Systems and methods for movement guidance systems

By generating a 3D model of the subject through the robotic system and imaging system, and using reference point objects and tracking systems for alignment, the problem of difficult alignment between patient space and image space during surgery is solved, thereby improving surgical efficiency and accuracy.

CN120731053APending Publication Date: 2025-09-30MAZOR ROBOTICS
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Patent Information

Application Number
CN202480013840.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-02-21
Filing Date
2024-02-18
Publication Date
2025-09-30

AI Technical Summary

Technical Problem

The existing technology requires time to align the patient space with the image space during surgery, which makes it difficult for the user to identify points in the subject space and the image space, affecting the efficiency of the surgery.

Method used

By using the robotic system and imaging system to generate a 3D model of the subject, and using reference point objects and tracking systems for alignment, coordinate system conversion is achieved between the robotic system, navigation system and imaging system, and the position of the instrument in the patient space is accurately located.

Benefits of technology

It enables rapid and accurate registration of image space with patient space during surgical operations, improves surgical efficiency and accuracy, and reduces the time it takes for users to identify points.

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Abstract

A system for assisting in guiding and performing a procedure on a subject is disclosed. The subject may be any suitable subject, such as a non-living subject and / or a living subject. The guides and systems may include various steerable or movable components, such as robotic systems, and may be registered to selected coordinate systems to assist movement of the robotic systems.
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Description

Technical Field

[0001] The subject disclosure relates generally to a tracking and navigation system, and more particularly to tracking guidance components and generative models. Background Art

[0002] This section provides background information related to the present disclosure which is not necessarily prior art.

[0003] Instruments can be navigated relative to a subject to perform various procedures. For example, the subject can include a patient undergoing surgery. During the surgical procedure, instruments can be tracked in an object or subject space. In various embodiments, the subject space can be a patient space defined by the patient. The position of the tracked instrument can be displayed on a display device relative to an image of the patient.

[0004] The patient's position can be determined using a tracking system. Typically, the patient is registered to the image by tracking the instrument relative to the patient to generate a transformation map between subject or object space (e.g., patient space) and image space. This typically requires time during surgery for a user (such as a surgeon) to identify one or more points in subject space and associate them with the typically identical points in image space.

[0005] After registration, the position of the instrument can be suitably displayed on a display device while the instrument is being tracked.The position of the instrument relative to the subject can be displayed as a graphical representation, sometimes referred to as an icon, on the display device. Summary of the Invention

[0006] This section provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.

[0007] According to various embodiments, an imaging system can be used to image a selected volume that can include a subject, a fiducial object, and / or other portion. The imaging system can collect image data. The image data can be used to generate a model. The model can have a selected clarity and / or resolution, including within a selected portion of the model.

[0008] The robotic system may include a suitable robotic system such as the Mazor X sold by Mazor Robotics Ltd. having a place of business in Israel and / or Medtronic, Inc. having a place of business in Minnesota, USA. TMRobotic guidance system. The robotic system can include a fiducial object that is imaged with the subject and can include one or more objects, such as an array of discrete objects. The discrete objects can include one or more shapes, such as a sphere, a cube, one or more rods that can all be in a plane or intersect a plane, etc. The fiducial object can be modeled in three-dimensional (3D) space as a 3D model. Fiducial features can be extracted from the 3D model. The fiducial features can be compared or reconciled with image fiducial features that are the imaged fiducial object or a portion thereof (e.g., the image fiducial feature can be a point relative to the center of a sphere or circle or a point relative to the intersection of a rod and a plane).

[0009] In various embodiments, different systems used relative to a subject can include different coordinate systems (e.g., positioning systems). For example, a robotic system can move relative to a subject that includes a robotic coordinate system. The robotic system can include a robotic portion (e.g., a robotic arm, a robotic joint, a robotic end effector) that can be fixed (including removably fixed) at a position relative to the subject. Therefore, due to various features of the robot, the movement of a portion of the robotic system relative to the base of the robotic system (i.e., the fixed portion of the robotic system) can be known. For example, encoders (e.g., optical encoders or potentiometer encoders, etc.) can be used to determine the movement or amount of movement of various joints (e.g., pivots, joints) of the robot. The position of the end effector (e.g., the tip) of the robot relative to the base of the robot is known. Given the known position of the subject relative to the base and the immovable relative position of the base and the subject, the position of the end effector relative to the subject is known during movement of the robot and / or during periods when the end effector is stationary. Therefore, the robot can define a coordinate system relative to the subject.

[0010] Various other parts can also be tracked relative to the subject. For example, a tracking system can be incorporated into a navigation system that includes one or more instruments that can be tracked relative to the subject. The navigation system can include one or more tracking systems that track various parts associated with the instruments, such as tracking devices. The tracking system can include a locator configured to determine the position of the tracking device in the navigation system's coordinate system. Determination of the navigation system's coordinate system can include those described in various references, including U.S. Patent No. 8,737,708, U.S. Patent No. 9,737,235, U.S. Patent No. 8,503,745, and U.S. Patent No. 8,175,681, all of which are incorporated herein by reference in their entirety. Specifically, the locator can track the subject within a volume relative to the subject. The navigation volume in which the device can be tracked can include or be referred to as a navigation coordinate system or navigation space. The determination or correlation between two coordinate systems can allow for, or also be referred to as, registration between the two coordinate systems. Additionally, the navigation system can be used to track one or more parts of a robotic system. Thus, the navigation system can track the robot and the subject in the same coordinate system using the selected tracking device.

[0011] In various embodiments, a first coordinate system, which may be a robot coordinate system, may be registered to a second coordinate system, which may be a navigation coordinate system. Thus, due to registration, also referred to as a transformation map in various embodiments, coordinates in one coordinate system may then be transformed into a different coordinate system, or a second coordinate system. Registration may allow for the use of two coordinate systems and / or switching between the two coordinate systems. For example, during surgery, a first coordinate system may be used for a first portion of the surgery, or a selected portion of the surgery, while a second coordinate system may be used during a second portion of the surgery. Furthermore, the two coordinate systems may be used to perform or track a single portion of the surgery, for example, to verify and / or collect additional information.

[0012] In addition, the image data and / or image of the selected part of the subject can be obtained. Image data can be used to generate or rebuild the model of the subject, such as the 3D (that is, volume) model of the subject. Model and / or other images can be displayed for users (such as surgeons) to view. Superimposed on a part of the model or image can be a graphical representation of the tracked part or component (such as an instrument). According to various embodiments, due to the registration of the image space (also referred to as the image coordinate system) to the subject space, the graphical representation can be superimposed on the model or image at an appropriate position. The subject space limited by the subject is registered to the method of the image space and can be included in the method disclosed in U.S. Patent No. 8,737,708, U.S. Patent No. 9,737,235, U.S. Patent No. 8,503,745 and U.S. Patent No. 8,175,681, all of which are incorporated herein by reference in their entirety. As discussed herein, the image displayed can be displayed on a display device. The image can be a direct image (e.g., a visible image, a 2D x-ray projection), a model reconstructed based on selected data (e.g., multiple 2D projections, a 3D scan (e.g., computed tomography), magnetic resonance image data), or other suitable image. Thus, the displayed image referred to herein can be a reconstructed or original image.

[0013] During a selected procedure, as a result of the selected procedure, such as imaging of a subject, a first coordinate system can be registered to subject space or a subject coordinate system. In various embodiments, the first coordinate system can be registered to the subject by imaging the subject using a portion of a fiducial fixed relative to a first component or system, such as a robotic system. Because the image of the subject includes the fiducial portion, the known position of the fiducial relative to the robotic system can be used to register the subject space relative to the robotic system. Thus, the position of the robotic system or a portion thereof, such as an end effector, can be known or determined relative to the subject. Due to the registration of the second coordinate system with the robotic coordinate system, tracking of additional components that are not fixed to the robot relative to a position determined or tracked by the robot can be allowed.

[0014] Tracking of instruments during a procedure (such as a surgical procedure or surgical treatment) allows for navigation of the procedure. When image data is used to define an image space, it can be associated or registered with a physical space defined by a subject, such as a patient. Thus, according to various embodiments, the patient defines a patient space in which instruments can be tracked and navigated. The image space defined by the image data can be registered to a patient space defined by the patient. Registration can be performed using fiducials that can be identified in the image data and the patient space.

[0015] Further areas of applicability will become apparent from the description provided herein.The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

[0017] Figure 1 is a schematic diagram illustrating an overview of a robotic system and a navigation system according to various embodiments;

[0018] Figure 2 is a detailed environmental view of a robotic system and a tracking system according to various embodiments, wherein the robotic system is in a first configuration;

[0019] Figure 3 is a schematic diagram of an imaging system for acquiring image data of a subject according to various embodiments;

[0020] Figure 4 is a schematic diagram of an imaging system for acquiring image data of a subject according to various embodiments;

[0021] Figure 5 is a detailed environmental view of the robotic system and the tracking system according to various embodiments, wherein the robotic system is in a second configuration; and

[0022] Figure 6 is a flow chart of a method or process for determining a Go Zone for movement of a robotic system, according to various embodiments.

[0023] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0024] Example embodiments will now be described more fully with reference to the accompanying drawings.

[0025] The subject disclosure relates to exemplary embodiments of performing surgical procedures on subjects, such as human patients. However, it should be understood that the systems and methods described herein are merely exemplary and are not intended to limit the scope of the claims included herein. In various embodiments, it should be understood that the systems and methods can be incorporated into and / or used with non-living objects. For example, these systems can be used to align coordinate systems between two systems for use on manufacturing systems and maintenance systems, etc. For example, automobile assembly may use one or more robotic systems that include separate coordinate systems that can be aligned together for coordinated or combined actions. Therefore, the exemplary illustrations of surgical procedures herein are not intended to limit the scope of the appended claims.

[0026] According to various embodiments, discussed herein are processes and systems for allowing alignment between various coordinate systems. In various embodiments, a first coordinate system, which may be a robot coordinate system, may be aligned to a second coordinate system, which may be an image coordinate system or space. A third coordinate space, such as a navigation space or coordinate system, may then be aligned to the robot or first coordinate system, and therefore aligned to the image coordinate system, without being separately or independently aligned to the image space. Similarly, the navigation space or coordinate system may be aligned directly or independently to the image coordinate system or space. The robot system or first coordinate system may then be aligned to the navigation space, and therefore aligned to the image coordinate system or space, without being separately or independently aligned to the image space.

[0027] Figure 1 FIG is a schematic diagram illustrating an overview of an operating room or surgical environment. In various embodiments, the operating room may include a surgical field in which a robotic system 20 and a navigation system 26 that may be used for various surgeries may be located. The robotic system 20 may include a Mazor X TM Robotic Guidance System. The robotic system 20 can be used to help guide selected instruments, such as drills, screws, etc., relative to the subject 30. The robotic system 20 can include a mount 34 that secures a portion, such as a robotic base 38, relative to the subject 30. The robotic system 20 can include one or more arms 40, such as an end effector 44, that can move or pivot relative to the subject 30. The end effector can be any suitable part, such as a tube, a guide, or a channel member. The end effector 44 can be moved relative to the base 38 by one or more motors. The position of the end effector 44 can be known or determined relative to the base 38 using one or more encoders located at one or more joints of the robotic system 20, such as a wrist joint 48 and / or an elbow joint 52.

[0028] The navigation system 26 can be used to track the position of one or more tracking devices, which may include a robot tracking device 54, a subject tracking device 58, an imaging system tracking device 62, and / or a tool tracking device 66. The tool 68 can be any suitable tool, such as a drill, tweezers, or other tool operated by the user 72. The tool 68 can also include an implant, such as a spinal implant or an orthopedic implant. It should be further noted that the navigation system 26 can be used to navigate any type of instrument, implant, or delivery system, including guidewires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc. In addition, these instruments can be used to navigate or map any area of ​​the body. The navigation system 26 and the various instruments can be used in any appropriate surgery, such as typically minimally invasive surgery or open surgery.

[0029] The imaging device 80 can be used to acquire pre-operative, intra-operative, or post-operative or real-time image data of a subject, such as subject 30. The image data can be used to reconstruct or generate an image of the subject and / or portions of the subject, or space relative to subject 30. Further, as discussed herein, the image data can be used to generate a model at more than one resolution. The model can be used for various purposes, such as determining an area for moving the end effector 44 and / or other portions of the robotic arm 40.

[0030] However, it should be understood that any suitable subject can be imaged and any suitable procedure can be performed with respect to the subject. In the example shown, the imaging system 80 comprises a 100 nm imaging system sold by Medtronic Navigation, Inc., having a place of business in Louisville, Colorado, USA. Imaging device. The imaging device 80 may have a generally annular gantry housing 82 in which the image capture portion is movably disposed. The image capture portion may include an x-ray source or emitting portion 83 ( Figure 3 and Figure 4 ), and the x-ray receiving portion or image receiving portion 85 ( Figure 3 and Figure 4) are positioned substantially or as nearly as practically possible 180 degrees from each other and are mounted on a rotor relative to a track or rail. The image capture portion can be configured to rotate 360 ​​degrees during image acquisition. The image capture portion can rotate about a center point or axis, allowing image data of the patient 80 to be acquired from multiple directions or in multiple planes. The imaging device 80 may include an imaging system disclosed in: U.S. Patent No. 7,188,998, U.S. Patent No. 7,108,421, U.S. Patent No. 7,106,825, U.S. Patent No. 7,001,045, and U.S. Patent No. 6,940,941, all of which are incorporated herein by reference or any appropriate portion thereof. In one example, the imaging device 80 may utilize flat panel technology having a 1,720×1,024 pixel image data capture partition.

[0031] The position of the imaging device 80 and / or a portion thereof (e.g., the image capturing portion) can be precisely known relative to any other portion of the imaging device 80. According to various embodiments, the imaging device 80 can know and recall precise coordinates relative to a fixed coordinate system or a selected coordinate system. This can allow the imaging system 80 to know its position relative to the patient 30 or other points in space. Additionally, as discussed herein, precise knowledge of the position of the image capturing portion can be used in conjunction with a tracking system to determine the position of the image capturing portion and image data relative to a tracked subject (such as the patient 30).

[0032] The imaging device 80 can also be tracked with the tracking device 62. According to various embodiments, the image data defining the acquired image space of the patient 30 can be inherently or automatically registered with respect to the target space. The target space can be the space defined by the patient 30 in the navigation system 26. Automatic registration can be achieved by including a determinable precise pose of the tracking device 62 and / or the image capture portion on the imaging device 80 (i.e., including at least three degrees of freedom position information (e.g., x, y and z coordinates) and / or three degrees of freedom orientation information). According to various embodiments, as discussed herein, imageable portions, virtual reference points and other features can also be used to allow automatic or other registration. However, it will be understood that image data of any subject that will define the subject space can be acquired. The patient space is an exemplary subject space. Registration allows a transformation map to be determined between the patient space and the image space.

[0033] The patient 80 can also be tracked using a patient tracking device, DRF, or tracker 58 as the patient moves. Alternatively or in addition, the patient 30 can be fixed within a navigation space defined by the navigation system 26 to allow for registration. As discussed further herein, registration of image space with patient space or subject space allows for navigation of the instrument 68 using image data. As the instrument 68 is navigated, the position of the instrument 68 can be displayed on the display device 84 relative to the acquired image data of the patient 30. Various tracking systems, such as those including an optical locator 88 or an electromagnetic (EM) locator 92, can be used to track the instrument 68.

[0034] More than one tracking system can be used to track the instrument 68 in the navigation system 26. According to various embodiments, these can include an electromagnetic (EM) tracking system having an EM locator 94 and / or an optical tracking system having an optical locator 88. As discussed herein, one or both of the tracking systems can be used to track a selected tracking device. It should be understood that, unless otherwise discussed, a tracking device can be a trackable portion of a selected tracking system. A tracking device does not necessarily refer to the entire component or structure to which the tracking device is attached or associated.

[0035] It should also be understood that the imaging device 80 may be other than The imaging device of the imaging device may additionally or alternatively include a fluoroscope C-arm. Other exemplary imaging devices may include fluoroscopes such as biplane fluoroscope systems, ceiling-mounted fluoroscope systems, catheterization laboratory fluoroscope systems, fixed C-arm fluoroscope systems, isocentric C-arm fluoroscope systems, 3D fluoroscope systems, etc. Other suitable imaging devices may also include MRI, CT, ultrasound, etc.

[0036] In various embodiments, the imaging device controller 96 can control the imaging device 80 and can receive image data generated by the image capture portion and store the image for later use. The controller 96 can also control the rotation of the image capture portion of the imaging device 80. It should be understood that the controller 96 need not be integral to the housing housing 82 and can be separate therefrom. For example, the controller can be part of the navigation system 26, which can include a processing system and / or control system 98, which can include a processing unit or processing portion 102. However, the controller 96 can be integrated with the housing 82 and can include a second processor or a separate processor, such as in a laptop computer.

[0037] The patient 30 may be secured to an operating table 104. According to one example, the operating table 104 may be an Axis® operating table sold by OSI, a division of Mizuho Ikakogyo Corporation having a place of business in Tokyo, Japan, or Orthopedic Systems, Inc. having a place of business in California, USA. Operating table. The patient positioning device can be used with the operating table and includes The clamp or patient positioning device set forth in commonly assigned U.S. patent application Ser. No. 10 / 405,068, entitled “An Integrated Electromagnetic Navigation And Patient Positioning Device,” filed on April 1, 2003, and published as U.S. Patent Application Publication No. 2004 / 0199072, which is hereby incorporated by reference herein.

[0038] Thus, the position of the patient 30 relative to the imaging device 80 can be determined by the navigation system 26. The tracking device 62 can be used to track and position at least a portion of the imaging device 80, such as the gantry or housing 82. As discussed further herein, the patient 30 can be tracked using the dynamic reference frame 58. Thus, the position of the patient 30 relative to the imaging device 80 can be determined. Further, due to the precise position of the imaging portion on the rails within the housing 82, the substantially inflexible rotors, etc., the position of the imaging portion can be determined relative to the housing 82. If the imaging device 80 is sold by Medtronic Navigation, Inc., having a place of business in Louisville, Colorado Imaging device, then imaging device 80 can include, for example, accuracy within 10 microns. Precise positioning of the imaging portion is further described in the following: U.S. Patent No. 7,188,998, U.S. Patent No. 7,108,421, U.S. Patent No. 7,106,825, U.S. Patent No. 7,001,045 and U.S. Patent No. 6,940,941, all of which are incorporated herein by reference.

[0039] According to various embodiments, the imaging device 80 can generate and / or emit x-rays from an x-ray source, which propagate through the patient 30 and are received by the x-ray imaging receiving portion. The image capture portion generates image data representing the intensity of the received x-rays. Typically, the image capture portion can include an image intensifier that first converts the x-rays into visible light and a camera (e.g., a charge-coupled device) that converts the visible light into digital image data. The image capture portion can also be a digital device that directly converts the x-rays into digital image data to generate or reconstruct an image, thereby potentially avoiding distortion caused by the initial conversion to visible light.

[0040] Two-dimensional and / or three-dimensional fluoroscopic image data that may be taken by imaging device 80 may be captured and stored in imaging device controller 96. Multiple image data acquired by imaging device 80 may also be captured and combined to provide a larger view or image of the entire area of ​​patient 30, rather than just a portion of patient 30. For example, multiple image data of the spine of patient 30 may be appended together to provide a complete view or set of image data of the spine.

[0041] The image data can then be forwarded from the imaging device controller 96 to a navigation computer and / or processor system 102, which can be part of a controller or workstation 98 having a display 84 and a user interface 106. It will also be appreciated that the image data need not be first stored in the controller 96 but can be transferred directly to the workstation 98. The workstation 98 can provide facilities for displaying the image data as an image 108 on the display 84 and for storing, digitally processing, or printing hard copy images of the received image data. The user interface 106, which can be a keyboard, mouse, stylus, touch screen, or other suitable device, allows the user 72 to provide input to control the imaging device 80 or adjust image settings of the display 84 via the imaging device controller 96. The workstation 98 can also instruct the imaging device controller 96 to adjust the image capture portion of the imaging device 80 to obtain various two-dimensional images along different planes, thereby generating representative two-dimensional image data and three-dimensional image data.

[0042] Continue to refer Figure 1 The navigation system 26 may also include a tracking system that includes one or both of an electromagnetic (EM) locator 94 and / or an optical locator 88. The tracking system may include a controller and an interface portion 110. The controller 110 may be connected to a processor portion 102 that may include a processor contained within a computer. The EM tracking system may include a system sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado. AXIEM TMNavigation system; or may be the EM tracking system described in the following patents: U.S. Patent Application Serial No. 7,751,865 entitled "METHOD AND APPARATUS FOR SURGICAL NAVIGATION"; U.S. Patent No. 5,913,820 entitled "Position Location System" issued on June 22, 1999; and U.S. Patent No. 5,592,939 entitled "Method and System for Navigating a Catheter Probe" issued on January 14, 1997; all of which are incorporated herein by reference. It should be understood that the navigation system 26 may also be or include any suitable tracking system, including a system having an optical positioner. or S7 TM Tracking systems, which can be used as optical positioners 88, are sold by Medtronic Navigation, Inc., located in Louisville, Colorado. Other tracking systems include acoustic, radiation, radar, and other tracking systems. Tracking systems can be used according to commonly known or described techniques in the references incorporated above. Details will not be included herein unless they clarify selected operations of the subject disclosure.

[0043] Wired or physical connections can interconnect the tracking system, imaging device 80, etc. Alternatively, rather than being directly coupled to the controller 110, various components, such as the instrument 68, can utilize wireless communication channels, such as disclosed in U.S. Patent No. 6,474,341, entitled "Surgical Communication Power System," issued on November 5, 2002, which is incorporated herein by reference. Furthermore, the tracking devices 62, 66, 54 can generate fields and / or signals that are sensed by the localizers 88, 94.

[0044] Various components of the navigation system 26, such as the instrument 68, and other components described in detail below, can be equipped with at least one and typically multiple tracking devices 66. The instrument can also include more than one type or form of tracking device 66, such as an EM tracking device and / or an optical tracking device. The instrument 68 can include a graspable or maneuverable portion at a proximal end, and the tracking device can be fixed near the maneuverable portion of the instrument 68.

[0045] Additional representative or alternative location and tracking systems are described in U.S. Patent No. 5,983,126, entitled "Catheter Location System and Method," issued on November 9, 1999, which is incorporated herein by reference. Navigation system 26 may be a hybrid system that includes components from various tracking systems.

[0046] According to various embodiments, the navigation system 26 can be used to track the instrument 68 relative to the patient 30. As described above, the tracking system can be used to track the instrument 68. Image data of the patient 30 or a suitable subject can be used to help the user 72 guide the instrument 68. However, the image data is registered to the patient 30. The image data defines an image space that is registered to the patient space defined by the patient 30. The registration can be performed automatically, manually, or a combination thereof as discussed herein. The tracking system can also be used to track the robotic system 20 or at least a portion thereof, such as a movable portion including the arm 40 and / or the end effector 44. In various embodiments, a registration or transformation map of the robotic coordinate system and the coordinate system defined by the subject can be made to determine the volume in which the robotic system can move. This can be accomplished at least in part due to the registration of the subject and the image space.

[0047] In general, registration allows the transformation map to generate the physical position of the instrument 68 relative to the image space of the image data. The transformation map allows the tracked position of the instrument 68 relative to the image data 108 to be displayed on the display device 84. A graphical representation 68i, also referred to as an icon, can be used to illustrate the position of the instrument 68 relative to the image data 108.

[0048] This may also allow registrations or transformation maps to be determined between various other coordinate systems relative to other parts, such as the robot coordinate system of the robotic system 20. For example, once the navigation coordinate system is determined in physical space and the image space is registered, any part tracked in the navigation space may be tracked relative to the subject space, as may any other part that has a transformation map to allow registration between a separate coordinate space and the image coordinate space. As described above, the registration to the navigation space relative to the subject 30 may be maintained by maintaining the tracking device on the subject 30. In an alternative and / or in addition, the subject 30 may be fixed in space relative to the navigation coordinate system.

[0049] According to various embodiments, a subject registration system or method that may use the tracking device 58 may include a tracking device as disclosed in U.S. Patent No. 11,135,025, which is incorporated herein by reference. Figure 1 and Figure 2The tracking device 58 may include a trackable portion or member 120, but may also function as or be operable as a fiducial assembly. The fiducial assembly 120 may include a clamp or other securing portion 124 and an imageable fiducial body 120. However, it should be understood that the member 120 may be separate from the tracking device 58. The securing portion 124 may be provided to secure any suitable portion, such as a portion of an anatomical structure. Figure 1 and Figure 2 As shown, the fiducial assembly 120 can be interconnected with a portion of the spine 126 , such as the spinous process 130 .

[0050] The fixing portion 124 can be interconnected with the spinous process 130 in any suitable manner. For example, a pin or screw can be driven into the spinous process 130. Alternatively or in addition, a clamp portion 124 can be provided to interconnect the spinous process 130. The fiducial portion 120 can be imaged using the imaging device 80. However, it should be understood that various parts of the subject, such as the spinous process, can also be used as the fiducial portion.

[0051] In various embodiments, when the fiducial portion 120 is imaged with the imaging device 80, image data is generated that includes or identifies the fiducial portion 120. The fiducial portion 120 can be identified in the image data automatically (e.g., by a processor executing a program), manually (e.g., by identification of a user 72 selecting a seed point), or a combination thereof (e.g., by identification of a user 72 selecting a seed point and segmentation performed by a processor executing a program). Methods of automatic imageable portion identification include those disclosed in U.S. Patent No. 8,150,494, issued April 3, 2012, which is incorporated herein by reference. Manual identification can include selecting an element (e.g., a pixel) or region in the image data where the imageable portion has been imaged. Regardless, the fiducial portion 120 identified in the image data can be used as a fiducial or fiducial location that can be used to align the image data or the image space of the image data with the patient space.

[0052] In various embodiments, to register the image space or coordinate system to another space or coordinate system, such as navigation space, fiducial portion 120 identified in image 108 can then be identified in a suitable manner in the subject space defined by subject 30. For example, if the fiducial portion was attached to subject 30 at the same location during the acquisition of image data to generate image 108, user 72 can move instrument 68 relative to subject 30 to contact fiducial portion 120. It should be understood that, as discussed above in various embodiments, fiducial portion 120 can be attached to subject 30 and / or can include an anatomical portion of subject 30. Additionally, tracking devices can be incorporated into fiducial portion 120, and they can remain with subject 30 after image acquisition. In this case, registration or identification of fiducial portion 120 can be performed in subject space. However, according to various embodiments, user 72 can move instrument 68 to contact fiducial portion 120. With tracking device 66 attached to instrument 68, a tracking system, such as one having optical positioner 88, can track the position of the instrument. This allows user 72 to identify, in navigation space, the location of fiducial portion 120 identified in image 108. After identifying the location of fiducial portion 120 in navigation space, which may include subject space, a transformation map may be made between the subject space defined by subject 30 in navigation space and the image space defined by image 108. Thus, the same or known location allows for registration, as discussed further herein.

[0053] During registration, a transformation map is determined between the image data coordinate system of the image data (which can be used to generate or reconstruct image 108) and the patient space defined by patient 30. Once registration occurs, instrument 68 can be tracked using a tracking system registered to the image data to allow the position of the tracked instrument 68 to be identified and illustrated as an icon superimposed on the image data. Registration of image 108 (or any selected image data) to subject 30 can occur at any suitable time.

[0054] After registering the image space to the patient space, the instrument 68 can be tracked relative to the image 108. Figure 1 As shown, an icon 68i representing the position of the instrument 68 in navigation space (which may include a six-degree-of-freedom position (including a 3D position and orientation)) can be displayed relative to the image 108 on the display 84. Due to the registration of image space to patient space, the position of the icon 68i relative to the image 108 can substantially identify or simulate the position of the instrument 68 relative to the patient 30 in patient space. As described above, this can allow the navigation process to occur.

[0055] As discussed herein, the robotic system 20 having a robotic system coordinate system can be registered to a navigation space coordinate system due to tracking by a reference tracking device 54 (e.g., if positioned and / or fixed to the robotic system 20 or relative to a known position of the robotic system) and / or due to tracking by a snapshot tracking device 160. The snapshot tracking device 160 can include one or more trackable portions 164 that can be tracked using a localizer 88 or any suitable localizer (e.g., optical, EM, radar). However, it should be understood that the snapshot tracking device 160 can be tracked using any suitable tracking system. The reference tracking device 54 can be fixed relative to a selected portion of the robotic system 20 to be tracked during surgery, and / or the snapshot tracking device 160 can be attached to a portion of the robotic system 20 during the registration process. After registration, the pose of the selected portion of the robotic system 20 can be determined using a tracking device (e.g., the tracking device 54) and / or using various sensors associated with the robotic system (such as position sensors associated with a motor or motion system of the robotic system 20).

[0056] Fixed reference tracking device (e.g. Figure 2 , schematically shown in the figure and designated by the numeral 140, may also be positioned within the navigation space. The fixed navigation tracker may include a patient tracker 58 that may be connected to the patient 30 and / or a robotic tracker 54 that may be fixed to the robotic system 20 (such as the base 34). Thus, the reference tracker may be any suitable tracker that is positioned alternatively and / or additionally to the snapshot tracker 160 within the navigation coordinate space during registration. For the discussion herein, reference will be made to the robotic tracker 54, however, the patient tracker 58 may also be used as the reference tracker. Further, the reference tracker may be positioned anywhere within the coordinate system in addition to or alternatively to the snapshot tracker, as long as the snapshot tracker 160 can be tracked relative to the reference tracker.

[0057] In various embodiments, the snapshot tracker 160 can be positioned at a known location relative to the end effector 44. For example, the snapshot tracker 160, including the trackable portion 164, extends from a rod or connecting member 168. The localizer 88 can then view or determine the position of the snapshot tracking device 160 relative to the reference tracking device 54 and / or the reference tracking device 58. Because the localizer 88 defines or can be used to define the navigation space, determining or tracking the position of the snapshot tracker 160 relative to the reference frame 54 can be used to determine the relationship between the position within the navigation space and the robotic space of the end effector 44. The snapshot tracker 160 can be used during registration and / or can be positioned relative to the end effector during any movement of the robotic system 20. In various embodiments, the snapshot tracker 160 can be positioned at or near the end effector to track the end effector in addition to tracking any instrument placed for use with the end effector 44.

[0058] refer to Figure 1 and Figure 2 And also refer to Figure 3 and Figure 4 , imaging system 20 can be used to capture image data of subject 30. As x-rays are emitted from source 83 and detected at detector 85, captured image data of subject 30 can be captured. It will be understood by those skilled in the art that x-rays may be attenuated and / or blocked by one or more portions of subject 30, and other x-rays may pass through portions of subject 30. The x-rays or attenuation of the x-rays detected at detector 85 can be generated to generate or reconstruct an image that can be displayed (such as image 108 of display device 84). Therefore, it will be understood that image data of subject 30 can be acquired, and an image and / or model can be generated based on the image data. The model can be generated to include various information and / or features that may include only direct image data and / or other data of the subject.

[0059] According to various embodiments, such as Figure 3As shown, imaging system 80 may include a source 83 that generates an x-ray beam 200, such as within a cone or triangle. X-rays may be generated at source 83 and detected at detector 85. Subject 30 may be positioned within x-ray beam 200 and attenuate and / or block the x-rays before they contact detector 85. Subject 30 may include an outer or exterior geometry 210. Exterior geometry 210 may be the outer boundary of subject 30. Subject 30 may also include various interior geometries or portions, such as spine 126. Subject 30 may also be divided into various portions, including a region between outer region 210 and spine 126, including a medial boundary 214. Additional regions may be defined between medial boundary 214 and spine 126. First and second regions 213, 222 may have image data captured at detector 85 in substantially the same manner as image data for other portions, such as spine 126. However, during reconstruction of the image data captured at detector 85, various regions may be reconstructed in images and / or models at different resolutions. Various resolutions may aid in generating speed and / or information for reconstruction.Further, one may choose to display only portions of the reconstruction, while allowing models or reconstructions of portions of subject 30 (such as outer extent 210) to be made and used for other purposes that do not include their display.

[0060] like Figure 3 As shown, cone 200 can capture the entire volume of subject 30 at once. Imaging system 80 can be any suitable imaging system, such as the one described above. Imaging system. Thus, the source 80 and detectors 83, 85 can be rotated within the gantry 82, such as generally in the direction of arrow 230. Images or image data of the subject 30 can be captured at various angles relative to the subject 30. In various embodiments, the subject 30 can be substantially stationary or immobile during the capture of image data of the subject 30, so that multiple image projections of the subject 30 can be acquired. This can facilitate three-dimensional reconstruction of the subject 30 at a selected time. In various embodiments, for example, the subject 30 can be placed on and / or secured to the support 104.

[0061] refer to Figure 4 , the imaging system 80 may acquire image data of the subject 30 when the subject 30 is not at the isocenter of the imaging system and / or during off-center image capture. Figure 4 As shown, a beam 200 may be emitted from a source 83 and detected at a detector 85. However, as Figure 4As shown, at any single detection position, the entire subject 30 may not be within the beam 200. However, as described above, the detector 85 and source 83 can be moved to various positions within the gantry to allow the view of the subject 30 to be captured. For example, Figure 4 As shown, image data may be captured using at least two positions of sources 83 and 83' and two positions of detectors 85, 85'. Multiple projections of subject 30 may be used to generate or reconstruct a selected image and / or model of subject 30. Thus, regardless of the position of subject 30 within imaging system 80, selected image data may be acquired and used to reconstruct an image or model of subject 30. Further, as Figure 4 As shown, various portions of subject 30 may be imaged or reconstructed, including outer boundary 210, medial boundary 214, and spine 216. However, as described above, first portion 213 and second portion 222 may also be reconstructed at various resolutions for various purposes.

[0062] As described above, the imaging system 80 may acquire image data of the subject 30. The image data of the subject 30 may include image data of all portions of the subject 30, at least for selected regions or areas of interest. Figure 2 As shown, spine 126 may be image data of subject 30. The acquired image data of subject 30 may also include soft tissue image data of tissue adjacent to the vertebrae of spine 126. The image data acquired using imaging system 80 may be used to identify various portions of the anatomy of subject 30, including spine 126 and other portions. In various embodiments, a reconstruction of spine 126 or at least a portion thereof may be performed and displayed as image 108. Image data of portions associated with spine 126 may also be captured in the image data using imaging system 80. This image data may be used to generate or reconstruct a model of one or more portions of subject 30 that includes spine 126.

[0063] In various embodiments, the spine 126 can be reconstructed at a high resolution, such as the maximum possible resolution. In various embodiments, the high resolution can be approximately 100 pixels per inch, 75 pixels per inch, or any suitable number. Thus, the image of the spine can be displayed in detail to allow surgery to be performed relative to the spine or portion of the spine 126. Figure 2 As shown, image 108 may include a detailed view of at least a single vertebra of spine 126. However, other portions of subject 30 may be reconstructed at a lower resolution. The lower resolution may be approximately 10 pixels per inch, 20 pixels per inch, or any suitable amount. In various embodiments, the low or lower resolution may be approximately 10% to 50% of the higher resolution.

[0064] As discussed above, the outer extent or boundary 210 of the subject 30 can be reconstructed at a low resolution, and the intermediate region relative to the intermediate portion 214 can be reconstructed at an intermediate resolution (such as 40% to about 70% of the high resolution). However, in various embodiments, the resolution of the outer extent of the subject 30 can be reconstructed with any resolution operable to help define a keep-out zone for portions of a procedure, such as for moving or placing the robotic system 40. The highest resolution portion can be used to reconstruct portions of the subject, such as the spine 126. Thus, for various purposes, such as those discussed further herein, image data can be reconstructed at a resolution selected to achieve speed of reconstruction, resolution, or reconstruction.

[0065] Go to Reference Figure 5 , the robotic system 20 includes an arm portion 40 that includes or has a moving portion. The end effector 44 can be a moving portion that moves relative to the subject 30. Figure 2 As shown, the end effector 44 can be positioned in a first posture relative to the subject 30. The end effector 44 can be positioned in the first posture relative to the patient tracking device 58 and the spine 126. During the procedure, such as after the first portion of the procedure, the end effector 44 can be optionally moved to a second position or posture. Moving the end effector 44 to the second posture can allow the end effector 44 to be positioned relative to a different or second portion of the subject 30 to assist in the procedure, particularly at a second time. Thus, the end effector 44 can be moved or traversed relative to the subject 30.

[0066] When moving the end effector 44 relative to the subject 30, the end effector 44 or any portion of the robotic arm 40 is selected so as not to contact the subject 30. It is also possible to select so that no portion of the robotic arm 40 contacts any other portion or item in the navigation space. Thus, the posture of the subject 30 can be determined, and the volume of the subject 30 includes the outer boundary of the subject, which outer boundary may include the soft tissue of the subject 30. The soft tissue volume of the subject 30 may include a volume or area that is selected so as not to be passed through or contacted by the robotic arm 40 including the end effector 44. Thus, it can be determined that all portions of the subject (including its soft tissue) are defined as a no-go zone or area for the movement of the robotic arm 40 including the end effector 44. As discussed herein, a no-go zone may be a volume in which the robotic arm 40 is selected not to move or be positioned.

[0067] The acquired image data of subject 30 may include image data of all parts of subject 30. Subject 30 may include bony tissue, such as that of spine 126, as well as soft tissue relative to spine 126. Therefore, in addition to hard tissue or bony tissue, the image data acquired using imaging system 80 can also be used to generate a model of subject 30. This model can be used to define no-go zones. Therefore, when the robotic arm moves relative to subject 30, the robotic arm can be controlled and instructed to avoid passing through various no-go zones.

[0068] The robotic arm 40 can move with various degrees of freedom relative to the subject 30 or anywhere in physical space. In various embodiments, the robotic arm 40 can move with substantially six degrees of freedom. The six degrees of freedom can include three axes of freedom, namely, the X-axis, the Y-axis, and the Z-axis, such as Figure 5 As shown. In addition, the degrees of freedom of movement of the robotic arm including the end effector 44 can include orientation, such as orientation about each of the three axes (including a first rotational or circular orientation 250 relative to the X-axis, a second orientation 254 relative to the Y-axis, and any third orientation 258 relative to the Z-axis). Therefore, the robotic arm 44 including the end effector 44 can move relative to the subject 30 in any suitable manner while not traversing a selected volume, which can also be referred to as a no-go zone or area. The robotic arm can include any suitable drive system for movement, such as one or more motors, cable drives, belt drives, etc.

[0069] refer to Figure 6 , discloses a process or method 300 for acquiring data of a subject and determining possible movement zones for a robotic system 20. As discussed herein, the robotic system can move relative to the subject 30. However, typically, they can be selected so that the robotic system 20 moves only in selected zones. The selected zones can be volumes defined in space, which can also be referred to as advance zones or areas. Typically, the advance zone allows the robotic system 20 to move without contacting another subject (such as the subject 30). No-advance zones or areas may not be included in the advance zone. Typically, anything that is not in the advance zone can be defined as a no-advance zone. As discussed herein, moving in the advance zone and / or moving only in the advance zone includes not moving in the no-advance zone.

[0070] Image data or volume data relative to subject 30 can be used to help define a no-go zone. The no-go zone can include a partition or volume that will include contact with subject 30 by robotic system 20. In addition, as discussed above, various parts can be tracked by a navigation system. Therefore, tracked parts can also be identified within the no-go zone to help ensure that robotic system 20 does not contact any parts during movement of robotic arm 40. As discussed herein, any part of the robotic system that can move can be a movable part, including arm 40, end effector 44, and / or other parts that can move relative to base 34 and / or relative to subject 30.

[0071] Figure 6 The method 300 shown in FIG. 3 may include various inputs. In various embodiments, for example, the initial input or subroutine may include a subroutine 310 that includes acquiring pre-operative or pre-operative image data in block 314. In various embodiments, in block 320, the pre-operative image data may be utilized to formulate a plan. The pre-operative image data acquired in block 314 may include magnetic resonance image (MRI) data, computed tomography (CT) image data, cone beam image data, fluoroscopic image data, or other types of appropriate image data. Image data of subject 30 may be acquired to assist in performing surgery on subject 30. Image data or other appropriate data in addition to and / or in place of image data may be acquired. Image data may be used to plan surgery. For example, planning surgery may include determining where an implant will be positioned, the size or geometry of the implant, the location of an incision, or other appropriate surgical procedures. However, subroutine 310 may at least include acquiring pre-operative or pre-operative image data that can be used during surgery, as discussed further herein.

[0072] Other inputs and / or procedures may occur relative to method 300. For example, in block 324, the subject may be positioned using fiducials. Placing fiducials in subject 30 may include positioning and / or securing imageable portions to subject 30. The fiducials may be imaged in pre-operative image data and / or intra-operative image data. The fiducials may be secured to various components, such as robotic system 20, to assist in determining the posture of robotic system 20 (including robotic arm 40) relative to subject 30. In various embodiments, for example, In robotic systems and surgeries, fiducials can be imaged intraoperatively to determine the source or origin of movement of the robotic system 20 relative to the subject 30 and / or other parts. The fiducials can be used to define the origin of the base 34 in the image data based on the image fiducials. The fiducials can also be positioned on the subject so that the fiducials can be imaged during imaging to allow the subject to be registered to the image data after the image data is acquired. The fiducials can be incorporated into the tracking device and / or separate from the tracking device. Similarly, the fiducials can be integrated with and / or separate from the tracking device associated with any other part (such as the robotic system 20).

[0073] Additionally or alternatively, in block 328, a subject tracking device (also referred to as a dynamic reference frame (DRF)) may be associated with the subject 30. Associating a fiducial in block 328 may include securing the fiducial to the subject 30. For example, as described above, the patient tracker 58 may be secured to the spinous process 130 of the spine 126 of the subject 30. The patient tracker 58 may include a fiducial portion and / or a tracking portion. The patient tracker 58 may include only one or the other and / or both the tracking portion and the fiducial portion. However, as described above, the patient tracker 58 may include only one or the other and / or both the tracking portion and the fiducial portion. Figure 3 and Figure 4 As shown, the patient tracker 58 can be positioned relative to the subject 30, such as during image data acquisition. Thus, the pose of the patient tracker 58 relative to the portion of the subject 30 can be determined.

[0074] refer to Figure 3 , the patient tracker 58 can be positioned relative to the subject 30. Figure 3 As shown, various portions of the subject 30 may be modeled and / or imaged. For example, an exterior geometry or portion 210 of the subject 30 may be determined and / or a model may be generated based on data acquired using the imaging system 80. The patient tracker 58 may have a known geometry or pose relative to the exterior 210. For example, Figure 3 As shown, the distance or geometric cone 340 between the patient tracking device 58 and the outer range 210 can be determined. Figure 5 In the subject or navigation space, the patient tracker 58 can include a tracking portion point or origin 344. Point 344 can be tracked using an appropriate tracking system, such as those discussed above. Thus, a pose or distance 340 can be determined between the tracking point 344 and any portion of the outer geometry 210 of the subject 30. Thus, the tracking pose accuracy 58 of the patient can be determined relative to the outer extent or surface 210 of the subject 30 using the tracking system.

[0075] The method or process 300 may include various parts, including the inputs or steps described above. The process 300 may then include acquiring intraoperative image data in block 360. Acquiring intraoperative image data in block 360 may include acquiring any suitable type of image data of the subject 30. As described above, the imaging system 80 may be used to acquire image data of the subject 30. During the acquisition of the image data, a posture or position of the imaging system 80 relative to the subject 30 may be determined, such as using This is understood by those skilled in the art when imaging system 80 is used. That is, during the acquisition of image data of subject 30, the pose of the portion of the image data of subject 30 acquired can be known or determined. In addition and / or alternatively, various tracking portions can be associated with imaging system 80. By tracking the pose of imaging system 80 during the acquisition of image data of subject 30, image data acquired using imaging system 80 can be automatically aligned with respect to subject 30. Additionally, according to various embodiments, image data of subject 30 can be acquired with a known or determined pose, and additionally due to tracking by patient tracker 58 and tracking of imaging system 80 using the tracker, the image data can be automatically aligned to the subject. Thus, the image data acquired using imaging system 80 can be image data of acquired subject 30 and include known or determined poses of various portions of the image data, such as any surface or segmented portion that can be made or determined by subject 30.

[0076] In block 364, the image data may be registered relative to any preoperative image data, such as the preoperative image data from block 314. In block 364, the intraoperative image data may also be registered to the subject 30 and / or the navigation space. Registration of the image data acquired from block 360 with the subject 30 may be performed in any suitable manner. As discussed above, the image data may be acquired at a known pose relative to the subject 30. Thus, as will be appreciated by those skilled in the art, the image data may be inherently or automatically registered to the subject 30. Additionally and / or alternatively, the image data acquired in block 360 may be registered to the subject 30 using known registration techniques. For example, portions of the subject 30 may be identified in the image data for registration to any suitable system, such as a navigation system or navigation space. The acquired image data of the subject 30 may include fiducials imaged with the subject and / or portions of the subject, such as portions of the vertebrae 126.

[0077] The image data of the subject can be registered relative to the navigation space and / or any other suitable portion, such as the robotic system 20. As described above, the origin of the robotic system can be determined relative to the subject and / or can be tracked, for example, using the robotic system tracker 54. Further, the subject 30 can be tracked using a patient or subject tracker 58. As described above, the pose of the subject tracker 58 can be determined relative to one or more portions of the subject 30, for example, by determining a sequence of recalling the poses of the subject tracker 58 relative to one or more portions of the subject 30, such as the outer extent 210, the vertebrae 126, or other suitable portions.

[0078] In addition to registering the intraoperative image data to the subject 30, the intraoperative image data may also be registered to the preoperative image data. Registration of the preoperative image data and the intraoperative image data may be performed according to known techniques (e.g., identifying common points). A transformation map may then be made between the two. This may allow a preoperative plan developed using the preoperative image data to be registered or transformed to the intraoperative image data, which allows the robotic system 20 and other parts to be registered to the subject 30. Thus, the preoperative image data may also be registered or transformed to the subject 30 and the navigation space or coordinate system and the robot space or coordinate system.

[0079] like Figure 6 As shown, registration of the intraoperative data with the preoperative image data is optional. However, registration can allow for ensuring that the intraoperative image data is aligned with the preoperative image data, and in particular, aligned with the planned preoperative image data. However, the acquired intraoperative image data can be used for various purposes, as discussed further herein.

[0080] The intraoperative image data acquired in block 360 can be used to reconstruct or generate a model of at least a first portion of the subject 30 at a selected resolution, which can be the first resolution in block 370. At block 374, the intraoperative image data can also be used to generate or reconstruct a second model or image of a second portion of the subject at a second resolution, which can be referred to as a region of interest. Initially, the first resolution and the second resolution can be the same or different resolutions. The first resolution and the second resolution can be used to generate two models at a selected speed, display clarity, refinement or fine positioning as discussed herein, or other appropriate purposes. Thus, based on various features and considerations (such as user input), the reconstruction at the first resolution and the second resolution can be at different or the same resolution. However, the reconstruction of at least two portions of the subject 30 can be performed in respective blocks 370, 374.

[0081] The reconstructions in blocks 370, 374 may include any suitable type of reconstruction. In various embodiments, the reconstruction may be an image of a vertebra and / or a general volume, for example. For example, the reconstruction may include image 108. The reconstruction in block 374 may be a reconstruction of a region of interest, such as one or more vertebrae in a spine. Thus, the second resolution may be a high resolution or very detailed resolution to allow viewing of various complex structures of a selected region of interest, such as a vertebra, such as a vertebra. Figure 5 As shown. The reconstruction or model generated in block 370 can have a lower resolution to illustrate the general boundary and / or define the general boundary. For example, the image data can be used to reconstruct the outer boundary 210 of the subject 30. The outer boundary 210 can be used for various purposes, such as defining the extent of the subject 30. The outer geometry or boundary of the subject 30 can be used when moving the robotic system 20 (including the end effector 44) relative to the subject 30 and / or the part connected to the subject 30. For example, the patient tracker 58 can be positioned on the subject 30, and based on the tracking pose of the patient tracker 58 and the reconstructed model based on the image data acquired using the imaging system 80, the pose or position of the patient tracker relative to the outer boundary 210 can be known. That is, the pose of the subject 30 can be known when the image data is acquired, and the boundary of the subject relative to the patient tracker 58, such as the outer boundary 210, can be known. Since the patient tracker 58 can be tracked in the navigation system and the pose of the robot 20 (such as the end effector 44) can also be known in the navigation system, the pose of the boundary 210 can be known relative to the end effector 44 to help determine the possible movement zone (i.e., advancement zone) of the end effector 44.

[0082] Thus, the pose of the tracked part can be determined in block 380. The determination of the tracked pose can be based on directly tracking the various parts, such as tracking the patient tracker 58, the instrument tracker 66, and the robot tracker 54. Other determinations can be made, such as determining the pose of the end effector 44 relative to the origin of the robotic system 20 (such as the base 34). Since the robotic system 20 can be registered with respect to the navigation coordinate system as described above, knowing the pose of the end effector 44 in the robotic coordinate system can allow its pose to be determined in the navigation coordinate system. Regardless, the determination of the pose of the movable part can be made in block 380.

[0083] In block 390, a determination of a go zone and / or a no-go zone may be made. The determination of a go zone and / or a no-go zone may include determining only the no-go zone and defining any area not within the no-go zone as a go zone. Therefore, for the purposes of the following discussion, it should be understood that either scenario may occur, but the discussion may relate to the determination of a no-go zone.

[0084] The determination of the no-go zone may be based on the determination or reconstruction of the outer boundary 210. Additionally, any tracked portion (such as the patient tracker 58) may also be determined to have a volume that is also within the no-go zone. Figure 5 As shown, the no-go zone can be the outer boundary of the subject, such as the skin surface of subject 30. The no-go zone can also include a volume extending around the patient tracker, such as volume 384. Other appropriate portions can also be determined to be in the no-go zone, and can also be temporary or permanent, such as instrument 68. Instrument 68 can be moved relative to the subject and can be tracked using the navigation system. Therefore, the position of instrument 68 can be a temporary no-go zone. In various embodiments, the user can also input a selected area or volume as a no-go zone. The user-input no-go zone can include a selected volume relative to the subject or other instruments that may not be tracked in the surgical partition.

[0085] However, a system such as the robotic system 20, a navigation system, or other appropriate system can determine a no-go zone. As will be appreciated by those skilled in the art, the determination of a no-go zone can be a process performed by a processor or a process or system. The process or system can execute instructions to determine an outer geometry based on image data and a reconstructed model based on the image data, thereby determining at least a portion of the no-go zone of the subject 30, such as the outer geometry 210. The advance zone and the no-go zone can be defined as being inside, outside, or between any one or more selected boundaries. Therefore, the advance zone and the no-go zone can be a selected three-dimensional volume located between and / or relative to a selected boundary. For example, as a volume within a boundary and / or between two boundaries.

[0086] As described above, the determination of a no-go zone, for example based on the pose of the tracked part and reconstruction of various models, can be used to determine the possible poses and / or possible movements of the robotic system 20 or its movable parts (such as the end effector 44 or the arm 40) to ensure that they do not pass through or stop in the no-go zone. Therefore, the process 300 may include determining the robotic advance zone in block 394. As described above, the robotic advance zone may include any portion that does not include the no-go zone. Therefore, the determination of the robotic advance zone in block 394 may be a determination of any possible range of motion of the robotic system that includes only the advance zone determination block 390 and does not include the no-go zone.

[0087] Thus, process 300 may also be an input and / or include a subroutine for moving the robot and subroutine 404. Subroutine 404 may be part of process 300 and / or separate therefrom. Thus, subroutine 400 may be executed solely by the robotic system based on input from other systems (such as a navigation system). Regardless, subroutine 404 may allow the robotic system to move only within the go zone and not within the no-go zone.

[0088] For example, a query or check may be made in block 410 as to whether the robot needs to move. If the robot does not move, a “no” path 414 may be followed to repeatedly determine whether the robot is to move in block 410 and / or determine the advance zone in block 394.

[0089] However, if it is determined that the robot will move, then the "yes" path 420 can be followed to determine the initial pose of the robotic system in block 424. The initial pose can be a recall of the last pose, tracking of the current pose (such as using a navigation system), tracking of the current pose (such as using the robotic system 20), or other suitable determination. In various embodiments, for example, the initial pose or current pose can be input by a user. However, it should be understood that the determination or assessment of the initial current pose can be automatic, manual, or a combination thereof.

[0090] In block 430, a final pose may be determined. The final pose may be the final pose or position of the end effector 44. For example, during the first portion of the procedure, the end effector 44 may be used to guide an instrument to position a first pedicle screw. After a period of time, for example, after the first pedicle screw has been positioned with the end effector 44 in the first pose, a second pedicle screw may be inserted with the end effector 44 in the second pose. Therefore, determining the second pose of the robotic system 20 may also include determining a path between the initial pose or the first pose and the second pose in block 434. When determining the path, a straight line between the first pose and the second pose may be evaluated. In block 434, it may be evaluated whether the straight line path is only within the advance zone. If it is determined that the straight line path is not only within the advance zone or includes a portion within the no-advance zone, a second path may be determined. Therefore, this process may be iterative to determine a path from the initial pose or the first pose to the second pose in block 434, which may be an efficient or optimal path. Regardless, in block 434, the path may be determined only within the advance zone. By determining that the path is only in the advance zone, the robotic system 20 (which may determine to include the end effector 44 or portions of the robotic arm 40) does not contact or interfere with portions of the subject 30, the patient tracker 58, or other portions selected to be in the no-advance zone as described above. While it may be selected to move the arm 40 or portions thereof only in the advance zone, it should be understood that selected movements in the no-advance zone may be selected automatically and / or with user input or override.

[0091] The path may be output in block 440. The output path may be output based on the determination in block 434 that the path is in the forward-only zone. In block 444, the path may be output and stored and / or used to control the movement of the robotic system. Thus, the path output in block 440 may be transmitted from the selected processor system and / or determined using the processor system of the robotic system 20 to control the movement of the robotic arm 40. Controlling the movement may include the speed, amount, and position of the movement or actuation of the robotic drive mechanism in the robotic arm 40, or other appropriate outputs. In various embodiments, for example, if the robotic arm 40 cannot traverse the forward-only zone path, the output of the path may include manual movement of the robotic arm 40. Therefore, it should be understood that the output path may include automatic movement of the robotic arm 40 and / or output for manual movement of the robotic arm 40.

[0092] Regardless, process 300 and / or subprocess 404 can be used to determine possible movements or paths of robotic arm 40 (including end effector 44) that can move end effector 44 without crossing a no-go zone. This can allow the robotic arm, including end effector 44, to move relative to subject 30 without contacting subject 30 and / or interfering with the procedure in a selected manner.

[0093] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, added, combined, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the techniques of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0094] Instructions are executable by a processor and may include software, firmware, and / or microcode, and may refer to programs, routines, functions, classes, data structures, and / or objects. The term "shared processor circuitry" encompasses a single processor circuit that executes some or all code from multiple modules. The term "grouped processor circuitry" encompasses a processor circuit that, in conjunction with additional processor circuits, executes some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or combinations thereof. The term "shared memory circuitry" encompasses a single memory circuit that stores some or all code from multiple modules. The term "grouped memory circuitry" encompasses a memory circuit that, in conjunction with additional memory, stores some or all code from one or more modules.

[0095] The apparatus and methods described herein may be implemented in part or in whole by a processor (also referred to as a processor module), which may include a special-purpose computer (e.g., created by configuring a processor) and / or a general-purpose computer for performing one or more specific functions embodied in a computer program. The computer program includes processor-executable instructions stored on at least one non-transitory, tangible computer-readable medium. The computer program may also include or rely on stored data. The computer program may include a basic input / output system (BIOS) that interacts with the hardware of the special-purpose computer, device drivers that interact with specific devices of the special-purpose computer, one or more operating systems, user applications, background services, background applications, etc.

[0096] A computer program may include: (i) assembly code; (ii) object code generated by a compiler from source code; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler; (v) descriptive text for parsing, such as HTML (Hypertext Markup Language) or XML (Extensible Markup Language). By way of example only, source code may be in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, ASP, Perl, HTML5, Ada, Active Server Pages (ASP), Perl, Scala, Erlang, Ruby, Visual Lua or To write.

[0097] The communication or connection may include wireless communications as described herein, which may be conducted in whole or in part in accordance with IEEE Standard 802.11-2012, IEEE Standard 802.16-2009, and / or IEEE Standard 802.20-2008. In various implementations, IEEE 802.11-2012 may be supplemented by Draft IEEE Standard 802.11ac, Draft IEEE Standard 802.11ad, and / or Draft IEEE Standard 802.11ah.

[0098] Processor, processor module, module, or "controller" are used interchangeably herein (unless otherwise specifically indicated), and each may be replaced by the term "circuitry." Any of these terms may refer to, be part of, or include: an application-specific integrated circuit (ASIC); digital, analog, or mixed analog / digital discrete circuitry; digital, analog, or mixed analog / digital integrated circuitry; combinational logic circuitry; field-programmable gate array (FPGA); processor circuitry (shared, dedicated, or grouped) that executes code; memory circuitry (shared, dedicated, or grouped) that stores code executed by the processor circuitry; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system on a chip.

[0099] For the purpose of illustration and description, the foregoing description of the embodiments has been provided. The above description is not intended to be exhaustive or to limit the present invention. The individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but are interchangeable and may also be used in selected embodiments, where applicable, even if not specifically shown or described. The same element or feature may vary in many ways. Such variations are not considered to depart from the present invention, and all such modifications are intended to be included within the scope of the present invention.

Claims

1. A method for determining movement of at least a movable part of a robotic system and moving the at least movable part to at least minimize contact with parts external to the robotic system, the method comprising: acquiring image data of the subject; generating a model of the subject based at least on the acquired image data; tracking a reference marker attached to the subject using a tracking system; determining a volume defined by the subject based on the generated model; defining a no-go zone relative to the determined volume; as well as The movable portion is tracked relative to the defined no-go zone.

2. The method according to claim 1, further comprising: The reference markers are tracked to determine a pose of at least one of a determined volume or a defined no-go zone defined by the subject.

3. The method according to claim 2, further comprising: A robot coordinate system is registered to the subject, wherein the subject at least partially defines the no-go zone.

4. The method according to claim 1, further comprising: registering the robot coordinate system to the image space defined by the generated model; registering the image space to the navigation space; Tracking the movable part relative to the defined no-go zone includes: tracking the movable part in the navigation space.

5. The method according to claim 4, further comprising: A graphical representation of the movable portion relative to the image is displayed.

6. The method according to claim 1, further comprising: performing at least a first portion of a procedure with the movable portion in the first position at a first time; at a second time, moving the movable portion to a second position; as well as A movement path of the movable portion from the first position to the second position that does not pass through the no-travel zone is determined.

7. The method according to claim 6, wherein: Determining a movement path of the movable part from the first position to the second position that does not pass through the prohibited area includes: Determine the first path; evaluating whether the determined first path passes through the no-go zone; and When the first path is evaluated as passing through the no-go zone, a second path is determined.

8. The method according to claim 6, further comprising: The determined path is output to control movement of the movable portion, including providing commands to a drive mechanism.

9. The method according to claim 8, further comprising: Input regarding the no-go zone is received from a user.

10. The method according to claim 6, further comprising: The robotic system is operated to move the movable portion to move along the determined path.

11. The method according to claim 10, further comprising: An end effector of the movable portion is positioned via the determined path.

12. The method according to claim 1, further comprising: The robotic system is provided relative to the subject.

13. A system for determining movement of at least a movable portion of a robotic system and moving the at least movable portion to at least minimize contact with portions external to the robotic system, the system comprising: Tracking system; a reference marker attached to the subject and configured to be tracked by the tracking system; a processor configured to execute instructions to: acquiring image data of the subject; generating a model of the subject based at least on the acquired image data; determining a volume defined by the subject based on the generated model; defining a no-go zone relative to the determined volume; as well as A posture of the movable portion relative to the defined no-go zone is determined.

14. The system according to claim 13, further comprising: The robotic system is configured to be fixed relative to the subject.

15. The system according to claim 14, further comprising: A tracked robotic system is configured to be tracked by the tracking system to allow determination of the pose of the movable part.

16. The system of claim 13, further comprising: An imaging system is configured to capture the image data.

17. The system of claim 13, wherein: Defining, by the processor system, the no-go zone relative to the determined volume includes determining an outside geometry of the subject based on the acquired image data.

18. A method for determining movement of at least a movable portion of a robotic system and moving the at least movable portion to at least minimize contact with portions external to the robotic system, the method comprising: positioning the robotic system relative to the subject; acquiring image data of the subject using an imaging system; Utilizes a processor to execute instructions to: reconstructing a model of the subject based at least on the acquired image data; determining an outer side geometry of the subject based on the reconstructed model; defining an advancement region relative to the determined outside geometry; receiving at least an endpoint pose of the movable portion; determining a path from a current pose of the movable part to the endpoint pose that moves the movable part only in the forward region; as well as Output the determined path.

19. The method according to claim 18, wherein Determining a path from the current pose of the movable part to the endpoint pose that moves the movable part only in the forward region includes: executing, with the processor, further instructions to: Determine the first path; evaluating whether the determined first path passes only through the forward region; and When it is evaluated that the first path passes through an area other than the forward area, a second path is determined.

20. The method according to claim 18, further comprising: An input regarding the advancement region is received from the user.

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