Methods and systems adding preoperative and real-time annotations in a navigation space

Abstract

Systems and methods for planning a surgical procedure are provided. Information corresponding to an examination of a patient and imaging data corresponding to a portion of an anatomy of the patient may be received. The imaging data may be used to construct a three-dimensional (3D) navigation space. The information corresponding to the examination of the patient may be added as annotations to the 3D navigation space. Additional annotations may be manually or automatically added preoperatively and / or in real-time. The annotations may be displayed as a surgical tool navigates the 3D navigation space during the surgical procedure.

Description

METHODS AND SYSTEMS ADDING PREOPERATIVE AND REAL-TIME ANNOTATIONS IN A NAVIGATION SPACEFIELD

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 617,355, filed 3 January 2024, the entire content of which is incorporated herein by reference.

[0002] The present technology generally relates to planning surgical procedures and relates more particularly to adding preoperative and real-time annotations to a three-dimensional (3D) navigation space used in surgical procedures.BACKGROUND

[0003] Planning one or more surgical steps for a surgical plan is based on several factors and inputs. Surgeons may identify one or more surgical procedures to perform to alleviate patient pain and / or discomfort. Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure or may complete a portion of or the entire surgical procedure autonomously or semi-autonomously.SUMMARY

[0004] This disclosure relates to methods and systems to plan and navigate medical devices into anatomical positions to complete diagnostic and / or therapeutic procedures.

[0005] Example aspects of the present disclosure include:

[0006] A method for planning a surgical procedure according to at least one embodiment of the present disclosure comprises receiving image data corresponding to a portion of an anatomy of a patient; constructing a three-dimensional (3D) navigation space using the image data; receiving and adding annotation data to the 3D navigation space; and displaying the annotation data as a surgical tool navigates the 3D navigation space.

[0007] Any of the aspects herein, wherein the annotation data comprises preoperative annotations.

[0008] Any of the aspects herein, wherein the annotation data comprises real-time data received from the surgical tool during the surgical procedure.

[0009] Any of the aspects herein, further comprising determining and displaying a location of the surgical tool as it moves through the 3D navigation space; and updating the display of the annotation data based on the location of the surgical tool.

[0010] Any of the aspects herein, wherein display of the annotation data fades based on a physical state of the patient.

[0011] Any of the aspects herein, wherein the physical state of the patient comprises a breath cycle of the patient.

[0012] Any of the aspects herein, wherein the annotation data comprises an amount of energy deployed to a surgical site.

[0013] Any of the aspects herein, wherein the annotation data comprises recording injection of a contrast fluid into the portion of the anatomy.

[0014] Any of the aspects herein, wherein the annotation data comprises at least one target and at least one no-fly zone.

[0015] Any of the aspects herein, further comprising determining and displaying a location of the surgical tool as it moves through the 3D navigation space; and triggering an alert when the location of the surgical tool is less than a threshold distance to a no-fly zone.

[0016] Any of the aspects herein, wherein the image data comprises images in different modalities.

[0017] Any of the aspects herein, wherein constructing the 3D navigation space comprises fusing preoperative images with a real-time image.

[0018] Any of the aspects herein, wherein the annotation data comprises a thermal profile or heat map of the portion of the anatomy.

[0019] Any of the aspects herein, further comprising generating a roadmap of the surgical procedure, wherein the roadmap includes multiple surgical points in a predetermined order; and guiding a user through the multiple surgical points in the predetermined order.

[0020] Any of the aspects herein, wherein the predetermined order starts with a deepest surgical point and ends with a shallowest surgical point.

[0021] Any of the aspects herein, wherein the predetermined order starts with a leftmost surgical point and ends with a rightmost surgical point.

[0022] Any of the aspects herein, further comprising determining and displaying a location of the surgical tool as it moves through the 3D navigation space; and controlling parameters of the surgical tool based on the determined location of the surgical tool.

[0023] Any of the aspects herein, wherein the surgical tool comprises a thermal therapy deployment device.

[0024] Any of the aspects herein, wherein the imaging data comprises at least one three- dimensional image is obtained from a CT scan or an MRI scan.

[0025] Any of the aspects herein, wherein the annotation data comprises information collected during a patient examination.

[0026] A surgical system for planning a surgical procedure according to at least one embodiment of the present disclosure comprises a processor to: construct a three-dimensional (3D) navigation space using image data corresponding to a portion of an anatomy of a patient; and receive and add annotation data to the 3D navigation space; and a screen to display the annotation data as a surgical tool navigates the 3D navigation space.

[0027] A surgical system for performing an ablation according to at least one embodiment of the present disclosure comprises a processor to: construct a three-dimensional (3D) navigation space using image data corresponding to an organ of a patient; and receive and add annotation data to the 3D navigation space; and a user interface to display the annotation data as a surgical tool navigates the 3D navigation space.

[0028] Any of the aspects herein, wherein the user interface comprises an augmented reality (AR) and / or a virtual reality (VR) user interface / display, including a virtual control panel.

[0029] Any of the aspects herein, wherein annotations may be made using voice control.

[0030] Any of the aspects herein, wherein annotations may be displayed in a virtual 3D navigation space.

[0031] Any aspect in combination with any one or more other aspects.

[0032] Any one or more of the features disclosed herein.

[0033] Any one or more of the features as substantially disclosed herein.

[0034] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0035] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments .

[0036] Use of any one or more of the aspects or features as disclosed herein.

[0037] 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.

[0038] 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.

[0039] 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, Yi-Ym, and Zi-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., Yi and Zo).

[0040] 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.

[0041] 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.

[0042] Numerous additional features and advantages of the present invention will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE DRAWINGS

[0043] 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.

[0044] Fig. 1 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0045] Fig. 2 is a flowchart according to at least one embodiment of the present disclosure;

[0046] Figs. 3A-B are flowcharts according to at least one embodiment of the present disclosure;

[0047] Fig. 4 is a flowchart according to at least one embodiment of the present disclosure; and

[0048] Figs. 5A-F are example user interface screenshots according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0049] 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.

[0050] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented insoftware, 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. 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).

[0051] 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.

[0052] 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.

[0053] While planning for a surgical procedure (e.g., liver ablation, cardiac ablation, structural heart, cardiac rhythm, renal denervation, etc.) doctors often use imaging to determine targets and anti-targets in a portion of an anatomy of a patient. During preoperative diagnostics, a patient may have multiple types of imaging done (e.g., magnetic resonance imaging (MRI), a computed tomography (CT) scan, ultrasound, etc.). These different imaging methods may provide the physician with different information regarding the area of interest. Additionally, during a procedure, there may be real-time imaging of the area of interest. The present disclosure dynamically merges preoperative and real-time imaging to construct a 3D navigation space. Additionally, the present disclosure adds annotations to the constructed 3D navigation space. The annotations may be manually added by a physician, and / or automatically added by the surgical navigation system. In other words, the present technology relates to methods and systems of merging preoperative and real-time annotations within a 3D navigation space constructed using multiple imaging modalities.

[0054] Liver ablation is a treatment that destroys liver tumors without removing them. This procedure may be used for patients with a one or more tumors when surgery is not a viable option due to poor health or reduced liver function. Radiofrequency Ablation (RFA) uses high- energy radio waves; a thin probe is inserted into the tumor through the skin, and a high- frequency current heats the tumor, destroying cancer cells. Microwave Ablation (MWA) uses electromagnetic waves to provide the energy to heat and destroy the tumor using a probe. Cryoablation (Cryotherapy) uses a thin metal probe to freeze the tumor, causing cancer cells to die. Ethanol (Alcohol) Ablation or percutaneous ethanol injection (PEI), injects concentrated alcohol directly into the tumor to damage cancer cells. Pulsed field ablation (PF A) uses short electric pulses to induce non-thermal changes in cell physiology to destroy tumor cells. Often, ablation can be done without surgery by inserting a needle or probe into the tumor through the skin, guided by ultrasound or CT scan.

[0055] As discussed above, physicians may perform preoperative planning to guide interoperative decision making. In the case of a liver tumor ablation procedure, preoperative planning may involve identifying ablative targets (e.g., tumors) and anti-targets (e.g., major blood vessels, the diaphragm, major bile ducts, etc.), as well as associated needle placement trajectories for targets and the intended ablative defect volumes / energy dose settings within the CT or MRI 3D navigation space. These planning annotations are 'left behind' in the preoperative patient / imagespace when the actual procedure begins. It would be helpful for physicians to be able to view their planning annotations and add additional annotations in real-time during the actual procedure.

[0056] This disclosure presents methods to carry preoperative planning annotations into the realtime 3D navigation space common to the patient to inform real-time surgical procedure decision making. This disclosure includes methods to modify and add annotations directly into the realtime 3D navigation space, including spatial energy dose annotations, therapy defect annotations, anti-target annotations, implant landing zones, etc. This disclosure also includes methods to track the patient position during both annotation registration into the 3D navigation space and continuously during the procedure to inform the user on when the two are aligned. This disclosure also proposes algorithms that guide procedural workflow informed by planning annotations and user preference settings.

[0057] Embodiments of the present disclosure use a combination of image processing and artificial intelligence to provide for carrying preoperative planning annotations into the real-time 3D navigation space common to the patient to inform real-time surgical procedure decision making. Embodiments of the present disclosure include methods to modify and add annotations directly into the real-time 3D navigation space. Embodiments of the present disclosure also include algorithms that guide procedural workflow informed by planning annotations, patient physical state (e.g., breath cycle, position, heart cycle, etc.), and user preference settings.

[0058] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) merging multiple imaging modalities, (2) allow users to view their preoperative planning annotations within a real-time patient space, (3) manually and automatically adding annotation within the real-time patient space, (4) improving the accuracy of surgical procedures; and / or (5) improving patient safety.

[0059] 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 plan a surgical procedure and / or carry out one or more other aspects of one or more of the methods disclosed herein.

[0060] The system 100 comprises a computing device 102, a surgical tool 111, a catheter tool I l la, one or more imaging devices 112, a robot 114, a navigation system 118, a database 130, and / or a cloud 134 or other network. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system100 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.

[0061] 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.

[0062] 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 surgical tool 111, imaging device 112, the robot 114, the navigation system 118, the database 130, and / or the cloud 134.

[0063] 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 methods 200, 300, and / or 400 described herein, or of any other methods. The memory 106 may store, for example, one or more image processing algorithms 120, one or more segmentation algorithms 122, one or more identification algorithms 124, and / or one or more annotation algorithms 126. Such instructions or algorithms may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. The algorithms and / or instructions may cause the processor 104 to manipulate data stored in the memory 106 and / or received from or via the user interface 110, the surgical tool 111, the imaging device 112, the robot 114, the database 130, and / or the cloud 134.

[0064] 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 a physician, the surgical tool 111, 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 surgical tool 111, 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 receiveinformation 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.

[0065] 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.

[0066] 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.

[0067] The imaging device 112 may be operable to image 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 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.

[0068] 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. The imaging device 112 may be capable of taking a 2D image, a 3D image, or a 4D image (X, Y, Z, and time) 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, a thermographic camera (e.g., an infrared camera), an optical 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.

[0069] 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. In embodiments, the first and second image data (e.g., the imaging data) may be fused or merged to construct a 3D navigation space. In embodiments, a plurality of images in different modalities may be fused.

[0070] 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 orother 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 may comprise one or more electromagnetic field generators and / or electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track a position and orientation (i.e., pose) of the imaging device 112, the robot 114 and / or robotic arm 116, and / or one or more surgical tools 111 (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).

[0071] 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 111 is in the proper trajectory, and / or how to move a tool 111 into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan.

[0072] 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 l l l(whether based on guidance from the navigation system 118 or not) to accomplish or to assist with a surgical task. For example, the surgical tool 111 may be a catheter with controls outside the body manipulated by the robot 114 to in-turn manipulate elements of the catheter inside the body to direct these elements to a specific location where therapy support, or the application of a therapy, is desired based on the annotations or waypoints prescribed by a therapy roadmap. 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.

[0073] 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 may be controlled in a single, shared coordinate space, or in separate coordinate spaces. In some embodiments, one or more of the robotic arms 116 may be used to hold and / or maneuver the surgical tool 111.

[0074] 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 111 (e.g., a catheter), 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.

[0075] 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).

[0076] In some embodiments, reference markers (i.e., navigation markers) may be placed on the robot 114 (including, e.g., on the robotic arm 116), the imaging device 112, the surgical tool 111, 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 or the surgical tool 111) 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 111, based on information and / or instructions generated by the navigation system 118, for example).

[0077] The system 100 or similar systems may be used, for example, to carry out one or more aspects of any of the methods 200, 300a-b, and / or 400 described herein. The system 100 or similar systems may also be used for other purposes.

[0078] In embodiments, the system 100 allows a user to make annotations on preoperative imaging denoting therapeutic targets, port of entry for ablating, device trajectories, creating waypoints to or from targets (e.g., a roadmap), to be registered into real-time 3D navigation space. The system 100 also includes guidance algorithms that orders surgical points (e.g., from deep too shallow, left to right, organ lobe), recommending a port of entry for ablating (based on location of tumor), suggesting which target to move to next (e.g., automatically highlighting the next tumor area to be targeted based on current location of probe), etc. When developing a surgical roadmap, the user and / or the system may consider a route that causes the least impact to patient, shortest travel distance, minimizing puncture, damage to surrounding areas, overlapping areas, vessels to avoid, minimizing image quality degradation from the intervention, minimizing overall damage to patient. When visualizing the surgical roadmap, the system 100 may provide arrows or similar indicia to direct the user to next target in a sequence (e.g., predetermine order of operation). During the procedure, the system 100 may automatically create procedural annotations (e.g., energy dose) in the 3D navigation space according to the location of the surgical tool 111 when a given energy dose occurred, allowing the user to confirm each target (e.g., surgical point) is addressed during the procedure.

[0079] Fig. 2 depicts a method 200 that may be used, for example, for planning a surgical procedure. Although the discussion herein relates to planning a surgical procedure, the present disclosure may also include visualizing and annotating a 3D navigation space in real-time (e.g., during a procedure).

[0080] The method 200 (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 200. The at least one processor may perform the method 200 by executing instructions stored in a memory, such as the memory 106. The instructions may correspond to one or more steps of the method 200 described below. The instructions may cause the processor to execute one or more algorithms, such as an image processing algorithm 120, a segmentation algorithm 122, one or more identification algorithms 124, and / or one or more annotation algorithms 126.

[0081] Step 202 of the method 200 comprises receiving, by the processor, image data corresponding to a portion of an anatomy of a patient. The image data may be received via a user interface such as the user interface 110 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 image 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 other embodiments, the image 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. The image may also be generated by and / or uploaded to any other component of a system such as the system 100. In some embodiments, the image may be indirectly received via any other component of the system or a node of a network to which the system is connected.

[0082] The image may comprise one or more 2D images, one or more 3D images, a 3D model, or a combination of one or more 2D images and one or more 3D images. In some embodiments, one imaging device may be used to obtain the image. In other embodiments, multiple imaging devices may be used to obtain the image. In examples wherein more than one image is received or multiple images are used to construct a 3D image, a first imaging device may obtain a first one of the images independently of a second imaging device obtaining a second one of the images. In another example, at least a first one of the images may be obtained with a first imaging device and at least a second one of the images may be obtained with a second imaging device.

[0083] The image may be processed using an image processing algorithm such as the image processing algorithm 120 to identify one or more features in the image, as will be described below. In some embodiments, feature recognition (using, e.g., an edge detection or other feature recognition algorithm) may be used to identify a feature of an anatomical element, a tool, and / or an instrument. For example, a contour of a vertebra, femur, or other bone may be identified in the image. In other embodiments, segmentation (using, e.g., a segmentation algorithm such as the segmentation algorithm 122) may be used to identify an anatomical element in the image.

[0084] The image may depict patient anatomy such as a spinal region. In some embodiments, the image may be a first image and the step 202 may also include receiving, by the processor, a second image. The first image may comprise detailed soft tissue information (e.g., the first image may be obtained from an MRI scan) and the second image may comprise detailed bony tissue information (e.g., the second image may be obtained from a CT scan). In other words, the image data may comprise a plurality of images of the same or different modalities. In step 204, the processor constructs a 3D navigation space using the image data received in step 202. In embodiments, the plurality of images are fused or merged together to construct the 3D navigation space. The step 204 may also include automatically combining, by the processor, the first image and the second image (and / or image data corresponding to the first image and image data corresponding to the second image). In some embodiments, combining the first image and the second image includes combining detailed soft tissue information and detailed bony tissue information.

[0085] An identification algorithm such as the identification algorithm 124 to identify the pathology location. Training data may be used to train the identification algorithm to identify the pathology location. The training data may include historical data (including, e.g., historical patient examination information, historical patient medical records, historical patient images, and / or any other data from past patients with the same or similar metrics as the patient and / or the same or similar pathologies as the patient, etc.).

[0086] In some instances, more than one possible pathology location may be identified (using, for example, the identification algorithm) in the image(s). In such instances, the information provided from the patient examination (which in some embodiments, may not be image-based) may be used to identify one or more of the possible pathology locations that is causing pain and / or discomfort to a patient. In other words, the information provided from the patient examination may be used to pinpoint the pathology location(s) that may be attributed to pain and / or discomfort of a patient. Thus, unnecessary surgical procedures to correct pathologies that are not affecting the patient may be avoided.

[0087] The pathology location may include information about a pose, a position, or an orientation of the pathology. For example, in some embodiments, the pathology may be an obstruction and the pathology location may specify a pose, a position, or an orientation of the obstruction.

[0088] Step 206 comprises receiving, by the processor, annotation data. Annotation data may comprise preoperative data, such as information corresponding to an examination of a patient and / or medical records. The information may be received via a user interface such as the user interface 110 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 information 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.

[0089] Annotation data may also comprise data generated by (e.g., using artificial intelligence) the computing device 102. Step 208 comprises adding, by the processor, the annotation data to the 3D navigation space. In some embodiments, an algorithm such as the annotation algorithm 126 adds the annotation data to the 3D navigation space. Step 210 comprises displaying, by the user interface, the annotation data. In embodiments, different annotation data is displayed as the surgical tool moves through the 3D navigation space. For example, as the user progresses through the surgical roadmap, annotations related to each target is displayed as the user works on each respective target. In other words, not all annotation data is displayed at the same time. In addition to the previously received annotation data, in step 212, annotation data may be added in real-time during a surgical procedure. For example, as the user traverses the surgical roadmap, each target may be marked complete. Additionally, the system 100 may collect data regarding the procedure and record the annotations in the appropriate area of the 3D navigation space. Although not shown, a file with the preoperative and real-time annotations may be exported and / or stored in memory, a database, in the cloud, etc. In another example, an injection of intravenous contrast, which allows for better differentiation of the soft tissues and can help define the type of lesion seen on a CT scan, may be injected into the patient. During injection of an intravenous contrast there is a finite time during which certain anatomical structures can be viewed based upon how the contrast washes through the vascular system. The annotation data may comprise recording how the contrast fluid enters the patient, image overlays or 2D / 3D segmentations of anatomical structures (e.g. vessels, tumors) visualized during contrast injections, etc. may be recorded as annotations.

[0090] The present disclosure encompasses embodiments of the method 200 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0091] Fig. 3A depicts a method 300a that may be used, for example, for planning a surgical procedure. Although the discussion herein relates to planning a surgical procedure, the present disclosure may also include visualizing and annotating a 3D navigation space in real-time (e.g., during a procedure).

[0092] The method 300a (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 300a. The at least one processor may perform the method 300a by executing instructions stored in a memory such as the memory 106. The instructions may correspond to one or more steps of the method 300 described below.

[0093] The method 300a comprises detecting, by the processor, a physical state of the patient (step 302); and displaying annotation data based on the physical state of the patient (step 304a). For example, a sensor may detect the breath cycle of the patient, and annotations are only displayed during the portion of the breath cycle when they were created. In other words, the annotations may fade in / out relative to the physical state of the patient when the annotation was created. In another example, annotations may be created during cardiac cycle events (e.g., diastole and systole), and fade in / out based on when the annotation was created. Note that each annotation may have a separate breath cycle creation period.

[0094] The present disclosure encompasses embodiments of the method 300a that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0095] Fig. 3B depicts a method 300b that may be used, for example, for planning a surgical procedure.

[0096] The method 300b (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 oneprocessor 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 300b. The at least one processor may perform the method 300b by executing instructions stored in a memory such as the memory 106. The instructions may correspond to one or more steps of the method 300b described below.

[0097] The method 300b comprises determining and displaying a location of the surgical tool as it moves through the 3D navigation space (step 303). Similar to the method 300a, annotation data is displayed based on the location of the surgical tool (step 304b). In embodiments, different annotation data is displayed as the surgical tool moves through the 3D navigation space. For example, as the user progresses through the surgical roadmap, annotations related to each target is displayed as the user works on each respective target. For example, as the user traverses the surgical roadmap, each target may be marked complete. In other words, not all annotation data is displayed at the same time.

[0098] As the surgical tool moves, the processor, detects if the surgical tool is within a threshold distance of an anti-target or no-fly zone. If yes, then an alert is triggered (step 305). If no, then the system continues to monitor the location of surgical tool relative to the location of any anti-target.

[0099] The present disclosure encompasses embodiments of the method 300b that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above. The present disclosure encompasses embodiments in which the method 300a and 300b are combined.

[0100] Fig. 4 depicts a method 400 that may be used, for example, for planning a surgical procedure. Although the discussion herein relates to planning a surgical procedure, the present disclosure may also include visualizing and annotating a 3D navigation space in real-time (e.g., during a procedure).

[0101] The method 400 (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 400. The at least one processor may perform the method 400 by executinginstructions stored in a memory such as the memory 106. The instructions may correspond to one or more steps of the method 400 described below.

[0102] The method 400 may continue from step 208 in the method 200. The method 400 comprises determining a location of the surgical tool within the 3D navigation space (step 402). Step 404 comprises collecting, by the processor, real-time annotation data. For example, as the user traverses the surgical roadmap, each target may be marked complete. Additionally, the system may collect data regarding the procedure (e.g., energy dosage) and record the annotations in the appropriate area of the 3D navigation space.

[0103] The present disclosure encompasses embodiments of the method 400 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0104] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Figs. 2, 3A-B, and 4 (and the corresponding description of the methods 200, 300a-b, and 400), as well as methods that include additional steps beyond those identified in Figs. 2, 3A-B, and 4 (and the corresponding description of the methods 200, 300a-b, and 400). 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.

[0105] Figs. 5 A-F illustrate user interface examples of a system used to plan a surgical procedure and / or carry out one or more other aspects of one or more of the methods described herein.

[0106] Fig. 5A is a dynamic visualization of an ultrasound image 504 and a device relative to each other in a 3D navigation space. 502b is an expanded view of the square 502.

[0107] Fig. 5B illustrates a user interface 500b that includes three separate portions 510b, 520b, and 530b. In the first portion 510b, an ultrasound image with annotations is displayed. Other images / modalities may be displayed. In the second portion 520b, the 3D navigation space is displayed relative to the ultrasound image in the first portion 510b. The third portion 530b includes an annotation window for adding annotations according to embodiments described herein.

[0108] Fig. 5C illustrates another example of a user interface according to the embodiments described herein.

[0109] Fig. 5D illustrates another example of a user interface according to the embodiments described herein.

[0110] Fig. 5E illustrates another example of a user interface according to the embodiments described herein.

[0111] Fig. 5F illustrates another example of a user interface according to the embodiments described herein.

[0112] 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 he 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.

[0113] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, ands 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.

[0114] Example 1. A method for planning a surgical procedure, the method comprising: receiving image data corresponding to a portion of an anatomy of a patient; constructing a three-dimensional (3D) navigation space using the image data; receiving and adding annotation data to the 3D navigation space; and visually displaying the annotation data as a surgical tool navigates the 3D navigation space.

[0115] Example 2. The method of example 1, wherein the annotation data comprises preoperative annotations.

[0116] Example 3. The method of example 1, wherein the annotation data comprises realtime data received from the surgical tool during the surgical procedure.

[0117] Example 4. The method of example 1, further comprising: determining and displaying a location of the surgical tool as it moves through the 3D navigation space; and updating the display of the annotation data based on the location of the surgical tool.

[0118] Example 5. The method of example 1, wherein display of the annotation data fades based on a physical state of the patient.

[0119] Example 6. The method of example 5, wherein the physical state of the patient comprises a breath cycle of the patient.

[0120] Example 7. The method of example 3, wherein the annotation data comprises an amount of energy deployed to a surgical site.

[0121] Example 8. The method of example 3, wherein the annotation data comprises recording injection of a contrast fluid into the portion of the anatomy.

[0122] Example 9. The method of example 2, wherein the annotation data comprises at least one target and at least one no-fly zone.

[0123] Example 10. The method of example 9, further comprising: determining and displaying a location of the surgical tool as it moves through the 3D navigation space; and triggering an alert when the location of the surgical tool is less than a threshold distance to a no- fly zone.

[0124] Example 11. The method of example 1, wherein the image data comprises images in different modalities.

[0125]

[0126] Example 12. The method of example 1, wherein constructing the 3D navigation space comprises fusing preoperative images with a real-time image.

[0127]

[0128] Example 13. The method of example 1, wherein the annotation data comprises a thermal profile or heat map of the portion of the anatomy. 1

[0129]

[0130] Example 14. The method of example 1, further comprising: generating a roadmap of the surgical procedure, wherein the roadmap includes multiple surgical points in a predetermined order; and guiding a user through the multiple surgical points in the predetermined order.

[0131] Example 15. The method of example 14, wherein the predetermined order starts with a deepest surgical point and ends with a shallowest surgical point.

[0132] Example 16. The method of example 14, wherein the predetermined order starts with a leftmost surgical point and ends with a rightmost surgical point.

[0133] Example 17. The method of example 1, further comprising: determining and displaying a location of the surgical tool as it moves through the 3D navigation space; and controlling parameters of the surgical tool based on the determined location of the surgical tool.

[0134] Example 18. The method of example 1, wherein the surgical tool comprises a thermal therapy deployment device.Example 19. A surgical system for planning a surgical procedure, the surgical system comprising: a processor to: construct a 3D navigation space using image data corresponding to a portion of an anatomy of a patient; and receive and add annotation data to the 3D navigation space; and a screen to display the annotation data as a surgical tool navigates the 3D navigation space.

[0135] Example 20. A surgical system for performing an ablation, comprising: a processor to receive and add annotation data to a 3D navigation space; and a user interface to display the annotation data as a surgical tool navigates the 3D navigation space.

Claims

CLAIMSWhat is claimed is:

1. A method for planning a surgical procedure, the method comprising: receiving image data (504) corresponding to a portion of an anatomy of a patient; constructing a three-dimensional (3D) navigation space (502b) using the image data (504); receiving and adding annotation data (530b) to the 3D navigation space; and visually displaying the annotation data (510b) as a surgical tool navigates (111) the 3D navigation space.

2. The method of claim 1, wherein the annotation data (510b) comprises at least one of: preoperative annotations, an amount of energy deployed to a surgical site, recording injection of a contrast fluid into the portion of the anatomy, a target, a no-fly zone, a thermal profile or heat map of the portion of the anatomy, and real-time data received from the surgical tool (111) during the surgical procedure.

3. The method of claim 1, further comprising: determining and displaying a location of the surgical tool (111) as it moves through the 3D navigation space (502b); and updating the display of the annotation data (510b) based on the location of the surgical tool (H l).

4. The method of claim 1, wherein display of the annotation data (510b) fades based on a physical state of the patient.

5. The method of claim 4, wherein the physical state of the patient comprises a breath cycle of the patient.

6. The method of claim 2, further comprising: determining and displaying a location of the surgical tool (111) as it moves through the 3D navigation space (502b); andtriggering an alert when the location of the surgical tool (111) is less than a threshold distance to the no-fly zone.

7. The method of claim 1, wherein constructing the 3D navigation space (502b) comprises fusing preoperative images (130) with a real-time image (112).

8. The method of claim 1, wherein the image data (504) may comprise images in different modalities.

9. The method of claim 1, further comprising: generating a roadmap of the surgical procedure, wherein the roadmap includes multiple surgical points in a predetermined order; and guiding a user through the multiple surgical points in the predetermined order.

10. The method of claim 9, wherein the predetermined order starts with a deepest surgical point and ends with a shallowest surgical point.

11. The method of claim 9, wherein the predetermined order starts with a leftmost surgical point and ends with a rightmost surgical point.

12. The method of claim 1, further comprising: determining and displaying a location of the surgical tool (111) as it moves through the3D navigation space (502b); and controlling parameters of the surgical tool (111) based on the determined location of the surgical tool (111).

13. The method of claim 1, wherein the surgical tool (111) comprises a thermal therapy deployment device.

14. A surgical system (100) for planning a surgical procedure, the surgical system comprising:a processor (104) to: construct a 3D navigation space (502b) using image data (504) corresponding to a portion of an anatomy of a patient; and receive and add annotation data (510b) to the 3D navigation space (502b); and a screen (110) to display the annotation data as a surgical tool (111( navigates the 3D navigation space (502b).

15. A surgical system (100) for performing an ablation, comprising: a processor (104) to receive and add annotation data (510b) to a 3D navigation space (502b); and a user interface (110) to display the annotation data (510b) as a surgical tool (111) navigates the 3D navigation space (502b).

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