Systems and methods for attaching a drape to one or more portions of a robotic arm

Abstract

A system according to at least one embodiment of the present disclosure includes: a robotic arm; a tracked portion attached to the robotic arm and tracked by a navigation system; a sterile drape covering the robotic arm and the tracked portion; and an attachment device attaching the sterile drape to the tracked portion such that a portion of the sterile drape disposed on the surface of the tracked portion is substantially smooth.

Description

Background Technology

[0001] This disclosure relates in general to surgical robot navigation, and more specifically to attaching a cover to a robotic arm to allow surgical navigation.

[0002] Surgical robots can assist surgeons or other healthcare providers in performing surgical procedures, or can autonomously complete one or more surgical procedures. Imaging can be used by healthcare providers for diagnostic and / or therapeutic purposes. Patient anatomy can change over time, especially after medical implants are placed within the patient's anatomy. Summary of the Invention

[0003] The exemplary embodiments of this disclosure advantageously achieve improved tracking and navigation of the robotic surgical apparatus by using an attachment device to attach a sterile drape to the robotic surgical apparatus. The attachment device can be positioned under or outside the sterile drape and can manipulate the drape such that one or more portions of the drape are substantially smooth relative to the underlying surface of the robotic surgical apparatus on which the sterile drape is laid. This substantial smoothness allows the navigation camera of the navigation system to detect and track navigation markers positioned under the sterile drape, thereby advantageously reducing human error, improving the accuracy budget of the surgical navigation system, and reducing the need for sterilization of additional equipment used during surgical procedures.

[0004] Examples of aspects of this disclosure include: A system according to at least one embodiment of the present disclosure includes: a robotic arm; a tracked portion attached to the robotic arm and tracked by a navigation system; a sterile drape configured to cover the robotic arm and the tracked portion; and an attachment device configured to attach the sterile drape to the tracked portion such that a portion of the sterile drape disposed on the surface of the tracked portion is substantially smooth.

[0005] Any aspect of this article, wherein the tracked portion includes multiple navigation markers.

[0006] In any aspect of this article, the plurality of navigation markers include two or more light-emitting diodes (LEDs).

[0007] In any aspect of this document, the sterile drape includes a plurality of connectors, the attachment device includes a plurality of receivers, and each of the plurality of connectors is coupled to a corresponding receiver of the plurality of receivers.

[0008] In any aspect of this article, the attachment device includes an adjustable spring configured to change the distance between a first receiver and a second receiver among the plurality of receivers.

[0009] In any aspect of this document, the plurality of connectors includes a plurality of pins, and the plurality of receivers includes a plurality of slots, wherein each slot receives each of the plurality of pins.

[0010] Any aspect of this article, wherein the plurality of connectors includes a plurality of magnets.

[0011] In any aspect of this document, the attachment device includes a flexible frame that matches the geometry of the tracked portion.

[0012] In any aspect of this document, the attachment device includes a clamping device that clamps at least two regions of the sterile drape to conform the portion of the sterile drape to the surface of the tracked portion.

[0013] In any aspect of this article, the attachment device includes a gripping device that closes around a second portion of the sterile drape.

[0014] A surgical system according to at least one embodiment of the present disclosure includes: a robotic arm; a navigation device coupled to the robotic arm, the navigation device including a plurality of navigation markers tracked by a navigation system; a sterile drape capable of covering at least one segment of the navigation device; and an attachment device attaching the sterile drape to the navigation device such that a portion of the sterile drape substantially conforms to the surface of the navigation device.

[0015] In any aspect of this article, the attachment device is adjustable such that the sterile tarpaulin remains substantially conformable to the surface of the navigation device as the robotic arm moves.

[0016] In any aspect of this article, the plurality of navigation markers include two or more light-emitting diodes (LEDs).

[0017] In any aspect of this document, the sterile drape includes a plurality of connectors, the attachment device includes a plurality of receivers, and each of the plurality of connectors is coupled to a corresponding receiver of the plurality of receivers.

[0018] In any aspect of this article, the attachment device includes an adjustable spring configured to change the distance between a first receiver and a second receiver among the plurality of receivers.

[0019] In any aspect of this document, the plurality of connectors includes a plurality of pins, the plurality of receivers includes a plurality of slots, and each of the plurality of slots is configured to receive a corresponding pin among the plurality of pins.

[0020] Any aspect of this article, wherein the plurality of connectors includes a plurality of magnets.

[0021] In any aspect of this document, the attachment device includes a flexible frame that matches the geometry of the navigation device.

[0022] In any aspect of this article, the attachment device includes a gripping device that closes around a second portion of the sterile drape.

[0023] A surgical system according to at least one embodiment of the present disclosure includes: a robotic arm; a navigation component connected to a distal portion of the robotic arm, the navigation component including a plurality of navigation markers tracked by a navigation system; a sterile drape capable of covering at least a portion of the navigation component; and an attachment device configured to attach the sterile drape to the navigation component such that a portion of the sterile drape substantially conforms to the surface of the navigation component.

[0024] Any one aspect can be combined with any one or more other aspects.

[0025] Any one or more of the features disclosed in this article.

[0026] This article generally discloses one or more of the features.

[0027] Any one or more of the features generally disclosed in this article are combined with any one or more other features generally disclosed in this article.

[0028] Any aspect / feature / implementation may be combined with any one or more other aspects / features / implementations.

[0029] Use any one or more of the aspects or features disclosed herein.

[0030] It should be understood that any feature described herein may be combined with any other feature as described herein to claim protection, regardless of whether the feature comes from an implementation of the same description.

[0031] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description, drawings, and claims.

[0032] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that possess both connective and disjoint qualities 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, a combination of elements selected from the same class (e.g., X1 and X2), and a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0033] The term "a" refers to one or more of the same entity. Therefore, the terms "a," "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising," "including," and "having" are used interchangeably.

[0034] The foregoing is a simplified overview of this disclosure to provide an understanding of some aspects thereof. This summary is neither a broad nor an exhaustive overview of this disclosure and its various aspects, embodiments, and configurations. It is not intended to identify key or essential elements of this disclosure, nor to define its scope, but rather to present the concepts of this disclosure in a simplified form as an introduction to the more detailed description presented below. It should be understood that other aspects, embodiments, and configurations of this disclosure may utilize one or more of the features set forth above or described in detail below, individually or in combination.

[0035] Many additional features and advantages of this disclosure will become apparent to those skilled in the art upon consideration of the embodiments described below. Attached Figure Description

[0036] The accompanying drawings are incorporated in and form a part of this specification to illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings illustrate only preferred and alternative examples of how to implement and use this disclosure, and these examples should not be construed as limiting this disclosure solely to the illustrated and described examples. Further features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated by the accompanying drawings referenced below.

[0037] Figure 1A Aspects of a system according to at least one embodiment of the present disclosure are shown; Figure 1BAdditional aspects of a system according to at least one embodiment of the present disclosure are shown; Figure 1C Aspects of the tracked portion attached to a robotic arm and an end effector according to at least one embodiment of the present disclosure are shown; Figure 2A Aspects of a first attachment device according to at least one embodiment of the present disclosure are shown; Figure 2B Additional aspects of the first attachment device according to at least one embodiment of the present disclosure are shown; Figure 2C Additional aspects of the first attachment device according to at least one embodiment of the present disclosure are shown; Figure 3A Aspects of a second attachment device according to at least one embodiment of the present disclosure are shown; Figure 3B Additional aspects of a second attachment device according to at least one embodiment of the present disclosure are shown; Figure 4A Aspects of a third attachment device according to at least one embodiment of the present disclosure are shown; Figure 4B Additional aspects of a third attachment device according to at least one embodiment of the present disclosure are shown; Figure 5A Aspects of a fourth attachment device according to at least one embodiment of the present disclosure are shown; Figure 5B Additional aspects of a fourth attachment device according to at least one embodiment of the present disclosure are shown; Figure 6A Aspects of a fifth attachment device according to at least one embodiment of the present disclosure are shown; Figure 6B Additional aspects of a fifth attachment device according to at least one embodiment of the present disclosure are shown; Figure 7A Aspects of a sixth attachment device according to at least one embodiment of the present disclosure are shown; Figure 7B Additional aspects of a sixth attachment device according to at least one embodiment of the present disclosure are shown; and Figure 8 It is a flowchart of at least one embodiment according to this disclosure. Detailed Implementation

[0038] It should be understood that the various aspects disclosed herein can be combined with combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example or embodiment, certain actions or events of any process or method described herein may be performed in a different order, and / or may be added, combined, or omitted entirely (e.g., implementing the disclosed technology may not require all described actions or events depending on the different embodiments of this disclosure). Furthermore, although some aspects of this disclosure are described for clarity as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, computing devices and / or medical devices.

[0039] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the function may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, the function may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (instructions alone or in combination). The computer-readable medium may include a non-transitory computer-readable medium that 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 desired program code in the form of instructions or data structures and is accessible by a computer).

[0040] 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 units), application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the term "processor" as used herein may refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, these technologies can be fully implemented in one or more circuit or logic elements.

[0041] Before explaining any embodiment of this disclosure in detail, it should be understood that this disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or illustrated in the accompanying drawings. This disclosure can have other embodiments and can be practiced or implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof, is intended to cover items listed thereafter and their equivalents, as well as additional items. In addition, this disclosure may use examples to illustrate one or more aspects thereof. 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 to, and does not limit, the scope of this disclosure.

[0042] The terms proximal and distal are used in this disclosure in their usual medical sense, with the proximal being closer to the operator or user of the system and further away from the patient's body or surgical area of ​​concern, and the distal being closer to the patient's body or surgical area of ​​concern and further away from the operator or user of the system.

[0043] Some robotic arms include devices with light-emitting diodes (LEDs) that enable navigation cameras in a navigation system to sense the robotic arm's position in space. This device is positioned under a drape (e.g., a sterile drape used during surgical procedures). The drape's positioning can affect the robotic arm's tracking because wrinkles, folds, and / or angles of the drape can distort the apparent position of the LEDs as seen by the navigation camera. Additionally, when the drape is tightly attached to the robotic arm, its movement can be restricted. Each movement of the robotic arm can alter the LEDs' position relative to the drape, potentially leading to inaccurate tracking of the robotic arm by the navigation camera.

[0044] According to embodiments of this disclosure, a unit can be added at the last joint of the robotic arm to lock the cover in place, making the cover smooth over the LED, thereby advantageously enhancing the navigation camera's ability to track the LED. The unit may include an attachment mechanism located on an end effector that pulls a portion of the cover to keep that portion under tension. The unit may include a sterilizable portion that uses mechanical force to hold the cover in place. The unit may include an attachment mechanism located on an end effector that clamps the cover to keep it under tension without requiring special or dedicated features on the cover. The unit may include a rubber ring welded or otherwise attached to the cover. When the rubber ring is installed, it generates tension in the cover, thereby holding the cover in place using friction. The unit may include a flexible frame (e.g., containing silicone, other flexible polymers, etc.) having the external geometry of the unit, such that the cover stretches over the tracked portion. The unit may include multiple slots into which multiple pins of the cover can be inserted, making the cover smooth over the LED. Multiple pins may include rigid plastic pins that are welded, glued, or otherwise attached to the cover cloth. The unit may include a clamp or clip having multiple flexible legs (e.g., comprising silicone, other flexible polymers, etc.) that are welded, glued, or otherwise attached to the cover cloth such that the cover cloth is smooth on the LED when attached to the robotic arm. The cover cloth may include multiple magnets magnetically coupled to a set of complementary magnets on the unit such that the cover cloth is smooth on the LED when coupled to the unit.

[0045] Such implementations advantageously allow the tracking device for the robotic arm to be positioned under the drape without negatively impacting the overall tracking accuracy. The smoothness of the drape on the tracked portion also advantageously reduces the amount of noise associated with tracking the robotic arm, thereby improving accuracy. By providing dedicated features for positioning the drape relative to the tracking device, the implementation discussed herein also advantageously reduces or eliminates user errors in drape positioning and maintains a consistent drape appearance and feel across the robotic arm across multiple surgical procedures or protocols. Because the tracking device is positioned under the drape, the implementation discussed herein advantageously eliminates the need for sterilization of the tracking device.

[0046] The embodiments disclosed herein provide technical solutions to one or more of the following problems: (1) inaccurate detection and tracking of the robotic arm by the navigation system; (2) sterilization of the navigation tracker; and (3) user errors when positioning the drape on the surgical arm.

[0047] First go to Figures 1A to 1C This document illustrates aspects of a system 100 according to at least one embodiment of the present disclosure. System 100 can be used to attach a drape to a robotic arm; control, position, and / or otherwise manipulate a surgical support system, surgical arm, and / or surgical instruments attached thereto; and / or perform one or more other aspects of the methods disclosed herein. System 100 includes a computing device 102, one or more imaging devices 112, a robot 114, a navigation system 118, a database 130, a sterile drape 132, and / or a cloud or other network 134. Systems according to other embodiments of the present disclosure may include more or fewer components than system 100. For example, system 100 may not include imaging devices 112, one or more components of computing device 102, database 130, and / or cloud 134.

[0048] The computing device 102 includes a processor 104, a memory 106, a communication interface 108, and a user interface 110. Other embodiments of the computing device according to this disclosure may include more or fewer components than computing device 102.

[0049] The processor 104 of computing device 102 may be any processor described herein or any similar processor. Processor 104 may be configured to execute instructions stored in memory 106 that enable processor 104 to perform one or more computational steps using or based on data received from imaging device 112, robot 114, navigation system 118, database 130 and / or cloud 134. Processor 104 may be or include, for example, 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 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 circuits.

[0050] Memory 106 may be or include RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible non-transitory memory used to store computer-readable data and / or instructions. Memory 106 may store information or data useful for performing any step of, for example, method 800 described herein or any step of any other method. Memory 106 may store instructions and / or machine learning models, for example, supporting one or more functions of robot 114. For example, memory 106 may store content (e.g., instructions and / or machine learning models) that, when executed by processor 104, enable image processing 120, segmentation 122, transformation 124, and / or registration 128. In some embodiments, such content may be organized into one or more applications, modules, packages, layers, or engines if provided as instructions. Alternatively or additionally, memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by processor 104 to implement the various methods and features described herein. Therefore, although the various contents of memory 106 can be described as instructions, it should be understood that the functions described herein can be implemented using instructions, algorithms, and / or machine learning models. These data, algorithms, and / or instructions enable processor 104 to manipulate data stored in memory 106 and / or data received from or via imaging device 112, robot 114, database 130, and / or cloud 134.

[0051] Communication interface 108 can be used to receive image data or other information from external sources (such as imaging device 112, robot 114, navigation system 118, database 130, cloud 134, and / or any other system or component not part of system 100), and / or to send instructions, images, or other information to external systems or devices (e.g., another computing device 102, imaging device 112, robot 114, navigation system 118, database 130, cloud 134, and / or any other system or component not part of system 100). Communication interface 108 may include one or more wired interfaces (e.g., USB port, Ethernet port, FireWire port) and / or one or more wireless transceivers or interfaces (configured to send and / or receive information, for example, via one or more wireless communication protocols such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, etc.). In some implementations, the communication interface 108 may be used to enable the computing 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.

[0052] The computing device 102 may also include one or more user interfaces 110. User interface 110 may be or include a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or providing information to a user. User interface 110 may be used, for example, to receive user selections or other user input regarding one or more steps 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 system 100 (e.g., by processor 104 or another component of system 100) or received by system 100 from a source external to system 100. In some embodiments, user interface 110 may be used to allow a surgeon or other user to modify instructions to be executed by processor 104 according to one or more embodiments of this disclosure, and / or modify or adjust settings displayed on user interface 110 or corresponding to other information on that user interface.

[0053] 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 housed separately from one or more other components of the computing device 102. In some embodiments, the user interface 110 may be positioned close to one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be positioned away from one or more other components of the computing device 102.

[0054] Imaging device 112 may be operable to image anatomical features (e.g., bones, veins, tissues, etc.) and / or other aspects of a patient's anatomy to produce 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 imaging device 112, including data in machine-readable, graphical / visual, and any other form. In various examples, image data may include data corresponding to a patient's anatomical features or a portion thereof. Image data may be or include preoperative images, intraoperative images, postoperative images, or images taken independently of any surgical procedure. In some embodiments, first imaging device 112 may be used to acquire first image data (e.g., a first image) at a first time, and second imaging device 112 may be used to acquire second image data (e.g., a second image) at a second time after the first time. Imaging device 112 may be capable of capturing two-dimensional (2D) or three-dimensional (3D) images to produce image data. Imaging device 112 may 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, C-arm, G-arm, or any other device utilizing X-ray-based imaging (e.g., a fluorescence microscope, 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 adapted to obtain images of a patient's anatomical features. Imaging device 112 may be entirely contained within a single housing, or may include transmitters / transmitters and receivers / detectors located in separate housings or otherwise physically separated.

[0055] In some embodiments, imaging device 112 may include 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 yet other embodiments, the same imaging device may be used to provide both first image data and second image data and / or any other image data described herein. Imaging device 112 may be operable to generate an image data stream. For example, imaging device 112 may be configured to utilize an open shutter operation, or to utilize shutter operations that alternate continuously between open and closed, to capture a series of images. For the purposes of this disclosure, unless otherwise specified, if the image data represents two or more frames per second, the image data may be considered continuous and / or provided as an image data stream.

[0056] In some embodiments, robot 114 may be mechanically coupled to a patient bed or operating table (e.g., attached to, mounted to, or mounted on the patient bed or operating table). In other embodiments, robot 114 may be mounted on a robotic trolley 144. Robotic trolley 144 may be or include a movement platform that enables robot 114 and / or its components to be positioned relative to the patient and / or the bed or operating table on which the patient is positioned. In some embodiments, robotic trolley 144 may include wheels that enable robotic trolley 144 to roll or move relative to the patient. Robotic trolley 144 may be detachable from the wheels, or the wheels may be locked so that once robotic trolley 144 is positioned in a desired location relative to the patient, it will remain fixed in that desired location. In other words, robotic trolley 144 may have mechanisms that enable robotic trolley 144 to remain fixed relative to the patient. Once the robotic cart 144 is positioned in the desired location, the mechanism can better ensure that the robot 114 and / or any other components on the robotic cart 144 do not move relative to the patient due to the mobility of the robotic cart 144.

[0057] Robot 114 can be any surgical robot or surgical robot system. Robot 114 can be, or includes, for example, Mazor X. ™ Stealth robot guidance system. Robot 114 may be configured to position imaging device 112 at one or more precise locations and orientations, and / or return imaging device 112 to the same location and orientation at a later point in time. Robot 114 may additionally or alternatively be configured to manipulate surgical instruments (whether or not based on guidance from navigation system 118) to perform or assist surgical tasks. In some embodiments, robot 114 may be configured to hold and / or manipulate anatomical elements during or in conjunction with surgical procedures. Robot 114 may include one or more robotic arms 116. In some embodiments, robotic arms 116 may include a first robotic arm and a second robotic arm, but robot 114 may include more than two robotic arms. In some embodiments, one or more robotic arms 116 may be used to hold and / or manipulate imaging device 112. In embodiments where imaging device 112 includes two or more physically separate components (e.g., transmitters and receivers), one robotic arm 116 may hold one such component, and another robotic arm 116 may hold another such component. Each robotic arm 116 can be positioned independently of other robotic arms. Robotic arms 116 can be controlled in a single shared coordinate space or in a separate coordinate space.

[0058] 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. Furthermore, the robotic arm 116 can be or is capable of being positioned in any pose, plane, and / or focal position. Pose includes both positioning and orientation. Therefore, an imaging device 112, surgical instrument, or other object held by the robot 114 (or more specifically, by the robotic arm 116) can be precisely positioned in one or more desired and specific positions and orientations.

[0059] In some embodiments, reference markers (i.e., navigation markers) may be placed on robot 114 (including, for example, on robotic arm 116), imaging device 112, or any other object in the surgical space. The reference markers may be tracked by navigation system 118, and the results of the tracking may be used by the operator of robot 114 and / or system 100 or any of its components. In some embodiments, navigation system 118 may be used to track other components of the system (e.g., imaging device 112), and the system may operate without using robot 114 (e.g., a surgeon manually manipulating imaging device 112 and / or one or more surgical instruments, for example, based on information and / or instructions generated by navigation system 118).

[0060] During operation, navigation system 118 can provide navigation for the surgeon and / or surgical robot. Navigation system 118 can be any navigation system currently known or developed in the future, including, for example, Medtronic StealthStation. ™The S8 surgical navigation system or any subsequent system thereof. Navigation system 118 may include one or more cameras or other sensors for tracking one or more reference markers (e.g., navigation markers 148A-148F), navigation trackers, or other objects within the operating room or other room where part or all of system 100 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, navigation system 118 may include one or more electromagnetic sensors. In various embodiments, navigation system 118 may be used to track the positioning and orientation (e.g., pose) of imaging device 112, robot 114 and / or robotic arm 116 and / or one or more surgical instruments (or more specifically, to track the pose of navigation portion 136 or other navigation trackers that are directly or indirectly attached to one or more of the foregoing in a fixed relationship). Navigation system 118 may include a display for displaying one or more images from an external source (e.g., computing device 102, imaging device 112, or other sources), or for displaying images and / or video streams from one or more cameras or other sensors of navigation system 118. In some implementations, system 100 may operate without the use of navigation system 118. Navigation system 118 may be configured to provide guidance to the surgeon or other users of system 100 or its components, to robot 114, or to any other element of system 100 regarding, for example, the pose of one or more anatomical elements, whether the tool is in the appropriate trajectory, and / or how to move the tool into the appropriate trajectory to perform the surgical task according to the preoperative or other surgical plan.

[0061] Database 130 may store information that associates one coordinate system with another coordinate system (e.g., associates one or more robot coordinate systems with a patient coordinate system and / or a navigation coordinate system). Database 130 may additionally or alternatively store, for example, one or more surgical plans (including, for example, pose information about the target and / or image information about the anatomical structures of the patient at and / or proximal to the surgical site, for use by the user of robot 114, navigation system 118 and / or computing device 102 or system 100); one or more useful images of surgical procedures performed by or with the assistance of one or more other components of system 100; information about sterile drapes 132 (e.g., type, size, material, sterilization instructions, etc.); information about tracked portion 136 (e.g., pose of navigation markers 148A-148F on tracked portion 136, type of connectors and other units that can be attached to tracked portion 136, etc.); information about attachment device 152 (e.g., type of attachment device, position of attachment device relative to tracked portion 136 or any other component of system 100, etc.); and / or any other useful information. Database 130 may be configured to provide any such information to computing device 102 or any other device of system 100 or any other device outside system 100, whether directly or via cloud 134. In some embodiments, database 130 may be or include 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.

[0062] Cloud 134 can be or represents the Internet or any other wide area network. Computing device 102 can connect to cloud 134 via communication interface 108 using a wired connection, a wireless connection, or both. In some embodiments, computing device 102 can communicate with database 130 and / or external devices (e.g., computing devices) via cloud 134.

[0063] The sterile drape 132 comprises a flexible sheet or other flexible structure (e.g., a flexible net, blanket, etc.) configured to be placed on (e.g., draped over, positioned on, wrapped around, laid on, etc.) one or more components of the system 100 (e.g., robot 114 or its components such as robot arm 116, tracked portion 136, robot cart 144, and combinations thereof). The sterile drape 132 may be transparent or translucent, allowing light to pass through it. In at least one embodiment, the sterile drape 132 may be placed on or at specific locations on or over parts of the robot 114 and / or its components. For example, the sterile drape 132 may cover robot arm 116 (or a portion of the robot arm, such as tracked portion 136). The sterile drape 132 reduces the risk of hazardous materials coming into contact with one or more components on which it is placed, and / or the risk of unintentional contact with one or more components on which it is placed. For example, a sterile drape 132 may form a barrier or protective layer between one or more components and the patient during surgical procedures or surgical protocols. This prevents anatomical tissue (e.g., blood) and other external debris (e.g., dirt, debris, dust, etc.) from contacting the one or more components, and may additionally or alternatively reduce the likelihood of infection by preventing contact between the one or more components and the patient's anatomical tissue. In some embodiments, the sterile drape 132 may comprise one or more portions made of various materials.

[0064] Embodiments of the sterile drape 132 may have or be of various sizes (e.g., different lengths, widths, and / or thicknesses), may be designed for a variety of surgical procedures or surgical tasks (e.g., spinal surgery, laparoscopic procedures, etc.), and may be designed to form a smooth protective barrier over a variety of surgical instruments, devices, and / or components (e.g., O-arms, robots and / or robotic arms, one or more components of navigation systems, etc.), or otherwise cover a variety of surgical instruments, devices, and / or components. In some cases, the sterile drape 132 may be designed to be loose in some areas (e.g., around the joints of the robotic arm 116 to allow the robotic arm 116 to move) and substantially smooth in other areas (e.g., around or near navigation markers 148A-148F to allow the navigation system 118 to track the tracked portion 136). In some embodiments, the sterile drape 132 may be specifically manufactured for a particular surgical procedure or surgical task. In such embodiments, the sterile cover 132 may include additional or alternative components (e.g., interfaces, markings, labels, stripes, combinations thereof, etc.) that facilitate the use of the sterile cover 132.

[0065] The sterile drape 132 (or one or more portions thereof) may be sterilized (e.g., disinfected). Sterilization reduces the likelihood of patient infection during surgical procedures or surgical protocols. In some embodiments, a first surface of the sterile drape 132 may be sterilized, and a second surface opposite the first surface may not be sterilized. When the sterile drape 132 is draped over a surgical instrument or surgical device, the first surface may face the patient (e.g., oriented towards the patient, the surface closest to the patient, the surface that contacts the patient, etc.), while the second surface may face away from the patient (e.g., oriented away from the patient, the surface furthest from the patient, the surface that contacts the robot, imaging device, surgical instrument, or other surgical instrument or surgical device rather than the patient, etc.). In such embodiments, the second surface may contact the surgical instrument or surgical device (e.g., a robotic arm holding a surgical instrument), while the first surface may face outward from the robotic arm, such that any contact between the sterile drape 132 and the patient (such as when a surgical instrument enters the patient's anatomy) occurs between the patient and the sterilized first surface.

[0066] The tracked portion 136 may be or include devices that enable the navigation system 118 to track the robotic arm 116. The tracked portion 136 may have a proximal end that can be coupled to the distal end of the robotic arm 116, and a distal end that can be coupled to the proximal end of the end effector 140. The tracked portion 136 includes navigation markers 148A-148F and attachment devices 152.

[0067] Navigation markers 148A-148F may be or include one or more active markers, one or more passive markers, or a combination of active and passive markers. For example, navigation markers 148A-148F may include a first navigation marker 148A, a second navigation marker 148B, a third navigation marker 148C, a fourth navigation marker 148D, a fifth navigation marker 148E, and a sixth navigation marker 148F. Navigation markers 148A-148F may be, for example, LEDs, infrared LEDs, reflective markers, etc. Navigation system 118 may be configured to obtain pose information describing the pose of navigation markers 148A-148F, which can be used to determine the relevant pose of the tracked portion 136 and to determine the pose of the robot arm 116 based on the known connections from the tracked portion 136 to the robot arm 116 (e.g., using transform 124 and registration 128). Navigation markers 148A-148F can be configured such that navigation system 118 can identify navigation markers 148A-148F when sterile drape 132 is positioned between navigation markers 148A-148F and navigation camera of navigation system 118. For example, navigation markers 148A-148F may include LEDs that emit light through sterile drape 132, allowing navigation system 118 to track tracked portion 136 once sterile drape 132 is positioned on tracked portion 136 and / or robotic arm 116.

[0068] The attachment device 152 may be or include a mechanism that enables the sterile drape 132 to be coupled to the tracked portion 136. The attachment device 152 may facilitate the placement of the sterile drape 132 onto the robotic arm 116 and / or other components (e.g., robotic trolley 144) within the surgical environment. As discussed in further detail below, the attachment device 152 may manipulate (e.g., clamp, push, pull, lock into place, etc.) one or more portions of the sterile drape 132 such that when the sterile drape 132 covers the robotic arm 116 and / or the tracked portion 136, one or more portions of the sterile drape 132 are smooth or substantially smooth relative to the robotic arm 116 and / or the tracked portion 136. In some embodiments, the attachment device 152 may be partially or wholly disposed within or on the tracked portion 136, while in other embodiments, the attachment device 152 may be disposed elsewhere, such as partially or wholly disposed within or on the end effector 140, other portions of the robotic arm 116, etc. In some embodiments, the attachment device 152 may initially be separate from the tracked portion 136, but then engaged with (e.g., slid onto, inserted into, connected to, etc.) the robotic arm 116, the tracked portion 136, and / or the end effector 140 to facilitate the placement of the sterile drape 132 on the robotic arm 116, the tracked portion 136, and / or the end effector 140. In some examples, the attachment device 152 may be separate from the end effector 140 such that the end effector 140 is not covered by or otherwise interacts with the sterile drape 132. In such examples, the end effector 140 can be viewed as a tool (e.g., via a tool changer) that can be attached to the robotic arm 116 such that the tool changer holds the sterile drape 132 for the duration of the surgery or surgical procedure, while the end effector 140 remains outside the sterile drape 132. Thus, the end effector 140 can provide a location outside the sterile drape 132 where multiple different tools can be attached during the procedure.

[0069] In some embodiments, the attachment device 152 can manipulate the sterile drape 132 such that one or more portions of the sterile drape 132 are smooth or substantially smooth relative to the portion of the surgical instrument or device on which the one or more portions are laid. For example, if a portion of the sterile drape 132 is laid on the tracked portion 136, the attachment device 152 can manipulate the sterile drape 132 such that the portion is smooth or substantially smooth relative to the outer surface of the tracked portion 136, such that the portion of the sterile drape 132 is free of wrinkles (e.g., ridges and / or grooves in the portion, areas folded onto itself, etc.). This smoothness allows the navigation system 118 to better track the tracked portion 136 because the portion of the sterile drape 132 minimizes obstruction, confusion, and / or distortion of the appearance of navigation markers 148A-148F as seen by the navigation camera of the navigation system 118. This, in turn, may result in improved navigation accuracy. In some embodiments, the attachment device 152 is manipulating the sterile drape 132 such that multiple portions of the sterile drape 132 are smooth or substantially smooth relative to portions of surgical instruments or devices on which multiple portions of the sterile drape 132 are laid (e.g., tracked portion 136, navigation markers 148A-148F, etc.). For example, the attachment device 152 is manipulating the sterile drape 132 such that each portion of the sterile drape 132 covering each navigation marker of each of the navigation markers 148A-148F is smooth or substantially smooth.

[0070] Unless otherwise specified, “substantially smooth” as used herein means that portion (1) of the sterile cover 132 has substantially the same shape and profile as the underlying surface to which the second portion of the sterile cover 132 is laid, and (2) is free of wrinkles (e.g., ridges and / or grooves in the second portion, areas of the second portion folded over itself, etc.). Alternatively, when specified as such, “substantially smooth” means that portion (1) is free of wrinkles, and (2) is within a distance of the underlying surface (e.g., within 1 mm, within 2 mm, within 3 mm, within 4 mm, within 5 mm, etc.). In still other embodiments, when specified as such, “substantially smooth” may mean that the portion is close enough to the underlying surface that one or more portions of the underlying surface (which may include, for example, the surface of navigation markers (such as one or more navigation markers in navigation markers 148A-148F)) may be identifiable, visible, or otherwise distinguishable by one or more components of system 100 (e.g., navigation system 118). To avoid ambiguity, within the scope of this disclosure, each of the foregoing definitions of "substantially smooth" may be used in conjunction with any implementation described herein.

[0071] End effector 140 may include a proximal end that can be attached to the distal end of the tracked portion 136, and a distal end having an operating portion for performing one or more surgical tasks. End effector 140 may include a surgical tool. The surgical tool may be configured to perform drilling, deburring, milling, cutting, sawing, reaming, tapping, etc., in anatomical tissues such as patient anatomy structures (e.g., soft tissue, bone, etc.). In some embodiments, system 100 may include multiple surgical tools, each performing a different surgical task (e.g., a surgical drill for drilling, a surgical milling machine for milling, a curette for removing anatomical tissue, a bone chisel for cutting bone, etc.). In other embodiments, the surgical tool may provide adapter interfaces to which different working ends can be attached to perform multiple different types of surgical manipulations (e.g., the surgical tool may be able to receive one or more different cutting heads, such that the surgical tool can perform drilling, milling, cutting, sawing, reaming, tapping, etc., depending on the cutting head attached to the surgical tool). The surgical tool may operate autonomously or semi-autonomously. Navigation system 118 can track the pose (e.g., positioning and orientation) of surgical instruments and / or navigate surgical instruments. For example, navigation system 118 can identify navigation markers 148A-148F on the tracked portion 136, and based on the identification of the tracked portion 136 and its connection to the end effector 140, use transformation 124 and registration 128 to determine the pose of the surgical instrument. In some embodiments, attachment device 152 may be partially or wholly disposed on or within the end effector 140.

[0072] System 100 or a similar system may be used, for example, to implement one or more aspects of the method 800 described herein. System 100 or a similar system may also be used for other purposes.

[0073] Next, turn to Figures 2A to 2CThis illustration shows aspects of an attachment device 202 according to an embodiment of the present disclosure. The attachment device 202 may be similar to or identical to attachment device 152. In other words, the attachment device 202 may be configured to facilitate connection between a sterile drape 132 and one or more components of a robot 114 (e.g., robot arm 116, tracked portion 136, end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed on one or more parts or segments of the robot 114 are substantially smooth. The sterile drape 132 may include a plurality of receivers 208A-208N attached thereto (e.g., welded to there, glued to there, etc.). The attachment device 202 includes a plurality of receivers 208A-208N and an adjustment mechanism 212, each of which may be disposed in or on the tracked portion 136. Receivers 208A-208N can be configured to connect with multiple connectors 204A-204N to attach a sterile drape 132 to the tracked portion 136. For example... Figure 2B As shown, the first connector 204A can be coupled to the first receiver 208A, and the second connector 204B can be coupled to the second receiver 208B, so that the sterile drape 132 rests on the outer surface 216 of the tracked portion 136. Once the surgical procedure or surgical protocol is completed, the connectors 204A-204N can be detached from the receivers 208A-208N, so that the sterile drape 132 can be removed from the tracked portion 136.

[0074] Once connectors 204A-204N engage with receivers 208A-208N, adjustment mechanism 212 can be actuated to change the distance between at least one receiver of receivers 208A-208N and one or more other receivers. Adjustment mechanism 212 can be actuated manually (e.g., by a user such as a physician), automatically (e.g., by motors located in or near the tracked portion 136, controlled by processor 104 to actuate adjustment mechanism 212), or semi-automatically (e.g., by motors located in the tracked portion 136, controlled based on input from the user via user interface 110). Adjustment mechanism 212 can change or alter the distance between a receiver and one or more other receivers to make one or more portions of sterile drape 132 substantially smooth. For example, adjustment mechanism 212 may include a spring that is compressible or extendable to move the first receiver 208A toward or away from the second receiver 208B, such that the distance between the first receiver 208A and the second receiver 208B decreases or increases. Changing the distance alters the tension applied to the portion 220 of the sterile cover 132 positioned between the first receiver 208A and the second receiver 208B, making the portion 220 substantially smooth relative to the outer surface 216. This substantial smoothness of the portion 220 allows light from the first navigation marker 148A and the second navigation marker 148B to pass through, enabling the navigation camera of the navigation system 118 to detect the tracked portion 136 and determine the pose of the tracked portion 136 based on the poses of the first navigation marker 148A and the second navigation marker 148B.

[0075] In some embodiments, the attachment device 202 may include a plurality of adjustment mechanisms such that the positioning of one or more receivers among receivers 208A-208N is adjustable relative to one or more other receivers among receivers 208A-208N. For example, the attachment device 202 may include a second adjustment mechanism (not shown) that moves a third receiver (not shown) relative to both the first receiver 208A and the second receiver 208B, such that a portion 220 of the sterile cover 132 can be moved along a third dimension (e.g., into or out). Figure 2C The page in the document is stretched so that portion 220 is substantially smooth. In some embodiments, one or more receivers of receivers 208A-208N may be directly or indirectly attached to adjustment mechanism 212, while one or more other receivers of receivers 208A-208N may be fixed relative to tracked portion 136.

[0076] In some implementations, the adjustment mechanism 212 can be adjusted until the portion 220 becomes substantially smooth relative to the outer surface 216. Adjustments made using the adjustment mechanism 212 can be terminated after: reaching a threshold (e.g., until the navigation camera of the navigation system 118 can detect components such as navigation markers 148A-148F set on the outer surface 216 of the tracked portion 136); until the adjustment mechanism 212 reaches its maximum mechanical limit (e.g., the spring in the adjustment mechanism 212 reaches its maximum compression or expansion); after a predetermined number of iterations or time (e.g., the motor controlling the adjustment mechanism 212 is turned on for 1 second, 2 seconds, 3 seconds, etc.); or combinations thereof.

[0077] refer to Figures 3A to 3B This illustration shows aspects of the attachment device 302 according to an embodiment of the present disclosure. The attachment device 302 may be similar to or identical to attachment devices 152 and / or 202. In other words, the attachment device 302 may be configured to facilitate connection of the sterile drape 132 to one or more components of the robot 114 (e.g., robot arm 116, tracked portion 136, end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed on one or more portions or segments of the robot 114 are substantially smooth. The attachment device 302 includes slots 308A-308N disposed on or in the tracked portion 136. The slots 308A-308N may be configured to receive a plurality of pins 304A-304N connected (e.g., welded to, glued to, etc.) to the sterile drape 132 for attaching the sterile drape 132 to the tracked portion 136 or to a device connected to the tracked portion 136. Figure 3B As shown, the first pin 304A can be engaged with the first slot 308A, and the first pin 304A can be engaged with the second slot 308B, such that the sterile drape 132 rests on the outer surface 312 of the tracked portion 136. The basic smoothness allows the navigation camera of the navigation system 118 to detect the first navigation marker 148A and the second navigation marker 148B, and to use this information to track and / or navigate the robotic arm 116. Once the surgical procedure or surgical protocol is completed, the pins 304A-304N can be disengaged from the slots 308A-308N, allowing the sterile drape 132 to be removed from the tracked portion 136.

[0078] In some embodiments, slots 308A-308N may have multiple different depths, allowing pins 304A-304N to be inserted at various depths. For example, the first slot 308A and the second slot 308B may each have two, three, four, five, or more depths, with the first pin 304A and the second pin 304B respectively inserted at these depths. The interiors of the first slot 308A and the second slot 308B may each have bias portions that lock the corresponding pins 304A, 304B at a predetermined depth while preventing further insertion. An additional force on the corresponding pins 304A, 304B can overcome the bias portions, thereby allowing the corresponding pins 304A, 304B to be further inserted into the slots 308A, 308B until the next bias portion is reached. In this way, pins 304A, 304B can be inserted at discrete depths. In such embodiments, pins 304A-304N can be inserted into the corresponding slots 308A-308N at various depths until a portion 316 of the sterile cover 132 is substantially smooth relative to the outer surface 312. In other words, pins 304A-304N can be inserted further and further into the corresponding slots 308A-308N until the portion 316 is stretched to be substantially smooth.

[0079] In some embodiments, pins 304A-304N may be or include magnets. In such embodiments, slots 308A-308N may each include complementary magnets, such that the magnets in pins 304A-304N are attracted to the magnets in slots 308A-308N, respectively. Pins 304A-304N can then be inserted into slots 308A-308N, and the magnets can attract each other to connect pins 304A-304N to slots 308A-308N, such that portion 316 is substantially smooth relative to the outer surface 312 of portion 316.

[0080] In some examples, the insertion of pins 304A-304N into the corresponding slots 308A-308N may cause the sterile cover 132 to be positioned on the outer surface 312, but which is substantially non-smooth relative to the outer surface. In such examples, and to ensure accurate navigation, the first navigation marker 148A and / or the second navigation marker 148B may be movable relative to the outer surface 312. For example, the first navigation marker 148A and the second navigation marker 148B may be movable relative to the outer surface 312 such that the first navigation marker 148A and the second navigation marker 148B are movable to protrude beyond the tracked portion 136. The first navigation marker 148A and the second navigation marker 148B may be moved away from the outer surface 312 and toward the sterile cover 132 until the first navigation marker 148A and the second navigation marker 148B contact the sterile cover 132 and both are substantially smooth relative to the sterile cover. The first navigation marker 148A and the second navigation marker 148B can be moved electrically, pneumatically, mechanically (e.g., using one or more springs), or in combination thereof, using a motor located, for example, inside the tracked portion 136. In the example above, the radius of the tracked portion 136 increases to meet the radius of the tracked portion 136, in contrast to the stretching of the sterile cover 132 to meet the radius of the tracked portion 136. In some cases, the first navigation marker 148A and the second navigation marker 148B can move toward the sterile cover 132 until the first navigation marker 148A and the second navigation marker 148B can be detected and tracked by the navigation camera of the navigation system 118.

[0081] refer to Figures 4A to 4B This diagram illustrates aspects of the attachment device 402 according to an embodiment of the present disclosure. The attachment device 402 may be similar to or identical to attachment devices 152, 202, and / or 302. In other words, the attachment device 402 may be configured to facilitate the connection of the sterile drape 132 to one or more components of the robot 114 (e.g., robot arm 116, tracked portion 136, end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed on one or more parts or segments of the robot 114 are substantially smooth. The attachment device 402 includes a first clamp 404A and a second clamp 404B. The first clamp 404A includes a first arm 412A and a second arm 416A forming a recess 408A, while the second clamp 404B includes a first arm 412B and a second arm 416B forming a recess 408B. The first clamp 404A and the second clamp 404B can be configured to engage with the tracked portion 136 to clamp the sterile drape 132 to the tracked portion 136. For example... Figure 4BAs illustrated, recesses 408A and 408B may each receive a portion of the tracked portion 136, while first arms 412A and 412B rest on the outer surface 420 of the tracked portion 136. First clamps 404A and 404B, attached to the tracked portion 136, clamp a sterile drape 132 such that a portion 424 of the sterile drape 132 is substantially smooth relative to the outer surface 420 of the tracked portion 136. In other words, the first clamp 404A clamps a first region or portion of the sterile drape 132 (in some cases, this first region or portion may correspond to a first end of the sterile drape 132), while the second clamp 404B clamps a second, different region or portion of the sterile drape 132 (in some cases, this second, different region or portion may correspond to a second end of the sterile drape 132 opposite to the first end) to secure the sterile drape 132 to the outer surface 420 of the tracked portion 136. In some embodiments, the attachment device 402 may include additional clamps, and the first clamp 404A and / or the second clamp 404B may include additional arms or other components that enable the first clamp 404A and / or the second clamp 404B to attach to or otherwise connect to the tracked portion 136. For example, the first clamp 404A and / or the second clamp 404B may each include three, four, five or more arms, each arm clamping into a corresponding recess on the tracked portion 136. In some cases, such as when the first clamp 404A and / or the second clamp 404B are positioned outside the sterile cover 132, the first clamp 404A and the second clamp 404B are sterilized.

[0082] refer to Figures 5A to 5BThis illustration shows aspects of an attachment device 502 according to an embodiment of the present disclosure. Attachment device 502 may be similar to or identical to attachment devices 152, 202, 302, and / or 402. In other words, attachment device 502 may be configured to facilitate connection of sterile drape 132 to one or more components of robot 114 (e.g., robot arm 116, tracked portion 136, end effector 140, etc.) such that one or more portions of sterile drape 132 disposed on one or more parts or segments of robot 114 are substantially smooth. Attachment device 502 includes a gripping device 504 configured to close around a portion of sterile drape 132 to stretch sterile drape 132 relative to the outer surface 508 of tracked portion 136. For example, sterile drape 132 may be disposed on and anchored in one or more areas of tracked portion 136, rather than at gripping device 504. The gripping device 504 can then close around a portion of the sterile drape 132, stretching a portion 512 of the sterile drape 132 to be substantially smooth on the outer surface 508 of the tracked portion 136. Following surgery or surgical procedures, the gripping device 504 can reopen to release the sterile drape 132, allowing it to be removed from the tracked portion 136. In some examples, actuation of the gripping device 504 can be similar to actuation of the adjustment mechanism 212; in other words, the gripping device 504 can close until the portion 512 is substantially smooth, undergoing actuation that satisfies one or more thresholds (e.g., until the navigation camera of the navigation system 118 detects the first navigation marker 148A and / or the second navigation marker 148B, until mechanical limits are reached, etc.). In some implementations, the gripping device 504 may be operated manually (e.g., by a user such as a physician), automatically (e.g., using a motor located in the tracked portion 136 and controlled by the processor 104), or semi-automatically (e.g., the motor located in the tracked portion 136 and controlled by the processor 104 is controlled based on input from the user via the user interface 110).

[0083] refer to Figures 6A to 6BThis illustration shows aspects of the attachment device 602 according to an embodiment of the present disclosure. The attachment device 602 may be similar to or identical to attachment devices 152, 202, 302, 402, and / or 502. In other words, the attachment device 602 may be configured to facilitate the connection of the sterile drape 132 to one or more components of the robot 114 (e.g., robot arm 116, tracked portion 136, end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed on one or more parts or segments of the robot 114 are substantially smooth. The attachment device 602 includes a first flexible portion 604 and a second flexible portion 608. The first flexible portion 604 and / or the second flexible portion 608 may be or comprise rubber bands or other flexible materials (e.g., natural or synthetic rubber, silicone, latex, etc.) such that each of the first flexible portion 604 and the second flexible portion 608 can be bent or wrapped around the tracked portion 136. In some embodiments, the first flexible portion 604 and / or the second flexible portion 608 may be or include a flexible frame that matches and / or conforms to the geometry of the tracked portion 136 (e.g., the first flexible portion 604 and / or the second flexible portion 608 matches the contour of the tracked portion 136), such that when the first flexible portion 604 and / or the second flexible portion 608 is attached to the tracked portion 136, the first flexible portion 604 and / or the second flexible portion 608 are flush with the outer surface 612 of the tracked portion 136. Once the surgical procedure or surgical protocol is completed, the first flexible portion 604 and the second flexible portion 608 can be removed from the tracked portion 136, allowing the sterile drape 132 to be removed from the tracked portion 136.

[0084] The first flexible portion 604 and / or the second flexible portion 608 may be attached (e.g., glued to, welded to, etc.) to the sterile cover 132 to facilitate the attachment of the sterile cover 132 to the tracked portion 136. For example, the first flexible portion 604 may be attached to a first portion of the sterile cover 132, and the second flexible portion 608 may be attached to a second portion of the sterile cover 132. When the first flexible portion 604 and / or the second flexible portion 608 are then attached to the tracked portion 136 (e.g., the first flexible portion 604 and / or the second flexible portion 608 slides or wraps around the tracked portion 136), such that a portion 616 of the sterile cover 132 is substantially smooth relative to the outer surface 612 of the tracked portion 136. In some embodiments, the first flexible portion 604 and / or the second flexible portion 608 may be flexible and attachable to the sterile cover 132 such that when the first flexible portion 604 and the second flexible portion 608 are attached to the tracked portion 136, the friction generated by the first flexible portion 604 and the second flexible portion 608 is sufficient to stretch the portion 616 to a substantially smooth state. In other words, the first flexible portion 604 and the second flexible portion 608 may be in an unstretched form before being attached to the tracked portion 136. Then, when the first flexible portion 604 and the second flexible portion 608 are attached to the tracked portion 136, the first flexible portion 604 and the second flexible portion 608 are stretchable such that the friction between each of the first flexible portion 604 and the tracked portion 136 generates a force that stretches the portion 616 of the sterile cover 132 to a substantially smooth state.

[0085] refer to Figures 7A to 7BThis illustration shows various aspects of the attachment device 702 according to an embodiment of the present disclosure. The attachment device 702 may be similar to or identical to attachment devices 152, 202, 302, 402, 502, and / or 602. In other words, the attachment device 702 may be configured to facilitate connection between the sterile drape 132 and one or more components of the robot 114 (e.g., robot arm 116, tracked portion 136, end effector 140, etc.), such that one or more portions of the sterile drape 132 disposed on one or more parts or segments of the robot 114 are substantially smooth. The attachment device 702 includes a base 704 from which legs 708A-708N extend. The base 704 is coupled to one or more portions of the sterile drape 132. The legs 708A-708N are configured to latch onto, connect to, or otherwise attach the attachment to the tracked portion 136 or a segment or portion thereof. For example, the legs 708A-708N may include a first leg 708A wrapped around a first end of the tracked portion 136 and a second leg 708B wrapped around a second end of the tracked portion 136, such that the attachment 702 remains fixed relative to the tracked portion 136 until a removal force is applied to the first leg 708A and / or the second leg 708B to detach the attachment 702 from the tracked portion 136. The base 704 may include a transparent or translucent portion or segment, or may otherwise include an orifice 720 (e.g., a hole, opening, etc.) across which a portion 712 of the sterile cover 132 extends. Figure 7A As shown, a portion 712 of the sterile cover 132 can extend through the orifice 720, allowing light to pass through the orifice 720 and the portion 712 of the sterile cover 132.

[0086] The attachment device 702 can attach a sterile drape 132 to the tracked portion 136. Legs 708A-708N of the attachment device 702 can hook or latch onto the tracked portion 136, such that a portion 712 of the sterile drape 132 is fixed relative to the tracked portion 136. In some embodiments, the attachment device 702 can be attached such that the portion 712 is positioned on one or more navigation markers (e.g., on a first navigation marker 148A and / or a second navigation marker 148B), such that the attachment device 702 is substantially smooth relative to the outer surface 716. The substantial smoothness of the attachment device 702 allows the navigation camera of the navigation system 118 to detect the first navigation marker 148A and the second navigation marker 148B, thereby enabling the navigation system 118 to determine the pose of the tracked portion 136 and track and / or navigate the robotic arm 116. Once the surgical procedure or surgical protocol is completed, the attachment device 702 can be removed from the tracked portion 136 (e.g., by a user such as a physician applying a removal force to detach the first leg 708A and the second leg 708B from their respective ends of the tracked portion 136), thus disconnecting the sterile drape 132 from the tracked portion 136.

[0087] While each of attachment devices 152, 202, 302, 402, 502, 602, and 702 has been discussed individually, it should be understood that any one or more attachment devices discussed herein may be used in combination with any other one or more attachment devices discussed herein. Additionally or alternatively, multiple different attachment devices may be used simultaneously for different portions of the sterile drape 132 and the device to which the sterile drape 132 will be attached (e.g., robot 114 or one or more components thereof). In some cases, one or more attachment devices may be disposed in or on the tracked portion 136 or other portions of the robotic arm 116 (e.g., partially or wholly disposed on or within the end effector 140, the robotic cart 144, one or more joints of the robotic arm 116, etc.). For example, attachment device 702 can be used to clamp one or more areas of the sterile drape 132 to the tracked portion 136, while attachment device 402 can be used further to hold the sterile drape 132 fixed relative to the end effector 140.

[0088] Figure 8 A method 800 is described that can be used, for example, to attach a sterile drape to a robotic arm.

[0089] One or more aspects of method 800 (and / or one or more steps thereof) may be implemented by, for example, at least one processor or otherwise performed. The at least one processor may be the same as or similar to 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 a navigation system (such as navigation system 118). Method 800 may also be performed using processors other than any processor described herein. The at least one processor may perform one or more portions of method 800 by executing elements stored in memory (such as memory 106). Elements stored in memory and executed by the processor may cause the processor to perform one or more steps of the functions shown in method 800. One or more portions of method 800 may be performed by a processor executing any content of the memory (such as image processing 120, segmentation 122, transformation 124, and / or registration 128).

[0090] Method 800 includes a robotic arm having a tracked portion and an attachment device relative to a patient position (step 804). The robotic arm may be similar to robotic arm 116. The tracked portion may be similar to or identical to tracked portion 136. The attachment device may be similar to or identical to attachment device 152, attachment device 202, attachment device 302, attachment device 402, attachment device 502, attachment device 602, and / or attachment device 702. A robotic trolley (such as robotic trolley 144) may be used to move the robotic arm to the patient position. Step 804 may include providing a sterile drape that can be attached to the robotic arm to separate the patient from the robotic arm and / or other surgical elements covered by the sterile drape.

[0091] Method 800 further includes attaching a sterile drape to a robotic arm using an attachment device (step 808). The sterile drape may be similar to or the same as sterile drape 132. The sterile drape can be attached to the robotic arm using any one or more mechanisms associated with attachment devices 152, 202, 302, 402, 502, 602, and / or 702. For example, the sterile drape may include multiple connectors (e.g., connectors 204A-204N) that can be respectively coupled to multiple receivers (e.g., receivers 208A-208N) associated with attachment device 202. As another example, the attachment device may include multiple slots (e.g., slots 308A-308N) into which one or more pins (e.g., pins 304A-304N) can be inserted to attach the sterile drape to the robotic arm or a portion thereof (e.g., to a tracked unit). As another example, the attachment device may include multiple clamps (e.g., first clamp 404A, second clamp 404B, etc.), each clamping an area of ​​the sterile drape to conform a portion of the sterile drape to the surface of the tracked portion.

[0092] In another example, the attachment device may include a flexible frame (e.g., a first flexible portion 604 and a second flexible portion 608) that matches the geometry of the outer surface of the tracked portion, such that a portion of the drape is substantially smooth relative to the outer surface when the flexible frame is attached to the tracked portion. In yet another example, the attachment device may include a base holding a portion of the sterile drape and a plurality of legs enabling the attachment device to engage with the tracked portion. In this example, the attachment device may be positioned on the tracked portion such that the portion of the sterile drape held by the base is positioned on a navigation marker, allowing a navigation camera associated with a navigation system to identify and track the navigation marker from behind the sterile drape.

[0093] Method 800 also includes tracking the robotic arm using a tracked portion by a navigation system while the robotic arm performs a surgical task (step 812). This navigation system may be similar to or the same as navigation system 118. Since a sterile drape is attached to the robotic arm via an attachment device, navigation markers on the tracked portion (e.g., navigation markers 148A-148F) may be visible or otherwise trackable by the navigation system. For example, a navigation camera associated with the navigation system may optically track the navigation markers, and the navigation system may determine the pose of the robotic arm based on the navigation markers. In some cases, the navigation system may navigate the robotic arm (or one or more parts thereof) to enable the robotic arm to perform a surgical task. The surgical task may be or include any step of a surgical procedure or surgical protocol using the robotic arm. For example, a surgical task may be or include drilling holes in a patient's vertebrae using the operating end of an end effector (e.g., end effector 140) to create holes into which pedicle screws can be inserted. As another example, a surgical task may be or include a robotic arm holding a tool guide for the surgeon to manually operate the surgical tools, such that the tool guide provides guidance for the trajectory of the surgical tools.

[0094] This disclosure covers embodiments of method 800 that include more or fewer steps than those described above and / or one or more steps that are different from those described above.

[0095] As noted above, this disclosure covers those with less than Figure 8 The method includes all steps identified in the diagram (and the corresponding description of method 800), as well as steps exceeding... Figure 8 The method includes additional steps of those steps identified herein (and the corresponding description of method 800). This disclosure also covers 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 includes registration or any other correlation.

[0096] The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. In the foregoing detailed description, for example, for the purpose of simplification, various features of this disclosure are grouped together in one or more aspects, embodiments, and / or configurations. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above. The approach of this disclosure should not be construed as reflecting an intention that the claims require more features than expressly recited in each claim. Rather, as reflected in the following claims, aspects of the invention lie in fewer than all the features of a single foregoing aspect, embodiment, and / or configuration. Therefore, the following claims are hereby incorporated into this detailed description, wherein each claim exists independently as a separate preferred embodiment of this disclosure.

[0097] Furthermore, while the foregoing has already included descriptions of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications may be made within the scope of this disclosure, for example, within the skill and knowledge of those skilled in the art, upon understanding of this disclosure. It is intended to obtain, to the permissible extent, rights including alternative aspects, embodiments, and / or configurations, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps of those claimed, regardless of whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and not to disclose for use in any patentable subject matter.

[0098] The following provides a set of example statements: Example 1: A system comprising: a robotic arm (116); a tracked portion (136) attached to the robotic arm (116) and tracked by a navigation system (118); a sterile drape (132) configured to cover the robotic arm (116) and the tracked portion (136); and attachment devices (152, 202, 302, 402, 502, 602, 702) configured to attach the sterile drape (132) to the tracked portion (136) such that a portion of the sterile drape (132) disposed on the surface of the tracked portion (136) is substantially smooth.

[0099] Example 2: The system according to Example 1, wherein the tracked part (136) includes a plurality of navigation markers (148A-148F).

[0100] Example 3: The system according to Example 2, wherein the plurality of navigation markers (148A-148F) include two or more light-emitting diodes (LEDs).

[0101] Example 4: The system according to any one of Examples 1 to 3, wherein the sterile cover (132) includes a plurality of connectors (204A-204N), wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a plurality of receivers (208A-208N), and wherein each of the plurality of connectors (204A-204N) is coupled to a corresponding receiver of the plurality of receivers (208A-208N).

[0102] Example 5: The system according to Example 4, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes an adjustable spring configured to change the distance between a first receiver (208A) and a second receiver (208B) among the plurality of receivers (208A-208N).

[0103] Example 6: The system according to Example 4, wherein the plurality of connectors (204A-204B) includes a plurality of pins (304A-304N), and wherein the plurality of receivers (208A-208N) includes a plurality of slots (308A-308N), wherein each slot receives each of the plurality of pins (304A-304N).

[0104] Example 7: The system according to Example 4, wherein the plurality of connectors (204A-204N) includes a plurality of magnets.

[0105] Example 8: The system according to any one of Examples 1 to 3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a flexible frame (604, 608) that matches the geometry of the tracked portion (136).

[0106] Example 9: The system according to any one of Examples 1 to 3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes clamping devices (404A, 404B) that clamp at least two regions of the sterile cover (132) to adapt the portion of the sterile cover (132) to the surface of the tracked portion (136).

[0107] Example 10: The system according to any one of Examples 1 to 3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a gripping device (504) that closes around a second portion of the sterile cover (132).

[0108] Example 11: A surgical system comprising: a robotic arm (116); a navigation device (136) coupled to the robotic arm (116), the navigation device (136) including a plurality of navigation markers (148A-148F) tracked by a navigation system (118); a sterile drape (132) capable of covering at least one segment of the navigation device (136); and attachment devices (152, 202, 302, 402, 502, 602, 702) attaching the sterile drape (132) to the navigation device (136) such that a portion of the sterile drape (132) is substantially conformally shaped to the surface of the navigation device (136).

[0109] Example 12: The surgical system according to Example 11, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) is adjustable such that the sterile drape (132) remains substantially conformal to the surface of the navigation device (136) as the robotic arm (116) moves.

[0110] Example 13: The surgical system according to Example 11, wherein the plurality of navigation markers (148A-148F) include two or more light-emitting diodes (LEDs).

[0111] Example 14: A surgical system according to any one of Examples 11 to 13, wherein the sterile drape (132) includes a plurality of connectors (204A-204N), wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a plurality of receivers (208A-208N), and wherein each of the plurality of connectors (204A-204N) is coupled to a corresponding receiver of the plurality of receivers (208A-208N).

[0112] Example 15: The surgical system according to Example 14, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes an adjustable spring configured to change the distance between a first receiver (208A) and a second receiver (208B) among the plurality of receivers (208A-208N).

[0113] Example 16: The surgical system according to Example 14, wherein the plurality of connectors (204A-204N) includes a plurality of pins (304A-304N), wherein the plurality of receivers (208A-208N) includes a plurality of slots (308A-308N), and wherein each of the plurality of slots (308A-308N) is configured to receive a corresponding pin among the plurality of pins (304A-304N).

[0114] Example 17: The surgical system according to Example 14, wherein the plurality of connectors (204A-204N) includes a plurality of magnets.

[0115] Example 18: A surgical system according to any one of Examples 11 to 13, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a flexible frame (604, 608) that matches the geometry of the navigation device (136).

[0116] Example 19: A surgical system according to any one of Examples 11 to 13, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a gripping device (504) that closes around a second portion of the sterile drape (132).

[0117] Example 20: A surgical system comprising: a robotic arm (116); a navigation component (136) connected to a distal portion of the robotic arm (116), the navigation component (136) including a plurality of navigation markers (148A-148F) tracked by a navigation system (118); a sterile drape (132) capable of covering at least one segment of the navigation component (136); and attachment devices (152, 202, 302, 402, 502, 602, 702) configured to attach the sterile drape (132) to the navigation component (136) such that a portion of the sterile drape (132) substantially conforms to the surface of the navigation component (136).

Claims

1. A system comprising: Robotic arm (116); The tracked portion (136) is attached to the robotic arm (116) and tracked by the navigation system (118); A sterile diaphragm (132) is configured to cover the robotic arm (116) and the tracked portion (136). and Attachment devices (152, 202, 302, 402, 502, 602, 702) are configured to attach the sterile cover (132) to the tracked portion (136) such that the portion of the sterile cover (132) disposed on the surface of the tracked portion (136) is substantially smooth.

2. The system of claim 1, wherein the tracked portion (136) comprises a plurality of navigation markers (148A-148F).

3. The system of claim 2, wherein the plurality of navigation markers (148A-148F) comprises two or more light-emitting diodes (LEDs).

4. The system according to any one of claims 1 to 3, wherein the sterile cover (132) comprises a plurality of connectors (204A-204N), wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a plurality of receivers (208A-208N), and wherein each of the plurality of connectors (204A-204N) is coupled to a corresponding receiver of the plurality of receivers (208A-208N).

5. The system of claim 4, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes an adjustable spring configured to change the distance between a first receiver (208A) and a second receiver (208B) among the plurality of receivers (208A-208N).

6. The system of claim 4, wherein the plurality of connectors (204A-204B) comprises a plurality of pins (304A-304N), and wherein the plurality of receivers (208A-208N) comprises a plurality of slots (308A-308N), wherein each slot receives each of the plurality of pins (304A-304N).

7. The system of claim 4, wherein the plurality of connectors (204A-204N) comprises a plurality of magnets.

8. The system according to any one of claims 1 to 3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a flexible frame (604, 608) that matches the geometry of the tracked portion (136).

9. The system according to any one of claims 1 to 3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes clamping devices (404A, 404B) that clamp at least two regions of the sterile drape (132) to conform the portion of the sterile drape (132) to the surface of the tracked portion (136).

10. The system according to any one of claims 1 to 3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) includes a gripping device (504) that closes around a second portion of the sterile tarpaulin (132).

11. A surgical system, the surgical system comprising: Robotic arm (116); A navigation device (136) is connected to the robot arm (116), and the navigation device (136) includes a plurality of navigation markers (148A-148F) tracked by a navigation system (118). A sterile cover (132) capable of covering at least one section of the navigation device (136); and Attachment devices (152, 202, 302, 402, 502, 602, 702) attach the sterile cover (132) to the navigation device (136) such that a portion of the sterile cover (132) is substantially conformable to the surface of the navigation device (136).

12. The surgical system of claim 11, wherein the attachment devices (152, 202, 302, 402, 502, 602, 702) are adjustable such that the sterile drape (132) remains substantially conformal to the surface of the navigation device (136) as the robotic arm (116) moves.

13. The surgical system according to any one of claims 11 to 12, wherein the sterile drape (132) comprises a plurality of connectors (204A-204N), wherein the attachment devices (152, 202, 302, 402, 502, 602, 702) comprise a plurality of receivers (208A-208N), and wherein each of the plurality of connectors (204A-204N) is coupled to a corresponding receiver of the plurality of receivers (208A-208N).

14. The surgical system according to any one of claims 11 to 13, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a flexible frame (604, 608) that matches the geometry of the navigation device (136).

15. A surgical system, the surgical system comprising: Robotic arm (116); A navigation component (136) is attached to the distal portion of the robot arm (116), and the navigation component (136) includes a plurality of navigation markers (148A-148F) tracked by a navigation system (118). A sterile cover (132) capable of covering at least one section of the navigation component (136); and Attachment devices (152, 202, 302, 402, 502, 602, 702) are configured to attach the sterile cover (132) to the navigation component (136) such that a portion of the sterile cover (132) is substantially conformable to the surface of the navigation component (136).

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