Patent ID: 12225181

DETAILED DESCRIPTION

Inventive concepts will now be described more fully hereinafter with reference to the accompanying drawings, in which examples of embodiments of inventive concepts are shown. Inventive concepts may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of various present inventive concepts to those skilled in the art. It should also be noted that these embodiments are not mutually exclusive. Components from one embodiment may be tacitly assumed to be present or used in another embodiment.

Various embodiments disclosed herein are directed to improvements in computer assisted navigation during surgery. An extended reality (XR) headset is operatively connected to the surgical system and configured to provide an interactive environment through which a surgeon, assistant, and/or other personnel can view and select among patient images, view and select among computer generated surgery navigation information, and/or control surgical equipment in the operating room. As will be explained below, the XR headset may be configured to augment a real-world scene with computer generated XR images. The XR headset may be configured to provide an augmented reality (AR) viewing environment by displaying the computer generated XR images on a see-through display screen that allows light from the real-world scene to pass therethrough for combined viewing by the user. Alternatively, the XR headset may be configured to provide a virtual reality (VR) viewing environment by preventing or substantially preventing light from the real-world scene from being directly viewed by the user while the user is viewing the computer generated XR images on a display screen. An XR headset can be configured to provide both AR and VR viewing environments. In one embodiment, both AR and VR viewing environments are provided by lateral bands of substantially differing opacity arranged between the see-through display screen and the real-world scene, so that a VR viewing environment is provided for XR images aligned with a high opacity band and an AR viewing environment is provided for XR images aligned with the low opacity band. In another embodiment, both AR and VR viewing environments are provided by computer adjustable control of an opacity filter that variably constrains how much light from the real-world scene passes through a see-through display screen for combining with the XR images viewed by the user. Thus, the XR headset can also be referred to as an AR headset or a VR headset.

FIG.1illustrates an embodiment of a surgical system2according to some embodiments of the present disclosure. Prior to performance of an orthopedic or other surgical procedure, a three-dimensional (“3D”) image scan may be taken of a planned surgical area of a patient using, e.g., the C-Arm imaging device104ofFIG.10or O-Arm imaging device106ofFIG.11, or from another medical imaging device such as a computed tomography (CT) image or MRI. This scan can be taken pre-operatively (e.g. few weeks before procedure, most common) or intra-operatively. However, any known 3D or 2D image scan may be used in accordance with various embodiments of the surgical system2. The image scan is sent to a computer platform in communication with the surgical system2, such as the computer platform910of the surgical system900(FIG.9) which may include the camera tracking system component6, the surgical robot4(e.g., robot2inFIG.1), imaging devices (e.g., C-Arm104, O-Arm106, etc.), and an image database950for storing image scans of patients. A surgeon reviewing the image scan(s) on a display device of the computer platform910(FIG.9) generates a surgical plan defining a target pose for a surgical tool to be used during a surgical procedure on an anatomical structure of the patient. Example surgical tools, also referred to as tools, can include, without limitation, drills, screw drivers, retractors, and implants such as a screws, spacers, interbody fusion devices, plates, rods, etc. In some embodiments, the surgical plan defining the target plane is planned on the 3D image scan displayed on a display device.

As used herein, the term “pose” refers to the position and/or the rotational angle of one object (e.g., dynamic reference array, end effector, surgical tool, anatomical structure, etc.) relative to another object and/or to a defined coordinate system. A pose may therefore be defined based on only the multidimensional position of one object relative to another object and/or to a defined coordinate system, only on the multidimensional rotational angles of the object relative to another object and/or to a defined coordinate system, or on a combination of the multidimensional position and the multidimensional rotational angles. The term “pose” therefore is used to refer to position, rotational angle, or combination thereof.

The surgical system2ofFIG.1can assist surgeons during medical procedures by, for example, holding tools, aligning tools, using tools, guiding tools, and/or positioning tools for use. In some embodiments, surgical system2includes a surgical robot4and a camera tracking system component6. The ability to mechanically couple surgical robot4and camera tracking system component6can allow for surgical system2to maneuver and move as a single unit, and allow surgical system2to have a small footprint in an area, allow easier movement through narrow passages and around turns, and allow storage within a smaller area.

A surgical procedure may begin with the surgical system2moving from medical storage to a medical procedure room. The surgical system2may be maneuvered through doorways, halls, and elevators to reach a medical procedure room. Within the room, the surgical system2may be physically separated into two separate and distinct systems, the surgical robot4and the camera tracking system component6. Surgical robot4may be positioned adjacent the patient at any suitable location to properly assist medical personnel. Camera tracking system component6may be positioned at the base of the patient, at the patient shoulders, or any other location suitable to track the present pose and movement of the pose of tracks portions of the surgical robot4and the patient. Surgical robot4and camera tracking system component6may be powered by an onboard power source and/or plugged into an external wall outlet.

Surgical robot4may be used to assist a surgeon by holding and/or using tools during a medical procedure. To properly utilize and hold tools, surgical robot4may rely on a plurality of motors, computers, and/or actuators to function properly. Illustrated inFIG.1, robot body8may act as the structure in which the plurality of motors, computers, and/or actuators may be secured within surgical robot4. Robot body8may also provide support for robot telescoping support arm16. The size of robot body8may provide a solid platform supporting attached components, and may house, conceal, and protect the plurality of motors, computers, and/or actuators that may operate attached components.

Robot base10may act as a lower support for surgical robot4. In some embodiments, robot base10may support robot body8and may attach robot body8to a plurality of powered wheels12. This attachment to wheels may allow robot body8to move in space efficiently. Robot base10may run the length and width of robot body8. Robot base10may be about two inches to about 10 inches tall. Robot base10may cover, protect, and support powered wheels12.

In some embodiments, as illustrated inFIG.1, at least one powered wheel12may be attached to robot base10. Powered wheels12may attach to robot base10at any location. Each individual powered wheel12may rotate about a vertical axis in any direction. A motor may be disposed above, within, or adjacent to powered wheel12. This motor may allow for surgical system2to maneuver into any location and stabilize and/or level surgical system2. A rod, located within or adjacent to powered wheel12, may be pressed into a surface by the motor. The rod, not pictured, may be made of any suitable metal to lift surgical system2. The rod may lift powered wheel12, which may lift surgical system2, to any height required to level or otherwise fix the orientation of the surgical system2in relation to a patient. The weight of surgical system2, supported through small contact areas by the rod on each wheel, prevents surgical system2from moving during a medical procedure. This rigid positioning may prevent objects and/or people from moving surgical system2by accident.

Moving surgical system2may be facilitated using robot railing14. Robot railing14provides a person with the ability to move surgical system2without grasping robot body8. As illustrated inFIG.1, robot railing14may run the length of robot body8, shorter than robot body8, and/or may run longer the length of robot body8. Robot railing14may further provide protection to robot body8, preventing objects and or personnel from touching, hitting, or bumping into robot body8.

Robot body8may provide support for a Selective Compliance Articulated Robot Arm, hereafter referred to as a “SCARA.” A SCARA24may be beneficial to use within the surgical system2due to the repeatability and compactness of the robotic arm. The compactness of a SCARA may provide additional space within a medical procedure, which may allow medical professionals to perform medical procedures free of excess clutter and confining areas. SCARA24may comprise robot telescoping support16, robot support arm18, and/or robot arm20. Robot telescoping support16may be disposed along robot body8. As illustrated in FIG.1, robot telescoping support16may provide support for the SCARA24and display34. In some embodiments, robot telescoping support16may extend and contract in a vertical direction. The body of robot telescoping support16may be any width and/or height configured to support the stress and weight placed upon it.

In some embodiments, medical personnel may move SCARA24through a command submitted by the medical personnel. The command may originate from input received on display34, a tablet, and/or an XR headset (e.g., headset920inFIG.9) as will be explained in further detail below. The XR headset may eliminate the need for medical personnel to refer to any other display such as the display34or a tablet, which enables the SCARA24to be configured without the display34and/or the tablet. The command may be generated by the depression of a switch and/or the depression of a plurality of switches, and/or may be generated based on a hand gesture command and/or voice command that is sensed by the XR headset as will be explained in further detail below.

As shown inFIG.5, an activation assembly60may include a switch and/or a plurality of switches. The activation assembly60may be operable to transmit a move command to the SCARA24allowing an operator to manually manipulate the SCARA24. When the switch, or plurality of switches, is depressed the medical personnel may have the ability to move SCARA24through applied hand movements. Alternatively or additionally, an operator may control movement of the SCARA24through hand gesture commands and/or voice commands that are sensed by the XR headset as will be explained in further detail below. Additionally, when the SCARA24is not receiving a command to move, the SCARA24may lock in place to prevent accidental movement by personnel and/or other objects. By locking in place, the SCARA24provides a solid platform through which the end effector26can guide a surgical tool during a medical procedure.

Robot support arm18can be connected to robot telescoping support16by various mechanisms. In some embodiments, best seen inFIGS.1and2, robot support arm18rotates in any direction in regard to robot telescoping support16. Robot support arm18may rotate three hundred and sixty degrees around robot telescoping support16. Robot arm20may connect to robot support arm18at any suitable location and by various mechanisms that enable rotation in any direction relative to robot support arm18. In one embodiment, the robot arm20can rotate three hundred and sixty degrees relative to the robot support arm18. This free rotation allows an operator to position robot arm20according to a surgical plan.

The end effector26shown inFIGS.4and5may attach to robot arm20in any suitable location. The end effector26can be configured to attach to an end effector coupler22of the robot arm20positioned by the surgical robot4. The example end effector26includes a tubular guide that guides movement of an inserted surgical tool relative to an anatomical structure on which a surgical procedure is to be performed.

In some embodiments, a dynamic reference array52is attached to the end effector26. Dynamic reference arrays, also referred to as “DRAs” herein, are rigid bodies which may be disposed on an anatomical structure (e.g., bone) of a patient, one or more XR headsets being worn by personnel in the operating room, the end effector, the surgical robot, a surgical tool in a navigated surgical procedure. The computer platform910in combination with the camera tracking system component6or other 3D localization system are configured to track in real-time the pose (e.g., positions and rotational orientations) of the DRA. The DRA can include fiducials, such as the illustrated arrangement of balls. This tracking of 3D coordinates of the DRA can allow the surgical system2to determine the pose of the DRA in any multidimensional space in relation to the target anatomical structure of the patient50inFIG.5.

As illustrated inFIG.1, a light indicator28may be positioned on top of the SCARA24. Light indicator28may illuminate as any type of light to indicate “conditions” in which surgical system2is currently operating. In some embodiments, the light may be produced by LED bulbs, which may form a ring around light indicator28. Light indicator28may comprise a fully permeable material that can let light shine through the entirety of light indicator28. Light indicator28may be attached to lower display support30. Lower display support30, as illustrated inFIG.2may allow an operator to maneuver display34to any suitable location. Lower display support30may attach to light indicator28by any suitable mechanism. In some embodiments, lower display support30may rotate about light indicator28or be rigidly attached thereto. Upper display support32may attach to lower display support30by any suitable mechanism.

In some embodiments, a tablet may be used in conjunction with display34and/or without display34. The tablet may be disposed on upper display support32, in place of display34, and may be removable from upper display support32during a medical operation. In addition the tablet may communicate with display34. The tablet may be able to connect to surgical robot4by any suitable wireless and/or wired connection. In some embodiments, the tablet may be able to program and/or control surgical system2during a medical operation. When controlling surgical system2with the tablet, all input and output commands may be duplicated on display34. The use of a tablet may allow an operator to manipulate surgical robot4without having to move around patient50and/or to surgical robot4.

As will be explained below, in some embodiments a surgeon and/or other personnel can wear XR headsets that may be used in conjunction with display34and/or a tablet or the XR head(s) may eliminate the need for use of the display34and/or tablet.

As illustrated inFIGS.3A and5, camera tracking system component6works in conjunction with surgical robot4through wired or wireless communication networks. Referring toFIGS.1,3and5, camera tracking system component6can include some similar components to the surgical robot4. For example, camera body36may provide the functionality found in robot body8. Robot body8may provide an auxiliary tracking bar upon which cameras46are mounted. The structure within robot body8may also provide support for the electronics, communication devices, and power supplies used to operate camera tracking system component6. Camera body36may be made of the same material as robot body8. Camera tracking system component6may communicate directly to an XR headset, tablet and/or display34by a wireless and/or wired network to enable the XR headset, tablet and/or display34to control the functions of camera tracking system component6.

Camera body36is supported by camera base38. Camera base38may function as robot base10. In the embodiment ofFIG.1, camera base38may be wider than robot base10. The width of camera base38may allow for camera tracking system component6to connect with surgical robot4. As illustrated inFIG.1, the width of camera base38may be large enough to fit outside robot base10. When camera tracking system component6and surgical robot4are connected, the additional width of camera base38may allow surgical system2additional maneuverability and support for surgical system2.

As with robot base10, a plurality of powered wheels12may attach to camera base38. Powered wheel12may allow camera tracking system component6to stabilize and level or set fixed orientation in regards to patient50, similar to the operation of robot base10and powered wheels12. This stabilization may prevent camera tracking system component6from moving during a medical procedure and may keep cameras46on the auxiliary tracking bar from losing track of a DRA connected to an XR headset and/or the surgical robot4, and/or losing track of one or more DRAs52connected to an anatomical structure54and/or tool58within a designated area56as shown inFIGS.3A and5. This stability and maintenance of tracking enhances the ability of surgical robot4to operate effectively with camera tracking system component6. Additionally, the wide camera base38may provide additional support to camera tracking system component6. Specifically, a wide camera base38may prevent camera tracking system component6from tipping over when cameras46is disposed over a patient, as illustrated inFIGS.3A and5.

Camera telescoping support40may support cameras46on the auxiliary tracking bar. In some embodiments, telescoping support40moves cameras46higher or lower in the vertical direction. Camera handle48may be attached to camera telescoping support40at any suitable location and configured to allow an operator to move camera tracking system component6into a planned position before a medical operation. In some embodiments, camera handle48is used to lower and raise camera telescoping support40. Camera handle48may perform the raising and lowering of camera telescoping support40through the depression of a button, switch, lever, and/or any combination thereof.

Lower camera support arm42may attach to camera telescoping support40at any suitable location, in embodiments, as illustrated inFIG.1, lower camera support arm42may rotate three hundred and sixty degrees around telescoping support40. This free rotation may allow an operator to position cameras46in any suitable location. Lower camera support arm42may connect to telescoping support40by any suitable mechanism. Lower camera support arm42may be used to provide support for cameras46. Cameras46may be attached to lower camera support arm42by any suitable mechanism. Cameras46may pivot in any direction at the attachment area between cameras46and lower camera support arm42. In embodiments a curved rail44may be disposed on lower camera support arm42.

Curved rail44may be disposed at any suitable location on lower camera support arm42. As illustrated inFIG.3A, curved rail44may attach to lower camera support arm42by any suitable mechanism. Curved rail44may be of any suitable shape, a suitable shape may be a crescent, circular, oval, elliptical, and/or any combination thereof. Cameras46may be moveably disposed along curved rail44. Cameras46may attach to curved rail44by, for example, rollers, brackets, braces, motors, and/or any combination thereof. Motors and rollers, not illustrated, may be used to move cameras46along curved rail44. As illustrated inFIG.3A, during a medical procedure, if an object prevents cameras46from viewing one or more DRAs being tracked, the motors may responsively move cameras46along curved rail44. This motorized movement may allow cameras46to move to a new position that is no longer obstructed by the object without moving camera tracking system component6. While cameras46is obstructed from viewing one or more tracked DRAs, camera tracking system component6may send a stop signal to a surgical robot4, XR headset, display34, and/or a tablet. The stop signal may prevent SCARA24from moving until cameras46has reacquired tracked DRAs52and/or can warn an operator wearing the XR headset and/or viewing the display34and/or the tablet. This SCARA24can be configured to respond to receipt of a stop signal by stopping further movement of the base and/or end effector coupler22until the camera tracking system can resume tracking of DRAs.

FIGS.3B and3Cillustrate a front view and isometric view of another camera tracking system component6′ which may be used with the surgical system ofFIG.1or may be used independent of a surgical robot. For example, the camera tracking system component6′ may be used for providing navigated surgery without use of robotic guidance. One of the differences between the camera tracking system component6′ ofFIGS.3B and3Cand the camera tracking system component6ofFIG.3A, is that the camera tracking system component6′ ofFIGS.3B and3Cincludes a housing that transports the computer platform910. The computer platform910can be configured to perform camera tracking operations to track DRAs, perform navigated surgery operations that provide surgical navigation information to a display device, e.g., XR headset and/or other display device, and perform other computational operations disclosed herein. The computer platform910can therefore include a navigation computer, such as one or more of the navigation computers ofFIG.14.

FIG.6illustrates a block diagram view of the components of the surgical system ofFIG.5used for the medical operation. Referring toFIG.6, the navigation cameras46on the auxiliary tracking bar has a navigation field-of-view600in which the pose (e.g., position and orientation) of the reference array602attached to the patient, the reference array604attached to the surgical instrument, and the robot arm20are tracked. The navigation cameras46may be part of the camera tracking system component6′ ofFIGS.3B and3C, which includes the computer platform910configured to perform the operations described below. The reference arrays enable tracking by reflecting light in known patterns, which are decoded to determine their respective poses by the tracking subsystem of the surgical robot4. If the line-of-sight between the patient reference array602and the navigation cameras46in the auxiliary tracking bar is blocked (for example, by a medical personnel, instrument, etc.), further navigation of the surgical instrument may not be able to be performed and a responsive notification may temporarily halt further movement of the robot arm20and surgical robot4, display a warning on the display34, and/or provide an audible warning to medical personnel. The display34is accessible to the surgeon610and assistant612but viewing requires a head to be turned away from the patient and for eye focus to be changed to a different distance and location. The navigation software may be controlled by a tech personnel614based on vocal instructions from the surgeon.

FIG.7illustrates various display screens that may be displayed on the display34ofFIGS.5and6by the surgical robot4when using a navigation function of the surgical system2. The display screens can include, without limitation, patient radiographs with overlaid graphical representations of models of instruments that are positioned in the display screens relative to the anatomical structure based on a developed surgical plan and/or based on poses of tracked reference arrays, various user selectable menus for controlling different stages of the surgical procedure and dimension parameters of a virtually projected implant (e.g. length, width, and/or diameter).

For navigated surgery, various processing components (e.g., computer platform910) and associated software described below are provided that enable pre-operatively planning of a surgical procedure, e.g., implant placement, and electronic transfer of the plan to computer platform910to provide navigation information to one or more users during the planned surgical procedure.

For robotic navigation, various processing components (e.g., computer platform910) and associated software described below are provided that enable pre-operatively planning of a surgical procedure, e.g., implant placement, and electronic transfer of the plan to the surgical robot4. The surgical robot4uses the plan to guide the robot arm20and connected end effector26to provide a target pose for a surgical tool relative to a patient anatomical structure for a step of the planned surgical procedure.

Various embodiments below are directed to using one or more XR headsets that can be worn by the surgeon610, the assistant612, and/or other medical personnel to provide an improved user interface for receiving information from and/or providing control commands to the surgical robot, the camera tracking system component6/6′, and/or other medical equipment in the operating room.

FIG.8illustrates a block diagram of some electrical components of the surgical robot4according to some embodiments of the present disclosure. Referring toFIG.8, a load cell (not shown) may be configured to track force applied to end effector coupler22. In some embodiments the load cell may communicate with a plurality of motors850,851,852,853, and/or854. As load cell senses force, information as to the amount of force applied may be distributed from a switch array and/or a plurality of switch arrays to a controller846. Controller846may take the force information from load cell and process it with a switch algorithm. The switch algorithm is used by the controller846to control a motor driver842. The motor driver842controls operation of one or more of the motors850,851,852,853, and854. Motor driver842may direct a specific motor to produce, for example, an equal amount of force measured by load cell through the motor. In some embodiments, the force produced may come from a plurality of motors, e.g.,850-854, as directed by controller846. Additionally, motor driver842may receive input from controller846. Controller846may receive information from load cell as to the direction of force sensed by load cell. Controller846may process this information using a motion controller algorithm. The algorithm may be used to provide information to specific motor drivers842. To replicate the direction of force, controller846may activate and/or deactivate certain motor drivers842. Controller846may control one or more motors, e.g. one or more of850-854, to induce motion of end effector26in the direction of force sensed by load cell. This force-controlled motion may allow an operator to move SCARA24and end effector26effortlessly and/or with very little resistance. Movement of end effector26can be performed to position end effector26in any suitable pose (i.e., location and angular orientation relative to defined three-dimensional (3D) orthogonal reference axes) for use by medical personnel.

Activation assembly60, best illustrated inFIG.5, may form of a bracelet that wraps around end effector coupler22. The activation assembly60may be located on any part of SCARA24, any part of end effector coupler22, may be worn by medical personnel (and communicate wirelessly), and/or any combination thereof. Activation assembly60may comprise of a primary button and a secondary button.

Depressing primary button may allow an operator to move SCARA24and end effector coupler22. According to one embodiment, once set in place, SCARA24and end effector coupler22may not move until an operator programs surgical robot4to move SCARA24and end effector coupler22, or is moved using primary button. In some examples, it may require the depression of at least two non-adjacent primary activation switches before SCARA24and end effector coupler22will respond to operator commands. Depression of at least two primary activation switches may prevent the accidental movement of SCARA24and end effector coupler22during a medical procedure.

Activated by primary button, load cell may measure the force magnitude and/or direction exerted upon end effector coupler22by an operator, i.e. medical personnel. This information may be transferred to one or more motors, e.g. one or more of850-854, within SCARA24that may be used to move SCARA24and end effector coupler22. Information as to the magnitude and direction of force measured by load cell may cause the one or more motors, e.g. one or more of850-854, to move SCARA24and end effector coupler22in the same direction as sensed by the load cell. This force-controlled movement may allow the operator to move SCARA24and end effector coupler22easily and without large amounts of exertion due to the motors moving SCARA24and end effector coupler22at the same time the operator is moving SCARA24and end effector coupler22.

In some examples, a secondary button may be used by an operator as a “selection” device. During a medical operation, surgical robot4may notify medical personnel to certain conditions by the XR headset(s)920, display34and/or light indicator28. The XR headset(s)920are each configured to display images on a see-through display screen to form an extended reality image that is overlaid on real-world objects viewable through the see-through display screen. Medical personnel may be prompted by surgical robot4to select a function, mode, and/or asses the condition of surgical system2. Depressing secondary button a single time may activate certain functions, modes, and/or acknowledge information communicated to medical personnel through the XR headset(s)920, display34and/or light indicator28. Additionally, depressing the secondary button multiple times in rapid succession may activate additional functions, modes, and/or select information communicated to medical personnel through the XR headset(s)920, display34and/or light indicator28.

With further reference toFIG.8, electrical components of the surgical robot4include platform subsystem802, computer subsystem820, motion control subsystem840, and tracking subsystem830. Platform subsystem802includes battery806, power distribution module804, connector panel808, and charging station810. Computer subsystem820includes computer822, display824, and speaker826. Motion control subsystem840includes driver circuit842, motors850,851,852,853,854, stabilizers855,856,857,858, end effector connector844, and controller846. Tracking subsystem830includes position sensor832and camera converter834. Surgical robot4may also include a removable foot pedal880and removable tablet computer890.

Input power is supplied to surgical robot4via a power source which may be provided to power distribution module804. Power distribution module804receives input power and is configured to generate different power supply voltages that are provided to other modules, components, and subsystems of surgical robot4. Power distribution module804may be configured to provide different voltage supplies to connector panel808, which may be provided to other components such as computer822, display824, speaker826, driver842to, for example, power motors850-854and end effector connector844, and provided to camera converter834and other components for surgical robot4. Power distribution module804may also be connected to battery806, which serves as temporary power source in the event that power distribution module804does not receive power from an input power. At other times, power distribution module804may serve to charge battery806.

Connector panel808may serve to connect different devices and components to surgical robot4and/or associated components and modules. Connector panel808may contain one or more ports that receive lines or connections from different components. For example, connector panel808may have a ground terminal port that may ground surgical robot4to other equipment, a port to connect foot pedal880, a port to connect to tracking subsystem830, which may include position sensor832, camera converter834, and DRA tracking cameras870. Connector panel808may also include other ports to allow USB, Ethernet, HDMI communications to other components, such as computer822. In accordance with some embodiments, the connector panel808can include a wired and/or wireless interface for operatively connecting one or more XR headsets920to the tracking subsystem830and/or the computer subsystem820.

Control panel816may provide various buttons or indicators that control operation of surgical robot4and/or provide information from surgical robot4for observation by an operator. For example, control panel816may include buttons to power on or off surgical robot4, lift or lower support16, and lift or lower stabilizers855-858that may be designed to engage powered wheels12(e.g., casters) to lock surgical robot4from physically moving. Other buttons may stop surgical robot4in the event of an emergency, which may remove all motor power and apply mechanical brakes to stop all motion from occurring. Control panel816may also have indicators notifying the operator of certain system conditions such as a line power indicator or status of charge for battery806. In accordance with some embodiments, one or more XR headsets920may communicate, e.g. via the connector panel808, to control operation of the surgical robot4and/or to received and display information generated by surgical robot4for observation by persons wearing the XR headsets920.

Computer822of computer subsystem820includes an operating system and software to operate assigned functions of surgical robot4. Computer822may receive and process information from other components (for example, tracking subsystem830, platform subsystem802, and/or motion control subsystem840) in order to display information to the operator. Further, computer subsystem820may provide output through the speaker826for the operator. The speaker may be part of the surgical robot, part of an XR headset920, or within another component of the surgical system2. The display824may correspond to the display34shown inFIGS.1and2.

Tracking subsystem830may include position sensor832and camera converter834. Tracking subsystem830may correspond to the camera tracking system component6ofFIG.3. The DRA tracking cameras870operate with the position sensor832to determine the pose of DRAs52. This tracking may be conducted in a manner consistent with the present disclosure including the use of infrared or visible light technology that tracks the location of active or passive elements of DRAs52, such as LEDs or reflective markers, respectively.

Functional operations of the tracking subsystem830and the computer subsystem820can be included in the computer platform910, which can be transported by the camera tracking system component6′ ofFIGS.3A and3B. The tracking subsystem830can be configured to determine the poses, e.g., location and angular orientation of the tracked DRAs. The computer platform910can also include a navigation controller that is configured to use the determined poses to provide navigation information to users that guides their movement of tracked tools relative to position-registered patient images and/or tracked anatomical structures during a planned surgical procedure. The computer platform910can display information on the display ofFIGS.3B and3Cand/or to one or more XR headsets920. The computer platform910, when used with a surgical robot, can be configured to communicate with the computer subsystem820and other subsystems ofFIG.8to control movement of the end effector26. For example, as will be explained below the computer platform910can generate a graphical representation of a patient's anatomical structure, surgical tool, user's hand, etc. with a displayed size, shape, color, and/or pose that is controlled based on the determined pose(s) of one or more the tracked DRAs, and which the graphical representation that is displayed can be dynamically modified to track changes in the determined poses over time.

Motion control subsystem840may be configured to physically move support16(e.g., vertical column), upper arm18, lower arm20, or rotate end effector coupler22. The physical movement may be conducted through the use of one or more motors850-854. For example, motor850may be configured to vertically lift or lower support16. Motor851may be configured to laterally move upper arm18around a point of engagement with vertical column16as shown inFIG.2. Motor852may be configured to laterally move lower arm20around a point of engagement with upper arm18as shown inFIG.2. Motors853and854may be configured to move end effector coupler22to provide translational movement and rotation along in about three-dimensional axes. The computer platform910shown inFIG.9can provide control input to the controller846that guides movement of the end effector coupler22to position a passive end effector, which is connected thereto, with a planned pose (i.e., location and angular orientation relative to defined 3D orthogonal reference axes) relative to an anatomical structure that is to be operated on during a planned surgical procedure. Motion control subsystem840may be configured to measure position of the end effector coupler22and/or the end effector26using integrated position sensors (e.g. encoders).

FIG.9illustrates a block diagram of components of a surgical system that includes imaging devices (e.g., C-Arm104, O-Arm106, etc.) connected to a computer platform910which can be operationally connected to a camera tracking system component6(FIG.3A) or6′ (FIGS.3B,3C) and/or to surgical robot4according to some embodiments of the present disclosure. Alternatively, at least some operations disclosed herein as being performed by the computer platform910may additionally or alternatively be performed by components of a surgical system.

Referring toFIG.9, the computer platform910includes a display912, at least one processor circuit914(also referred to as a processor for brevity), at least one memory circuit916(also referred to as a memory for brevity) containing computer readable program code918, and at least one network interface902(also referred to as a network interface for brevity). The display912may be part of an XR headset920in accordance with some embodiments of the present disclosure. The network interface902can be configured to connect to a C-Arm imaging device104inFIG.10, an O-Arm imaging device106inFIG.11, another medical imaging device, an image database950containing patient medical images, components of the surgical robot4, and/or other electronic equipment.

When used with a surgical robot4, the display912may correspond to the display34ofFIG.2and/or the tablet890ofFIG.8and/or the XR headset920that is operatively connected to the surgical robot4, the network interface902may correspond to the platform network interface812ofFIG.8, and the processor914may correspond to the computer822ofFIG.8. The network interface902of the XR headset920may be configured to communicate through a wired network, e.g., thin wire ethernet, and/or through wireless RF transceiver link according to one or more wireless communication protocols, e.g., WLAN, 3GPP 4G and/or 5G (New Radio) cellular communication standards, etc.

The processor914may include one or more data processing circuits, such as a general purpose and/or special purpose processor, e.g., microprocessor and/or digital signal processor. The processor914is configured to execute the computer readable program code918in the memory916to perform operations, which may include some or all of the operations described herein as being performed for surgery planning, navigated surgery, and/or robotic surgery.

The computer platform910can be configured to provide surgery planning functionality. The processor914can operate to display on the display912and/or on the XR headset920an image of an anatomical structure, e.g., vertebra, that is received from one of the imaging devices104and106and/or from the image database950through the network interface902. The processor914receives an operator's definition of where the anatomical structure shown in one or more images is to have a surgical procedure, e.g., screw placement, such as by the operator touch selecting locations on the display912for planned procedures or using a mouse-based cursor to define locations for planned procedures. When the image is displayed in the XR headset920, the XR headset can be configured to sense in gesture-based commands formed by the wearer and/or sense voice based commands spoken by the wearer, which can be used to control selection among menu items and/or control how objects are displayed on the XR headset920as will be explained in further detail below.

The computer platform910can be configured to enable anatomy measurement, which can be particularly useful for knee surgery, like measurement of various angles determining center of hip, center of angles, natural landmarks (e.g. transepicondylar line, Whitesides line, posterior condylar line), etc. Some measurements can be automatic while some others can involve human input or assistance. The computer platform910may be configured to allow an operator to input a choice of the correct implant for a patient, including choice of size and alignment. The computer platform910may be configured to perform automatic or semi-automatic (involving human input) segmentation (image processing) for CT images or other medical images. The surgical plan for a patient may be stored in a cloud-based server, which may correspond to database950, for retrieval by the surgical robot4.

During orthopedic surgery, for example, a surgeon may choose which cut to make (e.g. posterior femur, proximal tibia etc.) using a computer screen (e.g. touchscreen) or extended reality (XR) interaction (e.g., hand gesture based commands and/or voice based commands) via, e.g., the XR headset920. The computer platform910can generate navigation information which provides visual guidance to the surgeon for performing the surgical procedure. When used with the surgical robot4, the computer platform910can provide guidance that allows the surgical robot4to automatically move the end effector26to a target pose so that the surgical tool is aligned with a target location to perform the surgical procedure on an anatomical structure.

In some embodiments, the surgical system900can use two DRAs to track patient anatomy position, such as one connected to patient tibia and one connected to patient femur. The system900may use standard navigated instruments for the registration and checks (e.g. a pointer similar to the one used in Globus ExcelsiusGPS™ system for spine surgery).

A particularly challenging task in navigated surgery is how to plan the position of an implant in spine, knee, and other anatomical structures where surgeons struggle to perform the task on a computer screen which is a 2D representation of the 3D anatomical structure. The system900could address this problem by using the XR headset920to display a three-dimensional (3D) computer generated representations of the anatomical structure and a candidate implant device. The computer generated representations are scaled and posed relative to each other on the display screen under guidance of the computer platform910and which can be manipulated by a surgeon while viewed through the XR headset920. A surgeon may, for example, manipulate the displayed computer-generated representations of the anatomical structure, the implant, a surgical tool, etc., using hand gesture based commands and/or voice based commands that are sensed by the XR headset920.

For example, a surgeon can view a displayed virtual handle on a virtual implant, and can manipulate (e.g., grab and move) the virtual handle to move the virtual implant to a desired pose and adjust a planned implant placement relative to a graphical representation of an anatomical structure. Afterward, during surgery, the computer platform910could display navigation information through the XR headset920that facilitates the surgeon's ability to more accurately follow the surgical plan to insert the implant and/or to perform another surgical procedure on the anatomical structure. When the surgical procedure involves bone removal, the progress of bone removal, e.g., depth of cut, can be displayed in real-time through the XR headset920. Other features that may be displayed through the XR headset920can include, without limitation, gap or ligament balance along a range of joint motion, contact line on the implant along the range of joint motion, ligament tension and/or laxity through color or other graphical renderings, etc.

The computer platform910, in some embodiments, can allow planning for use of standard surgical tools and/or implants, e.g., posterior stabilized implants and cruciate retaining implants, cemented and cementless implants, revision systems for surgeries related to, for example, total or partial knee and/or hip replacement and/or trauma.

An automated imaging system can be used in conjunction with the computer platform910to acquire pre-operative, intra-operative, post-operative, and/or real-time image data of an anatomical structure. Example automated imaging systems are illustrated inFIGS.10and11. In some embodiments, the automated imaging system is a C-arm104(FIG.10) imaging device or an O-Arm®106(FIG.11). (O-Arm® is copyrighted by Medtronic Navigation, Inc. having a place of business in Louisville, Colo., USA). It may be desirable to take x-rays of a patient from a number of different positions, without the need for frequent manual repositioning of the patient which may be required in an x-ray system. C-arm104x-ray diagnostic equipment may solve the problems of frequent manual repositioning and may be well known in the medical art of surgical and other interventional procedures. As illustrated inFIG.10, a C-arm includes an elongated C-shaped member terminating in opposing distal ends112of the “C” shape. C-shaped member is attached to an x-ray source114and an image receptor116. The space within C-arm104of the arm provides room for the physician to attend to the patient substantially free of interference from the x-ray support structure.

The C-arm is mounted to enable rotational movement of the arm in two degrees of freedom, (i.e. about two perpendicular axes in a spherical motion). C-arm is slidably mounted to an x-ray support structure, which allows orbiting rotational movement of the C-arm about its center of curvature, which may permit selective orientation of x-ray source114and image receptor116vertically and/or horizontally. The C-arm may also be laterally rotatable, (i.e. in a perpendicular direction relative to the orbiting direction to enable selectively adjustable positioning of x-ray source114and image receptor116relative to both the width and length of the patient). Spherically rotational aspects of the C-arm apparatus allow physicians to take x-rays of the patient at an optimal angle as determined with respect to the particular anatomical condition being imaged.

The O-Arm®106illustrated inFIG.11includes a gantry housing124which may enclose an image capturing portion, not illustrated. The image capturing portion includes an x-ray source and/or emission portion and an x-ray receiving and/or image receiving portion, which may be disposed about one hundred and eighty degrees from each other and mounted on a rotor (not illustrated) relative to a track of the image capturing portion. The image capturing portion may be operable to rotate three hundred and sixty degrees during image acquisition. The image capturing portion may rotate around a central point and/or axis, allowing image data of the patient to be acquired from multiple directions or in multiple planes.

The O-Arm®106with the gantry housing124has a central opening for positioning around an object to be imaged, a source of radiation that is rotatable around the interior of gantry housing124, which may be adapted to project radiation from a plurality of different projection angles. A detector system is adapted to detect the radiation at each projection angle to acquire object images from multiple projection planes in a quasi-simultaneous manner. The gantry may be attached to a support structure O-Arm® support structure, such as a wheeled mobile cart with wheels, in a cantilevered fashion. A positioning unit translates and/or tilts the gantry to a planned position and orientation, preferably under control of a computerized motion control system. The gantry may include a source and detector disposed opposite one another on the gantry. The source and detector may be secured to a motorized rotor, which may rotate the source and detector around the interior of the gantry in coordination with one another. The source may be pulsed at multiple positions and orientations over a partial and/or full three hundred and sixty degree rotation for multi-planar imaging of a targeted object located inside the gantry. The gantry may further comprise a rail and bearing system for guiding the rotor as it rotates, which may carry the source and detector. Both and/or either O-Arm®106and C-arm104may be used as automated imaging system to scan a patient and send information to the surgical system2.

Images captured by an imaging system can be displayed on the XR headset920and/or another display device of the computer platform910, the surgical robot4, and/or another component of the surgical system900. The XR headset920may be connected to one or more of the imaging devices104and/or106and/or to the image database950, e.g., via the computer platform910, to display images therefrom. A user may provide control inputs through the XR headset920, e.g., gesture and/or voice based commands, to control operation of one or more of the imaging devices104and/or106and/or the image database950.

FIG.12illustrates a block diagram view of the components of a surgical system that include a pair of XR headsets1200and1210(head-mounted displays HMD1and HMD2), which may correspond to the XR headset920shown inFIG.13and operate in accordance with some embodiments of the present disclosure.

Referring to the example scenario ofFIG.12, the assistant612and surgeon610are both wearing the XR headsets1210and1210, respectively. It is optional for the assistant612to wear the XR headset1210. The XR headsets1200and1210are configured to provide an interactive environment through which the wearers can view and interact with information related to a surgical procedure as will be described further below. This interactive XR based environment may eliminate a need for the tech personnel614to be present in the operating room and may eliminate a need for use of the display34shown inFIG.6. Each XR headset1200and1210can include one or more cameras that are be configured to provide an additional source of tracking of DRAs or other reference arrays attached to instruments, an anatomical structure, the end effector26, and/or other equipment. In the example ofFIG.12, XR headset1200has a field-of-view (FOV)1202for tracking DRAs and other objects, XR headset1210has a FOV1212partially overlapping FOV1202for tracking DRAs and other objects, and the navigation cameras46has another FOV600partially overlapping FOVs1202and1212for tracking DRAs and other objects.

If one or more cameras is obstructed from viewing a DRA attached to a tracked object, e.g., a surgical instrument, but the DRA is in view of one or more other cameras the tracking subsystem830and/or navigation controller828can continue to track the object seamlessly without loss of navigation. Additionally, if there is partial occlusion of the DRA from the perspective of one camera, but the entire DRA is visible via multiple camera sources, the tracking inputs of the cameras can be merged to continue navigation of the DRA. One of the XR headsets and/or the navigation cameras46may view and track the DRA on another one of the XR headsets to enable the computer platform910(FIGS.9and14), the tracking subsystem830, and/or another computing component to determine the pose of the DRA relative to one or more defined coordinate systems, e.g., of the XR headsets1200/1210, the navigation cameras46, and/or another coordinate system defined for the patient, table, and/or room.

The XR headsets1200and1210can be operatively connected to view video, pictures, and/or other information received from and/or to provide commands that control various equipment in the surgical room, including but not limited to neuromonitoring, microscopes, video cameras, and anesthesia systems. Data from the various equipment may be processed and displayed within the headset, for example the display of patient vitals or the microscope feed.

Example XR Headset Components and Integration to Navigated Surgery, Surgical Robots, and Other Equipment

FIG.13illustrates an XR headset920which is configured in accordance with some embodiments of the present disclosure. The XR headset includes a headband1306configured to secure the XR headset to a wearer's head, an electronic component enclosure1304supported by the headband1306, and a display screen1302that extends laterally across and downward from the electronic component enclosure1304. The display screen1302may be a see-through LCD display device or a semi-reflective lens that reflects images projected by a display device toward the wearer's eyes.

The display screen1302operates as a see-through display screen, also referred to as a combiner, that reflects light from display panels of a display device toward the user's eyes. The display panels can be located between the electronic component enclosure and the user's head, and angled to project virtual content toward the display screen1302for reflection toward the user's eyes. The display screen1302is semi-transparent and semi-reflective allowing the user to see reflected virtual content superimposed on the user's view of a real-world scene. The display screen1302may have different opacity regions, such as the illustrated upper laterally band which has a higher opacity than the lower laterally band. Opacity of the display screen1302may be electronically controlled to regulate how much light from the real-world scene passes through to the user's eyes. A high opacity configuration of the display screen1302results in high-contrast virtual images overlaid on a dim view of the real-world scene. A low opacity configuration of the display screen1302can result in more faint virtual images overlaid on a clearer view of the real-world scene. The opacity may be controlled by applying an opaque material on a surface of the display screen1302.

According to some embodiments the surgical system includes an XR headset920and an XR headset controller, e.g., controller1430inFIG.14. The XR headset920is configured to be worn by a user during a surgical procedure and has a see-through display screen1302that is configured to display an XR image and to allow at least a portion of a real-world scene to pass therethrough for viewing by the user. The XR headset920also includes an opacity filter positioned between at least one of the user's eyes and the real-world scene when the see-through display screen1302is viewed by the user. The opacity filter is configured to provide opaqueness to light from the real-world scene. The XR headset controller is configured to communicate with a navigation controller, e.g., controller(s)828A,828B, and/or828C inFIG.15, to receive navigation information from the navigation controller which provides guidance to the user during the surgical procedure on an anatomical structure, and is further configured to generate the XR image based on the navigation information for display on the see-through display screen1302.

Opacity of the display screen1302may be configured as a gradient having a more continuously changing opacity with distance downward from a top portion of the display screen1302. The gradient's darkest point can be located at the top portion of the display screen1302, and gradually becoming less opaque further down on the display screen1302until the opacity is transparent or not present. In an example further embodiment, the gradient can change from about 90% opacity to entirely transparent approximately at the mid-eye level of the display screen1302. With the headset properly calibrated and positioned, the mid-eye level can correspond to the point where the user would look straight out, and the end of the gradient would be located at the “horizon” line of the eye. The darker portion of the gradient will allow crisp, clear visuals of the virtual content and help to block the intrusive brightness of the overhead operating room lights.

Variations in opacity can be achieved using an opacity filter1308, which may be integrated into the display screen1302or which may be a separate component that is configured to be positioned in the field of view of a user wearing the XR headset920. Using an opacity filter1308in this manner enables the XR headset920to provide VR capabilities, by substantially or entirely blocking light from the real-world scene, along an upper portion of the display screen1302and to provide AR capabilities along a middle or lower portion of the display screen1302. This allows the user to have the semi-translucence of AR where needed and allowing clear optics of the patient anatomy during procedures. Configuring the opacity filter1308as a gradient instead of as a more constant opacity band can enable the wearer to experience a more natural transition between a more VR type view to a more AR type view without experiencing abrupt changes in brightness of the real-world scene and depth of view that may otherwise strain the eyes such as during more rapid shifting between upward and downward views.

The display panels and display screen1302can be configured to provide a wide field of view see-through XR display system. In one example configuration they provide an 80° diagonal field-of-view (FOV) with 55° of vertical coverage for a user to view virtual content. Other diagonal FOV angles and vertical coverage angles can be provided through different size display panels, different curvature lens, and/or different distances and angular orientations between the display panels and curved display screen1302.

As further shown inFIG.13, an opacity filter1308can be configured as laterally extending bands1310,1312having different light transmissivities. In some embodiments, the XR headset controller is configured to display in a region of the see-through display screen aligned with a first laterally extending band1310of the opacity filter1308at least one of: 2D Axial, Sagittal, and/or Coronal view images of patient anatomy; a planned and/or currently tracked surgical tool pose; graphical model of surgical implant location; video from a medical instrument; and user selectable menu items triggering operations controlling medical equipment. The XR headset controller is further configured to display in another region of the see-through display screen that is aligned with a second laterally extending band1312of the opacity filter1308at least one of: a 3D graphical model of the anatomical structure and surgical planning information; 3D graphical model of a surgical instrument; animated 3D graphical model of a surgical instrument displayed with a pose relative to a graphical model of the anatomical structure that is modified to track in real-time measured poses of the surgical instrument relative to the anatomical structure; and a graphical model of the anatomical structure and the navigation information from the navigation controller which provides visual guidance to the user during the surgical procedure on the anatomical structure. In an alternate embodiment, the opacity filter1308may include a single laterally extending band1310, with the XR headset controller displaying content in another region of the see-through display screen1302that is not aligned with the laterally extending band1310of the opacity filter1308.

It is noted that while an unobstructed view of a prone patient is easily obtained by looking downwards with both the eyes and head, an augmented view of the patient can also be obtained by pitching the head down a bit further to look through the middle lens region.

In this manner the XR headset can be configured to provide the mixed capabilities and benefits of both VR and AR, straddling the VR-AR continuum in such a way as to maximize the utility for applications such as live interoperative surgery. The XR headset provides options for how much contrast is to be provided between displayed AR images (virtual content such as medical imagery) and the real-world scene, by selectively displaying the AR images within the high opacity upper lens region or in the lower opacity middle lens region. The user can make subtle head pitching movement to adjust the various regions relative to the real-world scene, e.g., to obtain an AR image overlay on an anatomical structure and to alternatively obtain an unobstructed view of the anatomical structure. The XR headset920can be configured to identify hand gestures and/or voice commands that control what types of AR content is displayed where on the lens forming the see-through display screen.

In this example, the display screen1302includes an optical combiner1318having an 80° diagonal field of view with a vertical field of view larger than many conventional wide-aspect-ratio designs, which provides many advantages in surgical and other environments. For example, smaller fields of view may force the user to move their head around in order to see significant amount of content, which is not ideal in a surgical setting where surgeon fatigue is known to impact outcomes. The large combiner1318can also act as a blood splatter guard while allowing the wearer to wear their own prescription glasses (or primary eye protection) underneath the display1302.

In this embodiment, the XR headset920ofFIG.13further includes a plurality of cameras1314having different capabilities and functions for providing accurate and precise display of images to a user. The XR headset920includes a frame1350configured to be worn by a user's head.

A stereo camera tracking subassembly1316is provided for tracking surgical instruments, references, robotic end effectors, etc., with accuracy and ergonomic benefits that are not available with conventional general purpose cameras and lenses. The stereo camera tracking subassembly1316includes a pair of high-precision stereo cameras1320. The stereo visible light cameras1320are angled approximately 6° with respect to a horizontal of the tracking subassembly1316(i.e., 12° with respect to each other). This is desirable for accurate tracking of surgical instruments, robotic end effectors and patient references during surgery because the fields of view of the stereo visible light cameras1320converge at the typical distance for the presence of such instruments during surgery. The field of view of the stereo visible light cameras1320is selected to be under 90° in this embodiment for low distortion and high accuracy, while still allowing of an appropriately large stereo tracking frustum as shown inFIGS.18A-18Dfor example.

In this embodiment, the stereo visible light cameras1320track in visible light. This allows the cameras to see tracking markers, the patient, and everything that is going on in the visible surgical field. In this example, the stereo visible light cameras1320do not rely on near infrared (NIR) or other non-visible illumination. The omission of NIR illuminators in this embodiment significantly reduces power consumption, weight, and component cost for the stereo visible light cameras1320, and may improve the appearance of the headset920.

In this example, the stereo visible light cameras1320are mechanically connected via a rigid mounting element1322, e.g., a single carbon fiber tube. The material of the carbon fiber tube1322is very rigid and is relatively insusceptible to thermal expansion, e.g., due to internal heating of the headset920. This rigidity and thermal stability in turn allows for the tracking subassembly1316to better maintain calibration and accuracy. In this example, the stereo visible light cameras1320include a right-side visible light camera1352and a left-side visible light camera1354coupled to the carbon fiber tube1322on opposite sides of the carbon fiber tube1322. The right-side visible light camera1352defines a field of view having a first center in a first direction1356extending away from the frame1350, and the left-side visible light camera1354defines a field of view having a second center in a second direction1358extending away from the frame1350. In this example, the first direction1356and the second direction1358intersect at an intersection point1360within a field of view of the user when the user is wearing the frame1350, and define an angle that is greater than 10 degrees and smaller than 15 degrees (e.g. substantially 12 degrees in this embodiment). In this example, the frame1350also defines a substantially horizontal reference plane1368when the frame1350is being worn by the user, with the first direction1356and the second direction1358being angled downwardly with respect to the horizontal reference plane1368at a downward angle that is greater than 50 degrees and less than 60 degrees (e.g., substantially 55 degrees in this embodiment).

The headset920further includes an NIR camera tracking subassembly1324that includes stereo NIR cameras1326with a much larger (e.g., 180°) field of view, and that substantially includes the stereo visible light cameras1320field of view. In this example, the stereo NIR cameras1326may have a lower resolution than the stereo visible light cameras1320. Each of the stereo NIR cameras1326has at least one NIR LED1328, which can be desynchronized from other tracking apparatuses in the OR as desired, so as not to interfere with such apparatuses, for example. This allows the NIR camera tracking subassembly1324to track hand movement of the surgeon independently of the surgical tool tracking of the visible light tracking subassembly1316. Because the LEDs1328have a relatively low intensity, objects in the field of view that are closer to the LEDs1328, such as a surgeon's hands, are brightly illuminated while objects that are farther away, such as background objects, are dimly illuminated. This allows a surgeon's hands to be brightly illuminated, with high contrast, by the NIR LEDs1328, which in turn allows for more accurate hand tracking by the NIR camera tracking subassembly1324.

In this example, the stereo NIR cameras1326include a right-side NIR camera1362and a left-side NIR camera1364coupled on opposite sides of the carbon fiber tube1322. The stereo NIR cameras1326also include at least one NIR light-emitting diode (LED)1366configured to illuminate a region within a field of view of the stereo NIR cameras1326. In this example the stereo visible light cameras1320and the stereo NIR cameras1326are both configured to capture respective stereoscopic visible light and NIR images within a common field of view of the user when the user is wearing the frame1350. In this example, the stereo visible light cameras1320are configured to capture the stereoscopic visible light images at a first resolution, and the stereo NIR cameras1326are configured to capture the stereoscopic NIR images at a second image resolution less than the first resolution. In this example, the stereo NIR cameras1326each define respective fields of view having centers that extend in directions1357extending away from the frame1350. In this example, the directions1357of the stereo NIR cameras1326intersect at the same intersection point1360within a field of view of the user as the stereo visible light cameras1320, but it should be understood that the directions1357of the stereo NIR cameras1326may converge on a different intersection point, as desired.

In some examples, the separation between the stereo NIR cameras1326may be less than or equal to 96 millimeters, or may be less than or equal to 64 millimeters. as desired. In this example, the stereo NIR cameras1326are separated by approximately 96 millimeters so that the lens1332of the loupe camera1330(described below) does not interfere with the stereo NIR cameras1326or LEDs1328. In this example, the headset920may also include a 6-axis inertial measurement unit (IMU) (not shown) that may include a 3-axis gyroscope and a 3-axis accelerometer. This IMU may allow for 1 kHz low latency head tracking, and may also infer the pitch and roll of external objects relative to a known coordinate system (i.e., gravity). This permits the NIR camera tracking subassembly1324to allow for interaction with virtual (i.e., software) content in a virtual space without breaking sterility. In this manner, the headset920may capture visible light stereoscopic images and NIR stereoscopic images of a scene during a particular time period. Locations of different objects within a three dimensional space may then be determined for the different sets of images.

The headset920further includes a centrally located loupe camera1330having high resolution (e.g., greater than the resolution of the stereo visible light cameras) and color capability, with a relatively low (e.g., 25°) field of view lens1332. This loupe camera1330may provide a digital zoom feature, which is up to 5× magnification in this embodiment. It should also be understood that an optical zoom mechanism may also be used. However, in this embodiment, a digital zoom is used to reduce cost, weight, and mechanical complexity. This loupe camera1330may be used in conjunction with the NIR camera tracking subassembly1324, for example to use hand tracking to pinch and drag digital imagery in and out of the field of view of the loupe camera1330, with color content dynamically zooming and panning on request. In this manner, the need for traditional analog surgical loupes, which require additional heavy and distracting eyewear, is reduced or eliminated.

In this example, all of the headset camera apparatuses, i.e., the stereo cameras1320,1326, and/or loupe camera1330, may be angled downwardly. For example, in this embodiment, the stereo visible light cameras1320may be angled downwardly at an approximate downward angle of 55°. The stereo NIR cameras1326may be angled downwardly with respect to the horizontal reference plane1368at a downward angle that is between 15° and 45° (e.g., substantially 35° in this embodiment). Applicants have recognized through experimentation that this approximate downward angle is advantageous for typical surgical procedures where the patient laying prone on a bed above waist level of the surgeon.

The headset920further includes a tightening wheel1334that allows a rear headset strap1336to be adjusted quickly and comfortably with one hand. The wheel1334in this example is made of a metal, such as steel, and may be heavier than necessary, to allow the wheel1334to act as a weighted counterbalance to balance the headset920on the user's head. Foams1338and/or other comfort elements may be removable for cleaning, sterilization, and/or replacement, and can be customized for different users and/or preferences. In this example, a top portion1340curves back over the head in such a way that the headset920is well supported without the need for a strap connecting the top portion1340to the rear headset strap1336, thereby reducing weight and enhancing comfort for the user's head.

The headset920may include tracking markers1342that may by external cameras for example, for collocating the headset920relative to patient anatomy and surgical equipment. In this example, the tracking markers1342are part of sticker plates1346that may be mounted into recessed and/or keyed locations for increased accuracy. The sticker plates1346may feature different patterns in order to differentiate one headset920from another or to recognize the left side of the headset from the right, for example.

Referring now toFIG.14, an alternative headset1420is illustrated having additional features. In this regard, headset1420includes a connector port1450for attachment of a removable surgical head lamp (not shown) or other electronic device or accessory. The ability to remove this lamp and/or other accessory allows the weight of the headset1420to be reduced for users that do not require an accessory, and also allows users to select from different kinds of lamps and other accessories for different applications. In this example, the connector port includes one or more keyed recesses1452for removably retaining a complementary keyed protrusion of the removable accessory, and one or more electrical contacts for providing power to the accessory and/or for data transfer between the accessory and the headset1430.

The headset1420further includes a plurality of cooling vents1454to facilitate airflow through the headset1420and around the internal electronic components thereof, to prevent overheating. In this example, inlet cooling vents (not shown) may be positioned under the headset and behind the display screen1402. This has the advantage of preventing blood spatter or other fluids or debris from being drawn into the inlet cooling vents during use. An internal fan (not shown) draws air through the headset1420and expels the hot air through the cooling vents1454on top of the headset1420. In this example, the cooling vents1454may include multiple staggered layers, to further reduce ingress of liquids while facilitating airflow. In this example at least one of the layers may be formed from carbon fiber, to further strengthen and stiffen the headset1420while reducing its weight. It should understood, however, that other cooling vent arrangements may be used, and may be positioned with different geometries and airflow patterns, as desired.

FIG.15illustrates electrical components of the XR headset920that can be operatively connected to the computer platform910, to one or more of the imaging devices, such as the C-arm imaging device104, the O-arm imaging device106, and/or the image database950, and/or to the surgical robot800in accordance with various embodiments of the present disclosure.

The XR headset920provides an improved human interface for performing navigated surgical procedures. The XR headset920can be configured to provide functionalities, e.g., via the computer platform910, that include without limitation any one or more of: identification of hand gesture based commands and/or voice based commands, display XR graphical objects on a display device1550. The display device1550may a video projector, flat panel display, etc., which projects the displayed XR graphical objects on the display screen1302. The user can view the XR graphical objects as an overlay anchored to particular real-world objects viewed through the display screen1302(FIG.13). The XR headset920may additionally or alternatively be configured to display on the display device1550video feeds from cameras mounted to one or more XR headsets920and other cameras.

Electrical components of the XR headset920can include a plurality of cameras1540, a microphone1542, a gesture sensor1544, a pose sensor (e.g., inertial measurement unit (IMU))1546, a display module1548containing the display device1550, and a wireless/wired communication interface1552. As will be explained below, the cameras1540of the XR headset may be visible light capturing cameras, near infrared capturing cameras, or a combination of both.

The cameras1540may be configured operate as the gesture sensor1544by capturing for identification user hand gestures performed within the field of view of the camera(s)1540. Alternatively the gesture sensor1544may be a proximity sensor and/or a touch sensor that senses hand gestures performed proximately to the gesture sensor1544and/or senses physical contact, e.g. tapping on the sensor or the enclosure1304. The pose sensor1546, e.g., IMU, may include a multi-axis accelerometer, a tilt sensor, and/or another sensor that can sense rotation and/or acceleration of the XR headset920along one or more defined coordinate axes. Some or all of these electrical components may be contained in the component enclosure1304or may be contained in another enclosure configured to be worn elsewhere, such as on the hip or shoulder.

As explained above, the surgical system2includes a camera tracking system component6/6′ and a tracking subsystem830which may be part of the computer platform910. The surgical system may include imaging devices (e.g., C-arm104, O-arm106, and/or image database950) and/or a surgical robot4. The tracking subsystem830is configured to determine a pose of DRAs attached to an anatomical structure, an end effector, a surgical tool, etc. A navigation controller828is configured to determine a target pose for the surgical tool relative to an anatomical structure based on a surgical plan, e.g., from a surgical planning function performed by the computer platform910ofFIG.9, defining where a surgical procedure is to be performed using the surgical tool on the anatomical structure and based on a pose of the anatomical structure determined by the tracking subsystem830. The navigation controller828may be further configured to generate steering information based on the target pose for the surgical tool, the pose of the anatomical structure, and the pose of the surgical tool and/or the end effector, where the steering information indicates where the surgical tool and/or the end effector of a surgical robot should be moved to perform the surgical plan.

The electrical components of the XR headset920can be operatively connected to the electrical components of the computer platform910through a wired/wireless interface1552. The electrical components of the XR headset920may be operatively connected, e.g., through the computer platform910or directly connected, to various imaging devices, e.g., the C-arm imaging device104, the I/O-arm imaging device106, the image database950, and/or to other medical equipment through the wired/wireless interface1552.

The surgical system2further includes at least one XR headset controller1430(also referred to as “XR headset controller” for brevity) that may reside in the XR headset920, the computer platform910, and/or in another system component connected via wired cables and/or wireless communication links. Various functionality is provided by software executed by the XR headset controller1430. The XR headset controller1430is configured to receive navigation information from the navigation controller828which provides guidance to the user during the surgical procedure on an anatomical structure, and is configured to generate an XR image based on the navigation information for display on the display device1550for projection on the see-through display screen1302.

The configuration of the display device1550relative to the display screen (also referred to as “see-through display screen”)1302is configured to display XR images in a manner such that when the user wearing the XR headset920looks through the display screen1302the XR images appear to be in the real world. The display screen1302can be positioned by the headband1306in front of the user's eyes.

The XR headset controller1430can be within a housing that is configured to be worn on a user's head or elsewhere on the user's body while viewing the display screen1302or may be remotely located from the user viewing the display screen1302while being communicatively connected to the display screen1302. The XR headset controller1430can be configured to operationally process signaling from the cameras1540, the microphone1542, and/or the pose sensor1546, and is connected to display XR images on the display device1550for user viewing on the display screen1302. Thus, the XR headset controller1430illustrated as a circuit block within the XR headset920is to be understood as being operationally connected to other illustrated components of the XR headset920but not necessarily residing within a common housing (e.g., the electronic component enclosure1304ofFIG.13) or being otherwise transportable by the user. For example, the XR headset controller1430may reside within the computer platform910which, in turn, may reside within a housing of the computer tracking system component6′ shown inFIGS.3B and3C.

Example XR Headset Component Optical Arrangement

FIG.16illustrates a block diagram showing an arrangement of optical components of the XR headset920in accordance with some embodiments of the present disclosure. Referring toFIG.16, the display device1550is configured to display XR images1600generated by the XR headset controller1430, light from which is projected by the display device1550as XR images1600toward the display screen1302. The display screen1302is configured to combine light of the XR images1600and light from the real-world scene1602into a combined augmented view1604that is directed to the user's eye(s)1610. The display screen1302configured in this manner operates as a see-through display screen. The XR headset920can include any plural number of navigation cameras1540. The cameras1540may be visible light capturing cameras, near infrared capturing cameras, or a combination of both.

The XR headset operations can display both 2D images and 3D models on the display screen1302. The 2D images may preferably be displayed in a more opaque band of the display screen1302(upper band) and the 3D model may be more preferably displayed in the more transparent band of the display screen1302, otherwise known as the environmental region (bottom band). Below the lower band where the display screen1302ends the wearer has an unobstructed view of the surgical room. It is noted that where XR content is display on the display screen1302may be fluidic. It is possible that where the 3D content is displayed moves to the opaque band depending on the position of the headset relative to the content, and where 2D content is displayed can be placed in the transparent band and stabilized to the real world. Additionally, the entire display screen1302may be darkened under electronic control to convert the headset into virtual reality for surgical planning or completely transparent during the medical procedure. As explained above, the XR headset920and associated

Other types of XR images (virtual content) that can be displayed on the display screen1302can include, but are not limited to any one or more of:1) 2D Axial, Sagittal and/or Coronal views of patient anatomy;2) overlay of planned vs currently tracked tool and surgical implant locations;3) gallery of preoperative images;4) video feeds from microscopes and other similar systems or remote video conferencing;5) options and configuration settings and buttons;6) floating 3D models of patient anatomy with surgical planning information;7) real-time tracking of surgical instruments relative to floating patient anatomy;8) augmented overlay of patient anatomy with instructions and guidance; and9) augmented overlay of surgical equipment.

Referring now toFIGS.17A and17B, a tether pack1750is connected between the headset920and computer platform910. The tether pack1750may provide power and data transfer for the headset920and/or any accessories, such as lamps via a cable apparatus1752. The cable apparatus1752may be detachable or permanently connected, as desired. The tether pack may include a quick-disconnect component1754for quick and safe disconnection from the computer platform, for example, if the cable becomes tangled or caught, thereby reducing the risk of neck strain or injury and/or damage to the headset920if excessive force is applied to the cable. Connection status may be monitored in this example by an LED indicator1756, which may indicate whether the headset920is powered, communicating properly, and/or passing internal diagnostic tests, etc. An input device1758, such as a wheel in this example, may control operation of headset components or accessories, such as lamp brightness for example. As shown inFIG.17B, the tether pack1750may be secured to the user, e.g., on a user's belt using a belt clip1760, to reduce the weight and bulk of the cable with respect to the headset930when moving around a surgical or other environment.

Referring now toFIGS.18A and18B, additional components may be provided in a tethered collar accessory1862, to be worn on around a user's neck, and shoulders to further reduce strain on a user's head and neck. In addition to causing neck strain, excess weight in the headset920can cause skin chafing, sweating, excess heat generation, and general discomfort. However, it is possible to remove many functional components of the headset920from the headset itself while maintaining mobility of the user and headset920. In this example, the displays, cameras and certain sensors (discussed above), such as inertial and other low-latency sensors, remain on the headset920. Other components, such as computing devices, batteries, charging connectors, wireless communication components, audio input and output systems, and/or input devices such as buttons, etc., can be included in the collar accessory1862and may be connected to components of the headset920by a wired tether1864for example. It should be understood that this single tether1864may be disconnected from one or both ends, as desired, for added flexibility in selecting cable length and for simplified repair of damaged cabling. Likewise, different headsets920may be used interchangeably with the collar accessory1862. The collar accessory1862may further reduce headset cable length and, in some embodiments, could provide a docking mechanism the headset920. It should also be understood that the relatively short length and location of the tether1864may also reduce snag hazards while improving signal integrity.

Another benefit of using a separate accessory is that the accessory can be detachable, so that components may be interchangeable and easily replaceable. In this manner, damaged components can be more easily replaced, and different accessories may be swapped out with different components having different functionalities.

The collar accessory1862ofFIGS.18A-18Bmay be worn inside clothing, such as surgical scrubs. Referring now toFIG.19, for example, a member of the surgical staff, e.g., a scrub nurse, could place the collar accessory1862around the back of a user's neck under the user's sterile scrubs. A magnetic latch1966may bind automatically to secure the collar accessory1862around the user's neck and shoulders. The collar accessory1862can then easily be removed by grabbing the back of the collar accessory1862and pulling it free, again without breaking sterility. This functionality may remove the need for a sterile drape or other additional sterility measures during surgery.

In this example, a computer module1968is positioned at the rear of the collar accessory1862and batteries1970are positioned towards the front of the collar accessory1862on either side of the magnetic latch1966. This helps balance the weight distribution of the collar accessory1862, thereby reducing the risk of the collar accessory1862falling off during use. The computer module1968may include a power and data connector1972for removably tethering the collar accessory1862and headset920to a computer platform910for example. Audio systems1974, such as microphones and/or speakers may also be included in the collar accessory1862. The speakers may employ directional audio, or may be incorporated in headset/earbud attachments, etc. as desired. For example, speakers may provide adequate audio performance, even when used through surgical scrub material. For embodiments that use headset or earbuds, the proximity of the collar accessory1862allows for shorter audio cabling, thereby reducing overall weight.

Referring now toFIGS.20A,20B, and21, a belt accessory2062is illustrated. In this embodiment, a single cable tether2064containing display, data and headset power is connected between the headset930and the belt accessory2062. As shown inFIG.21in particular, a belt clip2166may be used to secure the belt accessory2062around a user's waist. Batteries2170are distributed around the belt accessory2062to evenly distribute the weight of the components around the user's waist, and to increase ergonomics and comfort for the user. A computer module2168and power and data connector2172are disposed at a rear of the belt accessory2062. Similar to the collar accessory1862, the belt accessory2062can be worn under surgical scrubs and/or may be sheathed in a sterile drape, as desired, to maintain sterility while allowing adjustment of the belt accessory2062and for external components, such as input devices, LEDs, etc. to be visible and accessible to the user and/or surgical staff.

Further Definitions and Embodiments

In the above-description of various embodiments of present inventive concepts, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of present inventive concepts. Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which present inventive concepts belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense expressly so defined herein.

When an element is referred to as being “connected”, “coupled”, “responsive”, or variants thereof to another element, it can be directly connected, coupled, or responsive to the other element or intervening elements may be present. In contrast, when an element is referred to as being “directly connected”, “directly coupled”, “directly responsive”, or variants thereof to another element, there are no intervening elements present Like numbers refer to like elements throughout. Furthermore, “coupled”, “connected”, “responsive”, or variants thereof as used herein may include wirelessly coupled, connected, or responsive. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. Well-known functions or constructions may not be described in detail for brevity and/or clarity. The term “and/or” includes any and all combinations of one or more of the associated listed items.

It will be understood that although the terms first, second, third, etc. may be used herein to describe various elements/operations, these elements/operations should not be limited by these terms. These terms are only used to distinguish one element/operation from another element/operation. Thus, a first element/operation in some embodiments could be termed a second element/operation in other embodiments without departing from the teachings of present inventive concepts. The same reference numerals or the same reference designators denote the same or similar elements throughout the specification.

As used herein, the terms “comprise”, “comprising”, “comprises”, “include”, “including”, “includes”, “have”, “has”, “having”, or variants thereof are open-ended, and include one or more stated features, integers, elements, steps, components or functions but does not preclude the presence or addition of one or more other features, integers, elements, steps, components, functions or groups thereof. Furthermore, as used herein, the common abbreviation “e.g.”, which derives from the Latin phrase “exempli gratia,” may be used to introduce or specify a general example or examples of a previously mentioned item, and is not intended to be limiting of such item. The common abbreviation “i.e.”, which derives from the Latin phrase “id est,” may be used to specify a particular item from a more general recitation.

Example embodiments are described herein with reference to block diagrams and/or flowchart illustrations of computer-implemented methods, apparatus (systems and/or devices) and/or computer program products. It is understood that a block of the block diagrams and/or flowchart illustrations, and combinations of blocks in the block diagrams and/or flowchart illustrations, can be implemented by computer program instructions that are performed by one or more computer circuits. These computer program instructions may be provided to a processor circuit of a general purpose computer circuit, special purpose computer circuit, and/or other programmable data processing circuit to produce a machine, such that the instructions, which execute via the processor of the computer and/or other programmable data processing apparatus, transform and control transistors, values stored in memory locations, and other hardware components within such circuitry to implement the functions/acts specified in the block diagrams and/or flowchart block or blocks, and thereby create means (functionality) and/or structure for implementing the functions/acts specified in the block diagrams and/or flowchart block(s).

These computer program instructions may also be stored in a tangible computer-readable medium that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture including instructions which implement the functions/acts specified in the block diagrams and/or flowchart block or blocks. Accordingly, embodiments of present inventive concepts may be embodied in hardware and/or in software (including firmware, resident software, micro-code, etc.) that runs on a processor such as a digital signal processor, which may collectively be referred to as “circuitry,” “a module” or variants thereof.

It should also be noted that in some alternate implementations, the functions/acts noted in the blocks may occur out of the order noted in the flowcharts. For example, two blocks shown in succession may in fact be executed substantially concurrently or the blocks may sometimes be executed in the reverse order, depending upon the functionality/acts involved. Moreover, the functionality of a given block of the flowcharts and/or block diagrams may be separated into multiple blocks and/or the functionality of two or more blocks of the flowcharts and/or block diagrams may be at least partially integrated. Finally, other blocks may be added/inserted between the blocks that are illustrated, and/or blocks/operations may be omitted without departing from the scope of inventive concepts. Moreover, although some of the diagrams include arrows on communication paths to show a primary direction of communication, it is to be understood that communication may occur in the opposite direction to the depicted arrows.

Many variations and modifications can be made to the embodiments without substantially departing from the principles of the present inventive concepts. All such variations and modifications are intended to be included herein within the scope of present inventive concepts. Accordingly, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended examples of embodiments are intended to cover all such modifications, enhancements, and other embodiments, which fall within the spirit and scope of present inventive concepts. Thus, to the maximum extent allowed by law, the scope of present inventive concepts are to be determined by the broadest permissible interpretation of the present disclosure including the following examples of embodiments and their equivalents, and shall not be restricted or limited by the foregoing detailed description.