Patent ID: 12193756

DETAILED DESCRIPTION

The following discussion is presented to enable a person skilled in the art to make and use embodiments of the present disclosure. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the principles herein can be applied to other embodiments and applications without departing from embodiments of the present disclosure. Thus, the embodiments are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the embodiments. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the embodiments.

System Overview

The robotic computer system enables real-time surgical navigation using radiological patient images and guides the trajectory of specialized surgical instruments along a surgeon-specified path using a robotic arm. The system software reformats patient-specific CT images acquired before surgery, or fluoroscopic images acquired during surgery, and displays them on screen from a variety of views. Prior to operating, the surgeon may then create, store, access, and simulate trajectories. During surgery, the system guides the instruments to follow the trajectory specified by the user, and tracks the position of surgical instruments in or on the patient anatomy and continuously updates the instrument position on these images. The surgery is performed by the surgeon, using the specialized surgical instruments.

The software can also show how the actual position and path during surgery relate to the pre-surgical plan, and can help guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional and trajectory information obtained through the robotic computer system can serve to validate this judgment. An example robotic computer system that could be used with embodiments herein is the ExcelsiusGPS™ by Globus Medical.

Device Description

The robotic computer system is a Robotic Positioning System that includes a computer controlled robotic arm, hardware, and software that enables real time surgical navigation and robotic guidance using radiological patient images (pre-operative CT, intra-operative CT and fluoroscopy), using a dynamic reference base and positioning camera. The navigation and guidance system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument, including the end-effector of the robotic arm, on the patient images. This visualization can help guide the surgeon's planning and approach. As an aid to visualization, the surgeon can plan implant placement on the patient images prior to surgery. The information of the plan coupled with the registration provides the necessary information to provide visual assistance to the surgeon during free hand navigation or during automatic robotic alignment of the end-effector.

During surgery, the system tracks the position of GPS compatible instruments, including the end-effector of the robotic arm, in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. Standard non-navigated metallic instruments that fit through the guide tube at the selected trajectory may be used without navigation while the guide tube is stationary, for uses such as bone preparation (e.g. rongeurs, reamers etc.) or placing MIS implants (e.g. rod inserters, locking cap drivers) that are not related to screw placement. Navigation can also be performed without guidance. System software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions. robotic computer system surgical instruments are non-sterile, re-usable instruments that can be operated manually or with the use of the positioning system.

Robotic computer system instruments include registration instruments, patient reference instruments, surgical instruments, and end-effectors. Registration instruments incorporate arrays of reflective markers, and are used to track patient anatomy and surgical instruments and implants; components include the verification probe, surveillance marker, surgical instrument arrays, intra-op CT registration fixture, fluoroscopy registration fixture, and dynamic reference base (DRB). Patient reference instruments are either clamped or driven into any appropriate rigid anatomy that is considered safe and provides a point of rigid fixation for the DRB. Surgical instruments are used to prepare the implant site or implant the device, and include awls, drills, drivers, taps, and probes. End-effectors can be wirelessly powered guide tubes that attach to the distal end of the robotic arm and provide a rigid structure for insertion of surgical instruments.

Indications for Use

The robotic computer system is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons for navigating or guiding standard surgical instruments in open or percutaneous procedures. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to a CT-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Contraindications

Medical conditions which contraindicate the use of the robotic computer system and its associated applications include any medical conditions which may contraindicate the medical procedure itself.

Navigation Integrity

The robotic computer system has built-in precautions to support navigation integrity but additional steps should be taken to verify the accuracy of the system during navigation. Specific steps include:

Ensure the stabilizers have been engaged prior to using the robotic arm.

Do not move the dynamic reference base after successful registration.

Use a surveillance marker with every procedure to further confirm the accuracy of the images in relation to real-time patient anatomy.

If a surveillance marker alerts movement of patient relative to the dynamic reference base, perform a landmark check. If a landmark check fails, re-register the patient.

Use a verified navigation instrument to perform an anatomical landmark check prior to a procedure. If a landmark check fails, re-register the patient.

Compliance with Standards

This product conforms to the requirements of council directive 93/42/EEC concerning medical devices, when it bears the CE Mark of Conformity shown below, shown at right.

This product conforms to the requirements of standards listed below when it bears the following NRTL Certification Compliance Mark, shown at right.

Electric and electromagnetic testing have been performed in accordance with the following applicable standards: ANSI/AAMI ES60601-1, CSA C22.2 #60601-1, CISPR 11, IEC 60601-1 (including all national deviations), IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-9, IEC 60601-2-49 (only portions of this standard are used to demonstrate compliance and proper operation of the robotic computer system when used with high frequency surgical equipment such as a cauterizer), IEC 60825-1, IEC 62304, IEC 62366.

HF Surgical Equipment

Based on the robotic computer system floating applied part (type BF) and the safety testing performed, the system is compatible with the use of HF surgical equipment with no restrictions on the conditions of use.

EMC Compliance

In accordance with IEC 60601-1-2:2014 Edition 3 and 4, Medical Electrical Equipment needs special precautions regarding Electro Magnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the tables below. Portable and mobile RF communications equipment can adversely affect electrical medical equipment. The tables supply details about the level of compliance and provide information about potential interactions between devices. EMC Compliance tables from 3rd Edition are shown on the next page with values adjusted for 4th Edition where appropriate.

The robotic computer system has an optional 802.11 g/b/n wireless router and tablet option. When installed, this transmits RF power at 2.4 GHz (2.412-2.484 GHz) using DSSS or OFDM with DQPSK or QAM modulation. Maximum RF transmit power is 100 mW.

Recommended separation distancesSeparation distance according to frequency of transmitter (m)Rated maximum80 MHz to 800800 MHz tooutput power of150 kHz to 80 MHzMHz2.5 GHztransmitter (W)d = 1.2{square root over (P)}d = 1.2{square root over (P)}d = 2.3{square root over (P)}0.010.3*0.3*0.3*0.10.370.370.7411.171.172.33103.693.697.3810011.6711.6723.33*30 cm is the minimum recommended separation distance even though the calculation would yield a shorter distance. For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.NOTE 1:At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Cybersecurity

The robotic computer system adheres to industry best practices and FDA guidance on cybersecurity in medical devices. This includes firewall protection and additional protection against virus, malware, data corruption, and unauthorized system access.

System Overview

The robotic computer system consists of four main components: Robotic Base Station (shown below), Camera Stand (shown below), Instruments, and System Software.FIG.1illustrates a robotic system that includes a robotic base station and a camera stand.

Robotic Base Station

The Robotic Base Station is the main control center for the robotic computer system and includes the components shown below.FIG.2illustrates components of the robotic base station. The robotic base station includes a vertical column206that supports an upper arm200connected to a lower arm202, with a bracelet and end effector204connected to the lower arm202. An information ring220on the vertical column206is illuminated to provide information as described below. A monitor218is connected to the vertical column206. The robotic base station also includes a tablet compartment216, a control panel208, a connector panel210, stabilizers212, and rolling casters214.

Monitor

The monitor allows the surgeon to plan the surgery and visualize anatomical structures, instruments, and implants in real time. It is a high resolution, flat panel touch screen liquid crystal display (LCD) located on the vertical column. The monitor can be adjusted to the desired location with two hands. An external mouse is available for optional use with the monitor. The mouse is not intended for use within the sterile field.FIG.3illustrates the monitor of the robotic base station.

Tablet

An optional wireless tablet is available for use as a second touchscreen monitor for operative planning and software control. The main monitor remains active at all times during use. The user can lockout tablet use if desired. The tablet compartment is used to store the tablet. The tablet is not intended for use within the sterile field.

Control Panel

The control panel is located at the rear of the Robotic Base Station. This panel is used to display and control system power and general positioning functions.FIG.4illustrates the control panel on the rear of the Robotic Base Station and the control panel functions. The control panel includes: emergency stop button190, stabilizers disengage button402, a left position button404, a straight position button406, a right position button408, a vertical column up button410, a vertical column down button412, a dock position button414, a stabilizers engage button416, a battery status indicator418, a power button420, and a line power indicator422.

Control panel functionsButtonFunctionTo UseEmergencyRemoves power from motors andPress down to activate. ToStopapplies brakedeactivate and re-power, twistknob counterclockwise.Line PowerIlluminates when system is pluggedPress to turn ON/OFFIndicatorinto AC power outletPower ButtonPowers the Robotic Base StationPress to turn ON/OFFON/OFF. Illuminated when ON.BatteryIndicates level and state of chargeIndicatorAll bars are illuminated when fullychargedWhen operating on battery, numberof illuminated bars indicates percentof chargeBars progressively illuminate whenchargingStabilizersIlluminates when system is free toPress to disengage the stabilizersDisengagemoveto allow movement of the systemStabilizersIlluminates when system is securedPress to engage the stabilizers, toEngageto floorlock the system in placeLeft PositionMoves upper arm forward and lowerPress and hold button. Operatorarm at a 90° angle to the leftmay release button prior to finalRight PositionMoves upper arm forward and lowerposition and arm will stop inarm at a 90° angle to the right.current position.StraightMoves upper and lower arm forwardStop in current positionPositionDock PositionMoves upper and lower arm to restover the cabinetVerticalMoves vertical column upPress and hold button. OperatorColumn Upshould release button once theVerticalMoves vertical column downdesired height is reached.Column Down

Connector Panel

The connector panel is located at the rear of the Robotic Base Station. This panel contains external connection ports for various devices.FIG.5illustrates the connector panel located at the rear of the Robotic Base Station. The connector panel includes: an equipotential terminal562, a foot pedal connector563, a camera connector port564, an HDMI connector565, an ethernet connector566, and dual USB 3.0 ports567.

Connector panel functionsItemFunctionEquipotential TerminalUsed to connect to other auxiliary equipment; used by servicepersonnelFoot Pedal ConnectorConnects to the foot pedal cableCamera ConnectorConnects to the camera stand cableHDMI ConnectorConnects to an external monitorEthernet ConnectorConnects to a network or intra-operative imaging system forimage transferUSB Port 3.0Connects to a USB device for image transferConnects to C-Arm via video capture supplied with theFluoroscopy Registration Fixture

Casters and Stabilizers

The system consists of four casters with integrated stabilizers. The stabilizers are used to immobilize the system to ensure that it does not move during use.

Upper Arm, Lower Arm, and Vertical Column

The robotic arm, which consists of an upper and lower arm, is attached to the vertical column of the robotic computer system Robotic Base Station. This configuration allows for a wide range of motion.

The robotic computer system employs a state of the art drive control system along with high performance servo drives to accurately position and control the 5-axis robotic arm in an operating room environment.FIG.6illustrates the 5-axis robotic arm. The 5 axes of motion are identified below.

AxisTravel DistanceVertical 670≥480 mmShoulder 672−150° to 180°Elbow 674−150° to 150°Roll 676−135° to 135°Pitch 678−70° to 70°

Bracelet

The bracelet is located at the distal end of the lower arm. It is a load sensing component that allows user guided positioning of the robotic arm.

To initiate motion, squeeze the bracelet ring with the thumb and forefinger on opposite sides. While squeezed, apply light force toward the desired direction of motion. The robotic arm will move in the desired direction. The arm moves manually in any direction or along a trajectory if a screw plan is active.FIG.7illustrates the lower arm which includes a bracelet700and a bracelet ring722.

Information Ring

The information ring is located on the upper part of the vertical column. The information ring indicates the status of the robotic computer system. The information ring light blinks while the system is booting up; a solid green light is displayed when the system is ready. Individual colors are used to indicate status, as shown in the table below.FIG.8illustrates the upper part of the vertical column in which includes an information ring800that is limited to provide information indications to a user.

Information ring color indicationsColorDescriptionRedSystem is in an error state. Stop all tasks andresolve the issue immediately as it is either a safetyissue or a serious problem with the system.YellowSystem is in a state in which user intervention isrequired before a planned trajectory can be activated.GreenSystem is ready.

Camera Stand

The camera stand is mobile and adjusts in order to position the camera to view the operating field and optical markers.FIG.9illustrates the camera stand. The camera stand includes: a camera904; a camera laser alignment light906; a positioning handle908; a support arm910; a height adjustment handle912; a locking handle914; a docking handle916; a release handle918; a cable holder920; legs922; and casters924.FIG.10illustrates the rear view of the camera stand showing alignment buttons. The camera stand further includes a handle tilt button1020and a laser button1022.

Camera stand functionsItemFunctionCameraUsed to detect the reflective markers and is attached tothe top of the camera stand. For more information, pleaserefer to the NDI Passive Polaris Spectra User Guide.PositioningUsed to adjust the camera position to ensure the surgicalHandlefield is in view.Handle TiltUsed to adjust the angle of the positioning handle withButtonrespect to the camera in the field of view.LaserTurns the camera laser alignment light on and off. TheButtonlaser light is used for assistance in aligning the camera inthe field of view.ArmProvides a large range of positions for the camera.HeightAllows for adjustment of camera height.AdjustmentHandleLockingUsed to lock camera position.HandleDockingUsed to collapse the legs for docking the camera standHandleinto the Robotic Base Station.ReleaseReleases the camera from the Robotic Base Station.HandleCastersThe camera stand contains four casters. The rear castersare lockable to prevent the camera stand from moving.LegsThe camera stand legs swing inward for docking andoutward when deployed.CableProvides storage for the camera stand cable.Holder

Cabling

The following cable characteristics are required for connecting to external devices: HDMI—Connecting to an external HDMI Monitor requires a shielded HDMI-Male to HDMI-Male cable.

Network—Connecting to a Hospital network can be done with an unshielded CAT-5e Ethernet cable.

Electronic Components of Surgical Robot

FIG.79illustrates a block diagram of electronic components of a robot500portion of a robot surgical platform which is configured according to embodiments. The robot500can include platform subsystem502, computer subsystem520, motion control subsystem540, and tracking subsystem530. Platform subsystem502can include battery506, power distribution module504, platform network interface512, and tablet charging station510. Computer subsystem520can include computer522, display524, and speaker526. Motion control subsystem540can include driver circuit542, motors550,551,552,553,554, stabilizers555,556,557,558, end-effector544, and controller546(e.g., one or more processors and associated circuitry). Tracking subsystem530can include position sensor532and camera converter534which is connectable to a marker tracking camera570, e.g., via the platform network interface512. Robot500can include a foot pedal580and tablet computer590.

Input power is supplied to robot500via a power source560which may be provided to power distribution module504. Power distribution module504receives input power and is configured to generate different power supply voltages that are provided to other modules, components, and subsystems of robot500. Power distribution module504may be configured to provide different voltage supplies to platform network interface512, which may be provided to other components such as computer520, display524, speaker526, driver542to, for example, power motors550,551,552,553,554and end-effector544, ring514, camera converter534, and other components for robot500for example, fans for cooling the various electrical components.

Power distribution module504may also provide power to other components such as tablet charging station510that may be located within a tablet drawer. Tablet charging station510may be configured to communicate through a wired and/or wireless interface with tablet590. Tablet590may be used to display images and other information for use by surgeons and other users consistent with various embodiments disclosed herein.

Power distribution module504may also be connected to battery506, which serves as a temporary power source in the event that power distribution module504does not receive power from input power560. At other times, power distribution module504may serve to charge battery506when needed.

Other components of platform subsystem502can include connector panel508, control panel516, and ring514. Connector panel508may serve to connect different devices and components to robot500and/or associated components and modules. Connector panel508may contain one or more ports that receive lines or connections from different components. For example, connector panel508may have a ground terminal port that may ground robot500to other equipment, a port to connect foot pedal580to robot500, and/or a port to connect to tracking subsystem530. The tracking subsystem530can include a position sensor532, camera converter534, and the marker tracking camera570which may be supported by a camera stand. Connector panel516can include other ports to allow USB, Ethernet, HDMI communications to other components, such as computer520.

Control panel516may provide various buttons or indicators that control operation of robot500and/or provide information regarding robot500. For example, control panel516may include buttons to power on or off robot500, lift or lower stabilizers555-558that may be designed to engage casters to lock robot500from physically moving and/or to raise and lower the robot base and/or a vertical support for the robot arm. Other buttons may control robot500to stop movement of a robot arm in the event of an emergency, which may remove all motor power and apply mechanical and/or electromechanical brakes to stop all motion from occurring. Control panel516may also have indicators notifying the user of certain system conditions such as a line power indicator or status of charge for battery506.

Ring514may be a visual indicator to notify the user of robot500of different modes that robot500is operating under and certain warnings to the user.

Computer522of the computer subsystem520includes at least one processor circuit (also referred to as a processor for brevity) and at least one memory circuit (also referred to as a memory for brevity) containing computer readable program code. The processor may 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 processor is configured to execute the computer readable program code in the memory circuit to perform operations, which may include some or all of the operations described herein as being performed by a surgical robot and may further perform some or all of the operations described herein as being performed by a surgical implant planning computer.

The program code includes an operating system and software to operate robot500. Computer522may receive and process information from other components (for example, tracking subsystem530, platform subsystem502, and/or motion control subsystem540) in order to display information to the user. Further, computer subsystem520may include speaker526to provide audio notifications from the computer522to the user.

Tracking subsystem530can include position sensor532and camera converter534. The position sensor532may include the marker tracking camera570. Tracking subsystem530may track the location of markers that are located on the different components of robot500and/or instruments used by a user during a surgical procedure. This tracking may be conducted in a manner consistent with the present disclosure which can include the use of infrared technology that illuminates and enables tracking by the camera570of the location of active or passive elements, such as LEDs or reflective markers, respectively. The location, orientation, and position of structures having these types of markers may be provided to computer522which may be shown to a user on display524and/or tablet590. For example, a surgical instrument or other tool having these types of markers and tracked in this manner (which may be referred to as a navigational space) may be shown to a user in relation to a three dimensional image of a patient's anatomical structure, such as a CT image scan, fluoroscopic image, and/or other medical image.

The robot500can include a robot base that is coupled to a robot arm which is movable by the motors, e.g., one or more of motors550-554, relative to the robot base. The robot arm can include an upper arm connected to a vertical support and a lower arm that is rotatably coupled to an end of the upper arm and extends to couple to the end-effector544. Motion control subsystem540may be configured to physically move a vertical column of the robot500, e.g., raise and lower the robot arm and/or the robot base in a vertical direction, move an upper arm of the robot500, move a lower arm of the robot500, and/or rotate the end-effector544. The physical movement may be conducted through the use of one or more motors550-554. For example, motor550may be configured to vertically lift or lower the robot base and/or the robot arm in a vertical direction. Motor551may be configured to laterally move an upper arm around a point of engagement. Motor552may be configured to laterally move a lower arm around a point of engagement with the upper arm. Motors553and554may be configured to move the end-effector544in a manner that controls the roll and/or tilt, thereby providing multiple angles that end-effector544may be moved. These movements may be performed by controller546responsive to commands from the computer522and which may control these movements through load cells disposed on the end-effector544and activated by a user engaging these load cells to move the end-effector544in a desired manner.

The robot500may augment manual input by a user, e.g., when a user applies force to one or more load cells on the end-effector544, and/or provide automatic movement of the robot arm. The robot500may also augment manual movement by a user and/or provide automatic movement of a vertical column of the robot base. For automatic movement, the computer522may respond to receiving input from a user, such as by indicating on display524(which may be a touchscreen input device) the location of a surgical instrument or component on a three dimensional medical image of the patient's anatomy on display524. The computer522can control one or more of the motors550-554to perform automatic movement of the robot arm along a trajectory that has been computed to move the end effector544based on location of the user's input relative to the medical image. The user may initiate automatic movement by stepping on foot pedal580and/or by manipulation of another user interface.

Instruments

End Effector

The end-effector is the interface between the robotic arm and the system specific surgical instruments. It allows for a rigid connection through the sterile drape to provide precise positioning of instruments placed within its guide tube. The end-effector is provided as a separate component and is sterilized by the user prior to use.FIG.11illustrates the isometric and top view of the end-effector1122including a guide tube1122.

The end-effector is powered wirelessly from the robotic arm. This power is used to drive the active markers that are used by the camera to identify the location and orientation of the end-effector. The blue indicator LED illuminates when the end-effector is powered.

Two end-effectors are available to interface with various surgical instruments. They differ only in the diameter of the guide tube; the active markers have the same geometries. The end-effectors are etched with the guide tube diameter and are color-coded to help ensure that the corresponding size instruments are used.

The 15 mm end-effector is used with all navigated instruments except REVOLVE® instruments, and the 17 mm end-effector is used with REVOLVE® instruments. Non-navigated Globus instruments may be used with either end-effector; they are not sized to the guide tube, but must fit within the inner diameter

Instrument Sensing Ring

Located within the guide tube of the end-effector is an instrument sensing ring. A detector circuit is embedded within the sensing ring that detects when a metal instrument is inserted through the guide tube and disables the active markers and prevents movement of the robotic arm. The visible LED on the end-effector does not illuminate when a metallic instrument is inserted, indicating that an instrument is detected and the active IR emitters are disabled. Disabling the IR emitters prevents the robotic arm from moving. Non-metallic instruments are not identified by the sensing ring and may not be used in the guide tube.

Detent Mechanism

Size 15 mm end-effectors have a detent mechanism on the inside of the tube which interfaces with grooves on the array sleeves to resist array rotation. This aids in holding the tracking array oriented toward the camera while the operator rotates the instrument.FIG.12illustrates the detent mechanism120on the instrument sensing ring.

Scalpel

A specialized scalpel can be used to create a skin mark at the planned trajectory. Attach a standard scalpel blade to the handle.

Position the guide tube on the end-effector to the planned trajectory. Adjust the end-effector up or down along the trajectory to allow the scalpel to be viewed. Ensure that scalpel tip can be viewed before making the skin mark.

Note: The scalpel has a metal core within the radiolucent PEEK material and is detected while in the guide tube.FIG.13illustrates a scalpel used through the guide tube.

Cannulas

Cannulas, or dilators, can be used for performing minimally invasive or other techniques that require sequential tissue dilation. The cannulas should only be used under trajectory guidance. Note: The terms “cannula” and “dilator” are used interchangeably.

Prior to performing sequential tissue dilation, a scalpel may be used through the guide tube to create a skin mark at the desired trajectory. Move the guide tube away from the trajectory using the bracelet, and create an incision with a scalpel. Refer to the Scalpel section of this manual for instructions.

Once the guide tube is at the desired trajectory, position the outer cannula under the guide tube and above the incision, along the same trajectory. Insert the two inner cannulas into the guide tube and through the outer cannula, ay rest on the skin. To sequentially dilate the tissue, slowly insert the first (smallest) cannula into the incision using a cannula pusher. Then advance the second cannula in the same manner. Complete tissue dilation by slowly advancing the outer cannula over the inner cannula. Remove the inner cannula. Lower the guide tube until it sits just within the outer cannula. Perform surgery through the guide tube and outer cannula.FIG.14illustrates the trajectory of the outer cannula. Referring toFIG.14, a first inner cannula1400is slid into a second inner cannula1402along trajectory1404into the outer cannula1406which is placed within the incision1408.FIG.15illustrates one technique for dilating tissue with the devices.FIG.15aillustrates how the outer cannula is positioned above the incision.FIG.15billustrates how the cannulas is placed into the guide tube such that it rests on skin.FIG.15cillustrates how the first inner cannula is inserted into the incision.FIG.15dillustrates how the second inner cannula is then inserted into the incision.FIG.15eillustrates how the outer cannula is then inserted into the incision.FIG.15fillustrates both inner cannulas then being removed.FIG.15gillustrates lowering the guide tube until it sits within the outer cannula.

Navigated Instruments

The navigated surgical instruments for use with robotic computer system include drills, awls, probes, taps, and drivers, which may be used to insert Globus screws. These instruments can be used with arrays if navigation is desired, or without arrays if navigation is not used. Each instrument and corresponding array must be assembled prior to use. Instruments are identified by a unique array pattern that is recognized by the camera.

Navigated instruments are available for each Globus implant system. Refer to the specific system instrument brochures for more information.FIG.16illustrate some embodiments of the navigated instruments. The instruments include an awl1600, a probe1602, a drill1604, a tap1606, and a driver1608.

Arrays

Arrays have 4 posts for attaching reflective markers and are available for use with the surgical instruments. The navigated surgical instruments are assembled to a corresponding instrument array, designed with a unique marker pattern which identifies the instrument type. The array is etched with the specific instrument type, e.g. “AWL”, “PROBE”, “DRILL”, “TAP”, “DRIVER”. Each instrument array has a verification divot, used for instrument verification.

The verification probe has a built-in array with posts for the reflective markers and is used to verify each instrument before use.

Arrays used with instruments for the standard 15 mm end-effector are identified by a black sleeve. Arrays used with instruments for the 17 mm end-effector are identified by a tan sleeve.FIG.17illustrates the array1700with a release button1702, a handgrip1704, a marker post1706, an array sleeve1708, and array support1710.FIG.17also illustrates a verification divot1712between the array1700and the handgrip1704.FIG.18illustrates the verification probe.

Patient Attachment Instruments

Patient attachment instruments are secured to the patient's rigid anatomy, depending on the specific surgical procedure or preference, and are available in various configurations. These instruments may be secured to a variety of anatomical sites. The rod attachment instrument is designed to attach to an existing spinal rod.

Patient attachment instruments must be safely and rigidly secured to the patient to achieve navigation and guidance accuracy. Verify secure attachment by applying a light force to the distal end of the attachment instrument in all directions. If secure attachment is not maintained during the procedure, the surveillance marker will demonstrate excessive movement; if this occurs, reposition the patient attachment instrument and re-register the patient to the patient images.

Refer to the specific procedure in the Application section for recommended anatomical locations.FIG.19illustrates the patient attachment instruments, which include a bone clamp1900with surveillance marker, a quattro spike1902, a low profile quattro spike1904, and a rod attachment1906.

Bone Clamps

Bone clamps are clamped onto anatomical structures such as the spinous process, iliac crest, long bone, or any rigid bony structure that can be safely clamped.

The bone clamp is placed onto rigid bony anatomy. The clamp driver is used to tighten the bone clamp. To remove, loosen the bone clamp with the clamp driver, attach the removal tool and lift up the bone clamp.FIG.20illustrates tightening bone clamp using clamp driver.

Quattro Spikes

Quattro spikes are inserted into rigid bone of the iliac crest or long bone. The quattro spike is inserted into rigid bony anatomy and gently impacted with a mallet.

The low profile quattro spike is inserted using a guide post and impaction cap. Find the desired anatomy using the guide post. Place the patient attachment instrument over the guide post. Attach the impaction cap (for low profile quattro spike). Gently impact the assembly with a mallet to insert into bony anatomy. Remove the impaction cap and guide post from the spike.FIG.21illustrates the guide post2100and the quattro spike2102.FIG.22illustrates one method for inserting the quattro spike into rigid bony anatomy.FIG.22(a)illustrates positioning the quattro spike over the guide post.FIG.22(b)illustrates attaching the impaction cap.FIG.22(c)illustrates inserting the assembly into a rigid anatomy.FIG.22(d)illustrates removing the cap and guide pose.

Rod Attachment Instrument

The rod attachment instrument is designed to attach to an existing spinal rod (4.5 mm to 6.35 mm diameter). Position the instrument on the existing spinal rod and tighten the set screw with a driver. Ensure a rigid connection. To remove, loosen the set screw and disengage from the rod.FIG.23illustrates the rod attachment instrument2300including a set screw2302, which are attached to the existing spinal rod.

Surveillance Marker

FIG.24illustrates a surveillance marker. The surveillance marker is a single reflective marker used to monitor a shift in the Dynamic Reference Base (DRB). Surveillance markers may be used alone or in conjunction with a bone clamp.

Surveillance markers are directly inserted into the iliac crest or long bone, or may be attached to the spinous process using a bone clamp.FIG.25illustrates the use of a surveillance marker with a bone clamp. To use a bone clamp with the marker, attach a disposable surveillance marker240onto the tip of the bone clamp. Use the clamp driver to secure the bone clamp. Verify that the bone clamp is rigidly secured.

Registration Instruments

The Dynamic Reference Base (DRB) and patient attachment instruments are used in the patient registration process.

The DRB is an array with 4 posts for reflective markers and allows the camera to track the location of the patient. The DRB may be attached to any of the patient attachment instruments, using the knob and compression clamp.FIG.26illustrates the dynamic reference base, which includes marker posts2600connected to a compression clamp2602operated by a DRB knob2604.

Registration Fixtures

Intra-Op Ct Registration Fixture

The intra-op CT registration fixture, consisting of a registration fixture and pivoting arm, allows for any intra-operative CT image to be used with the robotic computer system software application. The pivoting arm and registration fixture are assembled prior to use by matching the starburst gears and snapping the two components together.

The intra-op registration fixture is placed onto a patient attachment instrument by clamping the compression clamp onto the shaft of the attachment instrument, allowing the fixture to hover over the surgical site. The fiducials are detected automatically in the intra-operative scan and are used to register the patient's anatomy during the scan to the DRB, which is tracked by the camera throughout the procedure. The reflective markers are detected by the camera. Once the registration is transferred to the DRB, the intra-op registration fixture is removed to provide access to the surgical site.FIG.27illustrates the intra-op registration fixture2712and pivoting arm2708.FIG.27further illustrates the compression clamp2602, the DRB knob2604, a starburst connection2406, a gear tooth joint2710, and a set of seven fiducials2714.

Fluoroscopy Registration Fixture

FIG.28illustrates the Fluoroscopy Registration Fixture. The Fluoroscopy Registration Fixture allows for any intra-operative fluoroscopic image to be used with the robotic computer system software application. The fluoroscopy fixture is attached to the image intensifier of the fluoroscope using the integrated clamps. The fluoroscope and Fluoroscopy Registration Fixture are draped and the reflective markers are placed on the fixture, outside of the drape. The fixture should be positioned such that the reflective markers are seen by the camera in all intended fluoroscope positions (AP, lateral, etc).

Robotic Arm Motion

The robotic computer system robotic arm positions the end-effector to guide instruments for screw insertion at the desired trajectory. The surgeon manually performs surgery while the instruments are aligned in the desired trajectory for accurate screw placement. Note: The terms “screw plan”, “screw trajectory” and “trajectory” are used interchangeably in this manual.

Motion of the robotic arm is only allowed with continuous pressing of the bracelet or foot pedal. The arm is manually moved by the user in Wrist mode, or is automatically moved to the selected trajectory in Trajectory mode.

In Wrist mode, the arm may be moved manually to any position within reach of the arm.

In Trajectory mode, the arm is automatically moved from the current position to the next screw plan when ready, or may be moved manually along a selected trajectory.

When moving from one screw plan to the next, the arm moves outwards along the current trajectory to a safe distance (200 mm) from the surgical site before moving to the new trajectory and downwards along the current trajectory to the anatomy.

Robotic arm motion modesModeSoftwareUser ActionAutomatic MotionManual MotionWrist ModeNo Plan SelectedPress Footn/aUser may movePedal orarm in theSqueeze Braceletdesired directionTrajectory modePlan SelectedPress Foot PedalArm movesAfter reaching theorautomatically totrajectory, user maySqueeze Braceletnew screw trajectorymove arm alongtrajectory only

Automatic motion of the arm occurs when moving the guide tube from the current position (either initially or at a current trajectory) to a new screw plan. Once the end-effector and attached guide tube have moved to a new screw plan, the guide tube is locked onto the trajectory and can be moved up and down along the trajectory.FIG.29illustrates the end effector motion when moving from one trajectory to the next, wherein 1, 2, and 3 are automatic movements; 4 is manual and optional. The illustrated movements include movement up along path2902from a starting position2900to clear the screw and patient, movement along a new trajectory path2904, movement downward to a safe starting position along path2906, and an optional movement along a trajectory path2908that may involve manual movement.

Automatic motion of the robotic arm may be stopped by the user, stopped by the system, or prevented.

To stop motion at any time, press the Emergency Stop button located on the base station.

Motion is stopped if the end-effector detects a force greater than 50N (111bs).

Motion is also stopped in Trajectory mode when the DRB or the end-effector is not in view of the camera.

Motion is prevented when the sensing ring in the guide tube detects a metallic instrument.

When a trajectory is selected, motion of the arm with guide tube is only allowed along the trajectory.

Stopping or preventing robotic arm motionMethodEmergency Stop button pressedEnd Effector detects force on arm greater than 50 N (11 lbs)Dynamic reference base not in view of camera (Trajectory modeonly)End Effector not in view of camera (Trajectory mode only)Sensing ring detects a metallic instrument in the guide tube

If the robot arm is not able to reach to a safe starting location due to its current position, an error message is shown. The message states “The arm cannot move back any further along the current end-effector trajectory. Acknowledging this message enables the arm to move to the selected plan trajectory from its current position”. The user may choose to move forward with the planned trajectory because the shorter starting position is acceptable. If the shorter starting position is not acceptable, a new trajectory must be used or the base must be repositioned.

To select a new trajectory, the user clears the selected trajectory and positions the robotic arm using the bracelet to a clear position. The bracelet provides flexibility for the user to move the arm around an obstacle.

To reposition the base, the stabilizers on the casters are disengaged, the station is moved to the desired location and the stabilizers are reengaged. Registration is unaffected because the patient reference (attachment instruments and DRB) has not moved with respect to the patient.

System Software

The system software is responsible for all motion control functions, navigation functions, data storage, network connectivity, user management, case management, and safety functions.

The top navigation bar takes the user through individual screens for each step of the procedure.

The respective tab for each step is highlighted when selected and the corresponding screen displayed. The activities performed under each tab are shown in the table below.

System software tabsTabMeaningConfigureSurgeon, imaging workflow, and anatomy selectionPreplanImplant system selection and desired anatomical locationidentificationVerifyNavigated instrument verificationImageLoading of patient images used for planning and navigationPlanEstimation of desired implant location with respect topatient imagesNavigateScrew plan with real-time display of navigated instrumentand implant (actual plan) with respect to patient images

System Setup

Power Up

FIG.30illustrates the power button3000, line power indicator3002and battery indicator3004. Press the Power Button3000on the control panel to turn the system on. The Power Button3000is illuminated when the system is on.

Undocking and Positioning Camera Stand

To release the camera stand from the Robotic Base Station, unwrap the cord holding the monitor arm and the camera arm together, and pull up on the release handle located on the camera stand. Once the legs of the camera stand have cleared the base station, they will automatically release and move outward.FIG.31illustrates the camera stand undocking.FIG.31(a)illustrates pulling up on the release handle located on the camera stand.FIG.31(b)illustrates clearing the legs of the camera stand legs automatically releasing and moving outward.

Unwrap the camera cord from the cord holder and plug into the connector panel on the base station.

Move the camera to the operating room (O.R.) table and engage the wheel brakes by stepping on the lever located on the wheel.

Align the camera to view the surgical field.

FIG.32illustrates the connection of the camera to the connector panel on the base station.FIG.33illustrates the camera positioning.

Press and hold the laser button located on the positioning handle of the camera to activate the camera's alignment laser and adjust the position so the laser points to the center of the surgical field.FIG.34illustrates pressing the laser button3400to activate a laser which facilitates user alignment of the camera.

Draping

A special surgical drape is designed for the robotic computer system Robotic Base Station. Drape the robotic arm, monitor and front of the base station, by following the instructions detailed in the package insert provided with the sterile drape.FIG.35illustrates the system with a sterile drape.

Positioning the Robotic Base Station

Unwrap the foot pedal from the foot pedal basket and position it on the level ground at a comfortable distance from the operator's feet. The foot pedal is IPX68 rated and is acceptable for use in areas where liquids are likely to be found. Plug the foot pedal cord into the connector panel. The foot pedal allows the arm to move to the active trajectory, similar to the action of the bracelet on the lower arm.

Position the Robotic Base Station next to the patient at a comfortable distance from the surgeon. Move the robotic arm, using the bracelet, around the planned trajectories to ensure the arm can reach all locations before engaging the stabilizers.FIG.36illustrates the foot pedal cable connection.

Press the Stabilizers Engage button on the control panel to lower the stabilizers on the casters. The button is illuminated when the stabilizers are engaged.FIG.37illustrates the buttons which are illuminated when the stabilizers engage (e.g. responsive to pressing the stabilizers engage button3700) and stabilizers disengage (e.g. responsive to pressing the stabilizers disengage3702).

Attaching End Effector to Robotic Arm

The end effector connects to the robotic arm through the interface plate over the custom drape. A magnetic assist helps to position and self-align the end effector.

The end effector is equipped with a drape-friendly clamp that allows it to be removed and reattached up to 3 times during a procedure without damaging the drape.FIG.38illustrates the robotic arm interface plate for connection to the end effector.

FIG.39illustrates opening the brackets on the end effector and place the end effector on the interface plate by aligning the V grooves and alignment spheres.

FIG.40illustrates squeezing the brackets on both sides of the end effector and press the handle down to lock into place.

FIG.41illustrates the correct and incorrect positioning of the handle down to lock into place.

Removing the End Effector

To remove the end-effector from the robotic arm, pull up on the handle to release the spring and side brackets.FIG.42illustrates the removal of the end effector.

Surgical Instrument Assembly

To assemble the surgical instruments for navigation, press the release button on the array sleeve and insert the instrument shaft into the sleeve of the respective instrument array. Slide the shaft through the sleeve until it clicks into place. Gently pull up on the instrument shaft to confirm it is locked.FIG.43illustrates inserting the instrument shaft into the array sleeve, and further illustrates a release button4300which releases the array.

Attach a quick connect handle on the proximal end of the shaft when needed. To remove the instrument from the array, push the release button located on the middle of the array.FIG.44illustrates the surgical instrument assembly.FIG.45illustrates attaching the quick connect handle on the proximal end of the shaft of the surgical instrument assembly.

Attach the disposable reflective markers to each of the marker posts of each instrument assembly. Ensure that the markers are fully seated on the posts.FIG.46illustrates attaching a reflective marker to one of a plurality of marker posts of the instrument assembly.FIG.46(a)illustrates lowering the reflective marker onto a marker post.FIG.46(b)illustrates the marker fully seated on the post.

Login

To login, type the four-digit pin on the touch screen of the monitor. The four digit pin is provided during system installation and can be changed by contacting Tech Support.FIG.47illustrates the login screen displayed on the monitor.

A case encompasses all of the data associated with performing a procedure, including surgeon preferences, medical images, and plans.

After logging in, the SELECT CASE page is displayed on the monitor.

To select an existing case, select the corresponding row from the case list. To start a new case, click the new case icon. Click the right arrows to advance to the next tab.FIG.48illustrates the case management screen displayed on the monitor.

Applications

Spine surgical procedures are supported by the robotic computer system.FIG.49illustrates the CONFIGURE tab used to display procedure types.

Spine Procedures

Spinal surgical applications supported by the robotic computer system are listed below.

Supported spine proceduresProceduresPatient PositionPosterior CervicalPronePosterior ThoracicProneAnterolateral ThoracicLateralPosterior LumbarProneLateral LumbarLateral

Globus spinal implant systems that are compatible with the robotic computer system are listed below.

Compatible spinal implant systemsCREO ® Stabilization SystemREVERE ® Stabilization SystemREVOLVE ® Stabilization SystemELLIPSE ® Occipito-Cervico-Thoracic Spinal SystemQUARTEX ® Occipito-Cervico-Thoracic Spinal SystemSI-LOK ® Sacroiliac Joint Fusion System

Procedure Setup

Configure Tab

After selecting a case, the CONFIGURE tab is displayed on the monitor.

Using the CONFIGURE tab, select the surgeon, the imaging modality and the procedure type. Click the right arrows to advance to the next tab.

Preplan Tab

Using the PREPLAN tab, select the implant system, desired vertebral level and orientation, and click the desired implant location on the anatomical model. Click the right arrows to advance to the next tab.FIG.50illustrates the PREPLAN tab displayed on the monitor to select the implant system, desired vertebral level and orientation.

Verify Tab

FIG.51illustrates the VERIFY tab displaying navigation details including visibility, location and verification status of the instruments selected on the PREPLAN tab. Verification is used to ensure all instruments are accurate and have not been damaged during handling and sterilization. The operator must assemble all instruments prior to verification (see Surgical Instrument Assembly).

The VERIFY tab shows CAMERA VIEW and INSTRUMENT STATUS.

CAMERA VIEW is a real-time view from the perspective of the camera with color circles indicating instrument location. A solid colored circle indicates that the instrument is visible by the camera, while a hollow circle indicates that it is not visible. The colored circle grows larger as the instrument is moved closer to the physical camera and smaller as it moves away from the camera. The ideal distance from the camera is approximately 2 meters or 6 feet.

INSTRUMENT STATUS lists each instrument and its verification status, with corresponding color circles to identify each instrument. The verification status is symbolized by a checkmark if verification is successful and an X-mark if the verification failed. When no icon appears, the instrument is not verified.

Instrument Verification

Verify each instrument as follows: place the tip of the instrument to be verified into verification divots located on the end-effector and on any other instrument array for convenience; ensure both instruments are visible and held steady; and use a pop-up screen appearing on the VERIFY tab to indicate the verification progress.FIG.52illustrates the pop-up screen appearing on the VERIFY tab to indicate the verification progress.FIG.53illustrates the verification divot1712which between the hand grip1704and the array1700.

Once verification is complete, verification status is indicated on the screen with the tip error displayed in mm. If verification has failed (red crossed circle), verification must be repeated until it is successful (green circle).

When all instruments are successfully verified, advance to the next tab.FIG.54illustrates the green circle indicating a successful verification.FIG.55illustrates the red crossed circle indicating a failed verification.

Patient Attachment Instruments

Patient attachment instruments are secured to rigid bony anatomy neighboring the surgical site. Select the desired instrument. Patient attachment instruments should be placed no more than 185 mm from the center of the surgical site to maintain accuracy.

Bone clamps are clamped onto anatomical structures such as the spinous process, iliac crest, long bone, or any rigid bony structure that can be safely clamped.

Quattro spikes are inserted into the iliac crest or a long bone.

Rod attachments are secured to an existing spinal rod, 4.5 mm to 6.35 mm in diameter.

Refer to the table below for recommended anatomic locations for the various patient attachment instruments.

Patient attachment instruments-recommended anatomic locationsRecommended PatientPatient AttachmentAttachment InstrumentSpine ProceduresPatient PositionInstrumentLocationPosterior CervicalProneBone ClampSpinous Process C2-T3Rod AttachmentExisting RodPosterior ThoracicProneBone ClampSpinous Process T1-L1Rod AttachmentExisting RodAnterolateral ThoracicLateralBone ClampSpinous Process T1-L1Posterior LumbarProneQuattro SpikeIliac CrestLow Profile Quattro SpikeIliac CrestBone ClampSpinous Process T12-L5Rod AttachmentExisting RodLateral LumbarLateralQuattro SpikeIliac CrestLow Profile Quattro SpikeIliac CrestBone ClampSpinous Process T12-L5Rod AttachmentExisting Rod

Dynamic Reference Base Insertion

Position the compression clamp on the Dynamic Reference Base (DRB) over the patient attachment instrument and tighten the knob. If needed, the clamp driver can be used to further tighten the knob.

Position the reflective markers on the DRB in the direction of the camera. Care should be taken with initial placement of the patient reference instrument as to not interfere with the surgical procedure.

Following navigation, the patient attachment instrument is removed.FIG.56illustrates securing a Dynamic Reference Base to a patient attachment instrument.FIG.57illustrates using a clamp driver to the Dynamic Reference Base.

Surveillance Marker

The surveillance marker is inserted into rigid bony anatomy to track the relative distance to the DRB, to identify unwanted shifts in the DRB during the procedure.

Surveillance markers are inserted into the iliac crest or long bone, or may be attached to the spinous process using a bone clamp. Verify that the clamp is rigidly secured. The surveillance marker should be placed no more than 185 mm from the Dynamic Reference Base. Refer to the table below for recommended anatomic locations.

Surveillance marker-recommended anatomic locationsPatientRecommended PatientPatientAttachmentAttachment InstrumentSpine ProceduresPositionInstrumentLocationPosterior CervicalProneBone ClampSpinous Process C2-T3Posterior ThoracicProneSingleIliac CrestBone ClampSpinous Process T1-L1Anterolateral ThoracicLateralBone ClampSpinous Process T1-L1Posterior LumbarProneSingleIliac CrestBone ClampSpinous Process T12-L5Lateral LumbarLateralSingleIliac CrestBone ClampSpinous Process T12-L5

Attach a disposable reflective marker to the marker post of the surveillance marker. Attach the impaction cap, designed to fit over the reflective marker sphere, onto the surveillance marker. Insert the surveillance marker into rigid bony anatomy near the surgical site, and gently impact with a mallet. Remove the impaction cap. Remove the reflective marker prior to using the removal tool.FIG.58illustrates the placement of the Dynamic Reference Base (DRB)5800and the surveillance marker5804. The DRB5800includes reflective markers5802.

To use a bone clamp with the marker, attach a disposable marker onto the tip of the bone clamp. Use the clamp driver to secure the bone clamp. Verify that the clamp is rigidly secured.

Removal

The quattro spikes and surveillance marker are removed from bony anatomy manually or using the removal tool. The bone clamp is removed by loosening the clamp with the clamp driver, attaching the removal tool and lifting up the bone clamp.FIG.59illustrates a quattro spike.FIG.60illustrates a quattro spike removal tool.FIG.61illustrates removing a quattro spike with a removal tool.

Intra-Operative Ct Imaging Workflow

Image Tab

Intra-Op Ct Registration Fixture Setup

FIG.62illustrates attaching a registration fixture6200to a pivoting arm6202. Place the pivoting arm starburst6206over the starburst6206on the registration fixture6200and rotate 90° to secure. Referring to the enlarged view6208of the pivoting arm6202positioned over the starburst6206, push the lock post6204from the bottom and rotate the arm 90° until the pin in the lock post6204is seated to secure the fixture. Enlarged view6210shows the pivoting arm6202attached and rotated to become secured to the registration fixture6200.

FIG.63illustrates a registration fixture connecting to a patient attachment instrument. Position the fixture on the patient attachment instrument post and tighten the compression clamp knob. If needed, the clamp driver can be used to further tighten the knob.

To release the pivoting arm, push the lock post on the fixture, rotate the pivoting arm and pull up.

The Intra-op CT Registration Fixture has six degrees of freedom and can be moved by adjusting one of the three joints so that it is stable and hovering over the surgical site. Only the metal fiducials embedded in the fixture need to be in the 3D scan (not the reflective markers). It is important that the Intra-op CT Registration Fixture does not move between the image acquisition and performing an anatomical landmark check.

Loading the Image

The IMAGE tab shows the steps needed to load a CT scan image. The image can be loaded from a USB drive or hard drive. If the image is transferred via the Ethernet, it automatically appears on the hard drive when the transfer is complete.

To view images on a USB drive, insert the USB drive into the USB port on the connector panel. To load an image, select the hard drive or USB drive icon and select the desired patient image. Click the right arrows to load the patient images and advance to the next tab.

Manual Registration

Automatic registration is performed when loading images.FIG.64illustrates a registered fiducial. If this step fails, the manual registration screen will be shown to allow manual registration as described below.

The image on the left panel of the registration screen is a full scan with a depiction of the intra-op CT.

The registration fixture and the seven fiducials should be visible below the image. Fiducials that are not registered need to be adjusted by the operator. On the screen, select a fiducial that is not registered; that image will appear on the right. Move the blue circle on the screen until it surrounds the white fiducial marker. The three small boxes at the bottom of the right panel show the x, y and z direction of the fiducial and all must be adjusted until the blue circle is centered. Ensure that all seven fiducials are properly identified by viewing the 3D model of the intra-op registration fixture. A fiducial may be deleted by selecting the delete icon on the right panel. Click the right arrows to confirm that the fiducials have been properly identified before proceeding to the next step.

Landmark Check

After registration has been completed, a landmark check should be performed to ensure that the registration was calculated successfully. Using the verification probe, touch an anatomical landmark or a fiducial on the registration fixture and verify that the corresponding location is shown on the system monitor. Repeat this process using 2-3 landmarks.

Removing Registration Fixture

Carefully remove the Intra-op CT Registration Fixture. Ensure the patient attachment instrument does not move.

Intra-Operative CT Imaging Workflow

Plan Tab

FIG.65illustrates the PLAN tab allowing the user to plan all screw trajectories on the patient image. Screws are preloaded on the right hand side of the screen, based on selections made in the PREPLAN tab.

To add a screw onto the planning page, drag and drop the appropriate screw label on the image at the desired slice.

The active screw plan is shown in green. Details of the active screw plan are shown on the lower right of the screen, including screw family, diameter, and length. Click on the right arrows to advance to the next tab once plans are complete for all screws.

Adjusting screw trajectoryScrew BodyPress and move along screen to translate the screw along the current planeof the anatomyScrew HeadPress and move to change the angle of the trajectory, pivoting along the tip ofthe screwScrew TipPress and move to change the angle of the trajectory, pivoting along the headof the screwScroll BarThe scroll bar is the dial control located above the head of the screw. Press thescroll bar and move to rotate the anatomy 360° about the screw.

Adjusting screw sizeScrew TipPress and move longitudinally to automatically adjust the length of thescrew to available screw sizesScrew DiameterPress the screw diameter button located on the right hand side of the screen toselect other options available with the selected implant setScrew LengthPress the screw length button located on the right hand side of the screen toselect other options available with the selected implant set

Intra-Operative CT Imaging Workflow Planning Operations

FIG.80illustrates a block diagram of a surgical system600that includes a surgical implant planning computer610which may be separate from and operationally connected to the robot500or at least partially incorporated therein. Alternatively, at least a portion of operations disclosed herein for the surgical implant planning computer610may be performed by components of the robot500such as by the computer subsystem520.

Referring toFIG.80, the surgical implant planning computer610includes a display612, at least one processor circuit614(also referred to as a processor for brevity), at least one memory circuit616(also referred to as a memory for brevity) containing computer readable program code618, and at least one network interface620(also referred to as a network interface for brevity). The network interface620can be configured to connect to a CT image scanner630, a fluoroscopy image scanner640, an image database650of medical images, components of the surgical robot500, the marker tracking camera570, and/or other electronic equipment.

When the surgical implant planning computer610is at least partially integrated within the surgical robot500, the display612may correspond to the display524and/or the tablet590, the network interface620may correspond to the platform network interface512, and the processor614may correspond to the computer522.

The processor614may 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 processor614is configured to execute the computer readable program code618in the memory616to perform operations, which may include some or all of the operations described herein as being performed by a surgical implant planning computer.FIGS.81through87illustrates various operations that can be performed by the processor614in accordance with some embodiments of the present disclosure.

Referring toFIGS.80and81, the processor614displays700on the display device a CT image of a bone that is received from the CT image scanner630through the network interface620. The processor614receives702a user's selection of a surgical screw from among a set of defined surgical screws, such as by a user touch selecting user-selectable indicia shown through a touch sensitive screen overlay on the display612. The processor614displays704a graphical screw representing the selected surgical screw as an overlay on the CT image of the bone.

The processor614controls706angular orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs, which may be provided by the user touch selecting and/or touch dragging a finger on the display614and/or via another user interface, such as a touchpad, joystick, dials, etc. The processor614stores708an indication of the selected surgical screw and an angular orientation and a location of the displayed graphical screw in a surgical plan data structure, e.g., within memory616, responsive to receipt of a defined user input, such as a user selecting a displayed indicia for providing a keyboard input. As will be described in further detail below, the processor614may control710the robot500based on the surgical plan data structure to move the robot arm relative to a patient.

The angular orientation and the location that is stored708in the surgical plan data structure may be configured to indicate the angular orientation and the location of the displayed graphical screw relative to an angular orientation and a location of the bone in the CT image. The operations to display704the graphical screw representing the selected surgical screw as an overlay on the CT image of the bone, can include determining a trajectory along an axis of the graphical screw, and displaying a trajectory line that extends from adjacent to a tip of the graphical screw and along the trajectory to facilitate a user visually orienting and positioning the graphical screw relative to a desired insertion location on the bone.

The operations to control706angular orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs, can include translating a location of the displayed graphical screw responsive to determining that the user has pressed on a touch-sensitive screen of the display device612over a screw body of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen. The operations can further include angularly pivoting the displayed graphical screw responsive to determining that the user has pressed on the touch-sensitive screen over a screw head and/or tip of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen.

Alternatively or additionally, the operations to control706angular orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs, can include selecting a length of the displayed graphical screw from among a set of defined lengths for surgical screws responsive to determining that the user has pressed on a touch-sensitive screen of the display device over a screw tip or a screw head of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen a measured distance. The selected length of the surgical screw is then stored708in the surgical plan data structure.

The operations to control706orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs, can include modifying a size and/or a rotational angle of the displayed graphical screw on the CT image responsive to tracking motion of a user's hand relative to an input device, such as by tracking motion of the user's finger on a touch sensitive screen overlay on the display612, on a touchpad, etc.

Intra-Operative Ct Imaging Workflow

Navigate Tab

FIG.66illustrates the NAVIGATE tab allowing the user to visualize the navigated instrument trajectory and the planned trajectory with respect to patient anatomy.

The robotic arm precisely aligns the end-effector to the planned trajectory. Select the desired screw label on the right of the screen. The screw plan is active when the screw label is highlighted and the robotic arm can be moved by the bracelet or pressing the foot pedal. The robotic arm first moves up in order to clear obstacles in the surgical field and then down along the trajectory. Once on the trajectory, the robotic arm can move up/down along the trajectory but does not move off of the trajectory unless the screw plan is deselected.

The real-time instrument/implant trajectory is displayed on the patient images along with the planned screw, allowing the user to confirm the desired trajectory. If the real-time trajectory is not acceptable, the user can return to the PLAN tab to select another trajectory. If the real-time trajectory is acceptable, the user inserts the screw according to the instrument's current trajectory to the desired depth.

GPS instruments are displayed as they are advanced through the end-effector. While navigating the instruments, periodically observe the monitor and surgical site to ensure consistency between tactile and navigation feedback. Non-navigated metallic Globus instruments may be used through the guide tube while it is stationary for surgical applications unrelated to screw placement.

Monitor the surveillance marker during the procedure. If the surveillance marker indicates significant movement of the DRB, perform an anatomical landmark check. If the landmark check is satisfactory, re-register the surveillance marker. If the landmark check fails, re-register the patient.

There are multiple navigation tab icons. Referring toFIG.66, the force gauge661indicates the force exerted on the end-effector. The image of the instrument at the bottom of the force gauge shows the active instrument in the end-effector or the end-effector image if no instrument is inserted. The surveillance marker error gauge662indicates the distance that the patient reference has moved in relation to the surveillance marker. The full range of the scale is 2 mm. The DRB icon663indicates dynamic reference base visibility. If the DRB is visible by the camera, the background is green. If the DRB is not visible by the camera, the background is red.

Intra-Operative CT Imaging Workflow Navigation Operations

As explained above, the surgical implant planning computer610can control710operations of the surgical robot500. Referring to the operational embodiment ofFIG.82, the processor614of the surgical implant planning computer610can control710the robot500by providing800the surgical plan data structure to the robot500to control movement of the robot arm relative to the robot base.

Referring to the alternative or additional operations ofFIG.83, the processor614of the surgical implant planning computer610can control710the robot500by controlling900selected ones of the motors550-554, either directly or indirectly via the computer522and/or controller546, responsive to content of the surgical plan data structure to regulate movement of the robot arm while positioning an end-effector544, which is connected to the robot arm, relative to a patient. The processor614can also control902angular orientation and location of the displayed graphical screw on the display612responsive to the movement of the robot arm while the end-effector544is positioned relative to the patient.

In a further embodiment, the processor614can directly or indirectly control900one or more of the motors550-554to move the end-effector544in a direction along a trajectory that is defined by the content of the surgical plan data structure, and can control902location of the displayed graphical screw responsive to the movement of the end-effector544along the trajectory.

In a further embodiment, while moving the end-effector544along the trajectory, the processor614can directly or indirectly control one or more of the motors550-554to resist movement of the end-effector544in a direction that is perpendicular to the trajectory until another operation is perform that cancels an end-effector trajectory constraint mode. In a further embodiment, prior to initiating the end-effector trajectory constraint mode, the processor614can directly or indirectly control one or more of the motors550-554to move the end-effector544in a direction upward away from the patient and then toward a location along the trajectory toward the patient, and prevent initiation of the end-effector trajectory constraint mode before reaching the location along the trajectory. The processor can control angular orientation and location of the displayed graphical screw responsive to the movement of the robot arm away from the patient and then toward the location along the trajectory.

Pre-Operative Ct Imaging Workflow

Image Tab

Loading the Image

The IMAGE tab shows the steps needed to load a CT scan image. The image can be loaded from a USB drive or hard drive. If the image is transferred through the Ethernet, it automatically appears on the hard drive when the transfer is complete.

To view images on a USB drive, insert the USB drive into the USB port on the connector panel. To load an image, select the hard drive or USB drive icon and select the desired patient image. Click the right arrows to load the patient images and advance to the next tab.

Pre-Operative Ct Imaging Workflow

Plan Tab

FIG.67illustrates the PLAN tab allowing the user to plan all screw trajectories on the patient image. Screws are preloaded on the right-hand side of the screen, based on selections made in the PREPLAN tab.

To add a screw onto the planning page, drag and drop the appropriate screw label on the image at the desired slice. The active screw plan is shown in green. Details of the active screw plan are shown on the lower right of the screen, including screw family, diameter, and length. Click on the right arrows to advance to the next tab once plans are complete for all screws.

Adjusting screw trajectoryScrew BodyPress and move along screen to translate the screw along the current planeof the anatomyScrew HeadPress and move to change the angle of the trajectory, pivoting along the tip ofthe screwScrew TipPress and move to change the angle of the trajectory, pivoting along the headof the screwScroll BarThe scroll bar is the dial control located above the head of the screw. Press thescroll bar and move to rotate the anatomy 360° about the screw.

Adjusting screw sizeScrew TipPress and move longitudinally to automatically adjust the length of thescrew to available screw sizesScrew DiameterPress the screw diameter button located on the right hand side of the screen toselect other options available with the selected implant setScrew LengthPress the screw length button located on the right hand side of the screen toselect other options available with the selected implant set

Pre-Operative CT Imaging Workflow Planning Operations

Pre-operative CT imaging workflow planning operations that can be performed by the surgical implant planning computer610and, more particularly by the processor614, are now described in the context of the embodiments shown inFIG.84.

Referring toFIG.84, the operations can include loading1000a CT image of a bone, which is received from the image database650through the network interface620, into the memory616. The operations include displaying1002the CT image on the display device612, and receiving1004a user's selection of a surgical screw from among a set of defined surgical screws. The operations display1006a graphical screw representing the selected surgical screw as an overlay on the CT image of the bone. The operations control1008angular orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs. The operations store1012an indication of the selected surgical screw and an angular orientation and a location of the displayed graphical screw in a surgical plan data structure responsive to user input. The surgical plan data structure is configured for use by the robot500to control movement of the robot arm in accordance with various embodiments disclosed herein.

The operations to display1006the graphical screw representing the selected surgical screw as an overlay on the CT image of the bone, can include determining a trajectory along an axis of the graphical screw, and displaying1010a trajectory line that extends from adjacent to a tip of the graphical screw and along the trajectory to facilitate a user visually orienting and positioning the graphical screw relative to a desired insertion location on the bone.

The operations to control1008angular orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs, can include translating a location of the displayed graphical screw responsive to determining that the user has pressed on a touch-sensitive screen of the display device612over a screw body of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen. The operations can alternatively or additionally include angularly pivoting the displayed graphical screw responsive to determining that the user has pressed on the touch-sensitive screen over a screw head and/or tip of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen.

The operations to control1008angular orientation and location of the displayed graphical screw relative to the bone in the CT image responsive to receipt of user inputs, can include selecting a length of the displayed graphical screw from among a set of defined lengths for surgical screws responsive to determining that the user has pressed on a touch-sensitive screen of the display device612over a screw tip or a screw head of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen a measured distance.

The selected length of the surgical screw is stored1012in the surgical plan data structure.

The operations can include controlling1014angular orientation and location of the displayed graphical screw responsive to the movement of the robot arm while the end-effector544is being positioned relative to a patient.

Pre-Operative Ct Imaging Workflow

Navigate Tab

The NAVIGATE tab allows the user to visualize the navigated instruments and trajectory alignment with respect to patient anatomy, according to the screw plan.

Registration Setup

FIG.68illustrates the first screen highlighting the three steps to complete before the fluoroscopy images can be taken to register the pre-operative CT image. Animation visually depicts the steps.

FIG.69illustrates a Fluoroscopy Registration Fixture attached to image intensifier. Attach the Fluoroscopy Registration Fixture to the image intensifier on the C-arm by turning the clamps clockwise until tight. Drape the fluoroscope and Fluoroscopy Registration Fixture and attach new reflective markers outside of the drape. Position the fixture such that the reflective markers are facing the camera. Attach the video capture cable (yellow jack) to the C-arm viewing station. Plug the video capture USB cable into either of the two USB ports on the robotic computer system connector panel.

Ensure that the Dynamic Reference Base is visible to the camera after the C-Arm is in place.

Register the surveillance marker by placing an instrument close to the reflective sphere on the surveillance marker but not touching. The box turns green when it is activated. Click the right arrows to advance to the next tab.

Pre-Operative CT Imaging Workflow Navigation Operations

Pre-operative CT imaging workflow navigation operations that can be performed by the surgical implant planning computer610and, more particularly by the processor614, are now described in the context of the embodiments shown inFIG.85.

Referring toFIG.85, the operations can include performing1100a registration setup mode that includes determining occurrence of a first condition indicating that a marker tracking camera570can observe to track reflective markers that are on a fluoroscopy registration fixture (e.g., connected to the fluoroscopy imager640), and further determining occurrence of a second condition indicating that the marker tracking camera570can observe to track dynamic reference base markers attached to the robot arm and/or an end-effector544connected to the robot arm. The operations display1102on the display device612an indication of when both of the first and second conditions occur, and determine that the registration setup mode is allowed to be marked satisfied when at least both of the first and second conditions are determined to occur.

Registration

Acquire the intra-operative fluoroscopic images, one AP and one lateral for each level planned. The same image may be used for multiple levels.

The following three conditions must be met prior to acquiring the images: (1) the DRB is visible by the camera; (2) the Fluoroscopy Registration Fixture is visible by the camera; and (3) a valid fluoroscopic image was taken.

FIG.70illustrates a lateral image within the NAVIGATE tab. Referring toFIG.70. Each of the three images on the left of the screen turns green when ready for image capture. When all three conditions are met, acquire the intra-operative fluoroscopic image and then select the CAPTURE button to transfer the image to the system. Once both images are successfully captured, the spinal level on the right side of the screen displays a check mark. Click the right arrows to advance to the next tab.

FIG.71illustrates selecting the desired level. To do so, the user drags and drops the planned screw onto the fluoroscopic images. Use the circle control points to roughly position the screw within the vertebral body. Ensure that the screw shank is positioned correctly, the head and tail of the screws are in the desired direction, and left/right are correctly oriented. Click the register button when complete to allow registration.

FIG.72illustrates a successful registration with a check mark being shown next to the active level. Click the right arrows when registration is complete.

Pre-Operative CT Imaging Workflow Navigation Operations

With further reference toFIG.85, the operations by the surgical implant planning computer610can further include operating1104while both of the first and second conditions are determined1104to continue to occur, to allow operations to be performed to obtain a first intra-operative fluoroscopic image of the patient along a first plane and to obtain a second intra-operative fluoroscopic image of the patient along a second plane that is orthogonal to the first plane. The operations determine that a registration mode is allowed to be marked satisfied when the first and second intra-operative fluoroscopic images have been obtained.

With further reference toFIG.85, the operations by the surgical implant planning computer610can further include displaying114the first and second intra-operative fluoroscopic images on the display device612. The operations display1108the graphical screw as an overlay on both of the first and second intra-operative fluoroscopic images. The operations control1110angular orientation and location of the displayed graphical screw relative to a bone in the first and second intra-operative fluoroscopic images responsive to receipt of user inputs.

Operations may alternatively or additionally include determining1112when the angular orientation and location of the displayed graphical screw relative to the bone in the first and second intra-operative fluoroscopic images satisfies a registration rule for corresponding to the angular orientation and the location of the displayed graphical screw in the surgical plan data structure, and then responsively displaying on the display device612an indication of when the registration rule is satisfied.

With further reference toFIG.85, the operations by the surgical implant planning computer610can further include, based on determining that the registration rule is satisfied, controlling1114one or more of the motors550-554responsive to content of the surgical plan data structure to regulate movement of the robot arm while positioning the end-effector544relative to the patient. The operations can further control1114angular orientation and location of the graphical screw that is displayed, responsive to the movement of the robot arm while the end-effector544is being positioned relative to the patient.

Landmark Check

After registration has been completed, a landmark check, or verification, should be performed to ensure that the registration was calculated successfully. Using the verification probe, touch an anatomical landmark and verify that the corresponding location is shown on the system monitor. Repeat this process using 2-3 landmarks.

Removing Registration Fixture

Carefully remove the Fluoroscopy Registration Fixture if desired.

Navigation

The robotic arm precisely aligns the end-effector on the planned trajectory. Select the desired screw label on the right of the screen.

The screw plan is active when the screw label is highlighted and the robotic arm can be moved by the bracelet or pressing the foot pedal. The robotic arm first moves up in order to clear obstacles in the surgical field and then down along the trajectory. Once on the trajectory, the robotic arm can move up/down along the trajectory but does not move off of the trajectory unless the screw is deselected.

FIG.73illustrates how the real-time instrument/implant trajectory is displayed on the patient images along with the planned screw, allowing the user to confirm the desired trajectory. If the real-time trajectory is not acceptable, the user can return to the PLAN tab to select another trajectory. If the real-time trajectory is acceptable, the user inserts the screw according to the instrument's current trajectory to the desired depth.

GPS instruments are displayed as they are advanced through the end-effector. While navigating the instruments, periodically observe the monitor and surgical site to ensure consistency between tactile and navigation feedback.

Non-navigated metallic Globus instruments may be used through the guide tube while it is stationary for surgical applications unrelated to screw placement.

Monitor the surveillance marker during the procedure. If the surveillance marker indicates significant movement of the DRB, perform an anatomical landmark check. If the landmark check is satisfactory, re-register the surveillance marker. If the landmark check fails, re-register the patient.

There are multiple navigation tab icons. Referring toFIG.73, the force gauge731indicates the force exerted on the end-effector. The image of the instrument at the bottom of the force gauge shows the active instrument in the end-effector or the end-effector image if no instrument is inserted. The surveillance marker error gauge732indicates the distance that the patient reference has moved in relation to the surveillance marker. The full range of the scale is 2 mm. The DRB icon733indicates dynamic reference base visibility. If the DRB is visible by the camera, the background is green. If the DRB is not visible by the camera, the background is red.

Fluoroscopic Imaging Workflow

Image Tab

Registration Setup

Referring toFIG.68the first screen highlights the three steps to complete before fluoroscopic images can be taken to register the patient. Animation visually depicts the steps.

Referring toFIG.69, attach the Fluoroscopy Registration Fixture to the image intensifier on the C-arm by turning the clamps clockwise until tight. Drape the fluoroscope and Fluoroscopy Registration Fixture and attach new reflective markers outside of the drape. Position the fixture such that the reflective markers are facing the camera. Attach the video capture cable (yellow jack) to the C-arm viewing station. Plug the video capture USB cable into either of the two USB ports on the robotic computer system connector panel.

Ensure that the Dynamic Reference Base is visible to the camera after the C-Arm is in place.

Register the surveillance marker by placing an instrument close to the reflective sphere on the surveillance marker but not touching. The box turns green when it is activated. Click the right arrows to advance to the next tab.

Image Acquisition

Acquire intra-operative fluoroscopic images, one AP and one lateral.

The following three conditions must be met prior to acquiring the images: (1) the DRB is visible by the camera; (2) the Fluoroscopy Registration Fixture is visible by the camera; and (3) a valid fluoroscopic image was taken.

FIG.74illustrates a lateral image within the NAVIGATE tab. Referring toFIG.74, each of the three images on the left of the screen turn green when ready for image capture. When all three conditions are met, acquire the intra-operative fluoroscopic image and then select the CAPTURE button to transfer the image to the system. Once both images are successfully captured, the level on the right side of the screen displays a check mark. Once the appropriate images have been loaded and selected, click on the right arrows to proceed.

Landmark Check

After registration has been completed, a landmark check, or verification, should be performed to ensure that the registration was calculated successfully. Using the navigated verification probe, touch an anatomical landmark and verify that the corresponding location is shown on the system monitor. Repeat this process using 2-3 landmarks.

Removing Registration Fixture

Carefully remove the fluoroscopy registration fixture if desired.

Fluoroscopic Imaging Workflow Operations

Fluoroscopic imaging workflow operations that can be performed by the surgical implant planning computer610and, more particularly by the processor614, are now described in the context of the embodiments shown inFIG.86.

Referring toFIG.86, the operations can include performing1200operations for a registration setup mode that include determining occurrence of a first condition indicating that the marker tracking camera570can observe to track reflective markers that are on a fluoroscopy registration fixture of the fluoroscopy imager640, and determining occurrence of a second condition indicating the marker tracking camera570can observe to track dynamic reference base markers attached to the robot arm and/or the end-effector544connected to the robot arm. While both of the first and second editions are determined to continue to occur, the processor614allows1204operations to be performed to obtain a first intra-operative fluoroscopic image of a patient along a first plane and to obtain a second intra-operative fluoroscopic image of the patient along a second plane that is orthogonal to the first plane. The operations may display1202on the display device612an indication of when both of the conditions occur. If one or both conditions cease to be satisfied before the first and second intra-operative fluoroscopic images are obtained, the system may interrupt further obtaining of the uncompleted first and second intra-operative fluoroscopic imaging and generate a notification to the user.

The operations can further include displaying1206the first and second intra-operative fluoroscopic images on the display device612. The operations can receive1208a user's selection of a surgical screw from among a set of defined surgical screws, and display1210a graphical screw representing the selected surgical screw as an overlay on both of the first and second intra-operative fluoroscopic images. The operations can control1212angular orientation and location of the displayed graphical screw relative to a bone shown in the first and second intra-operative fluoroscopic images responsive to receipt of user inputs, and store1214an indication of an angular orientation and a location of the displayed graphical screw in a surgical plan data structure responsive to receipt of a defined user input.

Fluoroscopic Imaging Workflow

Plan Tab

FIG.75illustrates the PLAN tab allowing the user to plan all screw trajectories on the patient image. Referring to75, screws are preloaded on the right side of the screen, based on selections made in the PREPLAN tab.

To add a screw onto the planning page, drag and drop the appropriate screw label on the image at the desired slice.

The active screw plan is shown in green. Details of the active screw plan are shown on the lower right of the screen, including screw family, diameter, and length. Click on the right arrows to advance to the next tab once plans are complete for all screws.

Adjusting screw trajectoryScrew HeadPress and move along screen to adjust the screw along the current plane of theanatomyScrew TipPress and move to change the angle of the trajectory, pivoting along the headof the screwScrew TrajectoryPress and move the screw along the 3D trajectory. This is useful to simulateactual advancement of the screw in 3D space. Both AP and Lateral images willbe updated to reflect the new screw position.

Adjusting screw sizeScrew DiameterPress the screw diameter button located on the right hand side of the screen toselect other options available with the selected implant setScrew LengthPress the screw length button located on the right hand side of the screen toselect other options available with the selected implant set

Fluoroscopic Imaging Workflow Planning Operations

Fluoroscopic imaging workflow operations for planning that can be performed by the surgical implant planning computer610and, more particularly by the processor614, are now described in the context of the embodiments shown inFIG.87.

Referring toFIG.87, operations to display the graphical screw representing the selected surgical screw as an overlay on both of the first and second intra-operative fluoroscopic images, can include determining1300a trajectory along an axis of the graphical screw and displaying a trajectory line that extends from adjacent to a tip of the graphical screw and along the trajectory to facilitate a user visually orienting and positioning the graphical screw relative to a desired insertion location on the bone.

Operations to control angular orientation and location of the displayed graphical screw relative to the bone shown in the first and second intra-operative fluoroscopic images responsive to receipt of user inputs, can include translating1302a location of the displayed graphical screw responsive to determining that the user has pressed on a touch-sensitive screen of the display device612over a screw body of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen. The operations can further include angularly pivoting1304the displayed graphical screw responsive to determining that the user has pressed on the touch-sensitive screen over a screw head and/or tip of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen.

Operations to control angular orientation and location of the displayed graphical screw relative to the bone shown in the first and second intra-operative fluoroscopic images responsive to receipt of user inputs, can include selecting1306a length of the displayed graphical screw from among a set of defined lengths for surgical screws responsive to determining that the user has pressed on a touch-sensitive screen of the display device612over a screw tip or a screw head of the graphical screw while moving location of the user's continued pressing along the touch-sensitive screen a measured distance. The selected length is stored1308in the surgical plan data structure.

Fluoroscopic Imaging Workflow

Navigate Tab

FIG.76illustrates the NAVIGATE tab allowing the user to visualize the navigated instrument trajectory and the planned trajectory with respect to patient anatomy.

The robotic arm precisely aligns the end-effector to the planned trajectory. Referring toFIG.76, select the desired screw label on the right of the screen.

The screw plan is active when the screw label is highlighted and the robotic arm can be moved by the bracelet or pressing the foot pedal. The robotic arm first moves up in order to clear obstacles in the surgical field and then down along the trajectory. Once on the trajectory, the robotic arm can move up/down along the trajectory but does not move off of the trajectory unless the screw plan is deselected.

The real-time instrument/implant trajectory is displayed on the patient images along with the planned screw, allowing the user to confirm the desired trajectory. If the real-time trajectory is not acceptable, the user can return to the PLAN tab to select another trajectory. If the real-time trajectory is acceptable, the user inserts the screw according to the instrument's current trajectory to the desired depth.

GPS instruments are displayed as they are advanced through the end-effector. While navigating the instruments, periodically observe the monitor and surgical site to ensure consistency between tactile and navigation feedback.

Non-navigated metallic Globus instruments may be used through the guide tube while it is stationary for surgical applications unrelated to screw placement.

Monitor the surveillance marker during the procedure. If the surveillance marker indicates significant movement of the DRB, perform an anatomical landmark check. If the landmark check is satisfactory, re-register the surveillance marker. If the landmark check fails, re-register the patient.

There are multiple navigation tab icons. Referring toFIG.76, the force gauge761indicates the force exerted on the end-effector. The image of the instrument at the bottom of the force gauge shows the active instrument in the end-effector or the end-effector image if no instrument is inserted. The surveillance marker error gauge762indicates the distance that the patient reference has moved in relation to the surveillance marker. The full range of the scale is 2 mm. The DRB icon763indicates dynamic reference base visibility. If the DRB is visible by the camera, the background is green. If the DRB is not visible by the camera, the background is red.

Navigation-Only Procedures

FIG.77illustrates how the robotic computer system may be used for navigation without the robotic arm and end effector. Pre-surgical planning is optional. Referring toFIG.77, all verified GPS instruments are visible on loaded patient images when moved within the view of the camera. The instruments are displayed with respect to the patient.

Refer to the corresponding application and imaging workflow for the imaging modality (pre-operative CT, intra-operative CT, or fluoroscopy).

Use the IMAGE tab to load the desired patient images.

After instrument registration has been completed, a landmark check, or verification, should be performed to ensure that the registration was calculated successfully. Using the navigated verification probe, touch an anatomical landmark and verify that the corresponding location is shown on the system monitor. Repeat this process using 2-3 landmarks.

Use the PLAN tab to plan screw placement if desired. Select the desired screw label on the right of the screen to choose the screw plan.

Use the NAVIGATE tab to display the screw and navigated instruments during the procedure.

Monitor the surveillance marker during the procedure. If the surveillance marker indicates significant movement of the DRB, perform an anatomical landmark check. If the landmark check is satisfactory, re-register the surveillance marker. If the landmark check fails, re-register the patient.

Trajectory-Only Procedures

FIG.78illustrates how the robotic computer system may be used for trajectory guidance using the robotic arm without navigated instruments. Referring to tFIG.78, the guide tube serves as a rigid retractor that can be moved within the surgical field or aligned to a trajectory automatically or manually.

Refer to the corresponding application and imaging workflow for the imaging modality (pre-operative CT, intra-operative CT, or fluoroscopy). Use the IMAGE tab to load the desired patient images.

A landmark check, or verification, should be performed to ensure that the registration was calculated successfully. Using the navigated verification probe, touch an anatomical landmark and verify that the corresponding location is shown on the system monitor. Repeat this process using 2-3 landmarks.

Use the PLAN tab to plan screw placement. Select the desired screw label on the right of the screen. The screw plan is active when the screw label is highlighted and the robotic arm can be moved by the bracelet or by pressing the foot pedal and moving the arm. The robotic arm first moves up to clear obstacles in the surgical field and then down along the specified trajectory. Once on the trajectory, the robotic arm can be moved up/down along the trajectory but does not move off of the trajectory unless the screw is deselected.

If using k-wires, use the cannulated awl to prepare the starting hole and place the k-wire into bone at the desired trajectory through the guide tube. The end effector should be moved away from the trajectory so the screw can be placed by k-wire guidance (deselect the screw plan).

Perform the surgical procedure using non-navigated metallic surgical instruments that fit through the guide tube diameter.

Monitor the surveillance marker during the procedure. If the surveillance marker indicates significant movement of the DRB, perform an anatomical landmark check. If the landmark check is satisfactory, re-register the surveillance marker. If the landmark check fails, re-register the patient.

Fluoroscopic Imaging Workflow Planning Operations

As explained above, the fluoroscopic imaging workflow operations for planning by the surgical implant planning computer610can include displaying the graphical screw representing the selected surgical screw as an overlay on both of the first and second intra-operative fluoroscopic images. The operations can determine1300a trajectory along an axis of the graphical screw and displaying a trajectory line that extends from adjacent to a tip of the graphical screw and along the trajectory to facilitate a user visually orienting and positioning the graphical screw relative to a desired insertion location on the bone.

The operations may further include directly or indirectly, e.g., via the computer522and/or controller546, controlling one or more of the motors550-554responsive to content of the surgical plan data structure to regulate movement of the robot arm while positioning the end-effector544relative to a patient. The operations can control (e.g.,1212inFIG.86) angular orientation and location of the displayed graphical screw responsive to the movement of the robot arm while the end-effector544is being positioned relative to the patient.

The operations can further include directly or indirectly, e.g., via the computer522and/or controller546, controlling the motors550-554to move the end-effector544in a direction along a trajectory defined by the content of the surgical plan data structure. The operations can further include controlling (e.g.,1212inFIG.86) location of the displayed graphical screw responsive to the movement of the end-effector544along the trajectory.

The operations can further include, while moving the end-effector544along the trajectory, directly or indirectly controlling the motors550-554to resist movement of the end-effector544in a direction perpendicular to the trajectory until another operation is perform that cancels an end-effector trajectory constraint mode.

The operations can further include, prior to initiating the end-effector trajectory constraint mode, directly or indirectly controlling the motors550-554to move the end-effector544in a direction upward away from the patient and then toward a location along the trajectory, and preventing initiation of the end-effector trajectory constraint mode before reaching the location along the trajectory. The operations can control angular orientation and location of the displayed graphical screw responsive to the movement of the robot arm away from the patient and then toward the location along the trajectory.

Software Error Messages

The system alerts the operator of errors through pop-up messages. The following list describes all possible errors and the actions to correct them.

MessageDescriptionProposed RemedyEnd EffectorThe End Effector is not attached toEnsure that the End Effector isDisconnectedthe robot arm.properly attached.Stabilizer Not DownStabilizers have not been deployed.Engage stabilizer.Registration NotThe patient scan did not passComplete registration.Completedautomatic registration or wasunregistered via the registration view.Registration NotRegistration has not yet beenTransfer registrationTransferredtransferred from the intra-op CTregistration fixture to the DynamicReference Base.Camera DisconnectedThe connection to the camera wasEnsure the camera isdropped, most likely as a result of aproperly connected.loose cable.Camera Frame RateThe frame rate of the camera hasToo many instruments in view ofDroppeddropped below the system's safethe camera. Removinglimit. This is usually due to too manyinstruments will increase thetracked instruments/objects in thecamera frame rate.camera's view.Camera CRC MismatchData from camera is not valid, orDisconnect camera from Roboticthere has been a cameraBase Station and reconnect.communication problem.End Effector Not VisibleThe End Effector is not currentlyEnsure the End Effector is in view ofvisible to the camera. (This will stopthe camera.or preventmotion as the End Effector fiducialsmust be visible to move the robotarm.)DRB Not VisibleThe Dynamic Reference Base is notEnsure the Dynamic Reference Basecurrently visible to the camera (thisis in view of the camera.will stop motion as the DynamicReference Base fiducials must bevisible to move the robot arm).E-Stop pressedSomeone has physically pressed theRotate the E-Stop button toE-Stop or Emergency Stop button onrelease.the Robot Base Station. This stopsmotion.PIB CommunicationCommunication to the PIBRestart the system.Dropped(Platform Interface Board) has beenlost. This severs communication tothe robotic arm, which stops orprevents motion.Surveillance MarkerThe surveillance marker has movedPerform an anatomical landmarkMovedbeyond its safety-critical limit incheck to ensure navigation is stillrelation to the Dynamic Referenceaccurate.Base.If navigation is inaccurate, either re-register the patient or discontinue usefor that procedure.Surveillance Marker NotThe surveillance marker has either shiftedPerform an anatomical landmarkVisibledramatically or moved a great distance,check to ensure navigation is stillwhich causes the camera to no longeraccurate.see it.If navigation is inaccurate, either re-register the patient or discontinue usefor that procedure.Active Trajectory NotThe robotic arm cannot create a tableMove Robotic Base Station to allowReachableof position points to move to athe arm to reach the trajectory.trajectory, based on the kinematicsequations used.Maximum TrajectoryWhen the robot arm is locked ontoRestart the move.Error Exceededa trajectory, if the actual position ofthe robot arm exceeds a certaindistance from the perceived trajectory,this error will occur. Could be relatedto excessive force on the End Effectoror kinematics issues.Excessive force on theExcessive force has been applied to theRemove the force.End Effectorload cell, over a certain limit (50 N or 11lbs)Excessive DynamicThe Dynamic Reference BasePerform an anatomical landmarkReference Baseposition has shifted relativelycheck to ensure navigation is stillMovementquickly, without movement of otheraccurate.objects in the view of the camera.If navigation is inaccurate, either re-register the patient or discontinue usefor that procedure.Move Enabled PressMove enabled is pressed whileRelease the foot pedal or bracelet,Erroractivating trajectory. Prevents thethen activate the trajectory.robot from instantly entering auto-move mode immediately afteractivating a trajectory.GMAS CommunicationCommunication with the GMAS controllerThe system shouldFailurehas been lost. This will stop orautomatically connect. If not,prevent motion as GMAS is no longerrestart the system.receiving updates from the client abouttrajectory and camera.Move Enabled TimeoutMove enable has been active forRelease the foot pedal or bracelet,longer than threshold, 90 seconds orthen re-engage the foot pedal ormore. This is a failsafe forbracelet.accidentally leaving the armengaged.Camera BumpedMassive bump to the camera, inCall Tech Support.which the camera is likely to bepermanently damaged. This is anerror thrown internally by theNDI software.Tool in End EffectorIf an instrument is in the EndRemove instrument from End Effector.Effector when attempting to move,motion will be disallowed and thiserror will be displayed.Move Enabled TestThe move enabled test has failed.Ensure no buttons are pressedFailureon the system and the systemwill automatically retry.Motion Homing FailureThe homing routine for the robotCall Tech Support.has failed. This causes the roboticarm to lose its relative positions. Thistest can beretried, but if it consistently fails, there areno user actions to fix.Need to HomeRobot has not run its homingCall Tech Support.routine, thus the robot arm doesnot know its relative positions.

Further Definitions and Embodiments

In the above-description of various embodiments of the present disclosure, aspects of the present disclosure may be illustrated and described herein in any of a number of patentable classes or contexts including any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. Accordingly, aspects of the present disclosure may be implemented in entirely hardware, entirely software (including firmware, resident software, micro-code, etc.) or combining software and hardware implementation that may all generally be referred to herein as a “circuit,” “module,” “component,” or “system.” Furthermore, aspects of the present disclosure may take the form of a computer program product comprising one or more computer readable media having computer readable program code embodied thereon.

Any combination of one or more computer readable media may be used. The computer readable media may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an appropriate optical fiber with a repeater, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device. Program code embodied on a computer readable signal medium may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

Computer program code for carrying out operations for aspects of the present disclosure may be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Scala, Smalltalk, Eiffel, JADE, Emerald, C++, C #, VB.NET, Python or the like, conventional procedural programming languages, such as the “C” programming language, Visual Basic, Fortran 2003, Perl, COBOL 2002, PHP, ABAP, dynamic programming languages such as Python, Ruby and Groovy, or other programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider) or in a cloud computing environment or offered as a service such as a Software as a Service (SaaS).

Aspects of the present disclosure are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the disclosure. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable instruction execution apparatus, create a mechanism for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computer readable medium that when executed can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions when stored in the computer readable medium produce an article of manufacture including instructions which when executed, cause a computer to implement the function/act specified in the flowchart and/or block diagram block or blocks. The computer program instructions may also be loaded onto a computer, other programmable instruction execution apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatuses or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

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 the invention. 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 this disclosure 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 unless expressly so defined herein.

The flowchart and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various aspects of the present disclosure. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of code, which comprises one or more executable instructions for implementing the specified logical function(s). It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. 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 involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

The terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting of the disclosure. 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. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. Like reference numbers signify like elements throughout the description of the figures.

The corresponding structures, materials, acts, and equivalents of any means or step plus function elements in the claims below are intended to include any disclosed structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosure in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the disclosure. The aspects of the disclosure herein were chosen and described in order to best explain the principles of the disclosure and the practical application, and to enable others of ordinary skill in the art to understand the disclosure with various modifications as are suited to the particular use contemplated.