Surgical navigation system

Abstract

The present disclosure relates generally to a surgical system. The surgical system includes one or more surgical instrument assemblies and / or a surgical navigation system. The surgical instrument assembly includes a tracking device that can be tracked by the surgical navigation system. The surgical system is also configured to allow a user to define one or more alert zones related to the patient’s anatomy and / or a surgical procedure path. The surgical system further includes an alert device in communication with the surgical navigation system such that the alert device is configured to provide a user-perceptible alert to a surgeon or medical staff based on a location of the surgical instrument relative to the defined alert zones and / or the surgical procedure path as determined by the surgical navigation system.

Description

Background Technology

[0001] In modern surgery, one of the most important instruments available to medical personnel is the electric surgical instrument, such as cordless drills, saws, wire-driven instruments, high-speed drills, and ultrasonic handheld devices. These instruments typically include a motor and / or processor within the handheld device or housing. Surgical instruments may include attachment features configured to receive cutting attachments designed to be applied to the surgical site to perform specific medical procedures. For example, a surgical drill can utilize cutting attachments such as drill bits, grinding heads, or reamers to make holes in tissue or selectively remove tissue such as bone. The ability to use electric surgical instruments on patients reduces the physical strain on surgeons when performing medical procedures. Furthermore, the use of electric surgical instruments allows for the faster and more accurate execution of most surgical procedures compared to previous manual equivalents.

[0002] Surgical navigation systems assist surgeons in navigating surgical instruments during procedures such as sinus, spinal, or neurosurgical procedures. These procedures may involve inserting surgical instruments into the surgical site, traversing the surgical path from the surgical site to the target surgical area, and manipulating the target surgical area. Some surgical navigation systems include a display on which the location of the surgical instruments is overlaid on one or more 2D graphical representations of the patient (e.g., CT or MRI images). Using this system, surgeons can identify the location of the surgical instruments, but not whether the instruments are correctly traveling along the surgical path or manipulating the target surgical area. Therefore, in some cases, surgical instruments may deviate from the surgical path or the target surgical area. Precise navigation of surgical instruments is also important because important anatomical features may be very close to the surgical path or the target surgical area. It is crucial to be aware of when surgical instruments deviate from their path and / or when they may approach important anatomical areas. Therefore, there is a need in the art to identify when surgical instruments deviate from their path and / or when they may approach important anatomical areas and to notify medical personnel. Summary of the Invention

[0003] This disclosure generally relates to a surgical system. The surgical system may generally include one or more surgical instrument assemblies and / or a surgical navigation system. The surgical instrument assemblies may include tracking devices capable of being tracked by the surgical navigation system. The surgical system may also be configured to allow a user to define one or more alarm zones associated with a patient's anatomy and / or surgical path. The surgical system may also include alarm devices communicating with the surgical navigation system, such that the alarm devices can be configured to provide user-perceptible alarms to surgeons or medical personnel based on the position of the surgical instruments relative to the defined alarm zones and / or surgical path, as determined by the surgical navigation system.

[0004] An exemplary configuration provides a surgical system configured to allow medical personnel to define alarm zones in a known coordinate system related to critical structures on a patient, to assist in surgical procedures. The surgical system also includes a navigation system. The system further includes a console that may include a control processor communicating with the navigation system. The system also includes a high-speed surgical instrument comprising a grinding head, which may include a variable-speed motor communicating with the control processor, the variable-speed motor being configured to rotate at a first cutting speed greater than 70,000 revolutions per minute and a second cutting speed less than 70,000 but greater than 60,000 revolutions per minute. The system also includes a foot switch communicating with the control processor for controlling the operation of the variable-speed motor of the high-speed surgical instrument. The system also includes a navigation system configured to actively determine the position of the grinding head relative to the alarm zone in a known coordinate system. The system also includes a navigation system configured to send a signal to the control processor to manipulate the variable-speed motor of the high-speed surgical instrument, such that when the navigation system determines that the grinding head has entered an alarm zone, the rotation of the grinding head is changed from a first cutting speed to a second cutting speed; and wherein the change in the grinding head from the first cutting speed to the second cutting speed produces a perceptible change to notify medical personnel that the grinding head has entered the alarm zone.

[0005] In another exemplary configuration, the surgical system is capable of defining an alarm zone in relation to a critical structure in a known coordinate system to assist medical personnel in performing surgery on a patient. The surgical system also includes a navigation system. The system further includes a high-speed surgical instrument that may include a grinding head and may include a variable-speed motor configured to rotate the grinding head. The system also includes a console that may include a control processor communicating with the variable-speed motor of the high-speed surgical instrument and being configured to receive data from the navigation system. The system also includes a foot switch communicating with the control processor for controlling the operation of the variable-speed motor of the high-speed surgical grinding head; the foot switch may include a tactile alarm device. The system also includes a navigation system configured to determine the position of the grinding head relative to the alarm zone and send data indicating the position of the grinding head relative to the alarm zone to the control processor, and the control processor configured to manipulate the tactile alarm device of the foot switch based on the position of the grinding head relative to the alarm zone in a known coordinate system to provide notification to medical personnel.

[0006] In yet another exemplary configuration, a surgical system is disclosed for use by medical personnel during surgical procedures on a patient. This surgical system also includes a surgical instrument assembly that may include: a console including a processor; a handheld device communicating with the processor on the console, the handheld device being coupled to an end effector and a variable-speed motor for driving the end effector; a switch operable by a medical personnel between a first position and a second position for controlling energization of the variable-speed motor; and a switch sensor configured to detect the position of the switch and transmit a first signal indicating the position of the switch to the processor. The system also includes a navigation system communicating with the processor, the navigation system being configured to actively determine the position of the end effector relative to a first boundary defined in a known coordinate system. The system further includes the navigation system being configured to transmit a second signal to the processor to de-energize the variable-speed motor based on the position of the end effector relative to the first boundary in the known coordinate system. The system also includes a processor configured to prevent the variable speed motor from being re-energized when the handheld device is powered off, until a subsequent first signal is received from the switch sensor indicating that the medical personnel have manipulated the position of the switch, while the end effector remains in the first position.

[0007] In another exemplary configuration, the surgical system is capable of defining an alarm zone in a known coordinate system to assist medical personnel in performing surgery on a patient. The surgical system also includes a navigation system. The system further includes a handheld surgical instrument for coupling to an end effector, the handheld surgical instrument including a motor configured to rotate the end effector. The system also includes a control processor disposed in the handheld surgical instrument, the control processor communicating with the motor and configured to receive data from the navigation system. The system also includes a trigger disposed on the handheld surgical instrument, the trigger communicating with the control processor to control the operation of the motor of the surgical instrument. The system further includes the fact that the trigger may include a tactile alarm device. The system further includes the fact that the navigation system is configured to send data to the control processor that the end effector has entered the alarm zone, and the control processor is configured to actuate the tactile alarm device of the trigger to notify medical personnel that the end effector has entered the alarm zone.

[0008] In yet another exemplary configuration, a surgical system is provided for use by a medical professional during surgical procedures on a patient. The surgical system also includes a handheld surgical instrument configured to drive an end effector and may include: a variable-speed motor for rotating the end effector; a trigger operable by a medical professional between a first position and a second position; and a trigger sensor configured to detect the position of the trigger and output a first signal indicating the position of the trigger. The system also includes a rechargeable battery module detachably coupled to the handheld surgical instrument, the battery module including: a transceiver configured to transmit and receive signals; and a battery processor communicating with the transceiver and the trigger sensor, the battery processor being configured to selectively supply power to the variable-speed motor of the handheld surgical instrument, at least in part, based on the first signal indicating the position of the trigger. The system also includes a navigation system communicating with the battery processor via the transceiver, the navigation system being configured to actively determine the position of the end effector relative to a first boundary defined in relation to a known coordinate system. The system also includes a navigation system configured to transmit a second signal to the battery processor to limit the power supply to the handheld surgical instrument based on the position of the end effector and the first boundary in a known coordinate system. The system further includes a battery processor configured to prevent the variable-speed motor from being energized when the battery processor limits the power supply to the handheld surgical instrument, until a subsequent first signal indicating that a medical professional has manipulated the position of the trigger is received from the trigger sensor.

[0009] In yet another exemplary configuration, a surgical system is provided for use by a medical professional during surgical procedures on a patient. The surgical system also includes a handheld surgical instrument configured to drive an end effector and may include: a variable-speed motor; a trigger operable by a medical professional between a first position and a second position; and a handheld processor configured to control energization of the variable-speed motor based at least in part on the position of the trigger. The system also includes a rechargeable battery module detachably coupled to the handheld surgical instrument, the battery module including: a transceiver configured to transmit and receive signals; and a battery processor communicating with the transceiver, the processor being configured to energize and de-energize the handheld surgical instrument. The system further includes a navigation system communicating with the battery processor via the transceiver, the navigation system being configured to actively determine the position of the handheld surgical instrument relative to a boundary in a known coordinate system. The system also includes the navigation system being configured to transmit a first signal to the battery processor to temporarily de-energize the handheld surgical instrument based on the position of the end effector relative to the boundary in the known coordinate system. The system further includes a navigation system configured to determine whether the movement of the end effector relative to the boundary is proximal or distal when the handheld surgical instrument is held at or adjacent to the boundary and after the battery processor de-energizes the handheld surgical instrument, and to transmit a second signal to the battery processor. The system also includes a battery processor configured to re-energize the handheld surgical instrument based on whether its movement relative to the boundary is proximal.

[0010] In yet another exemplary configuration, a surgical system is provided for use by a medical professional to perform surgical procedures on a patient. The surgical system further includes a handheld surgical instrument configured to receive an end effector, the handheld surgical instrument including: a variable-speed motor configured to rotate the end effector; a trigger operable by a medical professional between a first position and a second position; a trigger sensor configured to detect the position of the trigger and output a first signal indicating the position of the trigger; and a handheld processor configured to control energization of the variable-speed motor based at least in part on the first signal indicating the position of the trigger from the trigger sensor. The system also includes a navigation system in communication with the processor, the navigation system being configured to define a first boundary and actively determine the position of the surgical instrument relative to the first boundary and transmit a second signal to the handheld processor to deactivate the variable-speed motor when the trigger sensor indicates that the trigger is in the second position and the navigation system determines that the handheld surgical instrument is adjacent to and / or distal to the first boundary. The system also includes a handheld device processor configured to reactivate the variable speed motor upon receiving a subsequent first signal from the trigger sensor when the handheld surgical instrument remains adjacent to and / or distal to the first boundary, the subsequent first signal indicating that a medical professional has manipulated the trigger to move the trigger from the second position to the first position and back to the second position.

[0011] In yet another exemplary configuration, a surgical system is provided for use by medical personnel in performing spinal or neurosurgical procedures on a patient. The surgical system also includes a handheld surgical instrument configured to receive an end effector, the handheld surgical instrument comprising: a handheld component; a variable-speed motor disposed within the handheld component; a trigger operable by a medical personnel to activate and deactivate the variable-speed motor; a switch operable by a medical personnel between a first position and a second position to control the speed of the variable-speed motor; and a processor configured to control the energization of the variable-speed motor. The system also includes a navigation system in communication with the processor, the navigation system being configured to determine whether the switch is in the first position or the second position. The system further includes the navigation system being configured to transmit signals to the processor to control the energization of the variable-speed motor based on the switch being in the appropriate position and based on the type of end effector coupled to the handheld surgical instrument.

[0012] In yet another exemplary configuration, a surgical system is provided for use by medical personnel when performing surgical procedures on a patient. The surgical system further includes a handheld surgical instrument assembly, which may include: a handheld component; one of a first or a second end effector, each of which is detachably coupled to the handheld component; a variable-speed motor disposed within the handheld component; and a processor configured to control energization of the variable-speed motor. The system also includes a navigation system in communication with the processor, the navigation system identifying the first and second end effectors. The system further includes the navigation system being configured to define a first boundary in a known coordinate system based at least in part on the identification of the first end effector and to define a second boundary in a known coordinate system, different from the first boundary, based at least in part on the identification of the second end effector. The system further includes, upon identification of the first end effector, the navigation system being configured to transmit a first signal to the processor to control energization of the variable-speed motor based on the position of the first end effector relative to the first boundary. The system also includes a navigation system configured to send a signal to the processor when the second end effector is identified, to control the energization of the variable speed motor based on the position of the second end effector relative to the second boundary.

[0013] In another exemplary configuration, a method for navigating surgical instruments using a navigation system during a medical procedure on a patient is provided. The method further includes determining a planned orientation of a selected implant in a known coordinate system; creating multiple boundaries within the known coordinate system based on the orientation of the selected implant, the multiple boundaries including drill-specific boundaries and actuator-specific boundaries. The method also includes using the navigation system to track the position of the surgical instruments; activating drill-specific boundaries based on identifying the end effector as a drill (machine) instrument, and activating actuator-specific boundaries based on identifying the end effector as an actuator instrument. The method further includes controlling the energization of a motor of the handpiece when a drill instrument has been identified based on the drill-specific boundaries and the position of the handpiece. The method also includes controlling the energization of a motor of the handpiece when an actuator instrument has been identified based on the actuator-specific boundaries and the position of the handpiece.

[0014] In yet another exemplary configuration, a surgical system is provided for use by medical personnel during surgical procedures on a patient. The surgical system also includes a high-speed surgical instrument assembly, which may include: a console including a processor; a handheld device communicating with the processor of the console, the handheld device including an end effector and a variable-speed motor for driving the end effector; and a switch operable by a medical personnel between a first position and a second position to control the energization of the variable-speed motor. The system also includes a navigation system communicating with the processor, the navigation system being configured to actively determine the position of the handheld device relative to a boundary in a known coordinate system. The system further includes wherein the navigation system is configured to transmit a first signal to the processor to temporarily de-energize the handheld device when the navigation system determines that the position of the handheld device is at or adjacent to the boundary. The system also includes, upon re-energizing the variable-speed motor, the navigation system being configured to transmit a second signal to the processor to energize or de-energize the handheld device based on the movement of the handheld device being farther from the boundary.

[0015] In yet another exemplary configuration, a surgical system is provided for use by medical personnel during surgical procedures on a patient. The surgical system also includes a high-speed surgical instrument assembly, which may include: a console including a processor; a handheld device communicating with the processor of the console, the handheld device including an end effector and a variable-speed motor for driving the end effector; a first switch operable by a medical personnel between a first position and a second position to control the energization of the variable-speed motor in a positive direction; and a second switch operable by a medical personnel between the first position and the second position to control the energization of the variable-speed motor in an opposite direction. The system also includes a navigation system communicating with the processor, the navigation system being configured to actively determine the position of the handheld device relative to an alarm zone defined in relation to a critical structure of the patient. The system further includes wherein the navigation system is configured to transmit a first signal to the processor to de-energize the handheld device when the navigation system determines that the position of the handheld device has entered the alarm zone and the variable-speed motor is in the positive direction. The system also includes a second signal configured to send to the processor when the processor de-energizes the handheld device and when the handheld device remains in the alarm area, causing the processor to prevent the variable speed motor from being re-energized in the positive direction and to allow the variable speed motor to be re-energized in the reverse direction.

[0016] In another exemplary configuration, a surgical instrument assembly is used in conjunction with a navigation system configured to allow medical personnel to define patient-related alarm zones to assist in performing surgery on a patient. The surgical instrument assembly also includes a console that may include a control processor communicating with the navigation system. The assembly further includes a high-speed surgical grinding head assembly that may include a variable-speed motor communicating with the control processor, the variable-speed motor being configured to rotate the grinding head. The assembly also includes a foot switch movable between a first position and a second position for powering the variable-speed motor of the high-speed surgical grinding head assembly. The assembly also includes a foot switch sensor communicating with the control processor, the foot switch being configured to detect the position of the foot switch and transmit a first signal indicating the position of the foot switch to the control processor. The assembly also includes a tactile alarm device coupled to the foot switch and communicating with the control processor, the tactile alarm device being positioned on the foot switch such that when a medical personnel presses the foot switch to operate the high-speed surgical grinding head assembly, the tactile alarm device makes contact with the medical personnel's foot. The component also includes a navigation system configured to actively determine the position of the grinding head relative to an alarm zone in a known coordinate system. The component further includes a navigation system configured to send a second signal to the control processor to activate the tactile alarm device to issue a tactile alarm perceptible to medical personnel when the grinding head enters the alarm zone; while the grinding head is still in the alarm zone, the processor is configured to deactivate the tactile alarm device upon receiving a subsequent first signal from the foot switch sensor instructing a medical personnel to move the foot switch.

[0017] In yet another exemplary configuration, a surgical system is provided for use by medical personnel during surgical procedures on a patient. The surgical system further includes a drill assembly that may include: a console including a processor; a handheld device communicating with the processor on the console, the handheld device including an end effector and a variable-speed motor for driving the end effector; and a switch operable by a medical personnel between a first position and a second position to control the energization of the variable-speed motor. The system also includes a navigation system communicating with the processor, the navigation system being configured to actively determine the position of the handheld device relative to a boundary defined in relation to a critical structure of the patient. The system further includes the navigation system being configured to transmit a first signal to the processor in response to the end effector being adjacent to or distal to the boundary, causing the processor to adjust a torque mapping, wherein the variable-speed motor of the handheld device is powered via the torque mapping.

[0018] In yet another exemplary configuration, the surgical system is configured to allow medical personnel to define alarm zones associated with critical structures of a patient to assist in surgical procedures. The surgical system also includes a navigation system. The system further includes a console that may include a control processor communicating with the navigation system. The system also includes a high-speed surgical instrument containing a grinding head. The system also includes a foot switch communicating with the control processor for controlling the operation of the variable-speed motor of the high-speed surgical instrument. The system also includes a navigation system configured to: actively determine the position of the grinding head relative to the alarm zone; trigger an alarm response when the navigation system determines that the grinding head has entered the alarm zone; deactivate the alarm response based on a user input signal; and re-trigger the alarm response based on the grinding head being outside the alarm zone for a predetermined time and subsequently re-entering the alarm zone.

[0019] These and other configurations, features, and advantages of this disclosure will be apparent to those skilled in the art. This disclosure is not intended to be limited to or construed as being limited by these configurations, embodiments, features, and / or advantages. Attached Figure Description

[0020] When considered in conjunction with the accompanying drawings, the advantages of the invention will readily become apparent from the following detailed description, wherein:

[0021] Figure 1A This is a schematic diagram of a surgical system that includes multiple surgical instrument assemblies and a surgical navigation system for tracking the surgical instruments associated with each of the individual surgical instrument assemblies.

[0022] Figure 1B yes Figure 1A A schematic diagram of an alternative configuration for the surgical system.

[0023] Figure 2 This is a perspective view of an exemplary layout of a surgical operating room, including... Figure 1A-1B At least one of the surgical instrument components and a surgical navigation system are used to perform medical procedures on a patient.

[0024] Figure 3 Is in use Figure 1A-1B A schematic diagram of the surgical site as viewed from the surgeon's perspective when performing a medical procedure on a patient, using at least one of the surgical instrument components.

[0025] Figure 4A yes Figure 1A-1B A schematic diagram of a first exemplary surgical instrument of a surgical system, wherein the first surgical instrument is oriented relative to a patient in a first position.

[0026] Figure 4B yes Figure 4AA schematic diagram of the first surgical instrument, which is oriented in a second position relative to the patient.

[0027] Figure 4C yes Figure 4A A schematic diagram of the first surgical instrument, which is oriented in a third position relative to the patient.

[0028] Figure 4D yes Figure 4A A schematic diagram of the first surgical instrument, which is oriented in the fourth position relative to the patient.

[0029] Figure 5A yes Figure 1A-1B A schematic diagram of a second exemplary surgical instrument of a surgical system, the second surgical instrument being oriented at a first position relative to the patient and a defined first set of exemplary alarm zones.

[0030] Figure 5B yes Figure 5A A schematic diagram of a second surgical instrument, which is oriented in a second position relative to the patient and a defined first set of exemplary alarm zones.

[0031] Figure 5C yes Figure 5A A schematic diagram of a second surgical instrument, which is oriented in a third position relative to the patient and a defined first set of exemplary alarm zones.

[0032] Figure 5D yes Figure 5A A schematic diagram of a second surgical instrument, which is oriented in a third position relative to the patient and a defined second set of exemplary alarm zones.

[0033] Figure 5E yes Figure 5A A schematic diagram of a second surgical instrument, which is oriented in a third position relative to the patient and a defined second set of exemplary alarm zones.

[0034] Figure 5F yes Figure 5A A schematic diagram of the second surgical instrument, which also includes a battery module and a battery processor.

[0035] Figure 6 This is a schematic diagram of an exemplary surgical system that includes a navigation system and handheld surgical instruments, the handheld surgical instruments including a battery module and multiple end effectors.

[0036] Figure 7 This is a schematic diagram of an exemplary surgical system including a navigation system and a high-speed grinding head, which includes a console and multiple cutting grinding heads.

[0037] Figure 8 This is a schematic diagram of an exemplary graphical user interface (GUI) for a navigation system, which includes user-selectable objects related to the planning and / or execution of surgical procedures.

[0038] Figure 9 This is a schematic diagram of an exemplary graphical user interface (GUI) for a navigation system, which displays an image of the planned placement of a surgical implant and user-selectable objects related to the depth of the implant.

[0039] Figure 10 This is a schematic diagram of an exemplary graphical user interface (GUI) for a navigation system, which displays an image of the planned placement of a surgical implant and user-selectable objects related to the settings of each of the various surgical instruments used during the surgical procedure.

[0040] Figure 11A This is a schematic diagram of an exemplary graphical user interface (GUI) for a navigation system, which displays user-selectable objects related to the space defining the alarm zone.

[0041] Figure 11B yes Figure 11A An exemplary graphical user interface (GUI) diagram illustrating the space defining alarm zones from different angles.

[0042] Figure 11C yes Figure 11A An exemplary graphical user interface (GUI) diagram illustrating the space defining alarm zones from different angles.

[0043] Figure 12A This is a schematic diagram of an exemplary graphical user interface (GUI) for a navigation system, which displays user-selectable objects related to defining the boundaries of an alert area.

[0044] Figure 12B yes Figure 12A An exemplary graphical user interface (GUI) diagram illustrating the boundaries of the alarm zone defined from different angles.

[0045] Figure 12C yes Figure 12A An exemplary graphical user interface (GUI) diagram illustrating the boundaries of the alarm zone defined from different angles.

[0046] Figure 13A This is a schematic diagram of an exemplary graphical user interface (GUI) for a navigation system, illustrating a sagittal view of the patient space during the placement of a surgical implant.

[0047] Figure 13B yes Figure 13AA schematic diagram of an exemplary graphical user interface (GUI) illustrating an axial view of the patient space during the placement of a surgical implant. Detailed Implementation

[0048] Reliably tracking surgical instruments during surgical procedures to follow the planned surgical path and / or avoid critical anatomical structures is of paramount importance. Furthermore, providing feedback and / or notifying the medical personnel performing the procedure is of similar importance when surgical instruments become misaligned with the surgical path and / or pose a risk of impacting critical anatomical structures.

[0049] therefore, Figure 1A and Figure 1B An exemplary surgical system 10 is shown, which may include a surgical navigation system 100 for tracking one or more surgical instrument assemblies 200, 300, 400 to assist medical personnel, such as surgeons, in performing medical procedures. The surgical instrument assemblies include surgical instruments 220, 320, 420.

[0050] The surgical navigation system 100 may include a navigation interface comprising one or more display units 120 and one or more user input devices 130, such as one or more graphical user interfaces (GUIs) 150. The display units 120 of the surgical navigation system 100 may be configured to display various prompts or data input boxes. For example, the display unit 120 may be configured to display text boxes or prompts that allow the surgeon to manually input or select the type of surgical procedure to be performed. The display unit 120 may also be configured to display patient data, such as preoperative images or scans. As described above, preoperative images may be MRI scans, radiographic scans, or computed tomography (CT) scans based on the patient's anatomy. Preoperative images may be uploaded to the surgical navigation system 100 and displayed on the display unit 120. The display unit 120 may also be configured to display a surgical plan for a medical procedure overlaid on the patient data or images.

[0051] Surgical planning may include a surgical path for performing a medical procedure or a planned trajectory or orientation of a medical device during the procedure. Surgical planning may also include overlaying the location and / or orientation of an implant or medical device inserted during the procedure onto patient data or images. Surgical navigation system 100 is envisioned to include a display unit 120 configured to display and / or project a holographic image of the surgical path for performing a medical procedure or the planned trajectory or orientation of a medical device during the procedure. This may include projecting the surgical path onto a patient or other surface in the operating room. It may also include projecting the surgical path onto a head unit worn by the surgeon, such as lenses, shields, or glasses. An exemplary configuration of surgical navigation system 100 including a display unit worn by the surgeon for displaying a target trajectory and / or target site is disclosed in International Patent Application No. PCT / IB2018 / 053130, the entire contents of which are incorporated herein by reference.

[0052] User input device 130 and / or graphical user interface (GUI) 150 can be configured to allow surgeons to input or type patient data or modify surgical plans. Patient data may include patient images, such as preoperative images of the patient's anatomy. These images may be based on MRI, radiographic, or computed tomography (CT) scans of the patient's anatomy. Patient data may also include additional information related to the type of medical procedure being performed, the patient's anatomical features, the patient's specific medical condition, and / or operational settings for surgical navigation. For example, during spinal surgery, the surgeon may input information related to the specific vertebra on which the procedure is being performed via user input device 130 and / or GUI 150. The surgeon may also input various anatomical dimensions associated with the vertebra and / or the size and shape of any medical devices or implants to be inserted during the procedure. User input device 130 and / or GUI 150 may also be configured to allow surgeons to select, edit, or manipulate patient data. For example, the surgeon may identify and / or select anatomical features from the patient data. This can include selecting a surgical site, such as selecting the vertebra and / or a specific area on the vertebra where the medical procedure will be performed.

[0053] Surgeons may also be able to identify key anatomical features, such as those they may want to target or avoid during a medical procedure. For example, a surgeon may use user input device 130 and / or graphical user interface (GUI) 150 to select key anatomical structures such as cortical walls, nerves, blood vessels, or similar structures that they wish to avoid and to establish areas surrounding these structures. Surgeons may also use user input device 130 and / or GUI 150 to select and / or input target sites, target trajectories, target depths, or similar features for surgical paths to help guide the execution of medical procedures.

[0054] The system can be configured to utilize segmentation to facilitate the division of regions and / or boundaries of interest. This segmentation can be performed automatically, semi-automatically, or manually.

[0055] In one example of manual segmentation, the surgeon may also utilize user input device 130 and / or graphical user interface (GUI) 150 to define geometric primitives to define regions of interest. A method for defining geometric primitives for segmenting and visualizing cavities or orifices of the human body may include the following steps: performing manual pre-segmentation by defining closed geometric primitives in a 3D patient image to generate an initial envelope; analyzing the anatomical structures within the pre-segmented geometric primitives; adjusting the envelope using the results of the analysis; and visualizing the envelope. Adjustments to the visualized envelope may be based on anatomical structures analyzed using computed voxel correlation analysis, and adjustments to the visualized cell envelope may be achieved by computed surface meshes of voxels wholly and / or partially correlated to the cell. Furthermore, adjustments to the visualized envelope may be achieved by optimizing the type, orientation, position, and / or size of the closed geometric primitives. Exemplary methods and systems for defining geometric primitives and guiding surgical instruments are disclosed in U.S. Patent Application Nos. 15 / 300,414 and 15 / 582,637, both of which are incorporated herein by reference in their entirety.

[0056] User input device 130 and / or graphical user interface (GUI) 150 can also be configured to input surgical plans. This may include selecting surgical instruments to be used and devices and / or implants to be inserted. It may also include identifying the location and / or orientation (i.e., posture) of the device or implant placed in the patient's body. User input device 130 and / or graphical user interface (GUI) 150 may also allow the surgeon to select parameters of the implant to be inserted, such as the length and / or diameter of the screw to be inserted.

[0057] The surgical navigation system 100 may also include a navigation processor 140. The navigation processor 140 may be located on a personal computer or laptop computer. The navigation processor 140 may communicate with a user input device 130, a display unit 120, a central processing unit (CPU) and / or other processors, a memory (not shown), and a storage device (not shown). The navigation processor 140 may also include software and / or operating instructions related to the operation of the surgical navigation system 100 and for implementing the various routines and / or methods disclosed herein. The software and / or operating instructions may include a planning system configured to define the precise position and / or angular alignment of the implant relative to the patient 20. The navigation processor 140 may communicate directly or indirectly with the surgical instrument assemblies 200, 300, 400 via wired or wireless communication.

[0058] The navigation system may also include software used by the navigation processor 140 to control the operation of surgical instruments 220, 320, 420. This software may include a boundary and / or alarm zone generator. The boundary generator may be implemented on the navigation processor 140, instrument processors 215, 315, 415, and / or other components, such as on a separate processor or controller. Exemplary systems and methods for boundary generation can be found in U.S. Patent Publication No. 2004 / 0034283A1, the entire contents of which are incorporated herein by reference. The boundary generator may also be part of a separate system independent of the operation of surgical instruments 220, 320, 420. A boundary generator is a software program or module that generates one or more virtual boundaries for constraining the movement and / or operation of surgical instruments 220, 320, 420. In some examples, the boundary generator provides virtual boundaries that define virtual drill and / or actuator guidance (e.g., virtual implant planning guidance). These virtual boundaries or alert zones can also be provided for controlling the operation of surgical instruments 220, 320, 420 relative to key anatomical features, target depths, and / or target sites that the surgeon wishes to avoid. Virtual boundaries can be one-dimensional (1D), two-dimensional (2D), or three-dimensional (3D) and can include points, lines, axes, trajectories, planes (infinite planes or plane segments defined by anatomical structures or other boundaries), volumes, or other shapes, including complex geometries. Virtual boundaries can be represented by pixels, point clouds, voxels, triangular meshes, other 2D or 3D models, combinations thereof, etc. U.S. Patent Publication No. 2018 / 0333207 and U.S. Patent No. 8,898,043 are incorporated herein by reference, and any features thereof can be used to facilitate the planning or execution of surgical procedures. Multiple boundaries can be used to define regions.

[0059] Virtual boundaries can be used in a variety of ways. For example, navigation processor 140 can / or control certain operations / functions of surgical instruments 220, 320, 420 based on their relationship to the boundary (e.g., space, velocity, etc.). Other uses for the boundary are also envisioned.

[0060] The boundaries used to ensure that instruments are positioned at the desired depth can be defined by virtual planar boundaries, virtual volume boundaries, or other forms of virtual boundaries. Virtual boundaries can also be called virtual objects. Virtual boundaries can be defined relative to an anatomical model (such as a 3D skeleton model). In other words, points, lines, axes, trajectories, planes, volumes, etc., associated with the virtual boundary can be defined in a coordinate system fixed relative to the coordinate system of the anatomical model, allowing the tracking of the anatomical model (e.g., by tracking the related anatomical structures it has registered to) to also track the virtual boundary.

[0061] The anatomical model is registered to the first patient tracker, thus associating the virtual boundary with the anatomical model and its associated coordinate system. The virtual boundary can be implant-specific, defined, for example, based on the implant's size, shape, volume, etc., and / or patient-specific, defined, for example, based on the patient's anatomy. The virtual boundary can be created preoperatively, intraoperatively, or a combination thereof. In other words, the virtual boundary can be defined before the start of the surgical procedure, during the surgical procedure (including during tissue removal), or a combination thereof. The virtual boundary can be provided in various ways, such as by creating a virtual boundary via the navigation processor 140, receiving a virtual boundary from another source / system, etc. The virtual boundary can be stored in memory for retrieval and / or updating.

[0062] Furthermore, it is envisioned that in some cases, the virtual boundary may include multiple planar boundaries that can be used to delineate multiple target depths (e.g., three target depths) for a single instrument to be used in a single procedure. For example, the first virtual boundary represents the target depth of the drill used for drilling, the second virtual boundary represents the target depth of the tap, and the third virtual boundary represents the target depth of the driver used for inserting a screw, such as... Figure 5D As shown, and explained in more detail below, these multiple virtual boundaries can be activated one at a time by the navigation processor 140 to limit the cut to a plane at a time. The navigation processor 140 tracks the state of the surgical instruments 220, 320, 420 relative to the virtual boundaries.

[0063] The surgical navigation system 100 may also include a tracking unit 110, which includes one or more sensors 115. Sensors may include cameras, such as CCD cameras, CMOS cameras and / or optical imaging cameras, magnetic sensors, radio frequency sensors, or any other sensors suitable for detecting and / or sensing the position of tracking devices 230, 330, 430 of surgical instrument assemblies 200, 300, 400. A description of suitable tracking units and various locators that can be utilized with them can be found in U.S. Patent Publication No. 2017 / 0333137, which is incorporated herein by reference in its entirety.

[0064] refer to Figure 1A-1B Various exemplary surgical instrument assemblies 200, 300, and 400 are shown communicating with the surgical navigation system 100. Each of the various exemplary surgical instrument assemblies will be described in more detail below. Surgical instrument assemblies 200, 300, and 400 may be configured to communicate wirelessly with the surgical navigation system 100. Furthermore, each of surgical instrument assemblies 200, 300, and 400 may have multiple similar components capable of performing similar functions and / or operations. Similar components among each of the surgical instrument assemblies 200, 300, and 400 will include the same two-digit number, which is preceded by 2, 3, or 4 to reflect the associated surgical instrument assembly 200, 300, or 400. For example, each of surgical instrument assemblies 200, 300, and 400 may include surgical instruments 220, 320, and 420.

[0065] Surgical system 10 may include a first surgical instrument assembly 200 in communication with navigation system 100. For example, the first surgical instrument assembly 200 may be configured to include a first surgical instrument 220, such as a surgical drill or actuator, with a handhold 225. The handhold 225 may include a housing 210 configured to receive various components of the first surgical instrument 220. The handhold 225 may be shaped to define a handle or grip portion for a surgeon to hold while performing a medical procedure. Suitable handholds are described in U.S. Patent No. 5,747,953, the entire contents of which are incorporated herein by reference.

[0066] The first surgical instrument 220 may further include a first instrument processor 215 and a motor 245. Each of the first instrument processor 215 and the motor 245 may be disposed within the handpiece 225 of the first surgical instrument 220. The first instrument processor 215 and the motor 245 may communicate with each other, and the first instrument processor 215 may be configured to control the operation of the motor 245, thereby controlling the operation of the first surgical instrument 220. For example, the first surgical instrument 220 may include an end effector 240, such as a drill bit for drilling or a driver for inserting a screw. The end effector 240 may be coupled to the handpiece 225 of the first surgical instrument 220 such that the motor 245 may be operatively coupled to the end effector 240. For example, the motor 245 may be configured to rotate the drill bit 240 to drill and / or remove biological tissue. The first instrument processor 215 may communicate with the motor 245 and be configured to control the operation of the motor 245, thereby controlling the operation of the drill bit 240. The first instrument processor 215 can also communicate with the navigation processor 140 and is configured to exchange data relating to the position and / or orientation of the first surgical instrument 220, as well as data relating to the operation of the first surgical instrument 220. For example, the first instrument processor 215 and the navigation processor 140 can be configured to transmit data relating to the operation of the first surgical instrument 220 to each other based on the position and / or orientation of the first surgical instrument 220 detected by the surgical navigation system 100.

[0067] The first surgical instrument assembly 200 may also include a power supply 260. The power supply 260 may be detachably coupled to the handpiece 225 of the surgical drill 220. For example, the power supply 260 may include a removable battery pack. It is also contemplated that the power supply 260 may be formed as part of or disposed within the handpiece 225 of the first surgical instrument 220. The power supply 260 may be electrically connected to the first instrument processor 215 and / or the motor 245 and configured to selectively power the motor 245 to rotate the end effector 240. The power supply may also be a surgical console that powers the first surgical instrument via an electrical cord.

[0068] In the case where the power supply is in the form of a removable battery pack, the power supply 260 may also include a processor 265. The processor 265 can communicate with the first instrument processor 215 via power signals and / or data signals. The processor 265 and the first instrument processor 215 can be configured to communicate with each other to control the operation of the motor 245, and consequently, the operation of the first surgical instrument 220. For example, the processor 265 in the power supply 260 may be configured to recognize when the power supply 260 has dropped below a threshold charge level, such that the power supply 260 may be unable to continue operating the motor 245 at a minimum threshold for drilling or cutting biological tissue. The processor 265 may be configured to cut off any power to the first instrument processor 215 and / or the motor 245 to prevent operation of the end effector 240 until the power supply 260 has a sufficient charge level to operate the motor 245 at a rate above the minimum threshold for drilling or cutting biological tissue. The processor 265 in the power supply 260 may also communicate wirelessly with the navigation processor 140. The power supply 260 may include a transceiver configured to send and receive signals between the power supply 260 and the surgical navigation system 100 and / or the instrument processor 215.

[0069] Processor 265 and navigation processor 140 can be configured to transmit data related to the operation of the first surgical instrument 220 to each other based on the position and / or orientation of the first surgical instrument 220 detected by surgical navigation system 100. For example, navigation system 100 can be configured to transmit data to processor 265 based on the position and / or orientation of the first surgical instrument 220 detected by surgical navigation system 100, including instructions to cause processor 265 to stop supplying power to first instrument processor 215 and / or motor 245. Navigation system 100 can also be configured to transmit data to processor 265 based on the position and / or orientation of the first surgical instrument 220 detected by surgical navigation system 100, including instructions to cause processor 265 to continue and / or resume supplying power to first instrument processor 215 and / or motor 245.

[0070] The first surgical instrument assembly 200 may further include a switch 250, such as a trigger, button, or lever, operably coupled to the first instrument processor 215. The switch 250 may be configured to be operated by a medical personnel to control the energization of the variable-speed motor 245. For example, the switch 250 may operate between a first position, a power-off state, and a second position, an energized state. The first surgical instrument assembly 200 may further include a switch sensor configured to detect the position of the switch 250 based on user operation of the switch 250 and generate a signal indicating the position of the switch 250 and / or transmit this signal to the first instrument processor 215 to control the operation of the first surgical instrument 220. For example, the switch 250 may include a first position, a second position, and multiple intermediate positions between the first and second positions. The first position may be configured as an off position such that when the first instrument processor 215 receives a signal from the switch sensor that the switch 250 has detected that the switch 250 is in the first position, the first instrument processor 215 prevents energy from flowing from the power source 260 to the motor 245, preventing operation of the first surgical instrument 220. Alternatively, when the first instrument processor 215 receives a signal that the switch sensor has detected that the switch 250 is in the second position, the first instrument processor 215 can be configured to allow maximum energy flow from the power source 260 to the motor 245, allowing the first surgical instrument 220 to operate at maximum drilling or cutting speed. When the first instrument processor 215 receives a signal that the switch sensor has detected that the switch 250 is in one of the intermediate positions, the first instrument processor 215 can be configured to allow energy flow from the power source 260 to the motor 245 at a level corresponding to the position of the switch 250 between the first and second positions, allowing the first surgical instrument 220 to operate at an intermediate drilling or cutting speed. For example, if the first instrument processor 215 receives a signal that the switch sensor has detected that the switch 250 is positioned midway (50%) between the first and second positions, the first instrument processor 215 can be configured to allow energy flow from the power source 260 to the motor 245 at a level that allows the first surgical instrument 220 to operate at 50% of the maximum drilling or driving speed. Alternatively, the first instrument processor 215 may be configured to allow maximum energy flow from the power source 260 to the motor 245 at any time when the switch 250 is in a position other than the first position, thereby allowing the first surgical instrument 220 to operate at maximum drilling or cutting speed when the switch 250 is in the second position or any intermediate position. An exemplary switch sensor can be found in U.S. Patent No. 9,295,476, the entire contents of which are incorporated herein by reference.

[0071] The first surgical instrument assembly 200 may also include a first alarm device 255. The first alarm device 255 may include an auditory, tactile, and / or visually perceptible device. The first alarm device 255 may be configured to communicate with a processor of a first instrument processor 215 or a power supply 260. The first instrument processor 215 or other processor may be configured to send a signal based on pre-programmed conditions or settings to activate the first alarm device 255 to provide a warning or notification.

[0072] For example, as described above, the surgeon can use the user input device 130 to input defined conditions and / or settings into the surgical navigation system 100, such as selecting cortical walls, nerves, blood vessels, or similar anatomical structures that the surgeon wishes to avoid and establishing regions or zones around those anatomical structures. The surgeon can also use the user input device 130 to select and / or input target sites (one or more locations), target trajectories on one or more degrees of freedom, or no-cut zones, or similar features in the surgical path to help guide the surgeon in performing medical procedures. Based on data provided by the navigation processor 140, the first instrument processor 215 can be configured to send a signal to activate the first alarm device 255 when the end effector 240 of the first surgical instrument 220 enters one of the regions and / or zones as defined by the surgeon. Based on data provided by the navigation processor 140, the first instrument processor 215 or other processors can also be configured to send a signal to activate the first alarm device 255 when the end effector 240 of the first surgical instrument 220 leaves the trajectory and / or when the end effector 240 reaches the target site.

[0073] In an exemplary configuration, the first alarm device 255 may include a vibration device positioned to contact the surgeon and configured to vibrate to notify the surgeon of a specific condition or to provide a warning. In an exemplary configuration, such as... Figure 1A-1B As shown, the first alarm device 255 may include a vibration device coupled to a switch 250 for controlling the operation of the first surgical instrument 220. The first alarm device 255 may be configured to vibrate upon occurrence of a defined condition. Since the surgeon will be in continuous contact with the switch 250 when the first surgical instrument 220 is actuated, the surgeon will feel the vibration of the first alarm device 255 and be notified that a defined condition has occurred. The first alarm device 255 may be configured to generate vibration in a specific pattern or interval upon occurrence of the defined condition. Alternatively, the first alarm device 255 may be configured to generate a first vibration of a specific pattern or interval upon occurrence of a first condition and a second vibration of a different pattern or interval upon occurrence of a second condition.

[0074] The first alarm device 255 may also be configured as an auditory device, such as a loudspeaker, to provide an auditory alarm to the surgeon when a defined condition occurs. For example, the first alarm device 255 may include a loudspeaker configured to generate a specific sound when a defined condition occurs. Alternatively, the first alarm device 255 may include a loudspeaker configured to generate sound at specific patterns or intervals when a defined condition occurs. The loudspeaker may be included as part of a surgical navigation system.

[0075] In another configuration, the first alarm device 255 may be configured as a visually perceptible device or indicator, such as a visual display, configured to provide a visual alert to the surgeon upon the occurrence of a defined condition. For example, the first alarm device 255 may include a light configured to flash upon the occurrence of the defined condition. Alternatively, the first alarm device 255 may include multiple multi-color lights configured to illuminate and / or flash in a defined color or pattern upon the occurrence of the defined condition. Where the first alarm device is a display, the display may be configured to generate visual cues indicating the alarm condition. A navigation display 120 may be used as a display for the first alarm device 255, such that the navigation display 120 is configured to provide visual cues to alert the surgeon. For example, the navigation display 120 may be configured to display a prompt or window when the first alarm device 255 is triggered, thereby notifying the surgeon. Alternatively, the navigation display 120 may be configured to flash and / or change color upon the triggering of the first alarm device. One of the many advantages of using the navigation display 120 as the display for the first alarm device 255 is that the surgeon is already frequently looking at the navigation display 120 during the procedure, so if the navigation display 120 is configured to display notifications provided by the first alarm device 255, the surgeon is likely to receive visual notifications in a timely manner.

[0076] In some configurations, the removable power supply 260 may also include a first alarm device. For example, the removable power supply 260 may include a vibration motor or speaker that responds to signals generated by the navigation processor.

[0077] It is also envisioned that the first alarm device 255 may include a combination of auditory, tactile, and / or visual sensing devices. For example, the first alarm device 255 may be configured as a combination of auditory and tactile devices, such that the tactile device may be configured to vibrate to provide a first alarm and the auditory device may be configured to generate noise to provide a second alarm. The first and second alarms may indicate that the same defined condition has occurred, or the first and second alarms may indicate that different defined conditions have occurred. For example, the first alarm may be based on the misalignment of the first surgical instrument 220 with the target trajectory, while the second alarm may be based on the end effector 240 reaching the target site.

[0078] Although the first alarm device 255 is illustrated as a switch 250 coupled to or near the first surgical instrument assembly 200, it is conceivable that the first alarm device 255 can be coupled to and / or positioned in alternative locations. For example, when the first alarm device 255 includes a tactile device, it can be configured to be removably attached to a vibrating member of the surgeon. The first alarm device 255 can be configured as a wearable device, such as a wristband worn on the surgeon's wrist or arm, allowing the surgeon to feel the vibration of the first alarm device 255 when a defined condition occurs. Alternatively, when the first alarm device 255 includes an auditory device, it can be configured to be removably attached to a speaker of the surgeon. The first alarm device 255 can be configured as a Bluetooth speaker or earphone to be worn on the surgeon's head or positioned inside the surgeon's ear, allowing the surgeon to hear the noise generated by the first alarm device 255 when a defined condition occurs.

[0079] While not required, positioning the first alarm device 255 away from the first surgical instrument 220 has several advantages. For example, one advantage of positioning the first alarm device 255 away from the first surgical instrument 220 is that it allows for a reduction in the size of the first surgical instrument 220. This allows the first surgical instrument 220 to be fitted into a smaller space. A smaller first surgical instrument 220 provides less obstruction to the surgeon's view of the surgical site. Another advantage of positioning the first alarm device 255 away from the first surgical instrument 220, particularly in the case of a tactile device, is that the first alarm device 255 does not vibrate the first surgical instrument 220 or affect its movement, while still providing an alarm or notification to the surgeon. In highly technical procedures, an alarm that vibrates the first surgical instrument 220 could cause the surgeon to move the first surgical instrument 220 to an undesirable position due to being startled by the first alarm device 255 and / or the vibration imparting undesirable movement to the first surgical instrument 220.

[0080] The first surgical instrument assembly 200 may also include a tracking device 230. The tracking device 230 may be coupled to a handheld part 225 of the first surgical instrument 220. The tracking device 230 may include a plurality of markers 235 recognizable by the tracking unit 110 of the surgical navigation system 100. The markers 235 may include passive tracking elements (e.g., reflectors) for emitting optical signals to the sensor 115 (e.g., reflecting light emitted from the tracking unit 110). In other configurations, the markers 235 may be configured as active tracking markers. It is also contemplated that the markers 235 may include a combination of active and passive arrangements. The markers 235 may be arranged in positions and orientations defined or known relative to other markers 235 to allow the surgical navigation system 100 to determine the position and orientation (attitude) of the surgical instrument 220. For example, the markers 235 may be registered to the first surgical instrument 220 to allow the surgical navigation system 100 to determine the position and / or orientation of the end effector 240 or cutting portion of the first surgical instrument 220 within a defined space (e.g., a surgical area). In one exemplary configuration, the surgical navigation system 100 may be configured to determine the position and / or orientation of the end effector 240 or cutting portion of the second surgical instrument 220 relative to a target site on a target trajectory and / or a planned surgical path. In another exemplary configuration, the surgical navigation system 100 may also be configured to determine the position and / or orientation of the end effector 240 or cutting portion of the second surgical instrument 220 relative to key anatomical structures within the patient's body, and relative to user-defined boundaries, zones, and / or areas.

[0081] Surgical system 10 may alternatively include a second surgical instrument assembly 300 for use with navigation system 100. For example, the second surgical instrument assembly 300 may include a second surgical instrument 320 including a handheld component 325, such as a high-speed surgical burr or an ultrasonic surgical handheld component. The handheld component 325 may be coupled to a console 310 configured to control the operation of various components of the second surgical instrument 320. The handheld component 325 may be shaped to define a handle or grip portion for a surgeon to hold while performing a medical procedure. Exemplary second surgical instruments coupled to a console can be found in U.S. Patent No. 10,016,209 and U.S. Patent Publication No. 20190117322, which are incorporated herein by reference in their entirety.

[0082] The second surgical instrument 320 may further include a second instrument processor 315 and a motor 345. The second instrument processor 315 may be disposed within the console 310 of the second surgical instrument assembly 300. The motor 345 may be disposed within the handheld part 325 of the second surgical instrument 320. The second instrument processor 315 and the motor 345 can communicate with each other, and the second instrument processor 315 can be configured to control the operation of the motor 345, thereby controlling the operation of the second surgical instrument 320. For example, the second surgical instrument 320 may be connected to the console via a cord connecting the second instrument processor 315 to the motor 345, allowing communication between the second instrument processor 315 and the motor 345 to control the operation of the motor. The second instrument processor 315 may also include an end effector 340, such as a high-speed cutting head or an ultrasonic tip. The end effector 340 may be coupled to the handheld part 325 of the second surgical instrument 320, such that the motor 345 can be operatively coupled to the end effector 340. For example, motor 345 may be configured to actuate high-speed cutting head 340 to grind biological tissue and / or remove biological tissue from surgical sites or to vibrate an ultrasonic tip. Second instrument processor 315 may communicate with motor 345 and is configured to control the operation of motor 345, thereby controlling the operation of high-speed cutting head 340. Second instrument processor 315 may also communicate with navigation processor 140 and is configured to exchange data relating to the position and / or orientation of second surgical instrument 320, as well as data relating to the operation of second surgical instrument 320. For example, second instrument processor 315 and navigation processor 140 may be configured to transmit data relating to the operation of second surgical instrument 320 to each other based on the position and / or orientation of second surgical instrument 320 detected by surgical navigation system 100. Other surgical instruments are also envisioned to be coupled to the console and / or communicate with second instrument processor 315 disposed within console 310.

[0083] The second surgical instrument assembly 300 may also include a power source (not shown). The power source may be coupled to a control console 310 of the second surgical instrument assembly 300 and configured to supply power to a motor 345 of the second surgical instrument 320 to actuate the end effector 340. It is also envisioned that the control console 310 may include a cord configured to insert into a socket connected to an electrical grid to supply power to the second surgical instrument assembly 300. The power source may be electrically connected to the second instrument processor 315 and / or the motor 345 and configured to selectively supply power to the motor 345 to actuate the end effector 340.

[0084] The second surgical instrument assembly 300 may also include a switch 350, such as a foot switch, trigger, or button, operatively coupled to the second instrument processor 315. The switch 350 may be configured to generate and / or transmit signals to the second instrument processor 315 based on user input to control the operation of the second surgical instrument 320. For example, the switch 350 may include a first position, a second position, and multiple intermediate positions between the first and second positions. The first position may be configured as an off position such that when the second instrument processor 315 detects that the switch 350 is in the first position, the second instrument processor 315 prevents energy from flowing from the power source to the motor 345, preventing operation of the second surgical instrument 320. Alternatively, when the second instrument processor 315 detects that the switch 350 is in the second position, the second instrument processor 315 may be configured to allow maximum energy to flow from the power source to the motor 345, thereby allowing the second surgical instrument 320 to operate at maximum speed or displacement (e.g., maximum cutting speed, grinding speed, vibration speed, or vibration amplitude). When the second instrument processor 315 detects that the switch 350 is in one of the intermediate positions, the second instrument processor 315 can be configured to allow energy flowing from the power source to the motor 345 to correspond to the level of the switch 350 in the position between the first and second positions, allowing the second surgical instrument 320 to operate at an intermediate cutting or grinding speed. For example, if the second instrument processor 315 detects that the switch 350 is positioned midway between the first and second positions (50%), the second instrument processor 315 can be configured to allow energy flowing from the power source to the motor 345 to correspond to a level that allows the second surgical instrument 320 to operate at 50% of the maximum cutting or grinding speed. Alternatively, the second instrument processor 315 can be configured to allow maximum energy to flow from the power source to the motor 345 at any time when the switch 350 is in a position other than the first position, thereby allowing the second surgical instrument 320 to operate at the maximum cutting or grinding speed when the switch 350 is in the second position or any intermediate position.

[0085] Although not shown in the figures, it is conceivable that multiple surgical instruments 320 can be coupled to a console 310 and controlled by a foot switch. A switch 350, such as a foot switch, can be configured to control each of the multiple surgical instruments. For example, a single foot switch may include multiple buttons, each of which can be assigned to one of the multiple surgical instruments. An exemplary surgical system including switches coupled to a console to control multiple surgical instruments is disclosed in U.S. Patent Application No. 15 / 450,477, which is incorporated herein by reference in its entirety.

[0086] The second surgical instrument assembly 300 may also include a second alarm device 355. The second alarm device 355 may include auditory, tactile, and / or visually perceptible devices. The second alarm device 355 may be configured to communicate with the second instrument processor 315 or directly with the navigation processor. The second instrument processor 315 or the navigation processor may be configured to send a signal to activate the second alarm device 355, providing a warning or notification, based on pre-programmed conditions or settings.

[0087] For example, as described above, a surgeon can use the user input device 130 to input defined conditions and / or settings into the surgical navigation system 100, such as selecting cortical boundaries, nerves, blood vessels, or similar anatomical structures that the surgeon wishes to avoid and establishing boundaries or zones around these anatomical structures. The surgeon can also use the user input device 130 to select and / or input target sites, target trajectories, or similar features to help guide the surgeon in performing medical procedures. Based on data provided by the navigation processor 140, the second instrument processor 315 can be configured to send a signal to activate the second alarm device 355 when the end effector 340 of the second surgical instrument 320 enters one of the areas and / or zones around the anatomical structures as defined by the surgeon. For example, a surgeon can utilize the user input device 130 of the surgical navigation system 100 to define boundaries or zones relative to an anatomical model. This can include identifying key anatomical features, such as specific walls of a vertebral body, a central foramen, nerves, or blood vessels, and assigning zones to them. As described above, the navigation system 100 can include a boundary generator for generating virtual boundaries relative to key anatomical features within the patient's body. As part of generating those boundaries, the navigation system 100 can be configured to identify and / or define virtual boundaries based on a segmentation algorithm. While navigation system 100 generates one or more virtual boundaries, navigation system 140 may be further configured to allow the surgeon to select a depth or distance. After the surgeon selects a depth, navigation system 100 may be configured to project a second virtual boundary at a selected depth or distance from the initial virtual boundary. The region and / or volume defined between the initial and second virtual boundaries may define at least a portion of said region. Exemplary systems and / or methods for segmentation can be found in U.S. Patent Publication No. 2017 / 0061242A1, the entire contents of which are incorporated herein by reference.

[0088] It may also include identifying additional regions, which may include areas or regions surrounding key anatomical features, such as defining a second region surrounding the key anatomical feature, spaced a distance from the boundary of the key anatomical feature. It may also include defining additional subsequent regions, such as a third region surrounding the second region and spaced a distance from the boundary of the key anatomical feature greater than the distance between the second region and the key anatomical feature. In this exemplary configuration, the end effector 340 may first contact the outermost alarm region, triggering a second alarm device 355 to generate a first alarm. The end effector 340 may then contact the next alarm region closest to the key anatomical structure, triggering an alarm device 355 to generate a second alarm. The first and second alarms are configured to notify the surgeon that the end effector 340 has entered the corresponding alarm region assigned to the first and second alarms. The surgical navigation system 100 may be configured to allow the surgeon to define alarm regions or regions as needed for a specific procedure. Alarm regions may be configured as boundary lines or as areas surrounding key anatomical structures. For example, an alarm region may include an area or layer surrounding the key anatomical structure. The surgeon may define the thickness of the alarm region in the surgical navigation system 100. For example, a second alarm zone adjacent to a critical anatomical structure can be defined as a two-millimeter-thick area surrounding the critical anatomical structure. This thickness can vary depending on the type of procedure and / or the surgeon's preference to ensure that the critical anatomical structure is not touched. The surgeon can define a subsequent alarm zone that is adjacent to the second alarm zone and opposite to the critical anatomical structure, such that the subsequent alarm zone is farther away from the critical anatomical structure than the second alarm zone.

[0089] The surgeon may define the subsequent alarm zone as a five-millimeter-thick area surrounding the outermost perimeter of the second alarm zone. This thickness is obtained by manipulating the user input device, depending on the type of procedure and / or the surgeon's preference.

[0090] It should be understood that these alert zones can be automatically generated based on segmentation data from patient scans.

[0091] Based on data provided by navigation processor 140, second instrument processor 315 can also be configured to send a signal to activate second alarm device 355 when the end effector 340 of second surgical instrument 320 deviates from the trajectory and / or when the end effector 340 reaches the target site / area / boundary. For example, based on surgical navigation system 100 identifying that the end effector 340 and / or second surgical instrument 320 are not properly aligned with the target trajectory established as part of the planned surgical path, second alarm device 355 can be activated to generate at least one of an audible, tactile, or visually perceptible alarm. In this exemplary configuration, second alarm device 355 can generate a tactile alarm, such as vibrating switch 350 or detachable power supply, to notify the surgeon that the end effector 340 is not properly aligned with the target trajectory. Once the end effector 340 is properly aligned with the target trajectory, second alarm device 355 can be deactivated. The second alarm device 355 can be similarly configured to be activated upon the surgical navigation system 100 recognizing that the end effector 340 and / or the second surgical instrument 320 have reached a target site defined by the surgeon, thereby generating at least one of an audible, tactile, or visually perceptible alarm. For example, the second alarm device 355 can generate a tactile alarm, such as vibrating a switch 350, to notify the surgeon that the end effector 340 has reached the target site / area, such as a preferred depth or location relative to a key anatomical feature boundary. Once the end effector 340 has reached the target site, it is also envisioned that the console can be configured to deactivate the motor, thereby deactivating the end effector 340, to prevent the end effector 340 from exceeding the target site / area.

[0092] In an exemplary configuration, the second alarm device 355 may include a vibration device positioned to contact the surgeon and configured to vibrate to notify the surgeon of a specific situation or to provide a warning. In an exemplary configuration, such as... Figure 1A-1BAs shown, the second alarm device 355 may include a vibrating device, such as a foot switch, coupled to a switch 350 for controlling the operation of the second surgical instrument 320. The second alarm device 355 may be configured to vibrate when a defined condition occurs. For example, the second alarm device may include a vibrating device coupled to and / or communicating with the foot switch 350. In this configuration, the second alarm device 355 may be configured to cause the foot switch 350 to vibrate to notify the surgeon of the occurrence of a defined condition, such as the end effector 340 of the second surgical instrument 320 approaching and / or entering one of the defined alarm zones. Since the surgeon will be in continuous contact with the switch 350 when the second surgical instrument 320 is actuated, the surgeon will feel the vibration of the second alarm device 355 and be notified of the occurrence of the defined condition without affecting his or her grip on the handheld surgical instrument. The second alarm device 355 may be configured to generate vibration in a specific pattern or at intervals when a defined condition occurs. Alternatively, the second alarm device 355 may be configured to generate a first vibration of a specific pattern or interval when a first condition occurs, and a second vibration of a different pattern or interval when a second condition occurs. For example, the second alarm device 355 may be configured to alternately vibrate and stop when the end effector 340 of the second surgical instrument 320 approaches and / or enters the first alarm zone, and the second alarm device 355 may be configured to vibrate continuously when the end effector 340 of the second surgical instrument 320 approaches and / or enters the second alarm zone.

[0093] The second alarm device 355 may also be configured as an auditory device, such as a loudspeaker, to provide an auditory alarm to the surgeon when a defined condition occurs. For example, the second alarm device 355 may include a loudspeaker configured to generate a specific sound when a defined condition occurs. Alternatively, the second alarm device 355 may include a loudspeaker configured to generate a specific pattern or interval of sound when a defined condition occurs, such as when the end effector's position crosses a defined area / boundary.

[0094] In another configuration, the second alarm device 355 can be configured as a visually perceptible device, such as a visual display, configured to provide a visual alarm to the surgeon upon the occurrence of a defined condition. For example, the second alarm device 355 may include lights configured to flash upon the occurrence of the defined condition. Alternatively, the second alarm device 355 may include multiple multi-color lights configured to illuminate and / or flash in defined colors or patterns upon the occurrence of the defined condition. The display may be integrated into a handheld device or battery, or as part of a navigation system, or a combination thereof.

[0095] It is also envisioned that the second alarm device 355 may include a combination of auditory, tactile, and / or visually perceptible devices. For example, the second alarm device 355 may be configured as a combination of auditory and tactile devices, such that the tactile device may be configured to vibrate to provide a first alarm and the auditory device may be configured to generate noise to provide a second alarm. The first and second alarms may indicate that the same defined condition has occurred, or the first and second alarms may indicate that different defined conditions have occurred. For example, the first alarm may be generated based on the entry of the second surgical instrument 320 into the first zone, and the second alarm may be generated based on the entry of the end effector 340 into the second zone.

[0096] Although the second alarm device 355 is illustrated as a switch 350 coupled to the second surgical instrument assembly 300, it is conceivable that the second alarm device 355 can be coupled to and / or positioned in alternative locations. For example, when the second alarm device 355 includes a tactile device, it can be configured to be detachably attached to a vibrating member of the surgeon. The second alarm device 355 can be configured as a wristband worn on the surgeon's wrist or arm, allowing the surgeon to feel the vibration of the second alarm device 355 when a defined condition occurs. Alternatively, when the second alarm device 355 includes an auditory device, it can be configured to be detachably attached to a speaker of the surgeon. The second alarm device 355 can be configured as a Bluetooth speaker or earphone to be worn on the surgeon's head or positioned inside the surgeon's ear, so that the surgeon can hear the noise generated by the second alarm device 355 when a defined condition occurs.

[0097] While not required, positioning the second alarm device 355 away from the second surgical instrument 320 offers several advantages. For example, one advantage of positioning the second alarm device 355 away from the second surgical instrument 320 is that it allows for a reduction in the size of the second surgical instrument 320. This allows the second surgical instrument 320 to be fitted into a smaller space. A smaller second surgical instrument 320 provides less obstruction to the surgeon's view of the surgical site. Another advantage of positioning the second alarm device 355 away from the second surgical instrument 320, particularly when it is a tactile device, is that the second alarm device 355 does not vibrate or affect the movement of the second surgical instrument 320, while still providing an alarm or notification to the surgeon. In some medical procedures, surgeons may rely on their sense and / or touch of instruments to perform the procedure. For example, a surgeon may rely on the sense or touch of an instrument to recognize changes in torque, which can indicate changes in the consistency / density of biological material being cut and / or removed. The surgeon's sense and / or touch of the instrument can also indicate when the end effector is rotating freely, compared to when biological material is being cut / removed. In these exemplary cases, and in other cases where the surgeon's touch and / or sense of the instrument can help them perform medical procedures accurately, positioning the alarm device 355 away from the second surgical instrument 320, for example, in a foot switch 350. During highly technical procedures, positioning a vibrating alarm device on or near the second surgical instrument 320 may cause the surgeon to move the second surgical instrument 320 to an undesirable position due to being startled by the second alarm device 355 and / or the vibration imparting undesirable movement to the second surgical instrument 320. Vibration of the second surgical instrument 320 may also cause the end effector 340 to grasp or bite into biological material, resulting in undesirable outcomes, such as contact with critical anatomical features or removal / damage to biological material not intended for removal during a medical procedure.

[0098] The second surgical instrument assembly 300 may also include a tracking device 330. The tracking device 330 may be coupled to the handpiece 325 of the second surgical instrument 320. The tracking device 330 is similar to that described above for the first surgical instrument assembly.

[0099] Surgical system 10 may include a third surgical instrument assembly 400 in communication with navigation system 100. For example, the third surgical instrument assembly 400 may include a third surgical instrument 420, such as an ultrasound instrument, including a handheld component 425. The handheld component 425 may be coupled to a console 410 configured to control the operation of the components of the third surgical instrument 420. The handheld component 425 may be shaped to include a handle or grip portion for the surgeon to hold while performing medical procedures.

[0100] The third surgical instrument 420 may further include a third instrument processor 415 and a motor 445. The third instrument processor 415 may be disposed within the console 410 of the third surgical instrument assembly 400. The motor 445 may be disposed within the handheld part 425 of the third surgical instrument 420. The third instrument processor 415 and the motor 445 may communicate with each other. The motor 445 may include a piezoelectric element configured to expand and contract when an electric current is applied to the piezoelectric element. The piezoelectric element may include a plurality of disc-shaped piezoelectric elements arranged end-to-end in a stack. The third instrument processor 415 may be configured to control the operation of the motor 445, thereby controlling the operation of the third surgical instrument 420. For example, the third surgical instrument 420 may include an end effector 440, such as an ultrasonic tip assembly. The end effector 440 may include an ultrasonic tip assembly including a horn-shaped portion whose ultrasonic tip portion vibrates at ultrasonic speeds when the piezoelectric element expands and contracts. The ultrasonic tip assembly may also include an outer sheath at least partially disposed on the horn-shaped portion other than the ultrasonic tip portion. An end effector 440 may be coupled to a handpiece 425 of a third surgical instrument 420, such that a motor 445 may be operatively coupled to the end effector 440. For example, the motor 445 may be configured to actuate an ultrasonic tip assembly 440 to abrade and / or remove biological tissue from a surgical site. A third instrument processor 415 may communicate with the motor 445 and is configured to control the flow of current to a piezoelectric element, controlling the operation of the motor 445, and consequently controlling the operation of the ultrasonic tip assembly 440. The third instrument processor 415 may also communicate with a navigation processor 140 and is configured to exchange data relating to the position and / or orientation of the third surgical instrument 420, as well as data relating to the operation of the third surgical instrument 420. For example, the third instrument processor 415 and the navigation processor 140 may be configured to transmit data relating to the operation of the third surgical instrument 420 to each other based on the position and / or orientation of the third surgical instrument 420 detected by the surgical navigation system 100.

[0101] The third surgical instrument assembly 400 may also include a power source (not shown). The power source may be coupled to a console 410 of the third surgical instrument assembly 400 and configured to supply power to a motor 445 of the third surgical instrument 420 to actuate the end effector 440. For example, the power source may include a removable battery pack. It is also envisioned that the console 410 may include a cord configured to plug into a socket connected to the power grid to supply power to the third surgical instrument assembly 400. The power source may be electrically connected to the third instrument processor 415 and / or the motor 445 and configured to selectively supply power to the motor 445 to actuate the end effector 440.

[0102] The third surgical instrument assembly 400 may further include a switch 450, such as a foot switch, pedal, or button, operatively coupled to the third instrument processor 415. The switch 450 may be configured to generate and / or transmit signals to the third instrument processor 415 based on user input to control the operation of the third surgical instrument 420. For example, the switch 450 may include a first position, a second position, and multiple intermediate positions between the first and second positions. The first position may be configured as an off position such that when the third instrument processor 415 detects that the switch 450 is in the first position, the third instrument processor 415 prevents energy from flowing from the power source to the motor 445, thereby preventing operation of the third surgical instrument 420. Alternatively, when the first instrument processor 415 detects that the switch 450 is in the second position, the third instrument processor 415 may be configured to allow maximum energy to flow from the power source to the motor 445, thereby allowing the third surgical instrument 420 to operate with maximum displacement. When the third instrument processor 415 detects that the switch 450 is in one of the intermediate positions, the third instrument processor 415 can be configured to allow energy flowing from the power source to the motor 445 at a level corresponding to the position of the switch 450 between the first and second positions, to allow the third surgical instrument 420 to operate at an intermediate displacement. For example, if the third instrument processor 415 detects that the switch 450 is in the middle (50%) between the first and second positions, the third instrument processor 415 can be configured to allow energy flowing from the power source to the motor 445 at a level that allows the third surgical instrument 420 to operate at 50% of its maximum displacement. Alternatively, the third instrument processor 415 can be configured to allow maximum energy to flow from the power source to the motor 445 whenever the switch 450 is in a position other than the first position, so that the third surgical instrument 420 can operate at its maximum displacement when the switch 450 is in the second position or any intermediate position.

[0103] The third surgical instrument assembly 400 may also include a third alarm device 455. The third alarm device 455 may include an auditory, tactile, and / or visually perceptible device. The third alarm device 455 may be configured to communicate with a third instrument processor 415. The third instrument processor 415 may be configured to send a signal based on pre-programmed conditions or settings to activate the third alarm device 455 to provide a warning or notification. For example, as described above, a surgeon may use a user input device 130 to input defined conditions and / or settings into the surgical navigation system 100, such as selecting cortical boundaries, nerves, blood vessels, or similar anatomical structures that the surgeon wishes to avoid and establishing zones or regions around these anatomical structures. For example, a surgeon may utilize the user input device 130 of the surgical navigation system 100 to define zones or regions within patient data. This may include identifying key anatomical features, such as nerves or blood vessels, and assigning regions to them. It may also include identifying additional regions that include zones or regions surrounding key anatomical features, such as defining a second region surrounding a key anatomical feature spaced a distance from the boundary of the key anatomical feature. It may also include defining additional subsequent regions, such as a third region surrounding the second region and spaced from the boundary of the key anatomical feature at a distance greater than the distance between the second region and the key anatomical feature. In this exemplary configuration, the end effector 440 may first contact the outermost region, triggering alarm device 455 to generate a first alarm. The end effector 440 may then contact the next region closest to the key anatomical structure, triggering alarm device 455 to generate a second alarm. The first and second alarms are configured to notify the surgeon of the occurrence of the end effector 440 entering the corresponding region assigned to the first and second alarms.

[0104] The surgeon can also use the user input device 130 to select and / or input similar features of a target site, target trajectory, or surgical path to help guide the surgeon in performing medical procedures. Based on data provided by the navigation processor 140, the third instrument processor 415 can be configured to send a signal to activate the third alarm device 455 when the end effector 440 of the third surgical instrument 420 enters one of the areas and / or regions defined by the surgeon around the anatomical structure. Based on data provided by the navigation processor 140, the third instrument processor 415 can also be configured to send a signal to activate the third alarm device 455 when the end effector 440 of the third surgical instrument 420 deviates from the trajectory and / or when the end effector 440 reaches the target site. For example, based on the surgical navigation system 100 identifying that the end effector 440 and / or the third surgical instrument 420 are not correctly aligned with the target trajectory established as part of the planned surgical path, the third alarm device 455 can be activated to generate at least one of an audible, tactile, or visually perceptible alarm. In this exemplary configuration, the third alarm device 455 can generate a tactile alarm, such as vibrating a switch 450, to notify the surgeon that the end effector 440 is not properly aligned with the target trajectory. Once the end effector 440 is properly aligned with the target trajectory, the third alarm device 455 can be deactivated. The third alarm device 455 can similarly be configured to be activated to generate at least one of an audible, tactile, or visually perceptible alarm based on the surgical navigation system 100 recognizing that the end effector 440 and / or the third surgical instrument 420 have reached a surgeon-defined target site in the planned surgical path. For example, the third alarm device 455 can generate a tactile alarm, such as vibrating a switch 450, to notify the surgeon that the end effector 440 has reached the target site, such as a preferred depth. Once the end effector 440 has reached the target site, it is also envisioned that the console can be configured to deactivate the motor, thereby deactivating the end effector 340, to prevent the end effector 340 from exceeding the target site.

[0105] In an exemplary configuration, the third alarm device 455 may be configured as described above for the first and second alarm devices.

[0106] The third surgical instrument assembly 400 may also include a tracking device 430. The tracking device 430 may be coupled to the handheld part 425 of the third surgical instrument 420. The tracking device 430 may be similar to that defined above for other instrument assemblies.

[0107] The surgical instrument assemblies 200, 300, and 400 described above are intended as exemplary instruments and / or configurations within the surgical system 10 and are not intended to be limiting. Other types and forms of surgical instrument assemblies are also contemplated. Although multiple exemplary surgical instrument assemblies 200, 300, and 400 are depicted in the figures as part of the surgical system 10 and communicating with the surgical navigation system 100, it is contemplated that the surgical system 10 may include only a single surgical instrument assembly 200, 300, 400 and navigation system 100. Furthermore, although Figure 1A-1B The surgical system 10 shown includes three surgical instrument assemblies 200, 300, and 400 and a single surgical navigation system 100, but it is contemplated that the surgical system 10 can be configured to include any combination of surgical instrument assemblies 200, 300, and 400 and / or surgical navigation systems 100. For example, the surgical system 10 may include a single surgical instrument assembly 200, 300, and 400 and multiple surgical navigation systems 100.

[0108] refer to Figure 2 An exemplary configuration of a surgical room or operating room for performing medical procedures on a patient 20 using the surgical system 10 described above is shown. The surgical system 10, which includes a surgical navigation system 100 and at least one of the surgical instrument components 200, 300, and 400 described above, can be placed in the operating room around the patient 20 and / or the surgical site 30 where the medical procedure will be performed.

[0109] Although Figure 2 Only the second surgical instrument assembly 300 is shown, but it should be understood that this is merely an exemplary configuration of the surgical system 10, and it is contemplated that any number of surgical instrument assemblies 200, 300, 400 can be positioned within the operating room. As described above, the second surgical instrument assembly 300 includes a second surgical instrument 320, which includes an end effector 340 and a tracking device 330. The tracking device 330 includes a plurality of markers 335 capable of being identified and / or tracked by the surgical navigation system 100. The second surgical instrument 320 is coupled to a console 310 located remotely from the patient 20. The second surgical instrument assembly 300 also includes a switch 350 located remotely from the patient 20 and coupled to the console 310. The switch 350 communicates with the second surgical instrument 320 via a second instrument processor 315 (not shown) housed within the console 310.

[0110] Although Figure 2Not shown, but the second surgical instrument assembly 300 also includes the aforementioned second alarm device 355. Based on its configuration, the second alarm device 355 can be positioned on the switch 350, somewhere on the surgeon's body, and / or in a location within the operating room visible to the surgeon. For example, as described above, the second alarm device 355, including a tactile component, can be positioned on the surgeon's body, such as on their wrist or ankle. Alternatively, the second alarm device 355, including an auditory component, can be positioned on the surgeon's ear. In yet another configuration, the second alarm device 355 includes a visual device and can be positioned on the display unit 120 of the surgical navigation system 100 or a similar location that the surgeon can perceive but will not obstruct or interfere with the surgeon's observation of the surgical site 30. In other configurations, the second alarm device is a foot switch and is not easily observed during surgery because it is located under the operating room table.

[0111] Although not previously discussed, it is also envisioned that the surgical system 10 may further include an imaging system 500, such as a CT or MRI imaging device. The imaging system 500 may include a scanner 510 and a display unit 520. The scanner 520 may be used to capture images of the surgical site 30 of the patient 20 and display them on the display unit 520. For example, the scanner may include a C-arm configured to rotate around the patient 20 to generate multiple images of the surgical site 30. The imaging system 500 may also include a processor (not shown) containing software, as known to those skilled in the art, capable of acquiring multiple images captured by the scanner 510 and generating 2-D images and / or 3-D models of the surgical site 30. The display unit 520 may be configured to display the generated 2-D images and / or 3-D models.

[0112] The imaging system 500 can also communicate with the navigation processor 140 of the surgical navigation system 100. The imaging system 500 can be configured to communicate with the navigation processor 140 via a wired and / or wireless connection. For example, the imaging system 500 can be configured to provide the navigation processor 140 with preoperative and / or intraoperative image data, such as generated 2-D images and / or 3-D models of the surgical site 30. The navigation processor 140 can then be configured to provide the generated 2-D images and / or 3-D models to the navigation display unit 120, where the surgeon can use the user input device 130 or algorithms to identify and / or define corresponding areas and / or regions around key anatomical structures. For example, the surgeon can use the user input device 130 of the surgical navigation system 100 to define alarm areas around vertebrae, nerves, or blood vessels that the surgeon wishes to avoid during the medical procedure. The surgeon can use the user input device 130 of the surgical navigation system 100 to input and / or modify planned surgical paths, boundaries, or alarm areas to be used during the medical procedure.

[0113] refer to Figure 3 This illustrates an exemplary schematic diagram of the surgical site 30 of a patient 20 as seen from the surgeon's perspective during a medical procedure. Figure 3 The exemplary schematic diagram depicts an exemplary arrangement of the surgical system 10 described above during a medical procedure, including a second surgical instrument assembly 300. The second surgical instrument assembly 300 includes a second surgical instrument 320 positioned near the surgical site 30 and within the surgeon's field of vision, comprising a handheld component 325 and an end effector 340. Other components of the second surgical instrument assembly 300 communicate with the second surgical instrument 320 but are positioned away from the second surgical instrument 320 and outside the surgeon's field of vision. For example, when the surgeon is focused on the surgical site, the surgical navigation system 100, console 310, switch 350, and alarm device 355 can all be positioned away from the second surgical instrument 320 and outside the surgeon's field of vision. This can reduce obstacles for the surgeon in observing the surgical site and improve the surgeon's ability to focus on the surgical site 30 and / or perform the medical procedure.

[0114] refer to Figure 4A-5CThe illustrations show various schematic diagrams of the surgical system 10 during the execution of a medical procedure. To further explain the operation of the surgical system 10, the schematic diagrams of the surgical system 10 include one or more of the surgical instruments 220, 320, and 420 in different orientations relative to the patient 20. Surgical instruments 220, 320, and 420, such as the second surgical instrument 320, are shown in a first position relative to the surgical site 30 of the patient 20. Surgical instruments 220, 320, and 420 may include a console or housing 210, 310, and 410 containing instrument processors 215, 315, and 415. As described above, instrument processors 215, 315, and 415 may communicate with a navigation processor 140 of a navigation system. Surgical instruments 220, 320, and 420 may also include switches 250, 350, and 450, such as triggers, manual switches, or foot switches, which are connected to the console or housing 210, 310, and 410 and communicate with instrument processors 215, 315, and 415. Alarm devices 255, 355, and 455 may be connected to switches 250, 350, and 450 and communicate with instrument processors 215, 315, and 415. Although not shown in the figures, as described above, alarm devices 255, 355, and 455 do not need to be connected to switches 250, 350, and 450. Instead, it is envisioned that alarm devices 255, 355, and 455 may be independent of switches 250, 350, and 450. For example, alarm devices 255, 355, and 455 may be connected to the console or housing 210, 310, and 410 and communicate with instrument processors 215, 315, and 415 via wired or wireless means. It is also envisioned that the alarm devices 255, 355, and 455 are independent devices that communicate wirelessly with the instrument processors 215, 315, and 415, such as wristbands or armbands worn by surgeons.

[0115] Furthermore, as mentioned above, surgeons can use the surgical navigation system 100 to identify and / or define various boundaries, zones, target trajectories, target sites, etc., in preoperative and / or intraoperative patient data (e.g., CT or MRI scans). For example, such as Figures 4A-4C As shown, surgeons can use the surgical navigation system 100 to select and / or define virtual boundaries (boundaries 1, 2, 3) and / or alert regions (regions 1, 2, 3) relative to key anatomical structures or boundaries (e.g., central foramen, vertebral wall, nerves, or blood vessels) within the surgical site 30. This can include defining multiple virtual boundaries (boundaries 1, 2, 3) and / or alert regions (regions 1, 2, 3) at different distances from the key anatomical structures. For example, as... Figure 4A-5CAs shown, the surgical site 30 includes the vertebrae on which medical procedures will be performed. A first virtual boundary (boundary 1) can be defined relative to this critical anatomical structure, such as the outer boundary of the spinal cord. Boundary 1 can be defined manually by the surgeon using navigation system 100. However, the surgeon can also select boundary 1 from a list of virtual boundaries provided by the boundary generator software of navigation system 100. As described above, navigation system 100 may include software containing a boundary generator. Navigation processor 140 can be configured to provide a list of one or more virtual boundaries based on various data points selected or entered by the surgeon. For example, the surgeon can select the surgical site, the type of surgery, the type of surgical instruments 200, 300, 400 to be used, the type of device or implant to be inserted, etc., and the boundary generator can be configured to define one or more virtual boundaries for the user to select. The boundary generator can also be configured to define alarm regions (regions 1, 2, 3, 4). The first alarm region (region 1) can be defined as a first distance from the critical anatomical structure, such as the outer boundary of the spinal cord. Region 1 can be defined as the space between the first virtual boundary (boundary 1) and the second virtual boundary (boundary 2). Boundary 2 can be defined by the surgeon, including the surgeon inputting and / or selecting the desired depth of region 1, and the navigation system is configured to define boundary 2 based on that depth. For example, navigation system 100 can be configured to prompt the surgeon to input and / or select that depth, and then the navigation system can define boundary 2 based on that depth. Alternatively, the surgeon can select boundary 2 from a list of virtual boundaries provided by the boundary generator software of navigation system 100. For example, navigation system 100 can be configured to provide a list of end effectors 240, 340, 440, including a default depth for the alarm region of each of the end effectors 240, 340, 440, and the navigation system can be configured to define region 1 based on the end effector 240, 340, 440 selected by the surgeon.

[0116] In one exemplary configuration, the boundary generator can be configured to generate a second virtual boundary (boundary 2) at a default distance from a first virtual boundary (boundary 1), at least in part based on the surgical procedure being performed. For example, the boundary generator can be configured to generate boundary 2 at a distance of two millimeters from boundary 1. The surgeon can edit or modify the distance or depth between boundary 1 and boundary 2 using a graphical user interface (GUI) 150 and / or a user input device 130. The space defined between boundary 1 and boundary 2 can define a first alarm zone (area 1).

[0117] A second alert zone (zone 2) can be defined as a second distance from a critical anatomical structure, such that the second distance is greater than the first distance. Zone 2 can be defined as the space between boundary 2 and a third virtual boundary (boundary 3). Boundary 3 can be defined by the surgeon, or boundary 3 can be selected by the surgeon from a list of virtual boundaries provided by the boundary generator software of the navigation system 100. For example, the boundary generator can be configured to generate boundary 3 at a default distance from boundary 2, at least in part, based on the surgical procedure being performed. The surgeon can edit or modify the distance or depth between boundary 2 and boundary 3 using a graphical user interface (GUI) 150 and / or a user input device 130. A third alert zone (zone 3) can be defined at and / or include the boundary of a critical anatomical structure. A fourth virtual boundary (boundary 4) can also be defined at the perimeter and / or boundary of biological tissues such as vertebrae. It is also envisioned that the surgical navigation system 100 can be configured to define virtual boundaries (boundaries 1, 2, 3, 4) and / or alert zones (zones 1, 2, 3, 4) based on information selected or entered by the medical personnel. For example, the surgical navigation system 100 can be configured to define alarm regions (regions 1, 2, 3, 4) based on one or more of the following items input by a medical professional: the type of procedure to be performed, the site on the patient where the procedure will be performed, the type of implant 275 to be used, the type of surgical instruments 220, 320, 420 to be used, and / or the type of end effectors 240, 340, 440. The medical professional can then modify or change the virtual boundaries (boundaries 1, 2, 3, 4) and / or alarm regions (regions 1, 2, 3, 4) defined by the surgical navigation system 100 using the user input device 130 and / or the graphical user interface (GUI) 150. Similarly, it is envisioned that each region be automatically generated based on algorithms that identify certain key anatomical structures in the image data.

[0118] During a medical procedure to remove biological tissue from the vertebral surface at the surgical site, the end effectors 240, 340, and 440 of surgical instruments 220, 320, and 420 may approach one of the virtual boundaries (boundaries 1, 2, 3, and 4) and / or alarm regions (regions 1, 2, 3, and 4). As described above, the surgical navigation system 100 can be configured to track the position and / or orientation of the surgical instruments 220, 320, and 420 relative to the respective virtual boundaries (boundaries 1, 2, 3, and 4) and / or alarm regions (regions 1, 2, 3, and 4), and to transmit signals or instructions to instrument processors 215, 315, and 415 to activate alarm devices 255, 355, and 455 to notify the surgeon when the end effectors 240, 340, and 440 approach and / or enter one of the virtual boundaries (boundaries 1, 2, 3, and 4) and / or alarm regions (regions 1, 2, 3, and 4). For example, in the instance of virtual boundaries (boundaries 1, 2, 3, 4), the surgical navigation system 100 can be configured to track the position and / or location of surgical instruments 220, 320, 420 relative to each virtual boundary (boundaries 1, 2, 3, 4), and to transmit signals or instructions to instrument processors 215, 315, 415 to activate alarm devices 255, 355, 455 to notify the surgeon when the end effectors 240, 340, 440 are adjacent to and / or distal to the virtual boundaries (boundaries 1, 2, 3, 4). For example, instrument processors 215, 315, 415 activate alarm devices 255, 355, 455 based on the positioning of the tip of the end effector adjacent to the virtual boundaries (boundaries 1, 2, 3, 4). Instrument processors 215, 315, 415 activate alarm devices 255, 355, 455 based on the tip of the end effector being positioned at a distance defined distal to the virtual boundaries (boundaries 1, 2, 3, 4). Instrument processors 215, 315, and 415 can be configured to define this distance as the tip being located 0.5 mm, 1 mm, 2 mm, 3 mm, etc., distal to the virtual boundaries (boundaries 1, 2, 3, and 4). The surgical navigation system 100 can be configured to allow the surgeon to assign specific types of alarms to each of the virtual boundaries (boundaries 1, 2, 3, and 4) and / or alarm zones (zones 1, 2, 3, and 4). This can include auditory, tactile, and / or visual alarms for notifying the surgeon. Auditory, tactile, and / or visual alarms can be coupled to switches 250, 350, and 450, such as foot switches or triggers that the surgeon will contact when manipulating surgical instruments. As described above, there are several advantages to positioning alarm devices 255, 355, and 455, including tactile alarms, at switches 250, 350, and 450.This is especially true when alarm devices 355, 455, including tactile alarms, are positioned on switches 350, 450, which are located away from surgical instruments 320, 420, as is the case, for example, in the exemplary second and third surgical instrument assemblies 300, 400 as described above.

[0119] Once alarm devices 255, 355, and 455 have been activated, system 10 can be configured to allow the surgeon to deactivate alarm devices 255, 355, and 455. This can be done by pressing a button, switch, or icon configured to deactivate alarm devices 255, 355, and 455. The button, switch, and / or icon for deactivating alarm devices 255, 355, and 455 can be located on navigation system 140. For example, navigation display 120 can be configured to allow the user to select an icon to deactivate the touchscreen of alarm devices 255, 355, and 455. It is also envisioned that the surgeon can manipulate a button or switch on the user input device 130 of navigation system 100 to deactivate alarm devices 255, 355, and 455. It is also envisioned that buttons or switches for deactivating alarm devices 255, 355, 455 may be located on the housing 210 of surgical instrument assemblies 200, 300, 400 or on the console 310, 410, and that the surgeon may manipulate said buttons or switches to deactivate alarm devices 255, 355, 455. Alternatively, it is also envisioned that this can be achieved by manipulating triggers and / or foot switches 250, 350, 450 in a defined pattern or rhythm to deactivate alarm devices 255, 355, 455. For example, the system may be configured such that double-clicking switches 250, 350, 450 after alarm devices 255, 355, 455 have been activated will deactivate alarm devices 255, 355, 455 to allow the surgeon to continue the procedure uninterrupted. System 10 may be configured such that deactivating alarm devices 255, 355, 455 may require action by the surgeon, such as double-clicking switches 250, 350, 450. This ensures that the surgeon confirms and / or acknowledges receiving the alarm and has taken affirmative and explicit steps to deactivate alarm devices 255, 355, and 455. This prevents accidental deactivation of alarm devices 255, 355, and 455 without the surgeon receiving and / or being aware that they have been activated.

[0120] The surgical navigation system 100 can also be configured to provide alarms based on the position and / or orientation of the surgical instruments 220, 320, 420 relative to one or more virtual boundaries (boundaries 1, 2, 3, 4) and / or alarm regions (regions 1, 2, 3, 4), by manipulating the speed of motors 245, 345, 445 and, consequently, the speed of operation of end effectors 240, 340, 440. For example, the surgical navigation system 100 can be configured to reduce the motors 245, 345, 445 from maximum cutting speed to minimum cutting speed based on the position of the surgical instruments 220, 320, 420 relative to one or more virtual boundaries (boundaries 1, 2, 3, 4) and / or alarm regions (regions 1, 2, 3, 4).

[0121] This may include, once the end effector 340 approaches and / or moves to its distal side and / or enters the first alarm zone (zone 1), the surgical navigation system 100 sends a signal to the second instrument processor 315 to reduce the output of the motor 345 of the second surgical instrument 320 (e.g., a high-speed cutting head), reducing the rotation of the end effector 340 from its current operating speed, such as 75,000 RPM, to a lower speed, such as 60,000 RPM, which is still effective for cutting tissue. Manipulation of the speeds of the motors 245, 345, 445 of the surgical instruments 220, 320, 420, and the rotation of the end effectors 240, 340, 440 may be caused by instrument processors 215, 315, 415 configured to regulate the current and / or voltage supplied to the motors 245, 345, 445. For example, to decelerate the motors 245, 345, and 445 of surgical instruments 220, 320, and 420, instrument processors 215, 315, and 415 can be configured to reduce the voltage and / or current supplied to the motors 245, 345, and 445. Instrument processors 215, 315, and 415 can be configured to gradually reduce the current and / or voltage supplied to the motors 245, 345, and 445, thereby causing the rotation of the end effectors 240, 340, and 440 to gradually slow down. The gradual reduction of current and / or voltage allows the motors 245, 345, and 445 to slowly change from a first cutting speed to a second cutting speed. The reverse is also possible. Instrument processors 215, 315, and 415 can similarly be configured to accelerate the motors 245, 345, and 445 of surgical instruments 220, 320, and 420 by increasing the voltage and / or current supplied to the motors 245, 345, and 445.

[0122] The deceleration of motors 245, 345, and 445 of surgical instruments 220, 320, and 420 can be alerted or notified to the surgeon in the form of a tactile alarm perceived by the surgeon via handheld devices 225, 325, and 425. It is also envisioned that the deceleration of motors 245, 345, and 445 of surgical instruments 220, 320, and 420 can be alerted or notified to the surgeon in the form of an audible alarm, as the surgeon would hear the pitch change of motor 245 or perceive a change in cutting efficiency when motors 245, 345, and 445 decrease from maximum to minimum cutting speed. While it is not required that motors 245, 345, and 445 decrease from maximum to minimum cutting speed, it is desirable that motors 245, 345, and 445 do not decelerate below a predetermined minimum cutting speed to prevent end effectors 240, 340, and 440 from biting or gripping, or from going offline and / or deviating from their trajectory. This could cause the end effectors 240, 340, and 440 to come into contact with and / or damage critical anatomical structures. Further, it is envisioned that if the end effectors 240, 340, and 440 approach critical anatomical structures, the surgical navigation system 100 could also be configured to disable or stop motors 245, 345, and 445. This would prevent the end effectors 240, 340, and 440 from coming into contact with and / or damaging critical anatomical structures. During the tracking of surgical instruments 220, 320, and 420, as well as the end effectors 240, 340, and 440, it is envisioned that the tracking devices for the surgical instruments 220, 320, and 420 might be obstructed and leave the navigation system's field of vision. Furthermore, the navigation system 100 can be configured to disable or stop motors 245, 345, and 445 to prevent operation of end effectors 240, 340, and 440 if the tracking device of surgical instruments 220, 320, and 420 leaves the field of view of the navigation system for a defined period of time, thereby preventing operation of surgical instruments 220, 320, and 420 when their position in the patient space is unknown. An exemplary navigation system and / or method configured to prevent operation of surgical instruments when they are outside the field of view of the navigation system is described in U.S. Patent Publication No. 2016 / 0242858A1, the entire contents of which are incorporated herein by reference.

[0123] refer to Figure 4ASurgical instruments 220, 320, and 420, such as the second surgical instrument 320, are illustrated as being in a first position and / or orientation relative to the patient's surgical site 30. The surgical instruments 220, 320, and 420 can be configured to remove biological tissue from the surgical site 30. In the first position, end effectors 240, 340, and 440 are spaced apart from defined virtual boundaries (boundaries 1, 2, and 3) and / or outside the space defining each alarm zone (zone 1, 2, and 3). In this exemplary scenario, the surgical navigation system 100 can recognize that the end effectors 240, 340, and 440 are spaced apart from defined virtual boundaries (boundaries 1, 2, and 3) and / or outside the defined alarm zones (zones 1 and 2), and allows the surgical instruments 220, 320, and 420 to operate under normal working conditions when the operating switches 250, 350, and 450 are actuated to actuate the end effectors 240, 340, and 440. In this scenario, alarm devices 255, 355, and 455 can be configured to be inactive. The nested nature of boundaries 1, 2, and 3, as well as regions 1, 2, and 3 (each further away than the last), can provide progressively more alarms to ensure that the surgeon is aware that surgical instruments 220, 320, and 420 are very close to critical anatomical structures and / or target depths.

[0124] refer to Figure 4BSurgical instruments 220, 320, and 420 are illustrated in a second position relative to the patient's surgical site 30. In this second position, end effectors 240, 340, and 440 at least partially enter a second alarm region (region 2) while removing biological tissue. In this example, region 2 is defined between boundary 3 and boundary 2. In this exemplary scenario, surgical navigation system 100 can identify that end effectors 240, 340, and 440 are positioned adjacent to and / or distal to boundary 3 and / or have entered the space representing the second alarm region (region 2), and trigger one of the various alarms described above. For example, surgical navigation system 100 can be configured to send signals to instrument processors 215, 315, and 415 and / or navigation processor to activate alarm devices 255, 355, and 455 because end effectors 240, 340, and 440 are positioned adjacent to and / or distal to boundary 3 and / or have entered the second alarm region (region 2). Depending on the alarm type assigned to the second alarm zone (zone 2), alarm devices 255, 355, and 455 can be configured to provide a tactile alarm A, such as vibrating switches 250, 350, and 450. Alternatively, alarm devices 255, 355, and 455 can be configured to provide a visual alarm B, such as a flashing light on a navigation system's display. In yet another configuration, alarm devices 255, 355, and 455 can be configured to provide an audible alarm C, such as a beeping sound. The surgical navigation system 100 can also be configured to send signals to instrument processors 215, 315, 415 to reduce the output of motors 245, 345, 445 of surgical instruments 220, 320, 420, causing the rotation of end effectors 240 (e.g., surgical mortars), 340, 440 to decrease from a first cutting speed greater than 70,000 revolutions per minute (70,000 RPM) to a second cutting speed below 70,000 revolutions per minute but above 60,000 revolutions per minute (60,000 RPM). It is also envisioned that combinations of various alarms can be used, such as alarm devices 255, 355, 455 generating a combination of tactile alarm A and visual alarm B, as... Figure 4B As shown.

[0125] refer to Figure 4CThe second surgical instruments 220, 320, and 420 are illustrated in a third position relative to the patient's surgical site 30. In this third position, the end effectors 240, 340, and 440 are located distal to boundary 2 and / or have entered a first alarm region (region 1) defined between boundary 1 and boundary 2 while removing biological tissue. In this exemplary scenario, the surgical navigation system 100 can determine that the end effectors 240, 340, and 440 have entered the first alarm region (region 1) and trigger one of the aforementioned alarms. For example, the surgical navigation system 100 can be configured to send signals to instrument processors 215, 315, and 415 indicating the position of the end effectors 240, 340, and 440 relative to boundary 2 and / or region 1. If the end effectors 240, 340, 440 are positioned adjacent to and / or distal to boundary 2 and / or have entered the first alarm zone (area 1), the signal from the surgical navigation system 100 may include a command to activate alarm devices 255, 355, 455 by the instrument processors 215, 315, 415. Alternatively, it is also contemplated that the signal from the surgical navigation system 100 may include the position of the end effectors 240, 340, 440 relative to boundary 2 and / or area 1, and the instrument processors 215, 315, 415 may be configured to activate alarm devices 255, 355, 455 when the surgical navigation system 100 indicates that the end effectors 240, 340, 440 are positioned adjacent to and / or distal to boundary 2 and / or have entered the first alarm zone (area 1). Depending on the alarm type assigned to the first alarm zone (zone 1), alarm devices 255, 355, and 455 can be configured to provide a tactile alarm A, such as vibrating switches 250, 350, and 450. Alternatively, alarm devices 255, 355, and 455 can be configured to provide a visual alarm B, such as a flashing light. In yet another configuration, alarm devices 255, 355, and 455 can be configured to provide an audible alarm C, such as a beeping sound. The surgical navigation system 100 can also be configured to send signals to instrument processors 215, 315, and 415 to reduce the output of motors 245, 345, and 445 of surgical instruments 220, 320, and 420, thereby reducing the rotation of end effectors 240, 340, and 440 from 75,000 RPM to 60,000 RPM. Alternatively, the surgical navigation system 100 can be configured to disable or stop the rotation of the end effectors 240, 340, 440 once they enter the first alarm zone (zone 1) to prevent the end effectors 240, 340, 440 from moving within critical anatomical structures. This prevents the end effectors 240, 340, 440 from damaging critical anatomical structures. It is also envisioned that combinations of various alarms can be used, such as alarm devices 255, 355, 455 generating a combination of tactile alarm A, visual alarm B, and auditory alarm C, as... Figure 4CAs shown.

[0126] refer to Figure 4D The second surgical instruments 220, 320, and 420 are illustrated as being in the fourth position relative to the patient's surgical site 30. (As shown...) Figure 4DAs shown, the surgical navigation system and / or medical personnel select and / or define only two alarm regions, including a first alarm region (region 1) and a second alarm region (region 2). Region 2 represents a critical anatomical structure, such as the central foramen. Region 1 is defined between boundary 1 and boundary 2, where boundary 1 is the recognized perimeter of the critical anatomical structure, i.e., the boundary of the central foramen. As described above, this boundary can be identified by using a segmentation algorithm. In the fourth position, the end effectors 240, 340, and 440 are positioned adjacent to and / or distal to boundary 2 and / or have entered the first alarm region (region 1) while removing biological tissue. In this exemplary scenario, the surgical navigation system 100 can identify that the end effectors 240, 340, and 440 are positioned adjacent to and / or distal to boundary 2 and / or have entered the first alarm region (region 1) and trigger one of the various alarms described above. For example, the surgical navigation system 100 can be configured to send signals to instrument processors 215, 315, 415 indicating the position of end effectors 240, 340, 440 relative to boundary 2 and / or region 1. If the end effectors 240, 340, 440 are positioned adjacent to and / or distal to boundary 2 and / or have entered a first alarm region (region 1), the signals from the surgical navigation system 100 may include commands to cause the instrument processors 215, 315, 415 to activate alarm devices 255, 355, 455. Alternatively, signals from the surgical navigation system 100 may include the position of the end effectors 240, 340, 440 relative to boundary 2 and / or region 1, and instrument processors 215, 315, 415 may be configured to activate alarm devices 255, 355, 455 when the surgical navigation system 100 indicates that the end effectors 240, 340, 440 are positioned adjacent to and / or distal to boundary 2 and / or have entered the first alarm region (region 1). Depending on the alarm type assigned to each of boundary 2 and the first alarm region (region 1), alarm devices 255, 355, 455 may be configured to provide a tactile alarm A, such as vibrating switches 250, 350, 450. Alternatively, alarm devices 255, 355, 455 may be configured to provide a visual alarm B, such as a flashing light. In yet another configuration, alarm devices 255, 355, 455 may be configured to provide an audible alarm C, such as a beeping sound. The surgical navigation system 100 can also be configured to send signals to the instrument processors 215, 315, 415 to reduce the output of the motors 245, 345, 445 of the surgical instruments 220, 320, 420, causing the rotation of the end effectors 240, 340, 440 to decrease from a first cutting speed of more than 70,000 revolutions per minute (70,000 RPM) to a second cutting speed of less than 70,000 revolutions per minute but more than 60,000 revolutions per minute (60,000 RPM).Alternatively, the surgical navigation system 100 can be configured to disable or stop rotation of the end effectors 240, 340, 440 once they are positioned adjacent to and / or distal to boundary 2 and / or have entered the first alarm zone (zone 1), to prevent the end effectors 240, 340, 440 from contacting and / or entering the second alarm zone (zone 2) defined around the critical anatomical structures. This prevents the end effectors 240, 340, 440 from contacting and / or damaging the critical anatomical structures. It is also envisioned that combinations of various alarms, such as alarm devices 255, 355, 455 generating a combination of tactile alarm A, visual alarm B, and auditory alarm C, can be utilized.

[0127] refer to Figures 5A-5F Various schematic diagrams of one of the aforementioned surgical instrument assemblies 200, 300, and 400 are shown, including surgical instruments 220, 320, and 420 in different orientations relative to the patient 20. Reference Figure 5A Surgical instruments 220, 320, and 420, such as the first surgical instrument 220, are illustrated in a first position relative to the patient's surgical site 30. Surgical instruments 220, 320, and 420 may be configured to drill holes to remove biological tissue from the surgical site 30 or to drive screws, such as pedicle screws, into the surgical site. In this scenario, the surgeon can select and / or define a planned implant posture, such as one or more planned screw postures, including a target trajectory Axis-T and a target depth T. Alternatively, the navigation processor 140 may receive a planned surgical path, which is automatically generated based on segmentation of patient image data and the planned posture of the medical device or implant 275 to be inserted during the procedure.

[0128] The target trajectory Axis-T can include the desired orientation of the implant 275 to be inserted during the procedure and can be used to align with surgical instruments 220, 320, 420 and, consequently, with one or more end effectors 240, 340, 440 when preparing biological tissue for receiving the screw. The target depth T can include the desired depth or position in a known coordinate system. The target depth may also be referred to as a boundary and can be configured as a local plane perpendicular to the target trajectory. It is also envisioned that the surgical navigation system 100 can be configured to define the target trajectory Axis-T and the target depth T based on information selected or input by a medical professional. For example, the surgical navigation system 100 can be configured to define the target trajectory Axis-T and the target depth T based on one or more of the following items input by a medical professional: the type of procedure to be performed, the type or size of the implant 275 to be used, the type of surgical instruments 220, 320, 420 to be used, and / or the type of end effector 240, 340, 440.

[0129] In the first position, all portions of the end effectors 240, 340, and 440 are outside one or more defined virtual boundaries (boundaries 1, 2, 3, and 4) and / or alarm regions (regions 1, 2, 3, and 4). Therefore, no alarm is needed to notify the surgeon of potential contact with critical anatomical structures. However, as determined by the surgical navigation system 100, the surgical instruments 220, 320, and 420 are not aligned with the target trajectory Axis-T. In this exemplary scenario, the surgical navigation system 100 can be configured to trigger one of the various alarms described above. For example, the surgical navigation system 100 can be configured to send signals to the instrument processors 215, 315, and 415 to activate alarm devices 255, 355, and 455 because the orientation of the end effectors 240, 340, and 440 is not aligned with the target trajectory Axis-T. Depending on the alarm type assigned to the target trajectory Axis-T, alarm devices 255, 355, and 455 can be configured to provide tactile alarm A, such as vibrating switches 250, 350, and 450. Alternatively, alarm devices 255, 355, and 455 can be configured to provide visual alarm B, such as flashing lights. In yet another configuration, alarm devices 255, 355, and 455 can be configured to provide audible alarm C, such as a beeping sound. The surgical navigation system 100 can also be configured to send signals to instrument processors 215, 315, and 415 to reduce the output of motors 245, 345, and 445 of surgical instruments 220, 320, and 420, thereby reducing the rotation of end effectors 240, 340, and 440 from maximum cutting speed to minimum cutting speed. Alternatively, the surgical navigation system 100 can be configured to disable or stop the rotation of the end effectors 240, 340, 440 before they are aligned with the target trajectory Axis-T, to prevent the end effectors 240, 340, 440 from drilling misaligned holes. It is also envisioned that a combination of various alarms can be used, such as alarm devices 255, 355, 455 generating a combination of tactile alarm A, visual alarm B, and auditory alarm C. Figure 5A In this scenario, the surgeon has assigned a tactile alarm A, for example, to cause switches 250, 350, and 450 to vibrate when end effectors 240, 340, and 440 are not aligned with the target trajectory Axis-T. It is also envisioned that one or more of the aforementioned alarms could be assigned to this scenario to notify the surgeon when end effectors 240, 340, and 440 are adjacent to and / or distal to one of the virtual boundaries (boundaries 1, 2, 3, and 4), and / or approach and / or enter one of the alarm zones (zones 1, 2, 3, and 4).

[0130] Furthermore, it is envisioned that the surgical navigation system 100 may be configured to send signals only to activate alarm devices 255, 355, 455 to generate one of the aforementioned alarms, and / or deactivate / disable variable speed motors 245, 345, 445 to prevent actuation of the end effectors 240, 340, 440, when the end effectors 240, 340, 440 and / or surgical instruments 220, 320, 420 are positioned within a threshold distance of the patient and / or surgical site. This can be measured relative to a reference positioning RL and / or a reference coordinate system defined in a known coordinate system, such as a position on the bone. By calculating the distance between the reference positioning and the end effector, the navigation system can determine whether the surgical instruments are relatively close to the surgical site.

[0131] Alternatively, the surgical navigation system 100 can be configured to allow variable speed motors 245, 345, 445 to continuously actuate the end effectors 240, 340, 440 when they are outside a threshold distance (i.e., a safe distance) from the patient and / or surgical site, regardless of the position of the end effectors 240, 340, 440 and / or surgical instruments 220, 320, 420 relative to the target trajectory Axis-T. This may include deactivating all alarm devices 255, 355, 455 when the end effectors 240, 340, 440 and / or surgical instruments 220, 320, 420 are outside the threshold distance from the patient and / or surgical site. This allows medical personnel to continuously test the surgical instruments 220, 320, and 420 to ensure everything is in proper working order before approaching the surgical site and beginning the procedure. However, once the end effectors 240, 340, and 440 and / or the surgical instruments 220, 320, and 420 are within a threshold distance of the reference positioning / reference coordinate system, alarm devices 255, 355, and 455 can be activated and the surgical navigation system 100 can again transmit all appropriate signals to the processors 215, 315, and 415, thereby activating the alarm devices 255, 355, and 455 and / or deactivating the variable speed motors 245, 345, and 445 in the manner described above.

[0132] refer to Figure 5BSurgical instruments 220, 320, and 420, such as the first surgical instrument 220, are illustrated in a second position relative to the patient's surgical site 30. In this second position, end effectors 240, 340, and 440 are spaced apart from virtual boundaries (boundaries 1, 2, 3, and 4) and / or outside defined alarm areas (areas 1, 2, 3, and 4). End effectors 240, 340, and 440 are also correctly aligned with the target trajectory Axis-T. In this exemplary scenario, the surgical navigation system 100 can identify that end effectors 240, 340, and 440 are spaced apart from one or more of the virtual boundaries (boundaries 1, 2, 3, and 4) and / or outside one or more defined alarm areas (areas 1, 2, 3, and 4) and aligned with the target trajectory Axis-T, allowing surgical instruments 220, 320, and 420 to operate under normal working conditions when switches 250, 350, and 450 are actuated to actuate end effectors 240, 340, and 440. In this scenario, alarm devices 255, 355, and 455 may also be inactive.

[0133] refer to Figure 5CSurgical instruments 220, 320, and 420, such as the third surgical instrument 220, are illustrated in a third position relative to the patient's surgical site 30. In the second position, end effectors 240, 340, and 440 are spaced apart from one or more of the boundaries (boundaries 1, 2, 3, and 4) and / or outside one or more defined alarm zones (zones 1, 2, 3, and 4). End effectors 240, 340, and 440 are also correctly aligned with the target trajectory Axis-T. However, the tips of end effectors 240, 340, and 440 have reached or are adjacent to the target depth T at or near boundary 4. In this exemplary scenario, the surgical navigation system 100 can identify that the end effector 240, 340, 440 or implant 275 has reached the target depth T and is configured to disable or stop the rotation of the end effector 240, 340, 440 because it has reached the target depth T, thus preventing the end effector 240, 340, 440 from drilling a hole deeper than the target depth T. Furthermore, the surgical navigation system can be configured to trigger one of the various alarms described above. For example, the surgical navigation system 100 can be configured to send a signal to the instrument processors 215, 315, 415 to activate alarm devices 255, 355, 455 because the end effector 240, 340, 440 has reached the target depth T. Depending on the alarm type assigned to the target site T, alarm devices 255, 355, and 455 can be configured to provide a tactile alarm A, such as vibrating switches 250, 350, and 450, when the surgical navigation system 100 determines that the end effectors 240, 340, and 440 have reached the target site T. Alternatively, alarm devices 255, 355, and 455 can be configured to provide a visual alarm B, such as a flashing light. In yet another configuration, alarm devices 255, 355, and 455 can be configured to provide an audible alarm C, such as a beeping sound. The surgical navigation system 100 can also be configured to send signals to instrument processors 215, 315, and 415 to reduce the output of motors 245, 345, and 445 of surgical instruments 220, 320, and 420, thereby reducing the rotation of the end effectors 240, 340, and 440 from a maximum cutting speed to a minimum cutting speed. It is also envisioned that various combinations of alarms can be used, such as alarm devices 255, 355, and 455 generating a combination of tactile alarm A, visual alarm B, and auditory alarm C. For example... Figure 5A As shown, the surgeon has assigned a visual alarm B, such as a flashing light on switches 250, 350, and 450 when the end effectors 240, 340, and 440 have reached the target depth T.

[0134] refer to Figure 5D-5F Surgical instruments 220, 320, and 420, such as the first surgical instrument 220, are illustrated relative to the patient's surgical site 30. The first surgical instrument 220 can be configured to interact with the surgical site 30 described above. Figures 5A-5C The defined boundaries operate in a similar manner. However, in Figure 5D-5F The image shows some additional exemplary virtual boundaries (boundaries 4, 5, 6, 7) and / or alarm zones. For example, Figure 5D Various additional exemplary virtual boundaries (boundaries 4, 5, 6, 7) are shown. The virtual boundaries (boundaries 4, 5, 6, 7) may correspond to different depths for insertion of different end effectors 240 coupled to the first surgical instrument 220. It is envisioned that multiple different end effectors 240 (described in more detail below) may be coupled to the handpiece 225 of the first surgical instrument 220. Each different end effector 240 may be configured to perform different functions and / or operations as part of a procedure performed on the patient. The surgical navigation system 100 may be configured to identify which of the end effectors 240 is coupled to the handpiece 225 and define a corresponding virtual boundary (boundaries 4, 5, 6, 7) and / or alarm region corresponding to each of the respective end effectors 240A, 240B, 240C. A fourth virtual boundary (boundary 4) may correspond to the target depth of the selected implant 275. Each of the fourth, fifth, and sixth virtual boundaries (boundaries 5, 6, and 7) can be configured to correspond to a target depth for each of the respective end effectors 240A, 240B, and 240C. Based on the desired depth and / or location of the respective end effectors 240A, 240B, and 240C, each of the virtual boundaries (boundaries 5, 6, and 7) corresponding to each of the respective end effectors 240A, 240B, and 240C can be determined as a defined distance from the fourth virtual boundary (boundary 4). It is also envisioned that the fourth virtual boundary (boundary 4) and the fifth virtual boundary (boundary 5) are located at the same site. In this scenario, the fifth virtual boundary (boundary 5) corresponding to the first end effector 240A can define the initial target depth of the implant 275, and each subsequent virtual boundary (boundary 6, and 7) can be defined based on the distance from the fifth virtual boundary (boundary 5). For example, the first end effector 240A may include a drill, the second end effector 240B may include a tap, and the third end effector 240C may include a driver used in surgical procedures for preparing and inserting pedicle screws into the vertebrae. Figure 5DAs shown, a fifth virtual boundary (boundary 5) can be defined by the surgical navigation system 100 corresponding to the depth of the first end effector 240A, a sixth virtual boundary (boundary 6) can be defined by the surgical navigation system 100 corresponding to the depth of the second end effector 240B, and a seventh virtual boundary (boundary 7) can be defined by the surgical navigation system 100 corresponding to the depth of the third end effector 240C. Each of the virtual boundaries (boundaries 4, 5, 6, 7) may include a plane perpendicular to the axial positioning along the target axis Axis-T, corresponding to the target depth of the attached end effectors 240A, 240B, 240C. The navigation system 100 can be configured to define the virtual boundaries (boundaries 4, 5, 6, 7) based on the position of the surgical instruments and the known position of the tips of the respective end effectors 240A, 240B, 240C attached to the handpiece 225.

[0135] One or more of the aforementioned alarms and / or alarm devices 255, 355, 455 may be assigned to each of the virtual boundaries (boundaries 4, 5, 6, 7). While the virtual boundaries (boundaries 4, 5, 6, 7) are described as being defined by the surgical navigation system 100, it is also contemplated that they may be defined and / or selected by medical personnel. For example, medical personnel may use user input device 130 or graphical user interface (GUI) 150 to define or select virtual boundaries (boundaries 4, 5, 6, 7) within patient data. It is also contemplated that the virtual boundaries (boundaries 4, 5, 6, 7) may be defined and / or recommended by the surgical navigation system 100, and that medical personnel may use user input device 130 and / or graphical user interface (GUI) 150 to modify or change the virtual boundaries (boundaries 4, 5, 6, 7) defined by the surgical navigation system 100.

[0136] refer to Figure 5E Surgical instruments 220, 320, and 420, such as the first surgical instrument 220, are illustrated relative to the patient's surgical site 30. The first surgical instrument 220 can be configured to interact with the surgical site 30 described above. Figures 5A-5C The defined alarm zone operates in a similar manner. Figure 5E The illustration shows an alternative exemplary configuration of the alarm zones (zones 5 and 6). As mentioned above, the alarm zone can be defined to surround or abut key anatomical structures, such as... Figure 4A-5C The areas 1, 2, and 3 shown in the diagram are intended to alert medical personnel when approaching critical anatomical structures. Alert zones can also be defined as boundaries used to identify anatomical structures, such as... Figures 5A-5D Area 4, as indicated in the diagram, serves to warn medical personnel when approaching this boundary and to prevent damage to the cortical wall. (As shown) Figure 5EAs shown, alarm regions (regions 5 and 6) can be defined along the boundaries of opposite sides of the target trajectory Axis-T to warn medical professionals of any deviation from the target trajectory Axis-T. The shape or contour of the alarm regions (regions 5 and 6) can also be designed to match the shape of critical anatomical structures and / or boundaries. For example, the surgical navigation system 100 can be configured to define an alarm region (region 6) such that it curves around the outer periphery of the pedicle to warn medical personnel when the end effector 240 of the first surgical instrument 220 approaches the outer periphery of the vertebra, preventing medical professionals from damaging the outer periphery of the pedicle. The surgical navigation system 100 can also be configured to define an alarm region (region 5) such that its contour surrounds a critical anatomical structure (central foramen) within the vertebra to warn medical personnel when the end effector 240 of the first surgical instrument 220 approaches the critical anatomical structure, preventing medical personnel from contacting the critical anatomical structure.

[0137] refer to Figure 5F Surgical instruments 220, 320, and 420, such as the first surgical instrument 220, are indicated relative to the patient's surgical site 30. Virtual boundaries (boundaries 4, 5, 6, and 7) are similar to those described above. Figure 5D Those described. However, Figure 5F The system diagram illustrates an alternative arrangement of components, where the surgical instruments also include a battery module 260, which includes a battery processor 265. The system can be configured such that a navigation processor 140 communicates with the battery processor 265. The battery processor 265 can receive signals from the navigation processor 140 to manipulate the power flow from the battery module 260 to the handpiece 225, and consequently, to manipulate the variable speed motor 245, based on the position of the surgical instruments relative to virtual boundaries (boundaries 4, 5, 6, 7). Signals from the navigation processor 140 can be configured to indicate to the battery processor 265 that the position of the end effector 240 is adjacent to and / or distal to the virtual boundaries (boundaries 4, 5, 6, 7), thereby causing the battery processor 265 to interrupt the power flow from the battery module 260 to the handpiece 225, and consequently to the variable speed motor 245. Alternatively, signals from navigation processor 140 may include commands to battery processor 265 instructing it to interrupt power flow from battery module 260 to handpiece 225 and thus to variable speed motor 245, based on navigation system 100 determining that the position of end effector 240 is adjacent to and / or distal to virtual boundaries (boundaries 4, 5, 6, 7). Battery processor 265 may also communicate with instrument processor 215, allowing instrument processor 215 to be configured to deactivate motors based on data received from battery processor.

[0138] refer to Figure 6An exemplary configuration of a surgical system including a surgical navigation system 100 and the aforementioned first surgical instrument 220 is shown. Although in Figure 6 Only the first surgical instrument is shown, but it is conceivable that any of the aforementioned surgical instruments 220, 320, 420 could be included in the system. The surgical system may also include multiple end effectors 240A, 240B, 240C, which are detachably coupled to the handpiece 225 of the first surgical instrument 220. The end effectors 240A, 240B, 240C may also be referred to as end effectors, surgical accessories, and / or tool accessories. For example, the surgical system may include a first end effector 240A, which includes a drill for cutting and / or drilling in biological materials. The surgical system may also include a second end effector 240B, which includes a tap for creating threads on the inner surface of a hole or orifice. The surgical system may also include a third end effector 240C, which includes an actuator for driving or inserting a screw into a hole or orifice. Each of the end effectors 240A, 240B, and 240C may include instrument tracking devices 230A, 230B, and 230C, each of which includes a unique configuration and / or arrangement of markings 235A, 235B, and 235C. For example, the markings 235A, 235B, and 235C of the instrument tracking devices 230A, 230B, and 230C may include unique dimensions, shapes, and / or arrangements relative to the markings 235A, 235B, and 235C of other instrument tracking devices 230A, 230B, and 230C. Although not shown in the figures, it is also contemplated that each of the end effectors 240A, 240B, and 240C may be coupled to a separate handheld component 225, each of which may include a tracking device 230A, 230B, and 230C with a unique configuration and / or arrangement of markings 235A, 235B, and 235C. For example, the markers 235A, 235B, and 235C of the instrument tracking devices 230A, 230B, and 230C may include unique dimensions, shapes, and / or arrangements relative to the markers 235A, 235B, and 235C of other instrument tracking devices 230A, 230B, and 230C. The navigation system 100 can be configured to identify end effectors 240A, 240B, and 240C based on a known association with a particular handheld device 225 and the unique dimensions, shapes, and / or arrangements of the markers 235A, 235B, and 235C of the instrument tracking devices 230A, 230B, and 230C attached to that particular handheld device 225. The navigation system can then be configured to provide virtual boundaries (boundaries 4, 5, 6, and 7) and / or alarm zones (zones 4, 5, 6, and 7) for the appropriate end effectors 240A, 240B, and 240C currently being navigated.

[0139] The surgical navigation system 100 can be configured to identify which of the end effectors 240A, 240B, 240C is attached to the handpiece 225 of the first surgical instrument based on the arrangement and / or configuration of the markers 235A, 235B, 235C of the instrument tracking devices 230A, 230B, 230C. The surgical navigation system 100 can then be configured to define alarm zones. For example, the surgical navigation system 100 can be configured to define alarm zones and / or boundaries corresponding to the target depth of each of the end effectors 240A, 240B, 240C. Figure 5D An exemplary configuration of virtual boundaries (boundaries 4, 5, 6, 7) and / or alarm zones (zones 5, 6, and 7) is shown, wherein boundary 5 may correspond to the target depth of the first end effector 240A, boundary 6 may correspond to the target depth of the second end effector 240B, and boundary 7 may correspond to the target depth of the third end effector 240C. The surgical navigation system 100 may be programmed and / or configured to, when the surgical navigation system 100 determines that the surgical instruments 220, 320, 420 are at or adjacent to one or more of the virtual boundaries (boundaries 4, 5, 6, 7) or have entered one of the defined alarm zones, manipulate the speed of the motors 245, 345, 445 of the surgical instruments 220, 320, 420 and / or activate alarm devices 255, 355, 455. For example, when the surgical navigation system 100 detects that the first end effector 240A is connected to the handheld device 225, the surgical navigation system 100 can be configured to send a signal to the processors 215, 315, 415 of the surgical instrument 220 to deactivate the variable speed motors 245, 345, 445 when the first end effector 240A is adjacent to and / or distal to the boundary 5. When the surgical navigation system 100 detects that the second end effector 240B is connected to the handheld device 225, the surgical navigation system 100 can be configured to send a signal to the processors 215, 315, 415 of the surgical instrument 220 to deactivate the variable speed motors 245, 345, 445 when the second end effector 240B is adjacent to and / or distal to the boundary 6. When the surgical navigation system 100 detects that the third end effector 240C is engaged with the handheld device 225, the surgical navigation system 100 can be configured to send a signal to the processors 215, 315, 415 of the surgical instrument 220 to deactivate the variable speed motors 245, 345, 445 when the third end effector 240C is adjacent to and / or distal to the boundary 7. In other words, for a given end effector, only a specific alarm zone and / or virtual boundary is active. When an appropriate end effector enters the field, the surgical navigation system only activates the appropriate virtual boundary and / or alarm zone suitable for the identified end effector.

[0140] Once the surgical navigation system 100 has sent a signal to the processors 215, 315, 415 of the surgical instruments 220, 320, 420 to deactivate the variable speed motors 245, 345, 445, when the end effectors 240, 340, 440 are adjacent to and / or distal to one of the virtual boundaries and / or within one of the alarm zones, the processors 215, 315, 415 deactivate the variable speed motors 245, 345, 445, for example, by rotating the motors at 0 rpm. While the end effectors 240, 340, 440 remain adjacent to and / or distal to one of the virtual boundaries and / or within one of the alarm zones, after temporarily deactivating the variable speed motors 245, 345, 445, the processors 215, 315, 415 can be configured to restart the variable speed motors 245, 345, 445. The variable speed motors 245, 345, and 445 can be restarted by the processors 215, 315, and 415 after a defined time period, such as more than 1, 2, 3, or 4 seconds.

[0141] Alternatively, after processors 215, 315, and 415 receive a signal that switches 250, 350, and 450 have been actuated by the user, the variable speed motors 245, 345, and 445 can be reactivated by processors 215, 315, and 415. For example, the processors analyze the rhythm of switch activation within a defined time period. For example, processors 215, 315, and 415 can be configured to reactivate variable speed motors 245, 345, and 445 after receiving a signal from a switch sensor that switches 250, 350, and 450 have been actuated from a second position to a first position and back to the second position within half a second. The timing and number of times switches 250, 350, and 450 are actuated are intended only as an example rhythm and / or timeframe for reactivating variable speed motors 245, 345, and 445 after they have been deactivated due to entering an alarm zone. In one example, when the trigger or foot switch 250, 350, 450 has been fully released, the processors 215, 315, 415 can reactivate the motors 245, 345, 445.

[0142] Once motors 245, 345, and 445 are reactivated, the speed of end effectors 240, 340, and 440 can be controlled by manipulating switches or triggers 250, 350, and 450, just as in normal operation.

[0143] Once the variable speed motors 245, 345, and 445 have been reactivated, and the end effectors 240, 340, and 440 are adjacent to or to the far side of one of the virtual boundaries and / or still within one of the alarm zones, the surgical navigation system 100 will continue to track the position of the end effectors 240, 340, and 440 and / or the surgical instruments 220, 320, and 420.

[0144] However, upon reactivation, if the navigation system 100 detects that the end effectors 240, 340, 440 and / or surgical instruments 220, 320, 420 are moving further distally relative to the boundary and / or further into the alarm zone, or have traveled a threshold distance distal to the boundary and / or have traveled through a portion of the alarm zone, the surgical navigation system 100 may be configured to send subsequent signals to the processors 215, 315, 415 to again manipulate the speed of the variable speed motors 245, 345, 445 and / or deactivate the variable speed motors 245, 345, 445. For example, if the surgical navigation system 100 detects that the end effectors 240, 340, 440 have moved two millimeters distal to the virtual boundary and / or have entered further into the alarm zone, the surgical navigation system 100 may be configured to send subsequent signals to the processors 215, 315, 415 to again deactivate the variable speed motors 245, 345, 445. The surgeon will then need to go through one of the above processes again to reactivate the variable speed motors 245, 345, and 445. The navigation processor 140 and / or the instrument processors 215, 315, and 415 can be configured to allow only a limited number of reactivations, and / or can allow reactivation only when the end effectors 240, 340, and 440 are within a threshold distance of the boundary and / or region.

[0145] Alternatively, once the variable speed motors 245, 345, and 445 have been reactivated, and the end effectors 240, 340, and 440 are adjacent to and / or distal to one of the virtual boundaries and / or still within one of the alarm zones, if the surgical navigation system 100 determines that the end effectors 240, 340, and 440 are moving proximally relative to the virtual boundaries and / or are exiting the alarm zones, the surgical navigation system 100 can be configured to allow uninterrupted operation of the variable speed motors 245, 345, and 445. In other words, once the navigation system 100 determines that the end effectors 240, 340, and 440 have been reversed, the navigation processor 140 and / or instrument processors 215, 315, and 415 can be configured to allow normal operation of the surgical instruments 220, 320, and 420.

[0146] The first surgical instrument 220 may also include a mode switch 270 configured to change the operating characteristics of the variable speed motor 245. The switch may be configured to slide and / or rotate between two or more positions. For example, the mode switch may have a first position and a second position, wherein the mode switch may be configured to switch the variable speed motor between high and low speeds based on the position of the mode switch. Alternatively, the mode switch may be configured to switch the variable speed motor between high-torque and low-torque operating modes based on the position of the mode switch. In yet another configuration, the mode switch may be configured to switch the variable speed motor between high-speed and low-torque operating modes and low-speed and high-torque operating modes based on the position of the mode switch. The operating mode may be selected by a medical professional based on the type of procedure to be performed. For example, when performing a drilling process, the medical professional may want the surgical instrument 220 to be in a high-speed and low-torque operating mode. Alternatively, when performing a drive process, the medical professional may want the surgical instrument 220 to be in a low-speed and high-torque operating mode.

[0147] The surgical navigation system 100 can also be configured to determine the position of a mode switch 270. The surgical instrument 220 may include a mode switch sensor that detects the position of the mode switch 270. The processor 215 can then be configured to transmit the position of the mode switch to the surgical navigation system 100. Alternatively, the mode switch may include a tracker that allows the surgical navigation system 100 to determine the position of the mode switch 270. In yet another configuration, the surgical navigation system 100 may be configured to use machine vision to determine the position of the mode switch 270. As described above, the surgical navigation system can also be configured to determine which of a plurality of end effectors 240A, 240B, 240C is coupled to the handpiece 225 of the surgical instrument 220. As described above, specific operating modes may be advantageous for different procedures. Therefore, the surgical navigation system 100 may be configured to compare the operating modes of the end effectors 240A, 240B, 240C based on the identified position of the mode switch 270. Then, if the position of mode switch 270 does not match the preferred operating mode of the end effectors 240A, 240B, 240C connected to handpiece 225, the surgical navigation system 100 can be configured to send signals to processors 215, 265 of surgical instrument 220 to prevent operation of handpiece 225. For example, if drill-type end effector 240A is connected to handpiece 225 and the recommended operating mode is high speed and low torque, while mode switch 270 is in the low speed and high torque position, the surgical navigation system 100 can send signals to processors 215, 265, and processors 215, 265 can be configured to prevent the variable speed motor 245 from being energized before mode switch 270 is moved to the high speed and low torque position.

[0148] refer to Figure 7An exemplary configuration of a surgical system including the aforementioned surgical navigation system 100 and the second surgical instrument 320 is shown. Although in Figure 6 Only the first surgical instrument is shown, but it is conceivable that any of the surgical instruments 220, 320, 420 described above could be included in the system. The surgical system may also include multiple end effectors 340A, 340B, 340C, which are detachably coupled to the handpiece 325 of the second surgical instrument 320. The end effectors 340A, 340B, 340C may also be referred to as end effectors, surgical accessories, and / or tool accessories. For example, the surgical system may include a first end effector 340A, which includes a first grinding head 360A having a first diameter head D1. The surgical system may also include a second end effector 340B, which includes a second grinding head 360B having a second diameter head D2. The surgical system may also include a third end effector 340C, which includes a third grinding head 360C having a third diameter head D3. It is also envisioned that the head of each end effector 340A, 340B, 340C can vary due to its shape, material, and / or cutting type. It is also envisioned that the length of the shaft can vary from one end effector 340A, 340B, 340C to the next.

[0149] The surgical navigation system 100 can be configured to identify which of the end effectors 340A, 340B, and 340C is attached to the handpiece 325. An exemplary method of identifying the end effectors 340A, 340B, and 340C attached to the handpiece 325 is to use machine vision. In this exemplary configuration, the surgical navigation system 100 can be configured to identify the end effectors 340A, 340B, and 340C attached to the handpiece 325 based on the characteristics of each of the end effectors 340A, 340B, and 340C. For example, the surgical navigation system 100 can be configured to identify the end effectors 340A, 340B, and 340C based on the diameters D1, D2, and D3 of the heads 360A, 360B, and 360C. The surgical navigation system 100 can then be configured to define alarm zones based on the identified end effectors 340A, 340B, and 340C. For example, the surgical navigation system 100 can be configured to define alarm zones around one or more key anatomical structures. Figures 4A-4DAn exemplary configuration of virtual boundaries (boundaries 1, 2, 3) and / or alarm regions (regions 1, 2, and 3) is shown. Each virtual boundary and / or alarm region can be based on different distances surrounding a single critical anatomical structure, or multiple critical anatomical structures can be identified using one or more virtual boundaries and / or alarm regions. The surgical navigation system 100 can be programmed and / or configured to execute any of various alarm types when the surgical navigation system 100 determines that surgical instruments 220, 320, 420 have entered one of the defined alarm regions, such as deactivating surgical instruments 220, 320, 420, or activating alarm devices 255, 355, 455. For example, different end effector diameters may result in alarm regions of different thicknesses. In other words, the depth of the alarm region relative to the critical structure and / or boundary can be automatically adjusted and / or set by the navigation system 100 based on the identification of end effectors 240, 340, 440.

[0150] refer to Figure 8 The illustration shows an exemplary configuration of the graphical user interface (GUI) 150 of the navigation system 100. The GUI 150 can be configured as a touchscreen on the display 120 of the navigation system 100. Figure 8As shown, the graphical user interface (GUI) 150 may include a number of buttons and / or prompts that are selectable and / or operable by the surgeon. For example, the GUI 150 may include an exemplary alert interface 151 or window that includes a number of buttons that can be selected or manipulated by the user to modify or adjust various settings providing alerts during the performance of a medical procedure. The alert settings interface 151 may include tool selection buttons 152A, 152B. Tool selection buttons 152A, 152B may allow the surgeon to select surgical instrument components 200, 300, 400 from a populated list of surgical instruments, or may allow the surgeon to enter specific surgical instrument components 200, 300, 400 to be used during the surgical procedure. For example, tool selection buttons 152A, 152B may allow the surgeon to select a second surgical instrument 320 including a high-speed cutting burr. This allows the navigation system 140 to identify specific surgical instruments 320, allowing the navigation system to populate the virtual boundaries and / or alert areas to be used by the identified instruments. Tool selection buttons 152A and 152B can also be configured to allow surgeons to select surgical instrument assemblies 200, 300, and 400, as well as one or more end effectors 240, 340, and 440 that can be coupled to surgical instruments 220, 320, and 420. For example, a surgeon can select a first surgical instrument 220 and further select one or more end effectors 240A, 240B, and 240C that can be used during the procedure, allowing the navigation system to populate virtual boundaries and / or alarm areas for each of the end effectors 240A, 240B, and 240C.

[0151] The alarm setting interface 151 may also include one or more alarm buttons 156A, 156B, 156C, and 156D. Alarm buttons 162A, 162B, 156C, and 156D can be used to manipulate the various alarms described above. For example, the first alarm button 156A may be configured to allow a user to activate or deactivate an alarm related to the rotational speed of the end effectors 240, 340, and 440. For example, as described above, the navigation processor 140 and / or the machine processors 215, 315, and 415 may be configured to manipulate the rotational speed (RPM) of the end effectors 240, 340, and 440 based on the position of the end effectors 240, 340, and 440 relative to one or more virtual boundaries and / or alarm zones.

[0152] The second alarm button 156B can be configured to allow a user to activate or deactivate tactile alarms. For example, a user can manipulate the second alarm button 156B to activate one of the aforementioned tactile alarms. This may include configuring the navigation processor 140 to send signals to the surgical instrument assemblies 200, 300, 400 based on the position of the end effectors 240, 340, 440 relative to one or more virtual boundaries and / or alarm zones to activate the configured alarm devices 255, 355, 455 to provide tactile alarms to the surgeon.

[0153] The third alarm button 156C can be configured to allow a user to activate or deactivate visual alarms. For example, a user can manipulate the third alarm button 156C to activate one of the visual alarms. This may include configuring the navigation processor 140 to send signals to the surgical instrument assemblies 200, 300, 400 based on the position of the end effectors 240, 340, 440 relative to one or more virtual boundaries and / or alarm areas to activate the configured alarm devices 255, 355, 455 to provide a visual alarm to the surgeon.

[0154] The fourth alarm button 156D can be configured to allow a user to activate or deactivate one of the aforementioned auditory alarms. For example, a user can manipulate the fourth alarm button 156D to activate an auditory alarm, causing the navigation processor 140 to send a signal to the surgical instrument assemblies 200, 300, 400 based on the position of the end effectors 240, 340, 440 relative to one or more virtual boundaries and / or alarm zones to activate the configured alarm devices 255, 355, 455 to provide an auditory alarm to the surgeon.

[0155] The alarm setting interface 151 of the graphical user interface (GUI) 150A can also be one or more alarm graphics 158A, 158B. Alarm graphics 154A, 154B can be specific to particular surgical instruments and / or end effectors and can be configured to provide schematic and / or visual representations of the locations of various virtual boundaries and / or alarm zones. The first alarm graphic 158A can include a visual representation of the surgical area and any implants or devices to be inserted during the medical procedure to help the surgeon identify the site of the procedure and set various alarms. For example, such as... Figure 8 As shown, the first alarm graphic includes visual data of the vertebral body, with the area to be operated on outlined by dashed lines. The first alarm graphic may also include visual data of the pedicle screws to be inserted during the procedure.

[0156] The second alarm graphic 158B can be configured to provide a visual representation of the implant or device to be inserted during the procedure, and markings indicating the virtual boundaries (boundaries 5, 6, 7) relative to the implant or device, to assist the surgeon in adjusting or modifying sites where alarms assigned to each virtual boundary and / or alarm zone should be triggered. For example, as... Figure 8 As shown, the second alarm graphic 158B includes the following visual representations: the pedicle screw to be inserted, and the markings along the pedicle screw that will trigger various alarms during the procedure, indicating the positioning of each virtual boundary (boundary 1, 2, 3) relative to the pedicle screw.

[0157] The alarm setting interface 151 of the graphical user interface (GUI) 150A may also include virtual boundary setting interfaces 160A and 160B. Boundary setting interfaces 160A and 160B may include one or more prompts or buttons 162A, 162B, 162C, 162D, and 162E for setting and / or manipulating when the virtual boundary will trigger one or more of the aforementioned alarms. The first boundary setting interface 160A may include a first button 162A, which may be configured to identify the implant and / or device to be inserted during the procedure. This allows the navigation system 100 to determine which and how many virtual boundary and / or alarm areas to provide. For example, if a surgeon manipulates the first button 162A to indicate that a laminectomy will be performed, the navigation system 100 will understand that this is a resection procedure and will know to identify and provide various alarm areas around key structures of the vertebra to assist the surgeon in performing the procedure. Please note that if the surgeon manipulates the first button 162A to indicate that a pedicle screw surgery will be performed, the navigation system 100 will know to identify and provide the virtual boundaries required to assist the surgeon in drilling, tapping and placing the pedicle screw.

[0158] The second button 162B of the boundary setting interface 160A can be configured to include a depth button 162B. The depth button 162B can be configured to allow the surgeon to select the depth of the alarm area for resection procedures such as laminectomy. For example, Figure 8 The first boundary setting interface 160A shown indicates that the surgeon is setting an alarm for laminectomy based on manipulation of the first button 162A. Based on this selection by the surgeon, the second button 162B provides an operable button configured to allow the surgeon to select the depth of the alarm zone, which will be used by the navigation system 100 to trigger one or more of various alarms.

[0159] The alarm setting interface 151 can be configured to allow the alarm graphic 158A adjacent to the boundary setting interface 160A to be manipulated or changed based on the manipulation of the buttons 162A, 162B of the boundary setting interface 160A.

[0160] The second boundary setting interface 160B of the alarm setting interface 151 may include additional buttons 162C, 162D, 162E related to the configuration of each virtual boundary and / or alarm zone for triggering alarms during medical procedures. For example, Figure 8 As shown, the second boundary setting interface 160B can be configured to provide buttons 162C, 162D, and 162E for manipulating settings of alarms for the procedure used to insert pedicle screws. The third button 162C of the second boundary setting interface 160B can be configured to set the distance or depth of a reference location used to locate a virtual boundary (e.g., boundary 5) along the target trajectory. For example, as... Figure 8 As shown, the third button 162C includes a toggle switch to allow the surgeon to set the insertion depth of the first end effector, i.e., the drill, before an alarm is triggered. In the example, the user has set the third button 162C to 30 mm, instructing the navigation system 100 to trigger an alarm for the first end effector when it has traveled 30 mm or reached a depth of 30 mm. The second boundary setting interface 160B may include additional buttons 162D, 162E for manipulating and / or adjusting when an alarm should be triggered for the second end effector (i.e., the tap) and / or the third end effector (i.e., the driver for inserting the screw). As described above, the navigation system 100 can be configured such that the fourth and fifth buttons 162D, 162E for manipulating alarms for the second and third end effectors can manipulate the virtual boundary used to trigger the aforementioned alarm based on the virtual boundary used to trigger an alarm for the first end effector. For example, as indicated by the fourth button 162D, the virtual boundary used to trigger an alarm for the second end effector (i.e., the tap) should be shifted by zero millimeters (0-mm) relative to the virtual boundary used to trigger an alarm for the first end effector. However, the fourth button 162D can be manipulated to shift the boundary used to trigger an alarm for the second end effector as needed. Similarly, the fifth button 162E can be manipulated to modify or adjust the virtual boundary used to trigger an alarm for the third end effector.

[0161] The alarm setting interface 151 of the graphical user interface (GUI) 150A may also include alarm test buttons 164A and 164B. Alarm test buttons 164A and 164B can be configured to test and / or confirm that the selected alarm is active and functioning correctly. For example, during operation, after the surgeon has selected and / or entered all the various information related to the medical procedure into the alarm setting interface 151, the surgeon can select alarm test buttons 164A and 164B to confirm that the selected alarm is active. For example, if the surgeon selects a first alarm button 156A for a motor speed alarm and it is active, the surgeon can activate surgical instruments 220, 320, and 420 and press alarm test buttons 164A and 164B. Pressing alarm test buttons 164A and 164B commands the navigation system to send a test signal to instrument processors 215, 315, and 415 to activate the alarm associated with the first alarm button 156A, such as reducing the motor speed and thus reducing the dispensing speed of end effectors 240, 340, and 440. When the user selects alarm test buttons 164A and 164B, each of the various alarms already activated based on the manipulation of alarm buttons 156A, 156B, 156C, 156D, and 156E should be triggered. Any activated alarms that were not triggered when alarm test buttons 164A and 164B were selected should be further evaluated by the surgeon before the start of the medical procedure to confirm that they are actually functioning correctly.

[0162] refer to Figure 9 The illustration shows an exemplary graphical user interface (GUI) 150B as displayed on a display 120 of the navigation system 100. The GUI 150B can be configured to include a visual representation of a surgical plan, including the planned orientation of implants 275A, 275B in a known coordinate system. Implants 275A, 275B can define target axes Axis-T1, Axis-T2. The navigation system 100 can provide one or more virtual boundaries (boundaries 5, 6, 7) along the target axes Axis-T1, Axis-T2, as described above, representing the target depth of each of the various end effectors 240A, 240B, 240C used when executing the procedure. For example, as... Figure 9As shown, the first boundaries (boundaries 5A, 5B) are depicted along the target axes Axis-T1 and Axis-T2 of each implant 275A, 275B. Navigation system 140 can be configured to define the first boundaries (boundaries 5A, 5B) based on the target depth of the tip of a first end effector 240A (e.g., a drill for drilling holes for placing screws 275A, 275B). Navigation system 100 can be further configured to define the second boundaries (boundaries 6A, 6B) based on the target depth of a second end effector 240C (e.g., a tap for cutting threads in holes). It is envisioned that navigation system 100 can define the second boundaries (boundaries 6A, 6B) relative to the first boundaries (boundaries 5A, 5B) at least in part based on the selected implants 275A, 275B and their orientation. For example, navigation system 100 can define the first boundaries (boundaries 5A, 5B) along the target axes Axis-T1 and Axis-T2 within the patient's known coordinate system. Then, based on the selected implants 275A and 275B, the navigation system 100 can be configured to define a second boundary (boundary 6A and 6B) at a distance from the first boundary (boundary 5A and 5B) based on the selected implants 275A and 275B. The navigation system 140 can also be configured to define a third boundary (boundary 7A and 7B) based on the target depth of the third end effector 240C (e.g., a driver for placing screws 275A and 275B in holes). It is envisioned that the navigation system 100 can define the third boundary (boundary 7A and 7B) relative to the first boundary (boundary 5A and 5B) at least in part based on the selected implants 275A and 275B and their orientation. For example, the navigation system 100 can define the first boundary (boundary 5A and 5B) in the patient's known coordinate system along target axes Axis-T1 and Axis-T2. Then, based on the selected implants 275A and 275B, the navigation system can be configured to define a third boundary (boundary 7A and 7B) at a distance from the first boundary (boundary 5A and 5B) based on the selected implants 275A and 275B. For example, the navigation system can be configured to determine, based on the depth of the first boundary (boundary 1A and 1B) and the known length of the selected implants 275A and 275B, that the third boundary (boundary 7A and 7B) should be spaced thirty millimeters (30 mm) from the first boundary (boundary 5A and 5B) along the target axes Axis-T1 and Axis-T2. Although only the first boundary (boundary 5A and 5B), the second boundary (boundary 6A and 6B), and the third boundary (boundary 7A and 7B) are in... Figure 9As shown, but other virtual boundaries are conceivable. Navigation system 140 can be configured to define and assign virtual boundaries to each of the end effectors 240A, 240B, and 240C. The location of these virtual boundaries and / or the timing of their configuration for triggering one of the various alarms described above can be configured using alarm setting interface 151 regarding... Figure 8 Manipulate and / or adjust in the manner described.

[0163] Figure 9 The exemplary graphical user interface (GUI) 150B may also include a planning interface 166A, which includes a plurality of planning buttons 168A, 168B that a surgeon can manipulate to modify or adaptively adjust the placement of implants 275A, 275B. For example, the planning interface 166A may include a diameter button that can be manipulated by a surgeon to modify the diameter of the planning screw. The planning interface 166A may also include a length button that can be manipulated by a surgeon to modify the length of the planning screws 275A, 275B. The planning interface 166A may also allow a user to reposition the planning screws 275A, 275B by changing the position and / or orientation of the planning screws 275A, 275B relative to the patient model.

[0164] Figure 9 The planning interface 166A of the graphical user interface (GUI) 150B may also include an alarm button 170. As described above, the alarm button 170 can be configured to activate, modify, and / or disable one or more of the various alarms mentioned above. The graphical user interface (GUI) 150B can be configured such that the surgeon can open the corresponding alarm by selecting the alarm button 170. Figure 8 The interface described herein is similar to the boundary setting interface 160C. The boundary setting interface 160C may include additional buttons and / or prompts that can be manipulated by the surgeon to modify or adjust the virtual boundary and / or alarm zone configured to trigger one or more alarms.

[0165] refer to Figure 10 The illustration shows an exemplary boundary settings interface 160C that a surgeon can view when selecting the alarm button 170. For example, the user can view it from... Figure 9 In the graphical user interface (GUI) 150B, selecting the alarm button 170 of the planning interface 166A can cause the GUI 150B to open the boundary setting interface 160C for viewing on the navigation display 120. The boundary setting interface 160C may include an alarm button 156D, which is configured to allow the surgeon to activate or deactivate various alarms. The boundary setting interface 160C may also include one or more buttons 162C, 162D, 162E, similar to those described above. Figure 8The boundary setting interfaces 160A and 160B describe those. For example, boundary setting interface 160C may include three boundary manipulation buttons 162C, 162D, and 162E for each of the end effectors 240A, 240B, and 240C. As described above, manipulation of buttons 162C, 162D, and 162E can modify or manipulate the timing of alarm triggering for each of the end effectors 240A, 240B, and 240C. This allows surgeons to create customized surgical plans by modifying navigation system 100. Based on the values ​​entered by the surgeon using buttons 162C, 162D, and 162E, the positioning of each virtual boundary is updated within the surgical plan, which is used by the navigation system to trigger alarms during the procedure based on the position of each end effector 240A, 240B, and 240C relative to one or more virtual boundaries.

[0166] The graphical user interface (GUI) 150B may even include horizontal labels 174 displayed on the display 120 of the navigation system 100. The horizontal labels 174 can be configured to identify anatomical features or key structures. For example, as Figure 9 and 10 As shown, horizontal label 174 is configured to identify the third lumbar vertebra (L3). Horizontal label 174 can be used to identify any number of anatomical structures and / or regions of the patient. Alternatively, horizontal label 174 can be used to identify a specific posture, orientation, or view of the anatomical structure being displayed. Horizontal label 174 can be automatically assigned by the navigation system based on patient data. Alternatively, horizontal label 174 can be selected by the surgeon from a populated list. For example, patient data may include an image or representation of the patient's spine, and the surgeon can select the horizontal label 174 to be assigned to each vertebra. In yet another configuration, navigation system 100 can be configured to allow the surgeon to input horizontal label 174 using user input device 130 or graphical user interface (GUI) 150.

[0167] refer to Figures 11A to 11C The illustration shows an alternative exemplary graphical user interface (GUI) 150C as displayed on the display 120 of the navigation system 100. The GUI 150C can be configured to display multiple views of anatomical features, including virtual boundaries (boundaries 1, 2, 8, 9) and / or alert areas (area 1) shown relative to the anatomical features of the resection in a known coordinate system. Reference Figure 11A The graphical user interface (GUI) 150C displays a top view of the vertebrae, including virtual boundaries (boundaries 1, 2, 8, 9) and / or alert areas (area 1) associated with key anatomical structures. Similar to the graphical user interface (GUI) 150 described above, Figure 11AThe graphical user interface (GUI) 150C shown includes a planning interface 166B, which includes one or more buttons, such as alarm buttons 156D configured to activate and / or deactivate one or more of the alarms. The planning interface 166B may also include a planning button 168C, which is configured to allow the surgeon to manipulate the alarms and / or to trigger virtual boundaries (boundaries 1, 2, 8, 9) of one or more of the alarms. For example, the planning button 168C of the planning interface 166B may be configured to allow the user to increase or decrease the depth of one or more alarm areas in each alarm area by manipulating the distance between one or more virtual boundaries (boundaries 1, 2) that define at least a portion of the alarm area (area 1).

[0168] The graphical user interface (GUI) 150C may also include an alarm indicator 172, which is positioned within the display of anatomical features in relation to each virtual boundary (boundary 1, 2, 8, 9) and / or alarm area (area 1). The alarm indicator 172 may be positioned near a specific virtual boundary (boundary 1, 2, 8, 9) and / or alarm area (area 1) and is configured to identify to the surgeon whether an alarm assigned to the boundary (boundary 1, 2, 8, 9) and / or alarm area (area 1) near the alarm button is activated, deactivated, and / or dormant. For example, the alarm indicator 172 near the fourth boundary (boundary 4) displays a bell with a line passing through it. The navigation system 140 may be configured such that this symbol indicates that the alarm at the fourth boundary (boundary 4) is deactivated. Alternatively, the alarm indicators 172 near the first and second boundaries (boundaries 1, 2) display a bell without a line passing through it. The navigation system 140 can be configured such that the alarm indicator 172 indicates that alarms for the first and second boundaries (boundaries 1, 2) are activated. The alarm indicator 172 can also be selected and / or manipulated by the surgeon to activate or deactivate alarms assigned to specific virtual boundaries (boundaries 1, 2, 8, 9) and / or alarm zones (zone 1). For example, the alarm indicator 172 near the fourth boundary (boundary 4) can be configured such that manipulation of the alarm indicator 172 by the surgeon can result in activation or deactivation of the alarm at the fourth boundary (boundary 4).

[0169] refer to Figure 11B The side view of the vertebrae is displayed in the graphical user interface (GUI) 150C, including the positioning of each virtual boundary (boundary 1, 2, 8, 9). Although not shown in... Figure 11B The text appears to be incomplete and contains several grammatical errors and inconsistencies. A proper translation is not possible without the full Figure 11BThe graphical user interface (GUI) 150 may also include a planning interface 166, which includes one or more buttons 168 configured to allow the surgeon to manipulate various alarms and / or manipulate the locations of virtual boundaries (boundaries 1, 2, 8, 9) and / or alarm areas (area 1) that can be defined to trigger various alarms. The GUI 150C may also include an alarm indicator 172, which is positioned within the display of anatomical features in relation to the virtual boundaries (boundaries 1, 2, 8, 9) and / or alarm areas (area 1). The alarm indicator 172 may be positioned near a specific virtual boundary (boundary 1, 2, 8, 9) and / or alarm area (area 1) and can be manipulated by the surgeon to activate, deactivate, and / or suspend alarms assigned to that specific virtual boundary (boundary 1, 2, 8, 9) and / or alarm area (area 1). For example, the alarm button near the fourth boundary (boundary 4) can be configured such that manipulation of the alarm indicator 172 by the surgeon can cause the alarm for the fourth boundary (boundary 4) to be activated or deactivated. As described above, the alarm indicator 172 can also be configured to identify to the surgeon whether the alarms assigned to the boundaries (boundaries 1, 2, 8, 9) and / or alarm areas (area 1) near the alarm indicator 172 are activated or deactivated.

[0170] The graphical user interface (GUI) 150C may also include one or more labels 174A, 174B that identify anatomical structures displayed on the GUI 150C. For example... Figure 11B As shown, two labels 174A and 174B are displayed on a graphical user interface (GUI) 150C. The first label 174A identifies the primary anatomical structure, and the second label 174B identifies adjacent anatomical structures. The GUI 150C can be configured to allow a user to manipulate the GUI 150C to navigate between primary and adjacent anatomical structures. For example, a surgeon can select the first label 174A, identifying anatomical structures near the first label 174A as primary anatomical structures. The GUI 150C can be configured to display the primary anatomical structure at the center of the display 120. Alternatively, the surgeon can select the second label 174B, and the GUI 150C can be configured to identify anatomical structures near the second label 174B as primary anatomical structures and to center the anatomical structures near the second label 174B on the display 120. Although in Figure 11B Only two labels are displayed, but the graphical user interface (GUI) 150C can be configured to include any number of labels 174.

[0171] refer to Figure 11CA perspective view of the vertebrae is displayed in the graphical user interface (GUI) 150C, including the location of each virtual boundary (boundary 1, 2, 8, 9) and / or alarm area (area 1). Although not in Figure 11C The text appears to be incomplete and contains several grammatical errors and inconsistencies. A proper translation is not possible without the full Figure 11C The graphical user interface (GUI) 150 may also include a planning interface 166 containing one or more buttons 168 configured to allow the surgeon to manipulate various alarms and / or manipulate the positions of virtual boundaries (boundaries 1, 2, 8, 9) and / or alarm areas (area 1) that can be defined to trigger various alarms. The GUI 150 may also include alarm indicators 172 (not shown) positioned within a display of anatomical features in relation to the virtual boundaries (boundaries 1, 2, 8, 9) and / or alarm areas (area 1). As described above, the GUI 150 may be configured to include any number of labels 174. Figure 11C An exemplary configuration of a graphical user interface (GUI) 150C including multiple labels 174A, 174B, and 174C is illustrated. The GUI 150C can be configured to allow surgeons to navigate between anatomical structures associated with each of the labels 174A, 174B, and 174C by selecting the labels 174A, 174B, and 174C to view the anatomical structures.

[0172] refer to Figures 12A to 12C The illustration shows an alternative exemplary graphical user interface (GUI) 150D, as shown on the display 120 of the navigation system 100. The graphical user interface (GUI) 150D may include the above-described... Figures 11A to 11C The graphical user interface (GUI) 150C may include any and / or all features, buttons, and / or elements. The graphical user interface (GUI) 150D may also be compatible with the above. Figures 11A to 11C It functions and / or operates in the same or similar manner as the graphical user interface (GUI) 150C. For example... Figures 12A to 12C The graphical user interface (GUI) 150D shown may also include a view button 176. The view button 176 can be manipulated by the surgeon to switch and / or change between views of anatomical features including virtual boundaries (boundaries 1, 2, 8, 9) and / or alert areas (area 1). For example, in Figure 12A In this context, the view button 176 indicates that the graphical user interface (GUI) 150D is displaying an axial view of the anatomical features. Alternatively, the surgeon can utilize the view button 176 to cause the GUI 150D to display different views of the anatomical features and associated virtual boundaries (boundaries 1, 2, 8, 9) and / or alert areas (area 1). For example, refer to... Figure 12BThe view button 176 indicates that the graphical user interface (GUI) 150D is displaying a sagittal view of the anatomical features. (Reference) Figure 12C The view button 176 indicates that the graphical user interface (GUI) 150D is displaying a planar map of anatomical features.

[0173] It is also envisioned that the graphical user interface (GUI) 150D may include a zoom button 178, which is configured to allow the surgeon to manipulate the image on the display 120 of the navigation system 100 by zooming in and / or out. An exemplary configuration of the zoom button 178 of the graphical user interface (GUI) 150D is shown in... Figure 12A and 12B As shown in the diagram. The zoom button 178 can be included in any graphical user interface (GUI) described herein.

[0174] refer to Figure 13A and 13B The illustration shows an exemplary graphical user interface (GUI) 150E on the display 120 of the navigation system 100 during the navigation of surgical instruments 220, 320, and 420 during implantation 275. Similar to the GUI 150 described above, the GUI 150E includes labels 174 that identify anatomical structures displayed on the GUI 150E. The GUI 150E also includes a view button 176 configured to allow the surgeon to switch between views. For example, the surgeon can use the view button 176 to cause the GUI 150E to display, as shown in the image. Figure 13A The image shows a sagittal view of the anatomical structures. Alternatively, the surgeon can use the view button 176 to display the graphical user interface (GUI) 150E as shown. Figure 13B An axial view of the anatomical structure is shown. Although not shown in the figure, it is envisioned that other views of the anatomical structure could be displayed on the graphical user interface (GUI) 150E using the view button 176.

[0175] The graphical user interface (GUI) 150E can also be configured to display virtual boundaries (boundaries 5, 6, 7, 8) and / or alarm areas defined using the navigation system 100. As described above, during the navigation of surgical instruments 220, 320, 420, the navigation system 100 can be configured to send signals or commands to instrument processors 215, 315, 415 to trigger one of the aforementioned alarms based on the position of the end effectors 240, 340, 440 relative to one of the virtual boundaries (boundaries 5, 6, 7, 8) and / or alarm areas. Figure 13A and 13B As shown, based on the surgeon's Figure 8The alarm interface 151 described herein allows selection and / or input of information, and multiple virtual boundaries (boundaries 5, 6, 7, 8) and / or alarm areas (area 4) are displayed within a known coordinate system. The virtual boundaries (boundaries 5, 6, 7, 8) and / or alarm areas (area 4) are configured to trigger alarms. For example... Figure 13A and 13B As shown, the virtual boundaries (boundaries 5, 6, 7) can correspond to the desired depth of insertion for the end effector corresponding to each of the virtual boundaries (boundaries 5, 6, 7). The navigation system 100 can be configured to send signals or commands to the instrument processors 215, 315, 415 to trigger alarms based on the position of the end effectors 240, 340, 440 relative to the respective virtual boundaries (boundaries 5, 6, 7), as part of assisting the surgeon in navigating the surgical instruments 220, 320, 420 to place the implant 275 or device.

[0176] The graphical user interface (GUI) 150E can also be configured to display the planned orientation 280 of the implant 275 or the device. For example, as Figure 13A and 13B As shown, the graphical user interface (GUI) 150E can display and outline the planned orientation 280 of the implant in a known coordinate system to help the surgeon navigate surgical instruments 220, 320, 420 to place the implant 275 or device. Figure 13A and 13B As can be seen, the graphical user interface (GUI) 150E can display the end effector 240C driving the implant 275 into place relative to the planned pose 280 and the virtual boundaries (boundaries 5, 6, 7).

[0177] The graphical user interface (GUI) 150E may also include other user interface buttons 180, 182. User interface button 180 may be configured to lock or unlock the screen. For example, a surgeon may manipulate user interface button 180 to lock the screen, preventing changes from additional and / or unintentional touches on the GUI 150E. Alternatively, user interface button 182 may be configured to take screenshots and / or capture images currently displayed on the GUI 150E. For example, a surgeon may manipulate user interface button 182 to capture images displayed on the GUI 150E during navigation of surgical instruments 220, 320, 420 during procedure execution. User interface button 182 may also be configured to activate and / or deactivate video recording of images displayed on the GUI 150E. For example, a surgeon may manipulate user interface button 182 to start and stop video recording of images displayed on the GUI 150E during navigation of surgical instruments 220, 320, 420 during procedure execution.

[0178] Although not shown in the figures, during the navigation of surgical instruments 220, 320, 420, when one of various alarms is triggered based on the position of end effectors 240, 340, 440 relative to one or more virtual boundaries and / or alarm zones, the graphical user interface (GUI) 150 can be configured to provide or display a sleep button, allowing the user to sleep and / or temporarily deactivate the triggered alarm. The GUI 150 can be configured such that manipulation of the sleep button temporarily disables one or more of the alarms as described above. For example, when the sleep button is manipulated, the triggered alarm can be temporarily deactivated for a defined period of time, such as two seconds. After the defined period of time has elapsed, the alarm can be reactivated and triggered if necessary based on the position of the end effectors 240, 340, 440 relative to one or more virtual boundaries and / or alarm zones. As described above, it is also envisioned that manipulation of the sleep button can temporarily deactivate the triggered alarm until the end effectors 240, 340, 440 have moved a defined distance further away from one or more virtual boundaries and / or alarm zones. Alarms can be reactivated when the end effectors 240, 340, and 440 move a defined distance relative to one or more of the virtual boundaries and / or alarm zones. Alarms may be triggered depending on the direction of movement of the handpieces 225, 325, and 425 determined by the navigation system 140 and the position of the end effectors 240, 340, and 440 relative to one or more of the virtual boundaries and / or alarm zones. Various scenarios for triggering, silencing, and / or reactivating various alarms are described in more detail above.

[0179] The following is an example of how the hibernation function works:

[0180]

[0181] Note: Enabled and disabled alarm devices may not be muted - limit volume range.

[0182] Unless condition 1 or 2 above is met, double-clicking the trigger or foot switch will indeed affect the operation of the surgical instrument.

[0183] Methods for navigating surgical instruments:

[0184] Methods of navigating surgical instruments using a navigation system may include defining virtual boundaries (boundaries 5, 6, 7) and / or alert regions, such as regions 1, 2, 3, 4, within preoperative and / or intraoperative data of patient 20, which is provided as described above by imaging system 500 or by other similar means of imaging surgical site 30 of patient 20. The method may also include identifying the virtual boundaries (boundaries 5, 6, 7) and / or alert regions (regions 1, 2, 3, 4) and / or registering them to the patient. For example, this can be achieved by using user input device 130 of surgical navigation system 100 to identify and / or mark the virtual boundaries (boundaries 5, 6, 7) and / or alert regions (regions 1, 2, 3, 4) within the preoperative and / or intraoperative data. Defining virtual boundaries (boundaries 5, 6, 7) and / or alert regions (regions 1, 2, 3, 4) may include marking boundaries around critical anatomical structures (e.g., nerves) that the surgeon wishes to avoid during the medical procedure. It is also envisioned that each virtual boundary (boundary 5, 6, 7) can be identified by the surgical navigation system using a segmentation algorithm and / or a boundary generator. The virtual boundaries (boundary 5, 6, 7) can be user-selectable and / or user-modifiable. Multiple regions can be established, such as a first alert region (region 1) to inform surgeons that they are approaching a critical anatomical structure. The first alert region (region 1) can be at least partially defined by first and second virtual boundaries (boundary 1, 2), wherein the first and second boundaries are spaced apart by a user-selectable distance and / or depth, and the space defined between the first and second boundaries represents the alert region (region 1). A second alert region (region 2) can be defined within the first alert region (region 1), wherein the second alert region (region 2) is designed to inform surgeons that they are approaching a critical anatomical structure. A third alert region (region 3) can be defined within the first alert region (region 1) and the second alert region (region 2), wherein the third alert region (region 3) is a critical anatomical structure and is designed to inform surgeons that they are at the peripheral boundary and are about to damage the critical anatomical structure. The fourth alarm zone (zone 4) may be defined at the lateral boundary of the vertebra opposite the vertebral surface where the end effectors 240, 340, 440 initially enter the vertebra. Each of the alarm zones may be defined at least partially as an area or space defined between two or more virtual boundaries. The fourth alarm zone (zone 4) may notify the surgeon when the end effectors 240, 340, 440 approach the lateral boundary of the vertebra and are in danger of breaching the lateral boundary. This step may also include defining a planned surgical path, such as defining a target trajectory Axis-T and / or a target site T. The target trajectory Axis-T may include a preferred trajectory and / or posture to align and reach the target site T with the surgical instruments 220, 320, 420.A target trajectory Axis-T can be established based on a combination of factors, including but not limited to: avoiding critical anatomical structures, the type of medical procedure being performed, the type of implant being inserted, and the desired placement and / or orientation of the implant. For example, a target axis Axis-T can be established based on the preferred angle and / or location for inserting pedicle screws to attach the support member to the spine.

[0185] The method may also include tracking the position of surgical instruments 220, 320, 420 using the position and orientation of instrument tracking devices 230, 330, 430 relative to the patient 20 and / or surgical site 30. This can be achieved using a surgical navigation system 100. The instrument tracking devices 230, 330, 430 of the surgical instruments 220, 320, 420 can be registered to the surgical navigation system 100. Then, using the tracking unit 110, the surgical navigation system 100 can track the position, orientation, and / or attitude of the surgical instruments 220, 320, 420 during the execution of a medical procedure.

[0186] The method may also include manipulating the speeds of the variable-speed motors 245, 345, and 445 of the surgical instruments 220, 320, and 420 between maximum and minimum cutting speeds based on the position of the surgical instruments 220, 320, and 420 relative to defined virtual boundaries (boundaries 4, 5, 6, 7) and / or alarm zones (zones 1, 2, 3). For example, the surgical navigation system 100 may be configured to communicate to the instrument processors 215, 315, and 415 of the surgical instruments 220, 320, and 420 that the surgical instruments 220, 320, and 420 are adjacent to and / or distal to the virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7) and / or have entered a first alarm zone (zone 1), and command the instrument processors 215, 315, and 415 to reduce the speeds of the motors 245, 345, and 445 from the maximum cutting speed to the minimum cutting speed to notify the surgeon that the surgical instruments 220, 320, and 420 have entered the first alarm zone (zone 1). The surgical navigation system 100 can also be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the end effectors 240, 340, 440 of the surgical instruments 220, 320, 420 are about to cross the third alarm zone (zone 3) and command the instrument processors 215, 315, 415 to reduce the speed of the motors 245, 345, 445 and / or disable the motors 245, 345, 445, in order to notify the surgeon that the surgical instruments 220, 320, 420 are about to cross the third alarm zone (zone 3) and prevent the surgical instruments 220, 320, 420 from contacting and / or damaging critical anatomical structures. When surgical instruments 220, 320, and 420 enter one of the alarm zones (zones 1, 2, and 3) defined by the surgeon, reducing the speed of variable-speed motors 245, 345, and 445 from maximum to minimum cutting speed can produce an audibly perceptible change in pitch generated by the variable-speed motors 245, 345, and 445. This notifies the surgeon that surgical instruments 220, 320, and 420 are adjacent to and / or distal to virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, and 7) and / or have entered one of the alarm zones (zones 1, 2, and 3), without impairing the ability of surgical instruments 220, 320, and 420 to continue cutting biological tissue. Maintaining the minimum cutting speed prevents the end effectors 240, 340, and 440 of surgical instruments 220, 320, and 420 from grabbing or biting and ejecting them in an undesirable direction, potentially damaging critical anatomical structures within the patient 20.

[0187] The step of manipulating the speeds of the variable-speed motors 245, 345, and 445 of the surgical instruments 220, 320, and 420 between the maximum and minimum cutting speeds based on the positions of the surgical instruments 220, 320, and 420 may further include manipulating the speeds of the variable-speed motors 245, 345, and 445 of the surgical instruments 220, 320, and 420 between the maximum and minimum cutting speeds based on the surgical instruments 220, 320, and 420 relative to a defined target trajectory Axis-T and / or target location T. For example, the surgical navigation system 100 can be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the surgical instruments are misaligned with the target trajectory Axis-T at 220, 320, 420, and to command the instrument processors 215, 315, 415 to reduce the speed of the motors 245, 345, 445 from the maximum cutting speed to the minimum cutting speed, so as to notify the surgeon that the surgical instruments 220, 320, 420 are misaligned. The surgical navigation system 100 can also be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the end effectors 240, 340, 440 of the surgical instruments 220, 320, 420 have reached the target site T, and to command the instrument processors 215, 315, 415 to reduce the speed of the motors 245, 345, 445 and / or disable the motors 245, 345, 445, in order to notify the surgeon that the surgical instruments 220, 320, 420 have reached the target site T.

[0188] The method may also include activating alarm devices 255, 355, 455 to generate at least one of auditory, tactile, or visual notifications based on the position of surgical instruments 220, 320, 420 relative to defined virtual boundaries (boundaries 1, 2, 3) and / or alarm areas (areas 1, 2, 3). For example, the surgical navigation system 100 can be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the surgical instruments 220, 320, 420 are adjacent to and / or distal to a first virtual boundary (boundary 1) and / or have entered a first alarm zone (zone 1), and to command the instrument processors 215, 315, 415 to activate alarm devices 255, 355, 455 to generate at least one of auditory, tactile, or visual notifications to the surgeon that the surgical instruments 220, 320, 420 are adjacent to and / or distal to the first virtual boundary (boundary 1) and / or have entered the first alarm zone (zone 1). Combinations of alarm devices 255, 355, 455 and various types of notifications are also envisioned. For example, the surgical navigation system 100 may be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the surgical instruments 220, 320, 420 are adjacent to and / or at a distance from a first virtual boundary (boundary 1) and / or have entered a first alarm zone (zone 1), and to command the instrument processors 215, 315, 415 to activate alarm devices 255, 355, 455 to generate an auditory notification to the surgeon that the surgical instruments 220, 320, 420 are adjacent to and / or at a distance from the first virtual boundary (boundary 1) and / or have entered the first alarm zone (zone 1). Then, the surgical navigation system 100 can be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the surgical instruments 220, 320, 420 are adjacent to and / or at the distance of the second virtual boundary (boundary 2) and / or have entered the second alarm zone (zone 2), and to command the instrument processors 215, 315, 415 to activate the alarm devices 255, 355, 455 to generate a tactile notification to the surgeon that the surgical instruments 220, 320, 420 are adjacent to and / or at the distance of the second virtual boundary (boundary 2) and / or have entered the second alarm zone (zone 2).The surgical navigation system 100 can also be configured to communicate to the instrument processors 215, 315, 415 of the surgical instruments 220, 320, 420 that the end effectors 240, 340, 440 of the surgical instruments 220, 320, 420 are adjacent to and / or distal to a third virtual boundary (boundary 3) and / or about to cross a third alarm zone (zone 3), and instruct the instrument processors 215, 315, 415 to reduce the speed of motors 245, 345, 445 and / or disable motors 245, 345, 445 to notify the surgeon that the surgical instruments 220, 320, 420 are adjacent to and / or distal to the third virtual boundary (boundary 3) and / or about to cross the third alarm zone (zone 3), and to prevent the surgical instruments 220, 320, 420 from contacting and / or damaging critical anatomical structures. This is merely an exemplary configuration of various alarm combinations that the surgical system 10 may generate during the execution of medical procedures. It is envisioned that alarms of any type and / or combination can be assigned to virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) and / or alarm areas, target trajectories, and / or target sites. These alarms can be assigned by the surgeon when defining the alarm areas, target trajectories, and / or target sites within preoperative and / or intraoperative data using the surgical navigation system 100.

[0189] Alternative methods for using the surgical navigation system 100 to navigate surgical instruments 220, 320, 420 during medical procedures on a patient may include surgical instruments 220, 320, 420 including handheld components 225, 325, 425, and end effectors 240, 340, 440 coupled to the handheld components 225, 325, 425. The surgical instruments 220, 320, 420 may include variable-speed motors 245, 345, 445 for selectively actuating the end effectors 240, 340, 440, and processors 215, 315, 415 for controlling the energization of the variable-speed motors 245, 345, 445. The method may include selecting a medical implant 275, such as a pedicle screw. The method may also include identifying the site on the patient 20 where the medical implant 275 will be placed, from patient data stored on the surgical navigation system 100. For example, medical personnel can use user input device 130, such as a keyboard, touchscreen, or similar device, to select the site or portion of the patient 20 where the implant 275 will be placed, such as the vertebra. The surgical navigation system 100 can then be configured to define virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) based on the selected medical implant 275 and the identified site where the medical implant 275 will be placed. Alternatively, it is also envisioned that the surgical navigation system 100 can be configured to identify the type of end effector 240, 240, 440 of the handpieces 225, 325, 425 attached to the surgical instruments 220, 320, 420, and define one or more virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) based on the type of end effector 240, 340, 440 and / or the location of the procedure. For example, in a drilling procedure, the surgical navigation system can be configured to define a first boundary corresponding to the drill, a second boundary corresponding to the tap, and a third boundary corresponding to the actuator for placing the implant 275, each of these virtual boundaries being defined along the target trajectory Axis-T based on the planned orientation of the implant 275.

[0190] The method may also include the step of using a surgical navigation system 100 to track the position of surgical instruments 220, 320, 420. This may include using machine vision and / or using instrument trackers 230, 330, 430 coupled to the surgical instruments 220, 320, 420. When the surgical navigation system 100 determines that the surgical instruments 220, 320, 420 have entered any defined virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) and / or alarm zones (i.e., zones 1-8B), the surgical navigation system 100 may be configured to signal to processors 215, 265, 315, 415 to deactivate variable speed motors 245, 345, 445. For example, the surgical navigation system 100 may be configured to signal to the battery processor 265 of the first surgical instrument 220, wherein the battery processor 265 communicates with the first instrument processor 215. The battery processor 265 and / or instrument processor 215 can be configured to prevent current from flowing from a power source such as the battery 260 to the variable speed motor 245. This can be achieved using wired or wireless communication between the surgical navigation system 100 and the surgical instruments 220, 320, 420.

[0191] The method may also include steps of manipulating virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) and / or alert regions defined by the surgical navigation system based on the preferences of the medical personnel. For example, the medical personnel may increase the size and / or thickness of the alert regions to provide earlier warnings of surgical instruments 220, 320, 420 approaching boundaries or critical anatomical structures. The medical personnel may also reposition alert regions within patient data. This may include modifying the size, shape, and / or number of alert regions defined in the patient data. The medical personnel may similarly manipulate the axial position and / or depth of these virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) along the target trajectory Axis-T to provide end-effector-specific warnings. The axial position and / or depth of the virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) along the target trajectory Axis-T may also be manipulated based on the planned posture of implant 275 to provide earlier warnings of surgical instruments 220, 320, 420 approaching boundaries or target depths. Healthcare professionals can also reposition virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) within patient data. This can include modifying the location, depth, shape, and / or number of virtual boundaries (boundaries 1, 2, 3, 4, 5, 6, 7, 8, 9) defined within patient data.

[0192] The surgical instrument assemblies 200, 300, and 400 include a plurality of end effectors 240, 340, and 440 detachably coupled to handpieces 225, 325, and 425. The method may further include the step of coupling first end effectors 240A and 340A to handpieces 225 and 325. The surgical navigation system 100 may be configured to identify the first end effectors 240A and 340A and define a first boundary and / or a first alarm region based at least in part on the first end effectors. The first boundary may include the target depth of the first end effectors 240A and 340A. The method may further include the step of coupling second end effectors 240B and 340B to handpieces 225 and 325. The surgical navigation system 100 may be configured to identify the second end effectors 240B and 340B and define a second boundary and / or a second alarm region based at least in part on the second end effectors 240B and 340B. The second boundary may include the target depth of the second end effectors 240B and 340B, which may be different from the first boundary defined based on the first end effectors 240A and 340A.

[0193] The method may further include activating alarm devices 255, 355, 455 when the surgical navigation system 100 determines that surgical instruments 220, 320, 420 have entered one of the defined alarm zones. This may include activating auditory or tactile alarm devices. It may also include deactivating the variable-speed motors 245, 345, 445 of the surgical instruments 220, 320, 420. It may further include reducing the speed of the variable-speed motors 245, 345, 445 from a maximum cutting speed to a minimum cutting speed. This change in speed may generate tactile and auditory alarms that can be perceived by medical personnel.

[0194] The method may further include the step of assigning alarm types to each defined virtual boundary and / or alarm zone. The surgical navigation system 100 may be configured to automatically assign one or more different types of alarms to each defined virtual boundary and / or alarm zone based on previously saved medical personnel profiles or system configurations. Alternatively, medical personnel may use user input device 130 to assign one or more different alarm types to each of the defined virtual boundaries and / or alarm zones.

[0195] The method may further include identifying first end effectors 240A, 340A coupled to handpieces 225, 325, and the surgical navigation system 100 may be configured to define a first boundary and / or a first alarm region based at least in part on the first end effectors 240A, 340A. The method may then include disengaging the first end effectors 240A, 340A from handpieces 225, 325 and coupling second end effectors 240B, 340B to handpieces 225, 325, and the surgical navigation system 100 may be configured to identify the second end effectors 240B, 340B and define a second boundary and / or a second alarm region based at least in part on the second end effectors 240B, 340B.

[0196] The method may further include the step of identifying first end effectors 240A, 340A coupled to handheld devices 225, 325, and the surgical navigation system 100 may be configured to define a first boundary and / or a first alarm zone based at least in part on the first end effectors 240A, 340A. The method may then include applying the first end effectors 240A, 340A to the site in which a medical implant will be placed in the biological tissue. When the surgical navigation system 100 determines that surgical instruments 220, 320, 420 are adjacent to and / or distal to the first boundary and / or have entered the first alarm zone, the surgical navigation system 100 may be configured to send a signal to processors 215, 265, 315, 415 to deactivate variable speed motors 245, 345, 445. It is also envisioned that the surgical navigation system 100 may be configured to send a signal to activate one of the aforementioned alarm devices to generate one of the various types of alarms described above. The method may then include disengaging the first end effectors 240A, 340A from the handpieces 225, 325, 425 and coupling the second end effectors 240B, 340B to the handpieces 225, 325, 425. The surgical navigation system 100 may be configured to identify the second end effectors 240B, 340B and define a second boundary and / or a second alarm zone based at least in part on the second end effectors 240B, 340B. The method may also include applying the second end effectors 240B, 340B to the site in which a medical implant will be placed in the biological tissue. When the surgical navigation system 100 determines that the surgical instruments 220, 320, 420 are adjacent to and / or distal to the second boundary and / or have entered the second alarm zone, the surgical navigation system 100 may be configured to send a signal to the processor to deactivate the variable speed motor. It is also contemplated that the surgical navigation system 100 may be configured to send a signal to activate one of the aforementioned alarm devices to generate one of the various types of alarms described above.

[0197] In another configuration, the navigation system is configured to transmit a first signal to the console's processor based on the position of the end effector relative to the alarm zone. This signal allows the console to compare the sensed velocity with the desired velocity of the handpiece based on a torque map. Using the torque map, the console can determine the calculated torque of the cutting tool based on the sensed velocity of the cutting tool. Then, based on the calculated torque of the cutting tool and the sensed velocity of the cutting tool, the console can determine the calculated power consumed by the cutting tool. The torque map also provides the desired power consumed by the cutting tool, as well as the desired torque and desired velocity of the cutting tool at the desired power consumed. The navigation system can be configured to cause the console to adjust the torque map based on the end effector entering the alarm zone. More specifically, once the end effector is adjacent to and / or far from the virtual boundary and / or enters the alarm zone, the console can provide power to the grinding head with reduced torque, causing the end effector to cut less efficiently and / or less aggressively when the end effector is adjacent to and / or far from the virtual boundary and / or within the alarm zone.

[0198] Technical solutions covering other configurations of the above system:

[0199] I. A surgical instrument assembly for use with a navigation system configured to allow medical personnel to define alarm zones on a patient to assist in spinal or craniocerebral surgery, the surgical instrument assembly comprising:

[0200] The control console includes a control processor that communicates with the navigation system;

[0201] A high-speed surgical abrasive head includes a variable-speed motor in communication with the control processor, the variable-speed motor being configured to rotate the abrasive head at a first cutting speed greater than 70,000 revolutions per minute and a second cutting speed less than 70,000 revolutions per minute but greater than 60,000 revolutions per minute; and

[0202] A foot switch is used to control the operation of the variable speed motor of the high-speed surgical grinding head and communicates with the control processor;

[0203] The navigation system is configured to actively determine the position of the high-speed surgical grinding head relative to the patient;

[0204] The navigation system is configured to send a signal to the control processor when it determines that the high-speed surgical abrasive head has entered the alarm zone, thereby manipulating the variable-speed motor of the high-speed surgical abrasive head to change the rotation of the abrasive head from the first cutting speed to the second cutting speed; and

[0205] Specifically, when the high-speed surgical abrasive head changes from the first cutting speed to the second cutting speed, the change in the cutting speed causes an audibly perceptible change in the pitch generated by the high-speed surgical abrasive head, informing medical personnel that the high-speed surgical abrasive head has entered the alarm zone, without impairing the abrasive head's ability to continue cutting biological tissue.

[0206] II. The surgical instrument assembly according to technical solution I, wherein, when the grinding head changes from the first cutting speed to the second cutting speed, the change in the grinding head from the first cutting speed to the second cutting speed causes a tactilely perceptible change in the high-speed surgical grinding head to notify medical personnel that the high-speed surgical grinding head has entered the alarm zone, without impairing the ability of the grinding head to continue cutting biological tissue.

[0207] III. The surgical instrument assembly according to technical solution I, wherein the foot switch is movable between a first position and a second position; and

[0208] The variable speed motor is configured to be deactivated when the foot switch is in the first position, and the variable speed motor is configured to rotate the grinding head at a speed of at least 60,000 revolutions per minute when in the second position.

[0209] IV. The surgical instrument assembly according to technical solution I further includes an auditory alarm device configured to emit an alarm sound when the high-speed surgical grinding head enters the alarm area.

[0210] V. The surgical instrument assembly according to technical solution I further includes a tactile alarm device that comes into contact with medical personnel, the tactile alarm device being configured to issue a physical alarm that can be perceived by medical personnel when the high-speed surgical grinding head enters the alarm area.

[0211] VI. The surgical instrument assembly according to technical solution V, wherein the tactile alarm device is connected to the foot switch such that the physical alarm will be sensed in the accessory of a medical personnel in contact with the foot switch to control the operation of the variable speed motor of the high-speed surgical grinding head.

[0212] VII. The surgical instrument assembly according to technical solution V, wherein the alarm zone includes a first zone and a second zone; and

[0213] The tactile device is configured to generate a first notification when the high-speed surgical abrasive head enters the first region, and a second notification when the high-speed surgical abrasive head enters the second region.

[0214] VIII. The surgical instrument assembly according to technical solution I further includes an auditory alarm device and a tactile alarm device that come into contact with medical personnel, each of the auditory alarm device and the tactile alarm device being able to generate an alarm perceived by medical personnel when the high-speed surgical grinding head enters the alarm area.

[0215] IX. The surgical instrument assembly according to technical solution I further includes at least one of an auditory alarm device capable of generating a first notification and a tactile alarm device capable of generating a second notification;

[0216] The alarm zone includes a user-definable first zone and a user-definable second zone;

[0217] The navigation system can be configured to allow a user to assign one of the first notification or the second notification to either the first region or the second region; and

[0218] The navigation system can be configured to manipulate one of the auditory alarm device and the tactile alarm device based on the position of the high-speed surgical grinding head and the first or second notification assigned to one of the first or second regions.

[0219] X. A surgical system for use by medical personnel during spinal or craniocerebral surgery on a patient, said surgical system comprising:

[0220] Including the console that controls the processor;

[0221] A high-speed surgical grinding head includes a variable-speed motor in communication with the control processor, the variable-speed motor being configured to rotate the grinding head at a first cutting speed greater than 70,000 revolutions per minute and a second cutting speed between 60,000 revolutions per minute and 65,000 revolutions per minute.

[0222] A foot switch is used to control the operation of the variable speed motor of the high-speed surgical grinding head and communicates with the control processor;

[0223] A navigation system communicating with the console is configured to allow medical personnel to define alarm zones on the patient and actively determine the position of the high-speed surgical burr relative to the patient, transmitting the position to the control processor; and

[0224] The navigation system is configured to transmit signals to a control processor to manipulate the variable-speed motor of the high-speed surgical grinding head so as to change the rotation of the grinding head from the first cutting speed to the second cutting speed when the navigation system determines that the grinding head of the high-speed surgical grinding head has entered the alarm zone.

[0225] The transition of the grinding head from the first cutting speed to the second cutting speed causes an audibly perceptible change in the pitch of the variable speed motor of the high-speed surgical grinding head, informing medical personnel that the high-speed surgical grinding head has entered the alarm zone, without impairing the grinding head's ability to continue cutting biological tissue.

[0226] XI. The surgical system according to technical solution X, wherein, when the high-speed surgical abrasive head changes from the first cutting speed to the second cutting speed, the change in the abrasive head from the first cutting speed to the second cutting speed produces a tactilely perceptible change in the high-speed surgical abrasive head to notify medical personnel that the high-speed surgical abrasive head has entered the alarm zone, without impairing the abrasive head's ability to continue cutting biological tissue.

[0227] XII. The surgical system according to technical solution XI, wherein the foot switch is movable between a first position and a second position; and

[0228] The variable speed motor is configured to be deactivated when the foot switch is in the first position, and the variable speed motor is configured to rotate the grinding head at a speed of at least 60,000 revolutions per minute when in the second position.

[0229] XIII. The surgical system according to technical solution X further includes an auditory alarm device configured to emit an alarm sound when the high-speed surgical grinding head enters the alarm area.

[0230] XIV. The surgical system according to technical solution X further includes a tactile alarm device that comes into contact with medical personnel, the tactile alarm device being configured to issue a physical warning that can be perceived by medical personnel when the high-speed surgical grinding head enters the alarm area.

[0231] XV. The surgical system according to technical solution XIV, wherein the tactile alarm device is connected to the foot switch, such that the physical alarm will be sensed in the accessory of the medical personnel in contact with the foot switch, for controlling the operation of the variable speed motor of the high-speed surgical grinding head.

[0232] XVI. The surgical system according to technical solution XIV, wherein the alarm zone includes a first zone and a second zone; and

[0233] The tactile alarm device is configured to generate a first notification when the high-speed surgical abrasive head enters the first region, and a second notification when the high-speed surgical abrasive head enters the second region.

[0234] XVII. The surgical system according to technical solution X further includes an auditory alarm device and a tactile alarm device that come into contact with medical personnel, each of the auditory alarm device and the tactile alarm device being able to generate an alarm perceived by the medical personnel when the high-speed surgical grinding head enters the alarm area.

[0235] XVIII. A surgical system for use with a surgical navigation system capable of defining alarm zones on a patient to assist medical personnel in performing spinal or neurosurgical procedures, the surgical system comprising:

[0236] A high-speed surgical grinding head, comprising a variable-speed motor configured to rotate the grinding head;

[0237] The control console includes a control processor that communicates with the variable-speed motor of the high-speed surgical grinding head and is configured to receive data from a surgical navigation system relating to a defined alarm zone and the position of the high-speed surgical grinding head relative to the defined alarm zone.

[0238] A foot switch that communicates with the control processor, the foot switch being movable between a first position and a second position, for controlling the operation of the variable speed motor of the high-speed surgical grinding head;

[0239] When the foot switch is in the first position, the variable speed motor is deactivated and the grinding head rotates at a rate of zero revolutions per minute.

[0240] When the foot switch is in the second position, the variable speed motor is configured to rotate the grinding head at the maximum cutting rate;

[0241] When the foot switch is in the intermediate position between the first position and the second position, the variable speed motor is configured to rotate the grinding head at an intermediate rate between the minimum cutting rate and the maximum cutting rate; and

[0242] The navigation system is configured to send data to the control processor indicating that the grinding head has entered an alarm zone and to manipulate the variable speed motor of the high-speed surgical grinding head to reduce the rotation of the grinding head to the minimum cutting rate when the foot switch is positioned in the intermediate position or the second position.

[0243] XIX. The surgical system according to technical solution XVIII further includes a tactile alarm device connected to the foot switch and communicating with the console; and

[0244] The console is configured to manipulate the tactile alarm device to generate a physical notification that can be perceived by medical personnel when the grinding head enters the alarm area.

[0245] XX. A surgical instrument assembly for use with a navigation system capable of defining alarm zones on a patient to assist medical personnel in performing spinal or craniocerebral surgery, the surgical instrument assembly comprising:

[0246] A high-speed surgical grinding head, comprising a variable-speed motor configured to rotate the grinding head;

[0247] A console including a control processor, the control processor communicating with the variable-speed motor of the high-speed surgical grinding head and configured to receive data from the surgical navigation system; and

[0248] A foot switch that communicates with the control processor to control the operation of the variable speed motor of the high-speed surgical grinding head, the foot switch including a tactile alarm device;

[0249] The navigation system is configured to send data to the control processor indicating that the grinding head has entered a defined alarm zone, and is configured to operate the tactile alarm device of the foot switch to notify medical personnel when the grinding head enters the alarm zone.

[0250] XXI. A method for navigating a medical device with a variable-speed motor using a navigation system, said navigation system comprising a device tracker coupled to the medical device and a patient tracker coupled to a patient, the method comprising:

[0251] Define alarm zones in the patient's preoperative data;

[0252] Register the alarm zone to the patient tracker;

[0253] The position and orientation of the device tracker relative to the patient tracker are used to track the location of the medical device; and

[0254] The speed of the variable-speed motor of the medical device is controlled between the maximum and minimum cutting speeds based on the position of the medical device relative to the defined alarm zone.

[0255] XXII. The method according to technical solution XXI, wherein manipulating the speed of the variable speed motor includes reducing the speed of the variable speed motor from the maximum cutting speed to the minimum cutting speed when the medical device enters the defined alarm zone.

[0256] XXIII. The method according to technical solution XXII, wherein when the medical device enters the defined alarm zone, the variable speed motor is decelerated from the maximum cutting speed to the minimum cutting speed to produce an audibly perceptible change in the pitch generated by the variable speed motor, so as to notify medical personnel that the medical device has entered the defined alarm zone, but without affecting the medical device's ability to continue cutting biological tissue.

[0257] XXIV. The method according to technical solution XXI further includes activating an alarm device to generate at least one of auditory, tactile, or visual notification based on the position of the medical device relative to a defined alarm area.

[0258] XXV. The method according to technical solution XXIV, wherein the defined alarm zone includes a first zone and a second zone; and

[0259] The steps for activating the alarm device include generating a tactile notification when the medical device enters the first area and generating an auditory notification when the medical device enters the second area.

[0260] XXVI. A surgical system for use by medical personnel during spinal or craniocerebral surgery on a patient, said surgical system comprising:

[0261] A handheld surgical instrument configured to drive an end effector, comprising:

[0262] Variable speed motor;

[0263] A trigger that can be manipulated by medical personnel between a first position and a second position;

[0264] A trigger sensor configured to detect the position of the trigger and output a first signal indicating the position of the trigger;

[0265] A handheld device processor communicating with the trigger sensor, the handheld device processor being configured to control the energization of the variable speed motor based at least in part on the first signal indicating the position of the trigger;

[0266] A rechargeable battery module, detachably connected to the handheld surgical instrument, the battery module comprising:

[0267] A transceiver configured to send and receive signals;

[0268] A battery processor that communicates with the transceiver, the processor being configured to provide power to the handheld surgical instrument;

[0269] A navigation system that communicates with the battery processor via the transceiver is configured to actively determine the position of the surgical instruments relative to an alarm zone defined in relation to the patient.

[0270] The navigation system is configured to send a second signal to the battery processor to cut off power to the handheld surgical instrument when the navigation system determines that the position of the surgical instrument has entered the alarm zone; and

[0271] Wherein, when the battery processor cuts off power to the handheld surgical instrument and the surgical instrument remains in the alarm area, the handheld processor is configured to prevent power to the variable speed motor until a subsequent first signal indicating that a medical professional has manipulated the position of the trigger is received from the trigger sensor.

[0272] XXVII. The surgical system according to technical solution XXVI, wherein the rechargeable battery module further comprises:

[0273] A battery unit for storing electrical energy to power the variable speed motor of the handheld surgical instrument;

[0274] A switch, which communicates with the battery processor and is configured to control the flow of electrical energy from the battery cell, the switch having an on state configured to allow electrical energy to flow from the battery cell and an off state configured to prevent electrical energy from flowing from the battery cell.

[0275] XXVIII. A surgical system for use by medical personnel when performing surgical procedures on patients, the surgical system comprising:

[0276] A handheld surgical instrument configured to drive an end effector, comprising:

[0277] Variable speed motor;

[0278] A switch that can be operated by medical personnel between a first position and a second position;

[0279] A switch sensor configured to detect the position of the switch and output a first signal indicating the position of the switch; and

[0280] A handheld processor communicating with the switch sensor, the handheld processor being configured to control the energization of the variable speed motor based at least in part on the first signal indicating the position of the switch;

[0281] A power source, which is detachably connected to the handheld surgical instrument and configured to provide power to the handheld surgical instrument;

[0282] A navigation system in communication with the handheld processor, the navigation system being configured to actively determine the position of the surgical instruments relative to an alarm zone defined in relation to the patient;

[0283] The navigation system is configured to send a second signal to the handheld processor to power off the variable-speed motor when the navigation system determines that the position of the surgical instrument has entered the alarm zone; and

[0284] Specifically, when the handheld surgical instrument is de-energized and remains in the alarm zone, the handheld device processor is configured to prevent the variable speed motor from being re-energized until a subsequent first signal indicating that a medical professional has manipulated the position of the switch is received from the switch sensor.

[0285] XXIX. The surgical system according to technical solution XXVIII further includes a rechargeable battery module detachably connected to the handheld surgical instrument, the battery module comprising:

[0286] A transceiver configured to send and receive signals;

[0287] A battery unit for storing electrical energy to power the variable speed motor of the handheld surgical instrument;

[0288] A switch configured to control the outflow of electrical energy from the battery cell, the switch having an on state configured to allow electrical energy to flow out of the battery cell and an off state configured to prevent electrical energy from flowing out of the battery cell;

[0289] A battery processor that communicates with the transceiver and the switch is configured to operate the switch between the power-on state and the power-off state, at least in part based on the signal received by the transceiver.

[0290] XXX. A surgical system for use by medical personnel during surgical procedures on patients, the surgical system comprising:

[0291] High-speed grinding head assembly, the high-speed grinding head assembly comprising:

[0292] Includes the processor's console;

[0293] A handheld device that communicates with the processor of the console, the handheld device including an end effector and a variable speed motor for driving the end effector;

[0294] A foot switch, which can be operated by medical personnel between a first position and a second position, is used to control the power supply to the variable speed motor;

[0295] A switch sensor is configured to detect the position of the foot switch and transmit a first signal indicating the position of the foot switch to the processor;

[0296] A navigation system that communicates with the processor is configured to actively determine the position of the handheld device relative to an alarm area defined in relation to the patient;

[0297] The navigation system is configured to send a second signal to the processor to cut off power to the variable speed motor when the navigation system determines that the position of the handheld device has entered the alarm zone; and

[0298] Wherein, when the handheld device is powered off and while the handheld device remains in the alarm area, the processor is configured to prevent the variable speed motor from being powered on again until a subsequent first signal indicating that a medical personnel has manipulated the foot switch at the aforementioned position is received from the switch sensor.

[0299] XXXI. The surgical system according to technical solution XXX further includes a tactile alarm device that comes into contact with medical personnel, the tactile alarm device being configured to issue a physical warning that can be perceived by medical personnel when the high-speed surgical grinding head enters the alarm area.

[0300] XXXII. The surgical system according to technical solution XXX further includes an auditory alarm device and a tactile alarm device that come into contact with medical personnel, wherein each of the auditory alarm device and the tactile alarm device is capable of generating an alarm perceived by the medical personnel when the high-speed surgical grinding head enters the alarm area.

[0301] XXXII. A surgical system for use by medical personnel during spinal or craniocerebral surgery on a patient, said surgical system comprising:

[0302] A handheld surgical instrument configured to drive an end effector, comprising:

[0303] Variable speed motor;

[0304] A trigger that can be manipulated by medical personnel between a first position and a second position;

[0305] A handheld processor configured to control the energization of the variable speed motor based at least in part on the position of the trigger;

[0306] A rechargeable battery module, detachably connected to the handheld surgical instrument, the battery module comprising:

[0307] A transceiver configured to send and receive signals;

[0308] A battery processor that communicates with the transceiver, the processor being configured to power on and off the handheld surgical instrument;

[0309] A navigation system that communicates with the battery processor via the transceiver is configured to actively determine the position of the handheld surgical instrument relative to an alarm zone defined in relation to the patient.

[0310] The navigation system is configured to send a first signal to the battery processor to temporarily power off the handheld surgical instrument when the navigation system determines that the position of the handheld surgical instrument has entered the alarm zone.

[0311] While the handheld surgical instrument is held in the alarm area and after the battery processor powers off the handheld surgical instrument; and

[0312] The battery processor re-energizes the variable-speed motor, and the navigation system is configured to transmit a second signal to the battery processor based on the movement of the handheld surgical instrument relative to the patient's surgical site in a proximal or distal direction, so that the battery processor energizes or de-energizes the handheld surgical instrument.

[0313] XXXIV. A surgical system for use by medical personnel to perform surgical procedures on patients, the surgical system comprising:

[0314] A handheld surgical instrument configured to receive an end effector, the handheld surgical instrument comprising:

[0315] A variable-speed motor configured to rotate the end effector;

[0316] A trigger that can be manipulated by medical personnel between a first position and a second position;

[0317] A trigger sensor configured to detect the position of the trigger and output a first signal indicating the position of the trigger;

[0318] A handheld processor configured to control the energization of the variable speed motor based at least in part on a first signal from the trigger sensor indicating the position of the trigger.

[0319] A navigation system, communicating with the processor, is configured to define an alarm zone on the patient and actively determine the position of the surgical instrument relative to the alarm zone, and to transmit a second signal to the handheld processor to deactivate the variable-speed motor when the trigger sensor indicates the trigger is in a second position and the navigation system determines that the handheld surgical instrument has entered the alarm zone; and

[0320] When the handheld surgical instrument is held in the alarm area, the handheld processor is configured to reactivate the variable speed motor upon receiving a subsequent first signal from the trigger sensor, the subsequent first signal indicating that the medical personnel have manipulated the trigger to move the trigger from the second position to the first position and back to the second position.

[0321] XXXV. The surgical system according to technical solution XXXIV, wherein, when the handheld surgical instrument is held in the alarm area and the variable speed motor is reactivated, the navigation system is configured to: transmit a third signal to the handheld device processor to deactivate the variable speed motor when the navigation system determines that the handheld surgical instrument has moved a defined distance proximally toward the patient's surgical site (the alarm area).

[0322] XXXVI. The surgical system according to technical solution XXXIV, wherein, when the handheld surgical instrument is held in the alarm area while the variable speed motor is reactivated, the navigation system is configured to transmit a fourth signal to the handheld device processor to maintain the activation of the variable speed motor when the navigation system determines that the handheld surgical instrument is moving distally to the surgical site (the alarm area) of the patient.

[0323] XXXVII. A surgical system for use by medical personnel during spinal or craniocerebral surgery on a patient, said surgical system comprising:

[0324] A handheld surgical instrument configured to receive an end effector, the handheld surgical instrument comprising:

[0325] Variable speed motor;

[0326] A trigger, operable by medical personnel between a first and a second position, to activate and deactivate the variable-speed motor; and

[0327] A processor configured to control the power supply to the variable speed motor;

[0328] A navigation system that communicates with the processor is configured to allow medical personnel to define target axes on the patient and instrument testing distance thresholds;

[0329] The navigation system is configured to determine the actual axis of the handheld surgical instrument relative to the target axis, and to determine the position of the handheld surgical instrument relative to the target depth, and to compare the result with an instrument test distance threshold; and

[0330] When the navigation system determines that the position of the handheld surgical instrument is closer to the target depth than the instrument test distance threshold and the actual axis of the handheld surgical instrument is not aligned with the target axis, the navigation system is configured to send a first signal to the processor to prevent the variable speed motor from being powered on.

[0331] When the navigation system determines that the position of the handheld surgical instrument is farther from the target depth than the instrument test distance threshold, the navigation system will not cause the processor to block the power supply to the variable speed motor, regardless of whether the actual axis of the handheld surgical instrument is misaligned with the target axis.

[0332] XXXVIII. The surgical system according to technical solution XXXVII, wherein when the trigger is in the second position to activate the variable speed motor, the navigation system is configured to: transmit a fifth signal to the processor to deactivate the variable speed motor when the navigation system determines that the handheld surgical instrument is positioned on the target axis and has reached the target depth.

[0333] XXXIX. A surgical system for use by medical personnel during spinal or craniocerebral surgery on a patient, said surgical system comprising:

[0334] A handheld surgical instrument configured to receive an end effector, the handheld surgical instrument comprising:

[0335] Handheld items;

[0336] A variable speed motor is installed inside the handheld device;

[0337] A trigger that can be operated by medical personnel to activate and deactivate the variable speed motor;

[0338] A switch that can be operated by medical personnel between a first position and a second position to control the speed of the variable speed motor;

[0339] A processor configured to control the power supply to the variable speed motor;

[0340] A navigation system communicating with the processor is configured to determine whether the switch is in the first position or the second position; and

[0341] The navigation system is configured to send signals to the processor to control the energization of the variable speed motor based on the switch being in the appropriate position and based on the type of the end effector coupled to the handheld surgical instrument.

[0342] XL. The surgical system according to technical solution XXXIX, wherein the navigation system is configured to: when the navigation system identifies that the switch is in an incorrect position for the type of end effector coupled to the handheld surgical instrument, transmit the signal to the processor to deactivate the variable speed motor; and

[0343] The navigation system is configured to send a signal to the processor to activate the variable speed motor when the navigation system identifies that the switch is in the correct position for the type of end effector coupled to the surgical instrument.

[0344] XLI. The surgical system according to technical solution XXXIX or XL, wherein the handheld surgical instrument further includes a tracker connected to the switch; and

[0345] The navigation system is configured to determine whether the switch is in the first position or the second position based on the position of the tracker.

[0346] XLII. The surgical system according to any one of technical solutions XXXIX-XLI, wherein the handheld surgical instrument further includes a battery module; and

[0347] The processor is located within the battery module.

[0348] XLIII. A surgical system for use by medical personnel during spinal or craniocerebral surgery on a patient, the surgical system comprising:

[0349] A handheld surgical instrument assembly, the handheld surgical instrument assembly comprising:

[0350] Handheld items;

[0351] One of a first end effector or a second end effector, each of the first end effector and the second end effector being detachably connected to the handheld device;

[0352] A variable speed motor is installed inside the handheld device;

[0353] Optional feedback device, its vibration; and

[0354] A processor configured to control the energization of the variable speed motor and / or the vibration of the feedback device;

[0355] A navigation system communicating with the processor, the navigation system being configured to define a first alarm zone on the patient based at least in part on the first end effector, and to define a second alarm zone on the patient based at least in part on the second end effector; and

[0356] When the first end effector is coupled to the handheld device, the navigation system is configured to transmit a first signal to the processor, at least in part, based on the position of the first end effector relative to the first alarm area, to control the energization of the variable speed motor or to cause the feedback device to vibrate.

[0357] When the second end effector is coupled to the handheld device, the navigation system is configured to transmit signals to the processor, at least in part, based on the position of the second end effector relative to the second alarm area, to control the energization of the variable speed motor or to cause the feedback device to vibrate.

[0358] XLIV. The surgical system according to technical solution XLIII, wherein the navigation system is configured to actively determine the position of the handheld surgical instrument relative to the alarm area and transmit the position to the processor.

[0359] XLV. The surgical system according to technical solution XLIII, wherein the navigation system is configured to send a signal to the processor to deactivate the variable speed motor when the navigation system determines that the first end effector has entered the first alarm zone or the second end effector has entered the second alarm zone.

[0360] XLVI. The surgical system according to technical solution XLIII, wherein the handheld surgical instrument further includes:

[0361] A foot switch electrically connected to the processor; and

[0362] The feedback device is connected to the foot switch.

[0363] XLVII. The surgical system according to technical solution XLIII, wherein the navigation system is configured to allow the medical personnel to input the type of the first or second end effector coupled to the handheld surgical instrument.

[0364] XLVIII. A surgical system according to any one of technical solutions XLIII-XLVII, wherein the handheld surgical instrument assembly includes a battery module; and

[0365] The optional feedback device is located within the battery module.

[0366] XLIX. A surgical system for use by medical personnel during spinal or craniocerebral surgery on patients, said surgical system comprising:

[0367] High-speed grinding head assembly, the high-speed grinding head assembly comprising:

[0368] Includes the processor's console;

[0369] A handheld device that communicates with the processor of the console;

[0370] One of a first end effector or a second end effector, each of the first end effector and the second end effector being detachably connected to the handheld device;

[0371] A variable speed motor is installed inside the handheld device;

[0372] Optional feedback device; and

[0373] The processor is configured to control the energization of the variable speed motor and / or the vibration of the feedback device;

[0374] A navigation system communicating with the processor, the navigation system being configured to define a first alarm zone for the patient based at least in part on the first end effector, and a second alarm zone for the patient based at least in part on the second end effector; and

[0375] When the first end effector is coupled to the handheld device, the navigation system is configured to transmit a first signal to the processor, at least in part, based on the position of the first end effector relative to the first alarm area, to control the energization of the variable speed motor or activate the feedback device.

[0376] When the second end effector is coupled to the handheld device, the navigation system is configured to send signals to the processor, at least in part, based on the position of the second end effector relative to the second alarm area, to control the energization of the variable speed motor or activate the feedback device.

[0377] L. The surgical system according to technical solution XLIX, wherein the optional feedback device includes a tactile alarm device that comes into contact with medical personnel, the tactile alarm device being configured to issue a physical alarm that can be perceived by medical personnel when the high-speed surgical grinding head enters the alarm area.

[0378] LI. The surgical system according to technical solution XLIX, wherein the optional feedback device includes an auditory alarm device and a tactile alarm device that come into contact with medical personnel, each of the auditory alarm device and the tactile alarm device being able to generate an alarm perceived by medical personnel when the high-speed surgical grinding head enters the alarm area.

[0379] LII. The surgical system according to technical solution XLIX or L, wherein the high-speed grinding head assembly further includes a foot switch connected to the control console, the foot switch being movable between a first position and a second position to control the energization of the variable speed motor;

[0380] The medical personnel can deactivate the optional feedback device by manipulating the foot switch in a defined pattern within a defined time frame.

[0381] LIII. A method for navigating surgical instruments using a surgical navigation system during a medical procedure on a patient, the surgical instruments including a handheld device, an end effector coupled to the handheld device, a variable-speed motor for selectively actuating the end effector, and a processor for controlling the energization of the variable-speed motor, the method comprising:

[0382] Choosing medical implants;

[0383] The location where a medical implant will be placed on the patient is identified within the patient data stored on the surgical navigation system, wherein the surgical navigation system is configured to define an alarm zone based on the selected medical implant and the identified location where the medical implant will be placed.

[0384] Use a surgical navigation system to track the position of surgical instruments;

[0385] When the navigation system determines that a surgical instrument has entered a defined alarm zone, the surgical navigation system signals the processor to deactivate the variable speed motor.

[0386] LIV. The method according to technical solution LIII, wherein the method further includes the step of manipulating the alarm area defined by the surgical navigation system based on the preferences of medical personnel.

[0387] LV. The method according to technical solution LIII or LIV, wherein the method further includes the step of coupling a first end effector to a handheld device, the surgical navigation system being configured to identify the first end effector and define a first alarm zone based at least in part on the first end effector.

[0388] LVI. The method according to any one of technical solutions LIII-LV, wherein the method further comprises the step of coupling a second end effector to the handheld device, the surgical navigation system being configured to identify the second end effector and define a second alarm zone at least in part based on the second end effector.

[0389] LVII. The method according to any one of technical solutions LIII-LVI, wherein the method further comprises the step of activating an alarm device when the surgical navigation system determines that a surgical instrument has entered a defined alarm zone.

[0390] LVIII. The method according to any one of technical solutions LIII-LVII, wherein the method further comprises the step of assigning alarm types to each defined alarm zone.

[0391] LIX. The method according to technical solution LIII, wherein the method further includes the step of identifying a first end effector coupled to the handheld device, the surgical navigation system being configured to define a first alarm zone based at least in part on the first end effector;

[0392] Separate the first end effector from the handheld device;

[0393] By attaching the second end effector to the handheld device, the surgical navigation system is configured to identify the second end effector and define a second alarm zone based at least in part on the second end effector.

[0394] LX. The method according to technical solution LIII, wherein the method further includes the step of identifying a first end effector coupled to the handheld device, the surgical navigation system being configured to define a first alarm zone based at least in part on the first end effector;

[0395] The first end effector is applied to the biological tissue site where a medical implant will be placed;

[0396] When the navigation system determines that the surgical instruments have entered the first alarm zone, the surgical navigation system sends a signal to the processor to deactivate the variable speed motor;

[0397] Separate the first end effector from the handheld device;

[0398] The second end effector is coupled to the handheld device, and the surgical navigation system is configured to identify the second end effector and define a second alarm zone based at least in part on the second end effector;

[0399] Applying a second end effector to the biological tissue site where a medical implant will be placed; and

[0400] When the navigation system determines that the surgical instruments have entered the second alarm zone, the surgical navigation system sends a signal to the processor to deactivate the variable speed motor.

[0401] LXI. A surgical system for use by medical personnel during surgical procedures on patients, the surgical system comprising:

[0402] High-speed grinding head assembly, the high-speed grinding head assembly comprising:

[0403] Includes the processor's console;

[0404] A handheld device that communicates with the processor of the console, the handheld device including an end effector and a variable speed motor for driving the end effector;

[0405] A foot switch, which can be operated by medical personnel between a first position and a second position, to control the power supply to the variable speed motor;

[0406] A navigation system that communicates with the processor is configured to actively determine the position of the handheld device relative to an alarm area defined in relation to the patient;

[0407] The navigation system is configured to send a first signal to the processor to temporarily power off the handheld device when the navigation system determines that the position of the handheld device has entered the alarm zone;

[0408] When the processor temporarily de-energizes the handheld device, the handheld device remains within the alarm area; and

[0409] When the variable speed motor is re-energized, the navigation system is configured to send a second signal to the processor based on whether the movement of the handpiece is proximal or distal to the patient's surgical site, so as to energize or de-energize the handpiece.

[0410] LXII. A surgical instrument assembly for use with a navigation system configured to allow medical personnel to define alarm zones on a patient to assist in surgical procedures, the surgical instrument assembly comprising:

[0411] The control console includes a control processor that communicates with the navigation system;

[0412] A high-speed surgical grinding head assembly includes a variable-speed motor communicating with the control processor, the variable-speed motor being configured to rotate the grinding head;

[0413] A foot switch that can move between a first position and a second position to energize the variable speed motor of the high-speed surgical grinding head;

[0414] A foot switch sensor communicating with the control processor, the foot switch being configured to detect the position of the foot switch and transmit a first signal indicating the position of the foot switch to the control processor; and

[0415] A tactile alarm device is connected to the foot switch and communicates with the control processor. The tactile alarm device is positioned on the foot switch such that it comes into contact with the medical personnel when the medical personnel press the foot switch to operate the high-speed surgical grinding head.

[0416] The navigation system is configured to actively determine the position of the high-speed surgical grinding head relative to the patient;

[0417] The navigation system is configured to send a second signal to the control processor when the high-speed surgical grinding head enters the alarm zone to activate the tactile alarm device and issue a physical alarm that can be perceived by medical personnel; and

[0418] Wherein, when the high-speed surgical abrasive head is still in the alarm zone, the processor is configured to deactivate the alarm device upon receiving a subsequent first signal from the foot switch sensor, the subsequent first signal instructing medical personnel to move the foot switch between the first and second positions by a defined number of strokes within a defined time period.

[0419] LXIII. A surgical system for use by medical personnel during surgical procedures on patients, the surgical system comprising:

[0420] High-speed grinding head assembly, the high-speed grinding head assembly comprising:

[0421] Includes the processor's console;

[0422] A handheld device that communicates with the processor of the console, the handheld device including an end effector and a variable speed motor for driving the end effector;

[0423] A foot switch, which can be operated by medical personnel between a first position and a second position, to control the power supply to the variable speed motor;

[0424] A navigation system that communicates with the processor is configured to actively determine the position of the handheld device relative to an alarm area defined in relation to the patient;

[0425] The navigation system is configured to send a first signal to the processor to cause the processor to adjust the torque mapping in response to the end effector entering the alarm zone, and the handheld device is powered by the torque mapping.

[0426] LXIV. A surgical system for use by medical personnel during spinal or craniocerebral surgery on patients, the surgical system comprising:

[0427] A handheld surgical instrument configured to receive an end effector, the handheld surgical instrument comprising:

[0428] Handheld items;

[0429] A variable speed motor is installed inside the handheld device;

[0430] A trigger that can be operated by medical personnel to activate and deactivate the variable speed motor;

[0431] A switch that can be operated by medical personnel between a first position and a second position to control the speed of the variable speed motor;

[0432] A processor configured to control the power supply to the variable speed motor;

[0433] A navigation system communicating with the processor is configured to use machine vision to determine whether the switch is in the first position or the second position; and

[0434] The navigation system is configured to send signals to the processor to control the energization of the variable speed motor based on the switch being in the appropriate position and based on the type of the end effector coupled to the handheld surgical instrument.

[0435] According to the surgical system described in LXV, the handheld surgical instrument further includes a tracker connected to the switch; and

[0436] The navigation system is configured to determine whether the switch is in the first position or the second position based on the position of the tracker.

[0437] LXVI. The surgical system according to technical solutions LXIV or LXV, wherein the handheld surgical instrument further includes a battery module; and

[0438] The processor is located within the battery module.

[0439] LXVII. A surgical navigation system for guiding surgical instruments to perform medical procedures, said surgical navigation system being substantially as described in any of the foregoing technical solutions.

[0440] Several embodiments have been discussed in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be descriptive rather than restrictive. In view of the foregoing teachings, many modifications and variations are possible, and the invention may be practiced in ways other than those specifically described.

Claims

1. A surgical system configured to allow medical personnel to define alarm regions related to critical structures of a patient in a known coordinate system to assist in surgical procedures on the patient, said surgical system comprising: Navigation system; The control console includes a control processor that communicates with the navigation system; A high-speed surgical instrument including a grinding head, the high-speed surgical instrument including a variable-speed motor in communication with the control processor, the variable-speed motor being configured to rotate the grinding head at a first cutting speed greater than 70,000 revolutions per minute and a second cutting speed less than 70,000 revolutions per minute but greater than 60,000 revolutions per minute; and A foot switch is used to control the operation of the variable speed motor of the high-speed surgical instrument and communicates with the control processor; The navigation system is configured to actively determine the position of the grinding head relative to the alarm area in a known coordinate system; The navigation system is configured to: when the navigation system determines that the grinding head has entered an alarm zone, send a signal to the control processor to manipulate the variable-speed motor of the high-speed surgical instrument, causing the rotation of the grinding head to change from the first cutting speed to the second cutting speed; and Specifically, when the grinding head changes from the first cutting speed to the second cutting speed, the change in the grinding head from the first cutting speed to the second cutting speed produces a perceptible change, so as to notify medical personnel that the grinding head has entered the alarm zone.

2. The surgical system according to claim 1, wherein, When the grinding head changes from the first cutting speed to the second cutting speed, the change in cutting speed produces a tactilely perceptible change in the high-speed surgical instrument to notify medical personnel that the grinding head has entered the alarm zone.

3. The surgical system according to claim 1, wherein, The foot switch is movable between a first position and a second position; and The variable speed motor is configured to be deactivated when the foot switch is in the first position, and the variable speed motor is configured to cause the grinding head to rotate at a speed of at least 60,000 revolutions per minute when the foot switch is not in the first position.

4. The surgical system according to claim 3, wherein, When the grinding head enters the alarm zone, after receiving the signal from the navigation system to manipulate the variable speed motor from the first cutting speed to the second cutting speed, the control processor is configured to manipulate the variable speed motor of the high-speed surgical instrument to return the rotation of the grinding head to the first cutting speed when the user moves the foot switch.

5. The surgical system according to claim 4, wherein, Moving the foot switch is defined as moving the foot switch to the first position and repositioning the foot switch so that it is no longer in the first position.

6. The surgical system of claim 1 further includes an auditory alarm device configured to emit an alarm sound when the grinding head enters the alarm zone.

7. The surgical system of claim 1 further includes a tactile alarm device in contact with the medical personnel, the tactile alarm device being configured to issue a tactile alarm perceptible to the medical personnel when the grinding head enters the alarm area.

8. The surgical system according to claim 7, wherein, The tactile alarm device is coupled to the foot switch and includes a motor that vibrates when activated, such that the vibration of the motor provides a physical alarm that can be felt in the user's foot, the user's foot contacting the foot switch for controlling the operation of the variable speed motor of the high-speed surgical instrument.

9. The surgical system according to claim 1, wherein, The alarm zone includes a user-selectable first boundary and a user-selectable depth associated with the first boundary.

10. The surgical system of claim 1, further comprising at least one of an auditory alarm device and a tactile alarm device in contact with a medical professional, each of the auditory alarm device and the tactile alarm device being capable of generating an alarm perceived by the medical professional when the grinding head enters the alarm area.

11. The surgical system of claim 10, wherein, The alarm zone includes a first alarm zone and a second alarm zone, and the navigation system is configured to allow a user to assign one of a first notification type or a second notification type to the first alarm zone, the second alarm zone, or a combination thereof; and The navigation system is configured to manipulate one of the auditory alarm device and the tactile alarm device based on the position of the grinding head, a first alarm zone, a second alarm zone, and a first notification type or a second notification type assigned to one of the first alarm zone or the second alarm zone.

12. The surgical system of claim 1, further comprising at least one of an auditory alarm device capable of generating a first notification and a tactile alarm device capable of generating a second notification; in, The alarm zone includes a first boundary selectable by the user and a second boundary selectable by the user; The navigation system is configurable to allow a user to assign one of the first notification or the second notification to either the first boundary or the second boundary; and The navigation system is configured to manipulate one of the auditory alarm device and the tactile alarm device based on the position of the grinding head relative to the first boundary or the second boundary, so as to generate one of the first notification or the second notification.

13. The surgical system according to any one of claims 1 to 12, wherein, The navigation system includes a graphical user interface (GUI) that includes a graph of the alarm area, which can be selected by manipulating the graphical user interface (GUI).

14. The surgical system according to any one of claims 10-12, wherein, The navigation system includes a graphical user interface (GUI) configured to provide user-selectable icons, which are configured to disable at least one of the auditory alarm device and the tactile alarm device after the grinding head enters the alarm zone.

15. The surgical system of claim 14, wherein, The control processor is configured to reactivate at least one of the disabled auditory alarm devices and tactile alarm devices based on the position of the grinding head outside the alarm zone for a predetermined period of time and subsequently returning to the alarm zone.

16. The surgical system of claim 14, wherein, The control processor is configured to reactivate at least one of the disabled auditory alarm devices and tactile alarm devices when the grinding head moves.

17. The surgical system of claim 1, further comprising a user input device capable of generating a user input signal, the control processor being configured to return the grinding head to the first cutting speed based on the user input signal, wherein the control processor is configured to return the grinding head to the second cutting speed based on the position of the grinding head outside the alarm zone for a predetermined time and subsequently returning to the alarm zone.

18. The surgical system according to claim 1, wherein, The navigation system includes a graphical user interface (GUI) that includes a graphic representation of the alert area, which can be selected by manipulating the GUI; and When the grinding head enters the alarm zone, the graphical user interface (GUI) is also configured to provide a user-selectable button, which is configured to send a command to the control processor to manipulate the variable speed motor of the high-speed surgical instrument to change the rotation of the grinding head from the second cutting speed back to the first cutting speed.

19. The surgical system according to any one of claims 1 to 12, further comprising an instrument tracker for coupling to the high-speed surgical instrument and a patient tracker for coupling to the patient.

20. The surgical system according to any one of claims 1 to 12, wherein, The navigation system is configured to define a boundary based at least in part on a segmentation algorithm, the boundary defining the alarm area at least in part.

21. The surgical system of claim 20, wherein, The navigation system is also configured to provide user-selectable objects, which are configured to allow the user to manipulate the boundaries provided by the segmentation algorithm.

22. The surgical system according to any one of claims 1 to 12, wherein, The navigation system is configured to define a first boundary associated with the patient’s critical structures and to project a second boundary spaced a first distance from the first boundary, the first boundary and the second boundary defining a space representing an alarm area; and The navigation system is configured to send a signal to the control processor when the grinding head enters the space representing the alarm zone to manipulate the variable speed motor of the high-speed surgical instrument, causing the rotation of the grinding head to change from the first cutting speed to the second cutting speed.

23. The surgical system of claim 22, wherein, The second boundary is projected at a user-selectable distance from the first boundary.

24. The surgical system of claim 22, wherein, The second boundary is projected at the first distance relative to the first boundary based on a user-selectable depth.

25. The surgical system of claim 23, wherein, The second boundary includes a grid perpendicular to the target trajectory.

26. The surgical system according to any one of claims 1 to 12, wherein, The alarm zone includes a defined space, and the navigation system is configured to send a signal to the control processor when the navigation system determines that the grinding head has entered the space to manipulate the variable speed motor of the high-speed surgical instrument, causing the rotation of the grinding head to change from the first cutting speed to the second cutting speed.

27. The surgical system of claim 20, wherein, The navigation system is configured to send a signal to the control processor when the navigation system determines that the grinding head is adjacent to or far from the boundary to manipulate the variable speed motor of the high-speed surgical instrument, causing the rotation of the grinding head to change from the first cutting speed to the second cutting speed.

28. The surgical system according to any one of claims 1 to 12, wherein, If the navigation system is unable to determine the position of the grinding head relative to the patient within a defined time period, the navigation system is also configured to send a second signal to the control processor to deactivate the variable speed motor of the high-speed surgical instrument until the navigation system is subsequently able to determine the position of the grinding head relative to the patient.

29. The surgical system according to claim 7 or 8, wherein, The navigation system includes a graphical user interface (GUI) that includes a graph of the alert area, which can be selected by manipulating the GUI; and When the grinding head enters the alarm area, the graphical user interface (GUI) is also configured to provide a user-selectable icon, which is configured to send a command to the control processor to disable the tactile alarm device.

30. The surgical system of claim 29, wherein, The control processor is configured to reactivate the disabled tactile alarm device based on the position of the grinding head outside the alarm zone for a predetermined period of time and then returning to the alarm zone.

31. The surgical system according to claim 29, wherein, The control processor is configured to reactivate a disabled tactile alarm device based on a defined distance the grinding head moves distally relative to a boundary defining a portion of the alarm area.

32. The surgical system of claim 29, wherein, The control processor is configured to reactivate a disabled tactile alarm device based on a defined time period during which the grinding head rotates when it is adjacent to or far from a boundary defining a portion of the alarm area.

33. The surgical system according to claim 7 or 8, wherein, The tactile alarm device is configured to deactivate when the foot switch is moved while the grinding head is still within the alarm zone.

34. The surgical system of claim 33, wherein, The tactile alarm device is configured to deactivate when the medical staff moves the foot switch between a first position and a second position a defined number of strokes within a defined time period. The variable speed motor is configured to be deactivated when the foot switch is in the first position, and the variable speed motor is configured to cause the grinding head to rotate at a speed of at least 60,000 revolutions per minute when the foot switch is not in the first position.

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