System for verifying procedures

Abstract

A method and system for displaying image data of a subject and a model is disclosed. The model may include an implant or article model. The model may be used to assist in validating a procedure.

Description

TECHNICAL FIELD

[0001] This application claims the benefit of U.S. Nonprovisional Patent Application Serial No. 18 / 172,953, filed February 22, 2023, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to imaging a subject, and in particular to a system for acquiring image data and for generating a selected view of a subject with respect to a procedure. BACKGROUND

[0003] This section provides background information relating to the present disclosure and is not necessarily prior art.

[0004] A subject, such as a human patient, can undergo a procedure. The procedure can include a surgical procedure to correct or enhance an anatomical structure of the subject. Enhancement of the anatomical structure can include various procedures, such as movement or enhancement of bone, insertion of an implant (i.e., an implantable device), or other appropriate procedures.

[0005] A surgeon can perform a procedure on a subject with images of the subject based on projections of the subject. The images can be generated with one or more imaging systems, such as a magnetic resonance imaging (MRI) system, a computed tomography (CT) system, a fluoroscopy (e.g., a C-arm imaging system), or the like. SUMMARY

[0006] This section provides a general overview of the present disclosure and is not a comprehensive disclosure of its complete scope or all of its features.

[0007] According to various embodiments, a system for acquiring image data of a subject can be any appropriate imaging system. The imaging system can acquire images with x-rays, magnetic resonance, or the like. The image data can be two-dimensional (2D) or three-dimensional (3D). The images can be 2D or 3D images reconstructed or generated with selected image data. The subject can be a living patient (e.g., a human patient). The subject can also be an inanimate subject, such as a casing, a housing, or the like. Typically, the imaging system can acquire image data of an interior of the subject. The imaging system can include a movable source and / or detector that can be moved relative to the subject.

[0008] The imaging system can include a source and / or detector that can be moved to create multiple projections of the subject and / or generate 3D image data. In various embodiments, the multiple projections can be acquired in a linear path of movement of the source and / or detector. The multiple projections can then be combined, e.g., by stitching together, to generate or form a long view (also referred to as a long film). The long view can be a 2D view of the subject. However, in various embodiments, the long film can also be a 3D image. The 3D image can be reconstructed based on image data acquired with the imaging system.

[0009] Imaging systems for collecting image data can include those disclosed in U.S. Patent 10,881,371 to Helm et al., which is incorporated by reference herein. Imaging systems for collecting image data can include those disclosed in U.S. Patent Application No. 17 / 887,599, filed August 15, 2022, which is incorporated by reference herein. Additionally, various systems can be used to track and illustrate the pose of one or more tracked portions relative to a displayed image, such as those disclosed in U.S. Patent Nos. 11,135,025 and 11,547,491, which are incorporated by reference herein.

[0010] Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0011] The drawings described herein are for illustrative purposes only of selected embodiments and are not intended to limit the scope of the present disclosure.

[0012] Figure 1 is an environmental view of an imaging system in an operating room;

[0013] Figure 2 is a detailed schematic of an imaging system having a source and detector configured to move around a subject, according to various embodiments;

[0014] Figure 3 is an image of a subject;

[0015] Figure 4 is an image of a subject that is calibrated and includes a portion of a plan;

[0016] Figure 5 is a digital graphical illustration of a model of an implant;

[0017] Figure 6 is a flowchart of a process for generating a model, according to various embodiments;

[0018] Figure 7 is an illustration of a graphical representation of a model overlaid on an image of a subject according to various embodiments;

[0019] Figure 8 is a flowchart of a process of coordinating procedures according to various embodiments;

[0020] Figure 9 is an image of a subject;

[0021] Figure 10 is a 3D reconstruction of a subject;

[0022] Figure 11 is a graphical display of a plan for placing an implant after a procedure according to various embodiments;

[0023] Figure 12 is a flowchart of a process for generating a plan and a model according to various embodiments;

[0024] Figure 13 is a flowchart of a process for coordinating a procedure with a model according to various embodiments;

[0025] Figure 14 is a graphical display of a model overlaid on an image of a subject according to various embodiments;

[0026] Figure 15 is a graphical display of a plan and an image of a subject with the plan according to various embodiments;

[0027] Figure 16 is a graphical display of an image of a subject and a table of orientations of portions in the image according to various embodiments;

[0028] Figure 17 is a flowchart of a process for generating a plan according to various embodiments; and

[0029] Figure 18 is a flowchart of a process for coordinating a plan with a procedure according to various embodiments.

[0030] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings. DETAILED DESCRIPTION

[0031] Exemplary embodiments will now be described more fully with reference to the accompanying drawings.

[0032] An imaging system can be used to image a subject, as discussed further herein. The subject can be a living subject, such as a human patient. Image data of the human patient can be acquired and combined to provide an image of the human patient that is larger than any single projection acquired using the imaging system. However, it should be understood that image data of inanimate subjects can also be acquired, including the interior of an outer shell, a housing, a superstructure, and the like. For example, image data of an airframe can be acquired for various purposes, such as diagnosing a problem and / or planning repair work.

[0033] Experimental image data can be used for various purposes.For example, image data can be used to generate an image to help planning procedures, such as selecting or planning implants.The image generated or reconstructed can be used for planning and creating implants.When planning implants, a model such as a computer-aided design (CAD) model (also referred to as an implant model in this article) can be generated and include or have preserved specific size (for example, length, width, volume) and geometry (for example, the length between angle, one or more angles).Image and / or model can be used to help perform and / or verify procedures.

[0034] refer to Figure 1 , illustrates a schematic diagram of a procedure room 20. A user 24 (such as a surgeon) can perform a procedure on a subject (such as a patient 28). The subject can be placed on a support (such as a table 32 for the selected portion of the procedure). The table 32 does not interfere with the acquisition of image data using the imaging system 36. While performing the procedure, the user 24 can use the imaging system 36 to acquire image data of the patient 28 to allow the selected system to generate or create images to assist in performing the procedure. The image generated using the image data can be a two-dimensional (2D) image, a three-dimensional (3D) image, or an appropriate type of image, such as a generated or reconstructed model of the subject (such as a three-dimensional (3D) image that can be reconstructed using the image data and / or the image data is used to deform a standard model), a long view, a single projection view, etc. can be generated using the image data and displayed as an image 40 on a display device 44. The display device 44 may be part of and / or connected to a processor system 48 that includes an input device 52 (such as a keyboard) and a processor 56, which may include one or more processors, processor modules, and / or microprocessors in conjunction with the processing system 48, and selected types of non-transitory and / or transient memory 58. A connection 62 may be provided between the processor 56 and the display device 44 for data communication to allow the display device 44 to be driven to display or illustrate the image 40. The processor 56 may be any suitable type of processor, such as a general-purpose processor that executes instructions included in a program or a special-purpose processor such as an application-specific integrated circuit.

[0035] The imaging system 36 can be an O-Arm® imaging system sold by Medtronic Navigation, Inc. having a place of business in Louisville, CO, USA The imaging system. Includes The imaging system 36 or other appropriate imaging system can be used during a selected procedure, such as the imaging systems described in U.S. Patent Publication Nos. 2012 / 0250822, 2012 / 0099772, and 2010 / 0290690, all of which are incorporated by reference herein. In addition, the imaging system can include various features and elements, such as a slot filter, such as disclosed in U.S. Patent No. 10,881,371 to Helm et al. and U.S. Patent No. 11,071,507 to Helm et al., all of which are incorporated by reference herein. The imaging system 36 can also be or can alternatively be a C-arm, a fluoroscope, a computed tomography scan (CT), a mobile magnetic resonance imager (MRI), etc.

[0036] When, for example, including The imaging system 36, when, for example, including an imaging system, can include a mobile cart 60 that includes a controller and / or control system 64. The control system 64 can include a processor and / or processor system 66 (similar to the processor 56) and a memory 68 (e.g., a non-transitory memory). The memory 68 can contain various instructions executed by the processor 66 to control the imaging system 36, including various portions of the imaging system 36.

[0037] The imaging system 36 can include additional extra portions, such as an imaging gantry 70 in which a source unit (also referred to as a source assembly) 74 and a detector unit (also referred to as a detector assembly) 78 are positioned. In various embodiments, the detector 78, alone and / or with the source unit, can be referred to as an imaging head of the imaging system 36. The gantry 70 can be movably connected to the mobile cart 60. The gantry 70 can be O-shaped or ring-shaped, where the gantry 70 is substantially ring-shaped and includes a wall that forms a volume in which the source unit 74 and the detector 78 can move. The mobile cart 60 can also be mobile. In various embodiments, the gantry 70 and / or the cart 60 can be moved while acquiring image data, including moving both simultaneously. Also, the imaging system 36, via the mobile cart 60, can be moved from one operating room to another operating room (e.g., another room). The gantry 70 can be movable relative to the cart 60, as discussed further herein. This allows the imaging system 36 to be mobile and movable relative to the subject 28, allowing it to be used in multiple locations and with multiple procedures without the need for capital expenditure or space dedicated to a fixed imaging system.

[0038] The processor 66 can be a general purpose processor or a special purpose processor. The memory system 68 can be a non-transitory memory, such as a rotating disk or a solid state non-volatile memory. In various embodiments, the memory system can contain instructions to be executed by the processor 66 to perform functions and determine results, as discussed herein.

[0039] In various embodiments, the imaging system 36 can include an imaging system that acquires images and / or image data by using an emission of x-rays and detecting the x-rays after the x-rays interact with and / or are attenuated by the subject 28. X-ray imaging can be one imaging modality. It should be understood that other imaging modalities are also possible, such as other high energy beams, etc.

[0040] Thus, in the imaging system 36, the source unit 74 can be an x-ray emitter that can emit x-rays at and / or through the patient 28 to be detected by the detector 78. As understood by those skilled in the art, the x-rays emitted by the source 74 can be emitted in a cone 90 along a selected principal vector 94 and detected by the detector 78, as shown. Figure 2 The source 74 and the detector 78 can also be referred to together as a source / detector unit 98, particularly where the source 74 is generally diametrically opposed from the detector 78 within the gantry 70 (e.g., 180 degrees (°) apart).

[0041] The imaging system 36 can be moved in whole or in part relative to the subject 28. For example, the source 74 and the detector 78 can be moved around the patient 28, such as 360° motion, helical motion, partial circumferential motion, etc. The movement of the source / detector unit 98 within the gantry 70 can allow the source 74 to remain generally 180° opposed from the detector 78 (such as with a fixed interior gantry or rotor or moving system). Thus, the detector 78 can be said to move around (e.g., in a circumference or helix) the subject 28, and it should be understood that the source 74 remains opposed to the subject unless otherwise disclosed.

[0042] Also, the gantry 70 can be moved isometrically around an axis 102 in the direction of arrow 100 (also referred to as “swinging”) relative to the subject 28, such as by the cart 60, as shown. Figure 1 The gantry 70 can also be tilted relative to the long axis 106 of the patient 28, as shown by arrow 110. When tilted, the plane of the gantry 70 can be tilted or form a non-orthogonal angle with the axis 106 of the subject 28.

[0043] The gantry 70 can also move longitudinally relative to the subject 28 and / or the cart 60 in the direction of arrow 114 along the axis 106. In addition, the cart 60 can be moved to move the gantry 70. In addition, the gantry 70 can move up and down relative to the cart 30 and / or the subject 28 generally in the direction of arrow 118, generally transverse to the axis 106 and parallel to the axis 102.

[0044] The overall or partial movement of the imaging system 36 is to allow positioning of the source / detector unit (SDU) 98 relative to the subject 28. The imaging device 36 can be precisely controlled to move the SDU 98 relative to the subject 28 to produce precise image data of the subject 28. The imaging device 36 can be connected to the processor 56 via a connection 120, which can include a wired or wireless connection or physical media transfer from the imaging system 36 to the processor 56. Thus, image data collected with the imaging system 36 can be transferred to the processing system 56 for navigation, display, reconstruction, etc.

[0045] As discussed herein, the source 74 can include one or more x-ray sources for imaging the subject 28. In various embodiments, the source 74 can include a single source, which can be powered by more than one power source to produce and / or emit x-rays having different energy characteristics. In addition, more than one x-ray source can be the source 74 that can be powered to emit x-rays having different energy characteristics at selected times.

[0046] According to various embodiments, the imaging system 36 can be used with a non-navigation or navigation procedure. In a navigation procedure, a localizer and / or digitizer, including either or both of the optical localizer 130 and / or the electromagnetic localizer 138, can be used to produce a field and / or receive and / or transmit signals within a navigation space relative to the subject 28. Other navigation modalities can also be used, such as ultrasound, sonar, etc. The navigation space or navigation domain relative to the subject 28 can be registered with the image 40. As understood in the art, the correlation allows registration due to a determined conversion mapping of the navigation space defined within the navigation domain and the image space defined by the image 40. A patient tracker or dynamic reference frame 140 can be connected to the subject 28 to allow dynamic registration and maintain registration of the subject 28 with the image 40.

[0047] In various embodiments, imaging system 36 can generate image data that can be used to generate images 40, such as by reconstruction, and define an image space that can be registered with a patient space or a navigation space defined by and / or relative to patient 28. In various embodiments, the positioning of patient 28 relative to imaging system 36 can be determined by a navigation system that can incorporate one or more of the localizers in conjunction with patient tracking device 140 and imaging system tracking device 174 to assist and / or maintain registration. Thus, the positioning of patient 28 relative to imaging system 36 can be determined.

[0048] Manual or automatic registration of the image space to the subject space can occur. In various embodiments, registration can occur by matching fiducial points in the image data to fiducial points on patient 28. The fiducial points can be anatomical and / or artificial. Registration of the image space to the patient space allows for generation of a transformation mapping between the patient space and the image space. According to various embodiments, registration can occur by determining points that are substantially identical in the image space and the patient space. The identical points can include anatomical fiducial points or implanted fiducial points. Exemplary registration techniques are disclosed in U.S. Patent Application No. 12 / 400,273, filed March 9, 2009, now published as U.S. Patent Application Publication No. 2010 / 0228117; U.S. Patent No. 9,737,235, issued August 22, 2017, U.S. Patent No. 8,238,631, all of which are incorporated by reference herein.

[0049] According to various embodiments, imaging system 36 can be used with a non- navigation or a navigation procedure. In a navigation procedure, a localizer and / or digitizer, including any or both of optical localizer 130 and / or electromagnetic localizer 138, can be used to generate a field and / or receive and / or transmit signals within a navigation domain relative to patient 28. The navigation space or navigation domain relative to patient 28 can be registered with images 40. As understood in the art, the correlation allows for registration of the navigation space defined within the navigation domain and the image space defined by images 40. Patient tracker or dynamic reference frame 140 can be connected to patient 28 to allow for dynamic registration and maintenance of registration of patient 28 to images 40.

[0050] Once registered, a navigation system having or including imaging system 36 can be used and / or for performing a selected procedure. The selected procedure can use image data generated or acquired using imaging system 36. In addition, imaging system 36 can be used to acquire image data at different times relative to the procedure. As discussed herein, image data of patient 28 can be acquired prior to a procedure for collecting automatically registered image data or cine loop image data. Furthermore, imaging system 36 can be used to acquire images for confirming a portion of a procedure. Thus, image data can be acquired at any appropriate time and can be registered with patient 28.

[0051] During registration and tracking of the instrument 144, a graphical representation 180 (e.g., an icon, a marker, an animation, or other visual representation) may be displayed relative to the image 40, including being overlaid (e.g., superimposed) on the image. The image 40 may be any suitable image and may include one or more 2D images, such as 2D images acquired at different planes. The image may also be a 3D image, or any suitable image as discussed herein.

[0052] The patient tracking device or dynamic registration device 140 and the instrument 144 can then be tracked relative to the subject 28 to allow for navigation procedures. The instrument 144 can include a tracking device, such as an optical tracking device 148 and / or an electromagnetic tracking device 152, to allow the instrument 144 to be tracked using either or both of the optical locator 130 or the electromagnetic locator 138. The navigation / detection interface device 158 can communicate (e.g., wired or wireless) with the instrument 144 (e.g., via communication line 156), with the electromagnetic locator 138 (e.g., via communication line 162), and / or with the optical locator 130 (e.g., via communication line 166). The interface 158 can also communicate with the processor 56 via communication line 168 and can transmit information (e.g., signals) about various items connected to the interface 158. It should be understood that any communication link can be wired, wireless, physical medium transmission or movement, or any other suitable communication. However, a suitable communication system may be equipped with corresponding positioners to allow tracking of instrument 144 relative to subject 28, thereby allowing the tracked position of instrument 144 relative to image 40 to be illustrated for performing the procedure.

[0053] Those skilled in the art will appreciate that device 144 can be any suitable device, such as a cardiac or vascular stent, a spinal implant, a neural stent or stimulator, an ablation device, etc. Device 144 can be an interventional device, or can include or be an implantable device. Tracking device 144 allows the position (including x, y, z position and orientation) of device 144 relative to subject 28 to be viewed using registered image 40 without requiring direct viewing of device 144 within subject 28.

[0054] Further, the imaging system 36, such as the gantry 70, can include an optical tracking device 174 and / or an electromagnetic tracking device 178 to be tracked with the corresponding optical localizer 130 and / or electromagnetic localizer 138. Thus, the imaging device 36 can be tracked relative to the subject 28, as can the instrument 144, to allow for initial registration, automatic registration, or continued registration of the subject 28 relative to the image 40. Registration and navigation procedures are discussed in U.S. Patent No. 8,238,631, incorporated above, which is incorporated by reference herein. Upon registration and tracking of the instrument 144, an icon 180 can be displayed relative to the image 40, including overlaid on the image. The image 40 can be an appropriate image, and can include a long film image, a 2D image, a 3D image, or any appropriate image as discussed herein.

[0055] With continued reference to Figure 2 According to various embodiments, the source 74 can include a single assembly, which can include a single x-ray tube 190, which can be connected to a switch 194, which can interconnect a first power source 198 via a connection or power line 200. As discussed above, x-rays can be emitted from the x-ray tube 190 generally in a cone 90 toward the detector 78 and generally in a direction from the x-ray tube 190 as indicated by an arrow, beam arrow, beam, or vector 94. As understood by those skilled in the art, the switch 194 can turn on or off the tube 190 to emit x-rays having selected properties. The vector 94 can be a central vector or ray within the cone 90 of x-rays. The beam of x-rays can be emitted as a cone 90 or other suitable geometry. The vector 94 can include a selected line or axis related to further interaction of the beam, such as with a filter member, as discussed further herein.

[0056] The subject 28 can be positioned within the x-ray cone 90 to allow for acquisition of image data of the subject 28 based on emission of x-rays in the direction of the vector 94 toward the detector 78. The x-ray tube 190 can be used to generate two-dimensional (2D) x-ray projections of the subject 28, including selected portions of the subject 28 or any region, area, or volume of interest, from x-ray irradiation on or detection on a 2D or flat panel detector, such as the detector 78. The 2D x-ray projections can be reconstructed as discussed herein to produce and / or display a three-dimensional (3D) volume model of the subject 28, selected portions of the subject 28, or any region, area, or volume of interest. As discussed herein, the 2D x-ray projections can be image data acquired with the imaging system 36, while the 3D volume model can be generated or modeled from the image data.

[0057] To reconstruct or form 3D volume images, suitable techniques include expectation maximization (EM), ordered subset EM (OS-EM), simultaneous algebraic reconstruction technique (SART), and total variation minimization (TVM), as generally understood by those skilled in the art. Various reconstruction techniques can also and alternatively include machine learning systems and algebraic techniques. Application of 3D volume reconstruction based on 2D projections allows for efficient and complete volume reconstruction. Generally, algebraic techniques can include iterative processes to perform reconstruction of the subject 28 for display as an image 40. For example, pure or theoretical image data projections, such as those generated based on or from a “theoretical” patient atlas or stylized model, can be iteratively altered until the theoretical projection images match the acquired 2D projection image data of the subject 28. The stylized model can then be appropriately altered to a 3D volume reconstruction model of the acquired 2D projection image data of the selected subject 28 and can be used for surgical treatment, such as navigation, diagnosis, or planning. The theoretical model can be associated with the theoretical image data to construct the theoretical model. In this manner, the model or image data 40 can be constructed based on image data of the subject 28 acquired with the imaging device 36.

[0058] With continued reference to Figure 2 The source 74 can include various elements or features that can be moved relative to the x-ray tube 190. In various embodiments, for example, the collimator 220 can be positioned relative to the x-ray tube 190 to help form the cone 90 relative to the subject 28. The collimator 220 can include various features, such as movable components that can help position one or more filters within the cone 90 of x-rays prior to reaching the subject 28. One or more movement systems 224 can be provided to move all and / or portions of the collimator 220. Further, as discussed further herein, various filters can be used to shape the x-ray beam, such as to shape the cone 90 into a selected shape, prior to reaching the subject 28. In various embodiments, as discussed herein, the x-rays can be formed into thin fans or planes to reach and pass through the subject 28 and be detected by the detector 78. Accordingly, the source 74, including the collimator 220, can include a filter assembly, such as that disclosed in U.S. Patent No. 10,881,371 to Helm et al., which is incorporated by reference herein.

[0059] As discussed above, image data of a subject can be acquired. The image data can be processed and / or analyzed for various purposes, such as identifying an implant to be positioned in the subject. As discussed above, various procedures can be performed on the subject 28. In various embodiments, for example, a spinal fusion can be a procedure that includes an implant, which can include, among other things, a fixation member, a rod, or a plate connected to one or more vertebrae. The rod can be designed to help provide therapy to the subject 28. For example, a spinal implant can include an implant such as a rod including a CD and one or more implants of an implant member (e.g., a spinal implant) and / or system, including fixation portions, all of which are sold by Medtronic, Inc. having a place of business in Minnesota, USA. Further, a patient-specific rod can be designed based on information acquired about the subject 28 to help plan and determine an implant.

[0060] With continued reference to Figure 1 and Figure 2 and additional reference to Figure 3 image data of the subject 28 can be acquired. In various embodiments, for example, two-dimensional x-ray projections 300 of the subject 28 can be acquired. It should be understood that the x-ray projections can be acquired with the imaging system 36 or any appropriate imaging system. In various embodiments, the x-ray projections 300 can be standing x-rays of the subject 28. It should be understood that other appropriate image data can be of the subject 28, and the x-ray images are merely exemplary. Further, it should be understood that an implant procedure can be performed with respect to the subject 28, and a spinal rod implant is merely exemplary. Further, in various embodiments, the first image data can be used to plan a procedure for the subject 28.

[0061] Regardless, the image data 300 of the subject can be displayed on a display device and / or substantially automatically evaluated or manipulated. For example, a processor, such as the processor module described above, can evaluate the x-ray or other image data to calibrate the image data. In various embodiments, for example, a calibration module or portion 310 can be included in the image data. For example, the calibration module 310 can include a sphere having a known size or geometry. For example, the calibration module 310 as a sphere can include a known diameter 314. The diameter 314 can be any appropriate diameter, such as 1 centimeter (cm), 1 millimeter (mm), 5 cm, or any appropriate size. It should also be understood that the calibration module or member 310 need not be a sphere, but can include any appropriate geometry.

[0062] Regardless, the calibration module 310 can have a known geometry and / or size that can be used to calibrate the image 300. For example, the image 300 can include one or more vertebrae 316. The vertebrae 316 can be imaged in the image 300 and displayed and / or analyzed. Based on the known calibration module 310, including its geometry or size 314, the size or geometry of the vertebrae 316 can be known. For example, the image of the calibration module 310 can be analyzed relative to the vertebrae 316 to determine the dimensions of the vertebrae 316 based on the known geometry and / or size of the calibration module 310, such as the diameter 314. Thus, the size and geometry of the vertebrae can be known to have a size 320 that is a certain portion of the size of the calibration module 310. For example, the size 320 can be substantially equal to the diameter 314 of the calibration module 310. Thus, the size 320 of the vertebrae can be known to be equal to the size of the calibration module 310. Other suitable analyses can include determining the number of pixels that define the diameter 314 of the calibration module 310 and, thereby, the value or size of the pixels in the image data 300. A direct correlation can also be used, such as the size of the calibration module 310 in the image 300 pointing to any other suitable portion, such as the vertebrae 316. Additionally, the calibration can be made by referencing the vertebrae size on multiple imaging modalities (e.g., X-ray and CT), or directly from a single modality image with embedded calibration functionality (e.g., Multitom medical imaging system or the medical imaging system sold by EOSIMAGING. That is, the dimensions of the various components present in the first image data can be used to calibrate the other (e.g., second) image data relative thereto.

[0063] Once the image data 300 is calibrated, selected portions of the image data, including all of the image data and / or the region of interest in the image 300, can be calibrated such that the dimensions within the image data 300 can be known. For example, the size of the vertebrae 316, the distance between the vertebrae 316, the positioning of the vertebrae relative to one another, and other dimensions can be determined. Thus, the image data 300 can become calibrated image data 330, as Figure 4 shown.

[0064] The calibrated image 330 can be used for various purposes, such as planning a procedure. For an implant procedure, a selected positioning of one or more of the vertebrae 316 can be selected. For example, a first vertebra 316a can be selected to be moved a selected distance or positioned relative to a second vertebra 316b. In the calibrated image 330, the planned movement of the two vertebrae 316a, 316b relative to each other can cause a wedge or opening 342 to form and be visible in the calibrated image 330 during or after planning. It should be understood that planning of a procedure can be performed for any number of selected vertebrae, and the two vertebrae 316a, 316b are merely exemplary. Further planned positioning can be made to a screw, such as the first screw 344. Additionally, a rod or fixation member 350 can also be selected or planned. The rod 350 can be positioned or planned relative to the calibrated image 330 to help hold or move the vertebrae to a selected positioning, such as the positioning of the vertebrae 316a, 316b.

[0065] In the calibrated image 330, the planned positioning of the rod 350, selected vertebrae, and fixation members, such as the fixation screw 344, can be planned. For example, the user 24 can manually manipulate various portions of the calibrated image 330 to position the vertebrae or portions thereof. Additionally or as an alternative, various planning or support systems can be provided. For example, the Mazor X Stealth Computer and software systems can be used to help make the planning (both sold by Medtronic, Inc.). For example, selected processing modules (including those discussed above and / or including the Mazor X Stealth Computer and software systems) can analyze the calibrated image 330 as well as selected positioning of various vertebrae, fixation points, and the rod 350. Thus, automated systems can be utilized to perform and / or enhance the calibrated image 330 and related planning procedure, such as by utilizing a processor module to execute instructions.

[0066] Regardless, the calibrated image 330 is Figure 4 illustrated in FIG. 33, and can be used to plan or determine the geometry of the rod 350. Thus, turning to reference Figure 5 , a model can be formed from the rod 350. Figure 4 and Figure 5The illustrated rod 350 can be a model of a physical rod. The model 350 can include various features of a product, such as a selected size (e.g., length and cross-sectional dimension), geometry (e.g., curvature), etc. For example, the model 350 can include a selected geometry that can include a first segment 354 having a first length and curvature, a second segment 356 having a second length and curvature, and a third segment 360 having a third length and curvature. For example, the rod can include circular and elliptical cross-sections, as well as angular or common valve cross-sections, or any appropriate geometry.

[0067] The geometry of the rod model 350 can include any appropriate three-dimensional geometry. Thus, the rod model 350 can include curvature with respect to the medial and lateral sides of the subject 28, the inferior and superior sides of the subject 28, and the anterior and posterior sides of the subject 28. However, the rod model 350 can be developed to replicate the geometry of the subject generated within the calibrated image 330. Thus, the rod model 350 can include curvature based on the geometry of the subject 28 with respect to the medial and lateral sides of the subject 28, the inferior and superior sides of the subject 28, and the anterior and posterior sides of the subject 28. Figure 4 and Figure 5 Appropriate geometry and features of the illustrated plan are exemplified.

[0068] Turning reference Figure 6 is made to the process 370. The process 370 can exemplify to the portion of the extensive model 350 to be generated to as Figure 5 illustrated. The process 370 can begin in a start block 374 and include acquiring first image data in a block 378. Acquiring the first image data can include the uncalibrated image data 300, as Figure 3 illustrated. The image data can be image data of the subject 28 and can be acquired in any appropriate manner. For example, as discussed above, the image data 300 can include one or more two-dimensional projections of the subject 28. The image data can be acquired with an appropriate imaging system, such as an x-ray imaging system, an MRI imaging system, etc.

[0069] The image data can optionally be reconstructed in a block 384 to generate an image, as Figure 3 illustrated. Reconstructing the image in the block 384 can include generating an image based on the image data acquired with the selected imaging system. For example, as discussed above, the imaging system 36 can include an imaging system that can acquire multiple projections of the subject 28. For example, to implement an image that includes the entire spine of the subject 28, the gantry can be moved in the direction of the arrow 110. Thus, various projections can be stitched together to implement the image. Thus, the reconstruction of the image in the block 384 can be used to generate an appropriate image, the generated image to be viewed, etc.

[0070] ​The image data can then be calibrated in block 390. As discussed above, calibration of the image data can include evaluating the image data relative to a calibration member, such as calibration member 310. Calibration can include evaluating the image data based on the known geometry and size of calibration member 310. Thus, each portion of image 300 can have a known size and / or geometry based on calibration member 310.

[0071] Using the calibrated image data, a member size can be determined or selected in block 394. The member can be, for example, an implant including a rod as discussed above. The size of the member can include a length of the rod, such as the rod modeled as model 350. The size can also include a cross-sectional size, an overall length, a segmented length, or any other appropriate size. The segmented length can include a length or size between various portions of the rod that can differ in geometry, such as angles or changes and angles.

[0072] The geometry of the member can also be selected based on the calibrated image data to be determined in block 398. The geometry can include angles, a number of angles, distances between angles, geometry relative to the calibrated image 330, and three-dimensional space, among other appropriate geometrical configurations.

[0073] Based on the determined size and geometry from block 394 and block 398, a model 350 can be generated in block 402. The generated model can be any appropriate model, such as a computer aided design (CAD) model. As discussed herein, the model can be a digital format model that can be used for various purposes. The model can include a graphical representation of a rod that can be manufactured or produced for the subject 28 to be used by the user 24 during a procedure. Thus, the model 350 can include the determined size and geometry. The rod can also define a coordinate plane or coordinate space that can be displayed relative to an image of the subject, such as the calibrated image 330. In various embodiments, the model 350 that can be displayed is superimposed on the calibrated image 330 or any appropriate image, as discussed herein. The model 350 can be a model of any selected spinal implant and can be overlaid (i.e., superimposed) within an image based on a reference anatomy or preoperative surgical planning.

[0074] The model can then be saved in block 406. Saving the model in block 406 is optional, but can be used to allow the generated model to be saved for later purposes. However, it should be understood that saving the model in block 406 is optional, and the model can simply be used substantially instantaneously for a selected purpose, such as discussed herein. Thus, the process for generating the model 370 can end in block 410. The generation of the model, such as rod model 350, can be used to assist in planning and / or verifying a procedure as discussed herein.

[0075] Turning to referenceFigure 7 and Figure 8 , Model 350 can be used for Figure 8 4. The coordination or verification process 450 shown. The verification or coordination process may include displaying the rod model 350 as a graphical representation of the rod superimposed on a second image 454 of the subject. The second image 454 may be after the rod 458 is implanted and secured within the subject using one or more of the securing members, such as screws 462. The rod 458 may be imaged in the second image 454 of the subject 28, such as using the imaging system 36. For example, the image data may be acquired using an x-ray imaging system, and the rod 458 may be a radiopaque member. Thus, the rod 458 will appear in the image data 454 of the subject 28. The verification or coordination process may include displaying the model 350 superimposed on the image of the rod 458 within the subject to confirm that the placement of the rod 458 within the subject is in the selected or planned position.

[0076] Thus, the coordination process 450 may begin at block 470. The process may include overlaying a graphical representation, such as based on the rod model 350, on the rod image 458 on the display device. The process 450 may include calling or accessing the generated model at block 474. As discussed above, the generated model may be saved at block 406. However, the model may be called or accessed at block 474. Calling or accessing the model may include calling the model from memory, calling the model directly from the planning processor module, or other appropriate access. Regardless, the model may be called for a variety of purposes, as discussed herein. Also, as discussed above, the model may include specific features of the rod 458. The features of the rod may be used to generate the rod 458 to be implanted in the subject 28. When called, the model 350 may be used to generate an image displayed relative to the image of the subject 28, as discussed herein.

[0077] After planning model 350, model 350 may be used, such as during a manufacturing process, to create a rod that includes geometry, size, etc. specific to subject 28. The rod may then be implanted at some time, and the rod may be imaged within subject 28 in block 478 to acquire second image data. The second image data acquired in block 478 may be image data 454 and may be displayed as Figure 7 The image data 454 can be displayed on the display device 44. The display device can also display various

[0078] The acquired second image data may be image data of subject 28 acquired after a portion of a procedure, such as positioning of rod 458 within the subject. However, the second image data may be acquired at any suitable time, such as after a test placement of the rod, fixation of a single one of the fixation members, or temporary placement of the rod on subject 28.

[0079] However, in block 482, the second image data can be calibrated to the first image data. Calibrating the second image data to the first image data can occur according to various techniques, such as including a calibration member 310 in the image acquired in block 478. The calibration member 310 can be positioned relative to the subject 28 to acquire the second image data. Thus, the calibration member 310 can be used to calibrate the second image data to the subject.

[0080] Thus, the same calibration member 310 for the acquisition of the first image data and the second image data can ensure calibration between the first image data and the second image data. Additionally or as an alternative, the image data can be calibrated to each other, such as selecting the same portion in each image data. For example, a vertebra 316a can be identified in the calibrated image 330 as well as in the image data 454. The vertebra 316a can be identified by the user 24 in both image data. The selection of the vertebra 316a can also or alternatively be automatic, such as by segmenting and / or identifying the geometric boundary of the vertebra 316a. However, it should be appreciated that the determination of the geometry of the selected portion, such as the vertebra 316a, can be used to allow the processor module to substantially automatically segment the vertebra 316. The segmentation of the same portion in the first image data and the second image data, such as the vertebra 316a, can be used for the calibration of the second image data in block 482. As discussed above, the calibration can be performed according to the selected manner to achieve the determination of the proper size and geometry.

[0081] The second image data can be acquired in block 478 and can be calibrated to the first image data in block 482. Then, the calibrated image data can be utilized in block 488 to reconstruct an image. The reconstruction of the calibrated image data can be used to generate an image for display, such as the second image data 454. The second image can in turn be based on a plurality of projections, such as acquired with the imaging system 36. Thus, the image 454 can be reconstructed based on image data that is calibrated relative to and / or calibrated to be identical to the calibrated first image 330.

[0082] The reconstructed image can be displayed, such as on the display 44. Further, the model 350 can be displayed in block 492, such as superimposed on the display of the calibrated image. As Figure 7As shown, the model 350 can be displayed as superimposed (such as overlaid) on the image of the implant rod 458. The implant rod image 458 can be based on acquired image data of the subject 28 including the implant. The overlay of the model 350 can be displayed on the display device 44 as a graphical representation of the rod or other spinal implant or planned technique based on the generated model 350, as discussed above. Since the model was used to generate to the rod 458, the model 350 should be able to substantially overlay the image rod 458. Thus, the display device 44 can display the model 350 superimposed on the x-ray image of the rod 458. The model 350 can be substantially automatically overlaid and / or moved by the user 24 or any appropriate user each year to display the overlaid model 350 on the way image 458. Alternatively or additionally, the model 350 can represent the planned removal of bone or soft tissue that will change the anatomical shape, such as the anatomical shape of one or more vertebrae 316, and / or the orientation of two or more vertebrae relative to each other.

[0083] Since the rod model 350 was generated with calibrated image data 330, and the second image data 454 is calibrated to the same calibration, the rod model 350 is a true representation of the rod relative to the image 454, and should directly overlay the rod image 458 when aligned. When the rod model 350 substantially overlays the rod image 458, the procedure can be verified and / or reconciled with the plan. Reconciliation can be done by directly visualizing the overlay image, or by quantifying the difference between the coordinate planes of the rod model 350 and the position of one or more vertebral bodies. A difference can be outputted that is greater than a selected amount (e.g., 3 mm) or percentage such as greater than 10%. Thus, in block 500, the user 24 and / or a system, such as a processor module executing instructions to determine the amount of overlay, can be used to reconcile the procedure based on the display. Reconciliation can be manual, automatic, or a combination of both. For example, the user can move the model 350 to overlay on the rod image 458. The processor module can then execute instructions to determine the amount of border matching between the model 350 and the rod image 458. The amount of overlay can be determined by the user 24 only, by the processor module executing selected instructions only, or as a combination of both.

[0084] The process 450 can then end in block 510. Thus, the process 450 can be used to reconcile the placement of the rod in the subject 28, which can be imaged as the rod image 458 in the second image 454. The rod model overlaid on the rod image 458 can allow for verification or reconciliation of the planned procedure relative to the procedure performed. Thus, the user 24 can reconcile or confirm that the procedure is being performed relative to the plan.

[0085] As discussed above, a procedure for subject 28 can be planned relative to selected image data. The image data can be two-dimensional image data and can include a substantially two-dimensional plan to identify a planned curve of a portion of subject 28, such as the subject's spine. However, in various embodiments, the image data and related planning can be made relative to three-dimensional image data.

[0086] Referring to Figure 9 and Figure 10 Image data of subject 28 can be acquired with an appropriate imaging system. For example, image 550 can be generated with projections made or collected by imaging system 36. As discussed above, imaging system 36 can generate a plurality of projections of subject 28 and can be reconstructed, such as 2D reconstruction and / or 3D reconstruction. According to various embodiments, 2D images can also be registered to 3D images. Thus, a 3D image of subject 28, such as a CT scan, can be acquired and can be registered to image data acquired with a different or second imaging system. Regardless, first image data 550 of the subject can be acquired.

[0087] With continuing reference to Figure 9 and additional reference to Figure 12 A plan for a procedure can be generated. The procedure plan can be plan 560 that is initiated in start block 564. First image data can then be acquired in block 568. Acquisition of the first image data can be made with imaging system 36, as discussed above. Further, acquisition of the first image data can include acquisition of 2D image data and access to or registration of three-dimensional image data. Regardless, in block 572, the image data can be used to reconstruct a 3D image. With brief reference to Figure 10 A 3D reconstruction can be made and / or displayed on display device 44. The reconstruction can be based on registration of a plurality of image data of subject 28 and / or different image data acquired. Further, as discussed above, imaging system 36 can acquire image data of a subject that is stitched together, such as to generate a long film view that includes image data that is not collected at a single projection location. The long view can include, for example, an entire spine of a subject.

[0088] Image data can be calibrated in block 578. Returning reference to Figure 9 As discussed above, calibration member 310 can be included in the image data to allow calibration and / or reconstruction of the image data. Calibration member 310 can be used to identify the size and geometry of various portions of subject 28, such as vertebra 316. Thus, dimension 320 of vertebra 316 can be determined in a similar manner as discussed above. Further, the size and geometry of the subject or a selected region of interest, such as a spine or a portion of a spine, can also be made.

[0089] The calibrated image data may then be segmented in block 582. Figure 10 , the display device 44 may display the 3D image data as a 3D image or model 590. The 3D model may be based entirely on the acquired image data and / or a standard atlas model more appropriate for the selected subject (such as a human subject). However, regardless of the process, the 3D image data 590 may be analyzed by the user 24 and / or the processor module executing the selected instructions to plan the procedure. As discussed above, the processor module may execute the same instructions as the Mazor X Stealth sold by Medtronic, Inc., having a place of business in Minnesota, USA. The computer software and system may include instructions similar to those contained in the system. The 3D image data may be segmented in block 582, such as to segment vertebrae. Figure 10 As shown, 3D image 590 (e.g., displayed on display device 44) may have segmented vertebrae including vertebra 316a. Other vertebrae may also be segmented, including vertebra 316b. However, it should be understood that any suitable number of vertebrae may be segmented. Additional regions or selected regions of interest may also be segmented into units, including a first region of interest 594, a second region of interest 598, and a third region of interest 602. It should be understood that three regions of interest are merely exemplary and not required. Thus, more or fewer regions of interest may be selected, if desired.

[0090] The segmented image data may also be used to generate a model in block 610. The generated image model is exemplary and not required, but may be used for various purposes, such as planning, Figure 11 As shown. Model 614 may include dimensions of the segmented or fragmented portions, illustrated relative to one another to aid in planning. In block 618, regions of interest 594, 598, 602 may be selected at any appropriate time, such as using the generated model and / or in three-dimensional data 590. The selected region may help define the shape, course of the procedure, etc., for performing the procedure on subject 28.

[0091] Once the image data has been appropriately segmented and prepared, including pre-processing (e.g., segmentation, identification of selected regions, etc.), a plan may be determined. However, pre-processing may be performed using a selected processor module that may include various segmentation techniques, including edge detection by gradients, manual segmentation such as performed by user 24, or other appropriate pre-processing. Processing may allow the image data to be appropriately analyzed for planning and for generating 3D image data and / or a model of subject 28. However, as Figure 11 As shown, various planning components may be modified to assist in performing the procedure on subject 28 .

[0092] For example, a determined or planned selected shape of a region of interest can be made in block 624. As shown in Figure 10 The spine of the subject 28 can be displayed and its shape determined and / or planned to be achieved with a procedure (e.g., spinal implantation and / or fusion), as shown in block 624. In addition or in the alternative, various regions of interest can be identified and the shape of each of the regions of interest can also be determined or planned. Regardless of the technique, however, the shape of the spine can be determined and / or planned in block 624. In block 628, the shape of the spine can assist and / or determine the shape of an implant, such as a rod. As shown in Figure 11 The model 614 of the spine can include a rod model 634, which can be similar to the rod model 350 as discussed above. The rod model 634 can be designed or determined to achieve the shape of the spine determined in block 624. In addition, the model of each or a selected number of vertebrae can be identified, such as the first vertebra 316a as L4, the second vertebra 316b as L3, and the third vertebra 316c as L2. In block 628, the identification of the vertebrae can assist in forming a plan to achieve the selected shape of the spine and / or an implant, such as a rod.

[0093] A fixation point or region is determined in block 640. The fixation region can include the positioning of one or more screws, such as the planned positioning of a screw in L4. As shown in Figure 11 The graphical representation of the screw 644 can be instantiated with respect to the rod model 634 and with a selected orientation at the vertebra 316a, as shown in block 642. As understood by those skilled in the art, additional one or more additional fixation members can also be planned, as shown in Figure 11 For example, the L4 screw can include a plurality of screws, including two screws that can be inserted bilaterally, including representations of screws 644a and 644b. Further additional details can include orientation, size, etc. All of the information and planning can be displayed on the display device 44 and on a further panel 650 included in the graphical representation of the screw 644a.

[0094] Accordingly, in block 658, the shape of the rod can be identified and generated as a rod model or implant model. The generated rod model can include a three-dimensional model of geometry, size, etc. The rod model generated in block 658 can be for any of the selected regions of interest and / or the entire spinal portion. Accordingly, a plurality of rod models can be generated in block 658 and / or a single rod model can be generated. The rod model can also include and / or have created therefrom the model of the screw 644 and the orientation and positioning with respect to the vertebrae 316 of the subject. The model can be displayed on the display device 44 and / or superimposed on the image data of the subject, such as the 3D image 590. However, the model can be displayed on the subject model 614, as shown in Figure 11

[0095] ​According to various embodiments, the model can then be saved in block 664. The saving of the model can allow it to be called at a selected time to assist in a procedure, such as the coordination of a procedure. However, as discussed above, the model need not be saved. The procedure 560 can then end in block 670.

[0096] Turning to reference Figure 14 and Figure 13 A procedure similar to that discussed above can be performed on the subject 28. For example, a subject-specific implant can be generated based on the model generated as discussed above. The implant can include a rod for securing a portion of the spinal column, such as one or more vertebrae 316 in the subject 28. The rod can be substantially unique to the subject, and can be used in the procedure. Further, various securing members can be used to help secure the rod to the subject 28. Regardless, the rod can be implanted in the subject in an appropriate manner, such as those understood by one skilled in the art. Once the rod is implanted or any appropriate implant is implanted, the procedure can be coordinated with the plan, and it is verified that the plan is implemented or differs therefrom.

[0097] With reference to Figure 13 The process 700 is illustrated. The process 700 can be a verification process that can be similar to the verification process 450 discussed above. The verification or coordination process 700 can begin at a start block 710. The generated model block 658 can be called or accessed in a start block 714. As discussed above, the model can be saved for access at any appropriate time. Further, the model can be generated and accessed substantially immediately, such that the model is not saved. However, the model can be called in block 714, such as the positioning of the rod model 634 and the screws 644a, 644b, and any other appropriate features.

[0098] Second image data can then be acquired in block 718. The acquired second image data can be any appropriate image data, such as image data acquired with the imaging system 26. The image data can be two-dimensional image data, three-dimensional image data, or other appropriate image data. According to various embodiments, the three-dimensional image data can be generated by reconstructing a three-dimensional image based on image data acquired with the imaging system 26. However, the image data can be acquired in any appropriate manner, such as with a CT scan, an alert, or other appropriate manner as the imaging system 26.

[0099] Reconstruction of a 3D image can be performed in block 722, if necessary. The reconstructed 3D image can be based on the acquired second image data. The image data can be reconstructed in any appropriate manner, such as those discussed above.

[0100] The reconstructed image can then be calibrated and / or registered to the first image data in block 728. The calibration and / or registration of the reconstructed image or second acquired image data to the first image data can be a registration of the second image data to the first image data, a matching of the calibration using calibration means 310 (as discussed above), or the like. The reconstructed image data can be a model based on the second image data acquired in block 719 or can be a reconstruction of an image of the subject 28 based on the acquired image data. The reconstructed 3D image of block 722 and / or the calibrated image from block 728 can be displayed on the display device 44. The reconstructed image can include an image of image data including the implant portions, including the implant rod 734 and one or more implant screws 738. The image of the rod 734 and the image of the screws 738 can be displayed with the image data of the subject. The display can include a 3D image and / or multiple perspectives of the image, such as a medial-lateral view 742 and / or a posterior-anterior view 746. The one or more views can allow the user 28 to view the positioning of the implant, such as the rod with the x-ray rod image 734, to verify or reconcile the plan.

[0101] The generated model 634 can be overlaid, such as superimposed, on the x-ray images 742, 744. The rod model 634 can be overlaid on the image of the rod 734. Similarly, the planned positioning of the screws 644 can be overlaid on the x-ray screw images 738. The overlay of the rod and screws 634, 644 can be overlaid in any number of perspectives, such as in both images 742, 746. The display device 44 can also display various other outputs, such as a difference amount 754 or other appropriate outputs.

[0102] The overlaid model displayed on the acquired second image data can be displayed in block 760, and the user 24 can use the display to perform a reconciliation 764. The reconciliation can also be performed by the processor module, such as by executing instructions. The instructions can include determining an amount of alignment or misalignment of the rod model and screw model 634, 644 relative to the x-ray rod image 734 and the x-ray screw image 738. Further, when the images are segmented, the positioning of the vertebrae can also be compared between the first image data and the reconstruction. Thus, the reconciliation of the plan and the procedure can be performed by the processor module by determining an amount of alignment or shape of the vertebrae or a vertebrae orientation. The amount of alignment can include determining a side-to-side comparison between the various portions, such as the x-ray rod 734 and the rod model 634. As discussed above, the calibration and registration allow the generated model to substantially match the predicted procedure for confirming the reconciliation of the plan.

[0103] The procedure reconciliation can then end in block 770. The reconciliation can be used to determine a success of the procedure and / or the positioning of the implant relative to the plan.

[0104] The planning and procedure for performing a procedure on a subject 28 can be performed in accordance with various embodiments, including those discussed above and further discussed herein. It should be appreciated that various features, including images and processing, image analysis, and coordinated analysis, can be combined from any of the various embodiments.

[0105] In accordance with various embodiments, for example, in Figure 15 , Figure 16 , Figure 17 and Figure 18 Systems and methods for planning and coordinating a procedure are illustrated. The process 800 can begin in block 804 and first image data can be acquired in block 808. The first image data can be any appropriate type of image data, including that discussed above. Thus, the image data can be 2D, 3D, or other appropriate image data. The image data can be reconstructed into an image in block 812 and the image can be segmented in block 316. The reconstruction and / or segmentation of the image can be optional. However, in accordance with various embodiments, the image or image data can be segmented to identify various features in the image, such as vertebrae, as discussed above. The segmentation can include automatic segmentation based on executing instructions with a processor module to analyze the image data and / or manual input regarding segmented features in the image.

[0106] As shown in Figure 15 , the image can also be displayed on the display device 44. The image 820 can include generated image data of the subject and is displayed for viewing by the user. The implants planned for the procedure, including the selected geometry of various portions, such as the spine 824 and / or various vertebrae, such as vertebrae 316. The regions and / or anatomical locations of the vertebrae can be manipulated in the image 820 to generate the selected geometry or shape of the spine 824. As shown, the movement or alignment of various portions of the image can cause open or dark regions in the image 830. Additional various anatomical features can be identified, such as the transition point 834 between the thoracic and lumbar vertebrae.

[0107] The movement or alignment of the segmented portions to the selected geometry or shape can be performed in block 840 to determine the geometry between the segments that can be made and can be identified as the anatomical structure of the various portions of the planning 844. The determined geometry or planning between the segments made in block 840 can be illustrated or displayed as the planning 844, including the planning of various geometries to be achieved. The preoperative geometry can also be identified and displayed as the preoperative geometry in the table 848. The preoperative geometry and / or the planning geometry can be the planning or table 852 that can be displayed relative to the image 820. Thus, the user 24 can understand the current geometry and the planning geometry after the procedure.

[0108] If selected, a model of the implant, including the rod model 856, can also be generated in block 860. However, it should be appreciated that a model of the implant is not necessary. A determination of the planned geometry to be achieved can be generated and saved based on the image data of the subject taken in the planning. The planning can be performed or identified by the user 24 and / or based on selected constraints, such as alignment goals as targets (e.g., thoracic kyphosis, segment angle) or changes in vertebral position as targets (e.g., orientation of the vertebrae in a 3D plane).

[0109] The determined geometry or planning can be saved in block 866. The saving of the planning is optional and can not be necessary. However, the determined geometry of the planning can be used to identify and / or reconcile the procedure after the procedure is completed. The process 800 can then end in block 870. The user 24 can then perform the procedure on the subject. Figure 18 The reconciliation process 380 is illustrated in the middle.

[0110] The reconciliation process can begin in start block 884, followed by calling and / or accessing the determined or planned geometry between segments in block 890. The procedure can be performed on the subject before the second image data is acquired in block 894. The second image data of the subject can be acquired in any appropriate manner, such as with the imaging system 36. As discussed above, the image data can be 2D image data, 3D image data, or any appropriate image data. In block 900, the image data can be used to reconstruct an image. Further, the reconstructed image can be segmented in block 904. The image data and the reconstructed image or model can be displayed on the display device 44 as second image data or second reconstructed image data 910. The second image data can include various portions, such as one or more segmented or identified vertebrae 316a, 316b, and 316c.

[0111] In block 920, the geometry between the segments can be identified or determined in the second image. If selected, the determined geometry can be displayed on the display device 44 in a table or comparison table 926, which can include a column for the planning 930 and a second column for the image or actual 934. The planning geometry can be based on the called planning. The actual geometry or image geometry can be determined from at least the second image data.

[0112] The second image data can include segmented portions and / or allow for the evaluation of the angles of the various portions therein. Thus, the user 24 can identify elements or portions in the second image data and allow for measurements between the elements, such as the vertebrae. The angles and / or other anatomical areas between them can be compared to the planning. Thus, the second image data can be used to identify the geometry in the subject 28 after the procedure.

[0113] The comparison of the measured geometry can be used to determine a plan or coordinate a plan with a procedure. Thus, a comparison of the called / accessed geometry or plan with the determined geometry in the second image data is performed in block 940 and can allow for coordination of the procedure and block of 144. The user 24 can perform the coordination by comparing or evaluating the determined geometry with respect to the planned geometry. Further, the processor module can execute instructions to determine a difference between the planned geometry and the actual or image geometry. For example, the selected successful verification or confirmation can include removal of a 10° vertebral segment or change in endplate angulation.

[0114] The coordinate procedure 880 can then end in block 960. The coordinate procedure 880 can be used to coordinate a procedure performed on a subject. The coordination does not require calibration or measurement of image data in the first image data or the second image data, can allow for comparison between the first image data and the second image data to determine whether a plan has been achieved or compared to. Thus, the second image data can be evaluated to determine or coordinate a plan for a procedure or results of a procedure.

[0115] As discussed above, coordination of a procedure with a plan can be performed with image data acquired after or during a portion of the procedure. The procedure can include placement of an implant and / or shaping of a patient’s spine. The image data can be compared with a digital model based on the plan. The digital model can include a graphical representation of the implant and / or positioning of a portion of the subject, such as one or more vertebrae.

[0116] The foregoing description of implementations has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the application to the precise form disclosed. Individual elements or features of a particular implementation are generally not limited to that particular implementation, but, where applicable, are interchangeable and can be used in a selected implementation, even if not specifically shown or described. The same element or feature can be varied from implementation to implementation. These variations are not to be regarded as a departure from the application, and all such modifications are intended to be included within the scope of the application.

[0117] It should be understood that various aspects disclosed herein can be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that each of the methodologies or processes described herein can include certain acts or events or can not include certain acts or events described that, if omitted, can not change the basic nature of the methodology or process, for example, the manner in which the technology is or is used. Furthermore, although the subject application has been described in terms of certain implementations, it will be apparent to those of ordinary skill in the art that various alterations and modifications can be made to the implementations without departing from the scope of the application. Equally, where the description has not been presented in terms of specific implementations, the skilled person will be able to devise numerous alternative implementations with the aid of the disclosures. Accordingly, the application is not limited to the implementations described herein, but instead has wide applicability and scope.

[0118] In one or more examples, the described techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media can include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to

[0119] Instructions can be executed by one or more processors or processor modules, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term "processor" as used herein can refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

Claims

1. A system for planning a procedure, the system comprising: a processor module configured to execute instructions to: accessing first image data of a subject; calibrating the first image data; determining an implant geometry based on the planned positioning of a portion of the first image data; accessing second image data of the subject with the implant; calibrating the second image data to the same calibration as the first image data; as well as A graphical representation of the determined implant geometry is generated to be superimposed on or based on the accessed second image data and the image of the implant.

2. The system according to claim 1, further comprising: A display device is configured to display the second image data and the graphical representation superimposed on the displayed second image data.

3. The system according to claim 1, further comprising: an imaging system configured to acquire the second image data; The second image data is configured as at least one of two-dimensional images or reconstructed into a three-dimensional image.

4. The system of claim 1 , wherein the processor module for executing instructions to calibrate the first image data comprises: A size of the selected portion of the subject is determined.

5. The system of claim 4, wherein the processor module for executing instructions to determine the implant geometry based on the planned positioning of the portion in the first image data comprises: A size and geometry of a rod configured to achieve the planned positioning of the portion of the first image is determined.

6. The system of claim 5, wherein the processor module for executing instructions to generate the graphical representation of the determined implant geometry to be superimposed on the accessed second image data at the implant comprises: generating the graphical representation based on the model of the rod, the model of the rod having dimensions based on the calibration of the first image data and the second image data; Wherein a size and geometry of the graphical representation based on the model is calibrated to the dimensions of the second image data to illustrate a realistic position of the planned position.

7. The system of claim 1 , wherein the processor module for executing instructions further comprises: An input is received to move the generated graphical representation superimposed on the image.

8. The system of claim 1 , wherein the processor module for executing instructions to calibrate the second image data to the same calibration as the first image data comprises: Equal sizes of a portion of the first image data and a portion of the second image data are determined.

9. A system for planning a procedure, the system comprising: a processor module configured to execute instructions to: accessing first image data of a subject; reconstructing a first three-dimensional (3D) image of the subject using the accessed first image data; calibrating the 3D image; segmenting the 3D image to generate segments; determining a planned geometry of the segment of the segmented 3D image; determining a 3D implant geometry based on the planned geometry of the segments; accessing second image data of the subject with the implant; reconstructing a second 3D image of the subject using the accessed second image data; as well as A graphical representation of the determined 3D implant geometry is generated to be superimposed on the reconstructed second 3D image.

10. The system according to claim 9, further comprising: A display device is configured to display the graphical representation of the determined 3D implant geometry and the reconstructed second 3D image.

11. The system according to claim 9, further comprising: an imaging system configured to acquire the second image data; The second image data is configured to be reconstructed into a three-dimensional image.

12. The system of claim 1 , wherein the processor module is operable to execute instructions to calibrate the 3D image comprising: A size of the selected portion of the subject in the first image data is determined.

13. The system of claim 12, wherein the processor module for executing instructions to determine the 3D implant geometry based on the planned geometry of the segment comprises: A size and geometry of a rod is determined, the rod being configured to achieve the planned geometry of the segment of the segmented 3D image.

14. The system of claim 13, wherein the processor module for executing instructions to generate the graphical representation of the determined 3D implant geometry comprises: generating the graphical representation based on a model of the rod, the model of the rod having dimensions based on the segmented 3D image; wherein a size and geometry of the graphical representation based on the model is calibrated to dimensions of the second image data to illustrate a realistic positioning of the planned geometry of the segment of the segmented 3D image.

15. The system of claim 9, wherein the processor module is configured to execute instructions further comprising: An input is received to move the generated graphical representation superimposed on the image.

16. The system of claim 9, wherein the processor module for executing instructions to calibrate the reconstructed second 3D image to the same calibration as the 3D image is calibrated comprises: Equal sizes of a portion of the first image data and a portion of the second image data are determined.

17. A system for planning a procedure, the system comprising: a processor module configured to execute instructions to: accessing first image data of a subject having an initial geometry of a region of interest prior to a procedure; generating planned image data of the subject, the planned image data of the subject having a planned geometry of at least the region of interest after a procedure that differs from the initial geometry; accessing second image data of the subject after the procedure; determining a subsequent geometry of the region of interest; as well as A graphical representation of the determined subsequent geometry is generated.

18. The system of claim 17, further comprising: A display device is configured to display the graphical representation of the determined subsequent geometry, the graphical representation of the determined subsequent geometry comprising at least a representation of the determined subsequent geometry to be viewed by a user.

19. The system of claim 17, wherein the processor module for executing instructions to generate the planned image data of the subject comprises: The planned geometry is determined to include at least an angle between a first vertebra and a second vertebra.

20. The system of claim 17, wherein the processor module executes additional instructions comprising: The determined subsequent geometry of the region of interest is compared with at least the planned geometry of the region of interest.

Images