WO2025109596A1

WO2025109596A1 - Systems and methods for registration using one or more fiducials

Info

Publication number: WO2025109596A1
Application number: PCT/IL2024/051106
Authority: WO
Inventors: Rakefet Rozen
Original assignee: Mazor Robotics Ltd
Current assignee: Mazor Robotics Ltd
Priority date: 2023-11-22
Filing date: 2024-11-21
Publication date: 2025-05-30
Anticipated expiration: 2026-05-22

Abstract

Systems and methods for registration using one or more fiducials are provided. First image data depicting a fiducial and at least a portion of an anatomical element may be received and a registration process based on the fiducial may be performed. Second image data depicting the fiducial and at least the portion of the anatomical element may be received. Movement of the anatomical element that exceeds a threshold distance may be determined based on the fiducial and the registration of the anatomical element may be updated in response to determining the movement exceeds the threshold distance.

Description

SYSTEMS AND METHODS FOR REGISTRATION USING ONE OR MORE FIDUCIALS

BACKGROUND

[0001] The present disclosure is generally directed to registration, and relates more particularly to registration using one or more fiducials.

[0002] Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure, or may complete one or more surgical procedures autonomously. Imaging may be used by a medical provider for diagnostic and/or therapeutic purposes. Patient anatomy can change over time, particularly following placement of a medical implant in the patient anatomy.

BRIEF SUMMARY

[0003] Example aspects of the present disclosure include:

[0004] A system according to at least one embodiment of the present disclosure comprises an imaging device operable to obtain image data; a fiducial that is biocompatible and visible in the image data, wherein the fiducial is implanted in a patient near an anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive first image data depicting the fiducial and at least a portion of the patient; perform, based on the fiducial, a registration process; receive second image data depicting the fiducial and at least the portion of the anatomical element; determine, based on the fiducial, whether movement of the anatomical element exceeds a threshold distance; and update, based on the fiducial, the registration of the anatomical element with a navigation system in response to determining the movement exceeds the threshold distance.

[0005] Any of the aspects herein, wherein the fiducial comprises at least one of a liquid or a gel. [0006] Any of the aspects herein, wherein the imaging device comprises an ultrasound imaging device.

[0007] Any of the aspects herein, wherein the fiducial comprises at least three fiducials.

[0008] Any of the aspects herein, further comprising a robotic arm configured to position and orient the fiducial near the anatomical element.

[0009] Any of the aspects herein, wherein the anatomical element comprises one or more vertebrae.

[0010] Any of the aspects herein, wherein the fiducial is permanently implanted in the patient. [0011] Any of the aspects herein, wherein the imaging device comprises a first imaging device using ionizing radiation and a second imaging device using non-ionizing radiation, and wherein the first image data is received from the first imaging device and the second image data is received from the second imaging device.

[0012] Any of the aspects herein, wherein the imaging device uses non-ionizing radiation, and wherein the first image data and the second image data are received from the imaging device.

[0013] Any of the aspects herein, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: receive third image data depicting the fiducial and at least the portion of the anatomical element; determine, based on the fiducial, whether movement of the anatomical element exceeds the threshold distance; and update, based on the fiducial, the registration of the anatomical element with the navigation system in response to determining the movement exceeds the threshold distance.

[0014] Any of the aspects herein, wherein the third image data is received from the second imaging device.

[0015] Any of the aspects herein, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: determine, using image processing, a pose of the fiducial, wherein the registration is based on the pose of the fiducial.

[0016] A system according to at least one embodiment of the present disclosure comprises an imaging device operable to obtain image data, wherein the imaging device uses non-ionizing radiation; a fiducial that is biocompatible and visible in the image data, wherein the fiducial is implanted in a patient near a target anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive first image data depicting the fiducial and at least a portion of the target anatomical element; determine, using image processing, a pose of the fiducial; perform, based on the pose of the fiducial, a registration process; receive second image data depicting the fiducial and at least the portion of the target anatomical element; determine, based on the fiducial, whether movement of the target anatomical element exceeds a threshold distance; and update, based on the fiducial, the registration of the target anatomical element with a navigation system in response to determining the movement exceeds the threshold distance. [0017] Any of the aspects herein, wherein the fiducial is permanently implanted in the patient. [0018] Any of the aspects herein, wherein the fiducial comprises at least one of a liquid or a gel. [0019] Any of the aspects herein, wherein the imaging device comprises an ultrasound imaging device.

[0020] A method according to at least one embodiment of the present disclosure receiving, from an imaging device, first image data depicting a fiducial and at least a portion of a target anatomical element, the fiducial implanted near the target anatomical element; determining, using image processing, a pose of the fiducial; performing, based on the pose of the fiducial, a registration process; receiving second image data depicting the fiducial and at least the portion of the target anatomical element; determining, based on the fiducial, whether movement of the target anatomical element exceeds a threshold distance; and updating, based on the fiducial, the registration of the target anatomical element with a navigation system in response to determining the movement exceeds the threshold distance.

[0021] Any of the aspects herein, further comprising: receiving third image data depicting the fiducial and at least the portion of the target anatomical element; determining, based on the fiducial, whether movement of the anatomical element exceeds the threshold distance; and updating, based on the fiducial, the registration of the anatomical element with the navigation system in response to determining the movement exceeds the threshold distance.

[0022] Any of the aspects herein, wherein the fiducial comprises at least one of a liquid or a gel. [0023] Any of the aspects herein, wherein the imaging device comprises an ultrasound imaging device.

[0024] Any aspect in combination with any one or more other aspects.

[0025] Any one or more of the features disclosed herein.

[0026] Any one or more of the features as substantially disclosed herein.

[0027] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0028] Any one of the aspects/features/embodiments in combination with any one or more other aspects/features/embodiments .

[0029] Use of any one or more of the aspects or features as disclosed herein. [0030] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0031] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0032] The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl- Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y 1 and Zo).

[0033] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0034] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0035] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [0036] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below. [0037] Fig. 1 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0038] Fig. 2 is a flowchart according to at least one embodiment of the present disclosure; [0039] Fig. 3 is a flowchart according to at least one embodiment of the present disclosure;

[0040] Fig. 4 is a schematic illustration of an anatomical element and one or more reference markers according to at least one embodiment of the present disclosure; and

[0041] Fig. 5 is a flowchart according to at least one embodiment of the present disclosure.

DETAILED DESCRIPTION

[0042] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and/or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and/or a medical device.

[0043] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may 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 store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0044] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), 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 may 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.

[0045] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure. [0046] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0047] In surgical procedures such as robotic surgical procedures or robotic assisted surgical procedures for, for example, a spinal operation, at least one vertebra is initially registered using two X-ray images registered to a three-dimensional (3D) computerized tomography (CT) or magnetic resonance imaging (MRI) scan. During the surgical procedure, the patient may move. These movements result in reregistering the vertebra to account for the movement. Conventionally, the vertebra may be reregistered by obtaining another two X-ray images. Another conventional process is by using a 3D marker drilled into the vertebra and visible to the navigation system. The first option is time-consuming and includes undesirable patient exposure to ionizing radiation. The second conventional process may interfere with the robotic system.

[0048] Thus, according to at least one embodiment of the present disclosure, biocompatible fiducials may be inserted manually by a user or by a robot in a specific location close to the relevant or target anatomical element (e.g., a vertebra). Then by using an ultrasound probe in a small area where the fiducials were placed, a re-registration process can be applied. The re-registration process can be applied for various scenarios including, but not limited to, verification of non-movement of the anatomical element; and/or registration of the anatomical element after movement of the anatomical element.

[0049] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) determining movement of an anatomical element without the use of ionizing radiation, (2) enabling registration or reregistration of an anatomical element using imaging free of ionizing radiation, and (3) increasing patient and surgical team safety by reducing exposure to ionizing radiation.

[0050] Turning first to Fig. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to perform a registration using at least three reference markers 126 implanted in a patient and/or to carry out one or more other aspects of one or more of the methods disclosed herein. The system 100 comprises a computing device 102, one or more imaging devices 112, a robot 114, a navigation system 118, the one or more fiducials 126, a database 130, and/or a cloud or other network 134. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system 100 may not include the imaging device 112, the robot 114, the navigation system 118, one or more components of the computing device 102, the database 130, and/or the cloud 134.

[0051] The computing device 102 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102.

[0052] The processor 104 of the computing device 102 may be any processor described herein or any similar processor. The processor 104 may be configured to execute instructions stored in the memory 106, which instructions may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the imaging device 112, the robot 114, the navigation system 118, the database 130, and/or the cloud 134.

[0053] The memory 106 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer- readable data and/or instructions. The memory 106 may store information or data useful for completing, for example, any step of the method 500 described herein, or of any other methods. The memory 106 may store, for example, instructions and/or machine learning models that support one or more functions of the robot 114. For instance, the memory 106 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 104, enable image processing 120, segmentation 122, and/or registration 124.

[0054] The image processing 120 enables the processor 104 to process image data of an image (received from, for example, the imaging device 112, an imaging device of the navigation system 118, or any imaging device, etc.) for the purpose of, for example, identifying one or more anatomical elements and/or fiducials 126 depicted in the image data. The fiducial 126 may be biocompatible and implanted in the patient near a target anatomical element. The target anatomical element may be, for example, one or more vertebrae though it will be appreciated that the target anatomical element may be any soft tissue and/or hard tissue. The information may comprise, for example, identification of anatomical element(s) and/or the fiducial(s) 126, a boundary between an anatomical element, a boundary of hard tissue and/or soft tissue, etc. The image processing 120 may, for example, identify the anatomical element based on the fiducial(s) 126, and/or a boundary of the anatomical element by determining a difference in or contrast between colors or grayscales of image pixels. For example, a boundary of the anatomical element may be identified as a contrast between lighter pixels and darker pixels. The imaging processing 120 may also use segmentation 122, as described below.

[0055] The segmentation 122 enables the processor 104 to process image data of an image (received from, for example, the imaging device 112, an imaging device of the navigation system 118, or any imaging device) for the purpose of, for example, identifying individual objects and/or anatomical elements in the image data. In some embodiments, the segmentation 122 may be used by the image processing 120. The segmentation 122 may enable the processor 104 to identify a boundary of a fiducial 126 or an anatomical element by using, for example, feature recognition. For example, the segmentation 122 may enable the processor 104 to identify a vertebra in the image data. In other instances, the segmentation 122 may enable the processor 104 to identify a boundary of the fiducial 126 or an anatomical element by determining a difference in or contrast between colors or grayscales of image pixels.

[0056] The fiducial(s) 126 and/or anatomical element(s) identified from the image processing 120 and/or the segmentation 122 may enable the registration 124 to identify a target anatomical element based on the fiducial(s) 126, as will be described in more detail below.

[0057] The registration 124 enables the processor 104 to process the identified fiducial(s) 126 and/or anatomical element(s) obtained from the image processing 120 and/or the segmentation 122 to register the anatomical element(s) depicted in the image data based on the identified fiducial(s) 126 to, for example, a preliminary image of the patient. It will be appreciated that though the image processing 120, the segmentation 122, and the registration 124 are described separately, that the image processing 120 and/or the segmentation 122 may be part of or a step of the registration 124. For example, registering the one or more anatomical elements may comprise using the image processing 120 and/or the segmentation 122 to identify one or more fiducial(s) 126 and/or one or more anatomical element(s) depicted in the image data.

[0058] Such content, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein. Thus, although various contents of memory 106 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models. The data, algorithms, and/or instructions may cause the processor 104 to manipulate data stored in the memory 106 and/or received from or via the imaging device 112, the robot 114, the database 130, and/or the cloud 134.

[0059] The computing device 102 may also comprise a communication interface 108. The communication interface 108 may be used for receiving image data or other information from an external source (such as the imaging device 112, the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the imaging device 112, the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100). The communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 108 may be useful for enabling the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0060] The computing device 102 may also comprise one or more user interfaces 110. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104 or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 110 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.

[0061] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computer device 102.

[0062] The imaging device 112 may be operable to image the fiducial(s) 126, anatomical feature(s) (e.g., a bone, veins, tissue, etc.), and/or other aspects of patient anatomy to yield image data (e.g., image data depicting or corresponding to a bone, veins, tissue, etc.). “Image data” as used herein refers to the data generated or captured by an imaging device 112, including in a machine-readable form, a graphical/visual form, and in any other form. In various examples, the image data may comprise data corresponding to the fiducial(s) 126, an anatomical feature of a patient, or to a portion thereof. The image data may be or comprise a preoperative image, an intraoperative image, a postoperative image, or an image taken independently of any surgical procedure. In some embodiments, a first imaging device 112 may be used to obtain first image data (e.g., a first image) at a first time, and a second imaging device 112 may be used to obtain second image data (e.g., a second image) at a second time after the first time. In such embodiments, the first imaging device may use ionizing radiation (e.g., X-ray scans) and the second imaging device may be free of ionizing radiation (e.g., ultrasound scans). In other embodiments, the imaging device 112 may obtain the first image data and the second image data.

[0063] The imaging device 112 may be capable of taking a 2D image or a 3D image to yield the image data. The imaging device 112 may be or comprise, for example, an ultrasound scanner (which may comprise, for example, a physically separate transducer and receiver, or a single ultrasound transceiver), an 0-arm, a C-arm, a G-arm, or any other device utilizing X-ray-based imaging (e.g., a fluoroscope, a CT scanner, or other X-ray machine), a magnetic resonance imaging (MRI) scanner, an optical coherence tomography (OCT) scanner, an endoscope, a microscope, an optical camera, a thermographic camera (e.g., an infrared camera), a radar system (which may comprise, for example, a transmitter, a receiver, a processor, and one or more antennae), or any other imaging device 112 suitable for obtaining images of an anatomical feature of a patient. The imaging device 112 may be contained entirely within a single housing, or may comprise a transmitter/emitter and a receiver/detector that are in separate housings or are otherwise physically separated. [0064] In some embodiments, the imaging device 112 may comprise more than one imaging device 112. For example, a first imaging device may provide first image data and/or a first image, and a second imaging device may provide second image data and/or a second image. In still other embodiments, the same imaging device may be used to provide both the first image data and the second image data, and/or any other image data described herein. The imaging device 112 may be operable to generate a stream of image data. For example, the imaging device 112 may be configured to operate with an open shutter, or with a shutter that continuously alternates between open and shut so as to capture successive images. For purposes of the present disclosure, unless specified otherwise, image data may be considered to be continuous and/or provided as an image data stream if the image data represents two or more frames per second.

[0065] The robot 114 may be any surgical robot or surgical robotic system. The robot 114 may be or comprise, for example, the Mazor X™ Stealth Edition robotic guidance system. The robot 114 may be configured to position the imaging device 112 at one or more precise position(s) and orientation(s), and/or to return the imaging device 112 to the same position(s) and orientation(s) at a later point in time. The robot 114 may additionally or alternatively be configured to manipulate a surgical tool (whether based on guidance from the navigation system 118 or not) to accomplish or to assist with a surgical task. The robot 114 may also be configured to position and/or insert one or more fiducial(s) 126 into the patient and near a target anatomical element. In some embodiments, the robot 114 may be configured to hold and/or manipulate an anatomical element during or in connection with a surgical procedure. The robot 114 may comprise one or more robotic arms 116. In some embodiments, the robotic arm 116 may comprise a first robotic arm and a second robotic arm, though the robot 114 may comprise more than two robotic arms. In some embodiments, one or more of the robotic arms 116 may be used to hold and/or maneuver the imaging device 112. In embodiments where the imaging device 112 comprises two or more physically separate components (e.g., a transmitter and receiver), one robotic arm 116 may hold one such component, and another robotic arm 116 may hold another such component. Each robotic arm 116 may be positionable independently of the other robotic arm. The robotic arms 116 may be controlled in a single, shared coordinate space, or in separate coordinate spaces.

[0066] The robot 114, together with the robotic arm 116, may have, for example, one, two, three, four, five, six, seven, or more degrees of freedom. Further, the robotic arm 116 may be positioned or positionable in any pose, plane, and/or focal point. The pose includes a position and an orientation. As a result, an imaging device 112, surgical tool, or other object held by the robot 114 (or, more specifically, by the robotic arm 116) may be precisely positionable in one or more needed and specific positions and orientations.

[0067] The robotic arm(s) 116 may comprise one or more sensors that enable the processor 104 (or a processor of the robot 114) to determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm).

[0068] In some embodiments, reference markers (e.g., navigation markers) may be placed on the robot 114 (including, e.g., on the robotic arm 116), the imaging device 112, or any other object in the surgical space. The reference markers may be tracked by the navigation system 118, and the results of the tracking may be used by the robot 114 and/or by an operator of the system 100 or any component thereof. In some embodiments, the navigation system 118 can be used to track other components of the system (e.g., imaging device 112) and the system can operate without the use of the robot 114 (e.g., with the surgeon manually manipulating the imaging device 112 and/or one or more surgical tools, based on information and/or instructions generated by the navigation system 118, for example).

[0069] The navigation system 118 may provide navigation for a surgeon and/or a surgical robot during an operation. The navigation system 118 may be any now-known or future-developed navigation system, including, for example, the Medtronic StealthStation™ S8 surgical navigation system or any successor thereof. The navigation system 118 may include one or more cameras or other sensor(s) for tracking one or more reference markers, navigated trackers, or other objects within the operating room or other room in which some or all of the system 100 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system 118 may comprise one or more electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track a position and orientation (e.g., a pose) of the imaging device 112, the robot 114 and/or robotic arm 116, and/or one or more surgical tools (or, more particularly, to track a pose of a navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing). The navigation system 118 may include a display for displaying one or more images from an external source (e.g., the computing device 102, imaging device 112, or other source) or for displaying an image and/or video stream from the one or more cameras or other sensors of the navigation system 118. In some embodiments, the system 100 can operate without the use of the navigation system 118. The navigation system 118 may be configured to provide guidance to a surgeon or other user of the system 100 or a component thereof, to the robot 114, or to any other element of the system 100 regarding, for example, a pose of one or more anatomical elements, whether or not a tool is in the proper trajectory, and/or how to move a tool into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan.

[0070] The fiducial(s) 126 may be implanted in a patient near a target anatomical element to enable or aid in registration of the target anatomical element. The fiducial(s) 126 may be biocompatible such that the fiducial(s) 126 can be inserted permanently or temporarily into the patient. The fiducial(s) 126 are visible in image data from any imaging device 112 such as, for example, ultrasound imaging devices, X-ray imaging devices, etc. The fiducial(s) 126 may be, for example, a liquid or a gel, though it will be appreciated that in other embodiments the fiducial(s) 126 may be a solid material. The fiducial(s) 126 can be used in a registration processing using, for example the registration 124.

[0071] The fiducial(s) 126 may be used to identify the target anatomical element in instances where identification of the target anatomical element may be difficult in the image data. For example, a vertebra may be difficult to identify in ultrasound imaging, whereas the fiducial(s) 126 may be easily identified in the ultrasound imaging. Further, at least three fiducial(s) 126 may be implanted near the target anatomical element such that the at least three fiducial(s) 126 form a unique pattern and can aid in identification of the target anatomical element and identification of an orientation and/or position of the target anatomical element.

[0072] The fiducial(s) 126 may also be used to detect movement of the target anatomical element using imaging that is, for example, free of ionizing radiation. For example, first image data obtained from, for example, an ultrasound probe, depicting the fiducial(s) and at least a portion of the target anatomical element may be compared to second image data depicting the fiducial(s) and at least a portion of the target anatomical element and taken after the first image data. A difference in the first image data and the second image data (and in particular, a difference in a pose of the fiducial(s) 126 in the first image data compared to the second image data) may suggest that the target anatomical element has moved. In such instances, the registration may be updated to account for the movement of the target anatomical element. The process may be repeated as needed throughout a surgical procedure. For example, third image data may be obtained and compared to the second image data to determine if movement of the anatomical element has occurred. [0073] The database 130 may store information that correlates one coordinate system to another (e.g., one or more robotic coordinate systems to a patient coordinate system and/or to a navigation coordinate system). The database 130 may additionally or alternatively store, for example, one or more surgical plans (including, for example, pose information about a target and/or image information about a patient’s anatomy at and/or proximate the surgical site, for use by the robot 114, the navigation system 118, and/or a user of the computing device 102 or of the system 100); one or more images useful in connection with a surgery to be completed by or with the assistance of one or more other components of the system 100; and/or any other useful information. The database 130 may be configured to provide any such information to the computing device 102 or to any other device of the system 100 or external to the system 100, whether directly or via the cloud 134. In some embodiments, the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and/or another system for collecting, storing, managing, and/or transmitting electronic medical records including image data.

[0074] The cloud 134 may be or represent the Internet or any other wide area network. The computing device 102 may be connected to the cloud 134 via the communication interface 108, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 may communicate with the database 130 and/or an external device (e.g., a computing device) via the cloud 134.

[0075] The system 100 or similar systems may be used, for example, to carry out one or more aspects of any of the method 500 described herein. The system 100 or similar systems may also be used for other purposes.

[0076] Turning to Fig. 2, an example of a model architecture 200 that supports methods and systems (e.g., Artificial Intelligence (Al)-based methods and/or system) for processing image data and registering one or more anatomical elements is shown.

[0077] Image data 206 may be used by a processor such as the processor 104 as input for the image processing 120. The image processing 120 may output an identified target anatomical element 210 and/or an identified one or more fiducial(s) 126. In some embodiments, the image data 206 may be received from an imaging device such as the imaging 112, an imaging device of a navigation system such as the navigation system 118, or any other imaging device or component of a system such as the system 100. It will be appreciated that the image data 206 may depict the one or more fiducial(s) 126 and the image processing 120 may process the image data 206 to output pose information of the fiducial(s) 126 (which may then be used, for example, to determine the pose information of the fiducial(s) 126 and/or the associated target anatomical element 210). The pose information may correspond to computer-encoded data that described a pose of the fiducial(s) 126. For example, the pose information, in some embodiments, may comprise coordinates and/or an orientation of the fiducial(s) 126. In other examples, the pose information may comprise, for example, a matrix that describes the pose of the fiducial(s) 126. It will be appreciated that the pose information may be encoded in any number of ways and may include, for example, a description of a location of the fiducial(s) 126 in a reference space, a vector (e.g., a three-element vector), or a matrix.

[0078] As previously described, the image processing 120 may use the segmentation 122 to identify the fiducial(s) 126 and/or anatomical elements 210. The segmentation 122 may be configured to segment the fiducial(s) 126 and/or the anatomical elements 210 from the image data 206 to yield one or more identified anatomical elements 210 and/or identified fiducial(s) 126. Segmenting the fiducial(s) 126 and/or anatomical elements 210 from the image data 206 when the image data comprises a three-dimensional representation of the patient anatomy may comprise identifying a boundary of one or more fiducial(s) 126 and/or anatomical elements 210and forming a separate three-dimensional representation of the one or more fiducial(s) 126 and/or anatomical elements 210. In some embodiments, identifying the boundary may comprise identifying adjacent sets of pixels having a large enough contrast to represent a border of an anatomical element 210 depicted therein. In other embodiments, feature recognition may be used to identify a border of an anatomical element 210 and/or fiducial(s) 126. For example, a contour of a vertebrae may be identified using feature recognition.

[0079] The image processing 120 may be trained using historical image data. In other embodiments, the image processing 120 may be trained using the image data 206. In such embodiments, the image processing 120 may be trained prior to inputting the image data 206 into the image processing 120 or may be trained in parallel with inputting the image data 206 into the image processing 120.

[0080] As previously described, the image processing 120 may output an identified anatomical element 210 and/or identified fiducial(s) 126. The identified anatomical element 210 and/or the fiducial(s) 126 may be used by the processor 104 as input for a registration 124. The registration 124 may output one or more registered anatomical elements 216. The registration 124 may register the anatomical elements based on the fiducial(s) 126 identified in the image data 206. More specifically, in some embodiments, the registration 124 may use the identified fiducial(s) 126 and may use the pose information of the identified fiducial(s) 126 to register the anatomical element 210. The registration model 214 may be configured to register the one or more anatomical elements 210 to, for example, a preoperative image or any image.

[0081] The registration 124may be trained using historical or simulated image data depicting one or more anatomical elements 210 and one or more fiducial(s) 126, historical identified anatomical elements, and/or historical identified fiducial(s). In other embodiments, the registration 124 may be trained using the identified anatomical elements 210 and the fiducial(s) 126. In such embodiments, the registration 124 may be trained prior to inputting the identified anatomical elements 210 and the fiducial(s) 126 into the registration 124 or may be trained in parallel with inputting the identified anatomical elements 210 and the fiducial(s) 126 into the registration 124.

[0082] Fig. 3 depicts a method 300 that may be used, for example, for generating a model is provided.

[0083] The method 300 comprises generating a model (step 304). The model may be the image processing 120, the segmentation 122, and/or the registration 124. A processor such as the processor 104 may generate the model. The model may be generated to facilitate and enable, for example, identification of one or more anatomical elements and/or objects depicted in image data and registration of the one or more anatomical elements.

[0084] The method 300 also comprises training the model (step 308). In embodiments where the model is trained prior to a surgical procedure, the model may be trained using historical data from a number of patients. In some embodiments, the historical data may be obtained from patients that have similar patient data to a patient on which a surgical procedure is to be performed. In other embodiments, the historical data may be obtained from any patient.

[0085] In other embodiments, the model may be trained in parallel with use of another model. Training in parallel may, in some embodiments, comprise training a model using input received during, for example, or prior to a surgical procedure, while also using a separate model to receive and act upon the same input. Such input may be specific to a patient undergoing the surgical procedure. In some instances, when the model being trained exceeds the model in use (whether in efficiency, accuracy, or otherwise), the model being trained may replace the model in use. Such parallel training may be useful, for example, in situations, where a model is continuously in use (for example, when an input (such as, for example, an image) is continuously updated) and a corresponding model may be trained in parallel for further improvements.

[0086] In some embodiments, it will be appreciated that the model trained using historical data may be initially used as a primary model at a start of a surgical procedure. A training model may also be trained in parallel with the primary model using patient-specific input until the training model is sufficiently trained. The primary model may then be replaced by the training model.

[0087] The method 300 also comprises storing the model (step 312). The model may be stored in memory such as the memory 106 and/or a database such as the database 130 for later use. In some embodiments, the model is stored in the memory when the model is sufficiently trained. The model may be sufficiently trained when the model produces an output that meets a predetermined threshold, which may be determined by, for example, a user, or may be automatically determined by a processor such as the processor 104.

[0088] The present disclosure encompasses embodiments of the method 300 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.

[0089] Turning to Fig. 4, a schematic illustration of a view of an example target anatomical element 210 with one or more fiducials 126 is illustrated. As previously described, the fiducial(s) 126 may be implanted in a patient near the target anatomical element 210 to enable or aid in registration of the target anatomical element 210. As shown, three fiducials 126 are implanted in the patient and near the target anatomical element 210. It will be appreciated that the fiducials 126 may include on fiducial, two fiducial, or more than two fiducials 126. The fiducial(s) 126 are visible in image data from any imaging device 112 such as, for example, ultrasound imaging devices, X- ray imaging devices, etc. The fiducial(s) 126 may be used to identify the target anatomical element 210 in instances where identification of the target anatomical element 210 may be difficult in the imaging. For example, a vertebra may be difficult to identify in ultrasound imaging, whereas the fiducial(s) 126 may be easily identified in the ultrasound imaging.

[0090] As also previously described, the fiducial(s) 126 may also be used to detect movement of the target anatomical element 210. For example, first image data depicting the fiducial(s) 126 and at least a portion of the target anatomical element 210 may be compared to second image data depicting the fiducial(s) 126 and at least a portion of the target anatomical element 210 and taken after the first image data. A difference in the first image data and the second image data (and in particular, a difference in a pose of the fiducial(s) 126 in the first image data compared to the second image data) may suggest that the target anatomical element 210 has moved. In such instances, the registration may be updated to account for the movement of the target anatomical element.

[0091] Fig. 5 depicts a method 500 that may be used, for example, for a registration process using one or more fiducials such as the one or more fiducials 126 to identify a corresponding target anatomical element such as the target anatomical element 210.

[0092] The method 500 (and/or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 described above. The at least one processor may be part of a robot (such as a robot 114) or part of a navigation system (such as a navigation system 118). A processor other than any processor described herein may also be used to execute the method 500. The at least one processor may perform the method 500 by executing elements stored in a memory such as the memory 106. The elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 500. One or more portions of a method 500 may be performed by the processor executing any of the contents of memory, such as an image processing 120, a segmentation 122, and/or a registration 124.

[0093] The method 500 comprises receiving first image data (step 504). The first image data may be received or obtained from an imaging device such as the imaging device 112, which may be any imaging device such as an MRI scanner, a CT scanner, any other X-ray based imaging device, or an ultrasound imaging device. In other embodiments, the first image data may be received via a user interface such as the user interface 110, a database such as the database 130, and/or a communication interface such as the communication interface 108 of a computing device such as the computing device 102, and may be stored in a memory such as the memory 106 of the computing device. The first image data may also be received from an external database or image repository (e.g., a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and/or another system for collecting, storing, managing, and/or transmitting electronic medical records including image data), and/or via the Internet or another network. In some embodiments, the first image data may be indirectly received via any other component of the system or a node of a network to which the system is connected.

[0094] The first image data may be a two-dimensional image or a three-dimensional image (e.g., a three-dimensional representation) or a set of two-dimensional and/or three-dimensional images. The first image data may depict one or more fiducials such as the one or more fiducials 126 and at least a portion of a target anatomical element such as the target anatomical element 210. In some embodiments, the first image data may be captured preoperatively (e.g., before surgery) and may be stored in a system (e.g., a system 100) and/or one or more components thereof (e.g., a database 130). The stored image may then be received (e.g., by a processor 104), as described above, preoperatively (e.g., before the surgery) and/or intraoperatively (e.g., during surgery). In other embodiments, the first image data may be obtained during or prior to a surgical procedure. For example, the first image data may be used to establish an initial position of the fiducial(s) and the target anatomical element.

[0095] In some embodiments, the first image data may be obtained using an imaging device free of ionizing radiation such as, for example, an ultrasound probe. The fiducials may aid in registration of the anatomical elements as depicted in the ultrasound imaging as the fiducials may be clearly visible in the ultrasound imaging, whereas the anatomical elements may be difficult to identify in the ultrasound imaging. This beneficially reduces patient and surgical team exposure to ionizing radiation, thereby increasing the safety of the patient and the surgical team.

[0096] The method 500 also comprises determining a pose of the fiducial (step 508). As previously described, the fiducial(s) may be implanted in a patient near the target anatomical element to enable or aid in registration of the target anatomical element. The fiducial(s) 126 may be used to identify the target anatomical element in instances where identification of the target anatomical element may be difficult in the imaging. The fiducial(s) may also be used to detect movement of the target anatomical element. Pose information of the fiducial(s) may be obtained from processing the first image data depicting the fiducial(s) and at least a portion of the target anatomical element by a processor such as the processor 104 (or a processor of the navigation system) using image processing such as the image processing 120. In some embodiments, pose information of the target anatomical element may also be determined using, for example, the image processing. [0097] The method 500 also comprises performing a registration process (step 512). The registration may be the same as or similar to the registration 124. As previously described, the first image data may depict the fiducial(s) and the target anatomical element. The fiducial(s) and/or the target anatomical element as identified in the first image data enables the processor 104 to register the target anatomical element(s) depicted in the first image data based on the identified fiducial(s) using the registration. More specifically, the registration may transform, map, or create a correlation between the first image data and/or components thereof and an initial or preliminary image data, which may then be used by a system (e.g., a system 100) and/or one or more components thereof (e.g., a navigation system 118) to translate one or more coordinates in the patient coordinate space to one or more coordinates in a coordinate space of a robot (e.g., a robot 114) and/or vice versa. It will be appreciated that the registration may comprise registering between a 3D image (e.g., a CT scan) and one or more 2D images (e.g., fluoroscopy images) and/or vice versa, and/or between a 2D image and another 2D image and/or vice versa.

[0098] The method 500 also comprises receiving from the registration, a registered anatomical element (step 524). The registered anatomical element may be the same as or similar to the registered anatomical element 216. The registered anatomical element may be registered or correlated to, for example, the patient coordinate space and/or the robotic coordinate space. The registered anatomical element(s) may enable the navigation system to provide navigation during a surgical procedure.

[0099] The method 500 also comprises receive second image data (step 516). The step 516 may be the same as or similar to the step 504 described above. The second image data may depict the fiducial(s) and at least a portion of the target anatomical element. In some embodiments, the second image data is obtained at a time period after the first image data. For example, the first image data may be obtained near a beginning or a start of a surgical operation and the second image data may be obtained during the surgical operation.

[0100] The method 500 also comprises determining whether movement of an anatomical element exceeds a threshold distance (step 520). Determining whether movement of the anatomical element exceeds a threshold distance includes determining a distance difference between the fiducial(s) and/or the target anatomical element in the first image data and the second image dat. The distance difference can then be compared to the threshold distance. The distance difference can be determined automatically by, for example, the processor. In some embodiments the distance difference may be determined by a user such as, for example, a surgeon or other medical provider. Similarly, the threshold distance may be determined automatically by the processor or may be received as user input via, for example, the user interface.

[0101] The method 500 also comprises updating the registration (step 524). The registration may be updated when the movement of the anatomical element exceeds the threshold distance as determined in the step 520. The step 524 may be the same as or similar to the step 512 except that the second image data is received as input to the registration. Alternatively or additionally, the distance difference as determined in the step 520 may be received as input (whether with the second image data or without the second image data) to the registration.

[0102] The method 500 also comprises receiving third image data (step 528). The step 528 may be the same as or similar to the step 504 described above. The third image data may depict the fiducial(s) and at least a portion of the target anatomical element. In some embodiments, the third image data is obtained at a time period after the first image data and the second image data. For example, the first image data may be obtained near a beginning or a start of a surgical operation, the second image data may be obtained prior to a first surgical step, and the third image data may be obtained prior to a second surgical step. It will be appreciated that the first image data, the second image data, and the third image data may be taken at any time.

[0103] The method 500 also comprises determine whether movement of an anatomical element exceeds a threshold distance (step 532). The step 532 may be the same as or similar to the step 520 described above.

[0104] The method 500 also comprises updating the registration (step 536). The step 536 may be the same as or similar to the step 524 described above.

[0105] It will be appreciated that the method 500 may not include some of the steps above or may execute the steps in any order. For example, in some embodiments, the method 500 may not include the steps 528, 532, and 536. In other words, in some embodiments, the registration may be updated once during a surgical procedure based on movement detected in the first image data and the second image data. In still other embodiments, the method 500 may not include the steps 524, 528, 532, 536. In other words, no movement may be determined and thus, the registration may not be updated. [0106] The present disclosure encompasses embodiments of the method 500 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.

[0107] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 5 (and the corresponding description of the method 500), as well as methods that include additional steps beyond those identified in Fig. 5 (and the corresponding description of the method 500). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation. [0108] The following provides examples and alternatives disclosed herein.

[0109] Example 1. A system comprising: an imaging device operable to obtain image data; at least one fiducial that is biocompatible and visible in the image data, wherein the at least one fiducial is implanted in a patient near an anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive first image data depicting the at least one fiducial and at least a portion of an anatomical element; perform, based on the at least one fiducial, a registration process; receive second image data depicting the at least one fiducial and at least the portion of the anatomical element; determine, based on the at least one fiducial, whether movement of the anatomical element exceeds a threshold distance; and update, based on the at least one fiducial, the registration of the anatomical element with a navigation system in response to determining the movement exceeds the threshold distance. [0110] Example 2. The system of example 1, wherein the at least one fiducial comprises at least one of a liquid or a gel.

[0111] Example 3. The system of example 1 or 2, wherein the imaging device comprises an ultrasound imaging device.

[0112] Example 4. The system of any one of examples 1-3, wherein the at least one fiducial comprises at least three fiducials.

[0113] Example 5. The system of any one of examples 1-4, further comprising a robotic arm configured to position and orient the at least one fiducial near the anatomical element.

[0114] Example 6. The system of any one of examples 1-5, wherein the anatomical element comprises one or more vertebrae. [0115] Example 7. The system of any one of examples 1-6, wherein the at least one fiducial is permanently implanted in the patient.

[0116] Example 8. The system of any one of examples 1-7, wherein the imaging device comprises a first imaging device using ionizing radiation and a second imaging device using nonionizing radiation, and wherein the first image data is received from the first imaging device and the second image data is received from the second imaging device.

[0117] Example 9. The system of example 8, wherein the imaging device uses non-ionizing radiation, and wherein the first image data and the second image data are received from the imaging device.

[0118] Example 10. The system of example 9, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: receive third image data depicting the at least one fiducial and at least the portion of the anatomical element; determine, based on the at least one fiducial, whether movement of the anatomical element exceeds the threshold distance; and update, based on the at least one fiducial, the registration of the anatomical element with the navigation system in response to determining the movement exceeds the threshold distance.

[0119] Example 11. The system of example 10, wherein the third image data is received from the second imaging device.

[0120] Example 12. The system of any one of examples 1-11, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: determine, using image processing, a pose of the at least one fiducial, wherein the registration is based on the pose of the at least one fiducial.

[0121] Example 13. A system comprising: an imaging device operable to obtain image data, wherein the imaging device uses non-ionizing radiation; at least one fiducial that is biocompatible and visible in the image data, wherein the at least one fiducial is implanted in a patient near a target anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive first image data depicting the at least one fiducial and at least a portion of the target anatomical element; determine, using image processing, a pose of the at least one fiducial; perform, based on the pose of the at least one fiducial, a registration process; receive second image data depicting the at least one fiducial and at least the portion of the target anatomical element; determine, based on the at least one fiducial, whether movement of the target anatomical element exceeds a threshold distance; and update, based on the at least one fiducial, the registration of the target anatomical element with a navigation system in response to determining the movement exceeds the threshold distance.

[0122] Example 14. The system of example 13, wherein the at least one fiducial is permanently implanted in the patient.

[0123] Example 15. The system of example 13 or 14, wherein the at least one fiducial comprises at least one of a liquid or a gel.

[0124] Example 16. The system of any one of examples 13-15, wherein the imaging device comprises an ultrasound imaging device.

[0125] Example 17. A method comprising: receiving, from an imaging device, first image data depicting at least one fiducial and at least a portion of a target anatomical element, the at least one fiducial implanted near the target anatomical element; determining, using image processing, a pose of the at least one fiducial; performing, based on the pose of the at least one fiducial, a registration process; receiving second image data depicting the at least one fiducial and at least the portion of the target anatomical element; determining, based on the at least one fiducial, whether movement of the target anatomical element exceeds a threshold distance; and updating, based on the at least one fiducial, the registration of the target anatomical element with a navigation system in response to determining the movement exceeds the threshold distance.

[0126] Example 18. The method of example 17, further comprising: receiving third image data depicting the at least one fiducial and at least the portion of the target anatomical element; determining, based on the at least one fiducial, whether movement of the anatomical element exceeds the threshold distance; and updating, based on the at least one fiducial, the registration of the anatomical element with the navigation system in response to determining the movement exceeds the threshold distance.

[0127] Example 19. The method of example 17 or 18, wherein the at least one fiducial comprises at least one of a liquid or a gel.

[0128] Example 20. The method of any one of examples 17-19, wherein the imaging device comprises an ultrasound imaging device.

[0129] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0130] Moreover, though the foregoing has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

CLAIMS What is claimed is:

1. A system comprising: an imaging device (112) operable to obtain image data (206); at least one fiducial (126) that is biocompatible and visible in the image data, wherein the at least one fiducial is implanted in a patient near an anatomical element (210); a processor (104); and a memory (106) storing data for processing by the processor, the data, when processed, causes the processor to: receive first image data depicting the at least one fiducial and at least a portion of the anatomical element; perform, based on the at least one fiducial, a registration process (124); receive second image data depicting the at least one fiducial and at least the portion of the anatomical element; determine, based on the at least one fiducial, whether movement of the anatomical element exceeds a threshold distance; and update, based on the at least one fiducial, the registration of the anatomical element with a navigation system in response to determining the movement exceeds the threshold distance.

2. The system of claim 1, wherein the at least one fiducial comprises at least one of a liquid or a gel.

3. The system of claims 1 or 2, wherein the imaging device comprises an ultrasound imaging device.

4. The system of any one of the preceding claims, wherein the at least one fiducial comprises at least three fiducials.

5. The system of any one of the preceding claims, further comprising a robotic arm (116) configured to position and orient the at least one fiducial near the anatomical element.

6. The system of any one of the preceding claims, wherein the anatomical element comprises one or more vertebrae.

7. The system of any one of the preceding claims, wherein the at least one fiducial is permanently implanted in the patient.

8. The system of any one of the preceding claims, wherein the imaging device comprises a first imaging device using ionizing radiation and a second imaging device using non-ionizing radiation, and wherein the first image data is received from the first imaging device and the second image data is received from the second imaging device.

9. The system of claim 8, wherein the imaging device uses non-ionizing radiation, and wherein the first image data and the second image data are received from the imaging device.

10. The system of claim 9, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: receive third image data depicting the at least one fiducial and at least the portion of the anatomical element; determine, based on the at least one fiducial, whether movement of the anatomical element exceeds the threshold distance; and update, based on the at least one fiducial, the registration of the anatomical element with the navigation system in response to determining the movement exceeds the threshold distance.

11. The system of claim 10, wherein the third image data is received from the second imaging device.

12. The system of any one of the preceding claims, wherein the memory stores additional instructions for execution by the at least one processor that, when executed, further cause the at least one processor to: determine, using image processing, a pose of the at least one fiducial, wherein the registration is based on the pose of the at least one fiducial.

13. A method comprising: receiving, from an imaging device (112), first image data depicting at least one fiducial (126) and at least a portion of a target anatomical element (210), the at least one fiducial implanted near the target anatomical element; determining, using image processing, a pose of the at least one fiducial; performing, based on the pose of the at least one fiducial, a registration process (124); receiving second image data depicting the at least one fiducial and at least the portion of the target anatomical element; determining, based on the at least one fiducial, whether movement of the target anatomical element exceeds a threshold distance; and updating, based on the at least one fiducial, the registration of the target anatomical element with a navigation system in response to determining the movement exceeds the threshold distance.

14. The method of claim 13, further comprising: receiving third image data depicting the at least one fiducial and at least the portion of the target anatomical element; determining, based on the at least one fiducial, whether movement of the anatomical element exceeds the threshold distance; and updating, based on the at least one fiducial, the registration of the anatomical element with the navigation system in response to determining the movement exceeds the threshold distance.

15. The method of claims 13 or 14, wherein the at least one fiducial comprises at least one of a liquid or a gel.