the sum of the distances d e and dA.
• time-of-flight from the optical waveform emitter 123 can be configured to determine the distance from the optical waveform emitter 123 to the surface 105 of the tissue 103.
• a first waveform (or range of waveforms) can be utilized to determine the camera-to-critical structure distance d w and a second waveform (or range of waveforms) can be utilized to determine the distance to the surface 105 of the tissue 103.
• the different waveforms can be utilized to determine the depth of the critical structure 101 below the surface 105 of the tissue 103.
• the distance d A can be determined from an ultrasound, a registered magnetic resonance imaging (MRI), or computerized tomography (CT) scan.
• the distance d A can be determined with spectral imaging because the detection signal received by the imaging device 120 can vary based on the type of material, e.g., type of the tissue 103. For example, fat can decrease the detection signal in a first way, or a first amount, and collagen can decrease the detection signal in a different, second way, or a second amount.
• a surgical device 162 includes the optical waveform emitter 123 and the waveform sensor 122 that is configured to detect the reflected waveforms.
• the optical waveform emitter 123 is configured to emit waveforms for determining the distances d t and d w from a common device, such as the surgical device 162, as described herein.
• the surgical visualization system 100 includes a control system configured to control various aspects of the surgical visualization system 100.
• Figure 4 illustrates one embodiment of a control system 133 that can be utilized as the control system of the surgical visualization system 100 (or other surgical visualization system described herein).
• the control system 133 includes a control circuit 132 configured to be in signal communication with a memory 134.
• the memory 134 is configured to store instructions executable by the control circuit 132, such as instructions to determine and/or recognize critical structures (e.g., the critical structure 101 of Figure 1), instructions to determine and/or compute one or more distances and/or three-dimensional digital representations, and instructions to communicate information to a medical practitioner.
• the instructions stored within the memory 134 therefore constitute a computer program product comprising instructions which, when executed by the processor, cause it to perform as described above. Such instructions may also be stored on any computer-readable medium (such as an optical disc, an SD card, a USB drive, etc., or a memory of a separate device), from which they may be copied into the memory 134 or executed directly. The process of copying or direct execution involves the creation of a data carrier signal carrying the computer program product.
• the memory 134 can store surface mapping logic 136, imaging logic 138, tissue identification logic 140, and distance determining logic 141, although the memory 134 can store any combinations of the logics 136, 138, 140, 141 and/or can combine various logics together.
• the control system 133 also includes an imaging system 142 including a camera 144 (e.g., the imaging system including the imaging device 120 of Figure 1), a display 146 (e.g, a monitor, a computer tablet screen, etc.), and controls 148 of the camera 144 and the display 146.
• the camera 144 includes an image sensor 135 (e.g, the waveform sensor 122) configured to receive signals from various light sources emitting light at various visible and invisible spectra (e.g., visible light, spectral imagers, three-dimensional lens, etc.).
• the display 146 is configured to depict real, virtual, and/or virtually- augmented images and/or information to a medical practitioner.
• the image sensor 135 is a solid-state electronic device containing up to millions of discrete photodetector sites called pixels.
• the image sensor 135 technology falls into one of two categories: Charge-Coupled Device (CCD) and Complementary Metal Oxide Semiconductor (CMOS) imagers and more recently, short-wave infrared (SWIR) is an emerging technology in imaging.
• CCD Charge-Coupled Device
• CMOS Complementary Metal Oxide Semiconductor
• SWIR short-wave infrared
• Another type of the image sensor 135 employs a hybrid CCD/CMOS architecture (sold under the name “sCMOS”) and consists of CMOS readout integrated circuits (ROICs) that are bump bonded to a CCD imaging substrate.
• sCMOS hybrid CCD/CMOS architecture
• ROICs CMOS readout integrated circuits
• CCD and CMOS image sensors are sensitive to wavelengths in a range of about 350nm to about 1050nm, such as in a range of about 400nm to about lOOOnm.
• CMOS sensors are, in general, more sensitive to IR wavelengths than CCD sensors.
• Solid state image sensors are based on the photoelectric effect and, as a result, cannot distinguish between colors. Accordingly, there are two types of color CCD cameras: single chip and three-chip.
• Single chip color CCD cameras offer a common, low-cost imaging solution and use a mosaic (e.g, Bayer) optical filter to separate incoming light into a series of colors and employ an interpolation algorithm to resolve full color images. Each color is, then, directed to a different set of pixels.
• Three-chip color CCD cameras provide higher resolution by employing a prism to direct each section of the incident spectrum to a different chip. More accurate color reproduction is possible, as each point in space of the object has separate RGB intensity values, rather than using an algorithm to determine the color.
• Three-chip cameras offer extremely high resolutions.
• the control system 133 also includes an emitter (e.g., the emitter 106) including a spectral light source 150 and a structured light source 152 each operably coupled to the control circuit 133.
• a single source can be pulsed to emit wavelengths of light in the spectral light source 150 range and wavelengths of light in the structured light source 152 range.
• a single light source can be pulsed to provide light in the invisible spectrum (e.g, infrared spectral light) and wavelengths of light on the visible spectrum.
• the spectral light source 150 can be, for example, a hyperspectral light source, a multispectral light source, and/or a selective spectral light source.
• the tissue identification logic 140 is configured to identify critical structure(s) (e.g, the critical structure 101 of Figure 1) via data from the spectral light source 150 received by the image sensor 135 of the camera 144.
• the surface mapping logic 136 is configured to determine the surface contours of the visible tissue (e.g, the tissue 103) based on reflected structured light.
• the distance determining logic 141 is configured to determine one or more distance(s) to the visible tissue and/or the critical structure.
• Output from each of the surface mapping logic 136, the tissue identification logic 140, and the distance determining logic 141 is configured to be provided to the imaging logic 138, and combined, blended, and/or overlaid by the imaging logic 138 to be conveyed to a medical practitioner via the display 146 of the imaging system 142.
• the control circuit 132 can have a variety of configurations.
• Figure 5 illustrates one embodiment of a control circuit 170 that can be used as the control circuit 132 configured to control aspects of the surgical visualization system 100.
• the control circuit 170 is configured to implement various processes described herein.
• the control circuit 170 includes a microcontroller that includes a processor 172 (e.g., a microprocessor or microcontroller) operably coupled to a memory 174.
• the memory 174 is configured to store machine-executable instructions that, when executed by the processor 172, cause the processor 172 to execute machine instructions to implement various processes described herein.
• the processor 172 can be any one of a number of single-core or multicore processors known in the art.
• the memory 174 can include volatile and non-volatile storage media.
• the processor 172 includes an instruction processing unit 176 and an arithmetic unit 178.
• the instruction processing unit 176 is configured to receive instructions from the memory 174.
• the surface mapping logic 136, the imaging logic 138, the tissue identification logic 140, and the distance determining logic 141 can have a variety of configurations.
• Figure 6 illustrates one embodiment of a combinational logic circuit 180 configured to control aspects of the surgical visualization system 100 using logic such as one or more of the surface mapping logic 136, the imaging logic 138, the tissue identification logic 140, and the distance determining logic 141.
• the combinational logic circuit 180 includes a finite state machine that includes a combinational logic 182 configured to receive data associated with a surgical device (e.g. the surgical device 102 and/or the imaging device 120) at an input 184, process the data by the combinational logic 182, and provide an output 184 to a control circuit (e.g., the control circuit 132).
• Figure 7 illustrates one embodiment of a sequential logic circuit 190 configured to control aspects of the surgical visualization system 100 using logic such as one or more of the surface mapping logic 136, the imaging logic 138, the tissue identification logic 140, and the distance determining logic 141.
• the sequential logic circuit 190 includes a finite state machine that includes a combinational logic 192, a memory 194, and a clock 196.
• the memory 194 is configured to store a current state of the finite state machine.
• the sequential logic circuit 190 can be synchronous or asynchronous.
• the combinational logic 192 is configured to receive data associated with a surgical device (e.g.
• the surgical device 102 and/or the imaging device 120 at an input 426, process the data by the combinational logic 192, and provide an output 499 to a control circuit (e.g, the control circuit 132).
• the sequential logic circuit 190 can include a combination of a processor (e.g., processor 172 of Figure 5) and a finite state machine to implement various processes herein.
• the finite state machine can include a combination of a combinational logic circuit (e.g., the combinational logic circuit 192 of Figure 7) and the sequential logic circuit 190.
• Figure 8 illustrates another embodiment of a surgical visualization system 200.
• the surgical visualization system 200 is generally configured and used similar to the surgical visualization system 100 of Figure 1, e.g., includes a surgical device 202 and an imaging device 220.
• the imaging device 220 includes a spectral light emitter 223 configured to emit spectral light in a plurality of wavelengths to obtain a spectral image of hidden structures, for example.
• the imaging device 220 can also include a three-dimensional camera and associated electronic processing circuits.
• the surgical visualization system 200 is shown being utilized intraoperatively to identify and facilitate avoidance of certain critical structures, such as a ureter 201a and vessels 201b, in an organ 203 (a uterus in this embodiment) that are not visible on a surface 205 of the organ 203.
• the surgical visualization system 200 is configured to determine an emitter-to-tissue distance d e from an emitter 206 on the surgical device 202 to the surface 205 of the uterus 203 via structured light.
• the surgical visualization system 200 is configured to extrapolate a device-to-tissue distance d t from the surgical device 202 to the surface 205 of the uterus 203 based on the emitter-to- tissue distance d e .
• the surgical visualization system 200 is also configured to determine a tissue-to- ureter distance dA from the ureter 201a to the surface 205 and a camera-to ureter distance d w from the imaging device 220 to the ureter 201a.
• the surgical visualization system 200 is configured to determine the distance d w with spectral imaging and time-of-flight sensors, for example.
• the surgical visualization system 200 can determine (e.g, triangulate) the tissue-to- ureter distance dA (or depth) based on other distances and/or the surface mapping logic described herein.
• a surgical visualization system includes a control system configured to control various aspects of the surgical visualization system.
• the control system can have a variety of configurations.
• Figure 9 illustrates one embodiment of a control system 600 for a surgical visualization system, such as the surgical visualization system 100 of Figure 1, the surgical visualization system 200 of Figure 8, or other surgical visualization system described herein.
• the control system 600 is a conversion system that integrates spectral signature tissue identification and structured light tissue positioning to identify a critical structure, especially when those structure(s) are obscured by tissue, e.g., by fat, connective tissue, blood tissue, and/or organ(s), and/or by blood, and/or to detect tissue variability, such as differentiating tumors and/or non-healthy tissue from healthy tissue within an organ.
• the control system 600 is configured for implementing a hyperspectral imaging and visualization system in which a molecular response is utilized to detect and identify anatomy in a surgical field of view.
• the control system 600 includes a conversion logic circuit 648 configured to convert tissue data to usable information for surgeons and/or other medical practitioners. For example, variable reflectance based on wavelengths with respect to obscuring material can be utilized to identify the critical structure in the anatomy.
• the control system 600 is configured to combine the identified spectral signature and the structural light data in an image.
• the control system 600 can be employed to create of three-dimensional data set for surgical use in a system with augmentation image overlays. Techniques can be employed both intraoperatively and preoperatively using additional visual information.
• the control system 600 is configured to provide warnings to a medical practitioner when in the proximity of one or more critical structures.
• Various algorithms can be employed to guide robotic automation and semi-automated approaches based on the surgical procedure and proximity to the critical structure(s).
• a projected array of lights is employed by the control system 600 to determine tissue shape and motion intraoperatively.
• flash Lidar may be utilized for surface mapping of the tissue.
• the control system 600 is configured to detect the critical structure, which as mentioned above can include one or more critical structures, and provide an image overlay of the critical structure and measure the distance to the surface of the visible tissue and the distance to the embedded/buried critical structure(s).
• the control system 600 can measure the distance to the surface of the visible tissue or detect the critical structure and provide an image overlay of the critical structure.
• the control system 600 includes a spectral control circuit 602.
• the spectral control circuit 602 can be a field programmable gate array (FPGA) or another suitable circuit configuration, such as the configurations described with respect to Figure 6, Figure 7, and Figure 8.
• the spectral control circuit 602 includes a processor 604 configured to receive video input signals from a video input processor 606.
• the processor 604 can be configured for hyperspectral processing and can utilize C/C++ code, for example.
• the video input processor 606 is configured to receive video-in of control (metadata) data such as shutter time, wave length, and sensor analytics, for example.
• the processor 604 is configured to process the video input signal from the video input processor 606 and provide a video output signal to a video output processor 608, which includes a hyperspectral video-out of interface control (metadata) data, for example.
• the video output processor 608 is configured to provides the video output signal to an image overlay controller 610.
• the video input processor 606 is operatively coupled to a camera 612 at the patient side via a patient isolation circuit 614.
• the camera 612 includes a solid state image sensor 634.
• the patient isolation circuit 614 can include a plurality of transformers so that the patient is isolated from other circuits in the system.
• the camera 612 is configured to receive intraoperative images through optics 632 and the image sensor 634.
• the image sensor 634 can include a CMOS image sensor, for example, or can include another image sensor technology, such as those discussed herein in connection with Figure 4.
• the camera 612 is configured to output 613 images in 14 bit / pixel signals. A person skilled in the art will appreciate that higher or lower pixel resolutions can be employed.
• the isolated camera output signal 613 is provided to a color RGB fusion circuit 616, which in this illustrated embodiment employs a hardware register 618 and aNios2 co-processor 620 configured to process the camera output signal 613.
• a color RGB fusion output signal is provided to the video input processor 606 and a laser pulsing control circuit 622.
• the laser pulsing control circuit 622 is configured to control a laser light engine 624.
• the laser light engine 624 is configured to output light in a plurality of wavelengths (XI, X2, X3, ... Xn) including near infrared (NIR).
• the laser light engine 624 can operate in a plurality of modes.
• the laser light engine 624 can operate in two modes. In a first mode, e.g. , a normal operating mode, the laser light engine 624 is configured to output an illuminating signal. In a second mode, e.g, an identification mode, the laser light engine 624 is configured to output RGBG and NIR light. In various embodiments, the laser light engine 624 can operate in a polarizing mode.
• Light output 626 from the laser light engine 624 is configured to illuminate targeted anatomy in an intraoperative surgical site 627.
• the laser pulsing control circuit 622 is also configured to control a laser pulse controller 628 for a laser pattern projector 630 configured to project a laser light pattern 631, such as a grid or pattern of lines and/or dots, at a predetermined wavelength (X2) on an operative tissue or organ at the surgical site 627.
• the camera 612 is configured to receive the patterned light as well as the reflected light output through the camera optics 632.
• the image sensor 634 is configured to convert the received light into a digital signal.
• the color RGB fusion circuit 616 is also configured to output signals to the image overlay controller 610 and a video input module 636 for reading the laser light pattern 631 projected onto the targeted anatomy at the surgical site 627 by the laser pattern projector 630.
• a processing module 638 is configured to process the laser light pattern 631 and output a first video output signal 640 representative of the distance to the visible tissue at the surgical site 627.
• the data is provided to the image overlay controller 610.
• the processing module 638 is also configured to output a second video signal 642 representative of a three-dimensional rendered shape of the tissue or organ of the targeted anatomy at the surgical site.
• the first and second video output signals 640, 642 include data representative of the position of the critical structure on a three-dimensional surface model, which is provided to an integration module 643.
• the integration module 643 is configured to determine the distance (e.g., distance dA of Figure 1) to a buried critical structure (e.g, via triangularization algorithms 644), and the distance to the buried critical structure can be provided to the image overlay controller 610 via a video out processor 646.
• the foregoing conversion logic can encompass the conversion logic circuit 648 intermediate video monitors 652 and the camera 624 / laser pattern projector 630 positioned at the surgical site 627.
• Preoperative data 650 such as from a CT or MRI scan, can be employed to register or align certain three-dimensional deformable tissue in various instances.
• Such preoperative data 650 can be provided to the integration module 643 and ultimately to the image overlay controller 610 so that such information can be overlaid with the views from the camera 612 and provided to the video monitors 652.
• Embodiments of registration of preoperative data are further described in U.S. Pat. Pub. No. 2020/0015907 entitled “Integration Of Imaging Data” filed September 11, 2018, which is hereby incorporated by reference herein in its entirety.
• the video monitors 652 are configured to output the integrated/augmented views from the image overlay controller 610.
• a medical practitioner can select and/or toggle between different views on one or more displays.
• On a first display 652a which is a monitor in this illustrated embodiment, the medical practitioner can toggle between (A) a view in which a three-dimensional rendering of the visible tissue is depicted and (B) an augmented view in which one or more hidden critical structures are depicted over the three-dimensional rendering of the visible tissue.
• a second display 652b which is a monitor in this illustrated embodiment, the medical practitioner can toggle on distance measurements to one or more hidden critical structures and/or the surface of visible tissue, for example.
• the various surgical visualization systems described herein can be utilized to visualize various different types of tissues and/or anatomical structures, including tissues and/or anatomical structures that may be obscured from being visualized by EMR in the visible portion of the spectrum.
• the surgical visualization system can utilize a spectral imaging system, as mentioned above, which can be configured to visualize different types of tissues based upon their varying combinations of constituent materials.
• a spectral imaging system can be configured to detect the presence of various constituent materials within a tissue being visualized based on the absorption coefficient of the tissue across various EMR wavelengths.
• the spectral imaging system can be configured to characterize the tissue type of the tissue being visualized based upon the particular combination of constituent materials.
• Figure 10 shows a graph 300 depicting how the absorption coefficient of various biological materials varies across the EMR wavelength spectrum.
• the vertical axis 302 represents absorption coefficient of the biological material in cm' 1
• the horizontal axis 304 represents EMR wavelength in pm.
• a first line 306 in the graph 300 represents the absorption coefficient of water at various EMR wavelengths
• a second line 308 represents the absorption coefficient of protein at various EMR wavelengths
• a third line 310 represents the absorption coefficient of melanin at various EMR wavelengths
• a fourth line 312 represents the absorption coefficient of deoxygenated hemoglobin at various EMR wavelengths
• a fifth line 314 represents the absorption coefficient of oxygenated hemoglobin at various EMR wavelengths
• a sixth line 316 represents the absorption coefficient of collagen at various EMR wavelengths.
• Different tissue types have different combinations of constituent materials and, therefore, the tissue type(s) being visualized by a surgical visualization system can be identified and differentiated between according to the particular combination of detected constituent materials.
• a spectral imaging system of a surgical visualization system can be configured to emit EMR at a number of different wavelengths, determine the constituent materials of the tissue based on the detected absorption EMR absorption response at the different wavelengths, and then characterize the tissue type based on the particular detected combination of constituent materials.
• FIG 11 shows an embodiment of the utilization of spectral imaging techniques to visualize different tissue types and/or anatomical structures.
• a spectral emitter 320 e.g, the spectral light source 150 of Figure 4
• an imaging system to visualize a surgical site 322.
• the EMR emitted by the spectral emitter 320 and reflected from the tissues and/or structures at the surgical site 322 is received by an image sensor (e.g., the image sensor 135 of Figure 4) to visualize the tissues and/or structures, which can be either visible (e.g., be located at a surface of the surgical site 322) or obscured (e.g, underlay other tissue and/or structures at the surgical site 322).
• an imaging system e.g., the imaging system 142 of Figure 4
• the visualized tissues and structures can be displayed on a display screen associated with or coupled to the imaging system (e.g, the display 146 of the imaging system 142 of Figure 4), on a primary display (e.g, the primary display 819 of Figure 19), on anon-sterile display (e.g, the non-sterile displays 807, 809 of Figure 19), on a display of a surgical hub (e.g, the display of the surgical hub 806 of Figure 19), on a device/instrument display, and/or on another display.
• a display screen associated with or coupled to the imaging system e.g, the display 146 of the imaging system 142 of Figure 4
• a primary display e.g, the primary display 819 of Figure 19
• anon-sterile display e.g, the non-sterile displays 807, 809 of Figure 19
• a surgical hub e.g, the display of the surgical hub 806 of Figure 19
• device/instrument display e.g., the display of the surgical hub 806 of Figure 19
• the imaging system can be configured to tailor or update the displayed surgical site visualization according to the identified tissue and/or structure types.
• the imaging system can display a margin 330 associated with the tumor 324 being visualized on a display screen associated with or coupled to the imaging system, on a primary display, on a non-sterile display, on a display of a surgical hub, on a device/instrument display, and/or on another display.
• the margin 330 can indicate the area or amount of tissue that should be excised to ensure complete removal of the tumor 324.
• a size of the margin 330 can be, for example, in a range of about 5 mm to about 10 mm.
• the surgical visualization system can be configured to control or update the dimensions of the margin 330 based on the tissues and/or structures identified by the imaging system.
• the imaging system has identified multiple abnormalities 328 within the field of view (FOV). Accordingly, the control system can adjust the displayed margin 330 to a first updated margin 332 having sufficient dimensions to encompass the abnormalities 328.
• the imaging system has also identified the artery 326 partially overlapping with the initially displayed margin 330 (as indicated by a highlighted region 334 of the artery 326). Accordingly, the control system can adjust the displayed margin to a second updated margin 336 having sufficient dimensions to encompass the relevant portion of the artery 326.
• Tissues and/or structures can also be imaged or characterized according to their reflective characteristics, in addition to or in lieu of their absorptive characteristics described above with respect to Figure 10 and Figure 11, across the EMR wavelength spectrum.
• Figure 12, Figure 13, and Figure 14 illustrate various graphs of reflectance of different types of tissues or structures across different EMR wavelengths.
• Figure 12 is a graphical representation 340 of an illustrative ureter signature versus obscurants.
• Figure 13 is a graphical representation 342 of an illustrative artery signature versus obscurants.
• Figure 14 is a graphical representation 344 of an illustrative nerve signature versus obscurants.
• the plots in Figure 12, Figure 13, and Figure 14 represent reflectance as a function of wavelength (nm) for the particular structures (ureter, artery, and nerve) relative to the corresponding reflectances of fat, lung tissue, and blood at the corresponding wavelengths. These graphs are simply for illustrative purposes and it should be understood that other tissues and/or structures could have corresponding detectable reflectance signatures that would allow the tissues and/or structures to be identified and visualized.
• wavelengths for spectral imaging can be identified and utilized based on the anticipated critical structures and/or obscurants at a surgical site (e.g, “selective spectral” imaging). By utilizing selective spectral imaging, the amount of time required to obtain the spectral image can be minimized such that the information can be obtained in real-time and utilized intraoperatively.
• the wavelengths can be selected by a medical practitioner or by a control circuit based on input by a user, e.g, a medical practitioner. In certain instances, the wavelengths can be selected based on machine learning and/or big data accessible to the control circuit via, e.g, a cloud or surgical hub.
• Figure 15 illustrates one embodiment of spectral imaging to tissue being utilized intraoperatively to measure a distance between a waveform emitter and a critical structure that is obscured by tissue.
• Figure 15 shows an embodiment of a time-of-flight sensor system 404 utilizing waveforms 424, 425.
• the time-of-flight sensor system 404 can be incorporated into a surgical visualization system, e.g, as the sensor system 104 of the surgical visualization system 100 of Figure 1.
• the time-of-flight sensor system 404 includes a waveform emitter 406 and a waveform receiver 408 on the same surgical device 402 (e.g, the emitter 106 and the receiver 108 on the same surgical device 102 of Figure 1).
• the emitted wave 400 extends to a critical structure 401 (e.g, the critical structure 101 of Figure 1) from the emitter 406, and the received wave 425 is reflected back to by the receiver 408 from the critical structure 401.
• the surgical device 402 in this illustrated embodiment is positioned through a trocar 410 that extends into a cavity 407 in a patient.
• the trocar 410 is used in this in this illustrated embodiment, other trocars or other access devices can be used, or no access device may be used.
• the waveforms 424, 425 are configured to penetrate obscuring tissue 403, such as by having wavelengths in the NIR or SWIR spectrum of wavelengths.
• a spectral signal e.g., hyperspectral, multispectral, or selective spectral
• a photoacoustic signal is emitted from the emitter 406, as shown by a first arrow 407 pointing distally, and can penetrate the tissue 403 in which the critical structure 401 is concealed.
• the emitted waveform 424 is reflected by the critical structure 401, as shown by a second arrow 409 pointing proximally.
• the received waveform 425 can be delayed due to a distance d between a distal end of the surgical device 402 and the critical structure 401.
• the waveforms 424, 425 can be selected to target the critical structure 401 within the tissue 403 based on the spectral signature of the critical structure 401, as described herein.
• the emitter 406 is configured to provide a binary signal on and off, as shown in Figure 16, for example, which can be measured by the receiver 408.
• the time-of- flight sensor system 404 is configured to determine the distance d.
• a time-of-flight timing diagram 430 for the emitter 406 and the receiver 408 of Figure 15 is shown in Figure 16.
• the delay is a function of the distance d and the distance d is given by:
• the time-of-flight of the waveforms 424, 425 corresponds to the distance d in Figure 15.
• additional emitters/receivers and/or pulsing signals from the emitter 406 can be configured to emit a non-penetrating signal.
• the non-penetrating signal can be configured to determine the distance from the emitter 406 to the surface 405 of the obscuring tissue 403.
• Figure 17 illustrates another embodiment of a time-of-flight sensor system 504 utilizing waves 524a, 524b, 524c, 525a, 525b, 525c is shown.
• the time-of-flight sensor system 504 can be incorporated into a surgical visualization system, e.g, as the sensor system 104 of the surgical visualization system 100 of Figure 1.
• the time-of-flight sensor system 504 includes a waveform emitter 506 and a waveform receiver 508 (e.g., the emitter 106 and the receiver 108 of Figure 1).
• the waveform emitter 506 is positioned on a first surgical device 502a (e.g, the surgical device 102 of Figure 1), and the waveform receiver 508 is positioned on a second surgical device 502b.
• the surgical devices 502a, 502b are positioned through first and second trocars 510a, 510b, respectively, which extend into a cavity 507 in a patient.
• trocars 510a, 510b are used in this in this illustrated embodiment, other trocars or other access devices can be used, or no access device may be used.
• the emitted waves 524a, 524b, 524c extend toward a surgical site from the emitter 506, and the received waves 525a, 525b, 525c are reflected back to the receiver 508 from various structures and/or surfaces at the surgical site.
• the different emitted waves 524a, 524b, 524c are configured to target different types of material at the surgical site.
• the wave 524a targets obscuring tissue 503
• the wave 524b targets a first critical structure 501a (e.g., the critical structure 101 of Figure 1), which is a vessel in this illustrated embodiment
• the wave 524c targets a second critical structure 501b (e.g, the critical structure 101 of Figure 1), which is a cancerous tumor in this illustrated embodiment.
• the wavelengths of the waves 524a, 524b, 524c can be in the visible light, NIR, or SWIR spectrum of wavelengths.
• a spectral signal e.g., hyperspectral, multispectral, or selective spectral
• a photoacoustic signal can be emitted from the emitter 506.
• the waves 524b, 524c can be selected to target the critical structures 501a, 501b within the tissue 503 based on the spectral signature of the critical structures 501a, 501b, as described herein.
• Photoacoustic imaging is further described in various U.S. patent applications, which are incorporated by reference herein in the present disclosure.
• the emited waves 524a, 524b, 524c are reflected off the targeted material, namely the surface 505, the first critical structure 501a, and the second structure 501b, respectively.
• the received waveforms 525a, 525b, 525c can be delayed due to distances di a , d 2a , d 3a , dib, d 2 b, d 2c .
• the various distances di a , d 2a , d 3a , dib, d 2 b, d 2c can be calculated from the known position of the emiter 506 and the receiver 508.
• the positions can be known when the surgical devices 502a, 502b are robotically-controlled.
• Knowledge of the positions of the emiter 506 and the receiver 508, as well as the time of the photon stream to target a certain tissue and the information received by the receiver 508 of that particular response can allow a determination of the distances di a , d 2a , d 3a , dib, d 2 , d 2c .
• the distance to the obscured critical structures 501a, 501b can be triangulated using penetrating wavelengths. Because the speed of light is constant for any wavelength of visible or invisible light, the time-of-flight sensor system 504 can determine the various distances.
• the receiver 508 can be rotated such that a center of mass of the target structure in the resulting images remains constant, e.g, in a plane perpendicular to an axis of a select target structure 503, 501a, or 501b.
• Such an orientation can quickly communicate one or more relevant distances and/or perspectives with respect to the target structure.
• the surgical site is displayed from a viewpoint in which the critical structure 501a is perpendicular to the viewing plane (e.g, the vessel is oriented in/out of the page).
• Such an orientation can be default seting; however, the view can be rotated or otherwise adjusted by a medical practitioner.
• the medical practitioner can toggle between different surfaces and/or target structures that define the viewpoint of the surgical site provided by the imaging system.
• the receiver 508 can be mounted on the trocar 510b (or other access device) through which the surgical device 502b is positioned.
• the receiver 508 can be mounted on a separate robotic arm for which the three-dimensional position is known.
• the receiver 508 can be mounted on a movable arm that is separate from a robotic surgical system that controls the surgical device 502a or can be mounted to an operating room (OR) table or fixture that is intraoperatively registerable to the robot coordinate plane.
• the position of the emitter 506 and the receiver 508 can be registerable to the same coordinate plane such that the distances can be triangulated from outputs from the time-of- flight sensor system 504.
• TOF-NIRS near-infrared spectroscopy
• 16/729,796 entitled “Adaptive Surgical System Control According To Surgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,803 entitled “Adaptive Visualization By A Surgical System” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,807 entitled “Method Of Using Imaging Devices In Surgery” filed Dec. 30, 2019, U.S. Pat. App No. 17/493,913 entitled “Surgical Methods Using Fiducial Identification And Tracking” filed on October 5, 2021, U.S. Pat. App No. 17/494,364 entitled “Surgical Methods For Control Of One Visualization With Another” filed on October 5, 2021, U.S. Pat. App No.
• a surgical hub can be a component of a comprehensive digital medical system capable of spanning multiple medical facilities and configured to provide integrated and comprehensive improved medical care to a vast number of patients.
• the comprehensive digital medical system includes a cloud-based medical analytics system that is configured to interconnect to multiple surgical hubs located across many different medical facilities.
• the surgical hubs are configured to interconnect with one or more elements, such as one or more surgical instruments that are used to conduct medical procedures on patients and/or one or more visualization systems that are used during performance of medical procedures.
• the surgical hubs provide a wide array of functionality to improve the outcomes of medical procedures.
• the data generated by the various surgical devices, visualization systems, and surgical hubs about the patient and the medical procedure may be transmitted to the cloud-based medical analytics system. This data may then be aggregated with similar data gathered from many other surgical hubs, visualization systems, and surgical instruments located at other medical facilities. Various patterns and correlations may be found through the cloud-based analytics system analyzing the collected data. Improvements in the techniques used to generate the data may be generated as a result, and these improvements may then be disseminated to the various surgical hubs, visualization systems, and surgical instruments. Due to the interconnectedness of all of the aforementioned components, improvements in medical procedures and practices may be found that otherwise may not be found if the many components were not so interconnected.
• FIG 18 illustrates one embodiment of a computer-implemented interactive surgical system 700 that includes one or more surgical systems 702 and a cloud-based system (e.g., a cloud 704 that can include a remote server 713 coupled to a storage device 705).
• a cloud-based system e.g., a cloud 704 that can include a remote server 713 coupled to a storage device 705.
• Each surgical system 702 includes at least one surgical hub 706 in communication with the cloud 704.
• the surgical system 702 includes a visualization system 708, a robotic system 710, and an intelligent (or “smart”) surgical instrument 712, which are configured to communicate with one another and/or the hub 706.
• the intelligent surgical instrument 712 can include imaging device(s).
• the surgical system 702 can include an M number of hubs 706, an N number of visualization systems 708, an O number of robotic systems 710, and a P number of intelligent surgical instruments 712, where M, N, O, and P are integers greater than or equal to one that may or may not be equal to any one or more of each other.
• M, N, O, and P are integers greater than or equal to one that may or may not be equal to any one or more of each other.
• Data received by a surgical hub from a surgical visualization system can be used in any of a variety of ways.
• the surgical hub can receive data from a surgical visualization system in use with a patient in a surgical setting, e.g, in use in an operating room during performance of a surgical procedure.
• the surgical hub can use the received data in any of one or more ways, as discussed herein.
• the surgical hub can be configured to analyze received data in real time with use of the surgical visualization system and adjust control one or more of the surgical visualization system and/or one or more intelligent surgical instruments in use with the patient based on the analysis of the received data.
• Such adjustment can include, for example, adjusting one or operational control parameters of intelligent surgical instrument(s), causing one or more sensors of one or more intelligent surgical instruments to take a measurement to help gain an understanding of the patient’s current physiological condition, and/or current operational status of an intelligent surgical instrument, and other adjustments. Controlling and adjusting operation of intelligent surgical instruments is discussed further below. Examples of operational control parameters of an intelligent surgical instrument include motor speed, cutting element speed, time, duration, level of energy application, and light emission.
• 16/729,729 entitled “Surgical Systems For Proposing And Corroborating Organ Portion Removals” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,778 entitled “Surgical System For Overlaying Surgical Instrument Data Onto A Virtual Three Dimensional Construct Of An Organ” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,751 entitled “Surgical Systems For Generating Three Dimensional Constructs Of Anatomical Organs And Coupling Identified Anatomical Structures Thereto” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,740 entitled “Surgical Systems Correlating Visualization Data And Powered Surgical Instrument Data” filed Dec. 30, 2019, U.S. Pat. App. No.
• 16/729,737 entitled “Adaptive Surgical System Control According To Surgical Smoke Cloud Characteristics” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,796 entitled “Adaptive Surgical System Control According To Surgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,803 entitled “Adaptive Visualization By A Surgical System” filed Dec. 30, 2019, and U.S. Pat. App. No. 16/729,807 entitled “Method Of Using Imaging Devices In Surgery” filed Dec. 30,
• the surgical hub can be configured to cause visualization of the received data to be provided in the surgical setting on a display so that a medical practitioner in the surgical setting can view the data and thereby receive an understanding of the operation of the imaging device(s) in use in the surgical setting.
• information provided via visualization can include text and/or images.
• Figure 19 illustrates one embodiment of a surgical system 802 including a surgical hub 806 (e.g, the surgical hub 706 of Figure 18 or other surgical hub described herein), a robotic surgical system 810 (e.g. , the robotic surgical system 110 of Figure 1 or other robotic surgical system herein), and a visualization system 808 (e.g, the visualization system 100 of Figure 1 or other visualization system described herein).
• the surgical hub 806 can be in communication with a cloud, as discussed herein.
• Figure 19 shows the surgical system 802 being used to perform a surgical procedure on a patient who is lying down on an operating table 814 in a surgical operating room 816.
• the robotic system 810 includes a surgeon’s console 818, a patient side cart 820 (surgical robot), and a robotic system surgical hub 822.
• the robotic system surgical hub 822 is generally configured similar to the surgical hub 822 and can be in communication with a cloud. In some embodiments, the robotic system surgical hub 822 and the surgical hub 806 can be combined.
• the patient side cart 820 can manipulate an intelligent surgical tool 812 through a minimally invasive incision in the body of the patient while a medical practitioner, e.g., a surgeon, nurse, and/or other medical practitioner, views the surgical site through the surgeon’s console 818.
• An image of the surgical site can be obtained by an imaging device 824 (e.g, the imaging device 120 of Figure 1 or other imaging device described herein), which can be manipulated by the patient side cart 820 to orient the imaging device 824.
• the robotic system surgical hub 822 can be used to process the images of the surgical site for subsequent display to the surgeon through the surgeon’s console 818.
• a primary display 819 is positioned in the sterile field of the operating room 816 and is configured to be visible to an operator at the operating table 814.
• a visualization tower 811 can positioned outside the sterile field.
• the visualization tower 811 includes a first non-sterile display 807 and a second non-sterile display 809, which face away from each other.
• the visualization system 808, guided by the surgical hub 806, is configured to utilize the displays 807, 809, 819 to coordinate information flow to medical practitioners inside and outside the sterile field.
• the surgical hub 806 can cause the visualization system 808 to display a snapshot and/or a video of a surgical site, as obtained by the imaging device 824, on one or both of the non-sterile displays 807, 809, while maintaining a live feed of the surgical site on the primary display 819.
• the snapshot and/or video on the non-sterile display 807 and/or 809 can permit a non-sterile medical practitioner to perform a diagnostic step relevant to the surgical procedure, for example.
• the surgical hub 806 is configured to route a diagnostic input or feedback entered by a non- sterile medical practitioner at the visualization tower 811 to the primary display 819 within the sterile field, where it can be viewed by a sterile medical practitioner at the operating table 814.
• the input can be in the form of a modification to the snapshot and/or video displayed on the non-sterile display 807 and/or 809, which can be routed to the primary display 819 by the surgical hub 806.
• the surgical hub 806 is configured to coordinate information flow to a display of the intelligent surgical instrument 812, as is described in various U.S. Patent Applications that are incorporated by reference herein in the present disclosure.
• a diagnostic input or feedback entered by a non-sterile operator at the visualization tower 818 can be routed by the surgical hub 806 to the display 819 within the sterile field, where it can be viewed by the operator of the surgical instrument 812 and/or by other medical practitioner(s) in the sterile field.
• the intelligent surgical instrument 812 and the imaging device 824 which is also an intelligent surgical tool, is being used with the patient in the surgical procedure as part of the surgical system 802.
• Other intelligent surgical instruments 812a that can be used in the surgical procedure, e.g., that can be removably coupled to the patient side cart 820 and be in communication with the robotic surgical system 810 and the surgical hub 806, are also shown in Figure 19 as being available.
• Non-intelligent (or “dumb”) surgical instruments 817 e.g, scissors, trocars, cannulas, scalpels, etc., that cannot be in communication with the robotic surgical system 810 and the surgical hub 806 are also shown in Figure 19 as being available for use.
• An intelligent surgical device can have an algorithm stored thereon, e.g, in a memory thereof, configured to be executable on board the intelligent surgical device, e.g, by a processor thereof, to control operation of the intelligent surgical device.
• the algorithm can be stored on a surgical hub, e.g., in a memory thereof, that is configured to communicate with the intelligent surgical device.
• the algorithm is stored in the form of one or more sets of pluralities of data points defining and/or representing instructions, notifications, signals, etc. to control functions of the intelligent surgical device.
• data gathered by the intelligent surgical device can be used by the intelligent surgical device, e.g., by a processor of the intelligent surgical device, to change at least one variable parameter of the algorithm.
• a surgical hub can be in communication with an intelligent surgical device, so data gathered by the intelligent surgical device can be communicated to the surgical hub and/or data gathered by another device in communication with the surgical hub can be communicated to the surgical hub, and data can be communicated from the surgical hub to the intelligent surgical device.
• the surgical hub can be configured to communicate the changed at least one variable, alone or as part of the algorithm, to the intelligent surgical device and/or the surgical hub can communicate an instruction to the intelligent surgical device to change the at least one variable as determined by the surgical hub.
• the at least one variable parameter is among the algorithm’s data points, e.g, are included in instructions for operating the intelligent surgical device, and are thus each able to be changed by changing one or more of the stored pluralities of data points of the algorithm. After the at least one variable parameter has been changed, subsequent execution of the algorithm is according to the changed algorithm.
• operation of the intelligent surgical device over time can be managed for a patient to increase the beneficial results use of the intelligent surgical device by taking into consideration actual situations of the patient and actual conditions and/or results of the surgical procedure in which the intelligent surgical device is being used.
• Changing the at least one variable parameter is automated to improve patient outcomes.
• the intelligent surgical device can be configured to provide personalized medicine based on the patient and the patient’s surrounding conditions to provide a smart system.
• automated changing of the at least one variable parameter may allow for the intelligent surgical device to be controlled based on data gathered during the performance of the surgical procedure, which may help ensure that the intelligent surgical device is used efficiently and correctly and/or may help reduce chances of patient harm by harming a critical anatomical structure.
• variable parameter can be any of a variety of different operational parameters.
• variable parameters include motor speed, motor torque, energy level, energy application duration, tissue compression rate, jaw closure rate, cutting element speed, load threshold, etc.
• Figure 20 illustrates one embodiment of an intelligent surgical instrument 900 including a memory 902 having an algorithm 904 stored therein that includes at least one variable parameter.
• the algorithm 904 can be a single algorithm or can include a plurality of algorithms, e.g, separate algorithms for different aspects of the surgical instrument’s operation, where each algorithm includes at least one variable parameter.
• the intelligent surgical instrument 900 can be the surgical device 102 of Figure 1, the imaging device 120 of Figure 1, the surgical device 202 of Figure 8, the imaging device 220 of Figure 8, the surgical device 402 of Figure 15, the surgical device 502a of Figure 17, the surgical device 502b of Figure 17, the surgical device 712 of Figure 18, the surgical device 812 of Figure 19, the imaging device 824 of Figure 19, or other intelligent surgical instrument.
• the surgical instrument 900 also includes a processor 906 configured to execute the algorithm 904 to control operation of at least one aspect of the surgical instrument 900.
• the processor 906 is configured to run a program stored in the memory 902 to access a plurality of data points of the algorithm 904 in the memory 902.
• the surgical instrument 900 also includes a communications interface 908, e.g, a wireless transceiver or other wired or wireless communications interface, configured to communicate with another device, such as a surgical hub 910.
• the communications interface 908 can be configured to allow one-way communication, such as providing data to a remote server (e.g, a cloud server or other server) and/or to a local, surgical hub server, and/or receiving instructions or commands from a remote server and/or a local, surgical hub server, or two-way communication, such as providing information, messages, data, etc. regarding the surgical instrument 900 and/or data stored thereon and receiving instructions, such as from a doctor; a remote server regarding updates to software; a local, surgical hub server regarding updates to software; etc.
• a remote server e.g, a cloud server or other server
• two-way communication such as providing information, messages, data, etc. regarding the surgical instrument 900 and/or data stored thereon and receiving instructions, such as from a doctor; a remote server regarding updates to software
• the surgical instrument 900 is simplified in Figure 20 and can include additional components, e.g., a bus system, a handle, a elongate shaft having an end effector at a distal end thereof, a power source, etc.
• the processor 906 can also be configured to execute instructions stored in the memory 902 to control the device 900 generally, including other electrical components thereof such as the communications interface 908, an audio speaker, a user interface, etc.
• the processor 906 is configured to change at least one variable parameter of the algorithm 904 such that a subsequent execution of the algorithm 904 will be in accordance with the changed at least one variable parameter.
• the processor 906 is configured to modify or update the data point(s) of the at least one variable parameter in the memory 902.
• the processor 906 can be configured to change the at least one variable parameter of the algorithm 904 in real time with use of the surgical device 900 during performance of a surgical procedure, which may accommodate real time conditions.
• the processor 906 can be configured to change the algorithm 904 and/or at least one variable parameter of the algorithm 904 in response to an instruction received from the surgical hub 910.
• the processor 906 is configured to change the at least one variable parameter only after communicating with the surgical hub 910 and receiving an instruction therefrom, which may help ensure coordinated action of the surgical instrument 900 with other aspects of the surgical procedure in which the surgical instrument 900 is being used.
• the processor 906 executes the algorithm 904 to control operation of the surgical instrument 900, changes the at least one variable parameter of the algorithm 904 based on real time data, and executes the algorithm 904 after changing the at least one variable parameter to control operation of the surgical instrument 900.
• Figure 21 illustrates one embodiment of a method 912 of using of the surgical instrument 900 including a change of at least one variable parameter of the algorithm 904.
• the processor 906 controls 914 operation of the surgical instrument 900 by executing the algorithm 904 stored in the memory 902. Based on any of this subsequently known data and/or subsequently gathered data, the processor 904 changes 916 the at least one variable parameter of the algorithm 904 as discussed above. After changing the at least one variable parameter, the processor 906 controls 918 operation of the surgical instrument 900 by executing the algorithm 904, now with the changed at least one variable parameter.
• the processor 904 can change 916 the at least one variable parameter any number of times during performance of a surgical procedure, e.g, zero, one, two, three, etc.
• the surgical instrument 900 can communicate with one or more computer systems, e.g., the surgical hub 910, a remote server such as a cloud server, etc., using the communications interface 908 to provide data thereto and/or receive instructions therefrom.
• one or more computer systems e.g., the surgical hub 910, a remote server such as a cloud server, etc.
• Operation of an intelligent surgical instrument can be altered based on situational awareness of the patient.
• the operation of the intelligent surgical instrument can be altered manually, such as by a user of the intelligent surgical instrument handling the instrument differently, providing a different input to the instrument, ceasing use of the instrument, etc.
• the operation of an intelligent surgical instrument can be changed automatically by an algorithm of the instrument being changed, e.g., by changing at least one variable parameter of the algorithm. As mentioned above, the algorithm can be adjusted automatically without user input requesting the change.
• Automating the adjustment during performance of a surgical procedure may help save time, may allow medical practitioners to focus on other aspects of the surgical procedure, and/or may ease the process of using the surgical instrument for a medical practitioner, which each may improve patient outcomes, such as by avoiding a critical structure, controlling the surgical instrument with consideration of a tissue type the instrument is being used on and/or near, etc.
• the visualization systems described herein can be utilized as part of a situational awareness system that can be embodied or executed by a surgical hub, e.g, the surgical hub 706, the surgical hub 806, or other surgical hub described herein.
• a surgical hub e.g, the surgical hub 706, the surgical hub 806, or other surgical hub described herein.
• characterizing, identifying, and/or visualizing surgical instruments (including their positions, orientations, and actions), tissues, structures, users, and/or other things located within the surgical field or the operating theater can provide contextual data that can be utilized by a situational awareness system to infer various information, such as a type of surgical procedure or a step thereof being performed, a type of tissue(s) and/or structure(s) being manipulated by a surgeon or other medical practitioner, and other information.
• the contextual data can then be utilized by the situational awareness system to provide alerts to a user, suggest subsequent steps or actions for the user to undertake, prepare surgical devices in anticipation for their use (e.g., activate an electrosurgical generator in anticipation of an electrosurgical instrument being utilized in a subsequent step of the surgical procedure, etc.), control operation of intelligent surgical instruments (e.g, customize surgical instrument operational parameters of an algorithm as discussed further below), and so on.
• prepare surgical devices in anticipation for their use e.g., activate an electrosurgical generator in anticipation of an electrosurgical instrument being utilized in a subsequent step of the surgical procedure, etc.
• control operation of intelligent surgical instruments e.g, customize surgical instrument operational parameters of an algorithm as discussed further below
• an intelligent surgical device including an algorithm that responds to sensed data can be an improvement over a “dumb” device that operates without accounting for sensed data
• some sensed data can be incomplete or inconclusive when considered in isolation, e.g, without the context of the type of surgical procedure being performed or the type of tissue that is being operated on.
• the algorithm may control the surgical device incorrectly or sub-optimally given the particular context-free sensed data.
• the optimal manner for an algorithm to control a surgical instrument in response to a particular sensed parameter can vary according to the particular tissue type being operated on.
• the optimal manner in which to control a surgical stapler in response to the surgical stapler sensing an unexpectedly high force to close its end effector will vary depending upon whether the tissue type is susceptible or resistant to tearing.
• the surgical instrument’s control algorithm would optimally ramp down the motor in response to an unexpectedly high force to close to avoid tearing the tissue, e.g., change a variable parameter controlling motor speed or torque so the motor is slower.
• the instrument’s algorithm would optimally ramp up the motor in response to an unexpectedly high force to close to ensure that the end effector is clamped properly on the tissue, e.g., change a variable parameter controlling motor speed or torque so the motor is faster. Without knowing whether lung or stomach tissue has been clamped, the algorithm may be sub- optimally changed or not changed at all.
• a surgical hub can be configured to derive information about a surgical procedure being performed based on data received from various data sources and then control modular devices accordingly.
• the surgical hub can be configured to infer information about the surgical procedure from received data and then control the modular devices operably coupled to the surgical hub based upon the inferred context of the surgical procedure.
• Modular devices can include any surgical device that is controllable by a situational awareness system, such as visualization system devices (e.g, a camera, a display screen, etc.), smart surgical instruments (e.g, an ultrasonic surgical instrument, an electrosurgical instrument, a surgical stapler, smoke evacuators, scopes, etc.).
• a modular device can include sensor(s) configured to detect parameters associated with a patient with which the device is being used and/or associated with the modular device itself.
• the contextual information derived or inferred from the received data can include, for example, a type of surgical procedure being performed, a particular step of the surgical procedure that the surgeon (or other medical practitioner) is performing, a type of tissue being operated on, or a body cavity that is the subject of the surgical procedure.
• the situational awareness system of the surgical hub can be configured to derive the contextual information from the data received from the data sources in a variety of different ways.
• the contextual information received by the situational awareness system of the surgical hub is associated with a particular control adjustment or set of control adjustments for one or more modular devices. The control adjustments each correspond to a variable parameter.
• the situational awareness system includes a pattern recognition system, or machine learning system (e.g., an artificial neural network), that has been trained on training data to correlate various inputs (e.g. , data from databases, patient monitoring devices, and/or modular devices) to corresponding contextual information regarding a surgical procedure.
• a machine learning system can be trained to accurately derive contextual information regarding a surgical procedure from the provided inputs.
• the situational awareness system can include a lookup table storing precharacterized contextual information regarding a surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the contextual information. In response to a query with one or more inputs, the lookup table can return the corresponding contextual information for the situational awareness system for controlling at least one modular device.
• the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices when provided the contextual information as input.
• a surgical hub including a situational awareness system may provide any number of benefits for a surgical system.
• One benefit includes improving the interpretation of sensed and collected data, which would in turn improve the processing accuracy and/or the usage of the data during the course of a surgical procedure.
• Another benefit is that the situational awareness system for the surgical hub may improve surgical procedure outcomes by allowing for adjustment of surgical instruments (and other modular devices) for the particular context of each surgical procedure (such as adjusting to different tissue types) and validating actions during a surgical procedure.
• the situational awareness system may improve surgeon’s and/or other medical practitioners’ efficiency in performing surgical procedures by automatically suggesting next steps, providing data, and adjusting displays and other modular devices in the surgical theater according to the specific context of the procedure.
• Another benefit includes proactively and automatically controlling modular devices according to the particular step of the surgical procedure that is being performed to reduce the number of times that medical practitioners are required to interact with or control the surgical system during the course of a surgical procedure, such as by a situationally aware surgical hub proactively activating a generator to which an RF electrosurgical instrument is connected if it determines that a subsequent step of the procedure requires the use of the instrument. Proactively activating the energy source allows the instrument to be ready for use a soon as the preceding step of the procedure is completed.
• a situationally aware surgical hub can be configured to determine what type of tissue is being operated on. Therefore, when an unexpectedly high force to close a surgical instrument’s end effector is detected, the situationally aware surgical hub can be configured to correctly ramp up or ramp down a motor of the surgical instrument for the type of tissue, e.g, by changing or causing change of at least one variable parameter of an algorithm for the surgical instrument regarding motor speed or torque.
• a type of tissue being operated can affect adjustments that are made to compression rate and load thresholds of a surgical stapler for a particular tissue gap measurement.
• a situationally aware surgical hub can be configured to infer whether a surgical procedure being performed is a thoracic or an abdominal procedure, allowing the surgical hub to determine whether the tissue clamped by an end effector of the surgical stapler is lung tissue (for a thoracic procedure) or stomach tissue (for an abdominal procedure).
• the surgical hub can then be configured to cause adjustment of the compression rate and load thresholds of the surgical stapler appropriately for the type of tissue, e.g, by changing or causing change of at least one variable parameter of an algorithm for the surgical stapler regarding compression rate and load threshold.
• a type of body cavity being operated in during an insufflation procedure can affect the function of a smoke evacuator.
• a situationally aware surgical hub can be configured to determine whether the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type.
• the surgical hub can be configured to control a motor rate of the smoke evacuator appropriately for the body cavity being operated in, e.g, by changing or causing change of at least one variable parameter of an algorithm for the smoke evacuator regarding motor rate.
• a situationally aware surgical hub may provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.
• a type of procedure being performed can affect the optimal energy level for an ultrasonic surgical instrument or radio frequency (RF) electrosurgical instrument to operate at.
• Arthroscopic procedures for example, require higher energy levels because an end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid.
• a situationally aware surgical hub can be configured to determine whether the surgical procedure is an arthroscopic procedure.
• the surgical hub can be configured to adjust an RF power level or an ultrasonic amplitude of the generator (e.g., adjust energy level) to compensate for the fluid filled environment, e.g., by changing or causing change of at least one variable parameter of an algorithm for the instrument and/or a generator regarding energy level.
• a situationally aware surgical hub can be configured to determine what type of surgical procedure is being performed and then customize the energy level for the ultrasonic surgical instrument or RF electrosurgical instrument, respectively, according to the expected tissue profile for the surgical procedure, e.g., by changing or causing change of at least one variable parameter of an algorithm for the instrument and/or a generator regarding energy level.
• a situationally aware surgical hub can be configured to adjust the energy level for the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than just on a procedure-by-procedure basis.
• a situationally aware surgical hub can be configured to determine what step of the surgical procedure is being performed or will subsequently be performed and then update the control algorithm(s) for the generator and/or ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level at a value appropriate for the expected tissue type according to the surgical procedure step.
• a situationally aware surgical hub can be configured to determine whether the current or subsequent step of a surgical procedure requires a different view or degree of magnification on a display according to feature(s) at the surgical site that the surgeon and/or other medical practitioner is expected to need to view.
• the surgical hub can be configured to proactively change the displayed view (supplied by, e.g., an imaging device for a visualization system) accordingly so that the display automatically adjusts throughout the surgical procedure.
• a situationally aware surgical hub can be configured to determine which step of a surgical procedure is being performed or will subsequently be performed and whether particular data or comparisons between data will be required for that step of the surgical procedure.
• the surgical hub can be configured to automatically call up data screens based upon the step of the surgical procedure being performed, without waiting for the surgeon or other medical practitioner to ask for the particular information.
• a situationally aware surgical hub can be configured to determine whether a surgeon and/or other medical practitioner is making an error or otherwise deviating from an expected course of action during the course of a surgical procedure, e.g, as provided in a preoperative surgical plan.
• the surgical hub can be configured to determine a type of surgical procedure being performed, retrieve a corresponding list of steps or order of equipment usage (e.g., from a memory), and then compare the steps being performed or the equipment being used during the course of the surgical procedure to the expected steps or equipment for the type of surgical procedure that the surgical hub determined is being performed.
• the surgical hub can be configured to provide an alert (visual, audible, and/or tactile) indicating that an unexpected action is being performed or an unexpected device is being utilized at the particular step in the surgical procedure.
• operation of a robotic surgical system can be controlled by the surgical hub based on its situational awareness and/or feedback from the components thereof and/or based on information from a cloud (e.g, the cloud 713 of Figure 18).
• a cloud e.g, the cloud 713 of Figure 18
• 16/729,737 entitled “Adaptive Surgical System Control According To Surgical Smoke Cloud Characteristics” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,796 entitled “Adaptive Surgical System Control According To Surgical Smoke Particulate Characteristics” filed Dec. 30, 2019, U.S. Pat. App. No. 16/729,803 entitled “Adaptive Visualization By A Surgical System” filed Dec. 30, 2019, and U.S. Pat. App. No. 16/729,807 entitled “Method Of Using Imaging Devices In Surgery” filed Dec. 30, 2019.
• a lung resection e.g., a lobectomy
• a lung resection is a surgical procedure in which all or part, e.g., one or more lobes, of a lung is removed.
• the purpose of performing a lung resection is to treat a damaged or diseased lung as a result of, for example, lung cancer, emphysema, or bronchiectasis.
• the lung or lungs are first deflated, and thereafter one or more incisions are made on the patient’s side between the patient’s ribs to reach the lungs laparoscopically.
• Surgical instruments such as graspers and a laparoscope, are inserted through the incision.
• the area is dissected from the lung and removed from the one or more incisions.
• the dissected area and the one or more incisions can be closed, for example, with a surgical stapler or stitches.
• the lung since the lung is deflated during surgery, the lung, or certain portions thereof, may need to be mobilized to allow the surgical instruments to reach the surgical site. This mobilization can be carried out by grasping the outer tissue layer of the lung with graspers and applying a force to the lung through the graspers.
• graspers can cut off blood supply to one or more areas of the lung.
• a breathing tube is placed into the patient’s airway to allow each lung to be separately inflated during surgery.
• Inflation of the lung can cause the lung to move and match pre-operative imaging and/or allow the surgeon to check for leaks at the dissected area(s).
• inflating the whole lung working space is lost around the lung due to the filling of the thoracic cavity. Additionally, inflating a whole lung can take time and does not guarantee easy leak detection if multiple portions of the lung are operated on during the surgical procedure.
• Various aspects of the devices, systems, and methods described herein may relate to a surgical procedure performed on a colon.
• surgery is often the main treatment for early-stage colon cancers.
• stage extentent
• Some early colon cancers stage 0 and some early stage I tumors
• most polyps can be removed during a colonoscopy.
• a local excision or colectomy may be required.
• a colectomy is surgery to remove all or part of the colon. In certain instances, nearby lymph nodes are also removed.
• hemicolectomy partial colectomy
• segmental resection in which the surgeon takes out the diseased part of the colon with a small segment of non-diseased colon on either side.
• about one-fourth to one-third of the colon is removed, depending on the size and location of the cancer.
• FIG. 22 Major resections of the colon are illustrated in Figure 22, in which A-B is a right hemicolectomy, A-C is an extended right hemicolectomy, B-C is a transverse colectomy, C-E is a left hemicolectomy, D-E is a sigmoid colectomy, D-F is an anterior resection, D-G is a (ultra) low anterior resection, D-H is an abdomino-perineal resection, A-D is a subtotal colectomy, A-E is a total colectomy, and A-H is a total procto-colectomy.
• a colectomy can be performed through an open colectomy, where a single incision through the abdominal wall is used to access the colon for separation and removal of the affected colon tissue, and through a laparoscopic-assisted colectomy.
• a laparoscopic-assisted colectomy the surgery is done through many smaller incisions with surgical instruments and a laparoscope passing through the small incisions to remove the entire colon or a part thereof.
• the abdomen is inflated with gas, e.g., carbon dioxide, to provide a working space for the surgeon.
• the laparoscope transmits images inside the abdominal cavity, giving the surgeon a magnified view of the patient’s internal organs on a monitor or other display.
• a tumor within the rectum can cause adhesions in the surrounding pelvis, and as a result, this can require freeing the rectal stump and mobilizing the mesentery and blood supply before transection and removal of the tumor.
• multiple graspers are needed to position the tumor for removal from the colon.
• the tumor should be placed under tension, which requires grasping and stretching the surrounding healthy tissue of the colon.
• the manipulating of the tissue surrounding the tumor can suffer from reduced blood flow and trauma due to the graspers placing a high grip force on the tissue.
• the transverse colon and upper descending colon may need to be mobilized to allow the healthy, good remaining colon to be brought down to connect to the rectal stump after the section of the colon containing the tumor is transected and removed.
• Various aspects of the devices, systems, and methods described herein may relate to a surgical procedure performed on a stomach.
• surgery is the most common treatment for stomach cancer.
• the goal is to remove the entire tumor as well as a good margin of healthy stomach tissue around the tumor.
• Different procedures can be used to remove stomach cancer.
• the type of procedure used depends on what part of the stomach the cancer is located and how far it has grown into nearby areas.
• EMR endoscopic mucosal resection
• ESD endoscopic submucosal dissection
• Surgical tools e.g., MEGADYNETM Tissue Dissector or Electrosurgical Pencils
• MEGADYNETM Tissue Dissector or Electrosurgical Pencils are then passed through the working channel of the endoscope to remove the tumor and some layers of the normal stomach wall below and around it.
• a subtotal (partial) or a total gastrectomy that can be performed as an open procedure, e.g, surgical instruments are inserted through a large incision in the skin of the abdomen, or as a laparoscopic procedure, e.g, surgical instruments are inserted into the abdomen through several small cuts.
• a laparoscopic gastrectomy procedure generally involves insufflation of the abdominal cavity with carbon dioxide gas to a pressure of around 15 millimeters of mercury (mm Hg).
• the abdominal wall is pierced and a straight tubular cannula or trocar, such as a cannula or trocar having a diameter in a range of about 5 mm to about 10 mm, is then inserted into the abdominal cavity.
• a laparoscope connected to an operating room monitor is used to visualize the operative field and is placed through one of the trocar(s).
• Laparoscopic surgical instruments are placed through two or more additional cannulas or trocars for manipulation by medical practitioner(s), e.g, surgeon and surgical assistant(s), to remove the desired portion(s) of the stomach.
• laparoscopic and endoscopic cooperative surgery can be used to remove gastric tumors.
• This cooperative surgery typically involves introduction of an endoscope, e.g, a gastroscope, and laparoscopic trocars.
• a laparoscope and tissue manipulation and dissection surgical instruments are introduced through the trocar.
• the tumor location can be identified via the endoscope and a cutting element that is inserted into the working channel of the endoscope is then used for submucosal resection around the tumor.
• a laparoscopic dissection surgical instrument is then used for seromuscular dissection adjacent the tumor margins to create an incision through the stomach wall.
• the tumor is then pivoted through this incision from the intraluminal space, e.g, inside the stomach, to the extraluminal space, e.g, outside of the stomach.
• a laparoscopic surgical instrument e.g, an endocutter, can be used to then complete the transection of the tumor from the stomach wall and seal the incision.
• Surgical Procedures of the Intestine may relate to a surgical procedure performed on an intestine.
• a duodenal mucosal resurfacing (DMR) procedure can be performed endoscopically to treat insulin-resistant metabolic diseases such as type 2 diabetes.
• the DMR procedure can be an effective treatment because it affects detection of food.
• the DMR procedure inhibits duodenum function such that food tends to be sensed deeper in the intestine than normal, e.g, sensed after passage through the duodenum (which is the first part of the small intestine).
• the patient’s body thus senses sugar deeper in the intestine than is typical and thus reacts to the sugar later than is typical such that glycemic control can be improved.
• the irregular function of the duodenum changes the body’s typical response to the food and, through nervous system and chemical signals, causes the body to adapt its response to the glucose level to increase insulin levels.
• the duodenal mucosa is lifted, such as with saline, and then the mucosa is ablated, e.g., using an ablation device advanced into the duodenum through a working channel of an endoscope. Lifting the mucosa before ablation helps protect the duodenum’s outer layers from being damaged by the ablation. After the mucosa is ablated, the mucosa later regenerates.
• ablation devices are NeuWaveTM ablation probes (available from Ethicon US LLC of Cincinnati, OH).
• Another example of an ablation device is the Hyblate catheter ablation probe (available from Hyblate Medical of Misgav, Israel).
• Another example of an ablation device is the BarxxTM HaloFlex (available from Medtronic of Minneapolis, MN).
• FIG. 22A illustrates one embodiment of a DMR procedure.
• a laparoscope 1400 is positioned external to a duodenum 1402 for external visualization of the duodenum 1402.
• An endoscope 1404 is advanced transorally through an esophagus 1406, through a stomach 1408, and into the duodenum 1402 for internal visualization of the duodenum 1402.
• An ablation device 1410 is advanced through a working channel of the endoscope 1404 to extend distally from the endoscope 1404 into the duodenum 1402.
• a balloon 1412 of the ablation device 1410 is shown expanded or inflated in Figure 22A.
• the expanded or inflated balloon 1412 can help center the ablation device’s electrode so even circumferential ablating can occur before the ablation device 1410 is advanced and/or retracted to repeat ablation. Before the mucosa is ablated using the ablation device 1410, the duodenal mucosa is lifted, such as with saline.
• the ablation device 1410 can be expandable/collapsible using an electrode array or basket configured to expand and collapse.
• the laparoscope’s external visualization of the duodenum 1402 can allow for thermal monitoring of the duodenum 1402, which may help ensure that the outer layers of the duodenum 1402 are not damaged by the ablation of the duodenal mucosa, such as by the duodenum being perforated.
• thermal monitoring are discussed further, for example, below and in U.S. Pat. App No. 17/494,364 entitled “Surgical Methods For Control Of One Visualization With Another” filed on October 5, 2021.
• the endoscope 1404 and/or the ablation device 1410 can include a fiducial marker thereon that the laparoscope 1400 can be configured to visualize through the duodenum’s tissue, e.g, by using invisible light, to help determine where the laparoscope 1400 should externally visualize the duodenum 1402 at a location where ablation occurs.
• fiducial markers are discussed further, for example, in U.S. Pat. App No. 17/493,913 entitled “Surgical Methods Using Fiducial Identification And Tracking” filed on October 5, 2021 and in U.S. Pat. App No. 17/494,364 entitled “Surgical Methods For Control Of One Visualization With Another” filed on October 5, 2021.
• tissue often moves and/or changes during a surgical procedure.
• tissue is dynamic.
• the tissue may be distorted, stressed, or become otherwise deformed by a surgical fastening operation.
• the tissue may also be transected and/or certain portions and/or layers of tissue may be removed. Underlying tissue and/or structures may become exposed during the surgical procedure.
• embedded structures underlying the visible tissue and/or hidden tissue margins within an anatomical structure may also move.
• a resection margin may be concentrically positioned around a tumor prior to tissue deformation; however, as the anatomical structure is deformed during a surgical procedure, the resection margin may also become deformed.
• adjacent portions of tissue can shift, including those portions with previously -identified physical characteristics or properties.
• Generating 3D digital representations or models of the tissue as it is deformed, transected, moved, or otherwise changed during a surgical procedure presents various challenges; however, such dynamic visualization imaging may be helpful to a clinician in certain instances.
• an adaptive visualization system can provide visualization of motion at the surgical site. Structured light can be used with stereoscopic imaging sensors and multi-source coherent light to map light pattern distortions from one time frame to another time frame.
• mapping of light pattern distortions across frames can be used to visualize and analyze anatomic distortion.
• any superimposed 3D imaging such as embedded structures, tissue irregularities, and/or hidden boundaries and/or tissue margins, can be proportionately deformed with the 3D model.
• the visualization system can convey movement of the superimposed 3D imaging to a medical practitioner as the tissue is manipulated, e.g., dissected and/or retracted.
• An adaptive visualization system can obtain baseline visualization data based on situational awareness (e.g., input from a situational awareness system).
• a baseline visualization of an anatomical structure and/or surgical site can be obtained before initiation of a surgical procedure, such as before the manipulation and dissection of tissue at the surgical site.
• the baseline visualization image of the anatomical geometry can include a visualization of the surface of the anatomical structure and its boundaries.
• Such a baseline visualization image can be used to preserve overall orientation of the surgical site and anatomic structure even as local regions within the anatomic structure are progressively disrupted, altered, or otherwise manipulated during the surgical procedure. Maintaining the baseline visualization image can allow the disrupted regions to be ignored when mapping other imaging irregularities. For example, when mapping or overlaying structures and/or features obtained by other imaging sources, the baseline visualization image can be used and the distorted regions ignored to appropriately position the additional structures and/or features in the updated visualization image.
• Devices, systems, and methods for multi-source imaging may allow for enhanced 3D surgical visualization.
• the devices, systems, and methods can allow identification and accentuation of anatomical gateways by differentiating tissue planes, localized anomalies, and tissue configuration or composition to enhance a 3D model being used for visualization.
• multiple visualization views can be used to identify, locate, and define boundaries of connective soft tissue planes.
• the defined planes can be related to a structure and role of the tissue. Examples of the structure and role include tissue composition, tumor location, tumor margin identification, adhesions, vascularization, and tissue fragility. Irregularities can be localized and overlaid onto the defined tissue planes on a display. Properties of a displayed tissue plane may be visible on the display, such as by a medical practitioner highlighting or otherwise selecting the tissue plane. Examples of the properties include tissue type, collagen composition, organized versus remodeled disorganized fiber orientation, tissue viability, and tissue health.
• enhanced 3D surgical visualization includes augmenting cooperative imaging resulting from multiple visualization sources, e.g, from a plurality of imaging devices, to form a composite map.
• the composite map can identify localized aspects, markers, or landmarks.
• These enhanced components can be coupled to a surgical procedure plan or global anatomy to identify and highlight aspects of the tissue that correspond to steps in the surgical procedure plan and directions improving visualization during performance of the steps.
• a CT image of a patient can show a tissue plane between tissue segments.
• the CT image can be used to locate or identify the tissue plane and display the tissue plane relative to another image of the patient gathered by an imaging device, such as by overlaying a representation of the tissue plane on the image gathered by the imaging device and shown on the display.
• Figure 23 shows a CT image of a lung with two arrows pointing to an intersegmental plane between segments Si, S 2 , and S 3 .
• Other white lines and areas in the CT image are vessels and airways.
• Figure 24 shows another CT image of the lung with one arrow pointing to an intersegmental plane between segments Si and S 2 .
• Other white lines and areas in the CT image are vessels and airways.
• FIG. 25 illustrates one embodiment of a display showing a thoracoscopic view 1100 provided by a rigid scope and showing a tissue plane 1102.
• a flexible scope 1106 providing a flexible scope view 1108 is visible by the rigid scope and is thus shown in the thoracoscopic view 1100.
• the rigid scope view 1100 also shows first and second surgical instruments 1110, 1112 at the surgical site.
• the surgical instruments 1110, 1112 are each dissectors configured to dissect tissue, e.g., to separate tissue at the tissue plane 1102, for removal of a specimen 1104, such as a tumor, that is also visible in the rigid scope’s view 1100.
• the display also shows a ghosted thoracoscopic view 1114 and a 3D model 1116 showing the thoracoscopic visualization plane 1118 and the flexible scope visualization plane 1120.
• the display also shows the flexible scope view 1108, which is the view seen by the flexible scope 1106.
• the view 1100 provided by the rigid scope is the primary view on the display, as indicated by its size being larger than the flexible scope view 1108. The medical practitioner can switch between which view is the primary view, and thus which is the larger view on the display.
• Figure 26 illustrates another embodiment in which a CT image 1122 is enhanced with an overlay 1124 outlining an identified critical structure, which is a tumor in this example. Images taken over time can be used to develop the overlay 1124, as discussed herein.
• the overlay 1124 allows airways to be distinguished from the critical structure.
• the CT image 1122 shows a lung, but CT images of other anatomic structures can be similarly overlaid. Also images other CT images, such as ultrasound images or MRI images, could similarly have an overlay.
• enhanced 3D surgical visualization includes adaptive differentiation and mapping convergence of a first imaging system via a second imaging system.
• enhanced mapping and guidance can be provided using visualizations of a surgical site from different imaging sources.
• Images gathered by the first imaging system can be enhanced with images from the second imaging system such that the first imaging system is the primary system and the second imaging system is the secondary system.
• the images gathered by the first imaging system can be enhanced by adding information obscured from the first imaging system but visible by the second imaging system and/or by differentiating aspects of the primary imaging for secondary usage.
• the adaptive differentiation and mapping convergence can include progressive flexible scope imaging of the lung’s airways. A front view of lung airways is shown in Figure 27.
• Figure 28 and Figure 29 show one example of a path of advancement for a flexible scope 1130 in a lung.
• progressive imaging of the lung’s internal architecture linked to the scope’s tracked position and orientation can be used, e.g., by a surgical hub or other computer system, to enhance, and confirm or adjust, a CT mapping of the airway routes from a moving or indexing starting point to an intended destination, such as a tumor in the lung.
• a display can show the scope’s progressive advancement along the path of advancement and map (which may include altering) any changes in the CT scanned geometry as the flexible scope 1130 advances.
• the mapping of local adjacent anatomic structures as the flexible scope 1130 is advanced into position may improve detail along the path of advancement, may provide another data point to confirmation of the primary global CT mapping so as to allow more points of fiducial comparison, and/or may allow the medical practitioner controlling the flexible scope 1130 (and/or other medical practitioner) to define desired local nodal dissection (if any) around a tumor margin or within a zone of confirmation that would allow stoppage during the tumor extraction procedure to dissect out the desired nodes since their locations have already been identified and recorded.
• the progressive advancement can be enhanced by a Lidar array.
• the Lidar array allows more precise distance measurement to ultrasound surfaces and thus to the underlying structure.
• Figure 30 illustrates one embodiment of a display of nodes 1132 that may be defined and dissected as desired. Six nodes are shown, but a different number may be present.
• Figure 30 also shows the flexible scope 1130, as a radial endobronchial ultrasound (R-EBUS) probe, in an airway 1134 en route to its intended destination of a tumor 1136. Progressive radial ultrasound achieved using the R-EBUS probe 1130 can be used to facilitate the node 1132 identification and recording.
• R-EBUS radial endobronchial ultrasound
• the R-EBUS probe’s array can be positioned in a radially spinning connection that allows for circumferential scanning of the anatomy below the locally presented bronchial surface of the airway 1134 in which the scope 1130 is positioned, thereby enabling the scope 1130 to detect nodes, tumors, and irregularities in the anatomy as the scope 1130 is advanced in the lung.
• a secondary imaging system using wavelengths outside the visible light range can be used to identify and/or improve visualization features that are obscured from a primary imaging system using visible light and/or to augment the primary imaging system’s information regarding those features.
• a secondary imaging system uses multi-spectral imaging using non-visible light, such as light in infrared (IR) and ultraviolet (UV) spectrums, during a surgical procedure to identify features that are obscured to a primary imaging system using visible light for visualization. Light in the ultraviolet spectrum penetrates tissue poorly but can be helpful in identifying superficial crevices, shapes, and other features.
• Ultraviolet imaging can be performed, for example, using filters on a CMOS array with a UV source coupled to a primary light source or, for another example, using a multi-laser 480 Hz UV, R, G, B, IR imaging system where each spectrum is pulsed separately to create a composite 60 Hz image for display.
• Light in the infrared spectrum penetrates tissue well and can thus be helpful in identifying structure covered by superficial connective tissue, fat, or other thin tissues that prevent visible light imaging from seeing the underlying structure.
• Examples of multi-spectrum imaging such as those that can be used to calculate surface refractivity of tissue to determine the tissue’s composition and irregularities, are further described, for example, in U.S. Pat. Pub. No.
• the features may be obscured (fully or partially) to visible light imaging due to being covered by fluid, being covered by tissue, having a washed out contrast, having a similar color to adjacent structure(s), and/or having a similar reflectivity to adjacent structure(s).
• the secondary imaging may allow for visualization underneath obscuring fluid and/or tissue that visible light visualization cannot provide.
• the secondary imaging improves contrast of the features and may thus help identify features having a washed out contrast, having a similar color to adjacent structure(s), and/or having a similar reflectivity to adjacent structure(s).
• a washed out contrast may exist because a visual light imaging system is typically used with as high a brightness level (brightness intensity) as is possible or tolerable to improve visualization of the surgical site. However, the high brightness level tends to wash out the contrast of instruments and tissues, particularly any tissues directly outside of the focused-on site.
• the secondary information gathered by the secondary imaging system can be provided via overlay on a display showing the primary information gathered by the primary imaging system (or showing a 3D model generated using the primary images), which may allow a medical practitioner to look at one display for complete visualization information and/or may help the medical practitioner make better decisions on the fly regarding navigation, dissection, and/or other procedure steps than would be possible if only the primary imaging was available without the enhancement provided by the secondary imaging.
• the non- visible light can be projected at a different intensity than the visible light and/or can be varied over its exposure to improve resolution of identified contrasts, which may allow a surgical hub, a robotic surgical system, or other computer system (e.g., a controller thereof) to look for contrast separately from the visible light imaging and then overlay the visible and non- visible light imaging. If the surgical hub, robotic surgical system, or other computer system detects a contrast that is irregular or inconsistent, the surgical hub, robotic surgical system, or other computer system can automatically adjust field-programmable gate array (FPGA) isolation of the contrast to enhance it or can automatically adjust the intensity while using the irregular or inconsistent region as a focal guide to adjust contrasting to the portions of the image that are most difficult to contrast.
• FPGA field-programmable gate array
• Figure 31 illustrates one embodiment of a method 1140 of using a primary imaging system utilizing visible light and a secondary imaging system utilizing wavelengths outside the visible light range to identify and/or improve visualization features that are obscured from the primary imaging system.
• a surgical hub, a robotic surgical system, or other computer system determines 1142 that an image of a structure gathered by an imaging device (a scope in this example) of the primary imaging system are blurry or distorted.
• the surgical hub, robotic surgical system, or other computer system calculates f f44 a distance between the scope and the structure. Based on the calculated distance, the surgical hub, robotic surgical system, or other computer system determines 1146 whether the scope is within an optimal working range for visualization.
• the scope can be considered to be outside the optimal working range by being too far away from the structure for optimal non-blurry, non-distorted imaging. If the calculated distance is below a predetermined threshold minimum distance, the scope can be considered to be outside the optimal working range by being too close to the structure for optimal non-blurry, non-distorted imaging.
• the surgical hub, robotic surgical system, or other computer system causes 1148 the Z-axis of the scope to move in or out until the distance is within the optimal working range.
• the surgical hub, robotic surgical system, or other computer system determines 1150 whether an image of the structure gathered by the imaging device, after the causing 1148, is clear. If the image is determined 1150 to be clear, then automatic adjustment of the scope stops 1152 and the surgical procedure continues (invisible to the user).
• the surgical hub, robotic surgical system, or other computer system adjusts 1154 a light source of the primary imaging system and sweeps the Z- axis of the scope in and out within the optimal working range, e.g, to the predetermined maximum threshold distance and predetermined minimum threshold distance. Then, the surgical hub, robotic surgical system, or other computer system then determines 1156 whether an image of the structure gathered by the imaging device, after the adjustment 1154, is clear. If the image is determined 1156 to be clear, then automatic adjustment of the scope stops 1152 and the surgical procedure continues (invisible to the user).
• the surgical hub, robotic surgical system, or other computer system adjusts 1158 a light source of the secondary imaging system and sweeps the Z-axis of the scope in and out within the optimal working range. Then, the surgical hub, robotic surgical system, or other computer system determines 1160 whether an image of the structure gathered by the imaging device, after the adjustment 1158, is clear. If the image is determined 1160 to be clear, then automatic adjustment of the scope stops 1152 and the surgical procedure continues (invisible to the user). If the image is determined 1160 to not be clear, the surgical hub, robotic surgical system, or other computer system calculates 1162 best image settings from the first adjustment 1154 and the second adjustment 1158.
• the surgical hub, robotic surgical system, or other computer system determines 1164 whether an image of the structure gathered by the imaging device, with the calculated 1162 settings set, is clear. If the image is determined 1164 to be clear, then automatic adjustment of the scope stops 1152 and the surgical procedure continues (invisible to the user). If the image is determined 1164 to not be clear, the blurred or distorted image is likely due to fluid or other matter obstructing the scope’s lens. Thus, the surgical hub, robotic surgical system, or other computer system determines 1166 whether scope cleaning technology is installed on the scope.
• scope cleaning technology is determined 1166 to not be installed, the surgical hub, robotic surgical system, or other computer system causes 1168 a user notification, e.g, a visual alert on a display, an audible announcement, etc., to be provided indicating that the scope must be removed and cleaned or be replaced with a different scope.
• a user notification e.g, a visual alert on a display, an audible announcement, etc.
• the surgical hub, robotic surgical system, or other computer system activates 1170 the scope cleaning technology to clean the scope, such as by causing the scope’s lens to be sprayed with cleaning fluid.
• the first adjustment 1154 occurs again and the method 1140 continues as discussed above. If the surgical hub, robotic surgical system, or other computer system determines 1164 a second time that the image is not clear, the method 1140 can continue as discussed above or can instead proceed directly to causing 1168 a user notification since the previous cleaning was unsuccessful.
• the surgical hub, robotic surgical system, or other computer system adjusts 1154 the light source of the primary imaging system and the method 1140 continues as discussed above. If the surgical hub, robotic surgical system, or other computer system determines 1164 a second time that the image is not clear, the method 1140 can continue as discussed above or can instead proceed directly to causing 1168 a user notification since the previous cleaning was unsuccessful.
• local imaging such as multi-spectral light or ultrasound
• 3D constructs, mapping, or CT imaging can be used to adjust 3D constructs, mapping, or CT imaging based on identified deviations from a preoperative surgical plan or a preoperative scan to more up-to-date, higher precision, and/or improved imaging from a local imaging system.
• the local imaging can be used to adjust global imaging (e.g., a preoperative full body CT planned scan) or focused cone-beam CT intraoperative imaging based on changes, deviations, and/or irregularities identified locally using the local imaging.
• Examples of using an independent color cascade of illumination sources including visible light and light outside of the visible range to image one or more tissues within a surgical site at different times and at different depths, and using sequential laser light from differing sources to IR-R-B-G-UV coloration and determining properties of back scattered light and Doppler effect to track moving particles, are further described, for example, in U.S. Pat. Pub. No. 2019/0206050 entitled “Use Of Laser Light And Red-Green-Blue Coloration To Determine Properties Of Back Scattered Light' published July 4, 2019, which is hereby incorporated by reference in its entirety.
• a contrasting agent can be introduced into a patient’s physiologic system to highlight, fluoresce, or contrast anatomic structures intraoperatively.
• Contrast-enhanced ultrasound with microbubbles can be used, such as for blood perfusion in organs, thrombosis (such as in myocardial infraction), abnormalities in the heart, liver masses, kidney masses, inflammatory activity in inflammatory bowel disease, and a chemotherapy treatment response.
• Microbubble contrast materials are tiny bubbles of an injectable gas held in a supporting shell. The microbubble shells dissolve in the patient, usually within a range of about 10 minutes to about 15 minutes, and the gas is removed from the body through exhalation.
• ICG IT fluorescing can be used, such as for fluorescing blood vessels.
• barium sulfide and iodine, such as iodine-containing contrast medium (ICCM) can be used, such as for CT blood vessel imaging.
• ICCM iodine-containing contrast medium
• gadolinium can be used, such as for MRI imaging.
• Figure 32 illustrates one embodiment of a display showing an on-the-fly adaptation of vascular CT with real-time local scanning.
• the display includes a preoperative CT scan 1180 showing anticipated vascular location.
• the display also includes an adaptive real time view 1182 that includes real-time local scanning.
• the adaptive real time view 1182 includes ICG real-time vascular imaging 1184 indicating real-time vascular location overlaid with the relevant area 1186 (shown via a first color dotted line) of the preoperative CT scan 1180 and overlaid with a real time realigned vascular imaging 1188 (shown via a second color dotted line) based on the local imaging 1184 and the preoperative CT scan 1180.
• the overlays are shown with differently colored dotted lines in this illustrated embodiment but can be indicated in other ways, such as by differently styled lines (dotted versus dashed, etc.) of a same color, differently styled lines of different colors, lines of different brightness, etc.
• Devices and systems disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the devices can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the devices, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the devices can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination.
• the devices can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
• reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
• devices disclosed herein be sterilized before use. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).
• a liquid bath e.g., cold soak.
• An exemplary embodiment of sterilizing a device including internal circuitry is described in more detail in U.S. Pat. No. 8,114,345 issued February 14, 2012 and entitled “System And Method Of Sterilizing An Implantable Medical Device.” It is preferred that device, if implanted, is hermetically sealed. This can be done by any number of ways known to those skilled in the art.

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