System and method for monitoring offset during navigation support surgery

Abstract

To provide a system and method for a surgical treatment which trace a physical object near a target portion during surgical treatment.SOLUTION: In a surgical system, a navigation system and a surgical tool 86 are used. A tool tracker is provided on the surgical tool, and a patient tracker is provided on the target tissue of a patient. A system and a method detect an error state which degrades accuracy of a navigation guidance, and track and monitor an offset D between the tool and bones. An offset distance may be defined as a size of the minimum division between a tool tip end part and the tracked biological structure in a common coordinate system, or as a size of the maximum overlap between the tool tip end part and the tracked biological structure in the common coordinate system.SELECTED DRAWING: Figure 5B

Description

[Technical field]

[0001] The present disclosure relates generally to computer-assisted surgery. More specifically, the present disclosure relates to a method and apparatus for performing a surgical procedure on a patient. A system and technique for determining a monitor position offset of a device is disclosed. As a method, a non-transitory medium for a computer program, a computing device The present invention can be implemented as a surgical device and as a computer-assisted surgery system.

[0002] [CROSS REFERENCE TO RELATED APPLICATIONS] This application is a continuation of U.S. Provisional Patent Application No. 63 / 054,811, filed on July 22, 2020. No. 62 / 960,218, filed on January 13, 2020. Priority and all benefits are claimed, and the entire contents of these applications are incorporated by reference. No. 6,399,421, which is incorporated herein by reference in its entirety. [Background technology]

[0003] Navigation-assisted surgery is often performed using magnetic resonance imaging (MRI), computed tomography (CT), and Preoperative imaging using one or more of the following imaging techniques: computed tomography (CT), x-ray, or other imaging techniques The data generated through these techniques is based on the patient’s anatomy. The data is very accurate and can be stored in the memory or on the navigation system. A virtual three-dimensional (3D) model of the target's anatomy is generated based on the virtual three-dimensional (3D) model of the target's anatomy. During navigation-assisted surgery, the patient tracker can be aligned to the patient's anatomy. The navigation system may be associated with a surgical tool and the tool tracker may be associated with a surgical tool. The navigation system detects the location of the target object based on the associated tracker in the virtual space of the navigation system. Based on this, anatomical structures and surgical tools can be located and tracked to aid the surgeon or other medical personnel during surgery. It can provide important information to experts.

[0004] Surgical navigation systems are used extensively in industrial, aerospace, and medical applications. It is used to precisely locate and track physical objects in space and orientation. In the medical field, navigation systems are used to help surgeons or other medical professionals navigate, e.g. It can assist in the precise placement of surgical instruments relative to the patient's target site during surgery. The target site typically requires some form of therapy or treatment, such as tissue removal. The navigation system employs a localizer, which includes one or more The one or more sensors cooperate with the tracker to detect surgical information and a target site, For example, providing position and / or orientation data associated with a volume of tissue requiring treatment. These trackers allow surgeons to optimize tool placement based on pre-operative or intra-operative imaging of the patient. and the position and location of surgical tools overlaid on the monitor along with a virtual representation of the anatomy. These trackers also allow the navigation system to determine the direction of the vehicle. The motion control system monitors the relative positioning of the tool and the anatomy to ensure that the tool is aligned with the anatomy. It is possible to warn the user when approaching or entering an undesirable position. For example, the user may be informed that the tool is approaching or contacting patient tissue that is not intended to be contacted by the tool. This makes it possible to warn the user.

[0005] The localizer is typically positioned so that it has a field of view of the tracker. The localizer is designed to position the patient's target area within the target volume of the localizer. The tracker includes an identifiable array of fiducials or markers. , which are fixed to at least one of the surgical instrument or the patient, and The surgical navigation system moves with the patient. The position and orientation of the surgical instrument or patient are obtained, and the change in the obtained position and orientation is monitored over time. The term location is used by surgical navigation systems. The term orientation refers to the 3D coordinate values ​​of an object's coordinate system relative to a reference coordinate system. Refers to the pitch, roll, and yaw of an object's coordinate system relative to the system. Identifying the position and a given orientation The pitch, roll, and yaw values ​​of a given object are collectively referred to as the object's attitude in the reference frame. Once both the position and orientation (i.e., pose) are determined, the object can be The surgical site can be recognized by the navigation system and tracked by the surgical navigation system. (i.e., registered (recorded, aligned) by the surgical navigation system) (I).

[0006] The tracker attached to the patient and the tracker attached to the tool are used to properly align the bones and the treatment. The rigidity of the bone or tool, the rigid structure of the tracker, and and the fixation therebetween maintains a fixed relationship to the target site and the tool. In another form known in the art, the tracker is deformable and adapted to soft tissue such as skin. The tracker can be attached to a known deformation, which provides similar information as the rigid tracker. Thus, it comprises a pattern or array of markings, markers, or fiducials. By using separate trackers for the tool and the patient, the treating end of the surgical instrument is Accurate positioning at the target site by the surgeon assisted by the navigation system This can be done.

[0007] During the early stages of surgery, the object, whether it be a surgical tool or the patient's anatomy, Regardless of the type of surgical navigation system, calibration or registration must be performed. The process of registration, or alignment, is the process of establishing the relationship between a physical object and its tracker for use in surgical navigation. The objective of the present invention is to define the virtual representation of the objects and trackers as data in the application system. That is, it means defining them as virtual object data and virtual tracker data, respectively. The data, whether of the object or the tracker, may or may not be a model of the object. Rather, the virtual data contains sufficient information to identify or designate a particular point of interest. The virtual data may also include other information regarding the dimensional characteristics of the object. Virtual data can be established intraoperatively or from existing modeling or object specification data. The virtual data may be based on a computer-aided method, or may be based on imaging of the object in situ. The data can be generated from the imaging data through a process of segmentation. For example, preoperative imaging of a patient's anatomy can be used to store and It is possible to generate a 3D model of the anatomy as a virtual object in the virtual environment. Similarly, surgical tools can be manufactured according to known geometries and configurations. This geometry and structure is stored in the memory of the surgical navigation system and in the virtual environment. As virtual object data, it can be represented in a 3D model of the tool. To achieve this, additional reference pointers or frames with additional tracker reference arrays are provided. It may be necessary to touch off a reference point according to the alignment or calibration system. Alternatively, calibration may be performed using optical processes such as projected light patterns, optical recognition, or other methods. This may be established using conventional methods.

[0008] Localizers are typically variously adapted for beneficial use in particular surgical modalities. In one example, the localizer is a navigation The one or more navigation sensors may include one or more sensors suitable for use in a high frequency sensing cycle to accurately track small movements over small time increments By providing high-resolution tracking data, navigation It can be adapted for use in

[0009] The localizer may further include sensors suitable for machine vision or other applications beneficial to surgery. For example, the localizer may include one or more optical sensors to provide a video recording of a surgical procedure. The localizer may be equipped with a camera. A set of individual sensors that sense electrical properties or light, electromagnetic energy, or other properties. The method may include processing data representative of the localizer sensor outputs to determine the field of view or range of the localizer. This can provide important information about the surrounding surgical site.

[0010] Conventional surgical navigation systems support surgical tools used during medical procedures. The device may be adapted for use with a robotic arm or manipulator. By incorporating a robot arm manipulator into the navigation system, more advanced Control is provided such that movement of the surgical tool is controlled by or supported by the robotic arm. This is achieved with the aid of a joint assistant, allowing for proper placement of the tool relative to the anatomy. Incorporating encoders or other sensing technologies into the robotic arm to provide additional data; The position of the tool can be determined while it is being tracked by the navigation system. This information is compared and if a discrepancy occurs, the operator is alerted and the error is diagnosed. The surgery can be halted until the defect can be corrected. Summary of the Invention [Problem to be solved by the invention]

[0011] A surgical navigation system adapted for use without the assistance of a robotic manipulator. There is a need to improve the system. Excluding the tool introduces additional uncertainty and the navigation system may The risk of losing calibration or alignment to the cam or anatomy tracker is reduced by the or would be left without the ability to detect loss of alignment and warn the user. This can lead to improper placement of tools relative to the anatomy during surgery. Therefore, we aim to address the shortcomings of traditional navigation systems and to provide a more flexible and efficient navigation system during navigation-assisted surgery. Systems and methods that provide efficient techniques for monitoring offsets are well known in the art. It is required. [Means for solving the problem]

[0012] A method is provided for navigating a surgical instrument having a variable speed motor relative to a bone. The method uses a navigation system that includes a localizer having a localizer coordinate system. The instrument tracker is coupled to the surgical instrument. The patient tracker is coupled to the bone. The controller communicates with the navigation system. Control surgical instruments.

[0013] The method includes using a localizer to align the patient tracker to a localizer coordinate system. This registration defines the location of the bone relative to the localizer coordinate system. The method uses a localizer to align the instrument tracker to the localizer coordinate system. This alignment includes aligning the instrument tool tip relative to the localizer coordinate system. The location is defined.

[0014] The method includes defining the motor motion of the instrument when the instrument tool tip is not in contact with the bone. The method includes using the controller to monitor motor operation of the instrument during the medical procedure. and using a navigation system to monitor the position of the instrument tool tip relative to the bone. and determining when the instrument tool tip contacts the bone in the localizer coordinate system. Includes.

[0015] The method includes comparing motor motion with a monitored position of the instrument tool tip and The monitored position of the tool tip is in contact with the bone in the localizer coordinate system and the monitored The motor motion defined by the instrument tool tip is not in contact with the bone. and determining an error condition when the operation is equal to the error condition. This includes triggering an action when

[0016] In the method, defining the motor motion of the instrument when the tool tip is not in contact with the bone The steps include: applying a current when the instrument motor operates while the instrument tool tip is not in contact with the bone; This may include defining thresholds for force, voltage, current, or a combination thereof. The step of defining the surgical instrument may be performed by a controller, a navigation system, a surgical instrument, or the like. and storing data representative of motor operation in one or more of the memories in any combination of the above. It can be seen.

[0017] The method also includes defining a second motor operation of the instrument when the instrument tool tip is in contact with the bone. The method may include a step of defining a second motor operation. The monitored position is not in contact with the bone in the localizer coordinate system, and the monitored motor The motion corresponds to a second defined motor motion of the instrument when the instrument tool tip is in contact with the bone. When the two are equal, determining a second error condition. The method may include triggering a second action when the error condition is determined.

[0018] In the method, triggering one of the action or the second action. sound an audible alert, display a visual alert, or activate a tactile alert cutting off power to the surgical instrument, or a combination thereof. .

[0019] Navigate a surgical instrument with a variable speed motor relative to the bone and perform tool-to-bone ne) A method for monitoring offset is provided, the method comprising: The instrument tracker includes a navigation system that includes a localizer. The patient tracker is coupled to the surgical instrument. The patient tracker is coupled to the bone. The controller It communicates with the navigation system and controls the surgical instruments.

[0020] The method includes using a localizer to align the patient tracker to a localizer coordinate system. This registration defines the location of the bone relative to the localizer coordinate system. The method uses a localizer to align the instrument tracker to the localizer coordinate system. This alignment includes aligning the instrument tool tip relative to the localizer coordinate system. The location is defined.

[0021] The method defines a first motor motion of the surgical instrument that operates while not in contact with the bone. The method includes using the controller to control motor operation of the surgical instrument during the medical procedure. and using a navigation system to locate the bone in the localizer coordinate system. and monitoring the position of the instrument tool tip relative to the instrument.

[0022] The method includes comparing the monitored motor behavior to a defined motor behavior and When the motor motion deviates from the first motor motion, the tool tip and the bone are moved. and determining a contact time (or contact point) between the subject and the subject. In the method, the navigation system is used to locate the tip of the instrument in the localizer coordinate system. This involves determining the tool-bone offset as the distance between the tool and the bone surface. is described as a tool-to-bone offset, but the reference to "bone" is not intended to be limiting. Rather, such use of "bone" should be understood as any type of biological structure upon which surgery may be performed. and may be understood to include non-bone-type tissues such as skin, muscle, connective tissue, and nervous tissue. It should be understood that this method does not take any action if the tool-to-bone offset exceeds a certain amount. This includes triggering the

[0023] In this method, the step of triggering an action may include sounding an audible alert, a visual display visual alerts, activate haptic alerts, and cut power to surgical instruments. In the method, the predetermined size may include one of: The length may be equal to 0.5 millimeters. The step of triggering the action may include and prompting the user to update the model of the bone. The step of updating the model may include updating the model from the controller. contacting the resection surface of the bone with an instrument tool tip while power to the .

[0024] The method further comprises displaying the determined tool-bone offset on a display device. The method may further include: The method may include displaying an offset between the first and second inputs.

[0025] In the method, the step of monitoring the position of the instrument tool tip relative to the bone comprises The method may include tracking the location of the instrument tool tip and the location of the bone during the procedure, and may include performing navigation. The motion control system is used to monitor the location of the instrument tool tip in contact with the bone surface. The purpose of the present invention is to detect each occurrence during the procedure and to identify the sequence of tools and bone interbody joints that were determined during the medical procedure at each occurrence. and recording the offset value on the display device. The method may further include displaying the tool-to-bone offset of the series as a continuously updated value.

[0026] The method further includes defining a first level of magnitude and a second level of magnitude. In the method, the step of displaying the determined tool-to-bone offset includes: and displaying the offset in a first color when the bit is less than a first level magnitude. If the offset is between the magnitude of the first level and the magnitude of the second level, The second level is displayed in a second color different from the first color, and the offset is greater than the magnitude of the second level. If the offset is large, the offset is displayed in a third color different from the first color and the second color. The predetermined magnitude for triggering the action may be equal to the magnitude of the second level. The predetermined magnitude for triggering an action may be greater than the second level magnitude. The method may further include defining a third level of magnitude, The method also controls when the tool-to-bone offset is larger than the magnitude of the third level. The method further includes disabling power from the controller to the surgical instrument. Level 1 magnitude, second level magnitude, third level magnitude, or a combination of these The method may include prompting a user to input a value for the tool-to-bone offset. Disabling power from the controller to the surgical instrument when It may include.

[0027] A surgical system is provided. The surgical system includes a variable speed motor or actuator and The surgical system includes a surgical instrument having a tool tip and a power supply for providing the surgical instrument. a controller for controlling motor or actuator operation of the instrument; The controller is operable to monitor the data, the controller comprising a processor and a memory, the memory is operable to store information including information representative of an operation of the instrument. An instrument tracker is coupled to the instrument and a patient tracker is coupled to the bone.

[0028] The system includes a navigation system that includes a localizer. The system is configured to store information representing surgical instruments and information representing bones in a virtual space. The navigation system is operable to: Based on the virtual space location of the instrument and bones, the instrument can be operated to track the location of the instrument and bones in the virtual space during the movement. The localizer determines the location of the instrument tracker and the location of the patient tracker relative to the localizer coordinate system. and aligns the instrument and bone locations in cooperation with the instrument tracker and patient tracker, respectively. The controller and the navigation system are operable to collect information regarding the are in electronic communication and configured to cooperate with each other. The system determines the point in time of contact between the tool tip and the bone based on the change in motion. The tracker and navigation system detects the tracked location of the tool tip at the time of contact. Determine the tool-bone offset as the distance between the tool location and the tracked location of the bone. The controller and the navigation system also include an alert device. The apparatus may be further configured to trigger an action if the interbone offset is greater than a predetermined amount. It has been made.

[0029] Operate the surgical navigation system during surgery to verify tracking registration. The surgical navigation system includes a localizer coordinate system. The instrument tracker is coupled to the surgical instrument. The surgical instrument includes a surgical instrument tracker. The patient tracker is coupled to the patient's anatomy. The control console includes a The control console communicates with the surgical instrument and the patient's biometric data. Communicate with data that represents the structure.

[0030] The method includes tracking the surgical instruments and the anatomical structures using a navigation system. Using the control console, a first data set is generated that represents the tracked surgical instrument in a common coordinate system. and storing the tracked data and second data representative of the tracked anatomy. Based on the surgical instrument and the tracked anatomy, a tool tip is moved to the tracked anatomy. The method includes determining that the tool tip is within a predetermined proximity range to the predetermined Determining that the object has not deviated from a predetermined proximity range by more than a predetermined magnitude for a duration of time The method includes receiving first data representative of the tracked surgical instrument and the tracked anatomical structure. The method includes determining an offset distance based on second data representative of the offset. comparing the offset distance to a predetermined threshold and if the offset distance is greater than the predetermined threshold and triggering an action in the navigation system.

[0031] Optionally, the method further comprises displaying a prompt on a display, an audible alert, by one of making a sound, generating a tactile sensation, or a combination thereof; Prompting the user to verify the tracking alignment.

[0032] The method further comprises determining whether the tool tip is within a predetermined proximity range relative to the anatomical structure. The step defines a surface area of ​​the anatomy that is not to be ablated and defines a tool tip. and determining that the surface region is within a predetermined proximity range.

[0033] In this method, the offset distance is determined by the distance between the tool tip and the tracked biological object in the common coordinate system. as the measure of the minimum separation between the tool tip and the tracked structure in a common coordinate system It may be defined as the magnitude of maximum overlap between the anatomy.

[0034] In this method, when the tool tip is within a predetermined proximity to the tracked anatomy, Determining includes positioning the surgical instrument in a first pose relative to the tracked anatomy. and the surgical instrument may define a first proximal point of the tool tip, Determining the set distance may include determining a first offset distance. determining that the tool tip is within a predetermined proximity range to the tracked anatomy; and positioning the surgical instrument in a second pose relative to the tracked anatomy. and the surgical instrument may define a second proximal point of the tool tip to determine the offset distance. Determining a second offset distance may include determining a second offset distance.

[0035] The step of comparing the offset distance with a predetermined threshold value includes comparing the first offset distance with the predetermined threshold value. value and comparing the second offset distance to a predetermined threshold. Therefore, the step of initiating the action is the first offset distance, the second offset distance, the distance, or both the first offset distance and the second offset distance, are greater than a predetermined threshold. The method may include initiating an action if the threshold is exceeded.

[0036] The surgical instrument may include an elongated surface terminating in a tool tip, the elongated surface having a The second proximal point defines a longitudinal axis extending substantially parallel to the axis of the first proximal end of the first proximal end of the second ... The surgical instrument is at least 90 degrees from the first proximal point. and the second proximal point is a first proximal point relative to rotation about a center point. At least 90 degrees away from the position point.

[0037] Determining that the tool tip is within a predetermined proximity range to the tracked anatomical structure. may include positioning the surgical instrument at a third pose relative to the tracked anatomy. The surgical instrument may define a third proximal point, the third proximal point being adjacent to the first proximal point and the second proximal point. The step of determining an offset distance is different from the proximal point of the first embodiment. This may include determining

[0038] The step of comparing the offset distance with a predetermined threshold value includes comparing the first offset distance with the predetermined threshold value. comparing the second offset distance to a predetermined threshold; and and comparing the set distance to a predetermined threshold. , the first offset distance, the second offset distance, the third offset distance, or any of them. This may include initiating an action if the combination is greater than a predetermined threshold.

[0039] The step of triggering an action may include sounding an audible alert, displaying a visual alert, or the like. triggering a haptic alert, cutting power to the surgical instrument, or The composition may include one of the following combinations:

[0040] The predetermined threshold may include a first predetermined threshold and a second predetermined threshold. The step of triggering an action of the stem is performed when the offset distance is greater than a first predetermined threshold. triggering a first action when the difference is greater than a second predetermined threshold; triggering a second action if the offset distance is greater than a second predetermined threshold. The actions may include sounding an audible alert, displaying a visual alert, , activate a tactile alert, cut off power to the surgical instrument, or any combination thereof. It may include one of the combinations.

[0041] Surgical system with navigation system with control console and localizer The navigation system includes a first data representing a surgical instrument and a patient. The surgical instrument communicates with a second data representative of the anatomy of the surgical instrument.

[0042] The navigation system includes an instrument tracker coupled to the surgical instrument and a navigation tracker coupled to the anatomy. During operation, virtual The navigation system is operable to track surgical instruments and anatomical structures in space. The system tracks surgical instruments and anatomy and calculates the pose of the tracked surgical instruments and the anatomical structure. The system is configured to store data representing the pose in a common coordinate system.

[0043] The navigation system uses the tracked pose of the surgical instrument and the tracked shape of the anatomy. and determining, based on the momentum, that the tool tip is within a predetermined proximity range relative to the anatomical structure. The navigation system is configured to detect whether the tool tip is in a predetermined position for a predetermined duration. The navigation system may further be configured to determine that the object has not left the predetermined proximity range by more than the magnitude. The gating system tracks surgical instruments and tracked biological structures in a common coordinate system. The navigation system is further configured to determine an offset distance based on the structure. is further configured to compare the offset distance to a predetermined threshold.

[0044] The navigation system may include an alert device. The system is configured to trigger an action if the offset distance is greater than a given threshold. The alert device may be a foot switch, the foot switch further comprising: The vibration is operable to generate vibrations.

[0045] A method for providing navigational guidance for a surgical procedure is provided, the method comprising: The method includes registering the patient's anatomy to a common coordinate system. The patient's anatomy includes at least The method further comprises registering the surgical instrument to a common coordinate system. The method includes: during operation of the surgical instrument on the first bone of the patient's anatomy, The method includes tracking the patient's anatomy and the surgical instrument using a motion system. determining an offset distance according to the methods disclosed herein for a second bone; and The navigation system is used to guide the patient during the operation of the surgical instrument on the second bone of the anatomy. The present invention includes tracking the patient's anatomy and surgical tools.

[0046] A method of performing a surgical procedure is provided. The method includes coupling a patient tracker to a patient's anatomy. and coupling the instrument tracker to the surgical instrument, the surgical instrument comprising a tool tip. The method includes operating a navigation system to detect an instrument tracker and a patient tracker. This involves registering the surgical instruments to a common coordinate system and tracking the surgical instruments and the patient's anatomy. The method includes dwelling the tool tip in contact with the patient's anatomy for a predetermined duration. , starting a registration verification. The navigation system and configured to determine an offset distance based on the instrument and the tracked patient anatomy. The method includes evaluating the offset distance against a predetermined threshold.

[0047] The navigation system determines whether the offset distance is may be configured to trigger an action when the determined threshold is greater than a certain threshold, Actions can include sounding an audible alert, displaying a visual alert, or a tactile alert. activating the surgical instrument, cutting off power to the surgical instrument, or any combination thereof. The method may also include providing an input to a navigation system to trigger the navigation system to This may include terminating the action.

[0048] The step of resting the tool tip in contact with the biological structure includes resting the tool tip on a first biological structure at a first time. The surgical instrument may include resting the tool tip in contact with the contact point. At the time, the tool tip may be in a first orientation and a first proximal point of the tool tip may be in contact with a first anatomical structure. The method may further include contacting the tool tip with the second biological structure contact point at a second time. The method may further include resting the end portion. The surgical instrument is in a second position at a second time. and a second proximal point of the tool tip may contact the first anatomy contact point. The positioning system determines a first offset based on the first anatomy contact point and the first proximal point. determining a second offset distance based on the second anatomical contact point and the second proximal point; The method may be configured to determine the distance.

[0049] The step of evaluating the offset distance includes evaluating the first offset distance against a predetermined threshold. evaluating the second offset distance against a predetermined threshold, or a combination thereof. The compound may include one of the following combinations:

[0050] The patient's anatomy may include a first bone and a second bone, and the method includes surgically inserting a surgical instrument. applying and operating a surgical instrument to a first bone and applying and operating a surgical instrument to a second bone. and, the step of pausing the tool to initiate the alignment verification may further include pausing the tool to initiate the alignment verification. and then applying the surgical instrument to a second bone and operating the surgical instrument. Prior to this, the implant may be made in contact with a second bone.

[0051] Other objects, features and advantages of the present disclosure will become apparent from the following description taken in conjunction with the accompanying drawings. This will be easily recognized because it will be well understood.

[0052] Further advantages may be seen by reference to the following detailed description when considered in conjunction with the accompanying drawings. As will be better understood, it will be readily appreciated. [Brief description of the drawings]

[0053] [Figure 1]FIG. 1 is an illustration of a surgical system including a set of surgical tools for use in performing navigation-assisted surgery. [Diagram 2] FIG. 1 is a perspective view of a navigation system used in conjunction with surgical tools in performing navigation-assisted surgery. [Diagram 3] FIG. 2 illustrates a localizer coordinate system and a tracker coordinate system of a tracker connected to a surgical instrument. [Figure 4A] FIG. 1 illustrates a surgical instrument and a bone in a first relationship. [Figure 4B] FIG. 4B illustrates a navigation display representation of the relationship shown in FIG. 4A in a first error state. [Figure 5A] FIG. 13 illustrates a surgical instrument and a bone in a second relationship. [Figure 5B] FIG. 5B illustrates a navigation display representation of the relationship shown in FIG. 5A in a second error condition. [Figure 6] FIG. 13 shows a chart of actuator operation over time for a cutting operation. [Figure 7] 1 is a flow chart illustrating a first method of navigating a surgical instrument relative to a bone. [Figure 8] 13 is a flow chart showing a second method of navigating a surgical instrument relative to a bone and determining a tool-bone offset. [Figure 9] 13 is a flow chart illustrating a method for performing tracking registration verification. [Figure 10] 11 is a flow chart illustrating a second method for performing tracking registration verification. [Figure 11] 13 is a flow chart illustrating additional steps for performing tracking registration verification. [Figure 12] FIG. 1 illustrates a surgical instrument having an elongated surface for contacting bone. [Figure 13] FIG. 1 illustrates a surgical instrument having a spherical surface that contacts the bone. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0054] Figure 1 shows a set of surgical tools for use in performing navigation-assisted surgery on a patient. A surgical system 10 with tools is shown. The version shown in FIG. The surgical navigation system 20 includes a surgical navigation system 20 for detecting the position of various objects in the operating room. Such objects include, for example, surgical tools and patient The surgical navigation system 20 determines the relative positions of these objects. For the purpose of indicating to the surgeon the placement and orientation of the surgical tool, and in some cases, to indicate the location or orientation of the surgical tool associated with the operation of the surgical tool. These objects are tracked for the purpose of alerting the surgeon to certain events or occurrences that may occur. The imaginary cutting boundary can be associated with the patient's anatomy, and the system 10 can be used to The surgeon may be alerted when the surgical tool approaches the cutting boundary or when the surgical tool exceeds the cutting boundary. If the tool is stopped, the tool may be stopped.

[0055] The navigation system 20 includes a computer that houses a navigation computer 26. The navigation interface may include a navigation cart assembly 24. The navigation interface is in operative communication with the surgical computer 26. A first display 28 is located outside the sterile field of surgery, and a second display 29 is located inside the sterile field. The displays 28, 29 may include a second display 29 for displaying the computer screen. The navigation computer 26 is adjustably mounted to the support assembly 24. or to control certain aspects of the operation of the navigation computer 26. One or more inputs, such as a keyboard, mouse, or trackball, to select or control a function A device (not shown) may also be provided to facilitate alternative forms of input. Other hardware may be provided, for example to allow gesture-controlled input. Sensors may be provided in one or more displays for voice command control. A microphone may be provided for this purpose.

[0056] The localizer 34 communicates with the navigation computer 26. The localizer 34 is an optical localizer and includes a camera unit 36. 36 has an outer casing 38 that houses one or more optical sensors 40. The sensors 40 may be rigidly mounted to a common support structure. A common support structure can be provided for multiple optical sensors 40. Alternatively, multiple The rigid support structure common to the optical sensor is covered by a separate outer casing 38. As shown in FIG. 1, the multiple optical sensors 40 may be mounted on an elongated camera unit 36. , so that the optical sensor 40 is positioned stereoscopically relative to the surgical site. do.

[0057] Object detection based on sensing of electromagnetic energy within the visible or near-visible spectrum The present invention will be described in relation to optical localizers that include camera technology for locating and tracking objects. Other location and tracking technologies may also be used, for example in the microwave or radio spectrum. Alternatively, or in addition, electromagnetic energy from the Ultrasonic energy may be another alternative technology for locating and tracking objects. A common feature of these techniques that are useful for tracking and locating objects is that they are implemented in a navigation system. By generating or reflecting energy at the object being tracked and sensed, The ability to determine the location.

[0058] In some alternatives, such as that shown in FIG. 1, two optical sensors 40 are employed. In the embodiment, in order to avoid obstructing the view of the surgical site and the tracker present therein, Additional optical sensors may be provided in addition to the first set of optical sensors 40. The optical sensor 40 converts radiant energy, e.g., light, into a signal as a small burst of electrical current. The current can be varied and attenuated, and the current can be transmitted as information between electronic devices.

[0059] The camera unit 36 ​​may also or alternatively include a video camera 41 or other additional sensors. The video camera 41 may include a sensing device (not shown) that is used in the optical sensor 40. For example, the optical sensor 40 may include optical sensing technologies similar to or different from those described herein. configured to sense energy in the infrared or near infrared spectrum. The video camera 41 may be configured to transmit light within the visible spectrum. Good too.

[0060] The optical sensor 40 may be a separate charge-coupled device (CCD). Two two-dimensional CCDs are employed. In some cases, the optical sensor 40 is used for stereoscopic operation. In other alternatives, the optical sensor 40 may be a depth sensor, a laser range finder, or the like. In other alternatives, each may be a separate CCD or Multiple separate camera units 36 having two or more CCDs may be positioned around the operating room. It should be understood that the additional optical sensors may be used to allow the navigation system 20 to Throughout, the surgical site is viewed unobstructed through one or more of the optical sensors 40. The optical sensor 40 detects infrared (IR) radiation energy. The optical sensor may include a complementary metal oxide semiconductor (CCD) that can detect the light. Other sensors, including but not limited to complementary metal-oxide semiconductor (CMOS) active pixel sensors, Singing techniques may also be employed.

[0061] The camera unit 36 ​​is mounted on an adjustable arm or other articulating support structure of the cart assembly 24. The localizer 34 can be mounted on a structure (as described below). A target volume that includes the patient's anatomy and the surgical site where the tracker will be positioned. The imaging device can be selectively positioned using a preferably unobstructed field of view. In this case, the camera unit 36 ​​rotates about a rotation joint to obtain at least In another alternative, the camera unit 36 ​​is adjustable in at least one degree of freedom. The above degrees of freedom can be adjusted. When multiple camera units 36 are used, Each of the may be individually mounted for selective positioning about the surgical environment. The cart structure 24 supports a plurality of adjustable arms to accommodate a plurality of camera units 36. You may support it.

[0062] The camera unit 36 ​​communicates with the optical sensor 40 to receive signals from the optical sensor 40. The camera controller 42 may be connected via a wired or wireless connection. (not shown). One of them can be an IEEE 1394 interface, which provides high speed communication and It is a serial bus interface standard for isochronous real-time data transfer. Suitable connection types include Ethernet, Thunderbolt, USB interface, P Examples of this connection include CI Express and DisplayPort. In another alternative, the navigation The application computer incorporates the functionality of the camera controller 42 and therefore The optical sensor communicates directly with the navigation computer 26 to operate as a navigation controller 42. The signal from the optical sensor is processed by the camera controller 42. Alternatively, the camera controller 42 may transmit the signals to a navigation computer for processing. The signal may be communicated to the navigation computer 26 for processing. In so doing, the camera controller 42 may perform any pre-processing adjustments, reformatting, conversions, etc. It can be carried out.

[0063] The navigation computer 26 may be a personal computer or a laptop computer. The navigation computer 26 is in communication with displays 28, 29. The central processing unit (CPU), other processors, memory units, data storage units, and combinations thereof. The navigation computer includes: The software includes a camera unit 36, a camera controller 42 or the optical sensor 40 to represent the position and orientation of the object being tracked. The position and orientation signals, or data derived therefrom, are converted into Used by the navigation computer 26 for object tracking purposes. The assembly 24, the display 28, and the camera unit 36 ​​were released on May 25, 2010. No. 7,725,162 to Malackowski et al., entitled "Surgery System" Similar to that described in (incorporated herein by reference). It can be said that:

[0064] The surgical system 10, including the navigation system 20, is adapted to interface with various surgical tool systems. FIG. 1 shows a representative available tooling system. Although the present disclosure illustrates a system, other options may be available without departing from the scope of the present disclosure. It should be understood that such technology may be available at any time or in the future.

[0065] The surgical system 10 can be used in conjunction with a cordless power tool. The power tools may include sagittal saws, reciprocating saws, rotary drills, sternal saws, etc. In the example of FIG. The cordless power tool is shown as a cordless power driver 60. It should be understood that other tools may also be used. An example is the System 8 Cordless Dri sold by Stryker. The driver 60 includes a battery unit 61 that supplies power to the driver 60. The battery unit 61 may include a rechargeable battery pack. The battery 61 may be a smart battery pack, which may include a driver Electronics and processors for facilitating communication between 60 and the navigation computer 26 The data module 62 includes a data module having programming.

[0066] The driver 60 includes a driver controller 62 in operative communication with a data module 62. Alternatively, the functions of both the driver controller 64 and the data module 62 may be included. A single computer module may be provided that provides the functionality. 64 controls the operation of the driver 60, triggers 63, 65, driver motor 68, and The driver 60 communicates with other sensors or input controls such as instrumentation. A sensor is included to detect overheating of the driver motor 68 and to control the driver controller 64. This can disable the operation of the driver 60.

[0067] The driver 60 is provided with a tracker 70. The tracker 70 is an active type tracker. The tracker can be a passive or active tracker. An active tracker requires a power source. and actively generates and emits radiation at wavelengths detectable by the optical sensor 40. The active tracking system has an array of markers 72 (also called tracking elements or fiducials) that The marker 72 of the lacquer may be a light-emitting diode (LED), including an infrared LED, for example. The array of active markers may be in an "always on" state or may be in a surgical navigation system. Selectively emit (i.e., emit radiation) in response to commands from the navigation system 20. Such selective firing activation may be operatively turned on. In the case of the tracker, the navigation computer of the surgical navigation system 20 The active tracker can communicate with the sensor 26 via a wired or wireless connection. The receiver may be powered by an internal battery or may receive power from an externally connected power source. The wiring may include a wire.

[0068] Alternatively, the tracker 70 can be a passive tracker. The beam reflects ambient radiant energy or radiant energy emitted into the target space. For example, the camera unit 36 ​​may be equipped with one or more infrared LEDs to detect the marker 7. 2 and then sensed by optical sensor 40. Passive trackers typically do not require a power source.

[0069] Although described with reference to optical techniques including light reflective or light emitting markers, local light Other trackers consistent with the sensing technology of the user may be used. For example, a localizer may include an electromagnetic field generator, and the tracker may employ a coil or coil array. An example of the use of this technique is given in "Coil Arrangement for Electromagnetic Tracking Method a This can be understood from the disclosure of U.S. Patent No. 8,249,689 entitled "Digital Signal Processing System" No. 6,399,945, filed on Oct. 23, 2003, and which is incorporated herein by reference in its entirety.

[0070] The surgical system 10 may also be used with a general purpose integrated console or instrument platform. The general-purpose platform 80 includes a console 82 and a foot switch 4 and a powered surgical tool 86. The console 82 controls the connected tool 86. , and powers it. The instrument 86 may be a small bone orthopedic saw or drill, a high speed drill (e.g. For example, it may be a neurological or spinal application), an ENT shaver, a joint shaver, a bone mill, etc. An example of such a general-purpose platform is sold by Stryker Corporation and is called "System and Method od For Driving An Ultrasonic Handpiece As A Function Of The Mechanical Impedance As described in International Patent Publication No. 2015 / 021216 entitled "The Handpiece of a Compressor," Core 2 Console power tool driver and related tools, in its entirety The console 82 is a console and A data module 88 that facilitates communication with the navigation computer 26. .

[0071] Similar to the driver 60 described above, the instrument 86 is provided with a tracker 90. The tracker 90 is similar to the driver tracker 70 and includes an array of markers 72. 2 can be of the active or passive type and is sensed by a camera unit 36. The instrument 86 is sampled and matched to track and monitor the position and orientation of the instrument 86.

[0072] The surgical system 10 may also be used in conjunction with an ultrasonic aspirator system 100. The wave aspirator system 100 includes a console 102, a foot switch 104, and an aspirator tool. The console 102 controls and powers the connected aspirator tool 106. An example of such an ultrasonic aspirator system is sold by Stryker Corporation. The SONOPET iO Ultrasonic Aspirator is a The controller 102 is a device that facilitates communication between the console and the navigation computer 26. The controller 104 includes a data module 108.

[0073] The tool 106 includes an implement tracker 90 and a tracker 110 similar to the driver tracker 70. The tool tracker 110 tracks and monitors the position and orientation of the tool 106. The active or passive sensor 34 is sensed by the camera unit 36 ​​to detect the active or passive sensor. The driver tracker includes an array of markers 72, which may be passive. 70, the implement tracker 90, and the tool tracker 110 distinguish based on the arrangement of the markers 72. It is possible. Based on the description provided herein and the term "tool tracker" or "instrument tracker" etc. The names are not intended to be limiting, but merely for use with this disclosure. Used to distinguish between available surgical items. The tracker was updated on May 25, 2010. No. 7,725,162, entitled "Surgery System" to Malackowski et al. No. 2, the disclosure of which is incorporated herein by reference. The Tracker is incorporated herein by reference in its entirety. "Navigation Systems and Methods for Indicating and Reducing Linguistics" by Malackowski et al. As shown in U.S. Patent No. 9,566,120, entitled “Echo-of-Sight Errors,” No. 6,399,623, the disclosure of which is incorporated herein by reference. In yet another alternative, the tracker is attached in other manners as is conventional in the art. This may also be the case.

[0074] Although shown as separate structures attached to and extending from the surgical object, The lacquer may alternatively be integrated into the structure of the article itself. For example, the marker 72 may be In yet another alternative, the article may be formed directly into the structure of the tool or implement to be traced. The structure or characteristics of the device itself can be used as a tracker, eliminating the need for dedicated markers. In this case, the surface or edge of the article becomes visible to the navigation system, and the position of the article is determined. Additionally, markings or patterns may be used to track the location and orientation of an article. It may be included on a surface and used as a tracker, e.g., a linear barcode, or a 2D Barcodes (also known as QR codes) are used to manually track items. The features can be featured on the surface of the article that remain visible to the camera unit 36 ​​throughout the procedure. do.

[0075] Continuing with FIG. 2, the surgical system 10 is shown with a console 82, foot switches 84 and instruments. In an exemplary surgical environment for use with the universal tool platform 80 including 86, The surgical site includes a C-arm computer to provide intraoperative imaging of the patient's anatomy. A computed tomography (CT) system 120 is also provided. However, other imaging techniques, including MRI, X-ray, or videography, are being employed for intraoperative imaging. Generally, regardless of the technology selected, the imager is The information from the imager is then transferred to a 3D model of the tissue to be treated in the procedure. The process of preparing the virtual representation is The analysis can be done through segmentation of the image data. The process may be automated using machine learning. An exemplary process is No. 1,019,662 entitled "Image Analysis" issued on 20 U.S. Patent No. 8, entitled "Image Processing Method," issued on October 21, 2014. The information from the imager is used to measure the tissue to be treated. The tissue model is navigated by fixing a further tracker, the patient tracker 130, to the The images can be displayed in the imaging system 20 and tracked during the surgical procedure.

[0076] First, the object to be located and tracked during surgery is observed by an optical sensor. The object to be tracked is selected and inputs connected to the navigation computer 26 are By using a force device, objects can be identified. The navigation computer 26 may store a large amount of data in memory or data storage on the navigation computer 26. Detailed information about a number of objects can be stored, and the user can select objects from the object database. ,The objects to be tracked can be manually selected.

[0077] Additionally or alternatively, the navigation computer 26 may determine the location of the surgical site based on the preoperative surgical plan. In this case, navigation computer 26 may use a pre-determined time series to identify the object to be tracked. A preset list of workflow objects that can be used in the described surgical workflow. The navigation computer 26 may use software to implement a workflow. - It can actively search for and locate objects. For example, it can find different The size and shape of the pixels associated with the object may be stored in the navigation computer 26. By selecting or identifying the object to be located and tracked, the software: Corresponding pixels are identified and the software then uses conventional pattern recognition techniques to identify the corresponding pixels. The method operates to detect similar groups of pixels.

[0078] Additionally or alternatively, the object being located and tracked may be a An image capture device that draws or selects an object to be tracked on one or more displays 28, 29. For example, the optical sensor 40 or The image of the surgical site captured by the video camera 41 is displayed on one of the displays 28 and 29. The user may then use a mouse, digital pen, etc. , tracing the object to be located or tracked on the display 28 or 29. The software stores the pixels associated with the traced object in its memory. Each object can be identified by a unique identifier, such as by naming the object using clothing. This allows the stored pixels to be associated with a unique identifier. In this way, multiple objects can be stored. These objects are later detected using pattern recognition and related software. The navigation system 20 continuously captures images, reviews the images, and selects objects associated with them. By detecting the movement of the pixels that correspond to the object, the movement of these objects can be detected.

[0079] In conventional surgical navigation systems, the object to be tracked is first The pointer P is used to position the object. For example, the navigation pointer P is The navigation computer 26 may have a pointer tracker PT. The initial data corresponding to the location of the tip of the pointer P relative to the pointer PT can be stored. , whereby the navigation system 20 is positioned in the localizer coordinate system LCLZ. The location of the tip of the interferometer can be identified and tracked. Thus, the start of the surgical procedure Before, once all the objects are in their desired locations, one of the users can While identifying an object in the navigation system 20 using one of the force devices , all objects can be touched with the pointer P. So, for example, if the user When the tip of the pointer P touches the tool 86, the user can input the simultaneously triggering the acquisition of that point in the localizer coordinate system LCLZ (via the Once the points are collected, the user can select the object (by typing, pulling from a list of objects, etc.) The identity of the object can also be entered into the navigation software (e.g. via a navigation selection). Cut.

[0080] As shown, the camera unit 36 ​​captures the markers 70, 90, and 110 of the trackers 70, 90, and 110. 2 and provides navigation signals regarding the position of the tracker relative to the localizer 34. Based on the received signal, the navigation computer 26 The computer 26 determines the relative positions and orientations of the trackers 70, 90, 110 with respect to the localizer 34. The data indicates the direction of the rotation.

[0081] Prior to the start of the surgical procedure, additional data is loaded into the navigation computer 26. The position and orientation of the trackers 70, 90, 110 and the geometry of the object to which the trackers are attached. Navigation based on previously loaded data such as virtual object data representing the shape The computer 26 controls the working end of the surgical object (e.g., drill point, aspirator tip, etc.). and the orientation of the article relative to the tissue against which the working end will be applied.

[0082] The navigation computer also indicates the relative position of the working end of the surgical instrument with respect to the tissue. This information is rendered into a useful image and displayed on a display 28, 29. Based on the display, the user can determine the degree of tissue damage at the surgical site. The relative positions of the working ends of the surgical instruments can be viewed. As mentioned above, a touch screen 30 or other input / output device is provided to allow input of commands. It may include.

[0083] Next, as shown in FIG. 3, tracking of objects at the surgical site is generally performed using the localizer coordinate system The localizer coordinate system has an origin and relative x-axis, y-axis, and The localizer can be maintained in a stationary position during surgery. An accelerometer (not shown) mounted on the camera unit 36 ​​is preferably The localizer coordinate system LCLZ may be inadvertently changed by the surgeon. It can be used to track sudden or unexpected movements.

[0084] Each tracker 70, 90, 110 associated with a surgical object or a patient's anatomy It has its own coordinate system separate from the LCLZ coordinate system. The coordinate system associated with the tool tracker 90 has its own origin and relative x-, y-, and The navigation system 20 has a direction and an orientation that defines a z-axis. Based on this, the relative change in tracker origin and orientation with respect to the localizer coordinate system can be calculated. and monitors the position and orientation of the surgical object and the patient's anatomy.

[0085] During the initial stages of the surgical procedure, the tracker is The pose of each such item is fixed to the anatomy being measured. The pose of each such item is calculated using the tracker's coordinate system This alignment or calibration step allows the tracking item to be mapped to A fixed relationship is generated between the virtual representation of the geometry and the coordinate system of the associated tracker. In this way, the sensed movement of the tracker is detected by, for example, the localizer LC to the navigation computer 26 for other tracked objects in the common coordinate system of LZ The corresponding movement of the tracked item by the vehicle can be virtually represented.

[0086] Navigation systems have been used in conjunction with robotically controlled surgical systems; To provide navigation guidance for manual surgery using powered surgical tools Improved methods are needed. In accordance with the present disclosure, a method for providing an instrument to a patient's anatomy includes the steps of: An improved method of navigating a surgical instrument to verify tip position is provided. do.

[0087] In a first exemplary case, the surgical instrument includes a variable speed motor, such as driver motor 68. The variable speed motor is controlled by a controller. For example, the variable speed motor is In the case of driver 60, the control signal may be received from driver controller 64. , in the case of the universal tool platform 80, a control signal that controls a variable speed motor within the implement 86 may be received from the general console 82. The following description is not intended to be construed as being specific to a particular tool or tool type. This is not intended to be limiting and is not intended to be a method or The system may incorporate other now known or later developed surgical tools, tool systems, etc. Furthermore, the steps of one method may be implemented in the context of any other method. and features of one disclosed system may be practiced in any manner that falls outside the scope of the present disclosure. It may be practiced without and with any other features.

[0088] Although the previous paragraphs have been described with respect to control signals for a variable speed motor, this is not a limitation. Other alternative actuators are contemplated within the scope of this disclosure. For example, in the case of an ultrasonic aspirator: A variable speed motor is not employed, rather control signals from the aspirator console 102 control the aspirator tool. The aspirator tool 106 may control the operation of the aspirator tool 106, for example, by a tool actuator and A hollow tip that vibrates longitudinally along its axis, driven by a piezoelectric transducer as a The vibrations occur at frequencies corresponding to ultrasonic waves. The longitudinal vibrations of the tip The membrane is destroyed by the numerating effect. The high frequency vibration generates heat, so the protective shield The tip carries fluid to irrigate the tip. The irrigation intensity controls the application of heat from the tip to the tissue. If the irrigation is small, it can be modified as necessary. The generated heat can be used for cutting or coagulation purposes. Suction is applied via the aspirator tool 106. This can be used to remove fragmented tissue and also provide irrigation through the tip. By monitoring the operating characteristics of the control signal, the system determines whether the tool tip is in free space. It can detect when it is operating or when it is operating in contact with tissue.

[0089] Regardless of the type of surgical object, it is not possible to operate the object while it is in free space. and actuating the article while the article is in contact with the patient's anatomy, including bone or soft tissue, such as skin. The electric driver 60 or the variable speed motor may have different characteristics. For other articles that operate in free space, the power supplied to the motor is A drill, burr, or other tool type contacts tissue for material removal. When there is resistance applied to the rotation of the motor, such as when the motor is rotating, the Unless the power being applied is regulated, the rotation speed may decrease. For example, if the tool is In order to maintain a constant rotation speed, the current or voltage is adjusted to maintain a constant rotation speed when there is no contact with tissue. Similarly, other actuators may be employed and driven by motors. The tool may operate under a first condition when not in contact with tissue, and may operate under a second condition when in contact with tissue. The non-motor driven vehicle may operate under a second condition different from the first condition when the non-motor driven vehicle is in operation. Dynamic tools may also be practiced with the described methods and systems disclosed herein. It is intended that

[0090] A controller that drives the surgical article communicates with sensors on the article to operate the article. For example, in the electric screwdriver 60, The driver controller 64 controls the instantaneous rotation speed, applied power, and current of the driver motor 68. The device may receive signals indicative of pressure, current, temperature, etc. These signals are sent to the control unit several times per second. For example, the frequency is about 60 Hz, about 100 Hz, The frequency may be about 1000 Hz, or other suitable frequency. In other examples that do not employ a motor, a controller, in this case the aspirator console 102, may receive one or more signals indicative of the operational status of the item, i.e., the aspirator tool 106. Specifically, the aspirator console 102 measures the temperature at the tool tip, The flow rate of irrigation applied, vacuum applied to aspiration, etc. can be monitored.

[0091] The controller may include memory or data storage, or The may communicate with data storage, thereby recording operating conditions against recorded time. The controller may record the operating state when the surgical object begins to operate. The controller may start the operation and may continue it for the entire duration of the operation. The monitored operating conditions are analyzed to determine whether the surgical object is operating without contacting the patient's anatomy. A first characteristic operating state can be defined when the surgical object is in contact with the patient's anatomy. A second characteristic operating state may be further defined when the monitored The operating conditions can be defined according to the particular tool. For motor-driven tools, the operating conditions are may be applied power, current, voltage, rotational speed, etc.

[0092] As discussed above, the navigation system 20 may be used to navigate surgical items and the patient throughout a surgical procedure. The navigation system 20 tracks and monitors the position of the subject's anatomy. Through the operation computer 26, one or more computers control the surgical items employed in the surgical procedure. The monitored operational status of the surgical object is utilized to track the surgical object. The trace location can be verified and, if necessary, an error condition can be determined.

[0093] The navigation system 20 maintains a virtual representation of the surgical objects and the patient's anatomy. , and their relative positions are illustrated and visually rendered on the displays 28, 29. However, during surgery, the tracker may become displaced due to wear on the tools or tissue from the patient. De-texturing can change the fidelity of the virtual model to its physical counterpart. Therefore, the accuracy and reliability of the virtual representation in the navigation system 20 for the surgical procedure is improved. The reliability of the virtual representation in the navigation system 20 may be adversely affected. Comparison with operational conditions can provide important validation of system accuracy. In general, the navigation system 20 interfaces a virtual model of the surgical object with the patient's anatomy. indicates contact between the article and the anatomy, but the operating condition indicates no contact between the article and the anatomy If so, an error condition is determined and appropriate corrective action can be taken.

[0094] FIG. 4A illustrates a surgical object and a surgical device in a first relationship in which there is no contact between the surgical object and the biological structure. The anatomy of a patient is shown. In the illustrated example, the surgical object is an instrument 86, specifically a tool. The portion of the instrument 86 that includes the tip 87. The subject of the surgical procedure is a living patient, as shown in FIG. The body structure is a bone (vertebra V). The instrument 86 is energized by a general purpose console 82. The general purpose console 82 can control the power, voltage, current, and / or rotational speed of the instrument 86. The operating parameters of the instrument 86, which includes the first The first movement is in free space, i.e., no contact with the bone (vertebra V). According to the monitored parameters for operation in the space, the console 82 It can be attached.

[0095] FIG. 6 shows an example graph 160 of motor operation over time. In the first phase 162 indicates that the instrument is not powered and therefore motor operation is at its lowest level and is stationary. At some later time T1, the appliance is powered on and enters the first operating state 164. The patient's anatomy is then contacted at T2 during the surgical procedure. While in contact with the tissue, motor motion is at a higher level 166. The instrument is then moved to the tissue after the procedure. It is released from contact with the structure (168) and can then return to an unpowered state (170). .

[0096] FIG. 4B illustrates an exemplary user interface displayed by the navigation system 20. The navigation system 20 is configured to align the instrument 86 with the bone to be contacted (the vertebrae). V) on the display. It is divided into several sections, each of which can display different information. In a first section 142 of the user interface 140, the surgical items and the patient are The virtual representation of the anatomy may be (1) stored in the memory of the navigation system 26; (2) an optical sensor that reads the instrument tracker 90 and the patient tracker 130; The location of the surgical object and the patient's anatomy are determined based on the data detected by the sensor 40. The relative position is shown based on.

[0097] The navigation system 20 determines whether the surgical object is in contact with the patient's anatomy. or comparing the determined relationship as not being in contact with monitored operating parameters; The accuracy of the navigation guidance can be verified. In the example, an error condition exists and the navigation system 20 detects the tool tip of the instrument 86. Although it is determined that the end 87 is in contact with the vertebra V, the monitored motion parameters 4A, with the tool 86 in a position such that there is no contact between the tool tip 87 and the vertebra V. This corresponds to the above.

[0098] The navigation system 20 or console 82 may take action in response to determining the error condition. For example, a toolbar area of ​​the user interface 140 can be used to trigger an action. A visual alert 144 may be activated within area 146. The visual alert 144 may be Other visual alerts may be flashing or blinking indicator lights on the rear of the device. Alternatively, or in combination, on the console 82, the computer cart assembly 2 4, on the camera unit 36, or elsewhere. A visual alert may be a prompt for user action, an indication of information, or any other form or form of The information may take the form of a presentation, photograph, etc.

[0099] Other actions may also be triggered depending on the determination of an error condition. Actions can include displaying specific information about the error condition, or correcting the error condition. In Figure 4B, this may include suggesting corrective actions to In this case, the error information 148 is displayed in the first section 14 of the user interface 140. 2. Error information 148 is a message that an error has been detected. The error information 148 can indicate the nature of the error, in this case The navigation system 20 determines that the instrument 86 is in contact with the bone, i.e., the vertebra V. Although the tool is moving, the motor motion indicates that there is no contact between the tool and the bone. The report148 may, alternatively or in combination, recommend corrective actions; , it may be possible to indicate what a preferred corrective action for a particular situation might include. The navigation system determined that there was contact between the bone and the tool, but the motor motion If the tissue does not show contact, corrective action is to remove the tissue from the bone and The bone model was updated to reflect that the actual bone surface was no longer reflected in the virtual model. You may need to renew it.

[0100] Actions triggered upon detection of an error condition may be in addition to or instead of a visual alert. Triggered actions may include sounding an audible alert. and activating a tactile alert, cutting power to the surgical instrument, or any combination thereof. Sounding an audible alert may include one or more of a combination of any type of sound. The display of a visual alert may include a voice alarm, beep, buzzer, etc. The display 28 of the navigation system 20 may display a prompt indicating the nature of the error condition. , 29. Activating the haptic alert may include displaying the haptic alert on one or more of the This includes energizing the vibration function of the tool or foot switch, or both. Vibrations can be used to help users distinguish between different types of errors based solely on the type of vibration. can be characterized as a pattern of oscillations associated with a type of error. This may also be the case.

[0101] Another situation is shown in Figures 5A and 5B. In Figure 5A, the tool tip 87 of the instrument 86 is In this situation, the motor operation is monitored as shown in FIG. At time T2, the console 82 The motor motion is in free space, i.e., when the tool tip 87 of the instrument 86 is in contact with the bone. The first operating state 164, which corresponds to no contact, is no longer in the operating state. The sole communicates with the navigation computer 26 and includes a tool tracker 90 and a patient tracker. Based on the optical sensor data corresponding to the laser 130, the determined positions of the tool tip and the bone are At time T2, the tool-bone offset D can be calculated. The motion system measures the determined position of the tool tip 87 longitudinally along the length of the instrument 86. Measure the distance D between the tool and the nearest surface of the bone (vertebra V). This distance is the tool-bone interface. This value is displayed in the display area 28, 29 as a numeric measurement value of 150. The system can display the monitored motor motion relative to the fixture in free space. , i.e., not at the first level of magnitude corresponding to the operation of the instrument not in contact with the bone. Each time the tool is moved, the tool-to-bone offset may be measured. As shown in FIG. 6 at time T2, for example, every time the tool is in contact with the bone, the motor motion The signal includes a change in magnitude from a first level to a second level corresponding to motor operation. It is okay to be swallowed.

[0102] The tool-to-bone offset value may change over time as the surgical procedure progresses. Measurement 150 is a continuously updated value that changes based on the most recent evaluation of the tool-to-bone offset. In addition, by recording and displaying historical data, users can easily Track and monitor set trends and their magnitude for precise navigation guidance Recognize that if the risk of contamination increases to unreliable levels, corrective action may be required. For example, as shown in FIG. 5B, a portion of the user interface 140 may include Includes a graph of tool-to-bone offset values ​​152 that tracks and displays values ​​that change over time. Graph 152 shows the current value on the right side of the graph, and a trend line 154 of past values. , scrolling toward the left side of the display. The illustration is not intended to be limiting. It is not intended to be limiting and other graphic formats are contemplated without departing from the scope of this disclosure. do.

[0103] Tool-to-bone offsets are monitored and displayed to inform the user of the system status. For example, a numerical measurement of 150 can be expressed as a number depending on the size. Visual alerts 144 can be used to alert the user to a change of state. , illuminate in different colors, or flash at different frequencies. Enter the tool-to-bone offset threshold to trigger an action of type This may be programmed or the user may be prompted.

[0104] In one example, the tool-to-bone offset may be maintained at less than 0.50 mm. Or it may trigger a response action, such as turning off power to the appliance. It may be desirable to alert the user to a change in condition before the value is reached. 150 is displayed in the first color for values ​​between 0.00 mm and 0.25 mm The numerical measurement 150 can range from 0.25 mm to 0.4 mm. The numerical measurement 150 may be displayed in a second color different from the first color. For values ​​greater than 100%, the value may be displayed in a third color different from the first or second colors. Similarly, trendlines can be displayed in different colors as the values ​​change. The color may be green, the second color may be yellow, and the third color may be red. Provided as an example and not intended to be limiting.

[0105] In either the state shown in FIG. 4A and FIG. 4B or the state shown in FIG. 5A and FIG. 5B, the system It can alert users to error conditions and advise them on potential corrective actions. The preferred corrective action may depend on the particular error encountered. If an error condition occurs due to a broken or worn tool, the corrective action is to replace the tool. In another example, an error condition may occur when a tracker becomes displaced from its relationship to an associated tracked object. or the Navigation Cart Assembly is shaken or bumped. If so, it may be appropriate to realign the tracker with respect to the object in the localizer coordinate system. These examples are intended to be illustrative and limiting. It's not something like that.

[0106] FIG. 7 illustrates a first method 40 of navigating a surgical instrument having a variable speed motor relative to a bone. The method includes using a navigation system 20. As described above, the motion control system 20 includes a localizer having a localizer coordinate system and an external The method includes an instrument tracker connected to the surgical instrument and a patient tracker connected to the bone. A controller is used to communicate with the navigation system and control the surgical instruments.

[0107] In a first step 402 of the method 400 shown in FIG. 4, a user connects the patient tracker to a bone. Aligning the patient tracker ensures that the patient tracker coordinate system is localized to the This step also locates the bones relative to the patient tracker and The navigation system then determines the orientation of the patient tracker based on the detected movement of the patient tracker. The position and orientation of the bones are tracked and monitored based on the position and orientation of the bones in the navigation system. The virtual representation can be updated.

[0108] In a second step 404, the user aligns the instrument tracker with the surgical instrument. By aligning the instrument tracker, the instrument tracker coordinate system is aligned with the localizer coordinate system. This step also determines the location of the instrument tool tip relative to the instrument tracker and The navigation system determines the orientation of the instrument tracker based on the detected movement of the instrument tracker. and tracking and monitoring the position and orientation of the instrument tool tip based on the navigation system. The virtual representation of the fixture can be updated.

[0109] The method includes, at step 406, determining whether the surgical instrument or tool tip is in contact with the bone. The method includes defining the operation of a motor of the article. This defining step includes characterizing the operation of the motor. The power, voltage, current, rotational speed, or other operating parameter or combination of parameters The data representative of the operational parameters may include evaluating at least one of the alignments. may be stored in a memory of a controller that controls the operation of the surgical instrument. Alternatively or additionally, data may be sent from the controller to a navigation system. As a further alternative or in addition, the data may be stored in a memory or device embedded in the surgical instrument itself. The configuration may be stored on the tool or on another device in communication with the console.

[0110] During surgery and the operating parameters define the motor operation in free space. After the analysis, the method continues at step 408 by the controller controlling the motor operation of the tool. The monitoring includes periodically receiving a signal indicative of motor operation. and recording the signal as data representative of the operation of the motor when the signal was received. In this manner, the controller creates a record of motor motion over time during a surgical procedure. It can be achieved.

[0111] Concurrently with monitoring the motor operation, the method includes, in step 410, and monitoring the position of the tool tip of the instrument relative to the patient's bone using the stem. The trackers attached to the bones and the vertebrae are sensed by the navigation system. Based on the previous alignment, the relative positions of the tool tip and bone are determined by the navigation system. The system can calculate the temperature and humidity, and if necessary, can display it virtually on the display. As part of monitoring the tool tip and bone position, the navigation system It is possible to determine when contact is made between the instrument and the bone in the localizer coordinate system. can.

[0112] If it is determined that contact between the instrument and the bone has been made, the method continues at step 412. , comparing motor operation to a monitored position of a tool tip of the implement. A navigation system in communication with the instrument can assess motor operation. The evaluation included motor motion of the instrument when the tool tip was not in contact with the bone. The motor operation is considered to match the actual motor operation.

[0113] The navigation system determined that the instrument was in contact with the bone based on the tracking position. If motor motion indicates that the instrument is not currently in contact with the bone, the method In step 414, an error condition is determined. This reflects an anomaly that has entered the system. If the traced positions do not reflect the true physical positions of the instruments or bones, the navigation system Therefore, the accuracy and reliability of the system cannot be relied upon.

[0114] If an error condition is determined, the method continues at step 416 with a Triggering actions accordingly so that appropriate corrective action can be taken. .

[0115] In one alternative, the method optionally further comprises: and defining a second motor operation of the instrument when the tool tip of the instrument is not in contact with the bone. A data set representing operating parameters of the second motor operation as well as the first motor operation of the instrument when not in use is provided. The data includes power, voltage, current, and rotational speed, which characterize the operation of the motor while in contact with the bone. , or other operating parameters, or combinations of parameters. The data representing the second motor operation may be transmitted to a controller that controls the operation of the surgical instrument. Alternatively or in addition, the data may be stored in the controller. Thus, the data may be communicated to a navigation system. It may be stored in memory built into the surgical instrument itself.

[0116] Defining a second motor motion when the surgical instrument is in contact with the bone, the method further comprises: Although the monitor position of the tool tip of the model is not in contact with the bone in the localizer coordinate system, A second definition of motor motion is the motor motion when the tool tip of the instrument is in contact with the bone. The method can include determining a second error condition when the motor motion equals the determined motor motion. Upon determining that a second error condition exists, the method triggers a second action. This may include verifying that the problem is resolved so that appropriate corrective action can be taken.

[0117] For any of the above error conditions, the resulting action is an audible alert. sound a sound, display a visual alert, activate a tactile alert, or use a surgical instrument The above may include one or more of the following: Sounding an alarm may include any type of audio alarm, beep, buzzer, etc. Displaying a visual alert provides a navigation prompt indicating the nature of the determined error condition. The method may include displaying the visual alert on one or more of the displays of the application system. The visual alert may also include illuminating a light, such as an LED light, on the surgical instrument itself. , or any other visual type indication that an error condition has been determined. Activating the vibration may include energizing a vibration feature on the instrument or a foot switch. The vibration allows the user to distinguish between different types of errors based solely on the type of vibration. The error may be characterized as a pattern of oscillations associated with a type of error, such as .

[0118] Figure 5. A surgical instrument with a variable speed motor is navigated relative to the bone and the tool-bone off-axis is driven. A second method 500 for determining the set is shown. The second method 500 is similar to the first method 40 described above. 0. The steps of the second method 500 are performed to detect whether such similarities exist. It can be defined in relation to the steps of the first method 400. Specifically, 00 includes a navigation system, a surgical instrument, an instrument tracker, and The patient tracker is employed. Similarly, the controller communicates with the navigation system and Provide power to surgical instruments.

[0119] The second method 500 includes steps similar to steps 402 and 404, in which the patient tracker is aligned with the bone. The method includes aligning the instrument tracker to the surgical instrument in step 502, aligning the instrument tracker to the surgical instrument in step 504, and The second method 500 also includes a first step of applying a surgical instrument while the instrument is not in contact with the bone. This includes step 506, which defines the motor operation, which is the same as step 406 described above. Further similar to the first method 400, the second method 500 includes steps 408 and 409. 5. Monitoring motor operation with a controller, as in 508; and a navigation system to monitor the position of the tool tip of the instrument relative to the bone. Includes Top 510.

[0120] Unlike the first method 400, the second method 500 includes, in step 512, and comparing the determined motor motion to a determined first motor motion, the comparison comprising: This can be done repeatedly over time in successive cycles at regular intervals during surgery. 500 also performs step 514 to determine whether the comparison in step 512 results in a When the monitored motor operation is no longer the first motor operation, the tool position of the tool This involves determining the contact time (or point of contact) between the end and the bone. The dynamically monitored characteristics are defined as characteristics that represent the motor operation when the instrument is not in contact with the bone. If the motor motion changes from the first one, the time of contact between the instrument and the bone can be determined. do.

[0121] Once the time point of contact between the instrument and the bone is determined in step 514, the second method 500 In step 516, the navigation system is used to determine the device at the time of contact. The tool-bone distance is defined as the distance between the tip of the tool and the surface of the bone in the localizer coordinate system. A navigation system that monitors the position of the tool tip of the instrument and the bone. The motion system is defined as the monitored motor motion when the instrument is not in contact with the bone. Based on the controller's determination that the first motor motion is no longer the first motor motion, the tool tip A signal may be received from the instrument controller indicative of contact between the part and the bone.

[0122] Given the contact time, the navigation system calculates the tracked position of the tool tip and bone. When the navigation system determines that the tool tip has left the bone, The distance between the closest point of the tool tip in the isothermal coordinate system and the bone surface is calculated. In this case, the navigation system detects deviations from the defined motor behavior by the controller. Based on the determination, the tool tip is inserted into the bone a certain distance, assuming a contact point. In this case, the navigation system can determine that the tool tip is in the Calculate the perpendicular distance of the maximum penetration depth at any point on the bone surface. The distance is the tool-to-bone offset. In other words, the tool-to-bone offset is , the accuracy between the true physical position of the tool relative to the bone and the virtual representation of the tool's position relative to the bone. It is a measure of margin.

[0123] As mentioned above, there are several factors that can cause or increase the tool-bone offset. If the trackers are displaced or deformed after they are aligned, this can result in a decrease in navigation accuracy. Similarly, if the navigation cart assembly is shaken during surgery, If the camera unit shifts due to collisions, this can also lead to reduced navigation accuracy. Other factors include tool wear, tool deformation, or the removal of all tissue from the bone. To maintain consistent and highly accurate navigation, Therefore, it is preferable to keep the tool-bone offset small.

[0124] If the tool-bone offset becomes too large, the accuracy of the navigation guidance will be compromised. Therefore, the second method 500 may require corrective action. Step 518 for triggering an action if the interbone offset exceeds a given amount In one example, the predetermined size is 0.5 millimeters. When the instrument contacts the bone as determined by a change in motor motion monitored by The navigation system determined that the tip of the tool was 0.5 millimeters from the bone surface. Although described with reference to particular dimensions, this is not intended to be limiting. Additionally, different limitations may be applicable to different tools or different applications of the same tool. This step 518 of triggering an action may be performed based on the determination of an error condition. This is similar to step 416, which triggers an action in response to the result. The options, as described above, may include sounding an audible alert, displaying a visual alert, or providing a tactile Activating a visual alert, cutting power to the surgical instrument, or a combination of both. The embodiment may include one or more of the following:

[0125] To provide information to the user, the second method 500 automatically calculates the tool-to-bone offset value. The method may further include displaying the information on a display of the navigation system. The user may then use the navigation guidance provided by the navigation system. The accuracy of the procedure can be tracked and monitored. The step of determining the tool-bone offset may be repeated multiple times throughout the procedure; For example, the controller may determine the time of contact between the instrument and the bone based on changes in motor motion. The tool-to-bone offset display may be repeated each time the tool is determined. It may be a value that is continuously updated each time the setting is executed. Tool-to-bone offset value In addition to a numerical presentation of the data, this information may be displayed as a chart or line graph of values ​​over time. This may also be the case.

[0126] To further assist the user, the tool-to-bone offset value varies based on its size. For example, the size can be displayed as small as possible (tool-bone offset The first color indicates that the navigation guidance is accurate and the If the number of colors is large, the number of colors may be displayed in a second color different from the first color. If the number of colors is larger than the first and second colors, the color may be displayed in a third color different from the first and second colors. Combinations or visual representations may be employed as well.

[0127] To facilitate this dynamic display of tool-to-bone offset values, the second method 500 includes a The step of defining a magnitude of the first level and a magnitude of the second level may be included. The magnitude of the first level and the magnitude of the second level are set as default values ​​in the system. Alternatively, the magnitude of the first level and the magnitude of the second level can be determined as follows: It may be entered by the user at the start of operation or during system setup operations. In an example, the magnitude of the first level may be 0.25 mm and the magnitude of the second level The size may be 0.4 millimeters.

[0128] In one example, if the tool-to-bone offset is determined to be less than the magnitude of the first level, The displayed value can be presented in green. The tool-bone offset is the second level of magnitude. If it is determined that the offset is less than the tool-bone offset, the displayed value may be displayed in yellow. If the bit is greater than a second level of magnitude, the displayed value may be presented in red. These color designations are not intended to be limiting, but merely illustrative. In another case, the dynamic display of the tool-to-bone offset changes the color of the displayed value. Alternatively, or in addition, variable sizes may be utilized.

[0129] The first level magnitude and the second level magnitude of the tool-bone offset value are also Triggering one or more of the actions in step 518 of method 500 of claim 2. For example, when the tool-bone offset reaches the first level, If the tool-to-bone offset is exceeded or exceeded, a visual alert may be triggered and When the second level of loudness is reached or exceeded, a visual and an audible alert are generated. A combination may be triggered.

[0130] In addition, the magnitude of the third level is also the magnitude of the first level and the magnitude of the second level. The third level of magnitude can be defined in the same or different way as the system. Tool-bone offset determining when to disable power from the controller to the surgical tool When the tool-to-bone offset reaches the third level of magnitude, This could compromise the accuracy of the navigation system and pose a risk of harm, so The surgical instruments must be rendered unusable until action is taken.

[0131] As mentioned above, the navigation system is designed to detect certain errors or tool-bone offsets. Depending on the determined value of the set, corrective actions may be taken to improve the accuracy of the navigation guidance. It can alert users to conditions that require action. Several different corrective actions are available: Therefore, the appropriate fix may vary depending on the specific error you encounter. If the error condition results from a broken or worn tool, the corrective action is to replace the tool. In another example, an error condition may be detected by tracking the associated tracked object. If the damage is caused by displacing the force or if the navigation cart assembly is shaking or shaking When the tracker is realigned to the object in the localizer coordinate system, Remedial action may be appropriate.

[0132] In another example, in surgical procedures where large amounts of tissue are removed, the virtual representation of the anatomy can no longer be To improve this situation, virtual representations of the anatomy are used. Additional imaging, modeling, and alignment are required to redefine the location of the tissue surface within the In one example, the surgical instrument is not powered and the surgical instrument is placed in contact with the anatomy. Use the pointer to touch off multiple points on the resection surface and navigate You can redefine the surface of the virtual representation of the bone by creating a new point cloud for the motion system. Cut.

[0133] The disclosed method includes the steps of: The surgical system can be practiced using a surgical instrument equipped with a variable speed motor. The surgical instrument includes a power supply for providing power to the surgical instrument and a tool tip. The controller is in operative communication with the motor of the appliance. and a processor and information representative of the monitored motor operation. and a memory operable to store information including the information in the form of a signal. The system also includes a and a patient tracker connected to the patient's anatomy.

[0134] The surgical system also includes a navigation system. , a localizer and a navigation computer. The navigation computer The present invention relates to a virtual space, a processor, and a memory, the memory being configured to store a local information including information representative of the surgical instrument relative to the riser coordinate system and information representative of the patient's anatomy; Based on the information collected by the localizer, the navigation system: The localizer is operable to track the position of instruments and bones in the virtual space during surgery. aligns the position of the instrument tracker and the position of the patient tracker with respect to the localizer coordinate system. The device tracker and the patient tracker cooperate to obtain information on the position of the device and the bone. The device is operable to collect

[0135] The controller and the navigation system are in electronic communication and are designed to cooperate with each other. During surgery, the controller and navigation system control the motor movement of the instruments. Based on the change in the motion, the controller determines the time of contact between the tool tip and the bone. The navigation system also synchronizes the tracked position of the tool top with the bone track at the time of contact. Calculate the tool-bone offset as the distance between the measured position.

[0136] The surgical system may further include an alert device. The system further communicates with the alert device to notify the user when the tool-to-bone offset is greater than a predetermined amount. The alert device operates by triggering an action when the on the board 82, on the computer cart assembly 24, on the camera unit 36, or on the operating environment. Other visual alert devices such as lights or displays in other locations within the grounds may also be included. Visual alerts may be prompts for user action, informational displays, or other shapes, forms, or effects. The alert device may be in the form of a speaker, a bell, a horn, a buzzer, etc. Other audible alerts may include tones, alarms, prerecorded The alert device may include a recorded message, etc. The alert device may be perceptible to the user by vibration, etc. The device may include a tactile alert device capable of generating a tactile alert that is capable of sensing a tactile sensation.

[0137] In a configuration where the tracker is properly aligned with the surgical instrument and the patient's anatomy: The user places the unpowered tool tip of the surgical instrument in contact with the patient's anatomy. The navigation system can determine whether the tool tip is aligned in a common coordinate system without gaps or overlaps. Accurately determine contact with the patient's anatomy. However, the tracker, surgical instruments, or the biological structure is deflected or deformed, or the camera unit of the navigation system is obstructed. This can cause the alignment to be inaccurate. Therefore, the tool needs to be powered. and therefore the absence of tools operating in free space or in contact with the patient's anatomy. The navigation system performs the alignment verification operation that is not dependent on any parameters. It is desirable to provide a method for performing the above steps so that the user can be sure that the anatomy is not affected by the tool. The tool tip of the surgical instrument is placed in static, unpowered contact with the patient's anatomy so that the surgical instrument is Position the device and hold it there to allow the navigation system to verify alignment. It can be triggered.

[0138] As shown in Figure 9, surgical navigation was performed during surgery to verify tracking registration. A method 600 for operating the system is provided. In the method 600, a surgical navigation system As described above, the imaging system includes a localizer having a localizer coordinate system and a surgical An instrument tracker coupled to the instrument and a patient's anatomy, such as a vertebra, other bone, or soft tissue. and a patient tracker coupled to the patient anatomy. References to the patient anatomy, to a particular bone, or to bones in general are The method 600 should be broadly construed to include navigating, soft tissue, and other non-bone applications. A controller is used to communicate with the gating system and control the surgical instrument.

[0139] In a first step 602 of the method 600, a user aligns the patient tracker with the bone. By aligning the patient tracker, the patient tracker coordinate system is aligned with the localizer coordinate system. This step also relates the bones to the patient tracker. The navigation system determines the location and orientation of the patient tracker, Based on the motion of the bones, the position and orientation, i.e., posture, of the bones are tracked and monitored for navigation. The virtual representation of the anatomy in the imaging system can be updated.

[0140] In a second step 604 of the method 600, the user attaches the instrument tracker to the surgical instrument. Aligning the instrument tracker ensures that the instrument tracker coordinate system is aligned with the local coordinate system. This step 604 also relates the instrument track to the 3D coordinate system or other common coordinate system. defines the position and orientation of the instrument tool tip relative to the tool holder, thereby The system determines the position and orientation of the instrument tool tip based on the detected movement of the instrument tracker. That is, tracking and monitoring the pose and updating the virtual representation of the instrument in the navigation system. This can be done.

[0141] The method 600 uses a navigation system to determine the orientation of the anatomy and the location of the surgical instrument. The position of the anatomy and the instrument are monitored over time using a virtual representation that can be displayed to the user. The method includes steps 606, 608 of tracking the location of the patient's anatomy and the surgical tools. Tracking involves monitoring both the position and orientation of the tracked object. This information is then used to monitor the patient over time in continuous cycles at regular intervals during surgery. The navigation system measures the velocity, acceleration, and magnitude of the motion in a common coordinate system. Other quantities, including orientation, can be determined for other tracked objects.

[0142] The method 600 includes determining whether a tool tip of a surgical instrument is within a predetermined proximity to a patient's anatomy. The step includes determining that the navigation system is statically positioned. In addition to monitoring the position of the tool tip and the anatomy, the system also During surgery, the user may monitor the speed of the tool tip as it moves through the cutter when no power is being applied to the tool. During this procedure, the tool tip is placed in contact with the bone to provide the navigation system with surgical instruments and You are prompted to verify the alignment of the tracker on the patient's anatomy.

[0143] Since alignment is sensitive to errors, the navigation system If the end is determined to be resting within a predetermined proximity to the patient's anatomy, the navigation The navigation system can evaluate the alignment verification. ,The tool tip is determined to be stationary when the tracked position does not change for a,predetermined period of time. The predetermined period may be, for example, 3 seconds, 5 seconds, or some other duration. The predetermined proximity range can be preprogrammed into the navigation system. For example, it may be about 3 millimeters, about 1 millimeter, or about 0.5 millimeters. The predetermined proximity range may be determined by other methods appropriate to the level of accuracy that can be measured by the navigation system. It may be any distance value. During configuration of the navigation system, e.g. before surgery During activation, the user can select from a list of options to activate the device for a predefined period of time or for a predefined proximity range. The user may be prompted to select the distance of the surrounding area, or may be prompted to select the distance of the surrounding area using the touchpad, button selection, touch The user may be prompted to enter the duration or distance via a screen, or other input.

[0144] The navigation system is configured such that the tracking position and tracking orientation of the tool tip are static and a given When it does not change during the period, it can be determined that the tool tip is stationary; or A position is determined to be stationary when its position and orientation do not change beyond a certain magnitude. Alternatively, when the position and orientation do not change, or when a particular direction is When the change does not exceed a certain magnitude in a specific direction, such as when the change is in the direction toward the structure Alternatively, the position may be determined to be stationary.

[0145] The navigation system is operated with the tool tip resting in a static position and orientation close to the bone. If so, the method 600 includes determining 612 the offset distance. The offset distance is a measure of the inaccuracy in the system. receiving input from a user indicating that the tool tip is in static contact with the anatomical structure; Evaluate the tracking positions of the tool tip and the patient's anatomy. The results of this evaluation based on the tracking positions. based on the tracked positions and tracked orientations of the surgical instrument and the virtual representation of the patient's anatomy, It can be determined that the tool tip is a certain distance away from the bone or It can be determined that the bone has been penetrated a certain distance. The magnitude of the determined distance is This defines the tool-bone offset, which is the true physical location of the tool tip relative to the anatomy. and the accuracy between the virtual representation of the tool tip relative to the anatomical structure in the navigation system. The figure shows the margin of error.

[0146] When calculating the offset distance, the navigation system uses a virtual representation of the surgical instrument to Identify a first point of the virtual representation of the patient's anatomy, the first point being the closest proximal point to the virtual representation of the patient's anatomy. or the deepest penetration point or overlap of the virtual representation of the surgical instrument into the virtual representation of the patient's anatomy. If the first identification point of the instrument is outside the anatomical structure, the offset distance is The offset distance is the shortest distance between the identification point of the anatomy and a point on the surface of the virtual representation of the anatomy. The distance is perpendicular to the surface and outward. The first identification point of the instrument is the If it is inside, the offset distance is the distance between the first identification point and a certain point on the surface of the virtual representation of the anatomical structure. The offset distance is perpendicular and inward to the surface.

[0147] Once the offset distance is determined, the navigation system of method 600 continues in step 6 14, the calculated offset distance is adjusted to an acceptable extent for system inaccuracies. If the offset distance is greater than the predetermined threshold and the level is lower than desired, If the vehicle shows a high degree of accuracy, the navigation system will trigger actions accordingly. In one example, the predetermined threshold is 0.5 millimeters. The navigation system determines whether the tool tip is in static contact with the anatomy based on the tracked position. If the navigation system determines that the virtual representation of the tool tip is aligned with the anatomical structure, It is calculated to be 0.5 mm from the virtual representation. However, this is not intended to be limiting, and other limitations are contemplated. The limits may be applicable to different tools or different applications of the same tool. The options, as described above, may include sounding an audible alert, displaying a visual alert, or providing a tactile Activating a visual alert, disabling power to the surgical instrument, or a combination thereof. The combination may include one or more of the following:

[0148] The predetermined threshold may include multiple values ​​indicating different levels of accuracy, and the offset distance Different actions are triggered in response to a comparison of the value to a number of values. For example, the predetermined threshold may be: The triggering of the action may include a first predetermined threshold and a second predetermined threshold. , triggering a first action if the offset distance is greater than a first predetermined threshold. and triggering a second action if the offset distance is greater than a second predetermined threshold. The action may include an audible alert, a visual alert, a tactile alert, or any of the actions as described above, including various combinations thereof. may include:

[0149] The method 600 shown in FIG. 9 can be expanded as shown as method 620 in FIG. In one enhanced embodiment, the navigation system may, in step 622, Prompt the user to begin an alignment verification cycle as detailed in method 600 above. This prompting can be visual, such as by showing a message on the display. Alternatively, the visual prompt may include a flashing light or the like. The prompt may be an audible prompt such as a tone, beep, or pre-recorded message. The prompt may be presented to the user as a predetermined series of vibrations or a series of vibrations. Prompts may be presented as visual, auditory, tactile, etc. Or it may be presented to the user as a combination of tactile prompts.

[0150] The method 620 includes steps of determining a first offset with the surgical instrument in a first orientation. This step is performed in accordance with the steps of the method 600 shown in FIG. The static position of the tool tip comprises a first pose (position and orientation) of the surgical instrument. The method 620 includes determining 626 a second offset at a second pose. This may involve changing the position, orientation, or both of the surgical tool to bring the tool tip into contact with the anatomy and a second The tool tip must be placed in static contact with the anatomy in the second orientation. In contact with the vehicle, the navigation system determines a second offset value. Therefore, the navigation system can detect the tool-bone gap from two or more angles. The set can be evaluated to ensure the accuracy of the system at multiple angles.

[0151] In steps 624 and 626, a first offset is calculated from the first attitude and the second attitude, respectively. After determining the first offset and the second offset, the navigation system proceeds to step 628. In this step, the first offset and the second offset are compared to a tolerance threshold. The navigation system independently compares the first offset to a tolerance threshold and the second offset to a tolerance threshold. The offset of the first offset and the second offset can be compared to a tolerance threshold. Actions can be triggered if one or the other exceeds a tolerance threshold. Step 630 of triggering an action is similar to step 616 of triggering an action. It could be.

[0152] In response to the navigation system determining that the offset exceeds a tolerable threshold. When an action is triggered, the user provides input and aligns the tracker with the surgical instrument or the patient. Maintains system operation without the need for other corrective actions such as realigning to anatomy The navigation system may have the opportunity to Override or cancel actions triggered by offsets greater than the tolerance threshold. The navigation system can receive voice commands to cancel the input, such as keyboard, gesture input, or other input via a keypad, touch screen, etc. Can receive input to override or cancel a triggered action. The navigation system and surgical instruments can then return to normal operation.

[0153] FIG. 11 illustrates a method 620 for comparing the first and second offsets to a tolerance threshold. As an alternative or in addition to step 628, method 632 is shown. The system performs a step 634 to determine the first offset and the second offset in the first and second orientations. Upon determining the first offset and the second offset, the navigation system Based on the offset of the first and second orientations and the geometric relationship between the first and second orientations, or more specifically, Specifically, the tool tip is applied in static contact with the biological structure in a first position and a second position. Calculate the 3D offset based on the geometric relationship between specific contact points on the edge surface. Once the three-dimensional offset values ​​are determined, the navigation system can The original offset can be compared to a tolerance threshold. The tolerance threshold is the threshold for determining whether the first offset or the The offsets of the two can be the same or different in magnitude compared to the tolerance threshold. It's fine.

[0154] As a further alternative, methods 620 and 632 may include determining a third offset at a third pose as: In step 628 of the method 620, the first offset and comparing the second offset to a tolerance threshold includes comparing a third offset to a tolerance threshold. Similarly, in the method 632, step 634 may include: In addition to determining the first and second offsets in the attitude of the Further, in step 636, a third offset in the pose may be determined. In this case, the navigation system includes a first offset, a second offset, and a third offset. and a geometric relationship between the first pose, the second pose, and the third pose, or A first contact point, a second contact point, and a third contact point between the tool tip and the biological structure in the first, second, and third orientations. A three-dimensional offset can be calculated based on the touch point and the third touch point.

[0155] The calculation of the 3D offset depends on the geometry of the tool tip. In the first example, As shown, the tool tip 180 is substantially cylindrical, such as a drill bit or a router. , tapered, rounded conical, or elongated surface 182. The elongated surface 182 of the casing 180 defines a longitudinal axis L extending through the center and parallel to the elongated surface 182. To verify the alignment and determine the offset value, a biological specimen such as vertebra V is When placed in static contact with the structure, the contact point 1 between the tool tip 180 and the biological structure V 84 is, for example, the distance from the longitudinal axis of the elongated surface 182 equal to the radius of the elongated surface. Make sure it fits along the periphery 186 of the end.

[0156] In another example, as shown in FIG. 13, the tool tip 190 may be a substantially The spherical surface 192 of the tool tip 190 may include a center A center point 194 can be defined. To verify alignment and determine offset values When the tool tip 190 is placed in static contact with a biological structure such as a vertebra V, the tool tip 190 and the biological structure The contact point 196 between V and the center point 194 is, for example, equal to the radius of the spherical surface 192. It is on the surface of a spherical surface 192 at a distance.

[0157] Determining the three-dimensional offset, such as in step 636 of the method 632 shown in FIG. and a first offset by the surgical instrument in a first orientation relative to the anatomy; a second offset in the first orientation, and optionally a third offset in a third orientation. By positioning the surgical instruments in several different positions, Various views of the surgical instrument tracker are presented to the camera unit of the localizer. With a number of views, any alignment errors are identified by the navigation system. and can be unobscured by certain views of the instrument.

[0158] To ensure sufficient differentiation in the view of the surgical instruments by the navigation system, To achieve this, it is necessary to rotate the surgical instrument sufficiently from one position to the next. For example, Upon establishing the first offset distance in the first orientation, the surgical instrument is The contact point of the tool tip is approximately 90 degrees away from the contact point on the tool tip in the first position in the second position. As shown in FIG. 12, the tool tip 180 may be rotated away from the elongated surface 18. 2, the second contact point 188 rotates about the longitudinal axis L of the tool tip 180. 13, the tool tip may be approximately 90 degrees from the first contact point 184. If the portion 190 has a spherical surface 192, the second contact point 198 may be a center point in any plane. The rotation about 194 may be approximately 90 degrees from the first contact point 196. When the offset distance is determined, the third contact point 189, 199 in the third pose is The first contact point 184, 196 and the second contact point 197 in the first and second orientations, respectively. It may be about 90 degrees away from points 188, 198.

[0159] During the surgical procedure, a surgical instrument comes into contact with two or more bones, such as multiple vertebrae along the spine. In the early stages of surgery, the individual bones affected by the surgery are A tracker can be aligned to each of the bones. When proceeding to surgery on a bone, the user may proceed to surgery on the first bone following completion of the surgical intervention. The user can then verify the alignment of the tracker on the second bone. Trigger the navigation system by positioning it in static contact with the bones of the two Alternatively, the navigation system can be used to verify the tracking alignment process. Once the surgical planning step for the first bone is completed, the second bone is treated according to the surgical plan. The user may be prompted to verify the alignment before commencing surgical intervention.

[0160] The navigation system identifies the area of ​​bone that will come into contact with the tool tip for alignment verification. The bone parts designated for registration verification are still It may be any exposed portion of bone that is not targeted for resection according to the surgical plan. Select areas not targeted for intervention so bone surfaces match the virtual representation of the patient's anatomy This increases the likelihood of successful alignment and provides an accurate basis for verifying tracker alignment. The navigation system may be configured to recognize specific portions of the anatomy to identify the portion of the anatomy to the user. The patient's anatomy is highlighted, flagged, and indicated with arrows, outlines, or other symbols. A graphical representation of the can be displayed.

[0161] The above description has been given by way of illustration. The terminology used is intended to be illustrative rather than limiting. It should be understood that the above teachings are intended to be in the nature of clarity. In light of this, many modifications and variations are possible. Features or implementations may be practiced other than as specifically described.

[0162] item I. A method of navigating a surgical instrument having a variable speed motor relative to a bone, comprising: The method includes a localizer having a localizer coordinate system and a surgical instrument coupled to the localizer. A patient tracker coupled to a bone and a controller communicating with a navigation system. and a navigation system including a navigation controller, , controlling the surgical instrument, the method comprising: Using the localizer, align the patient tracker to the localizer coordinate system. defining a bone location of said bone relative to said localizer coordinate system; Using the localizer, align the instrument tracker to the localizer coordinate system. defining an instrument location of an instrument tool tip relative to said localizer coordinate system; Define the motor motion of the instrument when the instrument tool tip is not in contact with the bone. And, monitoring motor operation of the instrument during a medical procedure with the controller; The navigation system is used to monitor the position of the instrument tool tip relative to the bone. and when the instrument tool tip contacts the bone in the localizer coordinate system. Determining the comparing the motor motion to the monitored position of the instrument tool tip; The monitored position of the instrument tool tip is measured in the localizer coordinate system relative to the bone. and the monitored motor motion determines when the instrument tool tip is in contact with the bone. determining an error condition when the motor operation of the instrument is equal to the defined motor operation when the motor operation is not ... To do, triggering an action when an error condition is determined; A method comprising: II. Defining the motor operation of the instrument when the tool tip is not in contact with the bone. This definition is intended to mean that the motor operates while the instrument tool tip is not in contact with bone. Item I, including defining thresholds for power, voltage, current, or a combination thereof. The method described. III. Defining the motor operation includes the controller, the navigation system, and The mode may be stored in a memory of one or more of the stem, the surgical instrument, or a combination thereof. The method of any one of claims I to II, further comprising storing data representative of the data operation. IV. A second motor operation of the instrument when the instrument tool tip is in contact with the bone. The method according to any one of items I to III, further comprising defining: V. The monitored position of the instrument tool tip is forwardly aligned in the localizer coordinate system. the tool tip is not in contact with the bone and the monitored motor motion indicates that the tool tip is not in contact with the bone. When the second motor operation of the tool is equal to the second defined motor operation when the tool is in contact, determining an error condition; and performing a second action when the second error condition is determined. and triggering an operation. VI. Triggering one of the actions or the second action may include an audible alarm. sounding a sound, displaying a visual alert, activating a tactile alert, or cutting off power to the appliance, or a combination thereof. The method according to any one of claims 1 to 5. VII. A localizer having a localizer coordinate system and an instrument track coupled to a surgical instrument a patient tracker coupled to a bone and in communication with a navigation system; and a controller for powering the navigation system. 1. A method of navigating a surgical instrument having a variable speed motor, the method comprising: Using the localizer, align the patient tracker to the localizer coordinate system. defining a bone location of said bone relative to said localizer coordinate system; Using the localizer, align the instrument tracker to the localizer coordinate system. defining an instrument location of an instrument tool tip relative to said localizer coordinate system; defining a first motor motion of the surgical instrument that operates while not in contact with the bone; And, Using the controller to monitor motor operation of the surgical instrument during a medical procedure. And, Using the navigation system, a coordinate system is calculated for the bone in the localizer coordinate system. monitoring a position of the instrument tool tip; comparing the monitored motor motion with the defined motor motion; If the monitored motor operation deviates from the defined first motor operation, determining a point in time of contact between the instrument tool tip and the bone; At the time of contact, the navigation system is used to calculate the localizer coordinates Tool-bone offset as the distance between the tool tip and the bone surface in the instrument system and determining Triggering an action if the tool-bone offset exceeds a predetermined magnitude and, A method comprising: VIII. Triggering an action may include sounding an audible alert, a visual alert displaying a signal; activating a tactile alert; and cutting power to the surgical instrument. or a combination thereof. IX. The method of claim VII, wherein the predetermined size is 0.5 millimeters. X. Displaying said determined tool-bone offset on a display device. The method according to claim VII, further comprising: XI. Monitoring the position of the instrument tool tip relative to the bone tracking the instrument location of the instrument tool tip and the bone location of the bone during placement. The method further comprises contacting the surface of the bone with the navigation system. detecting each occurrence of the monitored position of the instrument tool tip during said movement; recording a set of tool-bone offset values ​​determined during said medical procedure as they occur; The method according to item VIII, further comprising: XII. Display a series of tool-to-bone offsets as sequentially updated values ​​on a display device. The method according to claim VII, further comprising displaying. XIII. Further comprising defining a first level of magnitude and a second level of magnitude. The step of displaying the determined tool-to-bone offset includes: displaying the offset in a first color if the offset is less than a magnitude of a level of 1; When the offset is between the magnitude of the first level and the magnitude of the second level, displaying the offset in a second color different from the first color; and If the offset is greater than the magnitude of the first color and the second color, and displaying the color of the image in a third color different from the first color. XIV. The predetermined magnitude for triggering an action is the second level of magnitude The method according to item XIII, XV. The predetermined magnitude for triggering an action is the second level of magnitude The method according to item XIII, XVI. The method further includes defining a third level of size, when the offset between the first and second levels is greater than the magnitude of the third level, The method of claim XIII, further comprising disabling power to the surgical instrument. XVII. The method further includes prompting a user to input the predetermined magnitude value. The method according to claim VII. XVIII. When the tool-to-bone offset is greater than the predetermined value, Disabling power from the rollers to the surgical instrument. method. XIX. Chart the tool-to-bone offsets over time. The method according to item XII, further comprising displaying. XX. Triggering an action prompts a user to update the bone model The method according to item VII, comprising: XXI. Updating the model of the bone includes updating the model of the bone from the controller to the surgical instrument. contacting the resection surface of the bone with the instrument tool tip while power to the bone is disabled; The method according to item XX, comprising: XXII. Operate the Surgical System During Surgery to Verify Tracking Registration 11. A method, comprising: the surgical system including a localizer having a localizer coordinate system. a navigation system and an instrument tracker coupled to the surgical instrument, The instrument includes a tool tip, an instrument tracker, and a patient tracker coupled to the patient's anatomy. and a control console in communication with the localizer, the control console comprising: a control console in communication with data representative of the surgical instrument and data representative of the patient's anatomy; and The navigation system is used to track the surgical instruments and the anatomical structures. Using the control console, a first storing the data and second data representative of the tracked anatomical structure; and the first data representing the tracked surgical instrument and the second data representing the tracked anatomical structure Based on the second data, the tool tip is positioned at a predetermined proximity to the tracked anatomy. determining that the signal is within the range; The tool tip is within the predetermined proximity range beyond a predetermined magnitude for a predetermined duration. determining that the subject has not left the range; the first data representing the tracked surgical instrument and the second data representing the tracked anatomical structure determining an offset distance based on the second data; and comparing the offset distance to a predetermined threshold; Triggering an action if the offset distance is greater than the predetermined threshold. and, A method comprising: XXIII. Displaying prompts on displays and / or audible alerts , generating haptic sensations, or a combination thereof. The method of claim XXII, further comprising prompting the user to verify the match. XXIV. DETERMINING WHEN THE TOOL TIP IS WITHIN A PRECISE PROXIMITY RANGES WITH RESPECT TO THE ANATOMICAL STRUCTURE This includes defining a surface area of ​​the anatomy that is not to be ablated, and the tool tip is and determining that the surface area is within a predetermined proximity range relative to the defined surface area. The method according to II. XXV. The offset distance is the distance between the tool tip and the tracked object in the common coordinate system. as the minimum separation between the tool tip and the anatomy of the object being measured, or Item XXI, defined as the magnitude of maximum overlap between the edge and the tracked anatomical structure. The method described in I. XXVI. The tool tip is within a predetermined proximity range to the tracked anatomical structure determining that the surgical instrument is positioned in a first pose relative to the tracked anatomy; the surgical instrument defines a first proximal point of the tool tip and a front Determining the offset distance includes determining a first offset distance; The method further comprises positioning the surgical instrument at a second pose relative to the tracked anatomy. the tool tip is within a predetermined proximity to the tracked anatomical structure. and determining that the surgical instrument is at a second proximal point of the tool tip. determining a second offset distance; and determining the offset distance includes determining a second offset distance. The method according to item XXII, comprising: XXVII. Comparing the offset distance to a predetermined threshold value comparing the first offset distance to the predetermined threshold; and comparing the second offset distance to the predetermined threshold. and initiating an action includes comparing the first offset distance, The second offset distance, or both the first offset distance and the second offset distance and initiating an action if the difference is greater than the predetermined threshold. The method according to XXVIII. The surgical instrument includes an elongated surface terminating in the tool tip, the elongated surface The long surface defines a longitudinal axis extending substantially parallel to the elongated surface, and the second proximal the point is at least 90 degrees from the first proximal point relative to rotation about the centerline. The method according to claim XXVI. XXIX. The surgical instrument includes a tool tip having a spherical surface defining a center point. and the second proximal point is at least as far away from the first proximal point as to rotation about the central point. The method according to item XXVI, wherein the first and second electrodes are 90 degrees apart. XXX. When the tool tip is within a predetermined proximity range to the tracked anatomical structure Determining includes positioning the surgical instrument in a third pose relative to the tracked anatomy. wherein the surgical instrument defines a third proximal point, the third proximal point being Differentiating the first proximal point and the second proximal point and determining the offset distance. The method of claim XXVI, further comprising determining a third offset distance. XXXI. Comparing the offset distance to a predetermined threshold value comparing the distance to the predetermined threshold; and comparing the second offset distance to the predetermined threshold. and comparing the third offset distance to the predetermined threshold; Initiating the action includes determining the first offset distance, the second offset distance, the third offset distance, or a combination thereof, is greater than the predetermined threshold. The method of claim XXX, comprising initiating an action on XXXII. The surgical instrument includes an elongated surface terminating in the tool tip, the elongated surface The proximal surface defines a longitudinal axis extending substantially parallel to the elongated surface, and the second proximal point is at least 90 degrees from the first proximal point relative to rotation about the longitudinal axis. , the third proximal point is relative to the first proximal point and the The method of claim XXX, wherein the second proximal point is at least 90 degrees away. XXXIII. The surgical instrument has a tool upper portion having a spherical surface defining a center point. the second proximal point being at least a few centimeters from the first proximal point with respect to rotation about the central point. and the third proximal point is at least 90 degrees away from the center point with respect to rotation about the center point. The first proximal point and the second proximal point are at least 90 degrees apart. method. XXXIV. Triggering an action may include sounding an audible alert, a visual alert, or displaying a message, activating a tactile alert, and cutting off power to the surgical instrument. and / or any combination thereof of the preceding items XXII to XXXIII. 2. The method according to any one of claims 1 to 11. XXXV. The predetermined threshold value includes a first predetermined threshold value and a second predetermined threshold value, Triggering an action of the navigation system includes determining whether the offset distance is greater than the first offset distance. a first action if the first predetermined threshold is greater than the second predetermined threshold but less than the second predetermined threshold. and triggering a first detection if the offset distance is greater than the second predetermined threshold. and triggering a second action, the first action being a first audible alarm. sounding a tone, displaying a first visual alert, and activating a first tactile alert. and / or a combination thereof, wherein the second action comprises a second audible Sounding an alert, displaying a second visual alert, and initiating a second tactile alert or any combination thereof, The method according to any one of claims 1 to 5. XXXVI. A method of providing navigation guidance for a surgical procedure, comprising: The method is as follows: Registering a patient's anatomy to a common coordinate system, the patient's anatomy comprising: including at least a first bone and a second bone; aligning a surgical instrument to the common coordinate system; During operation of the surgical instrument on the first bone of the patient's anatomy, the navigation tracking the patient's anatomy and the surgical instrument using a motion control system; Determining an offset distance according to claim 1 for the second bone; During operation of the surgical instrument on the second bone of the patient's anatomy, the navigation tracking the patient's anatomy and the surgical instrument using a motion control system; A method comprising: XXXVII. A method of performing a surgical procedure, said method comprising: coupling a patient tracker to a patient's anatomy; Coupling the instrument tracker to a surgical instrument, the surgical instrument having a tool tip. Including, Operate a navigation system to commonly align the instrument tracker and the patient tracker. registering to a coordinate system and tracking the surgical instrument and the patient's anatomy; Resting the tool tip in contact with the anatomy for a predetermined duration and To start a joint verification, The navigation system is adapted to align the tracked surgical instrument and the tracked patient. configured to determine an offset distance based on anatomy; evaluating the offset distance against a predetermined threshold; A method comprising: XXXVIII. The navigation system is configured to: a value that is greater than the threshold, the action being configured to trigger an action such as an audible Sound an alert, display a visual alert, activate a haptic alert, cutting off power to the surgical instrument, or any combination thereof. The method according to item XXXVII. XXXIX. Providing input to the navigation system to determine whether the triggered action The method according to item XXXVIII, further comprising terminating the process. XXXX. Resting the tool tip in contact with the anatomical structure at a first time point resting the tool tip in contact with a first anatomical contact point at The surgical instrument is in a first position, and a first proximal point of the tool tip is in contact with the first anatomical structure. and the method further comprises contacting a second biological structure contact point at a second time. and resting the tool tip, the surgical instrument being in a second position and a second proximal point of the tool tip contacting the first anatomical contact point; The navigation system is configured to determine a position of the anatomy based on the first anatomical contact point and the first proximal point. determining a first offset distance based on the second anatomy contact point and the second proximal point; Item XXXVII is configured to determine the second offset distance based on The method described. XXXXI. Evaluating the offset distance comprises: evaluating the second offset distance against the predetermined threshold; evaluating the presence or absence of a marker, or a combination thereof. . XXXXII. The first offset distance and the second offset distance, and the tool Based on a geometric relationship between the first proximal point and the second proximal point on the tip, estimating the offset distance further comprises: comparing the three-dimensional offset value with a predetermined three-dimensional offset threshold value; The method according to X. XXXXIII. The patient's anatomy includes a first bone and a second bone, and the method includes: applying and operating the surgical instrument to the first bone; applying and operating the surgical instrument to the second bone; Further comprising: Pausing the tool and initiating alignment verification is applied to the first bone. After actuating the surgical instrument and before actuating the surgical instrument against the second bone. in contact with the second bone.

Claims

1. A navigation system having a control console and a localizer, wherein the navigation system communicates first data representing a surgical instrument having a tool tip and second data representing a patient's biological structure, the navigation system tracks the surgical instrument and the biological structure in a virtual space during a surgical operation based on information collected by the localizer from an instrument tracker attached to the surgical instrument and a patient tracker attached to the biological structure, the navigation system tracks the surgical instrument and the biological structure, stores data representing the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked in a common coordinate system, determines that the tool tip is within a predetermined proximity range with respect to the biological structure based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked, determines that the tool tip has not moved away from the predetermined proximity range by more than a predetermined size over a predetermined period, obtains an offset distance based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked in the common coordinate system, compares the offset distance with a predetermined threshold value, A surgical system.

2. The surgical system according to claim 1, wherein the navigation system further triggers an action when the offset distance exceeds the predetermined threshold value.

3. The action according to claim 2, wherein the action includes any one of sounding an audible alert, displaying a visual alert, activating a tactile alert, cutting off power to the surgical instrument, and combinations thereof.

4. The surgical system according to claim 2, further comprising a foot switch that generates vibrations, wherein the action is the vibration of the foot switch.

5. The surgical system according to claim 2, wherein the navigation system receives an input for overriding the triggered action.

6. The surgical system according to any one of claims 1 to 5, wherein the predetermined threshold value is 0.5 millimeters.

7. The navigation system triggers a first action when the offset distance reaches or exceeds a first predetermined magnitude, and triggers a second action different from the first action when the offset distance reaches or exceeds a second predetermined magnitude different from the first predetermined magnitude, for the surgical system according to any one of claims 1 to 5.

8. The surgical system according to any one of claims 1 to 5, further comprising a display device that communicates electronically with the navigation system, and the navigation system further causes the obtained offset distance to be displayed on the display device.

9. For the surgical system according to claim 8, the offset distance is displayed in a first color when the offset distance is below the predetermined threshold, and is displayed in a second color different from the first color when the offset distance exceeds the predetermined threshold.

10. The navigation system prompts the user to verify the tracking alignment by any one of displaying a prompt on a display, sounding an audible alert, generating a tactile sensation, and combinations thereof, for the surgical system according to any one of claims 1 to 5.

11. The surgical system according to claim 10, wherein the navigation system prompts the user to confirm the tracking alignment for a second bone after completion of a stage of a surgical plan applied to a first bone and before the start of a surgical intervention according to the surgical plan for the second bone.

12. For the surgical system according to any one of claims 1 to 5, the navigation system determines that the tool tip is within a predetermined proximity range with respect to a determined surface area of the biological structure that is not to be excised, based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked, and thereby determines that the tool tip is within the predetermined proximity range with respect to the biological structure, based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked.

13. The surgical system according to any one of claims 1 to 5, wherein the offset distance is determined as either the magnitude of the minimum separation between the tool tip portion in the common coordinate system and the living body structure to be tracked or the magnitude of the maximum overlap between the tool tip portion in the common coordinate system and the living body structure to be tracked.

14. The navigation system Based on the posture of the surgical instrument to be tracked and the posture of the living body structure to be tracked, when the surgical instrument is in a first posture with respect to the living body structure to be tracked, it is determined that the tool tip portion is within the predetermined proximity range with respect to the living body structure to be tracked, When the surgical instrument is in the first posture, a first offset distance is obtained, Based on the posture of the surgical instrument to be tracked and the posture of the living body structure to be tracked, when the surgical instrument is in a second posture with respect to the living body structure to be tracked, it is determined that the tool tip portion is within the predetermined proximity range with respect to the living body structure to be tracked, When the surgical instrument is in the second posture, a second offset distance is obtained, The comparison between the offset distance and a predetermined threshold value is performed by comparing the first offset distance with the predetermined threshold value and comparing the second offset distance with the predetermined threshold value, An action is started when any one of the first offset distance, the second offset distance, and both the first offset distance and the second offset distance exceeds the predetermined threshold value. The surgical system according to any one of claims 1 to 5.

15. The navigation system according to claim 14, wherein the navigation system calculates a three-dimensional offset value based on the first offset distance, the second offset distance, and the geometric relationship between the first posture and the second posture, and compares the three-dimensional offset value with an allowable threshold value.

16. A navigation system including a control console and a localizer is provided, The navigation system communicates first data representing a surgical instrument having a tool tip portion and second data representing a patient's living body structure, Based on information collected by the localizer from an instrument tracker attached to the surgical instrument and a patient tracker attached to the living body structure, the navigation system tracks the surgical instrument and the living body structure in a virtual space during a surgical operation. The navigation system tracks the surgical instrument and the biological structure, stores data representing the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked in a common coordinate system, based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked, determines that the tool tip is within a predetermined proximity range with respect to the biological structure to be tracked when the surgical instrument is in a first posture with respect to the biological structure to be tracked, obtains a first offset distance when the surgical instrument is in the first posture, based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked, determines that the tool tip is within the predetermined proximity range with respect to the biological structure to be tracked when the surgical instrument is in a second posture with respect to the biological structure to be tracked, obtains a second offset distance when the surgical instrument is in the second posture, compares the first offset distance and the second offset distance with a predetermined threshold value, and starts an action when any one of the first offset distance, the second offset distance, and both the first offset distance and the second offset distance exceeds the predetermined threshold value, A surgical system.

17. A navigation system having a control console and a localizer, the navigation system communicates first data representing a surgical instrument having a tool tip and second data representing a biological structure of a patient, the navigation system tracks the surgical instrument and the biological structure in a virtual space during a surgical operation based on information collected by the localizer from an instrument tracker attached to the surgical instrument and a patient tracker attached to the biological structure, the navigation system tracks the surgical instrument and the biological structure, stores data representing the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked in a common coordinate system, based on the posture of the surgical instrument to be tracked and the posture of the biological structure to be tracked, determines that the tool tip is within a predetermined proximity range with respect to the biological structure to be tracked when the surgical instrument is in a first posture with respect to the biological structure to be tracked, obtains a first offset distance when the surgical instrument is in the first posture, Based on the posture of the surgical instrument to be tracked and the posture of the living body structure to be tracked, it is determined that the tool tip is within the predetermined proximity range with respect to the living body structure to be tracked while the surgical instrument is in a second posture with respect to the living body structure to be tracked, while the surgical instrument is in the second posture, a second offset distance is obtained, a three-dimensional offset value is calculated based on the first offset distance, the second offset distance, and the geometric relationship between the first posture and the second posture, the three-dimensional offset value is compared with an allowable threshold value, A surgical system.

Images