System for setting implant

Abstract

Systems and methods for disposing an implant are provided. The robotic arm may automatically orient the screw head to a predetermined orientation relative to the pedicle screw. The screw head may be pivotally coupled to a pedicle screw. The robotic arm may lock the screw head in a predetermined position.

Description

BACKGROUND OF THE DISCLOSURE

[0001] The present disclosure generally relates to controlling one or more surgical tools and, more particularly, to controlling the orientation and locking of a pedicle screw head of one or more surgical tools that orient and lock pedicle screws.

[0002] A surgical robot may assist a surgeon or other healthcare provider in performing a surgical procedure or may autonomously perform one or more surgical procedures. Articulated members providing controllable connections allow the surgical robot to reach areas of the patient's anatomy during various medical procedures. SUMMARY OF THE DISCLOSURE

[0003] Example aspects of the present disclosure include:

[0004] A system for setting an implant according to at least one embodiment of the present disclosure includes a processor; and a memory that stores data for processing by the processor, the data when processed causing the processor to: cause a robotic arm to automatically orient a screw head to a predetermined orientation relative to a pedicle screw, the screw head being pivotally coupled to the pedicle screw; and cause the robotic arm to lock the screw head in the predetermined orientation.

[0005] In any aspect of the aspects herein, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: plan the position of the pedicle screw to produce a predetermined position, and plan the orientation of the screw head relative to the pedicle screw to produce a predetermined orientation.

[0006] In any aspect of the aspects herein, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: cause the robotic arm to drive the pedicle screw to a predetermined position in an anatomical element; and cause the robotic arm to pivotally couple the screw head to the pedicle screw.

[0007] In any aspect of the aspects herein, wherein the pedicle screw and the screw head are pivotally coupled together, and wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: cause the robotic arm to drive the pedicle screw to a predetermined position in an anatomical element.

[0008] In any aspect of the aspects herein, wherein driving the pedicle screw, orienting the screw head, and locking the screw head are performed by a single tool.

[0009] In any aspect of the present disclosure, where the pedicle screws include a plurality of pedicle screws, the predetermined positions include a corresponding plurality of predetermined positions, and the screw heads include a plurality of corresponding screw heads, and where the robotic arm drives each of the plurality of pedicle screws to a corresponding one of the plurality of predetermined positions, and where the robotic arm orients and locks the corresponding one of the plurality of screw heads to the pedicle screw in a corresponding predetermined orientation.

[0010] In any aspect of the present disclosure, where the memory stores additional data for processing by the processor, the additional data, when processed, causes the processor to: receive a surgical plan that at least includes the predetermined orientation.

[0011] In any aspect of the present disclosure, further including a navigation system configured to track the orientation of the screw head, and where the memory stores additional data for processing by the processor, the additional data, when processed, causes the processor to: cause the navigation system to track the orientation of the screw head and verify the orientation of the screw head in a predetermined orientation.

[0012] In any aspect of the present disclosure, where the memory stores additional data for processing by the processor, the additional data, when processed, causes the processor to: cause the navigation system to display an image of the screw head and the orientation of the screw head on a display.

[0013] In any aspect of the present disclosure, further including an arm guide, and where the memory stores additional data for processing by the processor, the additional data, when processed, causes the processor to: receive a tool through the arm guide, and where the robotic arm operates the tool to orient and lock the screw head.

[0014] A system for setting an implant according to at least one embodiment of the present disclosure includes a robotic arm configured to orient a pedicle screw and a screw head; a processor; and a memory that stores data for processing by the processor, the data, when processed, causes the processor to: cause the robotic arm to drive the pedicle screw to a predetermined position in an anatomical element; cause the robotic arm to automatically orient the screw head to a predetermined orientation relative to the pedicle screw, the screw head being pivotally coupled to the pedicle screw; and cause the robotic arm to lock the screw head in the predetermined orientation.

[0015] In any aspect of the present disclosure, where a memory stores additional data for processing by a processor, the additional data, when processed, causes the processor to: plan the position of the screw to produce a predetermined position, and plan the orientation of the screw head relative to the pedicle screw to produce a predetermined orientation.

[0016] In any aspect of the present disclosure, where driving the pedicle screw, orienting the screw head, and locking the screw head are performed by a single tool.

[0017] In any aspect of the present disclosure, where the pedicle screw includes a plurality of pedicle screws, the predetermined positions include a corresponding plurality of predetermined positions, and the screw heads include a plurality of corresponding screw heads, and where a robotic arm drives each of the plurality of pedicle screws to a corresponding one of the plurality of predetermined positions, and where the robotic arm orients and locks the corresponding screw head of the plurality of screw heads to the pedicle screw at the corresponding predetermined position.

[0018] In any aspect of the present disclosure, further comprising an arm guide, and where a memory stores additional data for processing by a processor, the additional data, when processed, causes the processor to: receive a tool through the arm guide, and where the robotic arm operates the tool to orient and lock the screw head.

[0019] A system for setting an implant according to at least one embodiment of the present disclosure includes a pedicle screw; a screw head configured to be pivotally coupled to the pedicle screw; a robotic arm configured to orient and lock the screw head relative to the pedicle screw in a predetermined orientation; a processor; and a memory that stores data for processing by the processor, the data, when processed, causing the processor to: cause the robotic arm to drive the pedicle screw to a predetermined position in an anatomical element;

[0020] cause the robotic arm to automatically orient the screw head to a predetermined orientation relative to the pedicle screw, the screw head being pivotally coupled to the pedicle screw; and

[0021] cause the robotic arm to lock the screw head in the predetermined orientation.

[0022] In any aspect of the present disclosure, where a memory stores additional data for processing by a processor, the additional data, when processed, causes the processor to: plan the position of the screw to produce a predetermined position, and plan the orientation of the screw head relative to the pedicle screw to produce a predetermined orientation.

[0023] In any aspect of the present disclosure, where the pedicle screws include a plurality of pedicle screws, the predetermined positions include a corresponding plurality of predetermined positions, and the screw heads include a plurality of corresponding screw heads, and where a robotic arm drives each of the plurality of pedicle screws to a corresponding one of the plurality of predetermined positions, and where the robotic arm orients and locks the corresponding one of the plurality of screw heads to the pedicle screw.

[0024] In any aspect of the present disclosure, driving the pedicle screw, orienting the screw head, and locking the screw head are performed by a single tool.

[0025] In any aspect of the present disclosure, further including an arm guide, and where a memory stores additional data for processing by a processor, the additional data when processed causes the processor to: receive a tool through the arm guide, and where the robotic arm operates the tool to orient and lock the screw head.

[0026] Any one aspect is combined with any one or more other aspects.

[0027] Any one or more of the features disclosed herein.

[0028] Any one or more of the features generally disclosed herein.

[0029] Any one or more of the features generally disclosed herein are combined with any one or more other features generally disclosed herein.

[0030] Any one of the aspects / features / embodiments is combined with any one or more other aspects / features / embodiments.

[0031] Use any one or more of the aspects or features disclosed herein.

[0032] It should be understood that any feature described herein can be combined with any other feature described herein for protection, regardless of whether the features are from the same described embodiment.

[0033] Details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the technology described in the present disclosure will be apparent from the description, drawings, and claims.

[0034] 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 only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to elements such as X, Y, and Z or element classes such as X1-Xn, Y1-Ym, and Z1-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, combinations of elements selected from the same class (e.g., X1 and X2), and combinations of elements selected from two or more classes (e.g., Y1 and Zo).

[0035] The term “a” entity means one or more of that entity. Thus, the terms “a,” “one or more,” and “at least one” may be used interchangeably herein. It should also be noted that the terms “comprising,” “including,” and “having” may be used interchangeably.

[0036] The foregoing is a simplified overview of the present disclosure to provide an understanding of some aspects of the present disclosure. This Summary is neither an extensive nor an exhaustive overview of the present disclosure and its various aspects, embodiments, and configurations. It is neither intended to identify key or critical elements of the present disclosure nor to delineate the scope of the present disclosure, but rather to present selected concepts of the present disclosure in a simplified form as an introduction to the more detailed description presented below. As should be understood, other aspects, embodiments, and configurations of the present disclosure may make use, alone or in combination, of one or more of the features set forth above or described in detail below.

[0037] Many additional features and advantages of the present disclosure will become apparent to those of ordinary skill in the art upon consideration of the following description of the embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The drawings incorporated herein and forming a part of this specification illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the present disclosure. The drawings merely illustrate how to practice and use the preferred and alternative examples of the present disclosure, and these examples should not be construed as limiting the present disclosure to only the illustrated and described examples. Additional features and advantages will become apparent from the following more detailed description of the various aspects, embodiments, and configurations of the present disclosure, as illustrated by the accompanying drawings referred to below.

[0039] Figure 1 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0040] Figure 2is a block diagram of a system according to at least one embodiment of the present disclosure;

[0041] Figure 3 is a flowchart according to at least one embodiment of the present disclosure; and

[0042] Figure 4 is a flowchart according to at least one embodiment of the present disclosure. Detailed Description

[0043] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically presented in the specification and the drawings. It should also be understood that depending on the example or embodiment, certain actions or events of any of the processes or methods described herein can be performed in a different order and / or additional actions can be added, combined, or entirely omitted (e.g., depending on different embodiments of the present disclosure, not all of the described actions or events may be required to practice the disclosed technology). Additionally, although some aspects of the present disclosure are described for clarity as being performed by a single module or unit, it should be understood that the technology of the present disclosure can be performed by a combination of units or modules associated with, for example, a computing device and / or a medical device.

[0044] In one or more examples, the described methods, processes, and techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, the functions can be implemented using a machine learning model, a neural network, an artificial neural network, or a combination thereof (either alone or in combination with instructions). The computer-readable medium can include a non-transitory computer-readable medium, which corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store the desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0045] The 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 A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general-purpose microprocessor), 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 unit), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Thus, the term "processor" as used herein can refer to any one of the foregoing structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be implemented entirely in one or more circuits or logic elements.

[0046] Before explaining any embodiments of the present disclosure in detail, it is to be understood that the present disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or illustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways. Additionally, it is to be understood that the terminology and phraseology used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising," "including," or "having" and variations thereof herein is intended to cover the items listed thereafter and their equivalents, as well as additional items. Furthermore, the present disclosure may use examples to illustrate one or more of its aspects. Unless otherwise expressly stated, the use or listing of one or more examples (which may be indicated by "for example," "by way of example," "such as," or similar language) is not intended and does not limit the scope of the present disclosure.

[0047] The terms proximal and distal are used in their conventional medical meanings in the present disclosure, with proximal being closer to the operator or user of the system and farther from the surgical area of concern within or on the patient's body, while distal is closer to the surgical area of concern within or on the patient's body and farther from the operator or user of the system.

[0048] Pedicle screw implants are used to adjust or correct various spinal deformities. The pedicle screws can be implanted into one or more vertebrae of a patient, and a rod can be inserted into the pedicle screw heads of each pedicle screw. The rod substantially connects the pedicle screws and, when fixed to the pedicle screws, can adjust the patient's spine. The pedicle screw head is typically in a fixed position relative to the pedicle screw or can be positioned relative to the pedicle screw in a fixed number of orientations. In cases where the pedicle screw head is adjustable relative to the pedicle screw, manually orienting and locking the pedicle screw head can be difficult due to the user (such as a surgeon or other healthcare provider) having obstructed visibility of the working volume and / or due to the user's inability to accurately orient and lock the pedicle screw head in a precise orientation.

[0049] According to at least one embodiment of the present disclosure, a robotic system having a robot and a robotic arm can be used to precisely orient and lock the pedicle screw head. Such precision enables pre-planning of the orientation of the pedicle screw head, similar to planning the position of the pedicle screw. Thus, in some cases, the positions of multiple pedicle screws can be planned, and the orientations of the corresponding multiple pedicle screw heads can also be planned. During a surgical procedure for implanting a pedicle screw implant (whether during a MIS or open procedure), the pedicle screws can be placed in corresponding anatomical elements (e.g., vertebrae) and the corresponding pedicle screw heads can be oriented and locked in corresponding pre-determined orientations. Thus, since the pedicle screw heads will not need to be readjusted or will have reduced readjustment, the pedicle screw heads can be accurately oriented and locked in a desired orientation, potentially reducing the surgical procedure time.

[0050] Embodiments of the present disclosure provide technical solutions to one or more of the following problems: (1) accurately orienting and locking a pedicle screw head relative to a pedicle screw in a pre-determined orientation; (2) pre-planning one or more orientations of one or more pedicle screw heads; and (3) reducing surgical time and improving patient safety.

[0051] First, turning to Figure 1, which shows a block diagram of a system 100 according to at least one embodiment of the present disclosure. The system 100 can be used to control one or more surgical tools using a robotic system to set an implant, for example, to control, pose, and / or otherwise manipulate a surgical robotic system, a surgical robotic arm, and / or a surgical tool attached thereto, and / or to perform one or more other aspects of one or more of the methods disclosed herein. The system 100 includes a computing device 102, one or more imaging devices 112, a robot 114, a navigation system 118, a database 130, and / or a cloud or other network 134. Systems according to other embodiments of the present disclosure may include more or fewer components than the system 100. For example, the system 100 may not include one or more of the imaging device 112, the robot 114, the navigation system 118, the computing device 102, the database 130, and / or the cloud 134.

[0052] The computing device 102 includes 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 include more or fewer components than the computing device 102.

[0053] 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 that may cause the processor 104 to perform one or more computational steps using 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.

[0054] The memory 106 may be or include 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 that can be used to complete any steps of, for example, the methods 300 and / or 400 described herein or any other method. The memory 106 may store instructions and / or machine learning models that support one or more functions of the robot 114. For example, the memory 106 may store content (e.g., instructions and / or machine learning models) that, when executed by the processor 104, enables image processing 120 and / or pedicle screw planning 122. In some embodiments, such content may be organized into one or more applications, modules, packages, layers, or engines if provided as instructions.

[0055] Image processing 120 enables the processor 104 to process image data of an image (received from an imaging device such as imaging device 112, a navigation system 118, or any imaging device) for, for example, identifying information about anatomical elements such as anatomical element 240 and / or objects such as pedicle screw 236 and pedicle screw head 238 depicted in the image. The information can include, for example, identification of hard tissue and / or soft tissue, boundaries between hard tissue and soft tissue, boundaries of hard tissue and / or soft tissue, identification of pedicle screw 236 and pedicle screw head 238, etc. Image processing 120 can identify hard tissue, soft tissue, and / or boundaries of hard tissue and / or soft tissue, for example, by determining differences or contrasts between the colors or grayscales of image pixels. For example, a boundary between hard tissue and soft tissue can be identified as a contrast between brighter pixels and darker pixels. Image processing 120 can also be used to obtain pose information of pedicle screw 236, pedicle screw head 238, and / or anatomical element 240 for, for example, the purpose of confirming the pose of pedicle screw head 238 relative to pedicle screw 236.

[0056] Pedicle screw planning 122 enables the processor 104 to receive information about a desired alignment of a patient's spine and generate one or more predetermined positions of pedicle screw 236 and one or more predetermined orientations of pedicle screw head 238. Information about the desired alignment of the patient's spine can include dimensions of a desired shape and / or a three-dimensional model of the desired alignment. The predetermined positions and / or predetermined orientations can be transmitted directly to, for example, robot 114 and / or stored in a surgical plan 124, database 130, memory 106, or any memory of any component. Pedicle screw planning 122 can output a desired orientation of the pedicle screw head based on the information. In some embodiments, the desired orientation of the pedicle screw head can be based on the alignment of the rod slot and the rod of the pedicle screw head. Since this will result in an increased connection strength between the pedicle screw head and the rod, the desired orientation can also be based on placing the pedicle screw head perpendicular to the rod. It should also be understood that the rod slot of the pedicle screw head can be in any rotational orientation (e.g., top to bottom or medial to lateral) at the desired orientation of the pedicle screw head. Pedicle screw planning 122 can also output steps for orienting and locking the pedicle screw head in the desired orientation. Such steps can be automatically performed by, for example, robot 114 and / or the robotic arm 116 of robot 114, or can be manually performed by, for example, a surgeon or other healthcare provider.

[0057] The memory 106 may also store a surgical plan 124. The surgical plan 124 may include, for example, one or more steps for performing a surgical procedure and / or one or more parameters during the surgical procedure. In some embodiments, the surgical procedure may be a spinal procedure for correcting spinal deformities (e.g., spinal alignment, implant placement, osteotomy, fusion, and / or any other spinal procedure). For example, the surgical plan 124 may include one or more surgical steps for implant placement and setting, such as preparing an anatomical element (e.g., a vertebra), drilling in the anatomical element, tapping the anatomical element, decorticating the anatomical element, driving a pedicle screw 236 into the anatomical element, setting the pedicle screw head 238 to a predetermined orientation, and locking the pedicle screw head 238 in the predetermined orientation. The surgical plan 124 may also be stored in the database 130.

[0058] Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning patterns, artificial neural networks, deep neural networks, etc.) that may be processed by the processor 104 to perform the various methods and features described herein. Thus, although the various contents of the memory 106 may be described as instructions, it should be understood that the functions described herein may be implemented by using instructions, algorithms, and / or machine learning models. The data, algorithms, and / or instructions may cause the processor 104 to manipulate the data stored in the memory 106 and / or data 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 include a communication interface 108. The communication interface 108 may be used to receive image data or other information from external sources (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 that is not part of the system 100), and / or to transmit instructions, images, or other information to external systems or devices (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 that is not part of the system 100). The communication interface 108 may include one or more wired interfaces (e.g., USB ports, Ethernet ports, FireWire ports) and / or one or more wireless transceivers or interfaces (configured to transmit and / or receive information via one or more wireless communication protocols such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, etc.). In some embodiments, the communication interface 108 may be used to enable the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time required to complete computationally intensive tasks or for any other reason.

[0060] The computing device 102 may also include one or more user interfaces 110. The user interface 110 may be or include a keyboard, a mouse, a trackball, a monitor, a television, a screen, a touch screen, 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 user selections or other user input regarding any step of any of the methods described herein. Nevertheless, any required input for any step of any of the methods described herein may be automatically generated 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 used to allow a surgeon or other user to modify the instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and / or to modify or adjust the settings of other information displayed on or corresponding to the user interface 110.

[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 of the remaining components of the computing device 102. In some embodiments, the user interface 110 may be located near one or more of the other components of the computing device 102, while in other embodiments, the user interface 110 may be located remote from one or more of the other components of the computing device 102.

[0062] The imaging device 112 can be used to image anatomical features (e.g., bones, veins, tissues, etc.), objects such as pedicle screws 236 and pedicle screw heads 238, and / or other aspects of the patient's anatomy to generate image data (e.g., image data depicting or corresponding to bones, veins, tissues, etc.). As used herein, "image data" refers to data generated or captured by the imaging device 112, including data in machine-readable form, graphical / visual form, and in any other form. In different examples, the image data can include data corresponding to an anatomical feature or a part thereof of the patient. The image data can be or include preoperative images, intraoperative images, postoperative images, or images taken independently of any surgical procedure. In some embodiments, the first imaging device 112 can be used to obtain first image data (e.g., a first image) at a first time, and the second imaging device 112 can 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 2D images or 3D images to generate image data. The imaging device 112 can be or include, for example, an ultrasound scanner (which may include, for example, physically separate transducers and receivers, or a single ultrasound transceiver), an O-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 thermal imaging camera (e.g., an infrared camera), a radar system (which may include, for example, a transmitter, a receiver, a processor, and one or more antennas), or any other imaging device 112 suitable for obtaining images of the patient's anatomical features. The imaging device 112 can be fully contained within a single housing, or can include a transmitter / transmitter and a receiver / detector physically separated in separate housings or otherwise.

[0063] In some embodiments, the imaging device 112 can include more than one imaging device 112. For example, the first imaging device can provide first image data and / or a first image, and the second imaging device can provide second image data and / or a second image. In still other embodiments, the same imaging device can be used to provide both first image data and second image data and / or any other image data described herein. The imaging device 112 can be used to generate an image data stream. For example, the imaging device 112 can be configured to operate using an open shutter, or using a shutter that continuously alternates between open and closed, in order to capture sequential images. For the purposes of this disclosure, unless otherwise specified, if the image data represents two or more frames per second, the image data can be considered sequential and / or provided as an image data stream.

[0064] The robot 114 can be any surgical robot or surgical robot system. The robot 114 can be or include, for example, the Mazor X TM Stealth Edition robotic guidance system. The robot 114 can be configured to position the pedicle screw 236 at one or more precise positions and orientations (whether or not guided by the navigation system 118), and / or to orient the pedicle screw head 238 at a predetermined orientation relative to the pedicle screw 236. In some embodiments, the robot 114 can be configured to orient and / or operate surgical tools, such as the surgical tool 234 (which can be used to position the pedicle screw 236 and / or orient the pedicle screw head 238) and / or hold and / or manipulate anatomical elements during or in conjunction with a surgical procedure. The robot 114 can include one or more robotic arms 116. In some embodiments, the robotic arm 116 can include a first robotic arm and a second robotic arm, but the robot 114 can include more than two robotic arms. In some embodiments, one or more of the robotic arms 116 can be used to hold and / or manipulate the pedicle screw 236 and / or the pedicle screw head 238. Each robotic arm 116 can be positioned independently of the other robotic arms. The robotic arms 116 can be controlled in a single shared coordinate space or in separate coordinate spaces.

[0065] The robot 114 together with the robotic arms 116 can have, for example, one, two, three, four, five, six, seven or more degrees of freedom. Additionally, the robotic arms 116 can be positioned or locatable in any pose, plane, and / or focus. The pose includes position and orientation. Thus, the imaging device 112, the pedicle screw 236, the pedicle screw head 238, the surgical tool 234, or other objects held by the robot 114 (or more specifically, by the robotic arms 116) can be precisely positioned at one or more desired and specific positions and orientations.

[0066] The robotic arm 116 can include one or more sensors 126 that enable the processor 104 (or the processor of the robot 114) to determine the precise pose of the robotic arm (and any object or element, such as the pedicle screw head 238, held or fixed to the robotic arm) in space.

[0067] The sensor 126 can be a position sensor, a proximity sensor, a magnetometer, or an accelerometer. In some embodiments, the sensor 126 can be a linear encoder, a rotary encoder, or an incremental encoder. In still other embodiments, the sensor 126 can be an imaging sensor. Other types of sensors can also be used as the sensor 126. For example, the sensor 126 can be a force sensor configured to detect a force applied (e.g., either via the end effector of the robotic arm 116, a tool held by the end effector of the robotic arm 116, or otherwise) to the robotic arm 116. One or more sensors 126 can be positioned, for example, on the robotic arm 116 or elsewhere.

[0068] Data from the sensor 126 can be provided to the processor of the robot 114, the processor 104 of the computing device 102, and / or the navigation system 118. The data can be used to compute the position of the robotic arm 116 in space relative to one or more coordinate systems (e.g., based on coordinate system information stored in the memory 116). This computation can be based not only on the data received from the sensor 126, but also on data or information about, for example, the robot 114 or a part thereof or any other relevant object (such as, for example, physical dimensions), which can be stored in, for example, the memory 116 of the computing device 102 or any other memory.

[0069] In some embodiments, reference markers (i.e., navigation markers) can be placed on the robot 114 (including, for example, on the robotic arm 116), the imaging device 112, the surgical tool 234, or any other object in the surgical space. The reference markers can be tracked by the navigation system 118, and the results of the tracking can be used by the robot 114 and / or by an operator of the system 100 or any of its components. In some embodiments, the navigation system 118 can be used to track other components of the system (e.g., the imaging device 112), and the system can be operated without using the robot 114 (e.g., a surgeon can manually manipulate the imaging device 112 and / or one or more surgical tools, for example, based on information and / or instructions generated by the navigation system 118).

[0070] During operation, the navigation system 118 can provide navigation for the surgeon and / or the surgical robot. The navigation system 118 can be any known or future-developed navigation system, including, for example, the Medtronic StealthStation TMAn S8 surgical navigation system or any of its successor products. The navigation system 118 may include one or more cameras or other sensors for tracking one or more reference markers, navigation trackers, or other objects within the operating room or other rooms in which part 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 include one or more electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track the position and orientation (e.g., pose) of the imaging device 112, the robot 114, and / or the robotic arm 116 and / or one or more surgical tools 234 (or more specifically, to track the pose of a navigation tracker directly or indirectly attached to one or more of the foregoing in a fixed relationship). The navigation system 118 may include a display for displaying one or more images from an external source (e.g., the computing device 102, the imaging device 112, or other source) or for displaying images and / or video streams from one or more cameras or other sensors of the navigation system 118. In some embodiments, the system 100 may operate without using 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 its components, to the robot 114, or to any other element of the system 100 regarding, for example, the pose of one or more anatomical elements, whether a tool is in the proper trajectory, and / or how to move the tool into the proper trajectory to perform a surgical task according to a preoperative or other surgical plan.

[0071] The database 130 may store information associating one coordinate system to another (e.g., associating one or more robotic coordinate systems to a patient coordinate system and / or a navigation coordinate system). The database 130 may additionally or alternatively store, for example, one or more surgical plans 124 (including, for example, one or more predetermined positions for one or more pedicle screws 236, one or more predetermined orientations for one or more pedicle screw heads 238, pose information regarding a target, and / or image information regarding the patient anatomy at and / or near the surgical site) for use by the robot 114, the navigation system 118, and / or the user of the computing device 102 or the system 100; one or more images of a surgery that may be used in conjunction with or assisted by 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 any other device external to the system 100 or any other device of the system 100, either directly or via the cloud 134. In some embodiments, the database 130 may be or include a 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.

[0072] 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 using a wired connection, a wireless connection, or both via the communication interface 108. 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.

[0073] The system 100 or a similar system may be used, for example, to implement one or more aspects of any of the methods 300 and / or 400 described herein. The system 100 or a similar system may also be used for other purposes.

[0074] Turning Figure 2 FIG. shows a block diagram of a system 200 according to at least one embodiment of the present disclosure. The system 200 includes a computing device 202 (which may be the same as or similar to the above-described computing device 102), a navigation system 218 (which may be the same as or similar to the above-described navigation system 118), and a robot 214 (which may be the same as or similar to the above-described robot 114). In some embodiments, the system 200 may be used in conjunction with the system 100. Systems according to other embodiments of the present disclosure may include more or fewer components than the system 200. For example, the system 200 may not include the navigation system 218.

[0075] As shown, the robot 214 includes a robotic arm 216 extending from a base 240 (which may include one or more members 216A connected by one or more joints 216B). The base 240 may be stationary or movable. In some embodiments, the robot 214 may include one robotic arm or two or more robotic arms. In embodiments where the robot 214 includes more than two robotic arms, the robotic arms may operate in a shared or common coordinate space. By operating in a common coordinate space, the robotic arms avoid colliding with each other during use because the position of each robotic arm is known to the others.

[0076] In some embodiments, an arm guide 232 and a surgical tool 234 (which may be used, for example, to position a pedicle screw 236 and orient a pedicle screw head 238) may be disposed or supported on the end of the robotic arm 216. In other embodiments, the arm guide 232 and the surgical tool 234 are set or fixed to any part of the robotic arm 216. In other embodiments, any one or more tools, instruments, or components may be supported by, fixed to, or disposed on the robotic arm. The robotic arm 216 is capable of operating to perform one or more programmed movements and / or procedures autonomously and / or based on input from a surgeon or user.

[0077] As Figure 2 shown, the surgical tool 234 is supported by the robotic arm 216. The surgical tool 234 may be used to perform an action or procedure on a patient 210 and / or to position a pedicle screw 236 and / or a pedicle screw head 238 based on instructions from a surgeon and / or according to a surgical plan such as surgical plan 124. For example, the surgical tool 234 may be used to install an implant (such as a pedicle screw 236 and a pedicle screw head 238) in a patient 210's body by performing one or more steps, such as preparing an anatomical element 236 (e.g., a vertebra), drilling a hole in the anatomical element 236, tapping the anatomical element 236, decorticating the anatomical element 236, driving the pedicle screw 236 into the anatomical element 236, orienting the pedicle screw 236 in a predetermined orientation, and locking the pedicle screw head 238 in a predetermined orientation.

[0078] The pedicle screw 236 and the pedicle screw head 238 may be pivotally coupled to each other such that the pedicle screw head 238 can move or rotate about the pedicle screw 236 and be positioned in any orientation. In a conventional surgical procedure, it may be difficult to manually set the pedicle screw head 238 in an exact orientation, and it may also be difficult to manually lock the pedicle screw head 238 in a desired orientation. The robotic arm 116 advantageously enables precise positioning and locking of the pedicle screw head 238 in a desired orientation, thereby increasing the success rate of the surgical outcome.

[0079] Figure 3 Method 300 is depicted, which may be used to control, for example, one or more surgical tools (such as surgical tool 234) to position an implant (such as pedicle screw 236) and orient and / or lock a pedicle screw head (such as pedicle screw head 238). It should be understood that although method 300 is described with respect to setting and locking the pedicle screw 236 and the pedicle screw head 238, method 300 can be used to set, position, orient, place, lock, and / or install any implant.

[0080] Method 300 (and / or one or more of its steps) may be implemented 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 104 of the computing device 102 described above. The at least one processor may be part of a robot (such as robot 114) or part of a navigation system (such as navigation system 118). Processors other than any of the processors described herein may also be used to perform method 300. The at least one processor may perform method 300 by executing elements stored in a memory (such as memory 106). The elements stored in the memory and executed by the processor may cause the processor to perform one or more steps of the functions as shown in method 300. One or more parts of method 300 may be performed by a processor that executes any of the content of the memory (such as image processing 120 and / or pedicle screw planning 122).

[0081] Method 300 includes planning the position of the pedicle screw and the orientation of the pedicle screw head (step 304). The position and orientation can be planned using a processor (such as processor 104) to perform pedicle screw planning (e.g., pedicle screw planning 122). As previously described, pedicle screw planning enables the processor to receive information about the desired alignment of the patient's spine and generate one or more predetermined positions of the pedicle screw (such as pedicle screw 236) and one or more predetermined orientations of the pedicle screw head (such as pedicle screw head 238). The information about the desired alignment of the patient's spine can include the dimensions of the desired alignment and / or a three-dimensional model of the desired alignment. The predetermined position and / or the predetermined orientation can be directly transmitted to, for example, a robot (such as robot 114) and / or stored in a surgical plan (such as surgical plan 124), a database (such as database 130), a memory (such as memory 106), or any memory of any component.

[0082] It should be understood that method 300 may not include step 304. It should also be understood that the planning can include planning the position of one or more pedicle screws and the orientation of one or more pedicle screw heads. The planning can also include planning the trajectory of a surgical tool (such as surgical tool 234) to position one or more pedicle screws and orient and lock one or more pedicle screw heads.

[0083] Method 300 further includes receiving a surgical plan (step 308). The surgical plan can be the same as or similar to surgical plan 124. The surgical plan can include one or more surgical steps for installing and setting up the implant, such as preparing the anatomical element (e.g., vertebra), drilling in the anatomical element, tapping the anatomical element, decorticating the anatomical element, driving the pedicle screw into the anatomical element, setting the pedicle screw head in a predetermined orientation, and locking the pedicle screw head in a predetermined orientation. The surgical plan can be stored in a memory (such as memory 106), a database (such as database 130), the cloud (such as cloud 134), and / or any other component of the system (such as system 100 capable of storing surgical plan 124) and received therefrom.

[0084] It should be understood that method 300 may not include step 308.

[0085] Method 300 also includes causing a robotic arm to drive a pedicle screw into a pre-determined position in an anatomical element (step 312). The robotic arm can be the same as or similar to the robotic arm 116 of a robot such as robot 114. The pre-determined position can be determined, for example, in step 304, or the surgical plan can include a pre-determined orientation and can be received in step 308. In some embodiments, a surgical tool can be used to orient and drive the pedicle screw into the anatomical element (such as anatomical element 240). The surgical tool can include, for example, a driver configured to rotate or drive the pedicle screw into the anatomical element. In such embodiments, the anatomical element can be a vertebra, and the anatomical element can be prepared to receive the pedicle screw. For example, a hole can be drilled and tapped in the anatomical element, and a portion of the anatomical element can be reamed or milled to form a cavity that matches the shape of the pedicle screw head. In embodiments where the pedicle screw and the pedicle screw head are coupled together, the pedicle screw can then be driven into the aperture, and the pedicle screw head can be seated in the cavity. In embodiments where the pedicle screw and the pedicle screw head are not yet coupled together, the pedicle screw can be driven into the aperture, and step 316 described below can occur.

[0086] Method 300 also includes pivotally coupling a pedicle screw head to the pedicle screw (step 316). In some embodiments, the pedicle screw can be driven into the pre-determined position in step 312 without the pedicle screw head. In such embodiments, the robotic arm can use a surgical tool (whether the same surgical tool as used in step 312 or a different surgical tool) to pivotally couple the pedicle screw head to the pedicle screw. It should be understood that in some embodiments, the robotic arm can include an arm guide, such as the arm guide 232 configured to be able to receive and guide the surgical tool. The arm guide can also be configured to prevent the surgical tool from moving beyond a pre-determined depth in the case of, for example, drilling, tapping, reaming, driving, or any other task performed using the surgical tool.

[0087] It should be understood that method 300 may not include step 316, or step 316 can be performed before step 312. For example, in some embodiments, the pedicle screw head can be coupled to the pedicle screw before the start of the surgery. In such embodiments, the pedicle screw and the pedicle screw head can be driven together into the pre-determined position.

[0088] Method 300 further includes automatically orienting the pedicle screw head by the robotic arm to a pre-determined orientation (step 320). The pre-determined orientation can be determined, for example, in step 304, or the surgical plan can include the pre-determined orientation and can be received in step 308. The robotic arm can use a surgical tool (which can be the same or different from the surgical tool used in steps 312 and / or 316) to orient the pedicle screw head to the pre-determined orientation relative to the pedicle screw. As previously described, the pedicle screw and the pedicle screw head can be pivotally coupled to each other such that the pedicle screw head can move or rotate about the pedicle screw and be set to the orientation relative to the pedicle screw.

[0089] Method 300 further includes tracking the orientation of the pedicle screw head and verifying the orientation to the pre-determined orientation (step 324). The orientation of the pedicle screw head can be tracked by a navigation system such as navigation system 118. In such an embodiment, the navigation system can use imaging and / or markers to track the orientation of the pedicle screw head. In other embodiments, when the robotic arm has oriented the pedicle screw head to the pre-determined orientation, the pose of the robotic arm can be determined, and the pre-determined orientation can be related to the orientation of the pedicle screw head. In other embodiments, the image data from an imaging device such as imaging device 112 can be used to determine the orientation of the pedicle screw head. The image data can be processed by a processor using image processing such as image processing 120 to identify the pedicle screw head in the image data and determine the pose of the pedicle screw.

[0090] The orientation (such as tracked by the navigation system, determined by the robotic arm and / or image processing, etc.) can be compared with the pre-determined orientation to verify the actual orientation of the pedicle screw head. In some embodiments, if the difference between the orientation and the pre-determined orientation meets the orientation threshold, a notification can be generated. Such a notification can warn or inform the user (such as a surgeon or other healthcare provider) that the pedicle screw head may need adjustment to orient the pedicle screw head to the pre-determined orientation. In other cases, a notification can be generated to inform the user that the pedicle screw head is in the pre-determined orientation. In other embodiments, the angular difference between the pedicle screw head and another reference geometry (such as, for example, the surrounding anatomy, the global anatomy (hip ball or another vertebral body) or the stem) can be displayed to the user (such as a surgeon) for them to understand and confirm the angular difference.

[0091] In some cases, the pedicle screw head can be tracked to indicate when the pedicle screw head is aligned to correctly receive the rod, thus avoiding misalignment between the rod and the rod slot of the pedicle screw head. In such cases, the rotational orientation and angle of the pedicle screw head can be tracked until the pedicle screw head is aligned such that the rod slot of the pedicle screw head is aligned with the rod. The desired orientation of the pedicle screw head for aligning the rod slot with the rod can be planned preoperatively or intraoperatively by, for example, the processor 104 using the pedicle screw plan 122. In some embodiments, the desired orientation of the pedicle screw head can be received from a surgical plan such as the surgical plan 124, from a database such as the database 130, the cloud such as the cloud 134, or from any other component.

[0092] The pedicle screw plan 112 can receive the actual orientation of one or more pedicle screw heads and output an updated alignment of the patient's spine or an updated desired rod shape. In some embodiments, the pedicle screw plan 122 can also be used intraoperatively to update one or more desired orientations of one or more pedicle screw heads. For example, the pedicle screw shank can be placed into the intact portion of a vertebra having an anterior column burst fracture. The angle of the pedicle screw head pivotally attached to the pedicle screw shank can be set to a desired orientation that will restore the lordosis of the spine at the location of the vertebra. In such examples, the pedicle screw plan 122 can output the desired orientation of the pedicle screw head based on the fixed position of the rod such that the pedicle screw head is perpendicular to the rod. In this case, when the rod is coupled to the pedicle screw head, the vertebral body can be adjusted to the final lordotic position.

[0093] It should be understood that in some embodiments, the method 300 may not include step 324.

[0094] The method 300 further includes locking the pedicle screw head by the robotic arm in a predetermined orientation (step 328). The robotic arm can use a surgical tool to lock the pedicle screw head in a predetermined orientation. In some cases, the robotic arm can also unlock the pedicle screw head. For example, the pedicle screw head can be reoriented to move the vertebra to which the pedicle screw is attached, thereby adjusting the alignment of at least a portion of the patient's spine. In another example, the pedicle screw head can be adjusted to receive the rod.

[0095] In some embodiments, the surgical tool can be the same surgical tool for steps 312, 316, 320, and / or 328. In other embodiments, the surgical tool can be a different surgical tool for one or more of steps 312, 316, 320, and / or 328.

[0096] Method 300 also includes displaying an image of the pedicle screw head (step 332). The image of the pedicle screw head can be displayed on a user interface (such as user interface 110). In some embodiments, an image of the surgical tool can also be displayed together with the image of the pedicle screw head. In such embodiments, the image of the pedicle screw head can be superimposed on the image of the surgical tool. The image of the pedicle screw head can move together with the image of the surgical tool to illustrate to the user that the pedicle screw head matches the planned trajectory (which can also be shown).

[0097] Whether as an image of the pedicle screw head relative to the image of the pedicle screw and / or by displaying numerical values of the orientation, the image of the pedicle screw head can also show the orientation of the pedicle screw head. The user can use the displayed image to confirm and / or adjust the pedicle screw head and / or the pedicle screw to a desired orientation and / or position. Additionally or alternatively, the user can set the orientation of the pedicle screw head before locking the pedicle screw head in that orientation. In this case, step 332 can occur before or simultaneously with step 328. It should be understood that in some embodiments, the user can set the pedicle screw head in an orientation different from the orientation of the pedicle screw head defined by a surgical plan such as surgical plan 124 during the surgery.

[0098] It should be understood that method 300 may not include step 332.

[0099] Method 300, any step of method 300, or any combination of steps of method 300 can be repeated. For example, in some embodiments, the pedicle screw can include a plurality of pedicle screws, the pre-determined positions can include a corresponding plurality of pre-determined positions, and the screw heads can include a corresponding plurality of screw heads. In such embodiments, the robotic arm can drive each of the plurality of pedicle screws to the corresponding pre-determined position among the plurality of pre-determined positions. The robotic arm can also orient and lock the corresponding screw heads among the plurality of screw heads to the pedicle screws in the corresponding pre-determined orientations.

[0100] The present disclosure encompasses embodiments of method 300 that include more or fewer steps and / or one or more steps different from those described above.

[0101] Figure 4Depicts a method 400 that can be used to control, for example, one or more surgical tools (such as surgical tool 234) to form a prepared anatomical element (such as anatomical element 236) for receiving an implant (such as implant 238). Although method 400 will be described with respect to implanting an implant such as a pedicle screw implant, it should be understood that method 400 can be used to form a custom-shaped cavity for any purpose, reason, or use.

[0102] Method 400 (and / or one or more of its steps) can be implemented or otherwise performed, for example, by at least one processor. The at least one processor can be the same as or similar to processor 104 of computing device 102 described above. The at least one processor can be part of a robot (such as robot 114) or part of a navigation system (such as navigation system 118). A processor other than any of the processors described herein can also be used to perform method 400. The at least one processor can perform method 400 by executing elements stored in a memory (such as memory 106). The elements stored in the memory and executed by the processor can cause the processor to perform one or more steps of the functions shown in method 400. One or more portions of method 400 can be performed by a processor that executes any of the content of the memory (such as image processing 120 and / or trajectory planning 122).

[0103] Method 400 includes preparing an anatomical element (step 404). The anatomical element can be the same as or similar to anatomical element 236 and can include, for example, a vertebra. The anatomical element can be prepared for receiving, for example, an implant (such as implant 238). The implant can be a pedicle screw, although in other cases the implant can be, for example, a rod, cage, etc. Preparing the anatomical element can include scraping, polishing, marking, forming guide holes, or a combination thereof on the surface of the anatomical element. A surgical tool (such as surgical tool 234) can be used to prepare the anatomical element. The anatomical element can be manually prepared by a user operating the surgical tool or prepared by a robotic arm 116, 216 of a robot (such as robots 114, 214) to assist the user or automatically orient and operate the surgical tool. In some embodiments, an arm guide (such as arm guide 232) can be attached to the robotic arm and the surgical tool can be received through the arm guide. In such embodiments, the arm guide can be configured to receive the surgical tool (or any surgical tool) and prevent the surgical tool from moving beyond a predetermined depth. Whether the surgical tool is received by the arm guide or otherwise coupled to the robotic arm, the surgical tool is supported, oriented, and operated by the robotic arm. As previously described, the robotic arm is capable of precisely positioning and orienting a surgical tool such as the surgical tool and is configured to orient the surgical tool along a trajectory.

[0104] Method 400 further includes orienting the robotic arm to position the surgical tool to drill into the anatomical element (step 408). The surgical tool can be the same as or similar to the surgical tool used in step 404 to prepare the anatomical element. In other cases, the surgical tool can be a surgical tool different from the surgical tool used in step 404. Orienting the robotic arm to position the surgical tool can include orienting the robotic arm to position the surgical tool in one direction along a first trajectory to remove a first portion of the anatomical element (e.g., drill). In some embodiments, the first portion forms an aperture in the anatomical element. In such embodiments, the first trajectory can include the depth at which the surgical tool drills into the anatomical element. As previously described, the first trajectory can be obtained from the memory (such as memory 106) of a computing device (such as computing device 102), a surgical plan (such as surgical plan 124), and / or a database (such as database 130). In other cases, the first trajectory can be obtained from a processor performing trajectory planning (such as trajectory planning 122). As previously described, trajectory planning enables the processor to receive information about a desired custom-shaped cavity and / or a desired aperture and generate a trajectory for the surgical tool to remove one or more portions from the anatomical element. The one or more portions can form an aperture, a custom-shaped cavity, or any other shape, space, or combination of shapes.

[0105] Method 400 further includes orienting the robotic arm to position the surgical tool to tap the aperture (step 412). The surgical tool can be the same as or similar to the surgical tool used in step 404 and / or 408 to prepare the anatomical element and / or drill into the anatomical element. In other cases, the surgical tool can be a surgical tool different from the surgical tool used in step 404 and / or 408. Orienting the robotic arm to position the surgical tool can include orienting the robotic arm to position the surgical tool in one direction along a first trajectory to tap the aperture formed in step 408.

[0106] Method 400 also includes orienting a robotic arm to position a surgical tool to perform a decortication on an anatomical element (step 416). Step 416 can be the same as or similar to step 316 of method 300 described above. The surgical tool can be the same as or similar to the surgical tool used in steps 404, 408, and / or 412 to prepare the anatomical element, drill a hole in the anatomical element, and / or tap the orifice. In other cases, the surgical tool can be a surgical tool different from the surgical tool used in steps 404, 408, and / or 412. Orienting the surgical tool to perform a decortication can include orienting the surgical tool in at least one direction to remove a second portion of the anatomical element. It should be understood that the at least one direction can include any direction. The second portion removed from the anatomical element can form a custom-shaped cavity, such as the custom-shaped cavity 238 in the anatomical element. In some cases, the custom-shaped cavity can have a cross-sectional area larger than the cross-sectional area of the second surgical tool (or any surgical tool). In some embodiments, the custom-shaped cavity can be shaped to receive the head of a pedicle screw implant such that the head can be seated flush against the anatomical element. The custom-shaped cavity enables the pedicle screw implant to have a lower profile relative to the anatomical element. In the absence of such a custom-shaped cavity, the head and the pedicle screw may protrude and be exposed relative to the anatomical element.

[0107] As previously described, decortication of the anatomical element can include using a surgical tool to remove at least a portion of the anatomical element to form a custom-shaped cavity. Such decortication is achieved by the robotic arm precisely manipulating the surgical tool within a workspace that is not visually accessible to a user, such as a surgeon or other medical personnel. In other words, the robotic arm is capable of orienting and operating the surgical tool within a space that the user cannot specifically observe (e.g., during a MIS procedure). Thus, a cavity of complex geometry or shape can be formed by the robotic arm operating the surgical tool within a workspace where it is typically difficult to work.

[0108] Method 400 also includes causing the robotic arm to drive a pedicle screw into the hole (step 420). Step 420 can be the same as or similar to step 328 of method 300 described above. Causing the robotic arm to drive the pedicle screw into the hole can include the robotic arm using a surgical tool, such as a screwdriver, to drive the implant.

[0109] Method 400 also includes orienting and locking a screw head (424) pivotally coupled to a pedicle screw with a robotic arm. Step 424 may be the same as or similar to steps 320 and 328 of method 300 described above. It should be understood that steps 404, 408, 412, 416, 420, and / or 424 (e.g., preparing an anatomical element, drilling a hole in the anatomical element, tapping the orifice, forming a custom-shaped cavity (e.g., decortication), driving a pedicle screw into the hole, and / or orienting and locking the screw head relative to the pedicle screw) may be performed with the same surgical tool. It should also be understood that method 400 may include other steps, such as, for example, preparing an anatomical element and tapping the anatomical element, and in such cases, any combination of steps may be performed with the same surgical tool.

[0110] The present disclosure encompasses embodiments of method 400 that include more or fewer steps than those described above and / or one or more steps different from those described above.

[0111] As described above, the present disclosure encompasses methods having fewer steps than all of the steps identified in Figure 3 and Figure 4 (and the corresponding descriptions of methods 300 and 400), as well as methods that include additional steps beyond the steps identified in Figure 3 and Figure 4 (and the corresponding descriptions of methods 300 and 400). The present disclosure also encompasses methods that include 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 include registration or any other correlation.

[0112] The foregoing is not intended to limit the present disclosure to one or more forms disclosed herein. In the foregoing detailed description, for example, for purposes of simplifying the present disclosure, various features of the present disclosure are grouped together in one or more aspects, embodiments, and / or configurations. The features of the aspects, embodiments, and / or configurations of the present disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above. The methods of the present disclosure should not be construed as reflecting an intention that the claims require more features than are expressly recited in each claim. Instead, as reflected in the following claims, aspects of the present invention lie in less than all of the features of a single foregoing disclosed aspect, embodiment, and / or configuration. Accordingly, the following claims are hereby incorporated into this detailed description, where each claim stands on its own as a separate preferred embodiment of the present disclosure.

[0113] In addition, although the foregoing has included a description of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications are within the scope of the present disclosure. For example, they may be within the skills and knowledge of those skilled in the art. It is intended to obtain rights to include alternative aspects, embodiments, and / or configurations within the scope of what is permitted, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps of those claimed, whether or not such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and it is not intended to disclose any patentable subject matter.

Claims

1. A system for setting an implant, the system comprising: A processor; and a memory that stores data for processing by the processor, the data when processed causing the processor to: cause a robotic arm to automatically orient a screw head to a predetermined orientation relative to a pedicle screw, the screw head being pivotally coupled to the pedicle screw; and cause the robotic arm to lock the screw head in the predetermined orientation.

2. The system according to claim 1, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: plan the position of the pedicle screw to produce a predetermined position, and plan the orientation of the screw head relative to the pedicle screw to produce the predetermined orientation.

3. The system according to claim 2, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: cause the robotic arm to drive the pedicle screw into a predetermined position in an anatomical element; and cause the robotic arm to pivotally couple the screw head to the pedicle screw.

4. The system according to claim 2, wherein the pedicle screw and the screw head are pivotally coupled together, and wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: cause the robotic arm to drive the pedicle screw into a predetermined position in an anatomical element.

5. The system according to claim 4, wherein driving the pedicle screw, orienting the screw head, and locking the screw head are performed by a single tool.

6. The system according to claim 4, wherein the pedicle screw comprises a plurality of pedicle screws, the predetermined positions comprise a corresponding plurality of predetermined positions, and the screw head comprises a plurality of corresponding screw heads, and wherein the robotic arm drives each of the plurality of pedicle screws into a corresponding predetermined position of the plurality of predetermined positions, and wherein the robotic arm orients and locks the corresponding screw head of the plurality of screw heads to the pedicle screw in a corresponding predetermined orientation.

7. The system according to claim 1, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: receive a surgical plan comprising at least the predetermined orientation.

8. The system according to claim 1, wherein the system further comprises a navigation system configured to track the orientation of the screw head, and wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: cause the navigation system to track the orientation of the screw head, and verify the orientation of the screw head at the predetermined orientation.

9. The system according to claim 8, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: cause the navigation system to display an image of the screw head and the orientation of the screw head on a display.

10. The system according to claim 1, wherein the system further comprises an arm guide, and wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: receive a tool through the arm guide, and wherein the robotic arm operates the tool to orient and lock the screw head.

11. A system for setting an implant, the system comprising: A robotic arm configured to orient a pedicle screw and a screw head; A processor; and a memory that stores data for processing by the processor, the data when processed causing the processor to: cause the robotic arm to drive the pedicle screw to a predetermined position in an anatomical element; cause the robotic arm to automatically orient the screw head to a predetermined orientation relative to the pedicle screw, the screw head being pivotally coupled to the pedicle screw; and cause the robotic arm to lock the screw head in the predetermined orientation.

12. The system according to claim 11, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: plan the position of the screw to produce a predetermined position, and plan the orientation of the screw head relative to the pedicle screw to produce the predetermined orientation.

13. The system according to claim 11, wherein driving the pedicle screw, orienting the screw head, and locking the screw head are performed by a single tool.

14. The system according to claim 11, wherein the pedicle screws comprise a plurality of pedicle screws, the predetermined positions comprise a corresponding plurality of predetermined positions, and the screw heads comprise a plurality of corresponding screw heads, and wherein the robotic arm drives each of the plurality of pedicle screws to a corresponding one of the plurality of predetermined positions, and wherein the robotic arm orients and locks the corresponding one of the plurality of screw heads to the pedicle screw at the corresponding predetermined position.

15. The system according to claim 11, the system further comprising an arm guide, and wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: receive a tool through the arm guide, and wherein the robotic arm operates the tool to orient and lock the screw head.

16. A system for performing a surgical procedure, the system comprising: A pedicle screw; A screw head configured to be pivotally coupled to the pedicle screw; A robotic arm configured to orient and lock the screw head relative to the pedicle screw in a predetermined orientation; A processor; and a memory that stores data for processing by the processor, the data when processed causing the processor to: cause the robotic arm to drive the pedicle screw to a predetermined position in an anatomical element; cause the robotic arm to automatically orient the screw head to a predetermined orientation relative to the pedicle screw, the screw head being pivotally coupled to the pedicle screw; and cause the robotic arm to lock the screw head in the predetermined orientation.

17. The system according to claim 16, wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: plan the positions of the screws to produce predetermined positions, and plan the orientation of the screw heads relative to the pedicle screws to produce the predetermined orientation.

18. The system according to claim 16, wherein the pedicle screws comprise a plurality of pedicle screws, the predetermined positions comprise a corresponding plurality of predetermined positions, and the screw heads comprise a plurality of corresponding screw heads, and wherein the robotic arm drives each of the plurality of pedicle screws to a corresponding one of the plurality of predetermined positions, and wherein the robotic arm orients and locks the corresponding one of the plurality of screw heads to the pedicle screw.

19. The system according to claim 16, wherein driving the pedicle screws, orienting the screw heads, and locking the screw heads are performed by a single tool.

20. The system according to claim 16, the system further comprising an arm guide, and wherein the memory stores additional data for processing by the processor, the additional data, when processed, causing the processor to: receive a tool through the arm guide, and wherein the robotic arm operates the tool to orient and lock the screw head.

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