System and method for navigation and demonstration of procedures

Abstract

A system for assisting with a procedure is disclosed. During the procedure, an object can be moved relative to a subject, such as positioned and / or placed within the subject. The system and related methods can be used to assist in displaying and / or determining a pose of the object relative to the subject, such as a rigid portion of the subject. The system includes a processor system configured to execute instructions to: access image data of a subject having at least a first portion and a second portion of the subject; analyze a region of interest (ROI) between the first portion and the second portion; determine a ROI geometry of the region of interest; access a model of the object, the model including at least (i) dimensions of a rigid portion of the object and (ii) a plurality of possible configurations of a configurable portion of the object; and analyze the accessed model to determine a best fit of the object to achieve the ROI geometry; and output a result of the analysis of the accessed model.

Description

[0001] Cross-references to related applications

[0002] This application contains subject matter relating to U.S. Patent Application 16 / 861,356, also filed April 29, 2020. The entire disclosure of the aforementioned application is incorporated herein by reference. Technical Field

[0003] This disclosure relates to a system for performing a procedure, and more particularly to a system and method for displaying a part of a subject and / or a change in and / or a current posture relative to that part of the subject. Background Technology

[0004] This section provides background information in connection with this disclosure, which is not necessarily prior art.

[0005] In navigation systems used for various procedures such as surgical procedures and assembly procedures, instruments can be tracked. Instruments can be tracked using one or more tracking systems in various operating modes, such as determining position by measuring the effect of an electromagnetic (EM) field on a sensor coil and / or using optical sensors. The sensor coil may include a conductive material placed within the EM field, where a current is induced in the sensor coil. The measured induced current can be used to identify or determine the location of the instrument or object.

[0006] Electromagnetic fields can be generated using multiple coils (such as three orthogonally placed coils). Various transmitters or field generation systems incorporate the AxiEM™ electromagnetic navigation system, sold by Medtronic Navigation, Inc., which has a business location in Louisville, Colorado. The AxiEM™ electromagnetic navigation system may include multiple coils (which can be sensor coils) for generating an electromagnetic field sensed by a tracking device, allowing the use of navigation systems (such as…) Surgical navigation systems are used to track and / or display the tracked location of instruments.

[0007] The tracking system may also, or alternatively, include an optical tracking system. An optical tracking system includes, for example... Tracking systems include optical tracking systems, which consist of a set of cameras with a field of view to triangulate the position of the instrument. Summary of the Invention

[0008] This section provides a general overview of this disclosure and is not a full disclosure of the complete scope or all features of this disclosure.

[0009] A system for performing a procedure is disclosed. The procedure can be performed on a living subject (such as an animal, a human, or other selected patient). The procedure may also, or alternatively, include any suitable type of procedure, such as a procedure performed on an inanimate subject (e.g., an enclosed structure, fuselage, chassis, etc.). However, a navigation system can be used to perform the procedure, wherein a tracking system is capable of tracking one or more selected items.

[0010] Navigation systems can be used to navigate objects or items, such as devices, prostheses, or implants, relative to a subject during or simultaneously with a procedure. In various embodiments, the procedure may include procedures on the spine, such as spinal fusion, where two or more vertebrae are connected to a selected implant system or assembly. The implant system may contain more than one component interconnected at selected times. Positioning of a portion of the implant system, such as a screw, can be performed relative to a multi-bone structure containing vertebrae. The screw can be positioned into the vertebra along a selected trajectory and to a selected depth within the vertebra. In addition to the examples described above, other suitable procedures can be performed relative to and / or at the spine or other suitable locations.

[0011] At a selected time, such as for performing and / or planning procedures, image data of the subject may be acquired. The image data may be used to generate images displayed on a display device. The image data may include any suitable image data, such as calculated computed tomographic image data, magnetic resonance imaging data, or X-ray cone-beam imaging data (e.g., using an X-ray cone-beam imager). Furthermore, the imager may be any suitable imager, such as… Imaging systems, as discussed further herein, can employ a selected set of instructions, such as machine learning (e.g., computer vision algorithms), to identify portions within image data, such as individual vertebrae. These instructions may include machine learning techniques or processes, such as neural network systems, programmed to determine the boundaries (i.e., segments) of selected items, such as one or more vertebrae. Image data can be analyzed substantially or entirely automatically within the neural network to determine the boundaries of the vertebrae.

[0012] The selected workflow can be used to execute procedures efficiently and effectively. The workflow may involve the analysis or reference of image data to identify and / or segment selected portions or features in the images, such as segmenting specific vertebrae. The workflow can be used to operate the navigation system in an automated manner during procedure execution to provide information to users such as clinicians or surgeons. Image data with the boundaries of identified selected features (e.g., vertebrae or vertebral segments) can help or allow the system to automatically identify implant configuration and / or anatomical configuration or posture.

[0013] Further areas of applicability will become apparent from the description provided herein. The descriptions and specific examples in this overview are intended for illustrative purposes only and are not intended to limit the scope of this disclosure. Attached Figure Description

[0014] The accompanying drawings described herein are for illustrative purposes only, representing selected embodiments and not all possible specific implementations, and are not intended to limit the scope of this disclosure.

[0015] Figure 1 It is the environmental view of the navigation system;

[0016] Figure 2 It is a schematic flowchart of the segmentation process;

[0017] Figure 3A This is a schematic diagram of a patient space with an exemplary implant location between two vertebrae;

[0018] Figure 3A 'This is a schematic diagram of the generally uneven surface of a vertebra;

[0019] Figure 3B It is an exemplary display device user interface for image data and objects;

[0020] Figure 4A It is a detailed view of the volume between two vertebrae, with the implanted device contacting a single surface;

[0021] Figure 4B It is a detailed view of the volume between the two vertebrae, with the implant portion contacting both surfaces;

[0022] Figure 4C It is a detailed view of the first end of the implant in the selected configuration;

[0023] Figure 4D This is a schematic diagram of the end of an implant with a variable configuration;

[0024] Figure 5 It is a flowchart of the process for determining the appropriate geometry of an implant and defining and displaying its graphical representation;

[0025] Figure 6 It can be included in various implementation schemes. Figure 5 Detailed subroutines;

[0026] Figure 7 It can be included in various implementation schemes. Figure 5 Detailed subroutines;

[0027] Figure 8 It is a view of a display device that includes a user interface for displaying and scheduling procedures;

[0028] Figure 9 This is a schematic diagram of the implant tip;

[0029] Figure 10 It is a view of a multiconfiguration implant; and

[0030] Figure 11 It is a flowchart used to plan the procedure.

[0031] In several views of all the accompanying drawings, the corresponding reference numerals indicate the corresponding parts. Detailed Implementation

[0032] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0033] First refer to Figure 1 The diagram illustrates a navigation system 10. The navigation system 10 can be used by one or more users (such as user 12) for various purposes or procedures. The navigation system 10 can be used to determine or track the posture of an object (such as apparatus 16) within a volume. Posture can include both or all of three-dimensional position or translational position (X, Y, Z) and orientation (yaw, pitch, and roll). Orientation can include one or more degrees of freedom, such as three degrees of freedom. Therefore, posture can include at least six degrees of freedom information. However, it should be understood that any appropriate degree of freedom posture information (such as posture information less than six degrees of freedom) can be determined and / or presented to user 12.

[0034] Tracking the posture of device 16 can help user 12 determine the posture of device 16, even if device 16 is not directly visible to user 12. Various procedures may obstruct user 12's line of sight, such as performing repairs or assembling inanimate systems (e.g., robotic systems, assembling parts of an aircraft fuselage or automobile). Various other procedures may include surgical procedures, such as spinal procedures, neurological procedures, positioning deep brain simulation probes, or other surgical procedures performed on a living subject. In various embodiments, for example, the living subject may be human subject 20, and the procedure may be performed on human subject 20. However, it should be understood that for any suitable procedure, device 16 can be tracked and / or navigated relative to any subject. Tracking or navigating devices for procedures such as surgical procedures on human or living subjects is merely exemplary.

[0035] However, in various embodiments, as further discussed herein, the surgical navigation system 10 may incorporate various components or systems, such as those disclosed in U.S. Patent RE 44,305; 7,697,972; 8,644,907; and 8,842,893; U.S. Patent Application Publication 2004 / 0199072 and U.S. Patent Application Publication 2019 / 0328460, all of which are incorporated herein by reference. The navigation system may be used to track the posture of an object, as discussed herein. This posture may then be displayed for viewing by a user 12, as discussed herein.

[0036] Various components or systems of the navigation system 10 may include an imaging system 24 operable to image the subject 20, such as Imaging systems (sold by Medtronic, Inc., which has a business location in Minnesota), magnetic resonance imaging (MRI) systems, computed tomography (CT) systems, etc. Subject support 26 can be used to support or hold subject 20 during imaging and / or during the procedure. The same or different supports can be used for different parts of the procedure.

[0037] In various embodiments, the imaging system 24 may include a source 24s. The source may emit and / or generate X-rays. The X-rays may form cones 24c that impact the object 20, such as in a cone beam. Some of the X-rays pass through the object 20, while others are attenuated by the object. The imaging system 24 may also include a detector 24d to detect X-rays that are not completely attenuated or blocked by the object 20. Therefore, the image data may include X-ray image data. Further, the image data may be two-dimensional (2D) image data. However, it should be understood that other or different image data, such as magnetic resonance imaging data, positron emission tomography (PET) scans, or other suitable image data, may be acquired. In various embodiments, different image data from different modalities may be combined or registered with each other for use and navigation.

[0038] Image data can be acquired during surgical procedures, such as by one or more imaging systems discussed above, or prior to surgical procedures to display image 30 on display device 32. In various embodiments, even if the image data is 2D image data, the acquired image data can be used to form or reconstruct selected types of image data, such as three-dimensional volumes. Instrument 16 can be tracked in a trackable or navigable volume by one or more tracking systems. Tracking systems can include one or more tracking systems operating in the same or multiple and / or different ways or modes. For example, a tracking system may include an electromagnetic (EM) positioner 40, such as... Figure 1As shown herein, those skilled in the art will understand that other suitable tracking systems, including optical, radar, ultrasonic, etc., can be used in various embodiments. The EM locator 40 and tracking system discussed herein are merely exemplary tracking systems that can operate in conjunction with the navigation system 10. The posture of the device 16 relative to the subject 20, including three-dimensional position or translational position (X, Y, Z) and orientation (yaw, pitch, and roll), can be tracked within the tracking volume and then displayed as a graphical representation, also referred to as icon 16i, using the display device 32. In various embodiments, icon 16i may be overlaid on and / or adjacent to image 30. As discussed herein, the navigation system 10 may be incorporated into the display device 30 and operated to render image 30 from selected image data, display image 30, determine the posture of device 16, determine the posture of icon 16i, etc.

[0039] refer to Figure 1 The EM locator 40 is operable to generate an electromagnetic field using a transmitting coil array (TCA) 42 incorporated into the locator 40. The TCA 42 may include one or more coil groups or arrays. In various embodiments, more than one group is included, and each group may include three coils, also referred to as a triplet or triplet. The coils can be powered to generate or form an electromagnetic field by driving current through the coils of the coil group. When current is driven through the coils, the generated electromagnetic field extends away from the coil 42 and forms a navigation domain or volume 50, such as surrounding all or part of the head 20h, one or more spinal vertebrae 20v, or other suitable portion. The coils can be powered by a TCA controller and / or a power supply 52. ​​However, it should be understood that more than one EM locator may be provided in the EM locator 40, and each EM locator may be placed in a different and selected location.

[0040] The navigation domain or volume 50 typically defines a navigation space or patient space. As is generally understood in the art, an instrument 16, such as a drill, wire, implant, etc., can be tracked relative to a patient or subject 20 within the navigation space defined by the navigation domain using an instrument tracking device 56. For example, the instrument 16 can be freely moved by a user 12 relative to a dynamic reference frame (DRF) or a patient reference frame tracker 60, which is fixed relative to the subject 20. Both tracking devices 56 and 60 may include a tracking portion that is tracked using a suitable tracking system, such as a sensing coil (e.g., a conductive material formed in or placed in the coil) that senses and measures the intensity of an electromagnetic field, an optical reflector, an ultrasonic transmitter, etc. Since the tracking device 56 is connected to or associated with the instrument 16 relative to the DRF 60, the navigation system 10 can be used to determine the orientation of the instrument 16 relative to the DRF 60.

[0041] The navigation volume or patient space can be registered to the image space defined by the image 30 of the subject 20, and the icon 16i representing the device 16 can be shown using the display device 32 in a navigating (e.g., determined) and tracking posture, as superimposed on the image 30. Registration of the patient space to the image space and determination of the posture of the tracking device (e.g., using tracking device 56) relative to the DRF (e.g., DRF 60) can be performed as is commonly known in the art, including as disclosed in U.S. Patent RE 44,305; 7,697,972; 8,644,907; and 8,842,893; and U.S. Patent Application Publication 2004 / 0199072, all of which are incorporated herein by reference.

[0042] The navigation system 10 may also include a navigation processing or processor system 66. The navigation processor system 66 may include a display device 32, a TCA 40, a TCA controller 52, and other components and / or connections thereto. For example, a wired connection may be provided between the TCA controller 52 and the navigation processor module or unit 70. As discussed herein, the processor module or unit may be any suitable type of general-purpose or special-purpose processor configured or operable to execute instructions or perform selected functions. Furthermore, the navigation processor system 66 may have one or more user control inputs (such as a keyboard 72), and / or additional inputs, such as communication with one or more memory systems 74, which may be integrated or via a communication system. According to various embodiments, the navigation processor system 66 may include those disclosed in U.S. Patent RE 44,305; 7,697,972; 8,644,907; and 8,842,893; and U.S. Patent Application Publication 2004 / 0199072, all of which are incorporated herein by reference, or may also include those commercially available and sold by Medtronic Navigation, Inc., which has a place of business in Louisville, Colorado. Or Fusion™ surgical navigation system.

[0043] Tracking information (including information related to the electromagnetic fields sensed by the tracking devices 56, 60) can be transmitted via a communication system (such as a TCA controller, or possibly a tracking device controller 52) to a navigation processor system 66, which includes a navigation processor 70. Thus, the tracked posture of the device 16 can be shown as icon 16i relative to image 30. Various other memory and processing systems may also be provided with and / or communicate with the processor system 66, including a memory system 72 that communicates with the navigation processor 70 and / or the imaging processing unit 76.

[0044] As discussed above, the image processing unit 76 can be incorporated into the imaging system 24, such as... Imaging system. Image processing unit 76 may also include a suitable processor module and / or memory module and / or communicate with navigation processing unit 66. Therefore, imaging system 24 may include various parts movable within gantry 78, such as source 24s and X-ray detector 24d. Imaging system 24 may also be tracked by tracking device 80. However, it should be understood that the presence of imaging system 24 is not required when tracking a tracking device including instrument tracking device 56. Moreover, imaging system 24 can be any suitable imaging system, including MRI, CT, etc.

[0045] In various embodiments, the tracking system may include an optical locator 82. The optical locator 82 may include one or more cameras that observe or have a field of view defining or surrounding the navigation volume 50. The optical locator 82 may receive input light (e.g., infrared or ultraviolet light) to determine posture or to track a tracking device such as the instrument tracking device 56. It should be understood that the optical locator 82 may be used in conjunction with and / or alternatively for tracking the instrument 16, in conjunction with the EM locator 40.

[0046] Information from all tracking devices can be transmitted to the navigation processor 70 to determine the orientation of the tracked parts relative to each other and / or to position the instrument 16 relative to the image 30. The imaging system 24 can be used to acquire image data to generate or produce an image 30 of the object 20. However, it should be understood that other suitable imaging systems may also be used. As discussed above, the TCA controller 52 can be used to operate and power the EM locator 40.

[0047] The image 30 displayed using the display device 32 can be based on image data acquired from the object 20 in various ways. For example, the imaging system 24 can be used to acquire image data for generating image 30. However, it should be understood that other suitable imaging systems can be used to generate image 30 using image data acquired using the selected imaging system. The imaging system may include a magnetic resonance imaging (MRI) scanner, a computed tomography (CT) scanner, and other suitable imaging systems. Furthermore, the acquired image data can be two-dimensional or three-dimensional data and may have time-varying components, such as imaging a patient during heart rhythm and / or respiratory cycles.

[0048] In various embodiments, the image data is 2D image data generated using a cone-beam imaging system. The cone-beam used to generate the 2D image data can be an imaging system (such as...) This is part of an imaging system. The 2D image data can then be used to reconstruct a 3D image or model of the imaging object (such as patient 20). The reconstructed 3D image and / or an image based on the 2D image data can be displayed. Therefore, those skilled in the art will understand that selected image data can be used to generate image 30.

[0049] Furthermore, an icon 16i, identified as the tracking posture of device 16, can be displayed on display device 32 relative to image 30. Additionally, image 30 can be segmented for various purposes, including those further discussed herein. Segmentation of image 30 can be used to identify and / or define objects or portions within the image. Definitions can include or be made into a mask represented on the display. This representation can be displayed on the display, such as by overlaying a graphic overlay of the mask, and may also be referred to as an icon. The icon can be a segmented mask and may not be simplified in any way. In various embodiments, definitions can be used to identify the boundaries of various portions within image 30, such as the boundaries of one or more structures of an imaged patient, such as vertebrae 20v. Thus, image 30 can include images of one or more vertebrae of vertebrae 20v, such as first vertebrae 20vi and second vertebrae 20vii. As further discussed herein, vertebrae such as first vertebrae 20vi and second vertebrae 20vii can be defined in the image, which can include and / or assist in defining boundaries in images such as 3D and 2D images. In various implementations, the boundary can be represented by icon 20vi' or a second icon 20vii'. The boundaries 20vi' and 20vii' can be determined in an appropriate manner and for various purposes, which are also discussed further herein. Furthermore, as discussed herein, icons can be used to represent selected items for display, including the definition of objects, boundaries, etc.

[0050] According to various embodiments, image 30 can be segmented in a substantially automatic manner. In various embodiments, automatic segmentation can be incorporated into a neural network, such as a convolutional neural network (CNN). According to various embodiments, the CNN can be taught or made to determine various features, such as using probabilities or predictions. The various features can include objects (e.g., vertebrae) or parts or portions of objects (e.g., pedicles), and the segmentation or boundaries of these objects or portions. Selected segmentations can include segments identifying selected vertebrae, such as first vertebra 20vi and second vertebra 20vii. Selected segmentations can be displayed on display device 32 along with selected graphical representations (e.g., segmentation icons or representations of 20vi' and 20vii').

[0051] These icons are displayed individually on display 32 and / or overlaid on image 30 for observation by a selected user (e.g., user 12, who could be a surgeon or other suitable clinician). Furthermore, once identified, boundaries or other appropriate portions, whether or not displayed as icons, can be used for various purposes. Boundaries can identify the physical dimensions of a vertebra, the vertebra's position in space (i.e., as discussed above, due to registration of image 30 to subject 20), the possible trajectory of the boundary (e.g., for implantation placement), etc. Therefore, image 30 can be used to plan and / or execute procedures, whether to display icons 20vi', 20vii', or simply to determine the geometry of the boundaries without displaying them as icons.

[0052] Go to Reference Figure 2 Flowchart 100 illustrates a process or method for identifying a portion of an image, also known as image segmentation. Flowchart 100 is a general flowchart, and more specific processes or any specific procedure can be used to determine image portions, such as segmentation. However, typically, the segmentation process begins with input image data. The image data can include any suitable image data, such as computed tomography image data, magnetic resonance imaging data, or X-ray cone-beam imaging data. Furthermore, the imager can be any suitable imager, such as… Imaging systems, as discussed in this paper. The imaging system can be configured to acquire image data of 360 degrees around the subject, and includes 2D image data and / or 3D reconstruction based on 2D image data. Furthermore, Imaging systems can generate images using cone beams of X-rays.

[0053] In box 104, the image data may include 2D image data or a 3D model reconstructed from 2D image data. The 2D image data or the reconstructed 3D image data may originate from an imaging system such as imaging system 24. As discussed above, imaging system 24 may include... Imaging system. Imaging system 24 can generate multiple two-dimensional image data, which can be used to reconstruct a three-dimensional model of subject 20 including one or more vertebrae 20v. Input image data can also be acquired at any appropriate time, such as during the diagnostic or planning phase, rather than in the operating room, as... Figure 1 Specifically shown. However, image data of subject 20 can be acquired using imaging system 24, and said image data can be entered or accessed in box 104.

[0054] In box 106, the image data from box 104 can be processed using a selected system or according to a selected process such as a segmentation algorithm (e.g., thresholding, edge detection, region growing, clustering, watershed, machine learning), a neural network, or an artificial neural network. The analysis technique or process, such as an artificial neural network (ANN), can be a selected appropriate type of artificial neural network, such as a convolutional neural network (CNN) (e.g., Ahmed Abdulkadir, Soeren S. Lienkamp, ​​Thomas Brox, Olaf Ronneberger, “3D U-Net: Learning Dense Volumetric Segmentation from Sparse Annotation”, International Conference on Medical Image Computing and Computer-Assisted Intervention, Springer, Cham, pp. 424-432 (2016) (https: / / arxiv.org / pdf / 1606.06650.pdf(2016)) and / or U.S. Patent Application Publication 2019 / 0328460, both of which are incorporated herein by reference. A CNN can be taught or made to analyze the input image data from box 104 to segment selected portions of the image data. For example, as discussed above, the CNN in box 106 can be used to identify the boundaries of the vertebral bodies in the image data from box 104. As discussed above, the boundaries of the vertebral bodies can be displayed on the display device 32, alone and / or in combination with image 30.

[0055] Therefore, after the analysis from box 106, the output may include segmented image data, or the segmented data may be output in box 110. The output segmented data may be stored in a selected memory system, such as navigation memory 74 or segmented image memory 112 (see [link to documentation]). Figure 1 For various purposes, the output segmented image data can be segmented into selected parts, such as the vertebra 20v discussed above.

[0056] Therefore, flowchart 100 can begin in box 102, and then access or input image data in box 104 to output segmented image data (and / or a segmentation mask) in box 110, and display or store the segmented image data in box 114. The process can then end in box 118 and / or allow for further processing or workflows, as discussed further herein. However, it should be understood that selected portions of flowchart or process 100 may contain several additional steps beyond those discussed above. For example, a CNN can be developed and then taught to allow efficient and / or fast segmentation of selected portions of the image data accessed or input from box 104. Segmentation can be specific (e.g., identifying vertebrae) or general (e.g., identifying selected boundaries or varying contrast in the image data).

[0057] As discussed above, in flowchart 100, image data of subject 26 can be acquired using a selected imaging system such as imaging system 24, and selected portions thereof can be segmented for display on display device 32. While image data segmentation can be performed in any suitable manner, defined boundaries and edges of selected portions of the image data (e.g., vertebrae 20v) can be displayed for a selected procedure.

[0058] Continue to refer to Figure 1 and Figure 2 And refer to other sources. Figure 3A Selected vertebrae, such as vertebrae 20va and 20vb, can be two vertebrae imaged for display on a display device, such as vertebrae 20vi and 20vii. It should be understood that the two vertebrae 20va and 20vb can be any suitable vertebrae. The two vertebrae 20va and 20vb can be part of the subject 26 and exist in the navigation space or volume 50. Figure 3B As shown, the display device 32 can display image data of the vertebrae as 20vi and 20vii. However, it should be understood that the portions shown may be one or more cervical, thoracic, lumbar vertebrae or other suitable structures of the subject.

[0059] First refer to Figure 3AEach vertebra 20v can be tracked using a navigation system with selected tracking elements, such as vertebral tracking elements or devices 200, 204. Tracking devices 200, 204 can track within or in conjunction with the navigation system 10 to determine the posture of the corresponding vertebra 20va, 20vb. As discussed above, tracking devices 200, 204 can be rigidly connected to the corresponding vertebra 20va, 20vb. Therefore, movement of tracking devices 200, 204 can be used to determine the movement of the corresponding vertebra 20va, 20vb, including its current posture. Tracking devices 200, 204 can be any suitable tracking device, such as including EM tracking elements, optical tracking elements, acoustic tracking elements, or combinations thereof. Therefore, the navigation system 10 can be used to track the posture and / or movement of the associated tracking devices 200, 204, and this can be used to determine the posture of the corresponding vertebra 20va, 20vb.

[0060] As commonly understood by those skilled in the art, for example, the posture of vertebra 20va can be determined when the tracking device 200 is rigidly connected to or moved relative to vertebra 20va. For example, the tracking device 200 may be associated with vertebra 20va at selected times (e.g., rigidly connected or attached to the vertebra). The posture of the tracking device 200 relative to vertebra 20va can then be known. Due to the registration of the subject 26 (including vertebra 20va) with the image, the movement of the tracking device 200 can be used to determine the movement of all portions of vertebra 20va, and this can be used to determine the current posture of the corresponding vertebra image (e.g., vertebra 20vi) displayed on the display device 32.

[0061] Furthermore, as discussed above, the image can be segmented, allowing for the identification and display of individual parts of the vertebrae, such as their boundaries. For example, as... Figure 3B As shown, vertebra 20vi can have all the identifiable boundaries and / or various portions, such as its endplates. For example, vertebra 20vi can have an upper endplate 210 that is identified and depicted on the image of display device 32. It should be understood that various geometries, such as planes, lines, etc., can also be displayed relative to the depicted endplate 210. Similarly, vertebra 20vi can have a second endplate or rear endplate 214 that is identified and depicted. The endplate graphic representations 210, 214 can be displayed on display device 32 for user 12 to view and / or analyze relative to other portions. In various embodiments, multiple image portions can be displayed, such as also identifying the endplate of the second vertebra. Thus, the upper endplate 220 of the second vertebra 20vii can be depicted and shown on the display device as the lower endplate 224 of vertebra 20vii.

[0062] The identification of various surfaces or edges in an image segment can be used to analyze and / or depict the pose and / or movement of various segments. However, it should also be understood that any suitable edge, such as the femoral head, tibia, etc., can be segmented and delineated. For example, as... Figure 3B As shown, the endplates can be displayed on the display device 32 to show the posture of each endplate relative to each other. The endplates can be displayed individually or in combination with image portions such as images of vertebrae 20vi, 20vii. Therefore, the display 32 can display only the generated graphic representation (e.g., endplate display) and / or only image portions (e.g., segmented vertebrae 20vi, 20vii) or combinations thereof, such as... Figure 3B As shown. However, when the tracking device (e.g., tracking device 200) moves, the display of the image on the display device 32 can be updated, for example, substantially in real time, to show the posture of various components (e.g., vertebrae 20vi). Therefore, it should be understood that multiple tracking devices, such as the first tracking device and the second tracking devices 200, 204, can be tracked using the navigation system 10, which is capable of updating and displaying the corresponding posture of the vertebrae using the display device 32.

[0063] While tracking devices 200, 204 can be used to track the current posture of the corresponding vertebrae 20va, 20vb, it should be understood that the tracking devices can be associated with any suitable portion, such as the subject 26 and / or other portions of the device 16 and / or implant 230. Implant 230 can be positioned relative to various portions of the subject 26, such as between vertebrae 20va, 20vb. Vertebrae 20va, 20vb can have substantially ridge-like portions, such as their endplates, which can be segmented in an image (e.g., as discussed above) and can also be segmented on the vertebra itself. For example, vertebra 20va can have a lower endplate 214', and vertebra 20vb can have an upper endplate 220'. Endplates 214', 220' can be associated with the corresponding segmented and depicted endplates 214, 220 displayed on display device 32. Therefore, since vertebrae 20va and 20vb are rigid, the endplates move when any part of the corresponding vertebra moves. Thus, the posture of the endplates 214' and 220' can be determined by tracking devices 200 and 204 fixed to the rigid vertebrae 20va and 20vb. The tracking devices fixed to the vertebrae track the substantially real-time updates of the permissible posture of the vertebrae and the tracking of the movement of the corresponding endplates 214' and 220', so that the endplates 214' and 220' can be displayed as depicted on the display device 32.

[0064] Implant 230 or other suitable trackable object may have a tracking device 234 associated therewith. Tracking device 234 can be used to track selected portions of implant 230, such as a first portion or base portion 240. Implant 230 may also have a second portion or extension portion 244. The two portions 240, 244 of implant 230 may move relative to each other, as discussed further herein. However, tracking device 234 can be used to track implant 230 by associating it with at least a portion of implant 230. In various embodiments, tracking device 234 may be rigidly fixed to selected portions of implant 230, such as a main portion or base portion 240. Therefore, the orientation of the second portion 240 of implant 230 may not be known directly by or due to tracking device 234. As discussed above, navigation system 10 can be used to determine the orientation or movement of tracking device 234, and the orientation of the respective portions associated therewith can be determined due to known geometry or rigid configuration relative to tracking device 234.

[0065] Continue to refer to Figure 3A And a brief reference Figure 4A The implant 234 can be positioned to contact end plates 214', 220'. As discussed above, the first portion 240 can contact the first end plate 214', and the second portion 244 can contact the second end plate 220'. In the first configuration, such as in the non-extended or minimally extended position, the first portion 240 of the implant 230 can have a base surface 248 extending along an axis or plane 250 substantially parallel to the plane 252 of the second surface of the second portion 244 or the plate 256. The implant 230 can extend along a long axis 260, and each of the planes 250, 252 in the first configuration can be substantially perpendicular to it.

[0066] Continue to refer to Figure 4A And refer to other sources Figure 4B and Figure 4C The implant 230 can be moved to a second configuration, such as extending along the long axis 260. The first surface 248 of the first portion 240 can contact and be substantially fixed to the end plate 214'. The second portion 244 can extend along the axis 260 and contact and be substantially fixed relative to the end plate 220'. However, upon contacting the end plate 220', the end plate or surface 256 can be moved to a position not perpendicular to the long axis 260 and forming an acute interior angle 264 with respect to the plane 252. Therefore, by tilting or moving the surface 256 relative to the long axis 260, the second portion 244 can be moved relative to the first portion 240.

[0067] Continue to refer to Figures 4A to 4CThe second portion 244 can be moved relative to axis 260 in a selected manner, such as by rotating at an angle relative to the central axis 260, for example, by rotating approximately in the direction of the double arrow 268. Therefore, angle 264 can be formed at substantially any point around the central axis 260 relative to the major axis 260. In various embodiments, the position of the second portion 244 relative to the central axis 260, and thus relative to the first portion 240, may be due to the rigid position of the vertebrae 20va, 20vb. Therefore, the orientation of the first portion 240 relative to the second portion 244, and their relative position with respect to the central axis 260 (typically extending through the first portion 240), can be based on the position of the implant 230 relative to the portion of the positioned subject.

[0068] Furthermore, the implant 230 may have a previously known or existing model, such as a computer-aided design (CAD) model including the dimensions and geometry of the implant 230 and / or possible configurations of the implant 230. The CAD model of the implant 230 may be stored in selected memory for retrieval, such as in navigation memory 74 and / or image memory 112. Therefore, the model of the implant 230 can be retrieved to assist in displaying the model or graphical representation of the implant on the display 32 as an implant graphical representation 280.

[0069] As described above, the implant 230 may have a first portion 240 and a second portion 244, wherein the second portion 244 is movable relative to the first portion 240. Therefore, the second portion 244 may be positioned at an angle 264 relative to the central axis 260. Furthermore, the first or second portion, including corresponding ends 248, 256, may be formed as a plurality of parts that are also movable or deformable relative to the central axis 260. For example, such as... Figure 4C and Figure 4D As shown, the surface or plane 252 can be separated at the end 256 between the first portion 256a and the second portion 256b. Each of the two portions 256a, 256b can move relative to each other, such that the first portion 256a achieves an angle 264 relative to the central axis 260, while the second portion 256b can have an obtuse angle 290 relative to the central axis 260. Figure 4D As shown. Therefore, it should be understood that implant 230 may have multiple portions that are movable relative to a selected plane or axis, such as two portions 256a, 256b that are movable relative to a central axis 260. In various embodiments, a second portion 244 including portion 256 may be deformable to fit onto a surface in a selected manner. Deformation may include plastic deformation or elastic deformation. Thus, implant 230 may include one or more portions that are deformable by a series of movements and / or have deformable surfaces to deform to engage surfaces, such as the surface of bone.

[0070] The CAD model, accessible and / or invoked by the image processing unit 76 and / or the navigation processing unit 70, may include information about all movable parts of the implant 230 relative to each other and / or the range of motion of each part of the implant 230. Therefore, the CAD model can be used to determine all possible positions or configurations of the implant 230. Thus, the model can also be used to illustrate the current configuration of the implant, as discussed herein.

[0071] Therefore, in various embodiments, the display device 32 can be operated to display the implant 230 as a graphical representation 280 relative to other displayed portions (such as vertebrae 20vi, 20vii). The implant graphical representation 280 may be displayed relative to selected portions (such as rigid portions) including endplates 214, 220. As discussed above, endplates 214, 220 may be segmented in image data and may be segmented to include substantially planar structures, structures with facets, or selected contours. For example, the vertebrae 20vb, endplate, or surface 220' may include two portions, such as a first lateral portion 220'a and a second portion 220'b. The corresponding portions 220'a, 220'b may have different geometries and / or dimensions relative to each other. For example, the first portion 220'a may have a surface or portion displaced by a distance 294 relative to the second portion 220'b. In this case, when the implant 230 comprises two parts or parts 256a, 256b, the two parts can move in a non-uniform manner relative to the central axis 260, such as... Figure 4D As shown in the diagram. Similarly, the geometry of the implant and its possible movements can be stored in selected memory, such as in the CAD model included in navigation memory 74, and the image can be segmented to identify the different geometries of the two parts of the vertebra 20vb.

[0072] As discussed above, implant 230 may include tracking device 234 to allow tracking and navigation of implant 230 including first portion 240. Due to the known location of first portion 240 and the selected locations of various portions of the implant (e.g., the amount of extension of second portion 244 relative to first portion 240), the geometry of second portion 244 can be determined relative to the displayed image portion and used for display on display device 32, as further discussed herein. Generally, reference... Figure 5 The geometry of the implant 230 can be displayed in the graphic representation 280.

[0073] Therefore, first refer to Figure 5The process or method for determining the geometry of the implant 230 on the display device 32 and displaying it as a graphical representation 280 may include process 320. Process 320 may occur or be performed by a processor system (such as navigation processing unit 70 or image processing unit 76) executing selected instructions or in any suitable manner. As will be understood by those skilled in the art, process 320 may be incorporated into selected instructions of a particular processor design, as discussed herein. Process 320 may begin in start box 324. After the process in start box 324, which may be initiated by user 12, the display of graphical representation 280 may occur according to process 320. In various embodiments, for example, the process may include accessing image data in box 330 for subject 20. As discussed above, image data for subject 20 may include selected portions and / or the entire subject, but may include vertebrae 20va, 20vb. After accessing image data in box 330, the image data may be segmented in box 334. Segmentation of image data may occur according to any suitable process. Image data segmentation may include determining gradient edges, surfaces, etc., in the accessed image data from box 330. In various embodiments, for example, a convolutional neural network (CNN) may be used to perform image data segmentation to identify various surfaces and / or edges in the image data. It should be understood that any suitable segmentation algorithm and / or machine learning system can be used to identify portions of the image data. For example, in various embodiments, user 12 may select or identify points or pixels (e.g., using input to select pixels on a display device) as seed pixels for segmentation. Segmentation (e.g., using a CNN) may be performed by a processor system such as navigation processing unit 70 or image processing unit 76.

[0074] In process 320, segmented image data can be used to help display a graphical representation of implant 230 so that user 12 or other appropriate individual can understand its posture. Access to an object model can occur in box 338. This model can be accessed, for example, by calling from a memory system and / or generating it, such as by tracking a device that contacts one or more points on implant 230 and determining or inputting possible geometric configurations (e.g., extension or angular limitation). The model accessed in box 338 can include the entire geometry of implant 230, or any suitable object, including its geometry, material deformability (e.g., plastic deformation or flexure), dynamic geometry (e.g., rigid surface motion), etc. As discussed above, implant 230 can include one or more surfaces that can move relative to other surfaces and / or selected geometries, such as central axis 260. It should also be understood that various implants or objects can include substantially infinitely deformable surfaces (e.g., deformable fabrics or elastic polymers) that can substantially match any surface more rigid than the implant. Therefore, in various embodiments, the access model in box 338 may include the definition of implant 230, which includes the deformation of any or all or selected surfaces when in contact with a rigid or segmented surface in the image data.

[0075] Process 320 may also include registering an object to a subject in box 342. Registering an object to a subject may include registering image data to the subject and tracking the object relative to subject 20. For example, image data accessed from box 330 may be registered to subject 20, as discussed above. Additionally, tracking an object such as implant 230 relative to subject 20 may include tracking or knowing the position of object 230 and / or portions of the object relative to tracking device 230. Thus, in box 348, an object may be tracked or navigated relative to the subject. In box 352, the subject may also be tracked. Thus, the relative pose of subject 20 and object 230 may be known by tracking the object in box 348 and tracking the subject in box 352. In box 342, following and / or including the registration of image data, it may be possible to display a graphical representation of the image data, such as graphical representation 280, on display device 32, as shown above and further discussed herein.

[0076] When tracking the subject in box 352, the subject's pose can be determined in box 358. Determining the subject's pose in box 358 can include determining the poses of multiple parts of the subject 20, such as the poses of vertebrae 20va and 20vb relative to each other. Therefore, the pose of the subject 20 determined in box 358 can include determining the poses of multiple parts, which can be individually tracked portions of the subject 20 relative to each other. This allows the poses of one or more parts of the subject 20 to be determined in box 358.

[0077] The pose of an object relative to the pose of a subject determined in box 358 can be used to assess the pose of an object relative to the pose of a subject determined in box 364. When assessing the pose of an object, the pose of individual parts of the object (e.g., implant 230) relative to individual parts of the subject 20 can be determined. In various embodiments, the assessment of the pose of an object may include determining the angle of a single surface of the object 230 relative to another part of it (e.g., second part 244 relative to first part 240) based on the determined pose of the subject 258. However, in some cases, in addition to or as an alternative to the above discussion, the pose of the object being assessed relative to the determined pose of the subject may include determination based on a machine learning system or suitable algorithm to determine the position of multiple parts of the object 230 relative to multiple parts of the determined pose of the subject 20. Therefore, the determination of the pose of an object or the assessment of the pose of an object in box 364 may include a variety of assessment methods or procedures, as further discussed herein. The determination of the pose of an object and its configuration is further discussed herein.

[0078] Based on the pose evaluated in box 364, a graphical representation of the object relative to the subject can be generated in box 370. The generation of the graphical representation may include the display of geometric configurations, the display of detailed outlines of the object, the display of a CAD model of the object based on the evaluated relative pose, or other appropriate representations. In various implementations, such as Figure 3B As shown, object 230 can be displayed as a graphical object 280, which substantially represents object 230 for user 12 to view and understand. Therefore, when object 230 appears in physical space or patient space, the graphical representation 280 can substantially mimic or represent the object on display device 32 in real time.

[0079] The generated graphical representation can then be displayed in box 374. For example... Figure 3B As shown, the graphic representation can be displayed as a graphic representation 280 relative to the image portions of subject 20vi, 20vii. Therefore, the object can be displayed for viewing by user 12 or any suitable individual. It should also be understood that the graphic representation does not need to be displayed, but can simply be identified and evaluated for various purposes, such as later planning, preservation for subsequent evaluation, or other suitable purposes.

[0080] After generating a graphical representation in box 370 and / or displaying the generated graphical representation in box 374, process 320 may end in box 380. When process 320 ends in box 380, user 12 may complete the procedure for subject 20, complete a selected portion of the procedure for subject 20, or other appropriate procedures. For example, the procedure may be performed on the subject with the selected graphical representation displayed. Thus, user 12 can initiate process 320, and the process may end in box 380 after the object has been positioned in a selected location (e.g., at the test site, implantation site, etc.). The display of the generated graphical representation can be used by user 12 for various purposes later in and / or in the subsequent stages of the procedure. The process ending at box 380 can simply be used to end after determining a selected or defined single posture of the object relative to the subject, as discussed above.

[0081] Continue to refer to Figure 5 And refer to other sources Figure 6 As discussed above, the assessment of the subject's posture relative to the object can be determined in box 364. It should be understood that the assessment in box 364 can be performed in multiple different and / or unique processes that can be performed individually and / or in combination, as further discussed herein. Therefore, according to various embodiments, the assessment in box 364 can be understood as a general assessment and can include various subroutines or substeps. Therefore, refer to... Figure 6 An exemplary evaluation process 364' is illustrated. Subroutine 364' can be replaced in box 364 of process 300 as discussed above. However, it should be understood that additional steps and / or subroutines may be performed in place of subroutine 364' and / or in addition to it.

[0082] Subroutine 364' may include evaluating the edge pose of a subject portion in box 400. As discussed above, the individual subject portions may include the subject's vertebrae 20v. These can be segmented and depicted in image data, also as discussed above, and the evaluation of specific edge poses of selected portions of the subject can be performed in box 400. For example, the procedure may include placing the implant 230 between two vertebrae 20vi and 20vii. Thus, evaluating the edge poses of the two vertebrae, particularly the edges facing or opposite each other, may occur in box 400. The evaluation of edge poses may include determining the geometry of the edges relative to each other. The evaluation of the pose of the tracking portion of the object may also occur in box 404. As discussed above, the object 230 may include a tracking portion and a portion capable of movement relative to the tracking portion. Thus, the navigation system 10 may track and determine the pose of the tracking portion (such as the first portion 240) of the implant 230.

[0083] The current overall geometry of the object can be determined and / or recalled in box 408. The overall geometry of the object can include the pose of the first portion 240 (e.g., relative to edge 214') and the distance by which the second portion 244 has extended or moved relative to the first portion 240. As discussed above, the implant 230 can include an adjustment mechanism 246 that allows movement of the two portions 240, 244 relative to each other. Therefore, the overall geometry can include a first end 248 of the first portion 240 and an end or pivot point 245 (…). Figure 4C The length or distance between ( ). In box 412, the overall geometry can be used to determine whether any part of the object contacts the subject part. For example, as Figure 3A As shown, the second portion 244 can contact the vertebra 20vb. When the second portion 244 has extended or moved a selected distance or a certain distance from the first portion 240, the second portion 244 can contact the endplate 220' of the vertebra 20vb. Therefore, determining or recalling the current overall geometry of the object in box 408 can be used to determine in box 412 whether any part of the object is in contact with the subject. The recall or determination can be based on input (e.g., by user 12) and / or on input from the object (e.g., an encoder transmitting motion data).

[0084] Determining whether an object is in contact with a portion of the subject in box 412 can be based on tracking vertebrae 20va, 20vb and / or implant 230. As discussed above, navigation system 10 can track the individual portions and determine their poses relative to each other based on the various tracking devices 200, 204, 234. While navigation system 10 is able to track the first portion 240 due to the pose of tracking device 234, the specific geometry of the second portion 244 can generally be independent of the position of the first portion 240 unless it is in contact with other portions, such as vertebrae 20vb. Therefore, by tracking implant 230 relative to the two vertebrae 20va, 20vb, navigation system 10 can help determine whether the first portion 240 and the second portion 244 are in contact with portions of the subject 20, such as vertebrae 20v.

[0085] If it is determined in box 412 that the object is not in contact with the subject, then the "No" path 420 can be followed, and a graphical representation can be generated in box 370, as discussed above. In box 424, the generation of the graphical representation may include generating a graphical representation of the object without deformation. As discussed above, when only a portion or no portion is in contact with the subject 20, the implant 230 may have an undeformed or substantially straight or aligned geometry, such as... Figure 4A As shown. Therefore, the graphic representation displayed on the display device 32 can substantially match the illustration or representation of the implant 230, such as Figure 4A As shown. Therefore, a graphical representation can be displayed in box 374.

[0086] If it is determined in box 412 that the object is in contact with the subject portion, then the “yes” path 440 can be followed to determine in box 444 whether the contact causes deformation of the implant. Similarly, the implant 230 may contact the vertebra 20va, but the first portion 240 typically does not deform or change position relative to the long axis or central axis 260. Therefore, the face or end 248 may be approximately perpendicular to the long axis 260, as... Figure 4A As shown. Therefore, determining that the first part 240 contacts the vertebra 20va can lead to determining in box 444 that the contact does not cause deformation, and thus the "No" path 448 can be followed. It should be understood that other determinations can be made that no deformation occurs, and the "No" path 448 can be followed. If the "No" path 448 is followed, a non-deformed graphic can be generated in box 424, and the graphic representation can be displayed in box 374.

[0087] If it is determined that deformation is occurring, then the "yes" path 460 can be followed. As discussed above, and as... Figure 3A , Figure 3B and Figure 4B As shown, the second part 244 can deform or move relative to the long axis 260 when it contacts the vertebra 20vb. Figure 4B As shown, for example, the end or surface 256 can move relative to the central axis 260 at an angle or angle 264. Therefore, when it is determined that the end point or contact surface 256 has moved a distance from the surface 248 sufficient to enable the second part 244 to change its angle or move relative to the central axis 260, it can be determined in box 444 that deformation has occurred and can follow the "yes" path 460.

[0088] The edge geometry of the deformable portion can be determined in box 464 to match the portion contacting the subject. For example, a navigation system, such as a navigation processing unit or processor 70, can evaluate the geometry of the edge of vertebra 20vi in ​​an image, as discussed above. Given the known or determined geometry of portion 20vi and given that a second portion 244 is in contact with surface 220, it can be determined that the edge of the second portion 244 or surface 256 is at the same or parallel angle or plane as edge 220. Therefore, it can be determined that surface 256 has a geometry parallel to the edge of vertebra 20vi or surface 220.

[0089] Determining the edge geometry can include various techniques for determining a selected fit, such as a best fit, which can include one or more fits that achieve the selected result. Thus, a best fit can be selected to achieve range of motion, size, usability, configuration for use, etc. Therefore, the best fit can also be, or include, a fit to the determined edge portion relative to the subject portion. The best fit can be a fit to a selected threshold (e.g., greater than 50% contact) or other suitable threshold. Various techniques can include least-squares fitting techniques.

[0090] After the geometry is determined in box 464, a graphical representation can be generated in box 370, as discussed above. In box 470, graphical generation can include, or be a sub-part of, generating graphical representations of the edges or geometry of the defined deformable and non-deformable portions. To generate a graphical representation of the deformable portion in box 470, the navigation system 10 can generate graphics, such as... Figure 3B As shown. The graphic representation may include a first portion 240i and a second portion 244i, having corresponding edges that contact surfaces 214, 220 in the image for display on the display device 32. After the graphic representation is generated in frame 470, it can be displayed in frame 374.

[0091] Therefore, subroutine 364' can be used to generate a graphical representation of implant 230 based on the geometry of the determined image portions of subjects 20vi and 2vii. Thus, the representation 280 on display device 32 can more accurately match the actual or real-time geometry of implant 230, such as... Figure 3A As shown.

[0092] Continue to refer to Figure 5 And refer to other sources. Figure 7 Subroutine 364 can be used to assess the subject's posture, such as... Figure 7As shown. First, it should be understood that posture assessment can include various steps or procedures that are substantially the same as those discussed above; therefore, they will only be discussed briefly, and the reference numerals will be enclosed in double apostrophes. In this regard, the assessment of the subject's edge posture can be performed in box 400”, and the assessment of the posture of the tracked portion of the object can be performed in box 404”. The current overall geometry of the object being determined or invoked can also appear in box 408”, and it can be determined in box 412” whether any part of the object is in contact with the subject's part. As discussed above, if it is determined in box 412” that there is no deformation, the “No” path 420” can be followed to generate a graphical representation in box 370. Similarly, the generation of the graph can include sub-procedures such as generating a graphical representation of the undeformed object in box 424”. After the graphical representation is generated in box 424”, the display of the graphical representation can occur in box 374. However, as discussed above, if deformation does occur in box 412”, the “Yes” path 440 can be followed. The "Yes" path 440 can determine whether the contact portion is deformed in box 444. If it is determined that no deformation has occurred, a graphical representation of the undeformed object can be generated in box 424 by following the "No" path 448, and thus the graphical representation is displayed in box 374.

[0093] However, if deformation has been determined to have occurred or exists, a learned geometric analysis can be performed following the "yes" path 460. This learned geometric analysis can be based on the machine learning analysis or process in box 500. In the machine learning analysis in box 500, various learned or determined weights or categories can be used to analyze the current overall geometry of the portion in contact with subject 412” and the object determined in box 408”. For example, the pose of the opposing subject portion edges can be determined to analyze or weight the stress or force applied to the object. The machine learning analysis can also assess or determine the amount of motion or potential motion of the portion of implant 230.

[0094] As discussed above, and as Figure 4D As shown, the second part 244 may include individual parts that can also move relative to each other and / or the central axis 260. Therefore, machine learning analysis may include evaluating or determining the motion of the individual parts relative to each other based on geometry (such as surface 220') evaluated in the image, such as... Figure 3A As shown in the figure. The analysis may include surfaces 220 that are not flat or planar, and may include a variety of geometries that differ from planar geometry in order to deform the implant 230 in complex ways.

[0095] Furthermore, machine learning analysis can include loads and measurements, such as those relating to the forces applied to implant 230. For example, determining the overall geometry in box 408” can be used to analyze or evaluate the forces applied to implant 230 based on the posture of a portion of the subject determined in box 404”. Larger forces applied to implant 230 can include or cause greater deformation, which can be evaluated based on machine learning analysis in box 500.

[0096] In any case, as discussed above, the techniques of the process in box 500 can be used to determine the best fit to the edge portion of the determined subject portion. Therefore, the best fit can also be a fit to a selected threshold and / or include other considerations, including those discussed above.

[0097] Therefore, following the "yes" path 460, the geometry of the implant 230 can be evaluated based on the machine learning analysis in box 500. Following the machine learning analysis in box 500, a graphical representation of the deformed geometry of the implant can be generated in box 470, similar to that discussed above. Then, in box 374, the graphical representation can be displayed on a display device.

[0098] As discussed above, the determination of the graphical representation of an object can also alternatively be based, in part or in whole, on image representation and segmentation, as well as the object's tracking pose. As discussed above, image data can be segmented. Therefore, edges within the image can be identified. The pose of the tracked or determined object relative to a portion of the image can be used to determine the object's geometry within the region of interest, such as deformed geometry, as due to contact with at least one edge in the image. Therefore, the subject's tracking pose or pose determination may not be necessary. However, as discussed herein, the subject's configuration (e.g., deformed or not) can be determined using or needs to be determined from the pose of the subject or a portion of the subject defined within boxes 400, 400".

[0099] Machine learning analysis in box 500 can be used to evaluate and determine (e.g., segment) the geometry of a portion of the subject's image (e.g., a vertebra) to help determine the geometry of implant 230 for display on display device 32. Furthermore, user 12 can also analyze or view the geometry. User 12 or other suitable users can input the actual or observed geometry of implant 230 into navigation system 10. Therefore, machine learning process 500 can be updated by the user with the determined actual geometry or evaluated geometry to augment or modify the machine learning algorithm. Thus, if machine learning analysis is selected, the machine learning analysis in box 500 can be updated or modified over time to achieve higher accuracy. It should be understood that machine learning analysis 500 can be any suitable type of machine learning, such as neural networks, forest or tree analysis, or classification, or any suitable analysis.

[0100] In various implementation schemes, machine learning can be leveraged to further refine the physical / mechanical equations that define how the implant moves relative to segmented anatomical parts such as endplates on vertebral structures. Machine learning can also be used to analyze surrounding tissue density to understand the presence of frictional disturbances that could alter the intended geometry (or conversely, fluid-induced friction reduction within the joint). Machine learning can also be used to improve modeling / geometry determination algorithms based on a comparison of the determined solution and images of the actual configuration taken.

[0101] Regardless of the specific assessment in box 364, as discussed above, the deformable geometry of implant 230 can be determined and displayed on display device 32 due to the position between the various parts of the subject. Therefore, based on the contact between implant 230 and subject 20 and / or specific parts of subject 20 (e.g., vertebra 20v), user 12 can display the deformable geometry on the display device. Since implant 230 is in contact with subject 20, display device 32 can display a representation 280 of implant 230 that more adequately matches (e.g., within tolerable error) the geometry of implant 230 and subject. Furthermore, as discussed above, the generation of graphical representation 280 can occur substantially automatically via instructions executed by navigation system 10 (including processing unit 70 or any suitable processing unit). Therefore, the understanding of the geometry of the implant, or the display of the geometry of the implant in graphical representation 280, can be substantially instantaneous or real-time and does not require additional input or alteration from user 12. Therefore, the deformed or altered graphic representation 280 can be understood as being essentially automatic.

[0102] As discussed above, systems such as navigation system 10 can be used to determine and display the current posture and configuration of an object, such as implant 230, relative to the subject 20. The determination of the configuration, including the object's posture and geometric contours, can be based on the assessed posture and surface of the subject 20 and its tracking and navigation posture. Similarly, or additionally, determinations / plans can be made by assessing information about the subject 20 and / or a database of potential treatment subjects.

[0103] As discussed above, and as Figure 8 As shown, various parts of the anatomical structure, such as vertebra 20vii and vertebra 20vii, can be included in the image data. As discussed herein, the analyzed image data can be used to help determine or plan procedures, such as selecting or designing appropriate implants.

[0104] Image data can be acquired in any suitable manner, as discussed above. Furthermore, image data can include a variety of information, such as information included in a three-dimensional model, a two-dimensional planar image, or multiple two-dimensional images or projections. Image data can also include various types of data acquired and fused together, such as computed tomography (CT) or magnetic resonance imaging (MRI), which can include three-dimensional image data and planar X-ray images including projections through the subject 20. In any case, vertebrae can be included in image data 550, which can be analyzed and / or displayed using display device 32.

[0105] In various implementations, image 550 does not need to be displayed in a pre-analyzed or original configuration, but can be displayed on display device 32 after a selected analysis of image 550. Image analysis may include various processing steps, such as segmenting the data 550 comprising the respective vertebrae 20vi, 20vii. Segmentation may include identifying one or more boundaries or edges of the vertebrae, including the corresponding superior vertebral body boundaries 210, 220 and inferior vertebral body boundaries 214, 224, as discussed above. It should be understood that additional boundaries or edges, such as spinous process boundaries, facets, etc., may also be identified. Furthermore, it should be understood that boundaries 210-224 may be two-dimensional or three-dimensional boundaries. Therefore, as... Figure 8 As shown, when the boundary 210-224 is determined, it can be analyzed.

[0106] Continue to refer to Figure 8 And refer to other sources Figure 9 The surface geometry or shape of the corresponding vertebrae 20vi, 20vii can also be depicted and / or analyzed. For example, surface 214 may include irregular geometry, including substantially uneven surfaces. For example, the first outer portion 214a may be located at a distance below the plane defined by the second portion 214b. Thus, surface 214 may be substantially non-planar and include a three-dimensional configuration that can be analyzed and depicted according to selected techniques. As discussed above, segmentation algorithms, machine learning (e.g., convolutional neural network) systems, etc., can be used to determine the geometry of the identified portions in image 550. It should also be understood that the segmentation of image 550 may be based on input from user 12, such as user 12 identifying one or more points (e.g., pixels or voxels) in image 550 as seeds to assist in its segmentation and / or depiction. Furthermore, the user can identify individual portions or surfaces to be depicted for further analysis, such as the inferior and superior plates of vertebral bodies 20v in images 20vi, 20vii. Furthermore, the second vertebra 20vii may include a surface 220, which may also have a geometric shape, or may be substantially planar, such as Figure 9 As shown.

[0107] Therefore, continue to refer to Figure 8 and Figure 9 Relative geometries and / or spaces can be generated and / or defined between two vertebrae 20vi, 20vii. For example, the geometry of one or more distances between portions comprising vertebrae 20vi, 20vii can be determined. For example, a first distance can be determined between a mid-lateral point 560 of the first vertebra 20vii and a mid-lateral first lateral point 562 of the second vertebra 20vii. Similarly, a second distance 568 can be measured between a third mid-lateral point 572 and a fourth mid-lateral point 576. Distances 558, 568 can differ due to the surface geometries and configurations of the corresponding surfaces 214, 220. For example, as discussed above, a second portion 214b can extend further from the opposing surface 210 and the first portion 214a, and therefore the distance 568 extending from it can be less than the distance 558.

[0108] It should be understood that multiple distances can be measured between the two opposing surfaces 214, 220 of the corresponding vertebrae 20vi, 20vii. In various embodiments, these multiple distances can be used to substantially define the three-dimensional shape between the two vertebrae 20vi, 20vii. The area or volume between the two vertebrae 20vi, 20vii can be the geometry of the region of interest (ROI). The ROI geometry can be determined or defined in any suitable manner, and in various embodiments, including selected geometries such as cylinders, can be deformed or interpolated using appropriate techniques until it substantially matches the distance or configuration between the two vertebrae 20vi, 20vii. For example, as Figure 8 As shown, cylinder 590 can be positioned between the two vertebral surfaces 214, 220 and enlarged or altered until the geometry between the two vertebrae 20vi, 20vii substantially matches that of virtual cylinder 590. Therefore, the geometry of virtual cylinder 590 can be used to match the distances or geometric configurations (e.g., three-dimensional configurations) between surfaces 214, 220 and / or between surfaces 214, 220. Thus, the geometry between the two surfaces 214, 220 can be understood or analyzed according to appropriate techniques to determine the geometry and / or volume between the two surfaces 214, 220.

[0109] As discussed above, the area or volume between selected portions (such as surfaces 214 and 220) can be identified, including the morphology (e.g., geometry of a complex structure) between the two surfaces. The volume of the morphology can be defined by selected boundaries or surfaces, such as a cylinder whose diameter will fit the outer boundary of surface 214, such as diameter 600. It should be understood that diameter 600 can be any suitable outer boundary shape or geometry, and the diameter or circle is merely exemplary. However, cylinder 590 can be defined by dimensions, length, and geometry within a circle or boundary 600. It should be understood that cylinder 590 does not have to be a perfect cylinder and can be a complex shape including angular or curved regions or region 604. The morphology of regions such as cylinder 590 can be used to define the geometry of the volume between the two surfaces 214, 220. As discussed above, the identification of surfaces 214, 220 is due to the fact that selected segmentation of the image can be used to identify the region or volume between the two surfaces 214, 220. This definition, such as the geometric definition of cylinder 590, can be used for various purposes, such as those discussed in this article.

[0110] Therefore, refer to Figure 8 and Figure 9 And refer to other sources Figure 10 The defined cylindrical or void volume 590 and its various geometries, such as the boundary 600, can be used to aid in the selection or planning of prostheses, such as those discussed above or herein, to be positioned within the defined volume 590 between the two vertebrae 20vi and 20vii. Figure 10 As illustrated, a defined volumetric geometry can be compared to one or more possible implants. This comparison can be made visually, such as through a display on display device 32, graphical or automatic comparison, or any other suitable comparison.

[0111] For example, multiple implants or implant configurations may include a first implant 620, a second implant 624, and a third implant 628. Each implant 620, 624, 628 may have its own model, such as a CAD model, which may include information such as dimensions, geometry, and possible variations in geometry. As shown above, implant 230 may include two parts, such as a first part 240 and a second part 244. As discussed above, new parts may move relative to each other due to motion or adjustment members 246. These parts may then also rotate, such as the second part 244 rotating relative to the major axis 260 of implant 230. Therefore, the CAD models of various implants 620, 628 may include similar information.

[0112] In short, the first implant 620 may have at least one known and fixed length 632. The second end or adjustable end may be rotatable or adjustable to have a selected angle, such as between a first contact surface configuration 638 having a first angle 640 relative to the implant's major axis 644 and a second configuration surface 650 having a second angle 654 relative to the major axis 644. Furthermore, the dimensions of the respective surfaces 638, 650 relative to the first end 658 of the first portion or the fixing portion 660 may be determined. Therefore, the first implant 620 may be defined by the possible positions of the end faces 638, 650 relative to the first end 658 and their dimensions relative to that first end.

[0113] The second implant 624 may also include a first surface 680 having a first portion 684 having a first length 688. Similarly, the end face may have a first configuration 692 or 694 in the implant configuration, which may be at different angles 696, 698 relative to the major axis 704 of the implant 624. Likewise, various sizes and / or possible positional geometries may be included in the CAD model. Finally, for example, the implant 628 may include multiple portions, such as a first portion 710 and a second portion 714. The first portion 710 may be substantially fixed or rigid, such as having a substantially cylindrical or rectangular shape or configuration. The second portion 714 may be similar to the first implants 620, 624 and include a constructible or modifiable end surface 720. Thus, the second portion 714 may be adapted, as discussed above, and will not be elaborated further by those skilled in the art here. Furthermore, those skilled in the art will understand that portions 710, 714 of the third implant 628 may be joined together to form an implant and / or implanted separately from the implanted implant.

[0114] Regardless, the geometry including cylinder 690 and / or any defined geometry (e.g., outer geometry 600) can be compared with various possible configurations of implants 620, 624, 628 in an attempt to find a best fit, as discussed above. In various embodiments, the best fit can be determined relative to a threshold. For example, the selected or potential implant may fill a selected amount of a defined volume (e.g., at least 90%), but not more than the defined volume. In various embodiments, regardless of one or more criteria chosen, the algorithm for determining or refining the selection can be based on the mechanical and physical dynamics allowed by the implant.

[0115] For example, the process or system, such as navigation processor 66 and / or image processing unit 76, or other suitable processing units (e.g., may be incorporated into a planning processor system in a separate workstation or computer). One or more processors may execute instructions to compare the possible geometries of various implants (such as implant 620) with the geometry of cylinder 590. Various comparison techniques, such as at least square fitting, may be used to attempt to fill volume 590 with possible configurations of implant 620. It should be understood that multiple attempts may be made, such as trying each of the three implants 620, 624, 628, or a planning strategy may be determined based on selected fitting criteria. It should also be understood that more or fewer attempts and / or plans may be made. Figure 10 The three end plates shown are merely exemplary.

[0116] Continue to refer to Figures 8 to 10 And refer to other sources. Figure 11 The diagram illustrates a planned flowchart or process 750. Flowchart 750 can be a process executable by a selected processor (such as the processor discussed above). Instructions can be stored in selected memory (including the memory discussed above) for access by the processor. Therefore, process 750 can be understood as computer-executable instructions.

[0117] Therefore, process 750 can begin at start box 754. The process can then access subject data in box 756 and segment or delineate image data in box 760. The accessed subject image data and the segmentation of the subject image data can include the procedures discussed above and will not be repeated here. However, after segmenting the image data in box 760, the subject implantation region or region of interest (ROI) can be identified or selected in box 764.

[0118] The selection of the implantation region or region of interest (ROI) for the subject may include the area between two vertebrae, such as vertebrae 20vi and 20vii. In various implementations, such as those discussed above, user 12 may view the image and identify the ROI between the two surfaces 214 and 220. However, it should be understood that the user may also identify other regions; however, process 750 may be used to analyze the area between the two vertebrae or the two surfaces 214 and 220, as discussed above. This determination may be made by the user, such as by selecting surfaces 214 and 220 that have already been segmented in the image data, by the user identifying or selecting multiple points in the image, or by other appropriate mechanisms. This allows for the determination or selection of the implantation region or ROI within box 764.

[0119] The ROI is analyzed in box 768. This analysis may include further segmentation, such as selecting two regions of a surface, such as surface 214 comprising a first region 214a and a second region 214b. This analysis may include determining whether certain surfaces include variations large enough to require further segmentation or separation or other appropriate analysis.

[0120] After analyzing the ROI in box 768, the volumetric geometry of the implantation region or ROI is determined in box 772. Determining the volumetric geometry may include parts or steps, as discussed above, including defining the contour or boundary 600, cylinder 590, and various other geometries, such as offset region 604. The region geometry can be determined in box 772, as discussed above. If a geometry is selected, it can be saved in box 776, and therefore can be understood as not being necessary.

[0121] Using the geometry defined in box 772, one or more object model geometries can be invoked or input in box 780. Model geometries can include various geometries and / or, notably, variable or constructible geometries, as discussed above. For example, such as... Figure 10 As shown, various implants, including more than one implant, may include variable geometries that can be selected by the user during implantation and / or use. The object model may include this information for analysis or selection, as discussed further herein. Therefore, the object model geometry may include various geometries and / or variability for comparison with the volumetric geometry. The invoked model may include known or determined geometries. Due to one or more constructible parts, geometries or possible geometries based on multiple configurations may be included in the model.

[0122] A comparison of a volume geometry with an object model geometry can be performed in box 784. This comparison may include determining whether the model can fit within a selected volume, such as cylinder volume 590, as discussed above. The comparison may also include identifying all possible geometries of the object model geometry implant compared in box 784. Therefore, the comparison may include an analysis of the model and one or more geometries that can be realized by the object.

[0123] As discussed above, various comparison or fitting methods can be performed or used to determine the best fit (as understood by those skilled in the art), such as least-squares fitting, which can be used to determine whether the model will fit within the volume geometry to a selected degree. As understood by those skilled in the art, various thresholds can be determined for an appropriate or selected fit. Therefore, analysis of the model can be used to determine whether relevant objects can be used to fit or fill the ROI geometry (such as cylinder 590) to a selected threshold.

[0124] Following the comparison in box 784, it can be determined in box 790 whether the object model geometry fits the volume geometry. In box 784, if the geometry does not fit a selected threshold or degree, this determination can follow a "No" path to return to comparing the volume geometry with the object model geometry. It should be understood that the comparisons in loop or iteration 794 can be within individual or different model geometries. Furthermore, the loop can also include changes to the model geometry, such as adjustments to the end angles, as various models can include the ability to change the geometry due to user adjustments. Therefore, iterative loop 794 can allow comparison of multiple geometries of different implants and / or multiple geometries of a single implant. However, more than one comparison can occur in iterative loop 794 until determination 790 reaches a selected number of comparison steps (e.g., terminating after 15, 20, 25, or a selected number of comparisons) or when the model matches or fits the volume geometry to a selected degree. Thereafter, a "Yes" path 798 can be followed.

[0125] By following the "Yes" path 798, the output of the object model geometry identification for the fitted volume geometry can be performed in box 802. The output may include visual or physical output, such as an illustration of the selected implant on display device 32. The output may include the selected size, name, identification number, or other suitable identification information to allow selection or retrieval of a suitable implant.

[0126] For example, process 750 can be performed after acquiring image data of subject 20 during the planning phase. Therefore, during the planning phase, an object model of the selected subject or implant can be identified, enabling the acquisition and delivery of the implant for the selected procedure. Thus, the output may also include transmitting purchase orders or other information to the supplier of the implant. Furthermore, the output may include the output of the selected geometry, such as the length of the selected implant to be positioned during the procedure. Therefore, in box 802, the output may include the identification of the selected implant.

[0127] Process 750 can then end or terminate at end box 810. It is understood that end box 810 does not necessarily constitute the final termination of the process, but can be an end following the determination or output of the object model or object identification for the selected process. Therefore, any of these steps can occur within and / or after an end block, such as obtaining a prosthesis, implanting a prosthesis, or other appropriate steps.

[0128] However, as discussed above, subject data, such as image data, can be analyzed for various purposes. Image data can be analyzed to allow determination of the possible or real-time geometry of the implant due to its known or navigable position or posture relative to a part of the subject (e.g., a vertebra). Therefore, the implant can be displayed in real-time posture and configuration on display device 32 for the user 12 to understand. Furthermore, the analyzed geometry can be used to select or suggest implants for a chosen procedure, as discussed above.

[0129] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any process or method described herein may be performed in a different order, or may be completely added, combined, or omitted (e.g., performing the described technique may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

[0130] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium (e.g., a memory module) and executed by a hardware-based processing unit. Computer-readable media may include non-transitory computer-readable media, which correspond to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer).

[0131] Instructions may be executed by one or more processors (e.g., processor modules), such as one or more digital signal processors (DSPs), general-purpose microprocessors, graphics processing units (GPUs), application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the term "processor" as used herein may refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technique may be fully implemented in one or more circuit or logic elements.

[0132] Exemplary embodiments are provided to make this disclosure thorough and to fully communicate the scope of this disclosure to those skilled in the art. Numerous specific details, such as examples of particular components, apparatus, and methods, are set forth to provide a thorough understanding of embodiments of this disclosure. It will be apparent to those skilled in the art that specific details are not required, that exemplary embodiments may be embodied in many different forms, and should not be construed as limiting the scope of this disclosure. In some exemplary embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0133] The foregoing description of embodiments has been provided for illustrative and descriptive purposes. The foregoing description is not intended to be exhaustive or limiting of this disclosure. 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 be varied in many ways. Such variations should not be considered as departing from this disclosure, and all such modifications are intended to be included within the scope of this disclosure.

Claims

1. A system for implant configuration in a planning procedure, comprising: Processor system, the processor system being configured to execute instructions to: Access image data of the subject, which includes at least a first part and a second part of the subject; Analyze the region of interest (ROI) between the first part and the second part; Determine the volume geometry of the region of interest (ROI); Access to a model of an object, the model comprising at least (i) the dimensions of the rigid implant portion of the object and (ii) multiple possible configurations of the constructible implant portion of the object; as well as The accessed model is analyzed to determine the best fit of the object relative to a selected threshold, to achieve the volume geometry of the ROI; and Output the results of the analysis of the accessed model. The output of the analysis of the accessed model includes determining whether the object fills the determined ROI volume geometry by a selected threshold amount, but not greater than the determined ROI volume geometry.

2. The system of claim 1, wherein the processor system is further configured to perform: The region of interest in the image data is selected using input from the user.

3. The system according to any one of claims 1 or 2, wherein the plurality of possible configurations of the constructible implant portion of the object includes at least one or a combination thereof of the range of motion of the constructible implant portion, the range of plastic deformation of the constructible implant portion, and the range of elastic deformation of the constructible implant portion.

4. The system according to any one of claims 1 or 2, wherein outputting the results of the analysis of the accessed model comprises: The output indicates whether the object can reliably achieve the ROI volume geometry within the selected threshold or whether the object cannot achieve the ROI volume geometry within the selected threshold.

5. The system of claim 4, wherein the processor system is further configured to perform: The implant configuration of the object is evaluated based on the output of the analysis of the accessed model.

6. The system according to any one of claims 1 or 2, wherein the model of the object is a first model of a first object, wherein the processor system is further configured to perform: Access a second model of a second object, wherein the second model of the second object includes at least (i) the dimensions of the rigid portion of the second object and (ii) multiple possible configurations of the constructible portion of the second object; as well as Analyze the accessed second model to determine whether the second object can realize the ROI volume geometry based on the accessed second model; as well as Output the results of the analysis on the accessed second model.

7. The system of claim 6, wherein the processor system is further configured to perform: Compare the output results of the analysis on the accessed first model with the output results of the analysis on the accessed second model; and The comparison results are output as a comparison of the analysis results of the accessed first model and the analysis results of the accessed second model.

8. The system of claim 7, wherein the processor system is further configured to perform: The best fit between the first object or the second object and the volume geometry of the ROI is determined based on the results of the analysis output of the comparison of the first model accessed and the results of the analysis output of the second model accessed.

9. The system of claim 1, wherein the model is a first model and the object is a first object, wherein the processor system is further configured to perform: Determine whether the output of the analysis results for the accessed first model matches the ROI volume geometry within the selected threshold; If the output of the analysis of the accessed first model does not match the selected threshold for the ROI volume geometry: Access a second model of a second object, wherein the second model of the second object includes at least (i) the dimensions of the rigid portion of the second object and (ii) multiple possible configurations of the constructible portion of the second object; Analyze the accessed second model to determine whether the second object can realize the ROI volume geometry based on the accessed second model; as well as Output the results of the analysis on the accessed second model.

10. A system for planning an implant configuration, comprising: Processor system, the processor system being configured to execute instructions to: Access image data of the subject, which includes at least a first part and a second part of the subject; Analyze the region of interest (ROI) between the first part and the second part; Analyze the volume geometry of the region of interest (ROI); Access to a model of an object, the model comprising at least (i) the dimensions of the rigid implant portion of the object and (ii) multiple possible configurations of the constructible implant portion of the object; as well as Analyze the accessed model to determine whether the object can realize the volumetric geometry of the ROI; and Output the results of the analysis of the accessed model; and An output device, the output device being used to receive the output, In order to output the results of the analysis of the accessed model, the processor system is configured to execute the instructions to determine whether the object fills a selected threshold amount of the determined ROI volume geometry, but not greater than the determined ROI volume geometry.

11. The system of claim 10, further comprising: A user input device is used to input a selection of the region of interest in the image data using input from a user.

12. The system according to any one of claims 10 or 11, wherein the output device is operable to display whether the object can achieve the ROI volume geometry within a selected threshold.

13. The system according to any one of claims 10 or 11, wherein the model of said object is a first model of a first object, and wherein said processor system is configured to execute additional instructions to: Access a second model of a second object, wherein the second model of the second object includes at least (i) the dimensions of the rigid portion of the second object and (ii) multiple possible configurations of the constructible portion of the second object; as well as Analyze the accessed second model to determine whether the second object can realize the ROI volume geometry based on the accessed second model; as well as Output the results of the analysis on the accessed second model.

14. The system of claim 13, wherein the processor system is configured to execute additional instructions to: Compare the output results of the analysis on the accessed first model with the output results of the analysis on the accessed second model; and The comparison results are output as a comparison of the analysis results of the accessed first model and the analysis results of the accessed second model.

15. The system of claim 14, wherein the processor system is configured to execute additional instructions to: The best fit between the first object or the second object and the volume geometry of the ROI is determined based on the results of the analysis output of the comparison of the first model accessed and the results of the analysis output of the second model accessed.

16. The system according to any one of claims 10 or 11, wherein the model of said object is a first model of a first object, and wherein said processor system is configured to execute additional instructions to: Determine whether the output of the analysis results for the accessed first model matches the ROI volume geometry within the selected threshold; If the output of the analysis of the accessed first model does not match the selected threshold for the ROI volume geometry: Access a second model of a second object, wherein the second model of the second object includes at least (i) the dimensions of the rigid portion of the second object and (ii) multiple possible configurations of the constructible portion of the second object; as well as Analyze the accessed second model to determine whether the second object can realize the ROI volume geometry based on the accessed second model; as well as Output the results of the analysis on the accessed second model.

17. A method for planning the implant configuration, comprising: Access image data of the subject, which includes at least a first part and a second part of the subject; Analyze the region of interest (ROI) between the first part and the second part; Determine the volume geometry of the region of interest (ROI); Access to a model of an object, the model comprising at least (i) the dimensions of the rigid implant portion of the object and (ii) multiple possible configurations of the constructible implant portion of the object; as well as The accessed model is analyzed to determine the best fit of the object relative to a selected threshold, to achieve the volume geometry of the ROI; and Output the results of the analysis of the accessed model. The output of the analysis of the accessed model includes determining whether the object fills the determined ROI volume geometry by a selected threshold amount, but not greater than the determined ROI volume geometry.

18. The method of claim 17, wherein the object comprises a first object and a second object, and the model comprises a first model and a second model; The first model includes (i) a first dimension of the first rigid portion of the first object and (ii) a first plurality of possible configurations of the first constructible portion of the first object; The second model includes (i) a second dimension of the second rigid part of the second object and (ii) a second plurality of possible configurations of the second constructible part of the second object.

19. The method of claim 18, wherein analyzing the accessed model includes analyzing the first model and the second model to determine the best fit of at least one of the first object or the second object to achieve the ROI volume geometry.

Images