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WO2025134121A1 - Systèmes et procédés permettant de fixer un champ à une ou plusieurs parties d'un bras robotique - Google Patents

Systèmes et procédés permettant de fixer un champ à une ou plusieurs parties d'un bras robotique Download PDF

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Publication number
WO2025134121A1
WO2025134121A1 PCT/IL2024/051201 IL2024051201W WO2025134121A1 WO 2025134121 A1 WO2025134121 A1 WO 2025134121A1 IL 2024051201 W IL2024051201 W IL 2024051201W WO 2025134121 A1 WO2025134121 A1 WO 2025134121A1
Authority
WO
WIPO (PCT)
Prior art keywords
navigation
sterile drape
attachment device
tracked
robotic arm
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IL2024/051201
Other languages
English (en)
Inventor
Ziv SEEMANN
Dafna DOR
Moran GUTHMAN
Itay JERBY
Stanislav LOKSHIN
Adi Sandelson
Avi Gabriel MARCOVICI
Nimrod Dori
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Mazor Robotics Ltd
Original Assignee
Mazor Robotics Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mazor Robotics Ltd filed Critical Mazor Robotics Ltd
Publication of WO2025134121A1 publication Critical patent/WO2025134121A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B46/00—Surgical drapes
    • A61B46/10—Surgical drapes specially adapted for instruments, e.g. microscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00172—Connectors and adapters therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3937—Visible markers
    • A61B2090/3945—Active visible markers, e.g. light emitting diodes

Definitions

  • the present disclosure is generally directed to surgical robot navigation, and relates more particularly to attaching a drape to a robotic arm to permit surgical navigation.
  • Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure, or may complete one or more surgical procedures autonomously. Imaging may be used by a medical provider for diagnostic and/or therapeutic purposes. Patient anatomy can change over time, particularly following placement of a medical implant in the patient anatomy.
  • Example embodiments of the present disclosure beneficially enable improved tracking and navigation of robotic surgical equipment through the use of an attachment device that connects a sterile drape to the robotic surgical equipment.
  • the attachment device may be disposed underneath the sterile drape or outside the sterile drape, and may manipulate the sterile drape such that one or more portions of the sterile drape are substantially smooth with respect to the underlying surface of the robotic surgical equipment upon which the sterile drape is laid.
  • the substantial smoothness may enable a navigation camera of a navigation system to detect and track navigation markers disposed underneath the sterile drape, beneficially reducing human error, improving the accuracy budget of surgical navigation systems, and reducing the need to sterilize additional equipment used during a surgery or surgical procedure.
  • Example aspects of the present disclosure include:
  • a system comprises: 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 over a surface of the tracked portion is substantially smooth.
  • the tracked portion comprises a plurality of navigation markers.
  • the plurality of navigation markers comprise two or more Light Emitting Diodes (LEDs).
  • the sterile drape comprises a plurality of connectors
  • the attachment device comprises a plurality of receivers
  • each connector of the plurality of connectors couples with a respective receiver of the plurality of receivers.
  • the attachment device comprises an adjustable spring configured to change a distance between a first receiver and a second receiver of the plurality of receivers.
  • the plurality of connectors comprise a plurality of pins
  • the plurality of receivers comprise a plurality of slots, with each slot receiving each pin of the plurality of pins.
  • attachment device comprises a flexible frame that matches a geometry of the tracked portion.
  • attachment device comprises a clipping device that pinches at least two areas of the sterile drape to conform the portion of the sterile drape to the surface of the tracked portion.
  • attachment device comprises a gripping device that closes around a second portion of the sterile drape.
  • a surgical system comprises: a robotic arm; a navigation device coupled with the robotic arm, the navigation device comprising a plurality of navigation markers that are tracked by a navigation system; a sterile drape capable of covering at least a section of the navigation device; and an attachment device that attaches the sterile drape to the navigation device such that a portion of the sterile drape substantially conforms to a surface of the navigation device.
  • attachment device is adjustable such that the sterile drape remains substantially conformed to the surface of the navigation device when the robotic arm moves.
  • the plurality of navigation markers comprise two or more Light Emitting Diodes (LEDs).
  • the sterile drape comprises a plurality of connectors, wherein the attachment device comprises a plurality of receivers, and wherein each connector of the plurality of connectors couple with a respective receiver of the plurality of receivers.
  • the attachment device comprises an adjustable spring configured to alter a distance between a first receiver and a second receiver of the plurality of receivers.
  • the plurality of connectors comprise a plurality of pins
  • the plurality of receivers comprise a plurality of slots
  • each slot of the plurality of slots is configured to receive a respective pin of the plurality of pins.
  • attachment device comprises a flexible frame that matches a geometry of the navigation device.
  • attachment device comprises a gripping device that closes around a second portion of the sterile drape.
  • a surgical system comprises: a robotic arm; a navigation component connected to a distal portion of the robotic arm, the navigation component comprising a plurality of navigation markers that are tracked by a navigation system; a sterile drape capable of covering at least a section 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 a surface of the navigation component.
  • each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
  • each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl- Zo
  • the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y 1 and Zo).
  • Fig. IB shows additional aspects of the system according to at least one embodiment of the present disclosure
  • Fig. 1C shows aspects of a tracked portion attached to a robotic arm and an end effector according to at least one embodiment of the present disclosure
  • FIG. 2A shows aspects of a first attachment device according to at least one embodiment of the present disclosure
  • Fig. 2B shows additional aspects of the first attachment device according to at least one embodiment of the present disclosure
  • Fig. 2C shows additional aspects of the first attachment device according to at least one embodiment of the present disclosure
  • FIG. 3 A shows aspects of a second attachment device according to at least one embodiment of the present disclosure
  • Fig. 3B shows additional aspects of the second attachment device according to at least one embodiment of the present disclosure
  • Fig. 4A shows aspects of a third attachment device according to at least one embodiment of the present disclosure
  • Fig. 4B shows additional aspects of the third attachment device according to at least one embodiment of the present disclosure
  • FIG. 5A shows aspects of a fourth attachment device according to at least one embodiment of the present disclosure
  • Fig. 5B shows additional aspects of the fourth attachment device according to at least one embodiment of the present disclosure
  • Fig. 6A shows aspects of a fifth attachment device according to at least one embodiment of the present disclosure
  • Fig. 6B shows additional aspects of the fifth attachment device according to at least one embodiment of the present disclosure
  • FIG. 7A shows aspects of a sixth attachment device according to at least one embodiment of the present disclosure
  • Fig. 7B shows additional aspects of the sixth attachment device according to at least one embodiment of the present disclosure.
  • Fig. 8 is a flowchart according to at least one embodiment of the present disclosure.
  • the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions).
  • Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
  • processors such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuit
  • DSPs digital signal processors
  • proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.
  • Some robotic arms include devices with Light Emitting Diodes (LEDs) that enable a navigation camera of a navigation system to sense the robotic arm’s position in space.
  • the device is placed under a drape (e.g., a sterile drape used during the course of a surgery or surgical procedure).
  • the position of the drape can affect the tracking of the robotic arm, since wrinkles, folding, and/or angles of the drape can distort the apparent location of the LEDs as seen by the navigation camera.
  • the robotic arm’s movement may be constricted when the drape is tightly attached to the robotic arm. Each movement of the robotic arm may change the position of the LEDs relative to the drape, leading to possible inaccurate tracking of the robotic arm by the navigation camera.
  • a unit at the last joint of the robotic arm may be added that locks the drape in place such that the drape is smooth over the LEDs, beneficially enhancing the navigation camera’s ability to track the LEDs.
  • the unit may include an attachment mechanism on the end effector that pulls on a portion of the drape to keep the portion of the drape under tension.
  • the unit may include a sterilizable portion that keeps the drape in place using mechanical force.
  • the unit may include an attachment mechanism on the end effector that pinches the drape to keep the drape under tension without the need for a special or dedicated feature on the drape.
  • the unit may comprise a rubber ring that is welded or otherwise connected to the drape.
  • the unit may comprise a flexible frame (e.g., comprising silicon, other flexible polymers, etc.) with the shape of the external geometry of the unit, such that the drape stretches over the tracked portion.
  • the unit may comprise a plurality of slots into which a plurality of pins of the drape may slot, such that the drape is smooth over the LEDs.
  • the plurality of pins may comprise rigid plastic pins that are welded, glued, or otherwise attached to the drape.
  • the unit may comprise a clip or clamp with a plurality of flexible legs (e.g., comprising silicon, other flexible polymers, etc.) that is welded, glued, or otherwise attached to the drape, such that when attached to the robotic arm, the drape is smooth over the LEDs.
  • the drape may include a plurality of magnets that magnetically couple with a complementary set of magnets on the unit, such that the drape is smooth over the LEDs when coupled with the unit.
  • Such embodiments beneficially enable the tracking device for the robotic arm to be disposed under the drape without negatively impacting the total accuracy of the tracking.
  • the smoothness of the drape over the tracked portion also beneficially reduce the amount of noise associated with tracking the robotic arm, leading to increased accuracy.
  • embodiments discussed herein also beneficially reduce or eliminate user error in positioning the drape, and maintain a consistent drape look and feel on the robotic arm over the span of multiple surgeries or surgical procedures. Due to the positioning of the tracking device under the drape, embodiments discussed herein beneficially eliminate the need to sterilize the tracking device.
  • Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) inaccurate detection and tracking of robotic arms by a navigation system, (2) sterilizing navigation trackers, and (3) user error when positioning a drape over surgical arms.
  • the system 100 may be used to connect a drape to a robotic arm; control, pose, and/or otherwise manipulate a surgical mount system, a surgical arm, and/or surgical tools attached thereto; and/or carry out one or more other aspects of the method discussed herein.
  • the system 100 comprises 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 comprise more or fewer components than the system 100.
  • the system 100 may not include the imaging device 112, one or more components of the computing device 102, the database 130, and/or the cloud 134.
  • the computing device 102 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110.
  • Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102.
  • the processor 104 of the computing device 102 may be any processor described herein or any similar processor.
  • the processor 104 may be configured to execute instructions stored in the memory 106, which instructions may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the imaging device 112, the robot 114, the navigation system 118, the database 130, and/or the cloud 134.
  • the processor 104 may be or comprise, 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 Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry
  • the memory 106 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer- readable data and/or instructions.
  • the memory 106 may store information or data useful for completing, for example, any step of the method 800 described herein, or of any other methods.
  • the memory 106 may store, for example, instructions and/or machine learning models that support one or more functions of the robot 114.
  • the memory 106 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 104, enable image processing 120, segmentation 122, transformation 124, and/or registration 128.
  • Such content may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines.
  • the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein.
  • various contents of memory 106 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models.
  • the data, algorithms, and/or instructions may cause the processor 104 to manipulate data stored in the memory 106 and/or received from or via the imaging device 112, the robot 114, the database 130, and/or the cloud 134.
  • the communication interface 108 may be used for receiving image data or other information from an external source (such as the imaging device 112, the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the imaging device 112, the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100).
  • an external system or device e.g., another computing device 102, the imaging device 112, the robot 114, the navigation system 118, the database 130, the cloud 134, and/or any other system or component not part of the system 100.
  • the communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.1 la/b/g/n, Bluetooth, NFC, ZigBee, and so forth).
  • the communication interface 108 may be useful for enabling the computing device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
  • the computing device 102 may also comprise one or more user interfaces 110.
  • the user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user.
  • the user interface 110 may be used, for example, to receive a user selection or other user input regarding one or more steps of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104 or another component of the system 100) or received by the system 100 from a source external to the system 100.
  • the user interface 110 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.
  • the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102.
  • the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computing device 102.
  • the imaging device 112 may be operable to image anatomical feature(s) (e.g., a bone, veins, tissue, etc.) and/or other aspects of patient anatomy to yield image data (e.g., image data depicting or corresponding to a bone, veins, tissue, etc.).
  • image data refers to the data generated or captured by an imaging device 112, including in a machine-readable form, a graphical/visual form, and in any other form.
  • the image data may comprise data corresponding to an anatomical feature of a patient, or to a portion thereof.
  • the image data may be or comprise a preoperative image, an intraoperative image, a postoperative image, or an image taken independently of any surgical procedure.
  • a first imaging device 112 may be used to obtain first image data (e.g., a first image) at a first time, and a second imaging device 112 may be used to obtain second image data (e.g., a second image) at a second time after the first time.
  • the imaging device 112 may be capable of taking a two-dimensional (2D) image or a three-dimensional (3D) image to yield the image data.
  • the imaging device 112 may be or comprise, for example, an ultrasound scanner (which may comprise, for example, a physically separate transducer and receiver, or a single ultrasound transceiver), an O-arm, a C-arm, a G-arm, or any other device utilizing X-ray -based imaging (e.g., a fluoroscope, a CT scanner, or other X- ray machine), a magnetic resonance imaging (MRI) scanner, an optical coherence tomography (OCT) scanner, an endoscope, a microscope, an optical camera, a thermographic camera (e.g., an infrared camera), a radar system (which may comprise, for example, a transmitter, a receiver, a processor, and one or more antennae), or any other imaging device 112 suitable for obtaining images of an anatomical feature of a patient.
  • the imaging device 112 may be contained entirely within a single housing, or may comprise a transmitter/emitter and a receiver/detector that are in separate housings or
  • the imaging device 112 may comprise more than one imaging device 112.
  • a first imaging device may provide first image data and/or a first image
  • a second imaging device may provide second image data and/or a second image.
  • the same imaging device may be used to provide both the first image data and the second image data, and/or any other image data described herein.
  • the imaging device 112 may be operable to generate a stream of image data.
  • the imaging device 112 may be configured to operate with an open shutter, or with a shutter that continuously alternates between open and shut so as to capture successive images.
  • image data may be considered to be continuous and/or provided as an image data stream if the image data represents two or more frames per second.
  • the robot 114 may be mechanically coupled with (e.g., affixed to, attached to, mounted to, etc.) a patient bed or table.
  • the robot 114 may be disposed on a robot cart 144.
  • the robot cart 144 may be or comprise a mobile platform that enables the robot 114 and/or components thereof to be positioned relative to the patient and/or the bed or table on which the patient is positioned.
  • the robot cart 144 may comprise wheels that enable the robot cart 144 to roll or move relative to the patient.
  • the robot cart 144 may be detachable from the wheels or the wheels may lockable such that, once the robot cart 144 is positioned in a desired location relative to the patient, the robot cart 144 will remain fixed in the desired location.
  • the robot cart 144 may have a mechanism that enables the robot cart 144 to remain fixed relative to the patient. The mechanism may better ensure that the robot 114 and/or any other components on the robot cart 144 do not move relative to the patient due to the mobility of the robot cart 144 once the robot cart 144 has been positioned in the desired location.
  • the robot 114 may be any surgical robot or surgical robotic system.
  • the robot 114 may be or comprise, for example, the Mazor XTM Stealth Edition robotic guidance system.
  • the robot 114 may be configured to position the imaging device 112 at one or more precise position(s) and orientation(s), and/or to return the imaging device 112 to the same position(s) and orientation(s) at a later point in time.
  • the robot 114 may additionally or alternatively be configured to manipulate a surgical tool (whether based on guidance from the navigation system 118 or not) to accomplish or to assist with a surgical task.
  • the robot 114 may be configured to hold and/or manipulate an anatomical element during or in connection with a surgical procedure.
  • the robot 114 may comprise one or more robotic arms 116.
  • the robotic arm 116 may comprise a first robotic arm and a second robotic arm, though the robot 114 may comprise more than two robotic arms.
  • one or more of the robotic arms 116 may be used to hold and/or maneuver the imaging device 112.
  • the imaging device 112 comprises two or more physically separate components (e.g., a transmitter and receiver)
  • one robotic arm 116 may hold one such component
  • another robotic arm 116 may hold another such component.
  • Each robotic arm 116 may be positionable independently of the other robotic arm.
  • the robotic arms 116 may be controlled in a single, shared coordinate space, or in separate coordinate spaces.
  • the robot 114 together with the robotic arm 116, may have, for example, one, two, three, four, five, six, seven, or more degrees of freedom. Further, the robotic arm 116 may be positioned or positionable in any pose, plane, and/or focal point. The pose includes a position and an orientation. As a result, an imaging device 112, surgical tool, or other object held by the robot 114 (or, more specifically, by the robotic arm 116) may be precisely positionable in one or more needed and specific positions and orientations.
  • reference markers may be placed on the robot 114 (including, e.g., on the robotic arm 116), the imaging device 112, or any other object in the surgical space.
  • the reference markers may be tracked by the navigation system 118, and the results of the tracking may be used by the robot 114 and/or by an operator of the system 100 or any component thereof.
  • the navigation system 118 can be used to track other components of the system (e.g., imaging device 112) and the system can operate without the use of the robot 114 (e.g., with the surgeon manually manipulating the imaging device 112 and/or one or more surgical tools, based on information and/or instructions generated by the navigation system 118, for example).
  • the navigation system 118 may provide navigation for a surgeon and/or a surgical robot during an operation.
  • the navigation system 118 may be any now-known or future-developed navigation system, including, for example, the Medtronic StealthStationTM S8 surgical navigation system or any successor thereof.
  • the navigation system 118 may include one or more cameras or other sensor(s) for tracking one or more reference markers (e.g., navigation markers 148A-148F), navigated trackers, or other objects within the operating room or other room in which some or all of the system 100 is located.
  • the one or more cameras may be optical cameras, infrared cameras, or other cameras.
  • the navigation system 118 may comprise one or more electromagnetic sensors.
  • the navigation system 118 may be used to track a position and orientation (e.g., a pose) of the imaging device 112, the robot 114 and/or robotic arm 116, and/or one or more surgical tools (or, more particularly, to track a pose of the tracked portion 136 or other navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing).
  • the navigation system 118 may include a display for displaying one or more images from an external source (e.g., the computing device 102, imaging device 112, or other source) or for displaying an image and/or video stream from the one or more cameras or other sensors of the navigation system 118.
  • the system 100 can operate without the use of the navigation system 118.
  • the navigation system 118 may be configured to provide guidance to a surgeon or other user of the system 100 or a component thereof, to the robot 114, or to any other element of the system 100 regarding, for example, a pose of one or more anatomical elements, whether or not a tool is in the proper trajectory, and/or how to move a tool into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan.
  • the database 130 may store information that correlates one coordinate system to another (e.g., one or more robotic coordinate systems to a patient coordinate system and/or to a navigation coordinate system).
  • the database 130 may additionally or alternatively store, for example, one or more surgical plans (including, for example, pose information about a target and/or image information about a patient’s anatomy at and/or proximate the surgical site, for use by the robot 114, the navigation system 118, and/or a user of the computing device 102 or of the system 100); one or more images useful in connection with a surgery to be completed by or with the assistance of one or more other components of the system 100; information about the sterile drape 132 (e.g., type, dimensions, material, sterilization instructions, etc.); information about the tracked portion 136 (e.g., the pose of the navigation markers 148A-148F on the tracked portion 136, types of connectors and other units that can attach to the tracked portion 136, etc.); information about the attachment device 152 (e.g.,
  • the database 130 may be configured to provide any such information to the computing device 102 or to any other device of the system 100 or external to the system 100, whether directly or via the cloud 134.
  • the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and/or another system for collecting, storing, managing, and/or transmitting electronic medical records including image data.
  • 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.
  • the cloud 134 may be or represent the Internet or any other wide area network.
  • the computing device 102 may be connected to the cloud 134 via the communication interface 108, using a wired connection, a wireless connection, or both.
  • the computing device 102 may communicate with the database 130 and/or an external device (e.g., a computing device) via the cloud 134.
  • the sterile drape 132 comprises a flexible sheet or other flexible structure (e.g., a flexible mesh, a blanket, etc.) configured to be placed on (e.g., draped over, positioned on, wrapped about, laid over, etc.) one or more components of the system 100 (e.g., the robot 114 or components thereof such as the robotic arm 116, the tracked portion 136, the robot cart 144, combinations thereof, etc.).
  • the sterile drape 132 may be transparent or semi-transparent, such that light can pass through the sterile drape 132.
  • the sterile drape 132 may be placed over certain portions or at specific locations of the robot 114 and/or components thereof.
  • the sterile drape 132 may cover the robotic arm 116 (or a portion thereof such as the tracked portion 136).
  • the sterile drape 132 may reduce the risk of hazardous material contacting the one or more components over which the sterile drape 132 is placed, and/or of inadvertent contact with the one or more components over which the sterile drape 132 is placed.
  • the sterile drape 132 may form a barrier or protective layer between the one or more components and a patient during surgery or surgical procedure, which may prevent anatomical tissues (e.g., blood) and other external detritus (e.g., dirt, debris, dust, etc.) from contacting the one or more components, and may additionally or alternatively reduce the possibility of infection by preventing the one or more components from contacting anatomical tissue of the patient.
  • the sterile drape 132 may comprise one or more portions made from various materials.
  • Embodiments of the sterile drape 132 may have or be various sizes (e.g., different lengths, widths, and/or thicknesses), may be designed for various surgeries or surgical tasks (e.g., spinal surgeries, laparoscopic procedures, etc.), and may be designed to form a smooth protective barrier over or otherwise cover various surgical tools, instruments, and/or components (e.g., an 0-arm, a robot and/or robotic arm, one or more components of a navigation system, etc.).
  • various surgeries or surgical tasks e.g., spinal surgeries, laparoscopic procedures, etc.
  • a smooth protective barrier over or otherwise cover various surgical tools, instruments, and/or components (e.g., an 0-arm, a robot and/or robotic arm, one or more components of a navigation system, etc.).
  • the sterile drape 132 may be designed to be loose in some areas (e.g., around the joints of the robotic arm 116 to enable movement of the robotic arm 116) and to be substantially smooth in other areas (e.g., around or near the navigation markers 148A-148F to enable the navigation system 118 to track the tracked portion 136).
  • the sterile drape 132 may be specifically manufactured to be used in specific surgeries or surgical tasks.
  • the sterile drape 132 may comprise additional or alternative components (e.g., interfaces, markings, labels, stripes, combinations thereof, etc.) which may facilitate the use of the sterile drape 132.
  • the sterile drape 132 (or one or more portions thereof) may be sterilized (e.g., disinfected). The sterilization may reduce the possibility of infection to a patient during a surgery or surgical procedure. 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.
  • the first surface may face toward the patient (e.g., be oriented toward the patient, be the surface closest to the patient, be the surface that contacts the patient, etc.) while the second surface may face away from the patient (e.g., be oriented away from the patient, be the surface furthest from the patient, be the surface that contacts a robot, imaging device, surgical tool, or other surgical instrument or surgical device and not the patient, etc.) when the sterile drape 132 is draped over a surgical instrument or surgical device.
  • the tracked portion 136 may be or comprise a device that enables 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 a proximal end of an end effector 140.
  • the tracked portion 136 comprises navigation markers 148A-148F and an attachment device 152.
  • the navigation markers 148A-148F may be or comprise one or more active markers, one or more passive markers, or a combination of active and passive markers.
  • the navigation markers 148A-148F may comprise 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.
  • the navigation markers 148A-148F may be, for example, LEDs, infrared LEDs, reflective markers, and/or the like.
  • the navigation system 118 may be configured to obtain pose information describing a pose of the navigation markers 148A-148F, which may be used to determine a correlating pose of the tracked portion 136 and, based on the known connection of the tracked portion 136 to the robotic arm 116, the pose of the robotic arm 116 (e.g., using transformation 124 and registration 128).
  • the navigation markers 148A-148F may be configured such that the navigation system 118 can identify the navigation markers 148A-148F when the sterile drape 132 is disposed between the navigation markers 148A-148F and the navigation camera of the navigation system 118.
  • the navigation markers 148A-148F may comprise LEDs that emit light through the sterile drape 132, such that the tracked portion 136 can be tracked by the navigation system 118 once the sterile drape 132 has been disposed over the tracked portion 136 and/or the robotic arm 116.
  • the attachment device 152 may be or comprise a mechanism that enables the sterile drape 132 to be coupled with the tracked portion 136.
  • the attachment device 152 may facilitate placement of the sterile drape 132 on the robotic arm 116 and/or other components within a surgical environment (e.g., the robot cart 144).
  • the attachment device 152 may manipulate (e.g., pinch, push, pull, lock in place, etc.) one or more portions of the sterile drape 132 such that, when the sterile drape 132 is 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.
  • the attachment device 152 may be disposed partially or wholly within or on the tracked portion 136, while in other embodiments the attachment device 152 may be disposed elsewhere, such as partially or wholly within or on the end effector 140, other parts of the robotic arm 116, etc. In some embodiments, the attachment device 152 may be separate from the tracked portion 136 initially, but is then coupled 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.
  • the attachment device 152 may be separate from the end effector 140, such that the end effector 140 is not covered by or does not otherwise interact with the sterile drape 132.
  • the end effector 140 may be treated as a tool that is attachable to the robotic arm 116 (e.g., via a tool changer), such that the tool changer holds the sterile drape 132 for a duration of the surgery or surgical procedure while the end effector 140 remains outside the sterile drape 132.
  • the end effector 140 may provide a location outside the sterile drape 132 to which multiple different tools may be attached during the course of the surgery or surgical procedure.
  • the attachment device 152 may 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 over which the one or more portions are laid. For example, if a portion of the sterile drape 132 is laid over the tracked portion 136, the attachment device 152 may manipulate the sterile drape 132 such that the portion is smooth or substantially smooth relative to an outside surface of the tracked portion 136, such that the portion of the sterile drape 132 is free of wrinkles (e.g., ridges and/or furrows in the portion, areas where the portion folds onto itself, etc.).
  • wrinkles e.g., ridges and/or furrows in the portion, areas where the portion folds onto itself, etc.
  • the attachment device 152 may manipulate the sterile drape 132 such that multiple portions of the sterile drape 132 are smooth or substantially smooth relative to the portion of the surgical instrument or device (e.g., the tracked portion 136, the navigation markers 148A- 148F, etc.) over which the multiple portions of the sterile drape 132 are laid.
  • the attachment device 152 may manipulate the sterile drape 132 such that each portion of the sterile drape 132 that covers each navigation marker of the navigation markers 148A-148F is smooth or substantially smooth.
  • substantially smooth means that the portion of the sterile drape 132 (1) has substantially the same shape and contour as an underlying surface onto which the second portion of the sterile drape 132 is laid, and (2) is free of wrinkles (e.g., ridges and/or furrows in the portion, areas where the portion folds onto itself, etc.).
  • substantially smooth means that the portion (1) is free of wrinkles, and (2) is within a distance of an underlying surface (e.g., within 1 millimeter (mm), within 2 mm, within 3 mm, within 4 mm, within 5 mm, etc.).
  • substantially smooth may mean that the portion is close enough to an underlying surface that one or more portions of the underlying surface (which may include, for example, a surface of a navigation marker such as one or more of the navigation markers 148A-148F) may be identifiable, viewable, or can otherwise be distinguished by one or more components of the system 100 (e.g., a navigation system 118).
  • a navigation system 118 e.g., a navigation system 118
  • the end effector 140 may include a proximal end that is connectable to a distal end of the tracked portion 136, and a distal end with an operative portion that can be used to carry out one or more surgical tasks.
  • the end effector 140 may comprise a surgical tool.
  • the surgical tool may be configured to drill, burr, mill, cut, saw, ream, tap, etc. into anatomical tissues such as patient anatomy (e.g., soft tissues, bone, etc.).
  • the system 100 may comprise multiple surgical tools, with each surgical tool performing a different surgical task (e.g., a surgical drill for drilling, a surgical mill for milling, a curette for removing anatomical tissue, an osteotome for cutting bone, etc.).
  • the surgical tool may provide an adapter interface to which different working ends can be attached to perform multiple different types of surgical maneuvers (e.g., the surgical tool may be able to receive one or more different tool bits, such that the surgical tool can drill, mill, cut, saw, ream, tap, etc. depending on the tool bit coupled with the surgical tool).
  • the surgical tool may be operated autonomously or semi-autonomously.
  • the navigation system 118 may track the pose (e.g., position and orientation) of and/or navigate the surgical tool.
  • the navigation system 118 may identify the navigation markers 148A- 148F on the tracked portion 136 and, based on the identification and the coupling of the tracked portion 136 with the end effector 140, use transformation 124 and registration 128 to determine the pose of the surgical tool.
  • the attachment device 152 may be disposed partially or wholly on or within the end effector 140.
  • the system 100 or similar systems may be used, for example, to carry out one or more aspects of the method 800 described herein.
  • the system 100 or similar systems may also be used for other purposes.
  • the attachment device 202 may be similar to or the same as the attachment device 152.
  • the attachment device 202 may be configured to facilitate the connection of the sterile drape 132 with one or more components of the robot 114 (e.g., the robotic arm 116, the tracked portion 136, the end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed over one or more portions or sections of the robot 114 are substantially smooth.
  • the sterile drape 132 may comprise a plurality of receivers 208A-208N that connected thereto (e.g., welded thereto, glued thereto, etc.).
  • the attachment device 202 comprises a plurality of receivers 208A-208N and an adjustment mechanism 212, each of which may be disposed in or on the tracked portion 136.
  • the receivers 208A-208N may be configured to couple with a plurality of connectors 204A-204N to attach the sterile drape 132 to the tracked portion 136. As shown in Fig.
  • a first connector 204 A may couple with a first receiver 208 A and a second connector 204B may couple with a second receiver 208B, such that the sterile drape 132 rests on an outer surface 216 of the tracked portion 136.
  • the connectors 204A-204N may be decoupled from the receivers 208A-208N, such that the sterile drape 132 can be removed from the tracked portion 136.
  • the adjustment mechanism 212 can be actuated to change the distance of at least one receiver and one or more other receivers of the receivers 208A-208N.
  • the adjustment mechanism 212 may be actuated manually (e.g., by a user such as a physician), automatically (e.g., by motors disposed in or proximate the tracked portion 136 that are controlled by the processor 104 to cause actuation of the adjustment mechanism 212), or semi-automatically (e.g., by motors disposed in the tracked portion 136 that are controlled based on inputs from the user via the user interface 110).
  • the adjustment mechanism 212 may change or alter the distance between the receiver and the one or more other receivers to make one or more portions of the sterile drape 132 substantially smooth.
  • the adjustment mechanism 212 may comprise a spring that is compressible or extendable to move the first receiver 208 A toward or away from the second receiver 208B, such that the distance between the first receiver 208 A and the second receiver 208B decreases or increases.
  • the change distance may alter the tension applied to a portion 220 of the sterile drape 132 disposed between the first receiver 208 A and the second receiver 208B, such that the portion 220 becomes substantially smooth relative to the outer surface 216.
  • the substantial smoothness of the portion 220 may enable light from the first navigation marker 148A and the second navigation marker 148B to pass therethrough, enabling the navigation camera of the navigation system 118 to detect the tracked portion 136 and determine, based on the pose of the first navigation marker 148A and the second navigation marker 148B, a pose of the tracked portion 136.
  • the attachment device 202 may comprise a plurality of adjustment mechanisms, such that the positions of one or more receivers of the receivers 208A-208N are adjustable relative to one or more other receivers of the receivers 208A-208N.
  • the attachment device 202 may comprise a second adjustment mechanism (not shown) that moves a third receiver (not shown) relative to both the first receiver 208 A and the second receiver 208B, such that the portion 220 of the sterile drape 132 can be stretched along a third dimension (e.g., into or out of the page in Fig. 2C) to make the portion 220 substantially smooth.
  • one or more receivers of the receivers 208A-208N may be directly or indirectly attached to the adjustment mechanism(s) 212, while one or more other receivers of the receivers 208A-208N may be fixed relative to the tracked portion 136.
  • the adjustment mechanism 212 may be adjusted until the portion 220 becomes substantially smooth relative to the outer surface 216.
  • the adjustment using the adjustment mechanism 212 may terminate after a threshold value is reached (e.g., until the navigation camera of the navigation system 118 can detect components such as the navigation markers 148A-148F disposed on the outer surface 216 of the tracked portion 136), until the adjustment mechanism 212 reaches a maximum mechanical limit (e.g., a spring in the adjustment mechanism 212 reaches a maximum compression or expansion), after a predetermined number of iterations or time (e.g., the motors controlling the adjustment mechanism 212 are turned on for 1 second, 2 seconds, 3 seconds, etc.), combinations thereof, and/or the like.
  • a threshold value e.g., until the navigation camera of the navigation system 118 can detect components such as the navigation markers 148A-148F disposed on the outer surface 216 of the tracked portion 136
  • a maximum mechanical limit e.g., a spring in the adjustment mechanism 212 reaches a maximum
  • the attachment device 302 may be similar to or the same as the attachment device 152 and/or the attachment device 202.
  • the attachment device 302 may be configured to facilitate the connection of the sterile drape 132 with one or more components of the robot 114 (e.g., the robotic arm 116, the tracked portion 136, the end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed over one or more portions or sections of the robot 114 are substantially smooth.
  • the attachment device 302 comprises a slots 3O8A-3O8N disposed on or in the tracked portion 136.
  • the slots 3O8A-3O8N may be configured to receive a plurality of pins 304A-304N connected to (e.g., welded to, glued to, etc.) the sterile drape 132 to attach the sterile drape 132 to the tracked portion 136 or to a device connected to the tracked portion 136.
  • a first pin 304A may couple with a first slot 308 A and a first pin 304A may couple with a second slot 3O8B, such that the sterile drape 132 rests on an outer surface 312 of the tracked portion 136.
  • the substantial smoothness may enable the navigation camera of the navigation system 118 to detect the first navigation marker 148A and the second navigation marker 148B, and use such information to track and/or navigate the robotic arm 116.
  • the pins 304A-304N may be decoupled from the slots 3O8A-3O8N, such that the sterile drape 132 can be removed from the tracked portion 136.
  • the slots 3O8A-3O8N may have a plurality of different depths, such that the pins 304A-304N can be inserted at various depths.
  • the first slot 3O8A and the second slot 3O8B may each have two, three, four, five, or more depths at which the first pin 304A and the second pin 304B can be respectively inserted.
  • the interior of the first slot 3O8A and the second slot 3O8B may each have biased portions that lock the respective pin 304A, 304B at a predetermined depth, while preventing further insertion of the respective pin 304A, 304B.
  • the pins 304A, 304B can be inserted at discrete depths.
  • the pins 304A-304N may be inserted into respective slots 3O8A-3O8N with various degrees of depth until the portion 316 of the sterile drape 132 is substantially smooth with respect to the outer surface 312.
  • the pins 304A-304N may be inserted increasingly further into the respective slots 3O8A-3O8N until the portion 316 is stretched to be substantially smooth.
  • the pins 304A-304N may be or comprise magnets.
  • the slots 3O8A-3O8N may each comprise complementary magnets, such that the magnets in the pins 304A-304N are respectively attracted to the magnets in the slots 3O8A-3O8N.
  • the pins 304A-304N may then be inserted into the slots 3O8A-3O8N, and the magnets may attract one another to couple the pins 304A-304N with the slots 3O8A-3O8N such that the portion 316 is substantially smooth with respect to the outer surface 312 of the portion 316.
  • the insertion of the pins 304A-304N into the respective slots 3O8A- 3O8N may result in the sterile drape 132 being positioned on the outer surface 312, but not substantially smooth with respect to the outer surface.
  • the first navigation marker 148A and/or the second navigation marker 148B may be movable relative to the outer surface 312.
  • 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 can be moved to protrude out of 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 drape 132 until the first navigation marker 148A and the second navigation marker 148B contact the sterile drape 132 and are both substantially smooth with respect thereto.
  • the first navigation marker 148A and the second navigation marker 148B may be moved electrically using motors located, for example, within an interior of the tracked portion 136, pneumatically, mechanically (e.g., using a one or more springs), combinations thereof, and/or the like.
  • the radius of the tracked portion 136 increases to meet the sterile drape 132, as opposed to the sterile drape 132 stretching to meet the radius of the tracked portion 136.
  • first navigation marker 148A and the second navigation marker 148B may be moved toward the sterile drape 132 until the first navigation marker 148A and the second navigation marker 148B are detectable and trackable by a navigation camera of the navigation system 118.
  • the attachment device 402 may be similar to or the same as the attachment device 152, the attachment device 202, and/or the attachment device 302.
  • the attachment device 402 may be configured to facilitate the connection of the sterile drape 132 with one or more components of the robot 114 (e.g., the robotic arm 116, the tracked portion 136, the end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed over one or more portions or sections of the robot 114 are substantially smooth.
  • the attachment device 402 comprises a first clip 404A and a second clip 404B.
  • the first clip 404A comprises a first arm 412A and a second arm 416A that form a recess 408A
  • the second clip 404B comprises a first arm 412B and a second arm 416B that form a recess 408B
  • the first clip 404 A and the second clip 404B may be configured to couple with the tracked portion 136 to pin the sterile drape 132 to the tracked portion 136.
  • the recess 408A and the recess 408B may each receive a portion of the tracked portion 136, while the first arm 412A and the first arm 412B rest on an outside surface 420 of the tracked portion 136.
  • the attachment of the first clip 404 A and the second clip 404B to the tracked portion 136 may pinch the sterile drape 132 such that a portion 424 of the sterile drape 132 is substantially smooth with respect to the outside surface 420 of the tracked portion 136.
  • the first clip 404A pinches a first area or portion of the sterile drape 132 (which in some cases may correspond to a first end of the sterile drape 132) while the second clip 404B pinches a second different area or portion of the sterile drape 132 (which in some cases may correspond to a second end opposite the first end of the sterile drape 132) to pin the sterile drape 132 to the outside surface 420 of the tracked portion 136.
  • the attachment device 402 may comprise additional clips, and the first clip 404A and/or the second clip 404B may comprise additional arms or other components that enable the first clip 404A and/or the second clip 404B to attach to or otherwise connect with the tracked portion 136.
  • the first clip 404 A and/or the second clip 404B may each comprise three, four, five, or more arms that each respectively clip into respective recesses on the tracked portion 136.
  • the first clip 404A and the second clip 404B are sterilized.
  • an attachment device 502 may be similar to or the same as the attachment device 152, the attachment device 202, the attachment device 302, and/or the attachment device 402.
  • the attachment device 502 may be configured to facilitate the connection of the sterile drape 132 with one or more components of the robot 114 (e.g., the robotic arm 116, the tracked portion 136, the end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed over one or more portions or sections of the robot 114 are substantially smooth.
  • the attachment device 502 comprises a gripping device 504 configured to close around a portion of the sterile drape 132 to stretch the sterile drape 132 relative to an outer surface 508 of the tracked portion 136.
  • the sterile drape 132 may be disposed over the tracked portion 136 and anchored in one or more areas on the tracked portion 136 other than at the gripping device 504.
  • the gripping device 504 may then close around a portion of the sterile drape 132, such that a portion 512 of the sterile drape 132 is stretched to be substantially smooth over the outer surface 508 of the tracked portion 136.
  • the gripping device 504 may open again to release the sterile drape 132 so that the sterile drape 132 can be removed from the tracked portion 136.
  • the actuation of the gripping device 504 may be similar to the actuation of the adjustment mechanism 212; in other words, the gripping device 504 may close until the portion 512 is substantially smooth, subject to the actuation meeting one or more thresholds (e.g., until the navigation camera of the navigation system 118 can detect the first navigation marker 148A and/or the second navigation marker 148B, until a mechanical limit is reached, etc.).
  • the gripping device 504 may be operated manually (e.g., by a user such as a physician), automatically (e.g., using motors disposed in the tracked portion 136 and controlled by the processor 104), or semi-automatically (e.g., motors disposed in the tracked portion 136 and controlled by the processor 104 are controlled based on inputs from the user via the user interface 110).
  • the attachment device 602 may be similar to or the same as the attachment device 152, the attachment device 202, the attachment device 302, the attachment device 402, and/or the attachment device 502.
  • the attachment device 602 may be configured to facilitate the connection of the sterile drape 132 with one or more components of the robot 114 (e.g., the robotic arm 116, the tracked portion 136, the end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed over one or more portions or sections of the robot 114 are substantially smooth.
  • the attachment device 602 comprises 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 material (e.g., natural or synthetic rubber, silicone, latex, etc.) that enable each of the first flexible portion 604 and the second flexible portion 608 to bend or wrap around the tracked portion 136.
  • the first flexible portion 604 and/or the second flexible portion 608 may be or comprise flexible frame(s) that match and/or conform to the geometry of the tracked portion 136 (e.g., the first flexible portion 604 and/or the second flexible portion 608 matches the contours of the tracked portion 136), such that when the first flexible portion 604 and/or the second flexible portion 608 are connected to the tracked portion 136, the first flexible portion 604 and/or the second flexible portion 608 are flush with an outer surface 612 of the tracked portion 136.
  • the first flexible portion 604 and the second flexible portion 608 may be removed from the tracked portion 136, such that the sterile drape 132 is removed from the tracked portion 136.
  • the first flexible portion 604 and/or the second flexible portion 608 may be connected to (e.g., glued to, welded to, etc.) the sterile drape 132 to facilitate connection of the sterile drape 132 to the tracked portion 136.
  • the first flexible portion 604 may be connected to a first portion of the sterile drape 132 and the second flexible portion 608 may be connected to a second portion of the sterile drape 132.
  • 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 are slid over or wrapped around the tracked portion 136) such that a portion 616 of the sterile drape 132 is substantially smooth with respect to the outer surface 612 of the tracked portion 136.
  • the first flexible portion 604 and/or the second flexible portion 608 may be flexible and may be connected to the sterile drape 132 such that, when the first flexible portion 604 and the second flexible portion 608 are connected 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 be substantially smooth.
  • first flexible portion 604 and the second flexible portion 608 may be in an unstretched form before attachment to the tracked portion 136. Then, as the first flexible portion 604 and the second flexible portion 608 are connected to the tracked portion 136, the first flexible portion 604 and the second flexible portion 608 may stretch such that the friction between each of the first flexible portion 604 and the second flexible portion 608 and the tracked portion 136 generates a force that stretches the portion 616 of the sterile drape 132 to be substantially smooth.
  • an attachment device 702 may be similar to or the same as the attachment device 152, the attachment device 202, the attachment device 302, the attachment device 402, the attachment device 502, and/or the attachment device 602.
  • the attachment device 702 may be configured to facilitate the connection of the sterile drape 132 with one or more components of the robot 114 (e.g., the robotic arm 116, the tracked portion 136, the end effector 140, etc.) such that one or more portions of the sterile drape 132 disposed over one or more portions or sections of the robot 114 are substantially smooth.
  • the attachment device 702 comprises a base 704 from which legs 708A-708N extend.
  • the base 704 is coupled with one or more portions of the sterile drape 132.
  • the legs 708A-708N are configured to latch onto, connect with, or otherwise couple the attachment device 702 to the tracked portion 136 or a section or portion thereof.
  • the legs 708A-708N may comprise a first leg 708A that wraps around a first end of the tracked portion 136 and a second leg 708B that wraps around a second end of the tracked portion 136, such that the attachment device 702 remains fixed relative to the tracked portion 136 until a removal force is applied to the first leg 708 A and/or the second leg 708B to detach the attachment device 702 from the tracked portion 136.
  • the base 704 may comprise a portion or section that is transparent or semi-transparent, or may otherwise comprise an aperture 720 (e.g., a hole, an opening, etc.) across which a portion 712 of the sterile drape 132 extends. As shown in Fig. 7A, the portion 712 of the sterile drape 132 may extend through the aperture 720, such that light can pass through the aperture 720 and the portion 712 of the sterile drape 132.
  • the attachment device 702 may attach the sterile drape 132 to the tracked portion 136.
  • the legs 708A-708N of the attachment device 702 may hook or latch onto the tracked portion 136 such that the portion 712 of the sterile drape 132 is fixed relative to the tracked portion 136.
  • the attachment device 702 may be attached such that the portion 712 is positioned over one or more navigation markers (e.g., over the first navigation marker 148A and/or the second navigation marker 148B), such that the attachment device 702 is substantially smooth relative to the outside surface 716.
  • the substantial smoothness of the attachment device 702 may enable the navigation camera of the navigation system 118 to detect the first navigation marker 148A and the second navigation marker 148B, enabling the navigation system 118 to determine the pose of the tracked portion 136 and track and/or navigate the robotic arm 116.
  • the attachment device 702 may be removed from the tracked portion 136 (e.g., by application of a removal force by a user such as a physician to decouple the first leg 708 A and the second leg 708B from the respective ends of the tracked portion 136), such that the sterile drape 132 is disconnected from the tracked portion 136.
  • attachment device 152 While each of the attachment device 152, the attachment device 202, the attachment device 302, the attachment device 402, the attachment device 502, the attachment device 602, and the attachment device 702 have been discussed separately, it is to be understood that any one or more attachment devices discussed herein can be used in combination with any other one or more 1 attachment device 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 is to be attached (e.g., the robot 114 or one or more components thereof).
  • 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 on or within the end effector 140, the robot cart 144, one or more joints of the robotic arm 116, etc.).
  • the attachment device 702 may be used to clip one or more areas of the sterile drape 132 to the tracked portion 136, while the attachment device 402 may be used more distally to hold the sterile drape 132 secure relative to the end effector 140.
  • Fig. 8 depicts a method 800 that may be used, for example, to attach a sterile drape to a robotic arm.
  • One or more aspects of the method 800 may be carried out or otherwise performed, for example, by at least one processor.
  • the at least one processor may be the same as or similar to the processor(s) 104 of the computing device 102 described above.
  • the at least one processor may be part of a robot (such as a robot 114) or part of a navigation system (such as a navigation system 118).
  • a processor other than any processor described herein may also be used to execute the method 800.
  • the at least one processor may perform one or more portions of the method 800 by executing elements stored in a memory such as the memory 106.
  • the elements stored in memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 800.
  • One or more portions of a method 800 may be performed by the processor executing any of the contents of memory, such as an image processing 120, a segmentation 122, a transformation 124, and/or a registration 128.
  • the method 800 comprises positioning a robotic arm with a tracked portion and an attachment device relative to a patient (step 804).
  • the robotic arm may be similar to the robotic arm 116.
  • the tracked portion may be similar to or the same as the tracked portion 136.
  • the attachment device may be similar to or the same as the attachment device 152, the attachment device 202, the attachment device 302, the attachment device 402, the attachment device 502, the attachment device 602, and/or the attachment device 702.
  • the robotic arm may be moved into position relative to the patient using a robot cart such as the robot cart 144.
  • the step 804 may include providing a sterile drape that can be connected to the robotic arm to separate the patient from the robotic arm and/or other surgical elements covered by the sterile drape.
  • the method 800 also comprises attaching, using the attachment device, a sterile drape to the robotic arm (step 808).
  • the sterile drape may be similar to or the same as the sterile drape 132.
  • the sterile drape can be attached to the robotic arm using any one or more mechanisms associated with the attachment device 152, the attachment device 202, the attachment device 302, the attachment device 402, the attachment device 502, the attachment device 602, and/or the attachment device 702.
  • the sterile drape may comprise a plurality of connectors (e.g., connectors 204A-204N) that can respectively couple with a plurality of receivers (e.g., receivers 208A-208N) associated with the attachment device 202.
  • the attachment device may comprise a plurality of slots (e.g., slots 3O8A-3O8N) into which one or more pins (e.g., pins 304A-304N) can be inserted to connect the sterile drape to the robotic arm or portions thereof (e.g., to the tracked unit).
  • the attachment device may comprise a plurality of clips (e.g., the first clip 404 A, the second clip 404B, etc.) that each pinch an area of the sterile drape to conform a portion of the sterile drape to the surface of the tracked portion.
  • the attachment device may comprise flexible frames (e.g., first flexible portion 604 and the second flexible portion 608) that match the outer surface geometry of the tracked portion, such that a portion of the drape is substantially smooth relative to the outer surface when the flexible frames are attached to the tracked portion.
  • the attachment device may comprise a base that holds a portion of the sterile drape and a plurality of legs that enable the attachment device to be coupled with the tracked portion.
  • the attachment device may be disposed on the tracked portion such that the portion of the sterile drape held by the base is disposed over a navigation marker, such that a navigation camera associated with the navigation system can identify and track the navigation marker from behind the sterile drape.
  • the method 800 also comprises tracking, by a navigation system and using the tracked portion, the robotic arm as the robotic arm performs a surgical task (step 812).
  • the navigation system may be similar to or the same as the navigation system 118. Due to the attachment of the sterile drape to the robotic arm via the attachment device, navigation markers (e.g., navigation markers 148A-148F) of the tracked portion may be visible or otherwise capable of being tracked 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. The navigation system may in some cases navigate the robotic arm (or one or more components thereof) to cause the robotic arm to perform the surgical task.
  • navigation markers e.g., navigation markers 148A-148F
  • 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.
  • the navigation system may in some cases navigate the robotic arm (or one or more components thereof) to
  • the surgical task may be or comprise any step of a surgery or surgical procedure that uses the robotic arm.
  • the surgical task may be or comprise drilling a patient’s vertebra using the operative end of an end effector (e.g., the end effector 140) to create a hole into which a pedicle screw can be inserted.
  • the surgical task may be or comprise the robotic arm holding a tool guide for a surgeon to manually operate a surgical tool, such that the tool guide provides a guide for the trajectory of the surgical tool.
  • the present disclosure encompasses embodiments of the method 800 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.
  • the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 8 (and the corresponding description of the method 800), as well as methods that include additional steps beyond those identified in Fig. 8 (and the corresponding description of the method 800).
  • the present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein. Any correlation described herein may be or comprise a registration or any other correlation.
  • the foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure.
  • 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 an attachment device (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 over a surface of the tracked portion (136) is substantially smooth.
  • Example 2 The system of Example 1, wherein the tracked portion (136) comprises a plurality of navigation markers (148A-148F).
  • Example 3 The system of Example 2, wherein the plurality of navigation markers (148A-148F) comprise two or more Light Emitting Diodes (LEDs).
  • LEDs Light Emitting Diodes
  • Example 4 The system of any one of Examples 1-3, wherein the sterile drape (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 connector of the plurality of connectors (204A-204N) couples with a respective receiver of the plurality of receivers (208A-208N).
  • Example 5 The system of Example 4, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises an adjustable spring configured to change a distance between a first receiver (208 A) and a second receiver (208B) of the plurality of receivers (208A-208N).
  • Example 6 The system of Example 4, wherein the plurality of connectors (204A-204B) comprise a plurality of pins (304A-304N), and wherein the plurality of receivers (208A-208N) comprise a plurality of slots (3O8A-3O8N), with each slot receiving each pin of the plurality of pins (304A-304N).
  • Example 7 The system of Example 4, wherein the plurality of connectors (204A-204N) comprise a plurality of magnets.
  • Example 8 The system of any one of Examples 1-3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a flexible frame (604, 608) that matches a geometry of the tracked portion (136).
  • Example 9 The system of any one of Examples 1-3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a clipping device (404A, 404B) that pinches at least two areas of the sterile drape (132) to conform the portion of the sterile drape (132) to the surface of the tracked portion (136).
  • the attachment device 152, 202, 302, 402, 502, 602, 702
  • a clipping device 404A, 404B
  • Example 10 The system of any one of Examples 1-3, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a gripping device (504) that closes around a second portion of the sterile drape (132).
  • Example 11 A surgical system, comprising: a robotic arm (116); a navigation device (136) coupled with the robotic arm (116), the navigation device (136) comprising a plurality of navigation markers (148A-148F) that are tracked by a navigation system (118); a sterile drape (132) capable of covering at least a section of the navigation device (136); and an attachment device (152, 202, 302, 402, 502, 602, 702) that attaches the sterile drape (132) to the navigation device (136) such that a portion of the sterile drape (132) substantially conforms to a surface of the navigation device (136).
  • Example 12 The surgical system of Example 11, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) is adjustable such that the sterile drape (132) remains substantially conformed to the surface of the navigation device (136) when the robotic arm (116) moves.
  • Example 13 The surgical system of Example 11, wherein the plurality of navigation markers (148A-148F) comprise two or more Light Emitting Diodes (LEDs).
  • LEDs Light Emitting Diodes
  • Example 14 The surgical system of any of Examples 11-13, wherein the sterile drape (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 connector of the plurality of connectors (204A-204N) couples with a respective receiver of the plurality of receivers (208A-208N).
  • Example 15 The surgical system of Example 14, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises an adjustable spring configured to alter a distance between a first receiver (208 A) and a second receiver (208B) of the plurality of receivers (208A-208N).
  • Example 16 The surgical system of Example 14, wherein the plurality of connectors (204A-204N) comprise a plurality of pins (304A-304N), wherein the plurality of receivers (208A- 208N) comprise a plurality of slots (3O8A-3O8N), and wherein each slot of the plurality of slots (3O8A-3O8N) is configured to receive a respective pin of the plurality of pins (304A-304N).
  • Example 17 The surgical system of Example 14, wherein the plurality of connectors (204A-204N) comprise a plurality of magnets.
  • Example 18 The surgical system of any one of Examples 11-13, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a flexible frame (604, 608) that matches a geometry of the navigation device (136).
  • Example 19 The surgical system of any of Examples 11-13, wherein the attachment device (152, 202, 302, 402, 502, 602, 702) comprises a gripping device (504) that closes around a second portion of the sterile drape (132).
  • 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) comprising a plurality of navigation markers (148A-148F) that are tracked by a navigation system (118); a sterile drape (132) capable of covering at least a section of the navigation component (136); and an attachment device (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 a surface of the navigation component (136).

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Robotics (AREA)
  • Manipulator (AREA)

Abstract

La présente divulgation concerne, selon au moins un mode de réalisation, un système qui comprend : un bras robotique ; une partie suivie fixée au bras robotique et qui est suivie par un système de navigation ; un champ stérile qui recouvre le bras robotique et la partie suivie ; et un dispositif de fixation qui fixe le champ stérile à la partie suivie de telle sorte qu'une partie du champ stérile disposée sur une surface de la partie suivie soit sensiblement lisse.
PCT/IL2024/051201 2023-12-20 2024-12-19 Systèmes et procédés permettant de fixer un champ à une ou plusieurs parties d'un bras robotique Pending WO2025134121A1 (fr)

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US202363612870P 2023-12-20 2023-12-20
US63/612,870 2023-12-20

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9713498B2 (en) * 2013-03-15 2017-07-25 Stryker Corporation Assembly for positioning a sterile surgical drape relative to optical position sensors
US20220273386A1 (en) * 2021-03-01 2022-09-01 Mazor Robotics Ltd. Shrink sterile drape and related systems and methods
WO2023154301A2 (fr) * 2022-02-08 2023-08-17 Mobius Imaging, Llc Ensembles champs élastiques avec guides destinés à être utilisés avec des robots chirurgicaux
US11832913B2 (en) * 2017-10-04 2023-12-05 Mako Surgical Corp. Sterile drape assembly for surgical robot
WO2024068416A1 (fr) * 2022-09-29 2024-04-04 B. Braun New Ventures GmbH Élément de fixation d'élément de recouvrement, feuille de recouvrement stérile, système de fixation d'élément de recouvrement, système de recouvrement et robot chirurgical à élément de recouvrement

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9713498B2 (en) * 2013-03-15 2017-07-25 Stryker Corporation Assembly for positioning a sterile surgical drape relative to optical position sensors
US11832913B2 (en) * 2017-10-04 2023-12-05 Mako Surgical Corp. Sterile drape assembly for surgical robot
US20220273386A1 (en) * 2021-03-01 2022-09-01 Mazor Robotics Ltd. Shrink sterile drape and related systems and methods
WO2023154301A2 (fr) * 2022-02-08 2023-08-17 Mobius Imaging, Llc Ensembles champs élastiques avec guides destinés à être utilisés avec des robots chirurgicaux
WO2024068416A1 (fr) * 2022-09-29 2024-04-04 B. Braun New Ventures GmbH Élément de fixation d'élément de recouvrement, feuille de recouvrement stérile, système de fixation d'élément de recouvrement, système de recouvrement et robot chirurgical à élément de recouvrement

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