Systems and methods for associating components of a surgical instrument for navigation-assisted surgery

Abstract

A navigation assistance system for wirelessly controlling two or more handheld surgical instruments is provided. The system includes a handheld surgical instrument including an instrument processor and a control system configured to wirelessly transmit a broadcast signal including a pairing identifier and a control signal including a control identifier to the handheld surgical instrument. The instrument processor is configured to receive the broadcast signal and the control signal, determine whether the control identifier corresponds to the pairing identifier, and control a parameter of the handheld surgical instrument in response to determining that the control identifier corresponds to the pairing identifier.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims all benefit of and priority to U.S. Provisional Patent Application No. 63 / 375,055, filed September 8, 2022, the entire contents of which are expressly incorporated herein by reference. [Background technology]

[0002] Among the most important instruments available to medical personnel in modern surgery are handheld surgical tools such as burrs, razors, drills, saws, wire drivers, and ultrasonic tools. These handheld surgical tools are often powered, and therefore it is often desired that the tools be cordless for maneuverability and convenience, and therefore powered by a portable power source such as a rechargeable battery.

[0003] Navigation-assisted surgery offers improvements in pre-operative planning and peri-operative execution of pre-operative planning. Known systems visualize in real time the appearance of the instrument relative to the patient's anatomy by tracking with a localizer detecting navigation array coupled to the instrument.

[0004] Navigation-assisted surgery involving handheld surgical instruments is a particularly interesting and rapidly developing field. In certain procedures, such as spinal fusion, vertebral bodies receive pedicle screws. This is known to involve the use of a drill to create pilot holes in the cortical wall, a tap to form threads in the pilot holes, and a driver to secure the pedicle screws into the formed threads. Therefore, while it may be desirable to have multiple handheld surgical instruments in the sterile field, efficiently transitioning between these instruments in navigation-assisted surgery remains fraught with shortcomings. In each instance, it may be desirable to change instruments, and medical personnel may be required to interact with a user interface to ensure the system is tracking the correct instrument. For example, a surgeon may have to pause aspects of the procedure and engage a touchscreen display through multiple steps to have the localizer detect the navigation array of the instrument they wish to use. Systems involving state-of-the-art electronics, where each surgical instrument must be independently and simultaneously registered and controlled by the system, are complex and expensive, and the current state of the art lacks a navigation-assisted surgery system that can meaningfully integrate traditional instruments with the control-based and other desirable features of navigation-assisted surgery. Summary of the Invention

[0005] The presently disclosed navigation-assisted surgery system overcomes one or more of the aforementioned drawbacks. The navigation-assisted surgery system includes a display device, a user interface, a memory device, and a navigation controller in wired or wireless electronic communication with the user interface, the display device, and the memory device. The localizer detects and / or senses tracking elements of a navigation array coupled to a handheld surgical tool of a surgical instrument. The navigation controller receives an identification signal from the localizer tracking the navigation array. Each tracking element of the navigation array may have a different or unique configuration, arrangement, size, and / or shape. The localizer transmits the identification signal to the navigation controller. The identification signal indicates the arrangement of the tracking elements.

[0006] The surgical instrument includes a power source. The power source may be a rechargeable battery removably coupled to the handheld surgical instrument. A communication module of the power source is configured to wirelessly communicate with a communication module of the navigation-assisted surgical system. The navigation controller may receive at least a battery signal from the communication module, and the navigation controller may be further configured to cause at least a control signal to be transmitted from the communication module to the communication module of the power source.

[0007] The association between the navigation array, the end effector, and the power source may be established during pre-operative planning. The workflow may be performed on a GUI. The workflow includes a navigation controller receiving an identification signal. The action may be performed automatically, such that establishing the identity of the navigation array may be performed by machine vision. Alternatively, a user may provide user input to the GUI to establish the identity of the navigation array. The identification signal may be provided to the navigation controller, and the identity of the first navigation array may be stored in a memory device.

[0008] The navigation controller can create a first association between the end effector and the navigation array. The user input to the GUI can include a selection of an end effector type. The navigation-assisted surgery system can include a camera configured to capture images of the end effector, and an algorithm determines the identity of the end effector.

[0009] The navigation controller receives a battery signal transmitted wirelessly from the power source during operation of the handheld surgical tool. The power source provides current to the motor, and the battery signal may indicate the current being supplied by or drawn from the power source. The communication module of the power source wirelessly transmits the battery signal to a communication module of the navigation-assisted surgical system. The communication module may transmit the battery signal to the navigation controller. The battery signal or another signal may indicate the identity of the power source. The battery signal or another signal may transmit a code or authentication signature unique to the power source. Alternatively, two-way wireless communication may be established between the power source and the communication module, and the identity of the power source is transmitted to the navigation controller and stored in a memory device.

[0010] The navigation controller generates a second association between the power source and the navigation array based on the battery signal. The GUI may display a prompt or instruction to the user to operate the handheld surgical instrument. The prompt may be an arrow or other indicia, such as an animation, audible feedback, and / or tactile feedback. The navigation controller receives the battery signal and associates the identity of the power source with the identity of the navigation array. It is understood that additional associations may be provided between the power source and another identifiable component of the end effector or surgical instrument. The second association is stored in a memory device. The workflow may be performed for any number of additional surgical instruments. The workflow may be repeated for as many surgical instruments as shown.

[0011] The navigation-assisted surgery system independently tracks and controls the operation of each of the surgical instruments, particularly through wireless transmission of control signals to the power source. The navigation controller creates an association between the navigation array, the end effector, and the power source. Based on the association, the navigation-assisted surgery system can be configured to determine in real time the position and / or orientation of one or more end effectors, associate it with predefined virtual boundaries of respective aspects of the surgical plan, associate it with the power source, maintain bidirectional wireless communication with the associated power source, and transmit control signals to the associated power source when the determined position and / or orientation of the end effector crosses the associated predefined virtual boundary.

[0012] The navigation controller may determine the attitude of the patient tracker and the position and / or orientation of the end effector based on the attitude of the navigation array. The navigation-assisted surgery system is configured to continuously determine the position and / or orientation of the end effector relative to a predefined virtual boundary. If the position and / or orientation of the end effector approaches or crosses the predefined virtual boundary, the navigation-assisted surgery system is configured to alter the operation of the surgical instrument and / or activate a notification (alarm) device. The navigation-assisted surgery system may control the power source based on the position and / or orientation of the end effector and the attitude of the patient tracker. The navigation-assisted surgery system may wirelessly send a control signal to the communication module of the power source to alter, e.g., stop, the supply of current or power to the handheld surgical instrument, more particularly to the motor. The navigation-assisted surgery system may be configured to prevent the operation of the surgical instrument when the end effector is positioned or angled beyond a threshold magnitude from an aspect of the surgical plan, e.g., a target axis. Determination of the offset between the end effector and the target depth, target axis, etc. may be measured relative to a reference point and / or reference coordinate system defined in a known coordinate system.

[0013] The navigation-assisted surgical system may be configured to alter the operation of the surgical instrument by reducing the current supplied to the motor. The maximum output power may be reduced to an amount less than the power required to operate the surgical instrument at full speed or capacity. The motor may be a variable speed motor and may be designed to reduce speed when it is not receiving the power required to operate at full speed or capacity. If a particular end effector is configured to perform optimally at a different speed and / or torque, reducing the maximum output power of the power source to control the maximum speed of the surgical instrument may be related to the identity of the end effector.

[0014] By virtue of storing the associations established during pre-operative preparation, the navigation-assisted surgery system may control, or at least have the means to control, all of the surgical instruments simultaneously, thereby enabling the surgeon to handle and interchange multiple surgical instruments without further action. The navigation-assisted surgery system may not be assertive about which of the surgical instruments is being handled by the surgeon. When a predefined virtual boundary is crossed by one of the surgical instruments in operation, the navigation system may wirelessly transmit a control signal to the appropriate one of the power sources.

[0015] It may be desirable for the navigation-assisted surgical system to know which of the surgical instruments is in use. If the tracking array of only one of the surgical instruments is within the field of view of the localizer, the navigation-assisted surgical system may determine that the surgical instrument is in use. The navigation controller may generate or receive an in-use signal indicating that a particular one of the surgical instruments is in use. The navigation controller may create a second association between the power source and the navigation array based on the in-use signal. The in-use signal may be stored in a memory device. In an alternative example where more than one of the surgical instruments is within the field of view of the localizer, the navigation-assisted surgical system may request the surgeon to perform a “test pull” to determine which of the surgical instruments is in use. At that moment, a battery signal indicating the power drawn from the power source is wirelessly transmitted from the communication module of the power source to the communication module of the navigation-assisted surgical system. The battery signal is received by the navigation controller, which accesses the stored association stored in the memory device. Based on the stored associations, the navigation controller determines which one of the surgical instruments is in use.

[0016] The power source may include an inertial sensor configured to generate a movement signal when the handheld surgical instrument is handled. The inertial sensor is in electronic communication with a communication module of the power source. The movement signal may be generated by the inertial sensor and transmitted wirelessly to the communication module. The inertial sensor that generates the movement signal may also be used to associate the power source with the navigation array (and / or end effector) during pre-operative preparation. The navigation controller receives the movement signal, which indicates that the handheld surgical instrument is being handled or manipulated by a user, as detected by the inertial sensor. The navigation controller generates a third association between the power source and the navigation array based on the movement signal. The third association may be stored in a memory device.

[0017] The GUI may display prompts to guide the user to handle or manipulate one of the surgical instruments. The prompts may be arrows indicating a gesture the user should mimic to generate a movement signal. The movement may be six degrees of freedom, and the movement signals received by the navigation controller are compared to the gestures displayed on the GUI. If the movement signals match the gestures, the navigation controller generates a third association based on the movement signals. Any and all of the functionality of the navigation-assisted surgery system described herein may be realized by this embodiment using inertial sensors. The movement signals may also facilitate the navigation-assisted surgery system in determining which surgical instrument is in use.

[0018] Advantages of the present disclosure will be readily apparent as they become better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0019] [Figure 1] 1 is a perspective view of an exemplary arrangement of a surgical environment including a navigated surgical system and surgical instruments; [Figure 2] FIG. 1 is a schematic diagram of a surgical instrument within the field of view (FOV) of a localizer of a navigation-assisted surgery system. [Figure 3] FIG. 1 illustrates a display device displaying a graphical user interface (GUI) illustrating the steps of correlating components of a surgical instrument. [Figure 4] FIG. 10 shows a GUI illustrating another step in correlating components of a surgical instrument. [Figure 5] FIG. 10 shows a GUI illustrating another step in correlating components of a surgical instrument. [Figure 6] 1 is a schematic illustration of a surgical instrument positioned and oriented relative to a predefined virtual boundary and a predefined virtual region. Certain components of the navigation-assisted surgical system and the surgical instrument are represented schematically. [Figure 7]FIG. 1 illustrates a user being able to manipulate a surgical instrument in six degrees of freedom to mimic gestures displayed in a GUI to correlate components of the surgical instrument. [Figure 8] 1 is a flowchart detailing a method for controlling a handheld surgical tool. [Figure 9] 10 is a flow chart detailing an alternative method of controlling a handheld surgical tool including a power source in use. [Figure 10] 1 is a perspective view of an exemplary arrangement of a surgical environment including surgical instruments coupled to a surgical console. [Figure 11] 1 is a schematic diagram of a surgical environment including a navigation-assisted surgical system and two surgical instruments. [Figure 12] FIG. 12 is a schematic diagram of a method for pairing and controlling a surgical instrument by the navigation-assisted surgery system of FIG. 11. [Figure 13] FIG. 1 is a schematic diagram of a surgical environment including two navigation-assisted surgical systems and four surgical instruments. DETAILED DESCRIPTION OF THE INVENTION

[0020] 1 illustrates a surgical environment 10 including a navigation-assisted surgery system 12 for correlating components of at least one surgical instrument 100, 200, 300 to be used in navigation-assisted surgery. The component association may be performed during pre-operative preparation by an operating room technician or other medical personnel or before a surgeon performs a surgical plan for a medical procedure. The navigation-assisted surgery system 12 may further track and control the surgical instruments 100, 200, 300 to assist the surgeon in performing the medical procedure.

[0021] The navigation-assisted surgical system 12 includes a display device 14 and a user interface 16. The display device 14 and the user interface 16 may be integrated into a touchscreen display to provide a graphical user interface (GUI) 18. The display device 14 is configured to display information such as preoperative patient images and a surgical plan. For example, the surgical plan may include a predefined trajectory for an implant, such as a pedicle screw. The surgical plan may also include overlaying the position and / or orientation of the implant onto the patient image or data. The GUI 18 may be configured to allow the surgeon to input, select, edit, and / or manipulate the patient data and / or the surgical plan. In a spinal fixation procedure, the surgeon may enter information regarding the location, orientation, target location, and target depth at which the pedicle screw should be implanted, and / or the size and shape of the pedicle screw. The surgeon may also be able to identify critical anatomical features, such as cortical walls, nerves, blood vessels, or similar critical anatomical structures, from which predefined virtual boundaries or regions may be utilized to facilitate execution of the surgical plan by the navigation-assisted surgical system 12.

[0022] The navigation-assisted surgical system 12 includes a navigation controller 20. The navigation controller 20 is in wired or wireless electronic communication with the user interface 16, the display device 14, a central processing unit (CPU) and / or other processor, a memory device 26, and other hardware. The navigation controller 20 may include non-transitory computer memory for executing software and / or operating instructions related to the operation of the navigation-assisted surgical system 12 and the implementation of the methods disclosed herein. The localizer 22 includes one or more sensors 24 adapted to detect and / or sense the positions of tracking elements 135, 235, 335 of a navigation array 130, 230, 330 coupled to the handheld surgical tools 120, 220, 320 of the surgical instrument 100, 200, 300. One suitable localizer is disclosed in commonly assigned U.S. Patent No. 10,531,926, issued January 14, 2020, the entire contents of which are incorporated herein by reference. The localizer 22 is in communication with the navigation controller 20, which is configured to receive identification signals from the localizer 22 that track the navigation arrays 130, 230, 330.

[0023] In the illustrated embodiment, each of the handheld surgical tools 120, 220, 320 may have similar or identical structures, with several similar components capable of performing similar functions and / or operations, as described below. In alternative embodiments, the handheld surgical tools 125, 225, 325 may have different structures. The handheld surgical tools 125, 225, 325 are shaped to define a handle or gripping portion that is held by a surgeon during the performance of a medical procedure. The handheld surgical tools 125, 225, 325 may include a motor 145, 245, 345, and the surgical instruments 100, 200, 300 include an end effector 140, 240, 340 configured to be operably coupled to the motor 145, 245, 345. In the example of spinal fixation, the first end effector 140 may be a drill bit such that the first surgical instrument 100 operates as a drill, the second end effector 240 may be a tap bit such that the second surgical instrument 200 operates as a tap, and the third end effector 340 may be a driver tip configured to engage a pedicle screw such that the third surgical instrument 300 operates as a driver. The motors 145, 245, 345 may be configured to rotate the end effectors 140, 240, 340 to drill and tap pilot holes and / or drive pedicle screws. Other surgical instruments contemplated for use with the navigation-assisted surgical system 12 of the present disclosure include ultrasonic cutting instruments, burrs, razors, bone saws, and ablation electrodes, among others.

[0024] The navigation array 130, 230, 330 may be removably coupled to the handheld surgical tool 125, 225, 325 (and / or end effector 140, 240, 340) of the surgical instrument 100, 200, 300. One suitable coupler for removably coupling the navigation array 130, 230, 330 to the handheld surgical tool 125, 225, 325 is disclosed in commonly-owned U.S. Provisional Patent Application No. 63 / 154,273, filed February 26, 2021, the entire contents of which are incorporated herein by reference. The tracking elements 135, 235, 335 of the navigation array 130, 230, 330 may be passive tracking elements (e.g., reflectors) for reflecting light emitted from the localizer 22, active tracking elements (e.g., light-emitting diodes), or a combination thereof. Alternatively, the navigation-assisted surgery system 12 may utilize electromagnetic, radio frequency, or other suitable means for tracking the position and orientation (posture) of the navigation arrays 130, 230, 330. Calibration data associated with the end effectors 140, 240, 340 stored in the memory device 26 is associated with each one of the navigation arrays 130, 230, 330 in a manner described below, after which the navigation controller 20 can determine the position and / or orientation of the end effector 140, 240, 340, e.g., the tip of the end effector 140, 240, 340.

[0025] The tracking elements 135, 235, 335 of the navigation arrays 130, 230, 330 may each have a different or unique configuration, arrangement, size, and / or shape, such that the localizer 22 is configured to distinguish between the first navigation array 130, the second navigation array 230, and the third navigation array 330. The different arrangements are generally represented by the unique geometries shown in Figures 1 and 2. More specifically, based on the arrangement and / or spatial orientation of the tracking elements 135, 235, 335, the localizer 22 transmits an identification signal to the navigation controller 20, which is used to create specific associations between components of the surgical instruments 100, 200, 300, as described further below. In alternative configurations, such as those in which the tracking elements 135, 235, 335 are configured to pulse in a manner unique to the corresponding navigation array 130, 230, 330, the localizer 22 may transmit an identification signal to the navigation controller 20 based on detecting the pulse pattern of the tracking elements 135, 235, 335 of the navigation array 130, 230, 330. In yet other configurations, each array may include its own unique identifier and may transmit the unique identifier to the localizer using a transmitter, such as an antenna or infrared sensor / emitter. In another alternative configuration, such as a configuration in which the tracking elements 135, 235, 335 are configured to transmit navigation array signals specific to the corresponding navigation arrays 130, 230, 330 (e.g., a configuration in which the tracking elements 135, 235, 335 are antennas), the localizer 22 may transmit an identification signal to the navigation controller 20 based on receiving the navigation array signals from the tracking elements 135, 235, 335 of the navigation arrays 130, 230, 330.

[0026] 2 , the surgical instrument 100, 200, 300 includes a power source 160, 260, 360, e.g., a rechargeable battery. The power source 160, 260, 360 is configured to be removably coupled to the handheld surgical tool 120, 220, 320 and in electrical communication with the motor 145, 245, 345. The power source 160, 260, 360 is configured to selectively power the motor 145, 245, 345 to operate the end effector 140, 240, 340, e.g., upon activation of a switch 150, 250, 350 on the handheld surgical tool 120, 220, 320. Energizing the motor 145, 245, 345 changes the characteristics of energy provided by the power source 160, 260, 360. The energy characteristic may be the current draw or voltage drop in the power source 160, 260, 360 corresponding to the current supplied to the motor 145, 245, 345. The battery signal may indicate the current draw or voltage drop in the power source 160, 260, 360. In certain embodiments, the first surgical instrument 100 includes a first power source 160, the second surgical instrument 200 includes a second power source 260, and the third surgical instrument 300 includes a third power source 360. However, it is contemplated that the surgical environment 10 may include fewer power sources than handheld surgical instruments, and that power sources may be interchangeably moved and correlated between handheld surgical instruments in a manner described further below.

[0027] The power sources 160, 260, 360 include communication modules 165, 265, 365. The communication modules 165, 265, 365 of the power sources 160, 260, 360 are configured to communicate wirelessly with the communication modules 28 of the navigation-assisted surgical system 12. One exemplary wireless technology facilitating wireless communication between the communication modules 28, 165, 265, 365 is the Bluetooth® Low Energy protocol, although Wi-Fi, cellular, and other wireless technologies may also be utilized. The communication modules 165, 265, 365 of the power sources 160, 260, 360 may be transceivers configured to send signals to and receive signals from the communication modules 28 in electronic communication with the navigation controller 20. More specifically, the navigation controller 20 may be configured to receive at least a battery signal from the communications module 28, and the navigation controller 20 may further be configured to cause at least a control signal to be transmitted from the communications module 28 to the communications modules 165, 265, 365 of the power sources 160, 260, 360. Additional data and / or signals may be exchanged, such as signals indicating battery levels, or alerts or notifications, etc.

[0028] For convenience or efficiency in executing a surgical plan, it may be desirable to have multiple handheld surgical instruments near the surgical field, and more particularly, simultaneously within the field of view of the localizer 22. FIG. 1 shows a surgeon holding a first surgical instrument 100, with second and third surgical instruments 200, 300 positioned proximal to the surgical site 30 so as to be detectable by the localizer 22. FIG. 2 schematically depicts the first, second, and third surgical instruments 100, 200, 300 in the field of view (FOV) of the localizer 22. Efficiency is achieved by the presently disclosed navigated-assisted surgery system 12 being configured to independently track and control the operation of each of the surgical instruments 100 wirelessly, particularly through wireless transmission of control signals to the power sources 160, 260, 360. By utilizing the power source 160, 260, 360 in this manner, the internal hardware of the handheld surgical tool 120, 220, 320 does not necessarily need to include cutting edge electronics with its attendant complexity and increased manufacturing and assembly costs. Furthermore, doing so may enable tracking and control of conventional surgical tools, thereby eliminating the need to replace tools to retrofit a suite of surgical tools with navigational assistance capabilities.

[0029] To achieve such advantageous functionality, associations between the navigation arrays 130, 230, 330, the end effectors 140, 240, 340, and / or the power sources 160, 260, 360 are generated or determined by the navigation controller 20 of the navigated-assisted surgery system 12 and stored in the memory device 26. In other words, based on signals received during pre-operative preparation and / or during the performance of a procedure, the navigation controller 20 may determine which of multiple end effectors and multiple power sources are coupled to a given navigation array. For example, the navigation controller 20 may determine that the drill bit and first power source 160 are associated with the first navigation array 130, the tap bit and second power source 260 are associated with the second navigation array 230, and the driver tip and third power source 360 ​​are associated with the third navigation array 330. The aforementioned associations allow for end effectors 140, 240, 340 to be correlated to different aspects of the surgical plan, where different predefined virtual boundaries or regions are defined based on the end effectors 140, 240, 340 themselves. In other words, for example, the depth to which a pedicle screw may be allowed to be driven into a vertebra may be greater than the depth to which a drill may be allowed to prepare a pilot hole. Particular aspects of controlling the surgical instruments 100, 200, 300 are further described with reference to FIG. 6 , and additional disclosure is further described in commonly owned International Application PCT / US2020 / 053092, filed September 28, 2020, the entire contents of which are incorporated herein by reference. Briefly, the navigated-assisted surgery system 12 is configured to determine, in real time, the position and / or orientation of one or more end effectors 140, 240, 340 relative to the predefined virtual boundaries of each aspect of the surgical plan.Also, by maintaining two-way wireless communication with the associated power source 160, 260, 360, a control signal may be sent to the associated power source 160, 260, 360 when the determined position and / or orientation of the end effector 140, 240, 340 crosses an associated predefined virtual boundary.

[0030] The associations between the navigation array 130, 230, 330, the end effector 140, 240, 340, and the power source 160, 260, 360 may be established during pre-operative planning. It is also understood that the associations may be established or re-established during the execution of surgical planning for various reasons. Referring now to Figures 3-5, an exemplary workflow for establishing correlations is described. The exemplary workflow described may be considered "navigation array centric," in that the identity of the navigation array 130, 230, 330 is first established, and the end effector 140, 240, 340 and the power source 160, 260, 360 are associated with the identity of the navigation array 130, 230, 330. However, it is also contemplated that an alternative method may be "end-effector-centric" or "power source-centric," where the identity of each end effector 140, 240, 340 or power source 160, 260, 360 is first established and other components are associated with that identity. Further described methods include automatically detecting the identity of one or more of the navigation array 130, 230, 330, end effector 140, 240, 340, and power source 160, 260, 360 using machine vision or some alternative data reader, such as an optical reader or a radio frequency identification reader.

[0031] The workflow may be performed on the GUI 18, which may be a touchscreen display of the display device 14. The workflow involves the navigation controller 20 receiving an identification signal indicative of the navigation arrays 130, 230, 330. After the workflow is initiated, the GUI 18 may prompt the user to move the first surgical instrument 100, to which the first navigation array 130 is coupled, within the field of view of the localizer 22. The localizer 22 detects the alignment of the first tracking elements 135 of the first navigation array 130 and provides an identification signal to the navigation controller 20 based on the alignment. The navigation controller 20 may compare the identification signal with calibration data from a database of predefined navigation arrays. If the identification signal matches the calibration data for the first navigation array 130, the navigation controller 20 stores the identity of the first navigation array 130 in the memory device 26. The foregoing actions may be performed automatically, such that establishing the identity of the navigation arrays 130, 230, 330 may be performed by machine vision. As shown in Figure 3, the GUI 18 may provide a visual highlight to notify the user that the first navigation array 130 has been successfully identified, and may also provide a graphical representation of the first navigation array 130 so that the user can perform visual confirmation, if desired.

[0032] In particular embodiments, the user may be prompted to establish the identity of the navigation arrays 130, 230, 330 and then provide input to the GUI 18 to establish the identity. The GUI 18 may provide a graphical representation of all navigation arrays 130, 230, 330 currently detected by the localizer 22. The user may then select, on the GUI 18, which of the navigation arrays 130, 230, 330 to continue further configuration with. Figure 3 illustrates such an example, in which the localizer 22 has detected the first, second, and third navigation arrays 130, 230, 330 and the GUI 18 provides their graphical representations (in addition to text-based output). A user may select a navigation array 130, 230, 330 on the GUI 18 based on an arrangement of tracking elements 135, 235, 335 that matches the arrangement of tracking elements 135, 235, 335 supported on the handheld surgical tool 120, 220, 320 currently being held by the user. In other words, a user may hold one of the handheld surgical tools 120, 220, 320, observe the arrangement of tracking elements 135, 235, 335, and select a navigation array 130, 230, 330 that matches that arrangement on the GUI 18. In the illustrated example, the user selects a first navigation array 130, after which its icon may be visually highlighted. An identification signal may be provided to the navigation controller 20, and the identity of the first navigation array 130 may be stored in the memory device 26.

[0033] Referring to FIG. 4 , on subsequent output of the GUI 18, the workflow may include creating, by the navigation controller 20, a first association between the end effector 140, 240, 340 and the navigation array 130, 230, 330. The input may be a user input to the GUI 18 including a selection of a type of end effector 140, 240, 340. A type of surgical procedure may have been input in a previous step of the workflow, and the GUI 18 may display one or more of the end effectors 140, 240, 340 required for that type of surgical procedure. The end effectors 140, 240, 340 required for a spinal fixation procedure may include, for example, a drill bit, a tap bit, or a driver tip, as shown in FIG. 4 . Alternatively, a list of all potential end effectors may be provided on the GUI 18, for example, in a scrollable list. The user may select an end effector 140, 240, 340 on the GUI 18 that matches that of the end effector 140, 240, 340 coupled to the handheld surgical tool 120, 220, 320 currently being held by the user. In other words, the user may hold one of the handheld surgical tools 120, 220, 320, observe the end effectors 140, 240, 340, and select the appropriate end effector 140, 240, 340 on the GUI 18. In the illustrated example, the user selects the first end effector 140, after which its icon may be visually highlighted. Input may be provided to the navigation controller 20, and the input may be stored in the memory device 26.

[0034] In an alternative embodiment, the navigation-assisted surgery system 12 includes a camera (not shown) configured to capture images of the end effector 140, 240, 340. The images are processed by an algorithm in which characteristics of the end effector 140, 240, 340 that are identifiable in the captured images are used to automatically determine the identity of the end effector. Inputs provided to the navigation controller 20 are generated by machine vision.

[0035] The GUI 18 may display a graphical representation of the identity of the navigation array 130, 230, 330 previously established during the step of receiving input indicating the identity of the end effector 140, 240, 340. Figure 4 shows that the first navigation array 130 is displayed on the GUI 18 based on the selection from Figure 3 for convenient user reference during subsequent steps of the workflow.

[0036] The navigation controller 20 is configured to create a first association between the end effector 140, 240, 340 and the navigation array 130, 230, 330 based on the input and the identification signal. The first association may include associating calibration data of the end effector 140, 240, 340 with the navigation array 130, 230, 330, and more particularly, with the tracking elements 135, 235, 335 of the navigation array 130, 230, 330. As a result, the navigation controller 20 may determine and track the position and / or orientation of the end effector 140, 240, 340 as long as the tracking elements 135, 235, 335 remain within the field of view of the localizer 22. The first association may be stored in the memory device 26.

[0037] 5 , the workflow further includes using the navigation controller 20 to receive a battery signal transmitted wirelessly from the power source during operation of the handheld surgical tool 120, 220, 320. More specifically, during operation of the switch 150, 250, 350 or other electrical component capable of controlling the energy provided to the tool from the power source 160, 260, 360, the power source 160, 260, 360 provides current to the motor 145, 245, 345, and the battery signal may indicate the current being provided by or drawn from the power source 160, 260, 360. The communication module 165, 265, 365 of the power source 160, 260, 360 wirelessly transmits the battery signal to the communication module 28 of the navigation-assisted surgical system 12. The communication module 28 may transmit the battery signal to the navigation controller 20.

[0038] The battery signal or another signal may indicate the identity of the power source 160, 260, 360. In other words, the battery signal or other signal may transmit a code or authentication signature unique to the power source 160, 260, 360. Alternatively, during an earlier step in the workflow, bidirectional wireless communication may be established between the power source 160, 260, 360 and the communications module 28, and the identity of the power source 160, 260, 360 may be transmitted to the navigation controller 40 and stored in the memory device 26. For example, the power sources 160, 260, 360 may be “paired” to establish Bluetooth® wireless communication, after which the communications module 28 may instantly and / or simultaneously send a signal to one or more of the power sources 160, 260, 360 through known means of the Bluetooth® communication protocol.

[0039] The navigation controller 20 creates a second association between the power source 160, 260, 360 and the navigation array 130, 230, 330 based on the battery signal during operation of the handheld surgical instrument 120, 220, 320. When the handheld surgical instrument 120, 220, 320 is activated such that it is configured with a known one of the navigation arrays 130, 230, 330 and the navigation array 130, 230, 330 is within the field of view of the localizer 22, the navigation controller 20 receives the battery signal and associates the identity of the power source 160, 260, 360 with the identity of the navigation array 130, 230, 330. It is understood that a second or another association may also be between the power source 160, 260, 360 and another identifiable component of the end effector 140, 240, 340 or surgical instrument 100, 200, 300. The second association is stored in memory device 26; for example, the association may be stored in a look-up table.

[0040] To facilitate the creation of the second association, the GUI 18 may display a prompt 91 or instruction to the user to activate the handheld surgical tool 120, 220, 320. FIG. 5 shows a graphical representation of the surgical instrument 100, 200, 300. An exemplary prompt 91 is an arrow near the location of the switch 150, 250, 350 instructing the user to engage (e.g., pull the trigger) the switch 150, 250, 350. Other types of prompts are contemplated that provide intuitive instructions to the user to complete this step in the workflow, such as, for example, animation or other visual indicia, audible feedback, and / or tactile feedback. The GUI 18 may also display a graphical representation of the previously established identity of the navigation array 130, 230, 330 and / or the identity of the end effector 140, 240, 340. 5 illustrates that the first navigation array 130 and first end effector 140 are displayed on the GUI 18 based on the selections / inputs from FIGS. 3 and 4 for convenient user reference. Additionally, a graphical representation may be provided of the previously established navigation arrays 130, 230, 330 and / or end effectors 140, 240, 340. FIG. 5 illustrates that the first navigation array 130 and first end effector 140 are coupled to the first handheld surgical tool 120, the appearance of which should match the appearance of the first surgical instrument 100 held by the user. For example, the GUI 18 may indicate one or more colors or alphanumeric characteristics associated with the tracking arrays 130, 230, 330 that are associated with the identity of the end effector 140, 240, 340.

[0041] The above-described workflow may be performed for a single one of the surgical instruments 100, 200, and 300. In an exemplary embodiment, the same or similar preoperative setup may be performed for the second instrument 200, the third surgical instrument 300, and any number of additional surgical instruments. Following registration of the surgical instruments by correlation with the navigation-assisted surgical system 12 and its components, the surgical procedure may proceed with execution of the surgical plan. The surgical plan may be stored in the memory device 26. Preoperatively, the anatomical model is registered to a patient tracker (not shown) coupled to the patient so that a virtual boundary is associated with the anatomical model and associated coordinate system. The patient tracker may be, for example, a navigation array firmly fixed to the patient's vertebrae or other bones. The patient tracker includes tracking elements detectable by the localizer 22, so that the pose of the patient tracker can be determined by the navigation controller 20. The tracking elements 135, 235, 335 of the navigation array 130, 230, 330 can also be detected by the localizer 22, and the attitude of the navigation array 130, 230, 330 can be determined by the navigation controller 20. The navigation controller 20 can further determine the position and / or orientation of the end effector 140, 240, 340 based on the attitude of the navigation array 130, 230, 330.

[0042] 6, the navigation-assisted surgery system 12 may be configured to define notification (warning) regions and / or boundaries corresponding to target or maximum depths for each of the end effectors 140, 240, 340. For example, a first virtual boundary represents a target depth for a drill for drilling a hole, a second virtual boundary represents a target depth for a tap, and a third virtual boundary represents a target depth for a driver for inserting a screw. These multiple virtual boundaries may be activated one at a time by the navigation controller 20.

[0043] 6 shows a schematic representation of predefined virtual boundaries (Boundaries 1, 2, 3) overlaid on a patient image of the patient's anatomy at the surgical site 30. The virtual boundaries can be used in a variety of ways. For example, the navigation controller 20 can control specific movements / functions of the handheld surgical instruments 120, 220, 320 based on the relationship (e.g., spatial, velocity, etc.) of the handheld surgical instruments 120, 220, 320 and / or associated end effectors to the boundaries. Other uses of boundaries are also contemplated.

[0044] The boundary for ensuring that the instrument is positioned at the desired depth may be defined by a virtual planar boundary, a virtual volume boundary, or other form of virtual boundary. The virtual boundary may also be referred to as a virtual object. The virtual boundary may be defined relative to an anatomical model, such as a 3D bone model. In other words, points, lines, axes, trajectories, planes, volumes, etc. associated with the virtual boundary may be defined in a coordinate system defined relative to the coordinate system of the anatomical model, such that tracking of the anatomical model (e.g., by tracking associated anatomical structures registered to the anatomical model) also enables tracking of the virtual boundary.

[0045] In instances where the navigation-assisted surgical system 12 includes two or more surgical instruments 100, 200, 300, the navigation controller 20 may optionally be configured to select a predefined virtual boundary based on the end effector 140, 240, 340 associated with the navigation array 130, 230, 330 in use. For example, in instances where the navigation-assisted surgical system 12 includes a first surgical instrument 100 having a first end effector 140 and a second surgical instrument 200 having a second end effector 240 of a different type than the first end effector 140, the navigation controller 20 may determine whether the navigation array 130 associated with the first end effector 140 or the second navigation array 230 associated with the second end effector 240 is in use. The navigation controller 20 may then select a predefined virtual boundary based on the end effector corresponding to the navigation array in use. Methods and systems by which the navigation controller 20 determines which navigation array 130, 230, 330 is in use are described in more detail below. By providing this confirmation of which navigation array is in use, the system can help mitigate the risk of inadvertently controlling the wrong surgical instrument based on the intended virtual boundary. In certain embodiments of the system, the act of confirming which array is in use is omitted. In such embodiments, the first and second associations may be used instead.

[0046] The virtual boundary may be one-dimensional, two-dimensional, or three-dimensional and may include a volume or other shape, including complex geometric shapes. The virtual boundary may be represented by pixels, point clouds, voxels, triangular meshes, etc. The virtual boundary may be implant-specific (e.g., defined based on the size and shape of the pedicle screw) and / or patient-specific (e.g., defined based on the patient's anatomy). The virtual boundary may be created preoperatively, intraoperatively, or a combination thereof. The virtual boundary may be defined in a coordinate system defined relative to the coordinate system of the anatomical model, such that tracking of the anatomical model also enables tracking of the virtual boundary. The virtual boundary may be stored in memory device 26 for retrieval and / or updating. Further disclosure regarding defining boundaries and notification areas is disclosed in the aforementioned International Patent Application PCT / US2020 / 053092, and further in commonly assigned U.S. Patent No. 7,747,311, issued June 29, 2010, U.S. Patent No. 8,898,043, issued November 25, 2014, and U.S. Patent Publication No. 2018 / 0333207, published November 22, 2018, the entire contents of each of which are incorporated herein by reference.

[0047] The navigation-assisted surgical system 12 may be configured to continuously determine the position and / or orientation of the end effector 140, 240, 340 relative to one or more virtual boundaries. The navigation-assisted surgical system 12 may do so simultaneously for all of the surgical instruments 100, 200, 300 within the field of view of the localizer 22. If the end effector 140, 240, 340 is away from the virtual boundary, the surgical instrument 100, 200, 300 may operate normally. If the position and / or orientation of the end effector 140, 240, 340 approaches or crosses a predefined virtual boundary, the navigation-assisted surgical system 12 may alter the operation of the surgical instrument 100, 200, 300 and / or activate a notification device 255, 355, 455. One exemplary manner in which the navigation-assisted surgical system 12 alters the operation of the surgical instrument 100, 200, 300 is to at least temporarily prevent its operation. To do so, the navigation-assisted surgical system 12 may control and / or communicate with the power source 160, 260, 360 based on the position and / or orientation of the end effector 140, 240, 340 and the pose of the patient tracker or the pose of the patient determined in an alternative manner, such as using a surface topology system. In an exemplary embodiment, the communication module 28 of the navigation-assisted surgical system 12 may wirelessly transmit control signals to the communication modules 165, 265, 365 of the power source 160, 260, 360. The control signals may alter, e.g., stop, the supply of current or power to the handheld surgical tool 120, 220, 320, and more particularly to the motors 145, 245, 345. If no power is available, the motors 145, 245, 345 will be deactivated and the surgical instrument 100, 200, 300 will be prevented from operating. The control signal may alternatively brake the motor 145, 245, 345. The motor 145, 245, 345 and drive train of the handheld surgical tool 120, 220, 320 may be designed to limit any latency between an interruption in power and the end effector 140, 240, 340 coming to rest.

[0048] For example, with continued reference to FIG. 6 , the first end effector 140 is oriented relative to a target depth (T) on a target axis (axis T). The first end effector 140 is a drill bit configured to drill a pilot hole through the pedicle of a vertebra (surgical site 30) along the target axis to a target depth defined in the surgical plan. The target axis, target depth, or other aspects of the surgical plan may be defined by the surgeon and / or automatically generated based on segmentation of patient image data and an algorithm that determines the optimal target axis for a given patient anatomy. When the first end effector 140 approaches or crosses boundary 1, the navigation controller 20 wirelessly sends a control signal to the first power supply 160 to alter, e.g., terminate, or brake the current supplied to the first motor 145. The interruption in the operation of the first surgical instrument 100 should be noticeable to the surgeon.

[0049] It is also contemplated that the navigation-assisted surgical system 12 may be configured to prevent operation of the surgical instrument 100, 200, 300 when the end effector 140, 240, 340 is positioned or angled beyond a threshold amount from the surgical plan. The surgical instrument 100, 200, 300 may be disabled if it is not within a threshold range from the intended patient anatomy, as opposed to requiring a predefined virtual boundary to be breached. Determining the offset between the end effector 140, 240, 340 and the target depth, etc., may be measured relative to a reference location (RL) and / or reference coordinate system defined in a known coordinate system.

[0050] In certain embodiments, the navigation-assisted surgical system 12 may be configured to alter the operation of the surgical instrument 100, 200, 300 by reducing the current supplied to the motor 145, 245, 345. With appropriate circuitry in the power source 160, 260, 360, the maximum output power may be reduced to an amount less than the power required to operate the surgical instrument 100, 200, 300 at full speed or capacity. The motor 145, 245, 345 may be a variable speed motor and accordingly designed to reduce its speed when it is not receiving the power required to operate at full speed or capacity. Such an arrangement may be particularly well suited for situations in which the end effector 140, 240, 340 is approaching, but not crossing, a predefined virtual boundary. Gradual slowing of the surgical instrument 100, 200, 300 may be less abrupt from the surgeon's perspective and may be used in combination with preventing the movement of the surgical instrument 100, 200, 300 if the surgeon continues toward and crosses a predefined virtual boundary.

[0051] Additionally, reducing the maximum output power of the power source 160, 260, 360 to control the maximum speed of the surgical instrument 100, 200, 300 may be related to the identity of the end effector 140, 240, 340. Particular end effectors 140, 240, 340 are configured to perform optimally at particular speeds and / or torques. For example, a first surgical instrument 100 that is a drill may operate in a high-speed, low-torque mode, while a third surgical instrument 300 that is a driver may operate in a low-speed, high-torque mode. By virtue of the first and second associations, i.e., between the end effector 140, 240, 340 and power source 160, 260, 360 and the respective navigation arrays 130, 230, 330, the identity of the end effector 140, 240, 340 and power source 160, 260, 360 may be controlled accordingly.

[0052] In addition to controlling the operation of the surgical instruments 100, 200, 300, the navigation-assisted surgery system 12 of the present disclosure advantageously provides improved transitions between the surgical instruments 100, 200, 300 during the execution of a surgical plan. As mentioned above, it may be desirable to have multiple surgical instruments 100, 200, 300 in the operating room at a location convenient for the surgeon relative to the surgical site 30. Furthermore, known systems may require the surgeon or other user to pause aspects of the surgical procedure and interact with a user interface to tell the system that a change to the surgical instruments will be made. By virtue of remembering the associations established during pre-operative preparation, the navigation-assisted surgery system 12 may control, or at least have the means to control, all of the surgical instruments 100, 200, 300 simultaneously, thereby enabling the surgeon to manipulate and transition between the surgical instruments 100, 200, 300 without further action or input to the GUI 18. In other words, the navigation-assisted surgical system 12 may not be assertive about which of the surgical instruments 100, 200, 300 is being handled by the surgeon. Rather, the navigation-assisted surgical system 12 may only be concerned with the position and / or orientation of the end effector 140, 240, 340 relative to a predefined virtual boundary registered in the patient tracker. When the predefined virtual boundary is crossed by one of the surgical instruments 100, 200, 300 in operation, the navigation controller 20 receives a battery or identification signal from the power sources 160, 260, 360 (due to current draw or voltage drop) and may therefore wirelessly transmit a control signal to the appropriate one of the power sources 160, 260, 360.

[0053] In certain embodiments, it may be desirable for the navigation-assisted surgery system 12 to know which of the surgical instruments 100, 200, 300 are in use. "In use" may be considered to mean that the handheld surgical instrument 120, 220, 320 is being handled by the surgeon to be applied to the surgical site 30.

[0054] The navigation controller 20 may generate or receive an in-use signal indicating a particular one of the surgical instruments 100, 200, 300. Based on the in-use signal, the navigation controller 20 may create a second association between the power source 160, 260, 360 and the navigation array 130, 230, 330 (and / or the end effector 140, 240, 340). The in-use signal may be stored in the memory device 26.

[0055] In an alternative example where more than one of the surgical instruments 100, 200, 300 may be in the field of view of the localizer 22, the navigation-assisted surgical system 12 may simply require the surgeon to perform a "test pull" on the switches 150, 250, 350 of the handheld surgical instruments 120, 220, 320 to determine which of the surgical instruments 100, 200, 300 is in use.

[0056] It is also contemplated that the aforementioned "test pull" may be utilized to generate associations during pre-operative preparation. The workflow may include the surgeon momentarily operating the surgical instrument 100, 200, 300 within the field of view of the localizer 22. At that moment, a battery signal indicative of the power drawn from the power source 160, 260, 360 is wirelessly transmitted from the communication module 165, 265, 365 of the power source 160, 260, 360 to the communication module 28 of the navigation-assisted surgical system 12. The battery signal is received by the navigation controller 20, which accesses stored associations stored in the memory device 26. Based on the stored associations, the navigation controller 20 determines which of the surgical instruments 100, 200, 300 is in use and instantly determines its position and / or orientation relative to a predefined virtual boundary or target axis. The navigation controller 20 determines which one or more of the first surgical instrument 100, the second surgical instrument 200, and the third surgical instrument 300 are in use. Although the navigation-assisted surgical system 12 may simultaneously control the operation of all of the surgical instruments 100, 200, 300 as described above, one of the surgical instruments 100, 200, 300 may be considered to be in use to enable additional functionality of the navigation-assisted surgical system 12, as described below.

[0057] In particular, the navigation controller 20 may be configured to redisplay or update the display device 14 to indicate the aspect of the surgical plan related to which surgical instrument 100, 200, 300 is in use. For example, upon preparing the vertebrae, the surgeon may manipulate the third surgical instrument 300, which is a driver, and activate a “test pull.” This action causes the navigation controller 20 to access, from the memory device 26, the aspect of the surgeon’s plan associated with inserting the pedicle screws. The navigation controller 20 may send a display signal to the display device 14 to automatically update the GUI 18. The update may include providing a digital representation of the pedicle screws or any other desired visual change on the GUI. Furthermore, the surgeon’s display preferences may be defined preoperatively, perhaps for each aspect of the surgical plan, and the display preferences may be automatically updated as the surgeon moves between aspects of the surgical plan. Preferences may include anatomical view (eg, sagittal, axial, etc.), anatomical view alignment, on-screen indicia, and / or any other visual preferences for the GUI 18 that may be entered and saved in the software.

[0058] As an alternative to, or in addition to, a battery signal being received by the navigation controller 20 to create a second association between the power source 160, 260, 360 and the navigation array 130, 230, 330, the power source 160, 260, 360 may include an inertial sensor 170, 270, 370 (only 170 is identified) configured to generate a movement signal when the handheld surgical instrument 120, 220, 320 is handled. Referring now to FIG. 7 , the first inertial sensor 170 is in electronic communication with the first communications module 165 of the first power source 160. For example, when the surgeon handles the first surgical instrument 100, transitioning between the surgical instruments 100, 200, 300 during execution of a surgical plan, a movement signal is transmitted wirelessly to the communications module 28. Similar to the ease provided by performing the "test pull" described above, the surgeon need only handle the handheld surgical tool 120, 220, 320 for the navigation-assisted surgical system 12 to determine which surgical tool 100, 200, 300 is in use. Other techniques for determining which tool is in use are also contemplated and are contemplated as the basis for creating an association between the power source 160, 260, 360 and the tracking array 130, 230, 330 as described herein.

[0059] The inertial sensors 170, 270, 370 that generate the movement signals may also be used to associate the power source 160, 260, 360 with the navigation array 130, 230, 330 (and / or end effector 140, 240, 340) during pre-operative preparation. The navigation controller 20 receives the movement signals, which are indicative of the handheld surgical instrument being handled or manipulated by the user, as detected by the inertial sensors 170, 270, 370. The navigation controller 20 generates a third association between the power source 160, 260, 360 and the navigation array 130, 230, 330 based on the movement signals. The third association may be stored in the memory device 26.

[0060] To facilitate the navigation controller 20 in generating the third association, the GUI 18 may display prompts 93, 95 to guide the user to manipulate or manipulate one of the surgical instruments 100, 200, 300. In other words, to prevent possibly inadvertent or minor movements of the surgical instruments 100, 200, 300 from leading to a false third correlation, the GUI 18 may display prompts 93, 95 or instructions. FIG. 7 illustrates the prompts 93, 95 as arrows indicating the gestures the user should mimic to generate the movement signals. Because the surgical instruments 120, 220, 320 are handheld, they are movable in six degrees of freedom, represented by the directional arrows in FIG. 7: translation along the x-, y-, and z-axes, and rotation in pitch, yaw, and roll. The first prompt 93 instructs the user to move the surgical instrument 100 laterally to the right (translation along the z-axis), and the second prompt 95 instructs the user to roll the first surgical instrument (rotation about the x-axis). The gestures may be displayed in a predetermined order, which may include one, two, three, or more gestures in any one or more of the six degrees of freedom. The first inertial sensor 170 senses the movements, and the localizer 22 may also detect the movements by tracking the first navigation array 130. The movement signals are received by the navigation controller 20 and compared to the gestures displayed on the GUI 18. If the movement signals match the movements, the navigation controller 20 generates a third association based on the movement signals. Any and all of the functionality of the navigation-assisted surgery system 12 described herein may be realized by this embodiment using the inertial sensors 170, 270, 370.

[0061] 8 and 9, two alternative workflows 500, 600 are shown. Workflow 500 shown in FIG. 8 illustrates a workflow for controlling a handheld surgical instrument 120, 220, 320. Workflow 600 shown in FIG. 9 illustrates a workflow for controlling a handheld surgical instrument 120, 220, 320 with an active power source 160, 260, 360. In workflows 500 and 600, the navigation controller 20 determines the association between the navigation array 130, 230, 330 and the end effector 140, 240, 340 without associating the power source 160, 260, 360. Alternatively, in other workflows, the navigation controller 20 may determine the association between the navigation array 130, 230, 330 and the power source 160, 260, 360 without associating the end effector 140, 240, 340.

[0062] It should be noted that while the steps of workflow 500 and workflow 600 are shown in one order, any suitable ordering of the steps may be implemented. Furthermore, it should be understood that various aspects of workflow 500 may be combined with various aspects of workflow 600, and vice versa.

[0063] The workflow 500 includes a step 502 of associating an end effector 140, 240, 340 of the handheld surgical tool 120, 220, 320 with the navigation array 130, 230, 330. Specifically, the step 502 includes receiving an input indicating the type of end effector 140, 240, 340 coupled to the handheld surgical tool 120, 220, 320, which may be a user input to the GUI 18 including a selection of the type of end effector 140, 240, 340. Step 502 also includes using the navigation controller 20 to receive an identification signal from the localizer 22 detecting the navigation array 130, 230, 330; using the navigation controller 20 to create an association between the end effector 140, 240, 340 and the navigation array 130, 230, 330 based on the input indicating the type of end effector 140, 240, 340 and the identification signal; and storing the association using the memory device 26.

[0064] After the end effector 140, 240, 340 is associated with the navigation array 130, 230, 330, a virtual boundary may be selected during step 504. During step 504, the virtual boundary may be selected such that it is specific to the end effector 140, 240, 340 associated with the navigation array 130, 230, 330. This ensures that the end effector being used will match the boundary specifically designed for that end effector.

[0065] The workflow 500 also includes a step 506 of tracking the pose of the navigation array 130 , 230 , 330 and a step 508 of determining the position and / or orientation of the end effector 140 , 240 , 340 based on the pose of the navigation array 130 , 230 , 330 .

[0066] During step 510, the communications module 28 receives a battery signal transmitted wirelessly from the power source 160, 260, 360 of the handheld surgical instrument 120, 220, 320. The battery signal may be specific to the power source 160, 260, 360 of the handheld surgical instrument 120, 220, 320 so that the navigation controller 20 can determine to which power source 160, 260, 360 to transmit the signal. Thus, in some cases, the battery signal may be a battery identification signal.

[0067] After the battery signal is received during step 510, during step 512, the communications module 28 may wirelessly transmit a signal to the power source 160, 260, 360 associated with the battery signal. Additionally, after a virtual boundary is selected during step 504, the communications module 28 may transmit a signal to the power source 160, 260, 360 based on the determined position and / or orientation of the end effector 140, 240, 340 (determined during step 508) and the selected virtual boundary. In some instances, the power source 160, 260, 360 may then provide a control signal to the controller of the handheld surgical instrument 115, 215, 315 based on the signal received from the communications module 28, causing the controller of the handheld surgical instrument 115, 215, 315 to brake or otherwise stop or slow down the motor 145, 245, 345 of the handheld surgical instrument 120, 220, 320. In other instances, signals transmitted wirelessly from the communications module 28 control the characteristics of the energy being supplied from the power source 160, 260, 360 to the handheld surgical tool 120, 220, 320. For example, a signal transmitted wirelessly from the communications module 28 can terminate the current being supplied by the power source to the first motor 145. This can be accomplished using a switch on the power source.

[0068] In some configurations, the workflow 500 may also include determining a pose of a patient tracker coupled to the patient's anatomy at the surgical site 30, and controlling the handheld surgical tool 120, 220, 320 based on the position and / or orientation of the end effector 140, 240, 340 and the pose of the patient tracker. For example, in some instances, controlling the handheld surgical tool 120, 220, 320 may include providing a control signal to a controller of the handheld surgical tool 115, 215, 315 to cause the controller of the handheld surgical tool 115, 215, 315 to brake the motor 145, 245, 345 of the handheld surgical tool 120, 220, 320. In other examples, the step of controlling the handheld surgical instrument 120, 220, 320 may include controlling the characteristics of the energy being supplied to the handheld surgical instrument 120, 220, 320 from the power source 160, 260, 360, such as terminating the current being supplied to the first motor 145.

[0069] In instances where the navigation-assisted surgical system 12 includes two or more surgical instruments 100, 200, 300, the navigation controller 20 may alter the operation of a single handheld surgical instrument 120, 220, 320, or two or more handheld surgical instruments 120, 220, 320. To determine how to alter the operation of the handheld surgical instrument 120, 220, 320, the navigation controller 20 may determine which navigation array 130, 230, 330, and possibly which power source 160, 260, 360, is in use. This process is illustrated in the workflow 600 shown in FIG. 9.

[0070] It should be noted that the first and second surgical instruments 100 and 200, and their components, are described below for illustrative purposes only with respect to workflow 600. Workflow 600 may apply to a greater number of surgical instruments, and may alternatively or additionally apply to a third surgical instrument 300, or any combination of two or more surgical instruments 100, 200, 300.

[0071] Workflow 600 may include step 602 of associating a first end effector 140 with a first navigation array 130 and a second end effector 240 with a second navigation array 230. Specifically, step 602 includes receiving a first input indicating a type of first end effector 140 coupled to the first handheld surgical tool 120 and a second input indicating a different type of second end effector 240 coupled to the second handheld surgical tool 220. The first and second inputs may be user inputs to GUI 18 including selections of the types of first and second end effectors 140, 240. Step 502 also includes receiving, using navigation controller 20, first and second identification signals from localizer 22 detecting first and second navigation arrays 130, 230, respectively. Step 502 also includes generating, using the navigation controller 20, a first association between the first end effector 140 and the first navigation array 130 based on the first input and the first identification signal, and generating, using the navigation controller 20, a second association between the second end effector 240 and the second navigation array 230 based on the second input and the second identification signal. Step 502 also includes storing, using the memory device 26, the first and second associations.

[0072] The workflow 600 also includes a step 604 of tracking the attitude of the first and second navigation arrays 130, 230, and a step 606 of determining the position and / or orientation of the first and second end effectors 140, 240 based on the attitude of the first and second navigation arrays 130, 230, respectively.

[0073] The workflow 600 also includes a step 608 of determining the usage status of the first navigation array 130 and the second navigation array 230. Specifically, the step 608 may include determining the attitude of the first navigation array 130 and the attitude of the second navigation array 230 in a known coordinate system, determining the position and / or orientation of a reference point relative to the known coordinate system, and determining the usage status of the first navigation array 130 and the second navigation array 240 based on the attitude of the navigation array 130, the attitude of the second navigation array 230, and the position and / or orientation of the reference point. The reference point may be a point, surface, or volume in a coordinate system used to position the end effector 140, 240, 340 with respect to a target condition, such as a target object. In one specific embodiment, the reference point is the planned axis of a screw. For example, the reference point may be a surface of a bone, a point within a bone, an imaginary or virtual point in the known coordinate system, a volume in the known coordinate system, or a combination thereof. The position and / or orientation of the fiducial points are known to the patient tracker through registration and suitable planning steps.

[0074] After the usage status of the first navigation array 130 and the second navigation array 230 is determined, the navigation controller 20 may select the navigation array 130, 230 in use and a virtual boundary corresponding to the navigation array 130, 230 in use during step 610. The selected virtual boundary may correspond to the navigation array 130, 230 in use.

[0075] The workflow may also include step 612 of determining a usage status of the first power source 160 and the second power source 260 and determining the power source 160, 260 in use based on the usage status of the first power source 160 and the second power source 260. In some instances, determining the usage status of the first power source 160 and the second power source 260 includes receiving, with the communications module 28, first and / or second movement signals transmitted wirelessly from the first power source 160 and the second power source 260, respectively. The movement signals may indicate that the first and / or second power sources 160, 260 are being operated by a user and that the first and / or second power sources are in use, as detected by the first and / or second inertial sensors 170, 270, respectively.

[0076] In another example, determining the usage status of the first power source 160 and the second power source 260 includes receiving, using the communications module 28, first and / or second battery signals transmitted wirelessly from the first and / or second power sources 146, 260, respectively, during operation of the first and / or second handheld surgical instruments 120, 220. The battery signals may indicate the current being drawn from the first and / or second power sources 160, 260, respectively, and that the first and / or second power sources 160, 260 are in use during a “test pull” (described above). By determining whether a power source is in use when performing a procedure, the system can identify the battery that will receive commands to control the surgical instrument based on the position and / or orientation of the end effector, the same instrument the user is actively using, rather than tools prepared adjacent to it on a desk or preparation area behind it by one or more scrub technicians.

[0077] After the navigation controller 20 selects the virtual boundary and determines the power source 160, 260 in use, the navigation controller 20 may, during step 614, wirelessly transmit a signal to the power source 160, 260 in use based on the virtual boundary and the determined position and / or orientation of the end effector 140, 240 corresponding to the power source 160, 260 in use.

[0078] Signals may also and additionally be sent wirelessly to unused power sources 160, 260 to shut down both / all power sources 160, 260 or terminate the current being supplied to the motors 145, 245. This may be a beneficial approach to risk reduction in that if all instruments tracked by the localizer are shut down and thus one of the end effectors is replaced with a different array without providing an appropriate input signal to the navigation system, the navigation system may still stop the instrument from penetrating beyond the virtual boundary. In some instances, the navigation controller 20 may determine which power sources 160, 260 are in use based on the time it receives movement and / or battery signals, and may wirelessly send signals to the in-use and unused power sources 160, 260 based on the time it receives movement and / or battery signals. As an example, in an instance where the first switch 150 is engaged before the second switch 250, the navigation controller 20 may determine that the first handheld surgical instrument 120 is not in use and that the second handheld surgical instrument 220 is in use (or vice versa). The navigation controller 20 may then transmit a signal to the second handheld surgical instrument 220 before the first handheld surgical instrument 120. This utilization of time to receive a battery signal and / or a mobility signal ensures that the latency of communication between a power source in use and the navigation system is minimized and / or prioritized over the latency of communication between a power source not in use and the navigation system. In other words, the energy source in use will receive a signal from the navigation system before the power source not in use.

[0079] For ease of use when executing a surgical plan, it may be desirable for each of the surgical instruments 100, 200, 300 to include its own navigation array 130, 230, 330, end effector 140, 240, 340, and power source 160, 260, 360. For example, FIGS. 1 and 2 show three sets of components for the three surgical instruments 100, 200, 300. However, as mentioned, it may be suggested to re-establish the association during the execution of the surgical plan, or perhaps during pre-operative preparation. For example, one of the power sources 160, 260, 360 may use up all of its charge, or one of the communication modules 165, 265, 365 may lose two-way wireless communication with the communication module 28 of the navigation-assisted surgical system 12. The power source 160, 260, 360 may be interchangeably swapped between the handheld surgical instruments 120, 220, 320, and the first, second, and / or third associations may be re-established. A user may execute the above-described workflow by manipulating the GUI 18 to identify the navigation array 130, 230, 330 coupled to the handheld surgical instrument 120, 220, 320 to which the replaced power source 160, 260, 360 is now connected. The updated second association or updated third association based on the battery signal and the movement signal, respectively, is updated and stored in the memory device 26. Any aspect of the workflow may be used to re-establish the associations.

[0080] Additionally, it is contemplated that the surgical instruments 100, 200, 300 may be coupled to a console. As shown in FIG. 10 , the navigation-assisted surgical system 12 includes a console 400, which may be coupled to the surgical instruments 100, 200, 300 using cables. In FIG. 10 , the console 400 is shown coupled to a first surgical instrument 100 and a second surgical instrument 200. The first surgical instrument 100 includes a first handheld surgical instrument 120 coupled to a first navigation array 130, and the second surgical instrument 200 includes a second handheld surgical instrument 220 coupled to a second navigation array 230. It should be noted that the console 400 may be coupled to any suitable number of surgical instruments 100, 200, 300. For example, the console 400 may be coupled to one surgical instrument or three or more surgical instruments.

[0081] In instances where the navigation-assisted surgery system 12 includes a console 400, the console 400 may send signals to the first handheld surgical instrument 120 and the second handheld surgical instrument 220 to control their operation. The console may determine which of the first and second handheld surgical instruments is in use based on which port of the console is drawing current or which motor controller is active within the console. For example, the console 400 may send a signal to the in-use handheld surgical instrument to stop operation based on the position and / or orientation of the end effector associated with the in-use navigation array and based on a virtual boundary. As another example, the console 400 may send a signal to the in-use and unused handheld surgical instruments to stop operation of both the in-use and unused handheld surgical instruments.

[0082] In some instances, the navigation-assisted surgical system 12 may include an attachment module. In one such instance, the attachment module is coupled to both the power source and the handpiece. However, in other instances, the attachment module may be configured as a dongle and may be coupled to any suitable location on the handheld surgical instrument. For example, the attachment module may be coupled to the proximal end of the handheld surgical instrument, the distal end of the handheld surgical instrument, the handle of the handheld surgical instrument, or the barrel of the handheld surgical instrument. The attachment module may be coupled to the handheld surgical instrument using fasteners, clips, or locking members. One exemplary method for securing the attachment module to the handheld surgical instrument is described in WO2019035096, see the description of the measurement module.

[0083] In instances where an attachment module is provided, the attachment module enables communication with the navigation controller, so that the navigation controller communicates with the attachment module instead of the power source. A power source may still be included, but the power source may not have any wireless communication functionality. For example, in instances where the navigation-assisted surgical system 12 includes an attachment module, the communication module 28 may receive a module signal transmitted wirelessly from the attachment module of the handheld surgical instrument 120, 220, 320. The module signal may be unique to the attachment module of the handheld surgical instrument 120, 220, 320, so that the navigation controller 20 can determine which attachment module to send the signal to. In some cases, the module signal may be a module identification signal.

[0084] The attachment module may include a controller and a communications module. The attachment module may be self-powered by including a battery, or the attachment module may draw power from the handheld surgical tool to which it is connected via a wired or wireless attachment.

[0085] The attachment module may be coupled to the handheld surgical tool in such a manner that the controller of the attachment module is in electrical communication with the controller of the handheld surgical handpiece (referred to herein as the "tool controller"), e.g., by direct wired communication.

[0086] The controller of the attachment module may provide control signals to the controller of the handheld surgical handpiece.

[0087] As explained above, the power supply or attachment module may be configured to relay signals from the navigation system that, when processed by the instrument controller, control the state of the handheld surgical handpiece. The various states of the handheld surgical handpiece include, but are not limited to, an active state, an inactive state, a brake state, a not forward state, a speed control state, a torque control state, a precision rotation control state, a precision vibration control state, a tap drive state, and other states.

[0088] The instrument controller may determine status information of the handheld surgical handpiece during a surgical procedure. The status information may include motor status, forward switch status, reverse switch status, handpiece mode status, etc. Motor status information may indicate whether the motor is currently rotating or currently stopped. Motor status information may also indicate the angle of rotation of the motor or a component coupled to the motor. Forward switch status information may indicate whether the forward switch 151 is currently active or inactive. Reverse switch status information may include whether the reverse switch 153 is currently active or inactive. Handpiece mode status may indicate whether the handpiece is in a first torque mode, a second torque mode, a first speed mode, a second speed mode, a first vibration mode, or a second vibration mode, with the first mode for each type of status having a different value than the second mode. For example, when the handpiece is in a first torque mode, the handpiece may be operable to deliver a first range of torque values, and when the handpiece is in a second torque mode, the handpiece may be operable to deliver a second range of torque values, the second torque values ​​being higher than the first range of torque values.

[0089] Optionally, the attachment module or power source may receive and transmit status information from the instrument controller to the navigation system. This status information may enable the navigation system to control the state of the handheld surgical handpiece for more precision and better control. Further optionally, the navigation system may be operable to control the handheld surgical tool based on status information received from the handpiece via the power source or attachment module. In other words, the navigation system may take into account status information received from the powered surgical tool when considering which commands to give to the handheld surgical tool.

[0090] The navigation controller may transmit navigation signals to the handheld surgical tool via the attachment module or the power source based on the pose of the end effector associated with the attachment module or the power source. The navigation signals may provide an indication of the relative pose of the end effector with respect to one or more virtual objects / boundaries. For example, a first navigation signal may be provided when the end effector crosses a boundary associated with the target drilling depth, and optionally, a second navigation signal may be provided when the end effector is within a second boundary, the second boundary being positioned around the surgical site, and optionally, a third navigation signal may be provided when the end effector does not collide with any virtual objects or boundaries.

[0091] Depending on the type of navigation signal received by the instrument controller, the instrument controller may cause the handheld tool to proceed to the aforementioned state. For example, if a third navigation signal is received by the instrument controller, the instrument controller maintains the handheld surgical tool in the active state.

[0092] In instances where the instrument controller determines that the forward switch status of the handheld surgical handpiece is active and the navigation controller sends a first navigation signal indicating that the end effector has entered a virtual object boundary, the instrument controller may cause the surgical handpiece to proceed to a brake state. In instances where the instrument controller determines that the reverse switch status of the handheld surgical handpiece is active and the end effector has entered a virtual object, the instrument controller may enable continued motor operation if reversing the end effector rotation is acceptable and / or may allow the powered surgical handpiece to operate in a reverse-only state. In instances where the instrument controller determines that the forward switch status and the reverse status switch are both inactive and the navigation controller determines that the end effector has entered a virtual object, the instrument controller may cause the handheld surgical handpiece to proceed to a non-forward state. When in the non-forward state, the instrument controller may prevent operation of the motor of the handheld surgical handpiece even if the forward switch 151 is pressed. However, when in a non-forward state, the instrument controller may still allow operation of the motor of the handheld surgical handpiece when the reverse switch 153 is pressed.

[0093] The instrument controller may also control the handheld surgical handpiece to enter a speed control state. In such a state, the instrument controller may control the motor so that the speed of rotation of the motor does not exceed a predetermined maximum rotational speed. Additionally or alternatively, the speed control state may cause the instrument controller to maintain the speed of rotation of the motor above a predetermined maximum rotational speed. The instrument controller may take into account determinations made by the navigation controller before allowing the handheld surgical handpiece to enter the speed control state. For example, the instrument controller may automatically enable the speed control state in response to the navigation controller's determination of the end effector pose and virtual object, such as when the end effector approaches a critical structure.

[0094] The instrument controller may also control the handheld tool to advance to a precision rotation control state. In such a state, the instrument controller may precisely rotate the motor, such as by rotating the motor a predetermined angle, such as 360 degrees, in response to actuation of the switch 150. For example, in the precision rotation control state, the instrument controller may determine that the forward switch status is active, and the instrument controller may precisely rotate the motor a predetermined angle (e.g., 45 degrees) to implant a pedicle screw. As another example, in the precision rotation control state, the instrument controller may determine that the reverse switch status is active, and the instrument controller may precisely rotate the motor a predetermined angle (e.g., 45 degrees) to remove a pedicle screw. The instrument controller may automatically enable the precision rotation state based on the navigation controller's determination of the end effector pose and virtual object. This automatic enablement may provide more precise control of the handheld surgical handpiece when the end effector approaches a critical structure. The instrument controller may also take into account status information of the handheld surgical handpiece before allowing the handheld surgical handpiece to proceed to the precision rotation control state. For example, the instrument controller may enable the speed control state in response to determining that the status information indicates a quick trigger pull. In such an instance, the instrument controller may determine that the forward switch status or the reverse switch status is active only for a relatively short period of time (e.g., the forward switch status or the reverse switch status is active for less than a predetermined period of time).

[0095] As explained above, the instrument controller may respond in different ways to receiving different navigation signals from the navigation system. The instrument controller may cause the handheld surgical tool to proceed to one of several states in response to any of the potential navigation states of the end effector relative to one or more virtual boundaries / objects.

[0096] The instrument controller may be configured to automatically cause the handheld instrument to assume a particular state if a particular type of navigation signal is not received for a certain period of time. This may be advantageous in situations where wireless communication between the navigation system and the attachment module or battery has unexpected latency or experiences errors. In one example, if the instrument controller does not receive a navigation signal for a certain period of time, the instrument controller may cause the handheld instrument to assume the reverse-only state. One exemplary period is 100 ms. Thus, if the instrument controller does not receive a navigation signal indicating that no collision has occurred between the end effector and a particular virtual object within 100 ms of receiving the last navigation signal, the instrument controller may automatically cause the handheld surgical instrument to proceed to the reverse-only state.

[0097] FIG. 11 illustrates an alternative example of a navigation-assisted surgical system 12. In the example of FIG. 11, the navigation-assisted surgical system 12 includes a handheld surgical instrument 700 having an instrument processor 710. The navigation-assisted surgical system 12 also includes a control system, such as the navigation controller 20 described above. In the example of FIG. 11, the handheld surgical instrument 700 is configured to be paired with the navigation controller 20, and the instrument processor 710 is configured to control parameters of the handheld surgical instrument 700 after the handheld surgical instrument 700 is paired with the navigation controller 20. In the example of FIG. 11, the handheld surgical instrument 700 is paired with the navigation controller 20, and the navigation controller 20 wirelessly transmits control signals 520 to the instrument processor 710, which controls the parameters of the handheld surgical instrument 700 in response to receiving the control signals 520. As shown, the control signals 520 are transmitted wirelessly by the navigation controller 20 and received by the handheld surgical instrument 700 .

[0098] It is also contemplated that in some instances, the navigation-assisted surgical system 12 may include more than one handheld surgical instrument. For example, in the example of FIG. 11 , the navigation-assisted surgical system 12 includes a first handheld surgical instrument 700 as well as a second handheld surgical instrument 800. The second handheld surgical instrument 800 includes a second instrument processor 810. In the example of FIG. 11 , the second handheld surgical instrument 800 is configured to be paired with the navigation controller 20, and the second instrument processor 810 is configured to control parameters of the second handheld surgical instrument 800 after the second handheld surgical instrument 800 is paired with the navigation controller 20. 11 , the second handheld surgical instrument 800 is paired with the navigation controller 20, which wirelessly transmits a control signal 520 to the second instrument processor 810, which in response to receiving the control signal 520 controls parameters of the second handheld surgical instrument 800. The control signal 520 may be transmitted by a wireless antenna of the navigation controller 20. As shown in FIG. 11 , the control signal 520 is transmitted wirelessly by the navigation controller 20 and received by the second handheld surgical instrument 800. The second handheld surgical instrument can include the same features as described with respect to the other instruments described throughout.

[0099] To facilitate such wireless communication, the handheld surgical instrument 700, 800 may include a transceiver 715, 815. The transceiver 715, 815 may be in communication with the instrument processor 710, 810. The transceiver 715, 815 may be a modular component of the handheld surgical instrument 700, 800 or may be integrated into the handheld surgical instrument 700, 800. For example, the transceiver may be integrated into a removable battery of the handheld surgical instrument 700, 800 or may be a separate modular attachment.

[0100] FIG. 12 illustrates a method for pairing a handheld surgical instrument, such as the first and / or second handheld surgical instrument 700, 800 of FIG. 11 , to the navigation controller 20. As shown, to initialize the system, the navigation controller 20 transmits a broadcast signal 530 including a pairing identifier 535 to the handheld surgical instrument 700, 800. The broadcast signal 530 may be transmitted by a wireless antenna of the navigation controller 20 or by a controller coupled to the navigation system. The instrument processor 710, 810 is configured to receive the broadcast signal 530. The instrument processor 710, 810, or other components of the first and second handheld surgical instruments 700, 800, may include a memory device configured to store the pairing identifier 535 after receiving the broadcast signal 530. After the instrument processor 710, 810 stores the pairing identifier 535, the handheld surgical instrument 700, 800 is paired with the navigation controller 20.

[0101] In some instances, one of the navigation controller 20 and the instrument processor 710, 810 may determine whether the handheld surgical instrument 700, 800 is active before pairing the handheld surgical instrument 700, 800 with the navigation controller 20. In other words, the memory device may not store a pairing identifier until the system determines that a particular handheld instrument is actually intended to be paired with a particular navigation system. The handheld surgical instrument 700, 800 may be determined to be active if it is intended to be paired with the navigation controller 20. In such instances, the memory of the instrument processor 700, 800 stores a pairing identifier in response to determining that the handheld surgical instrument 700, 800 is active, thereby pairing the handheld surgical instrument 700, 800 with the navigation controller 20.

[0102] A variety of mechanisms for determining whether an instrument is active are contemplated and may be employed by one or more of the instrument processor, the navigation controller, or a combination thereof.

[0103] In one example, the instrument processor 710, 810 may determine that the handheld surgical instrument 700, 800 is active by detecting activation of a user interface, such as a trigger on the handheld surgical instrument 700, 800, or by selecting a particular tool on a touch screen associated with the navigation controller 20.

[0104] In another example, the instrument processor 710, 810 may be configured to determine that the handheld surgical instrument 700, 800 is active by detecting movement of the handheld surgical instrument 700, 800. For example, the instrument processor 710, 810 may be coupled to an inertial sensor 717, 817 (shown in FIGS. 11 and 12) configured to detect movement of the handheld surgical instrument 700, 800. The inertial sensor 717, 817 may be onboard a battery in the handheld surgical instrument 700, 800, integrated into the handheld surgical instrument 700, 800, or part of a modular mount.

[0105] In one example, the navigation controller 20 may be in electronic communication with a localizer, such as the localizer 22 described above, and the navigation controller 20 may be configured to determine that the handheld surgical instrument 700, 800 is active based on the localizer 22 detecting the handheld surgical instrument 700, 800. For example, the localizer 22 may detect a navigation array corresponding to the handheld surgical instrument 700, 800. As another example, the localizer 22 may detect a signature characteristic of the handheld surgical instrument 700, 800. The navigation controller 20 may determine that a particular handheld surgical instrument is active based on a spatial relationship between a tracker coupled to the handheld surgical instrument and a tracker coupled to the patient. For example, the navigation controller 20 may determine that a particular handheld surgical instrument is within a spatial region adjacent to the patient or within a particular distance from the patient or surgical site. Alternatively, the navigation controller 20 may determine that a particular handheld surgical instrument is active by identifying a particular movement pattern of the handheld surgical instrument. For example, the localizer 22 may detect movement of a tracker attached to the handheld surgical instrument, and the navigation controller 20 may identify that the movement of the tracker corresponds to a particular movement pattern of the handheld surgical instrument.

[0106] 12 also illustrates a method of controlling the handheld surgical instrument 700, 800 after the handheld surgical instrument 700, 800 is paired to the navigation controller 20. As shown, the navigation controller 20 transmits a control signal 520, including a control identifier 525, to the handheld surgical instrument 700, 800. The instrument processor 710, 810 is configured to receive the control signal 520. The instrument processor 710, 810 then determines whether the control identifier 525 corresponds to the pairing identifier 535. For example, the instrument processor 710, 810 may determine that the control identifier 525 matches the pairing identifier 535. The instrument processor 710, 810 may then control a parameter of the handheld surgical instrument 700, 800 in response to determining that the control identifier 525 corresponds to the pairing identifier 535. In this manner, the instrument processor 710, 810 controls parameters of the handheld surgical instrument 700, 800 in response to receiving the control signal 520 when the handheld surgical instrument 700, 800 is paired with the navigation controller 20. In other words, when the handheld surgical instrument 700, 800 is not paired with the navigation controller 20, the instrument processor 710, 810 does not control parameters of the handheld surgical instrument 700, 800 based on receiving the control signal 520.

[0107] The navigation controller 20 may be configured to transmit the control signal 520 based on a variety of conditions. In one example, the navigation controller 20 may be configured to transmit the control signal 520 based on a particular spatial relationship between the handheld surgical instrument and the patient. For example, the navigation system may send the control signal 520 when a portion of the handheld surgical instrument has a particular spatial relationship with the virtual boundary.

[0108] In such instances, the end effector and navigation array may be coupleable to the handheld surgical instrument 700, 800. The navigation controller 20 may be configured to determine the identity of the navigation array coupled to the handheld surgical instrument 700, 800. For example, the localizer 22 may be configured to detect the navigation array, and the navigation controller 20 may be configured to determine the identity of the navigation array based on the localizer 22 detecting the navigation array. The navigation controller 20 may then create an association between the end effector coupled to the handheld surgical instrument 700, 800 and the navigation array. The navigation controller 20 may then select a virtual boundary corresponding to the end effector based on the identity of the navigation array and determine the position and / or orientation of the end effector.

[0109] The navigation controller 20 may then determine that a motion or boundary condition exists based on the determined position and / or orientation of the end effector and the selected virtual boundary. The navigation controller 20 may determine that a motion condition exists based on determining that the end effector coupled to the handheld surgical instrument 700, 800 has not crossed the selected virtual boundary. The navigation controller 20 may determine that a boundary condition exists based on determining that the end effector coupled to the handheld surgical instrument 700, 800 has crossed the selected virtual boundary or has a particular relationship to the selected virtual boundary.

[0110] In some instances, the navigation controller 20 may wirelessly transmit the control signal 520 to the handheld surgical instrument 700, 800 in response to determining that a motion condition exists. For example, the navigation controller 20 may be configured to wirelessly transmit the control signal 520 to the handheld surgical instrument at a predetermined rate in response to determining that a motion condition exists. In such instances, the instrument processor 710, 810 may be configured to stop operation of the handheld surgical instrument 700, 800 in response to determining that a predetermined time has elapsed since receiving the control signal 520 from the navigation controller 20. After the instrument processor 710, 810 ceases to receive the control signal 520 within less than the predetermined time, the instrument processor controls a parameter of the handheld surgical instrument, such as slowing or stopping the end effector. This ensures that the handheld surgical instrument will no longer operate when there is a transmission problem that could result in unacceptable latency.

[0111] In an alternative example, the navigation controller 20 may wirelessly transmit the control signal 520 to the handheld surgical instrument 700, 800 in response to determining that a boundary condition exists, rather than in response to determining that an operating condition exists. In such an example, the instrument processor 710, 810 may be configured to control a parameter of the handheld surgical instrument in response to receiving the control signal 520. Thus, when the navigation controller 20 determines that the end effector has crossed a selected virtual boundary, the navigation controller 20 determines that a boundary condition exists. After the navigation controller 20 transmits the control signal 520, the instrument processor 710, 810 receives the control signal 520 and stops operation of the handheld surgical instrument 700, 800.

[0112] It is contemplated that a separate signal, other than the control signal 520, may be used as a “heartbeat” signal to monitor data transmission between the navigation controller and the instrument processor 710, 810. In such an instance, the control signal 520 is transmitted to the instrument processor when a boundary condition exists, rather than when an operating condition exists. During an operating condition, a heartbeat signal is transmitted from the navigation controller 20 to the instrument processor 710, 810. After the instrument processor 710, 810 ceases to receive the heartbeat signal for a time interval less than a predetermined time, the instrument processor controls a parameter of the handheld surgical instrument 700, 800, such as slowing or stopping an end effector coupled to the handheld surgical instrument 700, 800. This ensures that the handheld surgical instrument 700, 800 no longer operates when there is a transmission problem that could result in unacceptable latency.

[0113] Depending on the content of the control signal 520, the instrument processor 710, 810 may control various parameters of the handheld surgical instrument 700, 800. For example, the control signal 520 may cause the instrument processor 710, 810 to control the speed of an end effector coupled to the handheld surgical instrument 700, 800. As another example, the control signal 520 may cause the instrument processor 710, 810 to brake or control the current of a motor of the handheld surgical instrument 700, 800 to stop the motor.

[0114] In an example where the navigation-assisted surgical system 12 includes two or more handheld surgical instruments, such as the example of FIG. 11, both handheld surgical instruments 700, 800 may be controlled based on an end effector coupled to either of the handheld surgical instruments 700, 800 crossing one or more virtual boundaries.

[0115] For example, in an example where a first end effector and a first navigation array are coupled to a first handheld surgical instrument and a second end effector and a second navigation array are coupled to a second handheld surgical instrument, the navigation controller 20 may be configured to determine the identity of the first navigation array, determine the identity of the second navigation array, create an association between the first end effector and the first navigation array, create an association between the second end effector and the second navigation array, select a first virtual boundary corresponding to the first end effector based on determining the identity of the first navigation array, select a second virtual boundary corresponding to the second end effector based on determining the identity of the second navigation array, and determine the position and / or orientation of the first and second end effectors.

[0116] The navigation controller 20 may then determine that a motion condition exists based on determining that the first and second end effectors have not crossed the selected corresponding virtual boundaries. The navigation controller 20 may then wirelessly transmit control signals 520 to both handheld surgical instruments 700, 800 in response to determining that a motion condition exists. For example, the navigation controller 20 may be configured to wirelessly transmit control signals 520 to both handheld surgical instruments 700, 800 at a predetermined rate in response to determining that a motion condition exists or using a heartbeat signal. In such an instance, both instrument processors 710, 810 may be configured to stop operation of the handheld surgical instruments 700, 800 in response to determining that a predetermined time has elapsed since receiving the control signals 520 or the heartbeat signal from the navigation controller 20.

[0117] Alternatively, the navigation controller 20 may determine that a boundary condition exists based on determining that one of the first and second end effectors has crossed a selected corresponding virtual boundary. The navigation controller 20 may then wirelessly transmit control signals 520 to both handheld surgical instruments 700, 800 in response to determining that a boundary condition exists. In such an instance, both instrument processors 710, 810 may be configured to control respective parameters of the respective handheld surgical instruments in response to receiving the control signals 520.

[0118] FIG. 13 illustrates an example in which the navigation assistance system 12 includes a second control system. Such an example may occur when a first navigation controller 20 is located in a first operating room OR1 and a second navigation controller 20′ is located in a second operating room OR2. In such an example, each operating room OR1, OR2 may include one or more handheld surgical instruments. For example, in the example of FIG. 13, handheld surgical instruments 700, 800 are paired to the navigation controller 20 in the first operating room OR1, and handheld surgical instruments 900, 1000 are paired to the navigation controller 20′ in the second operating room OR2.

[0119] Additionally, Figure 13 illustrates an example in which a control signal transmitted by a control system in one operating room may be received by a handheld surgical instrument in a second operating room. Specifically, the navigation controller 20 in the first operating room OR1 transmits a control signal 520, which may be received by the instrument processors 710, 810, 910 when the handheld surgical instruments 700, 800, 900 are within range of the navigation controller 20. Additionally, the navigation controller 20' in the second operating room OR2 transmits a control signal 520', which may be received by the instrument processors 810, 910, 1010 when the handheld surgical instruments 800, 900, 1000 are within range of the navigation controller 20.

[0120] In the example of Figure 13, handheld surgical instruments 700, 800 are paired with a first navigation controller 20, and handheld surgical instruments 900, 1000 are paired with a second navigation controller 20'. For reference, handheld surgical instruments 700, 800, 900, 1000 are paired with their respective navigation controllers 20, 20' using the method described above and shown in Figure 12.

[0121] Thus, the instrument processor 710, 810 controls the parameters of the handheld surgical instrument 700, 800 in response to receiving the control signal 520 from the first navigation controller 20, and the instrument processor 910, 1010 controls the parameters of the handheld surgical instrument 900, 1000 in response to receiving the control signal 520' from the second navigation controller 20'. In other words, the instrument processor 710, 810 does not control the parameters of the handheld surgical instrument 700, 8000 in response to receiving the control signal 520' from the second navigation controller 20', and the instrument processor 910, 1010 does not control the parameters of the handheld surgical instrument 900, 1000 in response to receiving the control signal 520 from the first navigation controller 20. In the example of FIG. 13 , the navigation controller 20 provides the control signal 520, which is received by the instrument processor 710, 810, 910. The instrument processor 710, 810 receives the control signal 520 and controls the parameters of the handheld surgical instrument 700, 800 accordingly. However, the instrument processor 910 does not receive the control signal 520 and control the parameters of the handheld surgical instrument 900 accordingly (as represented by the "X" symbol above the handheld surgical instrument 900).

[0122] As explained above, this may be done via the control signal 520, which includes the control identifier 525. Each instrument processor 710, 810 is configured to receive the control signal 520. The instrument processor 710, 810 then determines whether the control identifier 525 corresponds to the pairing identifier 535. For example, the instrument processor 710, 810 may determine that the control identifier 525 matches the pairing identifier 535. The instrument processor 710, 810 may then control parameters of the handheld surgical instrument 700, 800 in response to determining that the control identifier 525 corresponds to the pairing identifier 535. In this manner, the instrument processor 710, 810 controls parameters of the handheld surgical instrument 700, 800 in response to receiving the control signal 520 when the handheld surgical instrument 700, 800 is paired with the navigation controller 20. In other words, if the handheld surgical instrument is not paired with the navigation controller 20, such as the handheld surgical instrument 900, 1000 of FIG. 13 which is paired with the navigation controller 20', the instrument processor 910, 1010 does not control the parameters of the handheld surgical instrument 900, 1000 based on receiving the control signal 520.

[0123] It should be understood that the terms instrument controller and instrument processor may be used interchangeably throughout.

[0124] The foregoing description is not intended to be exhaustive or to limit the present invention to any particular form. The terminology used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teachings, and the present invention may be practiced otherwise than as specifically described. It should be understood that any structure, function, and / or work flow steps described with respect to the first surgical instrument 100 or any of its components may also be included in and performed on the second surgical instrument 200, the third surgical instrument 300, or any additional surgical instruments.

[0125] For purposes of coverage or modification of the systems described herein, all aspects of WO2022185292A1 by the applicant are hereby contemplated, and WO2022185292A1 is incorporated herein by reference in its entirety.

[0126] Clause 1 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source coupled to the handheld surgical tool, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising: receiving an input indicating a type of end effector coupled to the handheld surgical tool; receiving, using the navigation controller, an identification signal from the localizer that detects the navigation array; using the navigation controller, creating an association between the end effector and the navigation array based on the input and the identification signal; storing the association using the memory device; receiving, using the navigation controller, a battery identification signal wirelessly transmitted from the power source to the communications module; and wirelessly transmitting a signal to the power source based on the battery identification signal and the attitude of the navigation array.

[0127] Clause 2 10. The method of claim 1, further comprising determining a position and / or orientation of the end effector based on the pose of the navigation array.

[0128] Clause 3 3. The method of clause 2, further comprising determining a posture of a patient tracker coupled to the patient's anatomy; and controlling the handheld surgical tool based on the position and / or orientation of the end effector and the posture of the patient tracker.

[0129] Clause 4 The method of any one of clauses 2 and 3, further comprising the steps of selecting a virtual boundary based on an identification signal from the navigation array, and wirelessly transmitting a signal from the communication module to the power source based on the determined position and / or orientation of the end effector and the virtual boundary.

[0130] Clause 5 The method of clause 4, wherein the power source provides a control signal to a controller of the handheld surgical instrument, and the control signal provided to the controller of the handheld surgical instrument causes the controller of the handheld surgical instrument to brake a motor of the handheld surgical instrument.

[0131] Clause 6 6. The method of any one of clauses 4 and 5, wherein a signal is transmitted wirelessly from the communications module to the power source to control a characteristic of the energy being supplied from the power source to the handheld surgical tool.

[0132] Clause 7 The method of any one of clauses 2 to 6, wherein the navigation-assisted surgical system further includes a second handheld surgical instrument, a second end effector coupled to the second handheld surgical instrument, a second navigation array coupled to the second handheld surgical instrument or the second end effector, and a second power source coupled to the second handheld surgical instrument, and the method further includes the steps of receiving a second input indicating a different type of second end effector coupled to the second handheld surgical instrument, receiving, using the navigation controller, a second identification signal from a localizer that detects the second navigation array, generating, using the navigation controller, a second association between the second end effector and the second navigation array based on the second input and the second identification signal, receiving, using the navigation controller, a second battery signal wirelessly transmitted from the second power source to the communications module, and storing the second association using a memory device.

[0133] Article 8 8. The method of clause 7, further comprising tracking an attitude of the second navigation array and determining a position and / or orientation of the second end effector based on the attitude of the second navigation array.

[0134] Article 9 9. The method of clause 8, further comprising determining a usage status of the navigation array and the second navigation array.

[0135] Article 10 10. The method of claim 9, wherein the step of determining the usage status of the navigation array or the second navigation array includes determining, in a known coordinate system, an attitude of the navigation array and an attitude of the second navigation array, determining a position and / or orientation of a reference point relative to the known coordinate system, and determining the usage status of the navigation array and the second navigation array based on the attitude of the navigation array, the attitude of the second navigation array, and the position and / or orientation of the reference point.

[0136] Article 11 11. The method of any one of clauses 9 and 10, further comprising determining a usage status of the power source and the second power source.

[0137] Article 12 The method of clause 11, wherein the power source includes an inertial sensor and the second power source includes a second inertial sensor, and the step of determining the usage status of the power source and the second power source includes: receiving, using a navigation controller, a movement signal transmitted wirelessly from the power source to a communication module, the movement signal detected by the inertial sensor indicating that the power source is being operated by a user and that the power source is in use; and receiving, using the navigation controller, a second movement signal transmitted wirelessly from the second power source to the communication module, the second movement signal detected by the second inertial sensor indicating that the second power source is being operated by a user and that the second power source is in use.

[0138] Article 13 13. The method of any one of clauses 11 and 12, wherein the step of determining the usage status of the power source and the second power source includes receiving, using the navigation controller, a battery signal transmitted wirelessly from the power source to the communications module during operation of the handheld surgical tool, the battery signal indicating current being drawn from the power source and that the power source is in use; and receiving, using the navigation controller, a second battery signal transmitted wirelessly from the second power source to the communications module during operation of a second handheld surgical tool, the second battery signal indicating current being drawn from the second power source and that the second power source is in use.

[0139] Article 14 The method of clause 13, further comprising the steps of instructing a user to activate a handheld surgical instrument, activating a user input device corresponding to the handheld surgical instrument in response to receiving a battery signal using the navigation controller, and activating a second user input device corresponding to a second handheld surgical instrument in response to receiving a second battery signal using the navigation controller.

[0140] Article 15 The method of any one of clauses 13 and 14, wherein the step of determining the usage status of the power source and the second power source includes determining the time of receiving a battery signal and determining the time of receiving a second battery signal.

[0141] Article 16 The method of any one of clauses 10 to 15, further comprising the steps of: selecting a navigation array in use from among the navigation array and the second navigation array based on a usage status of the navigation array and a usage status of the second navigation array; selecting a virtual boundary based on receiving an identification signal or a second identification signal from a localizer detecting the navigation array in use; determining a position of an end effector associated with the navigation array in use; selecting a power source in use from among the power source and the second power source based on a usage status of the power source and a usage status of the second power source; and wirelessly transmitting a signal from the communication module to the power source in use based on the determined position and / or orientation of the end effector associated with the navigation array in use and the selected virtual boundary.

[0142] Article 17 17. The method of clause 16, further comprising providing a control signal from the power source in use to a controller of a corresponding handheld surgical tool to cause the handheld surgical tool to shut down in response to receiving the signal transmitted wirelessly from the communications module to the power source in use.

[0143] Article 18 18. The method of any one of clauses 16 and 17, wherein a signal is transmitted wirelessly from the communications module to the power source in use to control the characteristics of the energy being supplied from the power source in use to the corresponding handheld surgical tool.

[0144] Article 19 The method of any one of clauses 16 to 18, further comprising: determining an unused power source from among the power source and the second power source based on the usage status of the power source and the usage status of the second power source; and wirelessly transmitting a second signal from the communication module to the unused power source based on the determined position and / or orientation of the end effector and the position of the selected virtual boundary.

[0145] Article 20 20. The method of clause 19, wherein the signal transmitted wirelessly from the communications module to the power source in use is transmitted before the second signal transmitted wirelessly from the communications module to the power source that is not in use.

[0146] Article 21 1. A navigation assistance system for wirelessly controlling a handheld surgical instrument having an end effector, a navigation array, and a power source each coupled to the handheld surgical instrument, the navigation assistance system comprising: a localizer including a sensor configured to detect the navigation array; and a control console in electronic communication with the localizer, the control console including a first communications module configured to wirelessly exchange signals with a second communications module of the power source; and a navigation controller configured to receive an input indicating a type of end effector coupled to the handheld surgical instrument, receive from the localizer an identification signal based on the localizer detecting the navigation array, associate the identification signal with the input indicating the type of end effector, receive a battery identification signal from the second communications module, and wirelessly transmit a signal to the power source based on the battery identification signal and the attitude of the navigation array.

[0147] Article 22 22. The navigation assistance system of clause 21, wherein the navigation controller is further configured to determine a position and / or orientation of the end effector based on the attitude of the navigation array.

[0148] Article 23 23. The navigation assistance system of clause 22, wherein the navigation controller is further configured to determine a posture of a patient tracker coupled to the patient's anatomical structure and control the handheld surgical tool based on the position and / or orientation of the end effector and the posture of the patient tracker.

[0149] Article 24 24. The navigation assistance system of clause 23, wherein the navigation controller is further configured to select a virtual boundary based on an identification signal from the navigation array and wirelessly transmit a signal to the power source based on the determined position and / or orientation of the end effector and the selected boundary.

[0150] Article 25 A navigation assistance system as described in clause 24, wherein the handheld surgical tool includes a handheld surgical tool controller, the power source is configured to provide a control signal to the handheld surgical tool controller, and the control signal provided to the handheld surgical tool controller causes the handheld surgical tool controller to brake a motor of the handheld surgical tool.

[0151] Article 26 26. A navigation assistance system as described in any one of clauses 24 and 25, wherein the navigation controller is configured to wirelessly transmit signals to control the characteristics of the energy being supplied from the power source to the handheld surgical tool.

[0152] Article 27 27. The navigation assistance system of any one of clauses 23 to 26, further configured to control a second handheld surgical tool to which a second end effector, a second navigation array, and a second power source are each coupled, wherein the sensor of the localizer is further configured to detect the second navigation array, the first communication module is further configured to wirelessly exchange signals with a third communication module of the second power source, and the navigation controller is further configured to receive a second input indicating a different type of second end effector coupled to the second handheld surgical tool, receive a second identification signal from the localizer based on the localizer detecting the second navigation array, associate the second identification signal with the second input, and receive a second battery signal from the third communication module.

[0153] Article 28 28. The navigation assistance system of clause 27, wherein the localizer sensor is further configured to track the attitude of the second navigation array, and the navigation controller is further configured to determine the position and / or orientation of the second end effector based on the attitude of the second navigation array, and to control the second handheld surgical instrument based on the position and / or orientation of the second end effector and the attitude of the patient tracker.

[0154] Article 29 29. The navigation assistance system of clause 28, wherein the navigation controller is further configured to determine a usage status of the navigation array and the second navigation array.

[0155] Article 30 30. The navigation assistance system of claim 29, wherein the navigation controller is configured to determine the usage status of the navigation array and the second navigation array by determining, in a known coordinate system, the attitude of the navigation array and the attitude of the second navigation array, determining the position and / or orientation of a reference location relative to the known coordinate system, and determining the usage status of the navigation array and the second navigation array based on the attitude of the navigation array, the attitude of the second navigation array, and the position and / or orientation of the reference location.

[0156] Article 31 31. A navigation assistance system as described in any one of clauses 29 and 30, wherein the navigation controller is further configured to determine a usage status of the power source and the second power source.

[0157] Article 32 32. The navigation assistance system of claim 31, wherein the power source includes an inertial sensor and the second power source includes a second inertial sensor, and the navigation controller is configured to determine the usage status of the power source and the second power source by receiving a movement signal wirelessly transmitted from the power source, the movement signal detected by the inertial sensor indicating that the power source is being operated by a user and that the power source is in use, and receiving a second movement signal wirelessly transmitted from the second power source, the second movement signal detected by the second inertial sensor indicating that the second power source is being operated by a user and that the second power source is in use.

[0158] Article 33 33. The navigation assistance system of any one of clauses 31 and 32, wherein the navigation controller is configured to determine the usage status of the power source and the second power source by receiving, during operation of the handheld surgical tool, a battery signal transmitted wirelessly from the power source, the battery signal indicating the current being drawn from the power source and that the power source is in use, and by receiving, using the navigation controller, a second battery signal transmitted wirelessly from a second power source during operation of a second handheld surgical tool, the second battery signal indicating the current being drawn from the second power source and that the second power source is in use.

[0159] Article 34 The navigation assistance system of clause 33, wherein the control console is configured to instruct a user to activate a handheld surgical instrument, and the navigation controller is further configured to activate a user input device corresponding to the handheld surgical instrument in response to receiving a battery signal, and to activate a second user input device corresponding to a second handheld surgical instrument in response to receiving a second battery signal.

[0160] Article 35 A navigation assistance system as described in any one of clauses 33 and 34, wherein the navigation controller is configured to determine the usage status of the power source and the second power source by determining the time of receiving the battery signal and determining the time of receiving the second battery signal.

[0161] Article 36 The navigation assistance system of any one of clauses 30 to 35, wherein the navigation controller is further configured to: select a navigation array in use from among the navigation array and the second navigation array based on a usage status of the navigation array and a usage status of the second navigation array; select a virtual boundary based on receiving an identification signal or a second identification signal from a localizer that detects the navigation array in use; determine a position of an end effector associated with the navigation array in use and a position of the selected virtual boundary; select a power source in use from among the power source and the second power source based on a usage status of the power source and a usage status of the second power source; and wirelessly transmit a signal from the communication module to the power source in use based on the determined position and / or orientation of the end effector associated with the navigation array in use and the selected virtual boundary.

[0162] Article 37 A navigation assistance system as described in clause 36, wherein the second handheld surgical tool includes a second handheld surgical tool controller, the second power source is configured to provide a control signal to the second handheld surgical tool controller, and the control signal provided to the second handheld surgical tool controller causes the second handheld surgical tool controller to brake a motor of the second handheld surgical tool.

[0163] Article 38 38. A navigation assistance system as described in any one of clauses 36 and 37, wherein the navigation controller is configured to wirelessly transmit signals to control characteristics of energy being supplied from the second power source to the second handheld surgical tool.

[0164] Article 39 39. The navigation assistance system of any one of clauses 36 to 38, wherein the navigation controller is further configured to determine an unused power source from among the power source and the second power source based on the usage status of the power source and the usage status of the second power source, and to wirelessly transmit a second signal to the unused power source based on the determined position of the end effector and the position of the selected virtual boundary.

[0165] Article 40 40. The navigation assistance system of clause 39, wherein the navigation controller is further configured to wirelessly transmit a signal to the power source in use prior to wirelessly transmitting a second signal to the power source that is not in use.

[0166] Article 41 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source coupled to the handheld surgical tool, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising the steps of: receiving an input indicating a type of end effector coupled to the handheld surgical tool; and receiving, with the navigation controller, an identification signal from the localizer detecting tracking elements of the navigation array, the identification signal being based on an arrangement of the tracking elements of the navigation array. generating, with the navigation controller, a first association between the end effector and the navigation array based on the input and the identification signal; receiving, with the navigation controller, a battery signal transmitted wirelessly from the power source to the communications module during operation of the handheld surgical tool, the battery signal indicating a current being drawn from the power source; generating, with the navigation controller, a second association between the power source and one of the navigation array and the end effector based on the battery signal; and storing, with a memory device, the first association and the second association.

[0167] Article 42 42. The method of clause 41, wherein the step of receiving input further comprises receiving, with a user interface, user input including a selection of an end effector type.

[0168] Article 43 43. The method of clause 42, wherein a representation of different types of surgical instruments is presented on the display, and selection of one of the different types therefrom is user input.

[0169] Article 44 44. The method of any one of clauses 41 to 43, further comprising the step of displaying on a display an aspect of the surgical plan associated with the type of end effector.

[0170] Article 45 42. The method of claim 41, wherein the navigation-assisted surgery system includes a camera, and the step of receiving input further includes using the camera to detect an end effector characteristic indicative of a type of end effector coupled to the handheld surgical tool.

[0171] Article 46 46. ​​The method of any one of clauses 41 to 45, further comprising associating the type of end effector with aspects of the surgical plan including a predefined virtual boundary based on the type of end effector.

[0172] Article 47 47. The method of clause 46, further comprising the steps of tracking a position of the navigation array, determining a position and / or orientation of the end effector based on the position of the navigation array, determining a position of a patient tracker coupled to the patient's anatomy, and controlling a power source based on the position and / or orientation of the end effector and the position of the patient tracker.

[0173] Article 48 48. The method of clause 47, further comprising wirelessly transmitting a control signal from the communication module to the power source when the position of the end effector crosses a predefined virtual boundary to control a characteristic of the energy being supplied from the power source to the handheld surgical tool.

[0174] Article 49 49. The method of clause 48, wherein the control signal is configured to terminate the current being supplied when the position of the end effector crosses a predefined virtual boundary.

[0175] Article 50 49. The method of any one of clauses 41 to 49, wherein the power source includes an inertial sensor, and the method further includes the steps of: receiving, using a navigation controller, a movement signal wirelessly transmitted from the power source to a communication module during operation of the handheld surgical tool, the movement signal being detected by the inertial sensor and indicating that the handheld surgical tool is being operated by a user; using the navigation controller, generating a third association between the power source and one of the navigation array and the end effector based on the movement signal; and storing the third association using a memory device.

[0176] Article 51 The method of clause 50, further comprising the steps of: using a display to display at least two gestures for the user to imitate to generate the movement signal; and comparing the movement signal with the at least two gestures.

[0177] Article 52 The navigation-assisted surgical system further includes a second handheld surgical instrument, a second end effector coupled to the second handheld surgical instrument, a second navigation array coupled to the second handheld surgical instrument or the second end effector, and a second power source coupled to the second handheld surgical instrument, and the method includes the steps of receiving a second input indicating a different type of second end effector coupled to the second handheld surgical instrument, receiving, using a navigation controller, a second identification signal from a localizer that detects second tracking elements of the second navigation array, the second identification signal being based on a second arrangement of the second tracking elements of the second navigation array, and receiving, using the navigation controller, a second input indicating a different type of second end effector coupled to the second handheld surgical instrument, the second input indicating a different type of second end effector coupled to the second handheld surgical instrument, and receiving, using a navigation controller, a second identification signal from a localizer that detects second tracking elements of the second navigation array, the second identification signal being based on a second arrangement of the second tracking elements of the second navigation array. 52. The method of any one of clauses 41 to 51, further comprising: generating a fourth association between the second end effector and the second navigation array based on the second identification signal; receiving, using the navigation controller, a second battery signal transmitted wirelessly from the second power source to the communications module during operation of the second handheld surgical tool, the second battery signal indicating current being drawn from the second power source; generating, using the navigation controller, a fifth association between the second power source and one of the second navigation array and the second end effector based on the second battery signal; and storing the fourth association and the fifth association using a memory device.

[0178] Article 53 53. The method of clause 52, wherein the handheld surgical tool and the second handheld surgical tool are selected from the group consisting of a drill, a tap, and a driver.

[0179] Article 54 The navigation-assisted surgery system further includes a second end effector coupled to the handheld surgical tool after the end effector is decoupled from the handheld surgical tool, and a second navigation array coupled to the handheld surgical tool or the second end effector after the end effector is decoupled from the handheld surgical tool, and the method includes receiving a second input indicating a different type of the second end effector coupled to the handheld surgical tool; receiving, using a navigation controller, a second identification signal from a localizer that detects second tracking elements of the second navigation array, the second identification signal being based on a second arrangement of the second tracking elements of the second navigation array; and 54. The method of any one of clauses 52 and 53, further comprising: using the navigation controller to generate a fourth association between the second end effector and the second navigation array based on the second input and the second identification signal; using the navigation controller to receive a battery signal transmitted wirelessly from the power source to the communications module during operation of the handheld surgical tool, the second battery signal indicating a current being drawn from the power source; using the navigation controller to generate a fifth association between the power source and one of the second navigation array and the second end effector based on the battery signal; and storing the fourth association and the fifth association using a memory device.

[0180] Article 55 55. A non-transitory computer memory configured to execute software comprising the steps of the method of any one of clauses 41 to 54.

[0181] Article 56 1. A navigation assistance system for wirelessly controlling a handheld surgical tool having an end effector, a navigation array, and a power source each coupled to the handheld surgical tool, the system comprising: a localizer including a sensor configured to detect tracking elements of the navigation array; and a control console in electronic communication with the localizer, the control console including a first communications module configured to wirelessly exchange signals with a second communications module of the power source; and a navigation controller configured to receive an input indicating a type of end effector coupled to the handheld surgical tool, receive an identification signal from the localizer, the identification signal based on an arrangement of the tracking elements of the navigation array, and receive a battery signal from the first communications module, the battery signal indicating current being drawn from the power source due to operation of the handheld surgical tool, and associate the identification signal with the input and the battery signal.

[0182] Article 57 The system described in clause 56, wherein the navigation controller is further configured to send a control signal from the first communication module to a second communication module of the power source to control a parameter of energy being supplied from the power source to the handheld surgical tool.

[0183] Article 58 58. The system of clause 56 or 57, further comprising a display in electronic communication with the control console.

[0184] Article 59 59. The system of any one of clauses 56 to 58, further comprising at least one of a handheld surgical tool, an end effector, a power source, and a navigation array.

[0185] Article 60 60. The system of any one of clauses 56 to 59, wherein the first communication module and the second communication module are configured to communicate wirelessly via a Bluetooth low energy protocol.

[0186] Article 61 A method of creating an association between a first end effector and a second end effector and a navigation-assisted surgical system prior to executing a surgical plan, wherein the first end effector, a first navigation array, and a first power source are coupled to a first handheld surgical instrument, and the second end effector, a second navigation array, and a second power source are coupled to a second handheld surgical instrument, the method comprising: manipulating the first handheld surgical instrument to orient the first navigation array so that it is detectable by a localizer of the navigation-assisted surgical system; providing a first user input to a user interface of the navigation-assisted surgery system, the first user input indicating a first type of first end effector; actuating the first handheld surgical instrument; handling a second handheld surgical instrument to orient a second navigation array so as to be detectable by a localizer of the navigation-assisted surgery system; providing a second user input to a user interface of the navigation-assisted surgery system, the second user input indicating a second type of second end effector, the first type being different from the second type; and actuating the second handheld surgical instrument.

[0187] Article 62 Clause 61. The method of claim 61, further comprising the steps of: disconnecting the first end effector and the first navigation array from the first handheld surgical instrument; coupling a third end effector and a third navigation array to the first handheld surgical instrument; handling the first handheld surgical instrument to orient the third navigation array so that it is detectable by a localizer of the navigation-assisted surgical system; providing a third user input to a user interface of the navigation-assisted surgical system, the third user input indicating a third type of the first end effector, the third type being different from the first type and the second type; and actuating the first handheld surgical instrument.

[0188] Article 63 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source coupled to the handheld surgical tool and having an inertial sensor, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, comprising the steps of: receiving an input indicating a type of end effector coupled to the handheld surgical tool; and receiving, with the navigation controller, an identification signal from the localizer detecting tracking elements of the navigation array during operation of the handheld surgical tool, the identification signal indicating a tracking element of the navigation array. receiving, using a navigation controller, a movement signal wirelessly transmitted from the power source to a communications module, the movement signal being detected by an inertial sensor and indicating that the handheld surgical tool is being manipulated by a user; using the navigation controller to generate a first association between the end effector and the navigation array based on the user input; using the navigation controller to generate a second association between the power source and one of the navigation array and the end effector based on the movement signal; and using a memory to store the first association and the second association.

[0189] Article 64 64. The method of clause 63, further comprising the step of displaying, using the display, a gesture that mimics movement of the handheld surgical tool by the user to generate a movement signal.

[0190] Article 65 65. The method of clause 64, further comprising the steps of displaying the gestures in a predetermined sequence and comparing the sequence of movements of the handheld surgical tool with the predetermined sequence.

[0191] Article 66 66. The method of claim 65, wherein the movement is at least one of a translational movement and a rotational movement.

[0192] Article 67 67. The method of claim 66, wherein the rotational movement is a rotation of at least one of pitch, yaw, and roll.

[0193] Article 68 68. The method of any one of clauses 63 to 67, further comprising the step of displaying on a display an aspect of the surgical plan associated with the type of end effector.

[0194] Article 69 68. The method of any one of clauses 63 to 67, further comprising correlating the type of end effector to aspects of the surgical plan including a predefined virtual boundary based on the type of end effector.

[0195] Article 70 Clause 69. The method of clause 69, further comprising the steps of tracking the attitude of the navigation array, determining the position and / or orientation of the end effector based on the attitude of the navigation array, and wirelessly transmitting a control signal from the communication module to the power source to control a characteristic of the energy being supplied from the power source to the handheld surgical tool based on the position and / or orientation of the end effector relative to a predefined virtual boundary.

[0196] Article 71 71. The method of clause 70, wherein the control signal is configured to terminate the current being supplied when the position and / or orientation of the end effector crosses a predefined virtual boundary.

[0197] Article 72 72. The method of any one of clauses 63 to 71, further comprising the step of receiving, using the navigation controller, a battery signal transmitted wirelessly from the power source to the communications module during operation of the handheld surgical tool, the battery signal indicating the current being drawn from the power source.

[0198] Article 73 73. The method of any one of clauses 63 to 72, wherein the step of receiving input further comprises receiving, using a user interface, user input including a selection of an end effector type.

[0199] Article 74 74. The method of any one of clauses 63 to 73, wherein the navigation-assisted surgery system includes a camera, and the step of receiving input further includes using the camera to detect an end effector characteristic indicative of a type of end effector coupled to the handheld surgical tool.

[0200] Article 75 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source coupled to the handheld surgical tool, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising: receiving an input indicating a type of end effector coupled to the handheld surgical tool; receiving, using the navigation controller, an identification signal from the localizer that detects tracking elements of the navigation array; creating, using the navigation controller, a first association between the end effector and the navigation array based on the input and the identification signal; receiving, using the navigation controller, an in-use signal indicating that the handheld surgical tool is in use; creating, using the navigation controller, a second association between the power source and one of the navigation array and the end effector based on the in-use signal; and storing, using the memory device, the first association and the second association.

[0201] Article 76 76. The method of clause 75, wherein the step of receiving an identification signal from a localizer includes detecting, with the localizer, an alignment and / or orientation of tracking elements of the navigation array.

[0202] Article 77 Clause 76. The method of clause 75, wherein the step of receiving an identification signal from a localizer includes detecting, with the localizer, a pattern of pulses of tracking elements of a navigation array.

[0203] Article 78 Clause 76. The method of clause 75, wherein the step of receiving an identification signal from the localizer includes receiving, with the localizer, a navigation array signal from a tracking element of the navigation array, and transmitting, with the localizer, an identification signal based on the navigation array signal.

[0204] Article 79 The surgical instrument includes a first handheld surgical instrument and a second handheld surgical instrument, a first end effector coupled to the first handheld surgical instrument, a second end effector coupled to the second handheld surgical instrument, a first navigation array coupled to the first handheld surgical instrument or the first end effector, a second navigation array coupled to the second handheld surgical instrument or the second end effector, a console coupled to the first handheld surgical instrument and the second handheld surgical instrument, a localizer, a display, a user interface, a memory device, and a navigation array. and a navigation controller, the method comprising the steps of receiving a first input indicating a type of a first end effector coupled to a first handheld surgical instrument, receiving a second input indicating a type of a second end effector coupled to a second handheld surgical instrument, receiving, using the navigation controller, a first identification signal from a localizer detecting the first navigation array, and receiving, using the navigation controller, a second identification signal from a localizer detecting the second navigation array. receiving, using a navigation controller, a first association between a first end effector and a first navigation array based on the first input and the first identification signal; using a navigation controller, a second association between a second end effector and a second navigation array based on the second input and the second identification signal; determining a usage status of the navigation array and the second navigation array; selecting an active navigation array from the first navigation array and the second navigation array based on the usage status of the first navigation array and the usage status of the second navigation array; selecting a virtual boundary based on receiving the identification signal or the second identification signal from a localizer that detects the active navigation array; coupling the first handheld surgical instrument and the second handheld surgical instrument to the console; determining a usage status of the first handheld surgical instrument and the second handheld surgical instrument;a step of selecting an active handheld surgical tool from among a first handheld surgical tool and a second handheld surgical tool; and a step of transmitting a signal from a console to the active handheld surgical tool to stop operation based on a position and / or orientation of an end effector associated with the active navigation array and the selected virtual boundary.

[0205] Article 80 The method of clause 79 further includes the steps of determining an unused handheld surgical tool from among the first handheld surgical tool and the second handheld surgical tool based on the usage status of the first handheld surgical tool and the usage status of the second handheld surgical tool, and sending a second signal from the console to the unused handheld surgical tool based on the position of the end effector and the position of the selected virtual boundary.

[0206] Article 81 81. The method of any one of clauses 79 and 80, wherein a signal sent from the console causes a controller of the handheld surgical tool in use to brake the motor of the handheld surgical tool in use.

[0207] Article 82 A navigation array assistance system for wirelessly controlling a first handheld surgical instrument having a first end effector, a first navigation array, and a first power source each coupled thereto, and a second handheld surgical instrument having a second end effector, a second navigation array, and a second power source each coupled thereto, the system comprising: a localizer including a sensor configured to detect the navigation array and the second navigation array; and a control console coupled to the handheld surgical instrument and the second handheld surgical instrument, the control console being in electronic communication with the localizer and configured to receive a first input indicative of a type of first end effector coupled to the first handheld surgical instrument, receive a second input indicative of a type of second end effector coupled to the second handheld surgical instrument, receive a first identification signal from the localizer detecting the first navigation array, receive a second identification signal from the localizer detecting the second navigation array, and generate a first association between the first end effector and the first navigation array based on the first input and the first identification signal; and a control console including a navigation controller configured to: generate a second association between a second end effector and a second navigation array based on the input and the second identification signal; determine a usage status of the navigation array and the second navigation array; select an active navigation array from among the first navigation array and the second navigation array based on the usage status of the first navigation array and the usage status of the second navigation array; select a virtual boundary based on an identification signal from a localizer that detects the active navigation array; determine a usage status of the first handheld surgical instrument and the second handheld surgical instrument; select an active handheld surgical instrument from among the first handheld surgical instrument and the second handheld surgical instrument based on the usage status; and send a signal to the active handheld surgical instrument to stop operation based on the position and / or orientation of the end effector associated with the active navigation array and the selected virtual boundary.

[0208] Article 83 The navigation assistance system described in clause 82, wherein the navigation controller is further configured to determine an unused handheld surgical tool from among the first handheld surgical tool and the second handheld surgical tool based on the usage status of the first handheld surgical tool and the usage status of the second handheld surgical tool, and to send a second signal to the unused handheld surgical tool based on the position of the end effector and the position of the selected virtual boundary.

[0209] Article 84 A navigation assistance system as described in any one of clauses 82 and 83, wherein the handheld surgical instrument and the second handheld surgical instrument each include a handheld surgical instrument controller, and a signal transmitted from the console causes the handheld surgical instrument controller of the handheld surgical instrument in use to brake the motor of the handheld surgical instrument in use.

[0210] Article 85 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source coupled to the handheld surgical tool, a localizer, a mounting module or antenna integrated with the handheld surgical tool, a display, a user interface, a memory device, and a navigation controller, the method comprising: receiving an input indicating a type of end effector coupled to the handheld surgical tool; receiving, using the navigation controller, an identification signal from the localizer that detects the navigation array; using the navigation controller, creating an association between the end effector and the navigation array based on the input and the identification signal; storing the association using the memory device; receiving, using the navigation controller, an attachment identification signal or a handheld surgical tool identification signal wirelessly transmitted from the attachment module or the handheld surgical tool to a communications module; and wirelessly transmitting a signal to the power source or controlling a parameter of the handheld surgical tool based on the attachment identification signal and the attitude of the navigation array.

[0211] Article 86 1. A navigation assistance system for wirelessly controlling a handheld surgical tool having an end effector, a navigation array, and a power source each coupled thereto, the navigation assistance system comprising: a localizer including a sensor configured to detect the navigation array; a control console in electronic communication with the localizer; and a navigation controller configured to receive an input indicating a type of end effector coupled to the handheld surgical tool, receive from the localizer an identification signal based on the localizer's detection of the navigation array, associate the identification signal with the input indicating the type of end effector, optionally receive a tool identification signal from the control console, and transmit a signal to the control console, wirelessly or via a wired connection, based on the attitude of the navigation array and optionally the tool identification signal.

[0212] Article 87 A method of operating a navigation-assisted surgery system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, optionally a mounting module coupled to the handheld surgical tool or an antenna integrated into the handheld surgical tool, a power source coupled to the handheld surgical tool, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising the steps of: receiving an input indicating a type of end effector coupled to the handheld surgical tool; receiving, using the navigation controller, an identification signal based on the navigation array, the identification signal optionally being based on an arrangement of tracking elements of the navigation array; and using the navigation controller to identify the end effector and the navigation array based on the input and the identification signal. and generating a first association between the navigation array and the handheld surgical instrument; receiving, using the navigation controller, an attachment module signal wirelessly transmitted from the attachment module to the communications module during operation of the handheld surgical instrument, or receiving, using the navigation controller, a signal wirelessly transmitted from an antenna integrated into the handheld surgical instrument, wherein the attachment module signal or other signal indicates current being drawn from a power source or that the tool is active; generating, using the navigation controller, a second association between the handheld surgical instrument or the attachment module and one of the navigation array and the end effector based on the attachment module signal or the signal from the antenna integrated into the handheld surgical instrument; and storing the first association and the second association using a memory device.

[0213] Article 88 1. A navigation assistance system for wirelessly controlling a handheld surgical tool having an end effector, a navigation array, and a power source each coupled thereto, the navigation assistance system comprising: a localizer; a control console in electronic communication with the localizer; and a navigation controller configured to receive an input indicating a type of end effector coupled to the handheld surgical tool, receive an identification signal from the localizer corresponding to the navigation array, receive a tool identification signal from the control console, and associate the identification signal from the localizer with the tool identification signal.

[0214] Article 89 A method of creating an association between a first end effector and a second end effector and a navigation-assisted surgical system prior to executing a surgical plan, wherein a first end effector, a first navigation array, a first mounting module or a first antenna, and a first power source are coupled to a first handheld surgical instrument, and a second end effector, a second navigation array, a second mounting module or a second antenna, and a second power source are coupled to a second handheld surgical instrument, the method comprising the steps of: manipulating the first handheld surgical instrument to orient the first navigation array so that it is detectable by a localizer of the navigation-assisted surgical system; providing a first user input to a user interface of a navigation-assisted surgical system, the first user input indicating a first type of first end effector; actuating the first handheld surgical instrument; handling a second handheld surgical instrument to orient a second navigation array so as to be detectable by a localizer of the navigation-assisted surgical system; providing a second user input to a user interface of the navigation-assisted surgical system, the second user input indicating a second type of second end effector, the first type being different from the second type; and actuating the second handheld surgical instrument.

[0215] Article 90 A method of operating a navigation-assisted surgical system including a handheld surgical instrument, an end effector coupled to the handheld surgical instrument, a navigation array coupled to the handheld surgical instrument or the end effector, an optional mounting module having an inertial sensor or an inertial sensor integrated into the handheld surgical instrument, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising the steps of receiving an input indicating the type of end effector coupled to the handheld surgical instrument, receiving an identification signal from the array using the navigation controller, and using the navigation controller to identify the inertial sensor of the mounting module. receiving a movement signal wirelessly transmitted from an inertial sensor integrated with the attachment module or handheld surgical tool, the movement signal being detected by the inertial sensor and indicating that the handheld surgical tool is being manipulated by a user; generating, using a navigation controller, a first association between the end effector and the navigation array based on user input; generating, using the navigation controller, a second association between the antenna of the attachment module or handheld surgical tool and one of the navigation array and the end effector based on the movement signal; and storing, using a memory, the first association and the second association.

[0216] Article 91 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source coupled to the handheld surgical tool, a mounting module or an antenna integrated with the handheld surgical tool, a localizer, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising the steps of receiving an input indicating a type of end effector coupled to the handheld surgical tool, and using the navigation controller to receive an identification signal from the localizer to detect the navigation array or an antenna integrated with the handheld surgical tool. receiving an identification signal based on a stored identifier stored in the navigation controller; using a navigation controller to create a first association between the end effector and the navigation array based on the input and the identification signal; using the navigation controller to receive an in-use signal indicating that the handheld surgical instrument is in use; using the navigation controller to create a second association between an antenna integrated in the attachment module or the handheld surgical instrument and one of the navigation array and the end effector based on the in-use signal; and storing the first association and the second association using a memory device.

[0217] Article 92 The surgical instrument includes a first handheld surgical instrument and a second handheld surgical instrument, a first end effector coupled to the first handheld surgical instrument, a second end effector coupled to the second handheld surgical instrument, a first navigation array coupled to the first handheld surgical instrument or the first end effector, a second navigation array coupled to the second handheld surgical instrument or the second end effector, an optional console coupled to the first handheld surgical instrument and the second handheld surgical instrument, a localizer, a display, a user interface, a memory device, and a navigation array. and a navigation controller, the method comprising the steps of: receiving a first input indicating a type of a first end effector coupled to a first handheld surgical instrument; receiving a second input indicating a type of a second end effector coupled to a second handheld surgical instrument; receiving, using the navigation controller, a first identification signal from a localizer detecting the first navigation array; and receiving, using the navigation controller, a second identification signal from a localizer detecting the second navigation array. receiving a command signal from a localizer that detects the navigation array in use; optionally coupling the first handheld surgical instrument and the second handheld surgical instrument to the console; and determining a usage status of the first handheld surgical instrument and the second handheld surgical instrument.a step of selecting an active handheld surgical tool from among a first handheld surgical tool and a second handheld surgical tool based on a usage status; and a step of sending a signal from a console or navigation controller to the active handheld surgical tool to stop operation based on a position and / or orientation of an end effector associated with the active navigation array and the selected virtual boundary.

[0218] Article 93 1. A navigation assistance system for wirelessly controlling a first handheld surgical instrument having a first end effector, a first navigation array, and a first mounting module each coupled thereto, and a second handheld surgical instrument having a second end effector, a second navigation array, and a second mounting module each coupled thereto, the system comprising: a localizer including a sensor configured to detect the navigation array and the second navigation array; and a control console coupled to the handheld surgical instrument and the second handheld surgical instrument, the control console being in electronic communication with the localizer and configured to receive a first input indicative of a type of first end effector coupled to the first handheld surgical instrument, receive a second input indicative of a type of second end effector coupled to the second handheld surgical instrument, receive a first identification signal from the localizer detecting the first navigation array, receive a second identification signal from the localizer detecting the second navigation array, generate a first association between the first end effector and the first navigation array based on the first input and the first identification signal, and generate a second association between the first end effector and the first navigation array based on the second input. and a control console including a navigation controller configured to generate a second association between a second end effector and a second navigation array based on the second identification signal, determine a usage status of the navigation array and the second navigation array, select a navigation array in use from among the first navigation array and the second navigation array based on the usage status of the first navigation array and the usage status of the second navigation array, select a virtual boundary based on the identification signal from a localizer that detects the navigation array in use, determine a usage status of the first handheld surgical instrument and the second handheld surgical instrument, select a handheld surgical instrument in use from among the first handheld surgical instrument and the second handheld surgical instrument based on the usage status, and send a signal to the handheld surgical instrument in use to control a state of the handheld surgical instrument based on the position and / or orientation of the end effector associated with the navigation array in use and the selected virtual boundary or virtual object.

[0219] Article 94 1. A method of operating a navigation-assisted surgical system including a handheld surgical instrument, an end effector coupled to the handheld surgical instrument, a navigation array coupled to the handheld surgical instrument or the end effector, a localizer, a mounting module, a communications module, a display, a user interface, a memory device, and a navigation controller, the method comprising: receiving an input indicating a type of end effector coupled to the handheld surgical instrument; receiving, using the navigation controller, an identification signal from the localizer that detects the navigation array; using the navigation controller, creating an association between the end effector and the navigation array based on the input and the identification signal; storing the association using the memory device; receiving, using the navigation controller, a module identification signal wirelessly transmitted from the mounting module to the communications module; and wirelessly transmitting a signal to the mounting module based on the module identification signal and the attitude of the navigation array.

[0220] Article 95 1. A method of operating a navigation-assisted surgical system including a handheld surgical tool including an instrument controller, an end effector coupled to the handheld surgical tool, a navigation array coupled to the handheld surgical tool or the end effector, a power source or mounting module coupled to the handheld surgical tool or an antenna integrated into the handheld surgical tool, a localizer, a memory device, and a navigation controller, the method comprising: wirelessly transmitting a navigation signal to the power source or mounting module or the antenna integrated into the handheld surgical tool based on an identification signal from the navigation controller and an attitude of the navigation array; and controlling a state of the handheld surgical tool based on the navigation signal.

[0221] Article 96 96. The method of clause 95, further comprising transitioning the hand-held tool from a first state to a second state of the hand-held tool based on receipt of a second navigation signal.

[0222] Article 97 The method of clause 95, comprising determining whether a subsequent navigation signal is received within a period of time after a first navigation signal is received, and transitioning the handheld tool from the first state to the second state of the tool if the subsequent navigation signal is not received within the period of time.

[0223] Article 98 97. The method of claim 96, wherein the first navigation signal is generated when the end effector collides with a first virtual object or boundary, and the second navigation signal is generated when the end effector collides with a second virtual object or boundary, the second virtual object being different from the first virtual object.

[0224] Article 99 97. The method of clause 96, wherein the first and second states are different.

[0225] Article 100 99. The method of claim 98, wherein the first and second states are selected from the following group: active state, inactive state, braking state, non-forward state, speed control state, torque control state, precision rotation control state, precision vibration control state, and tap drive state.

[0226] Article 101 Clause 98. The method of clause 97, wherein the first state is an active state and the second state is a non-forward state.

[0227] Article 102 96. The method of clause 95, further comprising determining a status of the handheld surgical instrument and controlling a state of the handheld surgical instrument based on the navigation signal and the status of the handheld surgical instrument.

[0228] Article 103 103. The method of claim 102, wherein the instrument status is selected from the following: motor status, forward switch status, reverse switch status, and handpiece mode status.

[0229] Article 104 Non-transitory computer memory configured to execute software comprising the steps of the method described in any one of clauses 87, 89 to 92, and 94 to 103.

[0230] Article 105 1. A navigation-aided system for wirelessly controlling a handheld surgical instrument, the navigation-aided system comprising: a handheld surgical instrument including an instrument controller; an end effector coupled to the handheld surgical instrument; a navigation array coupled to the handheld surgical instrument or the end effector; a power source or mounting module coupled to the handheld surgical instrument or an antenna integrated with the handheld surgical instrument; a localizer; a memory device; and a navigation controller configured to wirelessly transmit a navigation signal to the power source or mounting module or the antenna integrated with the handheld surgical instrument based on an identification signal from the navigation controller and an attitude of the navigation array, wherein the instrument controller is configured to control a state or parameter of the handheld surgical instrument based on the navigation signal.

[0231] Article 106 The system described in clause 105, wherein the instrument controller is further configured to transition the handheld surgical instrument from a first handheld tool state to a second handheld tool state based on receipt of the second navigation signal.

[0232] Article 107 The method of clause 105, wherein the instrument controller is further configured to determine whether a subsequent navigation signal is received within a period of time after a first navigation signal is received, and transition the handheld surgical instrument from the first handheld tool state to the second tool state if the subsequent navigation signal is not received within the period of time.

[0233] Article 108 107. The method of claim 106, wherein the navigation controller is further configured to generate a first navigation signal when the end effector collides with a first virtual object or boundary and to generate a second navigation signal when the end effector collides with a second virtual object or boundary, the second virtual object being different from the first virtual object.

[0234] Article 109 107. The method of clause 106, wherein the first and second states are different.

[0235] Article 110 109. The method of claim 108, wherein the first and second states are selected from the following group: active state, inactive state, braking state, non-forward state, speed control state, torque control state, precision rotation control state, precision vibration control state, and tap drive state.

[0236] Article 111 Clause 108. The method of clause 107, wherein the first state is an active state and the second state is a non-forward state.

[0237] Article 112 106. The method of clause 105, wherein the instrument controller is further configured to determine a status of the handheld surgical instrument and control a state of the handheld surgical instrument based on the navigation signal and the status of the handheld surgical instrument.

[0238] Article 113 113. The method of claim 112, wherein the instrument status is selected from a motor status, a forward switch status, a reverse switch status, and a handpiece mode status.

[0239] Article 114 A navigation assistance system for wirelessly controlling a first handheld surgical instrument having a first end effector and a first navigation array coupled thereto, and a second handheld surgical instrument having a second end effector and a second navigation array coupled thereto, the system comprising: a localizer including a sensor configured to detect the navigation array and the second navigation array; and a control console coupled to the handheld surgical instrument and the second handheld surgical instrument and in electronic communication with the localizer; receiving a first input indicative of a type of a first end effector coupled to the first handheld surgical tool; receiving a second input indicative of a type of a second end effector coupled to the second handheld surgical tool; receiving a first identification signal from a localizer that detects the first navigation array; receiving a second identification signal from a localizer that detects the second navigation array; generating a first association between the first end effector and the first navigation array based on the first input and the first identification signal; and generating an association between the second end effector and the first navigation array based on the second input and the second identification signal. and a navigation controller configured to generate a second association with the second navigation array, determine a usage status of the navigation array and the second navigation array, select a navigation array in use from among the first navigation array and the second navigation array based on the usage status of the first navigation array and the usage status of the second navigation array, select a virtual boundary based on an identification signal from a localizer that detects the navigation array in use, determine a usage status of the first handheld surgical instrument and the second handheld surgical instrument, select a handheld surgical instrument in use from among the first handheld surgical instrument and the second handheld surgical instrument based on the usage status, and send a signal to the handheld surgical instrument in use, and optionally to a handheld surgical instrument not in use, to control a state or parameter of the handheld surgical instrument based on the position and / or orientation of an end effector associated with the navigation array in use and the selected virtual boundary or virtual object.

Claims

1. 1. A navigation assistance system for wirelessly controlling a handheld surgical instrument, comprising: a handheld surgical instrument including an instrument processor; wirelessly transmitting a broadcast signal to the handheld surgical instrument, the broadcast signal including a pairing identifier; wirelessly transmitting a control signal including a control identifier to the handheld surgical instrument. The control system is configured as follows: Equipped with the instrument processor: receiving the broadcast signal from the control system; receiving the control signal from the control system; determining whether the control identifier corresponds to the pairing identifier; controlling a parameter of the handheld surgical instrument in response to determining that the control identifier corresponds to the pairing identifier. It is configured as follows: Navigation assistance systems.

2. The navigation assistance system of claim 1 , wherein the instrument processor comprises a memory configured to store the pairing identifier.

3. 3. The navigation assistance system of claim 2, wherein one of the control system and the instrument processor is configured to determine whether the handheld surgical instrument is active, and wherein the memory is configured to store the pairing identifier in response to one of the control system and the instrument processor determining that the handheld surgical instrument is active.

4. The navigation assistance system of claim 3 , wherein the instrument processor is configured to determine that the handheld surgical instrument is active by detecting activation of a user interface of the handheld surgical instrument.

5. The navigation assistance system of claim 3 , wherein the instrument processor is configured to determine that the handheld surgical instrument is active by detecting movement of the handheld surgical instrument.

6. 4. The navigation assistance system of claim 3, wherein the control system is in electronic communication with a localizer, and the control system is configured to determine that the handheld surgical instrument is active based on the localizer detecting the handheld surgical instrument.

7. a second handheld surgical instrument capable of coupling to each of the second end effector and the second navigation array, the second handheld surgical instrument including a second instrument processor; transmitting a second broadcast signal including a second pairing identifier to the second handheld surgical instrument; wirelessly transmitting a second control signal including a second control identifier to the second handheld surgical instrument. a second control system configured as follows: Furthermore, the second instrument processor: receiving the second broadcast signal from the second control system; receiving the second control signal from the second control system; determining whether the second control identifier corresponds to the second pairing identifier; controlling a parameter of the second handheld surgical instrument in response to determining that the second control identifier corresponds to the second pairing identifier. It is configured as follows: The navigation assistance system according to claim 1 .

8. an end effector and a navigation array are connectable to the handheld surgical instrument, and the control system includes: determining the identity of the navigation array; creating an association between the end effector and the navigation array; selecting a virtual boundary corresponding to the end effector based on the identity of the navigation array; Determining the position and / or orientation of the end effector further configured as follows: The navigation assistance system according to claim 1 .

9. the control system determining that a motion state exists based on the determined position and / or orientation of the end effector and the selected virtual boundary; wirelessly transmitting the control signal to the handheld surgical instrument in response to determining that the operating condition exists. further configured as follows: The navigation assistance system according to claim 8.

10. 9. The navigation assistance system of claim 8, wherein the control system is configured to determine that the motion condition exists based on determining that the end effector has not crossed the selected virtual boundary.

11. 9. The navigation assistance system of claim 8, wherein the control system is configured to wirelessly transmit the control signal to the handheld surgical instrument at a predetermined rate in response to determining that the motion condition exists, and wherein the instrument processor is configured to cease motion of the handheld surgical instrument in response to determining that a predetermined time has elapsed since receiving the control signal from the control system.

12. the control system determining that a boundary condition exists based on the determined position and / or orientation of the end effector and the selected virtual boundary; wirelessly transmitting the control signal to the handheld surgical instrument in response to determining that the boundary condition exists. further configured as follows: The navigation assistance system according to claim 8.

13. 13. The navigation assistance system of claim 12, wherein the control system is configured to determine that the boundary condition exists based on determining that the end effector has crossed the selected virtual boundary.

14. The navigation assistance system of claim 12 , wherein the instrument processor is configured to stop operation of the handheld surgical instrument in response to receiving the control signal.

15. a second handheld surgical instrument coupleable to each of the second end effector and the second navigation array, the second handheld surgical instrument including a second instrument processor; Furthermore, the control system transmitting the broadcast signal including the pairing identifier to the second handheld surgical instrument; determining the identity of the second navigation array; creating an association between the second end effector and the second navigation array; selecting a second virtual boundary corresponding to the second end effector based on determining the identity of the second navigation array; determining a position and / or orientation of the second end effector; determining that the motion state exists based on the determined positions and / or orientations of the end effector and the second end effector, the selected virtual boundary, and the selected second virtual boundary; wirelessly transmitting a control signal including a control identifier to the handheld surgical instrument and the second handheld surgical instrument in response to determining that the operating condition exists. It is further structured as follows: the second instrument processor: receiving the broadcast signal from the control system; receiving the control signal from the control system; determining whether the control identifier corresponds to the pairing identifier; controlling a parameter of the second handheld surgical instrument in response to determining that the control identifier corresponds to the pairing identifier. It is configured as follows:

10. The navigation assistance system according to claim 9.

16. The navigation assistance system of claim 1 , wherein the control system includes a wireless antenna configured to transmit the control signal and the pairing signal.

17. 1. A method of operating a navigational aid system for wirelessly controlling a handheld surgical instrument including an instrument processor, the navigational aid system including a control system, the method comprising: using the control system to wirelessly transmit a broadcast signal to the handheld surgical instrument, the broadcast signal including a pairing identifier; using the control system to wirelessly transmit a control signal to the handheld surgical instrument, the control signal including a control identifier; receiving the broadcast signal from the control system using the appliance processor; receiving the control signal from the control system using the instrument processor; determining, with the appliance processor, whether the control identifier corresponds to the pairing identifier; using the instrument processor to control a parameter of the handheld surgical instrument in response to determining that the control identifier corresponds to the pairing identifier; A method comprising:

18. determining whether the handheld surgical instrument is active; storing the pairing identifier in response to determining that the handheld surgical instrument is active; 20. The method of claim 17, further comprising:

19. an end effector and a navigation array are coupleable to the handheld surgical instrument; determining, with the control system, the identity of the navigation array; creating an association between the end effector and the navigation array using the control system; selecting, with the control system, a virtual boundary corresponding to the end effector based on the identity of the navigation array; determining a position and / or orientation of the end effector using the control system; using the control system to wirelessly transmit the control signal to the handheld surgical instrument based on the position and / or orientation of the end effector and the selected virtual boundary; 20. The method of claim 18, further comprising:

20. the navigation assistance system further includes a second control system and a second handheld surgical instrument coupleable to each of the second end effector and the second navigation array, the second handheld surgical instrument having a second instrument processor; transmitting, using the second control system, a second broadcast signal including a second pairing identifier to the second handheld surgical instrument; wirelessly transmitting, using the second control system, a second control signal including a second control identifier to the second handheld surgical instrument; receiving, with the second implement processor, the second broadcast signal from the second control system; receiving, with the second implement processor, the second control signal from the second control system; determining, with the second appliance processor, whether the second control identifier corresponds to the second pairing identifier; using the second instrument processor, controlling a parameter of the second handheld surgical instrument in response to determining that the second control identifier corresponds to the second pairing identifier; 20. The method of claim 17, further comprising:

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