WO2025079074A1 - Systems for calibrating and authenticating end effectors - Google Patents
Systems for calibrating and authenticating end effectors Download PDFInfo
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- WO2025079074A1 WO2025079074A1 PCT/IL2024/050991 IL2024050991W WO2025079074A1 WO 2025079074 A1 WO2025079074 A1 WO 2025079074A1 IL 2024050991 W IL2024050991 W IL 2024050991W WO 2025079074 A1 WO2025079074 A1 WO 2025079074A1
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- end effector
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- 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
- 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
- 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
- A61B90/90—Identification means for patients or instruments, e.g. tags
-
- 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
- A61B90/90—Identification means for patients or instruments, e.g. tags
- A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00477—Coupling
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00477—Coupling
- A61B2017/00482—Coupling with a code
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- 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
-
- 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
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- 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
- A61B2034/2074—Interface software
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- 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
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0803—Counting the number of times an instrument is used
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- 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
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0804—Counting number of instruments used; Instrument detectors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- 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
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- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
- A61B2562/085—Sensors provided with means for identification, e.g. barcodes or memory chips combined with means for recording calibration data
Definitions
- the present disclosure is generally directed to surgeries and surgical procedures, and relates more particularly to end effector calibration and authentication.
- 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.
- Providing controllable linked articulating members allows a surgical robot to reach areas of a patient anatomy during various medical procedures.
- Example aspects of the present disclosure include:
- a surgical system comprises: a robotic arm including an adapter on a distal end thereof; a navigation system to track a pose of the robotic arm; and an end effector comprising: an interface connectable to the adapter of the robotic arm to mechanically couple the end effector and the robotic arm; a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: determine that the interface of the end effector is connected to the adapter of the robotic arm; and transmit information stored in the memory and associated with the end effector to the navigation system, wherein the information transmitted to the navigation system supports the navigation system in tracking the pose of the robotic arm.
- the memory comprises an electrically erasable programmable read-only memory (EEPROM).
- EEPROM electrically erasable programmable read-only memory
- any of the aspects herein, wherein the information associated with the end effector comprises information about a geometry of the end effector.
- the information about the geometry comprises information generated by a coordinate measuring machine (CMM).
- CCM coordinate measuring machine
- any of the aspects herein, wherein the information associated with the end effector comprises information about a number of uses of the end effector.
- a system comprises: a robotic arm; and an end effector comprising: an operative portion disposed on a distal end of the end effector; an interface on a proximal end opposite the distal end, the interface connectable to an adapter of the robotic arm to mechanically couple the end effector and the robotic arm; a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: determine that the end effector is connected to the robotic arm; and transmit, when the end effector is connected to the robotic arm, information stored on the memory and associated with the end effector to a robotic controller that controls the robotic arm.
- the information associated with the end effector comprises information about a number of uses of the end effector.
- the processor transmits a warning to the robotic controller when an updated number of uses of the end effector exceeds a threshold value.
- a device comprises: an operative end; a processor; and a programmable memory storing data thereon that, when processed by the processor, enable the processor to: determine that the device has been coupled with a robotic arm; and transmit information associated with the device to a navigation system of the robotic arm.
- the information associated with the device comprises calibration information.
- the calibration information comprises information generated by a coordinate measuring machine (CMM).
- CCM coordinate measuring machine
- 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. 1A is a diagram of aspects of a system according to at least one embodiment of the present disclosure.
- Fig. IB is a block diagram of additional aspects of the system according to at least one embodiment of the present disclosure.
- Fig. 1C is a block diagram of additional aspects of an end effector according to at least one embodiment of the present disclosure.
- Fig. 2 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).
- 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.
- Different end effectors may be used in a robotics-assisted surgery or surgical procedures.
- Robotic surgical systems may include a fixed add-on at the end of a robotic arm that remains fixed on the arm and that facilitates connection of a tool changer unit to the robotic arm.
- the tool changer in turn facilitates the changing or switching out of different end effectors during the surgery or surgical procedure while maintaining the sterility of the robotic arm and the components thereof.
- the positional accuracy of the end effector is important to the success of the robotic surgical system, as inaccurate end effector placement or movement can be detrimental to the patient’s safety.
- the accuracy chain of the robot includes the robotic arm, the fixed add-on, the tool changer, and the end effector.
- the tracking of surgical components by the navigation system also contributes to the accuracy chain.
- the components in the accuracy chain contribute to the overall accuracy of the robotic surgical system, such that an inaccuracy in the navigation, tolerances, and/or the like contributes to the overall error of the system.
- One contributor of error in the accuracy is the manufacturing tolerances of the physical parts of the robotic surgical system (e.g., the fixed add-on, the tool changer, the end effector, etc.). Such manufacturing intolerances can contribute to the overall inaccuracy of the robotic surgical system.
- a computing chip with memory e.g., an EEPROM
- PCB printed circuit board
- the memory includes information useful in assisting a navigation system with tracking the physical part and/or useful in assisting a robotic controller in determining the pose (e.g., position and orientation) of the physical part.
- the memory may include a calibration file that is unique to the physical part.
- the calibration file may include calibration values measured using a high accuracy measurement system (e.g., a CMM, a contact measurement arm such as the FARO® Quantum Max FaroArm®, etc.).
- the calibration file may be programmed into the memory of the computing chip, which may remain in the physical part for the lifetime of the physical part.
- the computing chip memory may additionally or alternatively include an internal counter that can inform the robotic surgical system on the number of times the end effector has been used.
- the computing chip memory may additionally or alternatively include information about the end effector in which the computing chip memory is integrated, which can inform the robotic surgical system on the type of end effector that was connected to the tool changer, enabling tool authentication.
- Embodiments of the present disclosure beneficially increase yields of manufactured parts. By placing a computing chip with calibration information in the manufactured part, the measured manufactured part can have looser tolerance standards. This may in turn allow a greater number of manufactured parts to be eligible for use in the surgical system.
- Embodiments of the present disclosure beneficially improve surgeries and surgical procedures by enabling automatic calibration updates without user interference, further measurements, or validation.
- the user can simply connect the unit (e.g., the add-on, the end effector, etc.), and the information stored in the memory of the unit is sent from the connected unit to the robotic controller software for a calibration update.
- Embodiments of the present disclosure beneficially enhance patient safety by limiting the number of times a certain end effector can be used. Patient safety is also enhanced by reducing human error in performing tool authentication; tool authentication is automatically performed when the unit is connected to the robotic arm based on the information stored on memory of the unit.
- Embodiments of the present disclosure beneficially reduce the overall surgery time by reducing the number of tasks the user needs to perform to calibrate and authenticate the end effector before use. Embodiments of the present disclosure beneficially enhance patient safety by ensuring that the tool on the end effector is authenticated before use.
- Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) inaccurate mechanical parts, (2) overused mechanical parts, (3) navigation inaccuracies, and (4) calibration and authentication errors.
- the system 100 may be used to manage end effectors attached to a surgical mount system and/or a surgical arm; to 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 one or more of the methods disclosed herein.
- the system 100 comprises one or more imaging device(s) 112, a robot 114, a navigation system 118, a database 130, an add-on 132, a cloud or other network 134, a tool changer 136, an end effector 140.
- 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, the database 130, and/or the cloud 134.
- 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 comprises one or more robotic arms 116, a processor 120, a memory 122, a communication interface 124, and a controller 128.
- Robots according to other embodiments of the present disclosure may comprise more or fewer components than the robot 114.
- 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 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 or comprise 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 the end effector 140 and/or a component thereof such as 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 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, the add-on 132, the tool changer 136, the end effector 140 and components thereof such as a surgical tool, or other object held by or connected to the robot 114 (or, more specifically, held by or connected to the robotic arm 116) may be precisely positionable in one or more needed and specific positions and orientations.
- the robotic arm(s) 116 may comprise one or more sensors that enable the processor 120 (or another processor of another component of the system 100) to determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm such as the add-on 132, the tool changer 136, and/or the end effector 140).
- the processor 120 of the robot 114 may be any processor described herein or any similar processor.
- the processor 120 may be configured to execute instructions stored in the memory 122, which instructions may cause the processor 120 to carry out one or more computing steps utilizing or based on data received from the imaging device 112, the navigation system 118, the database 130, the cloud 134, and/or the end effector 140.
- the processor 120 may be or comprise 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.
- DSPs digital signal processor
- the memory 122 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 122 may store information or data useful for completing, for example, one or more steps of the method 200 described herein, or of any other methods.
- the memory 122 comprises an EEPROM.
- the memory 122 may store, for example, instructions and/or machine learning models that support one or more functions of the robot 114.
- the memory 122 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 120, enable image processing, segmentation, transformation, and/or registration.
- Such content may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines.
- the memory 122 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 120 to carry out the various method and features described herein.
- machine learning models e.g., machine learning models, artificial neural networks, deep neural networks, etc.
- 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 120 to manipulate data stored in the memory 122 and/or received from or via the imaging device 112, the database 130, the add-on 132, the cloud 134, the tool changer 136, and/or the end effector 140.
- the communication interface 124 may be used for receiving image data or other information from an external source (such as the imaging device 112, the navigation system 118, the database 130, the add-on 132, the cloud 134, the tool changer 136, the end effector 140, 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., the imaging device 112, the robot 114, the navigation system 118, the database 130, the add-on 132, the cloud 134, the tool changer 136, the end effector 140, and/or any other system or component not part of the system 100).
- an external source such as the imaging device 112, the navigation system 118, the database 130, the add-on 132, the cloud 134, the tool changer 136, the end effector 140, and/or any other system or component not part of the system 100.
- the communication interface 124 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth).
- the communication interface 124 may be useful for enabling the robot 114 (or one or more components thereof) to communicate with one or more other processors discussed herein, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
- the controller 128 may be configured to automatically control one or more functions and/or components of the robot 114. In some embodiments, the controller 128 may utilize the processor 120 to perform computations during the course of controlling the one or more functions and/or components of the robot 114. In some embodiments, the controller 128 may be configured to actuate one or more motors in one or more joints of the robotic arm 116 to, for example, cause the robotic arm 116 to move. In some embodiments, the controller 128 may receive information from the add-on 132, the tool changer 136, and/or the end effector 140, and use such information to authenticate and control the add-on 132, the tool changer 136, and/or end effector 140.
- the controller 128 may receive authentication information from the end effector 140, and compare such information to information stored, for example, in the database 130. When the authentication information from the end effector 140 does not match the information in the database 130, the controller 128 may prevent the end effector 140 from being used in the surgery or surgical procedure. In another example, the controller 128 may receive usage information from the add-on 132 associated with a number of times the add-on 132 has been used. If the number of times the add-on 132 has been used exceeds a threshold value, the controller 128 may prevent the add-on 132 from being used in the surgery or surgical procedure. Such information stored in the add-on 132, the tool changer 136, and the end effector 140 and received by the controller 128 is discussed in further detail below.
- 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, 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 components thereof, and/or one or more surgical tools (or, more particularly, to track a pose of a navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing).
- the navigation system 118 may include a display (including, for example, the user interface 110) for displaying one or more images from an external source (e.g., 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 navigation system 118 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110.
- reference markers e.g., navigation markers
- 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).
- the processor 104 may be similar to or the same as any processor discussed herein (e.g., the processor 120).
- 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 database 130, the cloud 134, and/or any other component of the system 100.
- the memory 106 may be similar to or the same as any memory discussed herein (e.g., the memory 122).
- 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 comprises an EEPROM.
- the memory 106 may store information or data useful for completing, for example, one or more steps of the method 200 described herein, or of any other methods.
- the communication interface 108 may be similar to or the same as any communication interface discussed herein (e.g., the communication interface 124).
- 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 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., the imaging device 112, the robot 114, the database 130, the cloud 134, and/or any other system or component not part of the system 100).
- an external source such as the imaging device 112, the robot 114, the database 130, the cloud 134, and/or any other system or component not part of the system 100.
- the user interface 110 may be or comprise one or multiple user interfaces.
- the user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user.
- the user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104, the processor 120, 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 (or in some embodiments the processor 120) 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 processor 104 and/or the processor 120 may utilize a user interface 110 that is housed separately from the navigation system 118.
- the user interface 110 may be located proximate one or more other components of the robot 114, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the robot 114.
- 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 system 100; information about planned surgical tools to be used and connected to the robotic arm 116 to carry out the surgery or surgical procedure); 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 related to the add-on 132, the tool changer 136, and/or the end effector 140, and/or any other useful information.
- the database 130 may be configured to provide any such information to any 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 robot 114, the navigation system 118, the database 130, and/or the like may be connected to the cloud 134 via the communication interface 108 and/or the communication interface 124, using a wired connection, a wireless connection, or both.
- one or more components of the system 100 may communicate with the imaging device 112, the database 130, any other component of the system 100, and/or an external device (e.g., a computing device outside the system 100) via the cloud 134.
- the add-on 132 has a proximal end with an interface that is connectable to the distal end of the robotic arm 116 to attach the add-on 132 to the robotic arm 116.
- the add-on 132 has a distal end that facilitates connection of the robotic arm 116 to the tool changer 136.
- the add-on 132 comprises a fixed add-on that remains on the robotic arm 116 through the course of the surgery or surgical procedure.
- the add-on 132 may comprise one or more slots, threads, sockets, and/or the like that enable the add-on 132 to mechanically couple with the robotic arm 116.
- the add-on 132 comprises a processor 148, a memory 152, and a motor driver 156.
- the add-on 132 may omit one or more components than those depicted in Fig. IB.
- the add-on 132 may omit the motor driver 156 and operate as a passive mechanical component.
- the add-on 132 may comprise additional components, such as temperature sensors, Light Emitting Diodes (LEDs), LED driver circuit(s), communication interfaces, and/or the like disposed on a PCB stored in the add-on 132.
- the LED driver circuit(s) may enable the add-on 132 to emit light from the LEDs.
- the LEDs may be disposed in a predetermined arrangement on the add-on 132 which may enable, for example, registration based on the detection of the LEDs using image data from the imaging devices 112 and processing by the navigation system 118.
- the memory 152 of the add-on 132 may comprise a calibration file including calibration and authentication information that enables the controller 128 to calibrate and authenticate the add-on 132, as discussed in further detail below.
- the processor 148 may be similar to or the same as any processor discussed herein (e.g., the processor 104, the processor 120, etc.).
- the processor 148 may be configured to execute instructions stored in the memory 152, which instructions may cause the processor 148 to carry out one or more computing steps utilizing or based on data received from the imaging device 112, the robot 114, the database 130, the cloud 134, and/or any other component of the system 100.
- the memory 152 may be similar to or the same as any memory discussed herein (e.g., memory 106, the memory 122, etc.).
- the memory 152 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 152 may store information or data useful for completing, for example, one or more steps of the method 200 described herein, or of any other methods.
- the memory 152 comprises an EEPROM that is programmable to store information specific to the add-on 132.
- the EEPROM may comprise information about the position of LEDs on the add-on 132; specification information associated with the dimensions, operating conditions, and the like of the add-on 132; usage information associated with the add-on 132; authentication information of the add-on 132; and/or any other useful information.
- Such information may be sent by the processor 148 to the controller 128 upon the add-on 132 being attached to the robotic arm 116.
- the motor driver 156 may drive one or more components of the end effector 140.
- the motor driver 156 may send signals to and receive signals from the end effector 140 through the tool changer 136 to control the end effector 140 and/or components of the end effector 140 such as control surgical tools (e.g., surgical drills, reamers, etc.).
- the motor driver 156 may be similar to or the same as the processor 148, such as when the motor driver 156 comprises an integrated circuit chip that controls one or more components of the end effector 140.
- the motor driver 156 may control a locking mechanism of the add-on 132 that locks and unlocks the tool changer 136 such that the tool changer 136 can or cannot move relative to the add-on 132.
- the locking mechanism may be mechanical (e.g., the tool changer 136 is blocked from attaching to or detaching from the add-on 132 by bolt(s) and/or the like), electrical (e.g., the tool changer 136 receives an electrical signal from the locking mechanism that causes the tool changer 136 to lock or unlock), combinations thereof, and/or the like.
- the tool changer 136 may comprise a proximal end that connects to the distal end of the add-on 132.
- the tool changer 136 may comprise one or more mechanical interfaces at a distal end thereof that enable different end effectors to connect to the robotic arm 116.
- the tool changer 136 may comprise an adjustable distal end to enable end effectors of different shapes and sizes to be coupled to the robotic arm 116.
- the tool changer 136 comprises a tool changer controller 160 and a tool changer receiver 164.
- the tool changer controller 160 may operate to generate control signals (or in some cases receive control signals from other components of the system 100) that are passed to the tool changer receiver 164.
- the tool changer controller 160 may control, for example, an interlocking feature of the tool changer 136 such that the end effector 140 can only be uncoupled from the tool changer 136 when the tool changer 136 is positioned near or within a tool stand.
- the tool changer controller 160 may determine that the tool changer 136 is coupled with the end effector 140. The tool changer controller 160 may determine this information based on sensors, based on signals generated when the end effector 140 has effectively coupled with the tool changer 136, based on the step in the surgical procedure, combinations thereof, and/or the like. Once the tool changer controller 160 determines that the tool changer 136 and the end effector 140 are coupled, the tool changer controller 160 may send a signal to the tool changer receiver 164 to keep the interlocking feature locked until the tool changer receiver 164 receives a further signal.
- the tool changer controller 160 may generate and/or send the further signal to the tool changer receiver 164 when the tool changer 136 has been placed back in the tool stand (e.g., after the end effector 140 has been used and the surgery or surgical procedure has progressed to the next step), such that the tool changer controller 160 changes the interlocking feature to an unlocked state.
- the tool changer controller 160 may be disposed in the add-on 132 and the tool changer receiver 164 may be disposed in the end effector 140.
- an EEPROM in the memory 152 may comprise information associated with the add-on 132 and components thereof (e.g., the tool changer controller 160)
- an EEPROM in the memory 172 may comprise information associated with the end effector 140 and components thereof (e.g., the tool changer receiver 164).
- the communication between the add-on 132 and the end effector 140 may occur through the tool changer controller 160 and the tool changer receiver 164, where the tool changer receiver 164 is unique to the end effector 140 and the tool changer controller 160 is unique to the add-on 132.
- the end effector 140 may include a proximal end that is connectable to the tool changer 136 and a distal end that comprises an operative portion 180 that can be used to carry out one or more surgical tasks.
- the end effector 140 may comprise an active end effector, such as when the operative portion 180 comprises a surgical tool, or a passive end effector, such as when the operative portion 180 comprises a tool guide.
- the end effector 140 also comprises a memory 172, and may additionally comprise a processor 168 and a motor controller 176.
- the operative portion 180 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 operative portion 180 may comprise a tool guide.
- the tool guide may provide a passive hole through which a surgical tool or component may pass to reach a surgical site.
- the tool guide may be or comprise a hollow cylinder that can be aligned with a planned trajectory of a surgical tool.
- the guide provides a visual indicator to an operator (e.g., a surgeon) of the planned trajectory of the surgical tool.
- the operative portion 180 comprising the tool guide may be attached to the robotic arm 116 and the robotic arm 116 may move such that the tool guide is positioned at the planned surgical entry point.
- Another robotic arm 116 with a surgical tool (e.g., a surgical drill) may then be positioned such that the surgical tool enters the surgical site through the tool guide.
- the operative portion 180 may be controlled by a motor controller 176.
- the motor controller 176 may be connected to or otherwise communicate with one or more motors disposed in or connected to the end effector 140.
- the motor controller 176 may control the operation of the motors, such that the motor controller 176 controls movement of the end effector 140 and/or one or more components thereof such as the operative portion 180.
- the motor controller 176 may control the motors based on signals sent from the robot 114 or components thereof (e.g., the controller 128), the navigation system 118 or components thereof (e.g., the processor 104), the addon 132, the tool changer 136 (e.g., based on interactions between the tool changer controller 160 and the tool changer receiver 164), and/or the like.
- the motor controller 176 may control one or more motors of the operative portion 180 to cause movement of the surgical tool, to turn the surgical tool on and off, combinations thereof, and/or the like.
- the processor 168 may be similar to or the same as any processor discussed herein (e.g., the processor 104, processor 120, the processor 148, etc.).
- the processor 168 may be configured to execute instructions stored in the memory 172, which instructions may cause the processor 168 to send information stored in the memory 172 to one or more components of the system 100 (e.g., to the robot 114, to the navigation system 118, to the add-on 132, to the tool changer 136, etc.). Additionally or alternatively, the instructions may cause the processor 168 write to or otherwise update information stored in the memory 172, such as to update information about the number of uses of the end effector 140, as discussed in further detail below.
- the memory 172 may be similar to or the same as any memory discussed herein (e.g., the memory 122).
- the memory 172 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein such as an EEPROM, 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, one or more steps of the method 200 described herein, or of any other methods. In some cases, both the processor 168 and the stored on a printed circuit board disposed in the end effector 140.
- the memory 172 is reprogrammable memory, such that information stored in the memory 172 can be erased and reprogrammed.
- the memory 172 may be unique to the end effector 140.
- each end effector 140 may have a separate memory 172 embedded in the end effector 140 and containing information unique to the end effector 140.
- the memory 172 comprises end effector type information 184, authentication information 188, calibration information 192, end effector usage information 194, and miscellaneous information 196.
- the end effector type information 184 may indicate whether the end effector 140 is an active end effector (e.g., the operative portion 180 comprises an active surgical tool such as a surgical drill) or a passive end effector (e.g., the operative portion 180 comprises a passive surgical tool such as a tool guide).
- the end effector type information 184 may be accessed by the processor 168 and sent to the controller 128 of the robot 114. In some cases, the end effector type information 184 may be sent to the navigation system 118 to help the navigation system 118 track the end effector 140.
- the navigation system 118 may be able to better track the end effector 140 when the navigation system 118 has information about the type of end effector in use (e.g., a passive end effector may not move as compared to an active end effector which may move).
- the controller 128 may render the end effector type information 184 to the user interface 110 to enable a user to view the end effector type information 184.
- the controller 128 may compare the end effector type information 184 to information stored in the database 130 to authenticate the end effector 140.
- the surgical plan may call for the use of an active end effector capable of resecting anatomical tissue, and the end effector type information 184 may specify that the end effector 140 is an active end effector that includes a surgical drill.
- the controller 128 may receive the end effector type information 184 and, since the end effector type information 184 matches the end effector type required by the surgical plan, the controller 128 may determine that the end effector 140 connected to the robotic arm 116 is the correct end effector.
- the surgical plan may call for the use of an active surgical drill, but the end effector type information 184 may specify that the end effector 140 is a passive instrument (e.g., a tool guide) that cannot resect anatomical tissue.
- the controller 128 may determine that the end effector 140 is not the correct end effector for the current step of the procedure.
- the controller 128 may render a warning (e.g., a flashing light) to the display to notify the user that the incorrect end effector has been attached. Additionally or alternatively, the controller 128 may disable use of the robotic arm 116 and/or components thereof until the improper end effector 140 is removed.
- a warning e.g., a flashing light
- the authentication information 188 may comprise information that enables the system 100 or components thereof (e.g., the processor 120 of the robot 114) to authenticate the end effector 140.
- the end effector type information 184 may be or comprise information associated with the manufacturing source, date of manufacturing, lot number, model number, serial number, recommended operating settings, operating parameters, combinations thereof, and/or the like.
- the authentication information 188 may be accessed by the processor 168 and sent to the controller 128 of the robot 114.
- the controller 128 may compare the authentication information 188 to information stored in the database 130 to authenticate the end effector 140.
- the surgical plan for a surgical procedure may call for the use of an end effector manufactured by a first manufacturer, and the authentication information 188 may specify that the end effector 140 was manufactured by the first manufacturer.
- the controller 128 may receive the authentication information 188 and, since the authentication information 188 matches the surgical plan, the controller 128 may determine that the end effector 140 connected to the robotic arm 116 is an acceptable end effector for performing the surgical procedure. In some cases, the controller 128 may be able to control the end effector 140 once the end effector 140 has been authenticated.
- the surgical plan may call for the use of an end effector manufactured by the first manufacturer, but the authentication information 188 may specify that the end effector 140 was manufactured by a second, different manufacturer.
- the controller 128 may determine that the end effector 140 is not acceptable to perform the current step of the procedure.
- the controller 128 may render a warning (e.g., a flashing light) to the display to notify the user that the incorrect end effector has been attached.
- the controller 128 may disable use of the robotic arm 116 and/or components thereof until the improper end effector 140 is removed.
- the calibration information 192 may comprise information about the dimensions of the end effector 140 and/or components thereof (e.g., the operative portion 180).
- the dimensions may be based on one or more measurements of the end effector 140 generated with one or more measurement systems.
- the dimensions of the end effector 140 may be generated using a CMM.
- the CMM may capture the geometry of the end effector 140 based on sensing of discrete points on the surface of the end effector 140.
- the measurements of the end effector 140 may be stored as the calibration information 192 in the memory 172.
- the calibration information 192 may be accessed by the processor 168 and sent to the controller 128.
- the processor 168 may send the information once the end effector 140 is coupled to the robotic arm 116 (e.g., via the tool changer 136).
- the controller 128 may receive the calibration information 192 and use the calibration information 192 along with the known pose of the robotic arm 116 to register the end effector 140 to the robot 114.
- the controller 128 may additionally or alternatively register the end effector 140 to any other coordinate system, and send such information to the navigation system 118 to enable the navigation system 118 to track the pose of the end effector 140.
- the end effector usage information 194 may comprise information about a number of times the end effector 140 has been used.
- the end effector usage information 194 may comprise an integer number representative of the number of times the end effector 140 has connected to a robotic arm 116 and/or a component thereof (e.g., the tool changer 136) and/or the number of times the end effector 140 has been used in a surgery or surgical procedure.
- the end effector usage information 194 may be updated and saved to the memory 172 once the end effector 140 has been connected to the tool changer 136.
- the end effector usage information 194 may indicate that the end effector 140 has been used three times.
- the processor 168 may access the memory 172 and update the end effector usage information 194 to indicate that the end effector 140 has been used four times. Additionally or alternatively, the processor 168 may send the end effector usage information 194 to one or more components of the system 100, such as to the user interface 110 so that the end effector usage information 194 can be rendered to a display and reviewed by a user (e.g., a physician, a member of surgical staff, etc.).
- a user e.g., a physician, a member of surgical staff, etc.
- the end effector usage information 194 may be updated by the processor 168 after the end effector 140 has been used and returned to the tool stand.
- the memory 172 is updated after the end effector 140 has been used and the surgical procedure requiring the end effector 140 has concluded.
- the processor 168 may access the end effector usage information 194 and send the end effector usage information 194 to the controller 128, and the controller 128 may determine whether the end effector 140 has exceeded a predetermined number of uses.
- the predetermined number of uses may be or comprise a threshold value stored, for example, in the database 130.
- the controller 128 may disable use of the end effector 140 such as by preventing the operative portion 180 of the end effector 140 from receiving power.
- the controller 128 may cause the processor 168 to write instructions to the memory 172 that specify that the end effector 140 is not to be used again.
- the controller 128 may render a warning to the user interface 110 that notifies the user that the end effector 140 has exceeded the threshold number of uses.
- the threshold number of uses may be based on the specifications of the surgery or surgical procedure, the surgical plan, surgeon preference, combinations thereof, and/or the like.
- the miscellaneous information 196 may comprise any other useful information associated with the end effector 140 and/or components thereof.
- the miscellaneous information 196 may comprise historical data associated with the end effector 140, such as the dates on which the end effector 140 was used, overall time of use of the end effector 140, combinations thereof, and/or the like.
- the above discussion of the memory 172 and the elements thereof is not limiting to the end effector 140, and other components of the system 100 may have such information stored in an erasable and programmable memory that is unique to that component.
- the memory 152 of the add-on 132 may comprise an EEPROM or any similar erasable and programmable memory that stores information about the add-on 132.
- the system 100 or similar systems may be used, for example, to carry out one or more aspects of the method 200 described herein.
- the system 100 or similar systems may also be used for other purposes.
- Fig. 2 depicts a method 200 that may be used, for example, to calibrate and authenticate an end effector used during a surgery or surgical procedure.
- One or more steps of the method 200 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 104 of the navigation system 118, the processor 120 of the robot 114, the processor 148 of the add-on 132, and/or the processor 168 of the end effector 140.
- a processor other than any processor described herein may also be used to execute one or more steps of the method 200.
- the at least one processor may perform one or more steps of the method 200 by executing elements stored in a memory such as the memory 106, the memory 122, the memory 152, and/or the memory 172.
- the elements stored in the memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 200.
- One or more portions of a method 200 may be performed by the processor executing any of the contents of memory, such as an image processing, a segmentation, a transformation, and/or a registration.
- the method 200 comprises receiving a manufactured end effector (step 204).
- the manufactured end effector may be similar to or the same as the end effector 140.
- the method 200 also comprises saving information associated with the end effector to a memory stored on a PCB of the end effector (step 208).
- the saved information may be or comprise information such as the end effector type information 184, the authentication information 188, the end effector usage information 194, miscellaneous information 196, combinations thereof, and/or the like.
- the step 208 may be repeated for additional or alternative end effectors that are to be used in the surgery or surgical procedure.
- the method 200 also comprises measuring the end effector and generating measurement information (step 212).
- the end effector may be measured using any high accuracy measurement system, such as a CMM.
- the CMM may generate measurement information indicative of the dimensions of the end effector.
- the measurement information may comprise information about the geometry of the end effector (e.g., the surface geometry, the curvature of one or more surfaces of the end effector, etc.).
- the method 200 also comprises saving the measurement information to the memory (step 216).
- the measurement information may be saved to the memory 172 of the end effector.
- the memory 172 may comprise an EEPROM or other programmable memory, and the processor 168 may write the measurement information to the EEPROM.
- the measurement information may be stored as calibration information 192.
- the method 200 also comprises determining that an interface of the end effector is connected to an adapter of a robotic arm (step 220).
- the end effector 140 may be used during a surgery or surgical procedure. For example, during the course of the surgery or surgical procedure the end effector 140 may be connected to the tool changer 136.
- the processor 168 (or any other processor discussed herein) may determine that the end effector 140 has interfaced with the tool changer 136 (e.g., based on a signal generated when the end effector 140 mechanically couples with the tool changer 136).
- the method 200 also comprises transmitting information stored on the memory and associated with the end effector to a navigation system and/or to a robotic controller (step 224).
- the controller 128 may determine that the end effector 140 is connected to the robotic arm 116 and request information from the memory 172.
- the processor 168 may access the memory 172 and send any of the information stored therein to the controller 128.
- the information may comprise the end effector type information 184, the authentication information 188, the calibration information 192, the end effector usage information 194, the miscellaneous information 196, combinations thereof, and/or the like. Additionally or alternatively, the processor 168 may send the information to the navigation system 118.
- the controller 128 or the navigation system 118 may perform authentication of the end effector 140 and register, based on the calibration information 192, the end effector 140 and the robotic arm 116.
- the method 200 also comprises tracking the robotic arm as the robotic arm carries out a surgical task (step 228).
- the navigation system 118 may use one or more reference markers to track the pose of the robotic arm 116 as the robotic arm 116 performs a surgical task associated with the surgery or surgical procedure.
- the robotic arm 116 may perform a step of drilling a vertebra of a patient for the insertion of a pedicle screw.
- the navigation system 118 may track the pose of the robotic arm 116 based on the movement of markers attached to the robotic arm 116 and, based on the registration, determine and track the pose of the end effector 140 as the drilling step is performed.
- the navigation system 118 may send the pose information of the end effector 140 to the robot 114 to enable the controller 128 to more effectively control the robotic arm 116. In some embodiments, the navigation system 118 may send a signal to the controller 128 at various steps during the surgery or surgical procedure (e.g., when the end effector 140 is first connected, when the end effector 140 has completed the surgical task, when the end effector 140 has been moved to the tool stand, etc.).
- the method 200 also comprises updating information in the memory (step 232).
- the controller 128 may send a signal to the processor 168 to update the information stored in the memory 172 such as the end effector usage information 194.
- the updating of the end effector usage information 194 may comprise increasing an integer value representative of the number of times the end effector 140 has been used.
- the end effector usage information 194 may be updated when the end effector 140 is connected to the tool changer 136 but before the end effector 140 is used in the surgical task. In other embodiments, the end effector usage information 194 may be updated after the end effector 140 is used to carry out the surgical task.
- the end effector 140 may perform a drilling step, and the end effector 140 is then returned to the tool stand.
- the controller 128 may instruct the processor 168 to write the updated number of uses to the memory 172.
- the controller 128 may prevent the end effector 140 from being decoupled from the tool changer 136 until the processor 168 confirms with the controller 128 (e.g., via a return signal) that the end effector usage information 194 has been updated.
- the present disclosure encompasses embodiments of the method 200 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.
- the present disclosure also encompasses embodiments of the method 200 that are performed with respect to other components of the system 100 other than the end effector, such as with respect to the add-on 132.
- the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 2 (and the corresponding description of the method 200), as well as methods that include additional steps beyond those identified in Fig. 2 (and the corresponding description of the method 200).
- 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 surgical system (100), comprising: arobotic arm (116) including an adapter (136) on a distal end thereof; a navigation system (118) to track a pose of the robotic arm (116); and an end effector (140) comprising: an interface connectable to the adapter (136) of the robotic arm (116) to mechanically couple the end effector (140) and the robotic arm (116); a processor (104, 120, 148, 168); and a memory (106, 122, 152, 172) storing data thereon that, when processed by the processor (104, 120, 148, 168), enable the processor (104, 120, 148, 168) to: determine that the interface of the end effector (140) is connected to the adapter (136) of the robotic arm (116); and transmit information stored in the memory (106, 122, 152, 172) and associated with the end effector (140) to the navigation system (118), wherein the information transmitted to the navigation system (118) supports the navigation system (118) in
- Example 2 The surgical system of Example 1, wherein the memory (106, 122, 152, 172) comprises an electrically erasable programmable read-only memory (EEPROM).
- EEPROM electrically erasable programmable read-only memory
- Example 3 The surgical system of any of Examples 1 to 2, wherein the information associated with the end effector (140) comprises information about a geometry of the end effector (140).
- Example 4 The surgical system of Example 3, wherein the information about the geometry comprises information generated by a coordinate measuring machine (CMM).
- CCM coordinate measuring machine
- Example 5 The surgical system of any of Examples 1 to 4, wherein the information associated with the end effector (140) comprises information about a number of uses of the end effector (140).
- Example 6 The surgical system of Example 5, wherein the information about the number of uses of the end effector (140) is updated based on information sent from the navigation system (118) to the processor (104, 120, 148, 168).
- Example 7 The surgical system of any of Examples 5 to 6, wherein the information about the number of uses of the end effector (140) is updated at a conclusion of a surgical procedure in which the end effector (140) was used.
- Example 8 The surgical system of any of Examples 5 to 6, wherein the information about the number of uses of the end effector (140) is updated when the interface is connected to the adapter (136).
- Example 9 A system (100), comprising: a robotic arm (116); and an end effector (140) comprising: an operative portion (180) disposed on a distal end of the end effector (140); an interface on a proximal end opposite the distal end, the interface connectable to an adapter (136) of the robotic arm (116) to mechanically couple the end effector (140) and the robotic arm (116); a processor (104, 120, 148, 168); and a memory (106, 122, 152, 172) storing data thereon that, when processed by the processor (104, 120, 148, 168), enable the processor (104, 120, 148, 168) to: determine that the end effector (140) is connected to the robotic arm (116); and transmit, when the end effector (140) is connected to the robotic arm (116), information stored on the memory (106, 122, 152, 172) and associated with the end effector (140) to a robotic controller (128) that controls the robotic arm (116).
- Example 10 The system of Example 9, wherein the information associated with the end effector (140), when processed by the robotic controller (128), indicates that the end effector (140) is an active end effector.
- Example 11 The system of any of Examples 9 to 10, wherein the operative portion (180) of the active end effector is capable of resecting anatomical tissue.
- Example 12 The system of Example 9, wherein the information associated with the end effector (140), when processed by the robotic controller (128), indicates that the end effector (140) is a passive end effector.
- Example 13 The system of Example 12, wherein the operative portion (180) of the passive end effector comprises a tool guide.
- Example 14 The system of any of Examples 9 to 13, wherein the information associated with the end effector (140) comprises information about a number of uses of the end effector (140).
- Example 15 The system of Example 14, wherein the number of uses of the end effector (140) is updated at a conclusion of a surgical procedure in which the end effector (140) was used.
- Example 16 The system of any of Examples 14 to 15, wherein the processor (104, 120, 148, 168) transmits a warning to the robotic controller (128) when an updated number of uses of the end effector (140) exceeds a threshold value.
- Example 17 A device (140), comprising: an operative end (180); a processor (168); and a programmable memory (172) storing data thereon that, when processed by the processor (168), enable the processor (168) to: determine that the device (140) has been coupled with a robotic arm (116); and transmit information associated with the device (140) to a navigation system (118) of the robotic arm (116).
- Example 18 The device of Example 17, wherein the information associated with the device (140) comprises calibration information.
- Example 19 The device of Example 18, wherein the calibration information comprises information generated by a coordinate measuring machine (CMM).
- CCM coordinate measuring machine
- Example 20 The device of any of Examples 17 to 19, wherein the information associated with the device (140) comprises authentication information, and wherein the authentication information, when processed by a robotic controller (128), enables the robotic controller (128) to control the operative end (180) of the device (140).
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Abstract
A surgical system according to at least one embodiment of the present disclosure includes: a robotic arm including an adapter on a distal end thereof; a navigation system to track a pose of the robotic arm; and an end effector including: an interface connectable to the adapter of the robotic arm to mechanically couple the end effector and the robotic arm; a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: determine that the interface of the end effector is connected to the adapter of the robotic arm; and transmit information stored in the memory and associated with the end effector to the navigation system, where the information transmitted to the navigation system supports the navigation system in tracking the pose of the robotic arm.
Description
SYSTEMS FOR CALIBRATING AND AUTHENTICATING END EFFECTORS
BACKGROUND
[0001] The present disclosure is generally directed to surgeries and surgical procedures, and relates more particularly to end effector calibration and authentication.
[0002] Surgical robots may assist a surgeon or other medical provider in carrying out a surgical procedure, or may complete one or more surgical procedures autonomously. Providing controllable linked articulating members allows a surgical robot to reach areas of a patient anatomy during various medical procedures.
BRIEF SUMMARY
[0003] Systems and methods according to the present disclosure enable automatic calibration of surgical components without the need for further measurements or validation. End effector parts can be measured using a high-accuracy measurement system, such as a coordinate measuring machine (CMM), and calibration information associated with the measurements can be stored in an erasable and programmable memory unique to the end effector. The calibration information can then be automatically sent to a robotic controller once the end effector is connected to the robot, allowing the robotic controller to perform registration of the end effector and the robot. The unique erasable and programmable memory beneficially increases the yield of manufactured parts available for use in surgeries or surgical procedures, and increases the speed and accuracy of registration.
[0004] Example aspects of the present disclosure include:
[0005] A surgical system according to at least one embodiment of the present disclosure comprises: a robotic arm including an adapter on a distal end thereof; a navigation system to track a pose of the robotic arm; and an end effector comprising: an interface connectable to the adapter of the robotic arm to mechanically couple the end effector and the robotic arm; a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: determine that the interface of the end effector is connected to the adapter of the robotic arm; and transmit information stored in the memory and associated with the end effector to the navigation
system, wherein the information transmitted to the navigation system supports the navigation system in tracking the pose of the robotic arm.
[0006] Any of the aspects herein, wherein the memory comprises an electrically erasable programmable read-only memory (EEPROM).
[0007] Any of the aspects herein, wherein the information associated with the end effector comprises information about a geometry of the end effector.
[0008] Any of the aspects herein, wherein the information about the geometry comprises information generated by a coordinate measuring machine (CMM).
[0009] Any of the aspects herein, wherein the information associated with the end effector comprises information about a number of uses of the end effector.
[0010] Any of the aspects herein, wherein the information about the number of uses of the end effector is updated based on information sent from the navigation system to the processor.
[0011] Any of the aspects herein, wherein the information about the number of uses of the end effector is updated at a conclusion of a surgical procedure in which the end effector was used.
[0012] Any of the aspects herein, wherein the information about the number of uses of the end effector is updated when the interface is connected to the adapter.
[0013] A system according to at least one embodiment of the present disclosure comprises: a robotic arm; and an end effector comprising: an operative portion disposed on a distal end of the end effector; an interface on a proximal end opposite the distal end, the interface connectable to an adapter of the robotic arm to mechanically couple the end effector and the robotic arm; a processor; and a memory storing data thereon that, when processed by the processor, enable the processor to: determine that the end effector is connected to the robotic arm; and transmit, when the end effector is connected to the robotic arm, information stored on the memory and associated with the end effector to a robotic controller that controls the robotic arm.
[0014] Any of the aspects herein, wherein the information associated with the end effector, when processed by the robotic controller, indicates that the end effector is an active end effector.
[0015] Any of the aspects herein, wherein the operative portion of the active end effector is capable of resecting anatomical tissue.
[0016] Any of the aspects herein, wherein the information associated with the end effector, when processed by the robotic controller, indicates that the end effector is a passive end effector.
[0017] Any of the aspects herein, wherein the operative portion of the passive end effector comprises a tool guide.
[0018] Any of the aspects herein, wherein the information associated with the end effector comprises information about a number of uses of the end effector.
[0019] Any of the aspects herein, wherein the number of uses of the end effector is updated at a conclusion of a surgical procedure in which the end effector was used.
[0020] Any of the aspects herein, wherein the processor transmits a warning to the robotic controller when an updated number of uses of the end effector exceeds a threshold value.
[0021] A device according to at least one embodiment of the present disclosure comprises: an operative end; a processor; and a programmable memory storing data thereon that, when processed by the processor, enable the processor to: determine that the device has been coupled with a robotic arm; and transmit information associated with the device to a navigation system of the robotic arm. [0022] Any of the aspects herein, wherein the information associated with the device comprises calibration information.
[0023] Any of the aspects herein, wherein the calibration information comprises information generated by a coordinate measuring machine (CMM).
[0024] Any of the aspects herein, wherein the information associated with the device comprises authentication information, and wherein the authentication information, when processed by a robotic controller, enables the robotic controller to control the operative end of the device.
[0025] Any aspect in combination with any one or more other aspects.
[0026] Any one or more of the features disclosed herein.
[0027] Any one or more of the features as substantially disclosed herein.
[0028] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.
[0029] Any one of the aspects/features/embodiments in combination with any one or more other aspects/features/embodiments .
[0030] Use of any one or more of the aspects or features as disclosed herein.
[0031] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.
[0032] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.
[0033] The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as XI -Xn, Yl-Ym, and Zl- Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y 1 and Zo).
[0034] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.
[0035] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.
[0036] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0037] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative
examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below. [0038] Fig. 1A is a diagram of aspects of a system according to at least one embodiment of the present disclosure;
[0039] Fig. IB is a block diagram of additional aspects of the system according to at least one embodiment of the present disclosure;
[0040] Fig. 1C is a block diagram of additional aspects of an end effector according to at least one embodiment of the present disclosure; and
[0041] Fig. 2 is a flowchart according to at least one embodiment of the present disclosure.
DETAILED DESCRIPTION
[0042] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and/or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a processor and/or a medical device.
[0043] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., RAM, ROM, an electrically erasable programmable read-only memory
(EEPROM), flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).
[0044] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple Al l, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.
[0045] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure. [0046] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.
[0047] Different end effectors may be used in a robotics-assisted surgery or surgical procedures. Robotic surgical systems may include a fixed add-on at the end of a robotic arm that remains fixed on the arm and that facilitates connection of a tool changer unit to the robotic arm. The tool changer in turn facilitates the changing or switching out of different end effectors during the surgery or surgical procedure while maintaining the sterility of the robotic arm and the components thereof.
[0048] The positional accuracy of the end effector is important to the success of the robotic surgical system, as inaccurate end effector placement or movement can be detrimental to the patient’s safety. The accuracy chain of the robot includes the robotic arm, the fixed add-on, the tool changer, and the end effector. The tracking of surgical components by the navigation system also contributes to the accuracy chain. The components in the accuracy chain contribute to the overall accuracy of the robotic surgical system, such that an inaccuracy in the navigation, tolerances, and/or the like contributes to the overall error of the system. One contributor of error in the accuracy is the manufacturing tolerances of the physical parts of the robotic surgical system (e.g., the fixed add-on, the tool changer, the end effector, etc.). Such manufacturing intolerances can contribute to the overall inaccuracy of the robotic surgical system.
[0049] According to at least one embodiment of the present disclosure, a computing chip with memory (e.g., an EEPROM) is integrated into a printed circuit board (PCB) of one or more physical parts of the robotic surgical system that are part of the accuracy chain. The memory includes information useful in assisting a navigation system with tracking the physical part and/or useful in assisting a robotic controller in determining the pose (e.g., position and orientation) of the physical part. For example, the memory may include a calibration file that is unique to the physical part. The calibration file may include calibration values measured using a high accuracy measurement system (e.g., a CMM, a contact measurement arm such as the FARO® Quantum Max FaroArm®, etc.). The calibration file may be programmed into the memory of the computing chip, which may remain in the physical part for the lifetime of the physical part. The computing chip memory may additionally or alternatively include an internal counter that can inform the robotic surgical system on the number of times the end effector has been used. In some cases, the computing chip memory may additionally or alternatively include information about the end effector in which the computing chip memory is integrated, which can inform the robotic surgical system on the type of end effector that was connected to the tool changer, enabling tool authentication.
[0050] Embodiments of the present disclosure beneficially increase yields of manufactured parts. By placing a computing chip with calibration information in the manufactured part, the measured manufactured part can have looser tolerance standards. This may in turn allow a greater number of manufactured parts to be eligible for use in the surgical system. Embodiments of the present disclosure beneficially improve surgeries and surgical procedures by enabling automatic calibration updates without user interference, further measurements, or validation. The user can simply connect the unit (e.g., the add-on, the end effector, etc.), and the information stored in the memory of the unit is sent from the connected unit to the robotic controller software for a calibration update. Embodiments of the present disclosure beneficially enhance patient safety by limiting the number of times a certain end effector can be used. Patient safety is also enhanced by reducing human error in performing tool authentication; tool authentication is automatically performed when the unit is connected to the robotic arm based on the information stored on memory of the unit. Embodiments of the present disclosure beneficially reduce the overall surgery time by reducing the number of tasks the user needs to perform to calibrate and authenticate the end effector before use. Embodiments of the present disclosure beneficially enhance patient safety by ensuring that the tool on the end effector is authenticated before use.
[0051] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) inaccurate mechanical parts, (2) overused mechanical parts, (3) navigation inaccuracies, and (4) calibration and authentication errors.
[0052] Turning first to Figs. 1A-1C, aspects of a system 100 according to at least one embodiment of the present disclosure are shown. The system 100 may be used to manage end effectors attached to a surgical mount system and/or a surgical arm; to 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 one or more of the methods disclosed herein. The system 100 comprises one or more imaging device(s) 112, a robot 114, a navigation system 118, a database 130, an add-on 132, a cloud or other network 134, a tool changer 136, an end effector 140. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system 100 may not include the imaging device 112, the database 130, and/or the cloud 134.
[0053] The imaging device 112 may be operable to image anatomical feature(s) (e.g., a bone, veins, tissue, etc.) and/or other aspects of patient anatomy to yield image data (e.g., image data
depicting or corresponding to a bone, veins, tissue, etc.). “Image data” as used herein refers to the data generated or captured by an imaging device 112, including in a machine-readable form, a graphical/visual form, and in any other form. In various examples, the image data may comprise data corresponding to an anatomical feature of a patient, or to a portion thereof. The image data may be or comprise a preoperative image, an intraoperative image, a postoperative image, or an image taken independently of any surgical procedure. In some embodiments, a first imaging device 112 may be used to obtain first image data (e.g., a first image) at a first time, and a second imaging device 112 may be used to obtain second image data (e.g., a second image) at a second time after the first time. The imaging device 112 may be capable of taking a 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 are otherwise physically separated.
[0054] In some embodiments, the imaging device 112 may comprise more than one imaging device 112. For example, a first imaging device may provide first image data and/or a first image, and a second imaging device may provide second image data and/or a second image. In still other embodiments, the same imaging device may be used to provide both the first image data and the second image data, and/or any other image data described herein. The imaging device 112 may be operable to generate a stream of image data. For example, the imaging device 112 may be configured to operate with an open shutter, or with a shutter that continuously alternates between open and shut so as to capture successive images. For purposes of the present disclosure, unless specified otherwise, image data may be considered to be continuous and/or provided as an image data stream if the image data represents two or more frames per second.
[0055] The robot 114 comprises one or more robotic arms 116, a processor 120, a memory 122, a communication interface 124, and a controller 128. Robots according to other embodiments of the present disclosure may comprise more or fewer components than the robot 114. In some embodiments, the robot 114 may be mechanically coupled with (e.g., affixed to, attached to, mounted to, etc.) a patient bed or table. In other embodiments, the robot 114 may be disposed on a robot cart 144. The robot cart 144 may be 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. In some embodiments, 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. In other words, 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.
[0056] The robot 114 may be or comprise 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 the end effector 140 and/or a component thereof such as a surgical tool (whether based on guidance from the navigation system 118 or not) to accomplish or to assist with a surgical task. In some embodiments, the robot 114 may be configured to hold and/or manipulate an anatomical element during or in connection with a surgical procedure.
[0057] In some embodiments, the robotic arm 116 may comprise a first robotic arm and a second robotic arm, though the robot 114 may comprise more than two robotic arms. In some embodiments, one or more of the robotic arms 116 may be used to hold and/or maneuver the imaging device 112. In embodiments where the imaging device 112 comprises two or more physically separate components (e.g., a transmitter and receiver), one robotic arm 116 may hold one such component, and another robotic arm 116 may hold another such component. Each robotic
arm 116 may be positionable independently of the other robotic arm. The robotic arms 116 may be controlled in a single, shared coordinate space, or in separate coordinate spaces.
[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. 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, the add-on 132, the tool changer 136, the end effector 140 and components thereof such as a surgical tool, or other object held by or connected to the robot 114 (or, more specifically, held by or connected to the robotic arm 116) may be precisely positionable in one or more needed and specific positions and orientations.
[0059] The robotic arm(s) 116 may comprise one or more sensors that enable the processor 120 (or another processor of another component of the system 100) to determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm such as the add-on 132, the tool changer 136, and/or the end effector 140).
[0060] The processor 120 of the robot 114 may be any processor described herein or any similar processor. The processor 120 may be configured to execute instructions stored in the memory 122, which instructions may cause the processor 120 to carry out one or more computing steps utilizing or based on data received from the imaging device 112, the navigation system 118, the database 130, the cloud 134, and/or the end effector 140. The processor 120 may be or comprise 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.
[0061] The memory 122 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 122 may store information or data useful for completing, for example, one or more steps of the method 200 described herein, or of any other
methods. In one embodiment, the memory 122 comprises an EEPROM. The memory 122 may store, for example, instructions and/or machine learning models that support one or more functions of the robot 114. For instance, the memory 122 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 120, enable image processing, segmentation, transformation, and/or registration. Such content, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 122 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 120 to carry out the various method and features described herein. Thus, although various contents of memory 122 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 120 to manipulate data stored in the memory 122 and/or received from or via the imaging device 112, the database 130, the add-on 132, the cloud 134, the tool changer 136, and/or the end effector 140. [0062] The communication interface 124 may be used for receiving image data or other information from an external source (such as the imaging device 112, the navigation system 118, the database 130, the add-on 132, the cloud 134, the tool changer 136, the end effector 140, 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., the imaging device 112, the robot 114, the navigation system 118, the database 130, the add-on 132, the cloud 134, the tool changer 136, the end effector 140, and/or any other system or component not part of the system 100). The communication interface 124 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 124 may be useful for enabling the robot 114 (or one or more components thereof) to communicate with one or more other processors discussed herein, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
[0063] The controller 128 may be configured to automatically control one or more functions and/or components of the robot 114. In some embodiments, the controller 128 may utilize the
processor 120 to perform computations during the course of controlling the one or more functions and/or components of the robot 114. In some embodiments, the controller 128 may be configured to actuate one or more motors in one or more joints of the robotic arm 116 to, for example, cause the robotic arm 116 to move. In some embodiments, the controller 128 may receive information from the add-on 132, the tool changer 136, and/or the end effector 140, and use such information to authenticate and control the add-on 132, the tool changer 136, and/or end effector 140. For example, the controller 128 may receive authentication information from the end effector 140, and compare such information to information stored, for example, in the database 130. When the authentication information from the end effector 140 does not match the information in the database 130, the controller 128 may prevent the end effector 140 from being used in the surgery or surgical procedure. In another example, the controller 128 may receive usage information from the add-on 132 associated with a number of times the add-on 132 has been used. If the number of times the add-on 132 has been used exceeds a threshold value, the controller 128 may prevent the add-on 132 from being used in the surgery or surgical procedure. Such information stored in the add-on 132, the tool changer 136, and the end effector 140 and received by the controller 128 is discussed in further detail below.
[0064] 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, navigated trackers, or other objects within the operating room or other room in which some or all of the system 100 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system 118 may comprise one or more electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track a position and orientation (e.g., a pose) of the imaging device 112, the robot 114 and/or robotic arm 116 and components thereof, and/or one or more surgical tools (or, more particularly, to track a pose of a navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing). The navigation system 118 may include a display (including, for example, the user interface 110) for displaying one or more images from an external source (e.g., imaging device 112 or other source) or for displaying an image and/or video stream from the one or more cameras or other sensors of
the navigation system 118. In some embodiments, the system 100 can operate without the use of the navigation system 118. The navigation system 118 may be configured to provide guidance to a surgeon or other user of the system 100 or a component thereof, to the robot 114, or to any other element of the system 100 regarding, for example, a pose of one or more anatomical elements, whether or not a tool is in the proper trajectory, and/or how to move a tool into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan. The navigation system 118 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110.
[0065] In some embodiments, reference markers (e.g., navigation markers) may be placed on the imaging device 112, the robot 114 (including, e.g., on the robotic arm 116), or any other object in the surgical space. The reference markers may be tracked by the navigation system 118, and the results of the tracking may be used by the robot 114 and/or by an operator of the system 100 or any component thereof. In some embodiments, the navigation system 118 can be used to track other components of the system (e.g., imaging device 112).
[0066] The processor 104 may be similar to or the same as any processor discussed herein (e.g., the processor 120). 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 database 130, the cloud 134, and/or any other component of the system 100.
[0067] The memory 106 may be similar to or the same as any memory discussed herein (e.g., the memory 122). 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. In one embodiment, the memory 106 comprises an EEPROM. The memory 106 may store information or data useful for completing, for example, one or more steps of the method 200 described herein, or of any other methods.
[0068] The communication interface 108 may be similar to or the same as any communication interface discussed herein (e.g., the communication interface 124). 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 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., the imaging device 112, the robot 114, the database 130, the cloud 134, and/or any other system or component not part of the system 100).
[0069] The user interface 110 may be or comprise one or multiple user interfaces. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104, the processor 120, or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 110 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 104 (or in some embodiments the processor 120) 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.
[0070] Although the user interface 110 is shown as part of the navigation system 118, in some embodiments, the processor 104 and/or the processor 120 (or any other processor discussed herein) may utilize a user interface 110 that is housed separately from the navigation system 118. In some embodiments, the user interface 110 may be located proximate one or more other components of the robot 114, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the robot 114.
[0071] 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 system 100; information about planned surgical tools to be used and connected to the robotic arm 116 to carry out the surgery or surgical procedure); 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 related to the add-on 132, the tool changer 136, and/or the end effector 140, and/or any other useful information. The database 130 may be configured to provide any such information to any device of the system 100
or external to the system 100, whether directly or via the cloud 134. In some embodiments, the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and/or another system for collecting, storing, managing, and/or transmitting electronic medical records including image data.
[0072] The cloud 134 may be or represent the Internet or any other wide area network. The robot 114, the navigation system 118, the database 130, and/or the like may be connected to the cloud 134 via the communication interface 108 and/or the communication interface 124, using a wired connection, a wireless connection, or both. In some embodiments, one or more components of the system 100 may communicate with the imaging device 112, the database 130, any other component of the system 100, and/or an external device (e.g., a computing device outside the system 100) via the cloud 134.
[0073] The add-on 132 has a proximal end with an interface that is connectable to the distal end of the robotic arm 116 to attach the add-on 132 to the robotic arm 116. The add-on 132 has a distal end that facilitates connection of the robotic arm 116 to the tool changer 136. In some embodiments, the add-on 132 comprises a fixed add-on that remains on the robotic arm 116 through the course of the surgery or surgical procedure. In some embodiments, the add-on 132 may comprise one or more slots, threads, sockets, and/or the like that enable the add-on 132 to mechanically couple with the robotic arm 116. The add-on 132 comprises a processor 148, a memory 152, and a motor driver 156. In some embodiments, the add-on 132 may omit one or more components than those depicted in Fig. IB. For example, the add-on 132 may omit the motor driver 156 and operate as a passive mechanical component. In some embodiments, the add-on 132 may comprise additional components, such as temperature sensors, Light Emitting Diodes (LEDs), LED driver circuit(s), communication interfaces, and/or the like disposed on a PCB stored in the add-on 132. The LED driver circuit(s) may enable the add-on 132 to emit light from the LEDs. The LEDs may be disposed in a predetermined arrangement on the add-on 132 which may enable, for example, registration based on the detection of the LEDs using image data from the imaging devices 112 and processing by the navigation system 118. Additionally or alternatively, the memory 152 of the add-on 132 may comprise a calibration file including calibration and authentication information that enables the controller 128 to calibrate and authenticate the add-on 132, as discussed in further detail below.
[0074] The processor 148 may be similar to or the same as any processor discussed herein (e.g., the processor 104, the processor 120, etc.). The processor 148 may be configured to execute instructions stored in the memory 152, which instructions may cause the processor 148 to carry out one or more computing steps utilizing or based on data received from the imaging device 112, the robot 114, the database 130, the cloud 134, and/or any other component of the system 100.
[0075] The memory 152 may be similar to or the same as any memory discussed herein (e.g., memory 106, the memory 122, etc.). The memory 152 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 152 may store information or data useful for completing, for example, one or more steps of the method 200 described herein, or of any other methods. In one embodiment, the memory 152 comprises an EEPROM that is programmable to store information specific to the add-on 132. For example, the EEPROM may comprise information about the position of LEDs on the add-on 132; specification information associated with the dimensions, operating conditions, and the like of the add-on 132; usage information associated with the add-on 132; authentication information of the add-on 132; and/or any other useful information. Such information may be sent by the processor 148 to the controller 128 upon the add-on 132 being attached to the robotic arm 116.
[0076] The motor driver 156 may drive one or more components of the end effector 140. For example, the motor driver 156 may send signals to and receive signals from the end effector 140 through the tool changer 136 to control the end effector 140 and/or components of the end effector 140 such as control surgical tools (e.g., surgical drills, reamers, etc.). In some embodiments, the motor driver 156 may be similar to or the same as the processor 148, such as when the motor driver 156 comprises an integrated circuit chip that controls one or more components of the end effector 140. In some embodiments, the motor driver 156 may control a locking mechanism of the add-on 132 that locks and unlocks the tool changer 136 such that the tool changer 136 can or cannot move relative to the add-on 132. The locking mechanism may be mechanical (e.g., the tool changer 136 is blocked from attaching to or detaching from the add-on 132 by bolt(s) and/or the like), electrical (e.g., the tool changer 136 receives an electrical signal from the locking mechanism that causes the tool changer 136 to lock or unlock), combinations thereof, and/or the like.
[0077] The tool changer 136 may comprise a proximal end that connects to the distal end of the add-on 132. The tool changer 136 may comprise one or more mechanical interfaces at a distal end
thereof that enable different end effectors to connect to the robotic arm 116. The tool changer 136 may comprise an adjustable distal end to enable end effectors of different shapes and sizes to be coupled to the robotic arm 116. The tool changer 136 comprises a tool changer controller 160 and a tool changer receiver 164. The tool changer controller 160 may operate to generate control signals (or in some cases receive control signals from other components of the system 100) that are passed to the tool changer receiver 164. The tool changer controller 160 may control, for example, an interlocking feature of the tool changer 136 such that the end effector 140 can only be uncoupled from the tool changer 136 when the tool changer 136 is positioned near or within a tool stand.
[0078] In one example, the tool changer controller 160 may determine that the tool changer 136 is coupled with the end effector 140. The tool changer controller 160 may determine this information based on sensors, based on signals generated when the end effector 140 has effectively coupled with the tool changer 136, based on the step in the surgical procedure, combinations thereof, and/or the like. Once the tool changer controller 160 determines that the tool changer 136 and the end effector 140 are coupled, the tool changer controller 160 may send a signal to the tool changer receiver 164 to keep the interlocking feature locked until the tool changer receiver 164 receives a further signal. The tool changer controller 160 may generate and/or send the further signal to the tool changer receiver 164 when the tool changer 136 has been placed back in the tool stand (e.g., after the end effector 140 has been used and the surgery or surgical procedure has progressed to the next step), such that the tool changer controller 160 changes the interlocking feature to an unlocked state.
[0079] In some embodiments, the tool changer controller 160 may be disposed in the add-on 132 and the tool changer receiver 164 may be disposed in the end effector 140. In such embodiments, an EEPROM in the memory 152 may comprise information associated with the add-on 132 and components thereof (e.g., the tool changer controller 160), while an EEPROM in the memory 172 may comprise information associated with the end effector 140 and components thereof (e.g., the tool changer receiver 164). In these embodiments, the communication between the add-on 132 and the end effector 140 may occur through the tool changer controller 160 and the tool changer receiver 164, where the tool changer receiver 164 is unique to the end effector 140 and the tool changer controller 160 is unique to the add-on 132.
[0080] The end effector 140 may include a proximal end that is connectable to the tool changer 136 and a distal end that comprises an operative portion 180 that can be used to carry out one or
more surgical tasks. The end effector 140 may comprise an active end effector, such as when the operative portion 180 comprises a surgical tool, or a passive end effector, such as when the operative portion 180 comprises a tool guide. The end effector 140 also comprises a memory 172, and may additionally comprise a processor 168 and a motor controller 176.
[0081] The operative portion 180 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.). In some embodiments, 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.). In other embodiments, 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.
[0082] Additionally or alternatively, the operative portion 180 may comprise a tool guide. The tool guide may provide a passive hole through which a surgical tool or component may pass to reach a surgical site. For example, the tool guide may be or comprise a hollow cylinder that can be aligned with a planned trajectory of a surgical tool. As a result, the guide provides a visual indicator to an operator (e.g., a surgeon) of the planned trajectory of the surgical tool. In some cases, the operative portion 180 comprising the tool guide may be attached to the robotic arm 116 and the robotic arm 116 may move such that the tool guide is positioned at the planned surgical entry point. Another robotic arm 116 with a surgical tool (e.g., a surgical drill) may then be positioned such that the surgical tool enters the surgical site through the tool guide.
[0083] The operative portion 180 may be controlled by a motor controller 176. The motor controller 176 may be connected to or otherwise communicate with one or more motors disposed in or connected to the end effector 140. The motor controller 176 may control the operation of the motors, such that the motor controller 176 controls movement of the end effector 140 and/or one or more components thereof such as the operative portion 180. The motor controller 176 may control the motors based on signals sent from the robot 114 or components thereof (e.g., the
controller 128), the navigation system 118 or components thereof (e.g., the processor 104), the addon 132, the tool changer 136 (e.g., based on interactions between the tool changer controller 160 and the tool changer receiver 164), and/or the like. In one example, such as when the operative portion 180 comprises a surgical tool, the motor controller 176 may control one or more motors of the operative portion 180 to cause movement of the surgical tool, to turn the surgical tool on and off, combinations thereof, and/or the like.
[0084] The processor 168 may be similar to or the same as any processor discussed herein (e.g., the processor 104, processor 120, the processor 148, etc.). The processor 168 may be configured to execute instructions stored in the memory 172, which instructions may cause the processor 168 to send information stored in the memory 172 to one or more components of the system 100 (e.g., to the robot 114, to the navigation system 118, to the add-on 132, to the tool changer 136, etc.). Additionally or alternatively, the instructions may cause the processor 168 write to or otherwise update information stored in the memory 172, such as to update information about the number of uses of the end effector 140, as discussed in further detail below.
[0085] The memory 172 may be similar to or the same as any memory discussed herein (e.g., the memory 122). The memory 172 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein such as an EEPROM, 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, one or more steps of the method 200 described herein, or of any other methods. In some cases, both the processor 168 and the stored on a printed circuit board disposed in the end effector 140. The memory 172 is reprogrammable memory, such that information stored in the memory 172 can be erased and reprogrammed. In one embodiment, the memory 172 may be unique to the end effector 140. In other words, each end effector 140 may have a separate memory 172 embedded in the end effector 140 and containing information unique to the end effector 140. The memory 172 comprises end effector type information 184, authentication information 188, calibration information 192, end effector usage information 194, and miscellaneous information 196.
[0086] The end effector type information 184 may indicate whether the end effector 140 is an active end effector (e.g., the operative portion 180 comprises an active surgical tool such as a surgical drill) or a passive end effector (e.g., the operative portion 180 comprises a passive surgical tool such as a tool guide). The end effector type information 184 may be accessed by the processor
168 and sent to the controller 128 of the robot 114. In some cases, the end effector type information 184 may be sent to the navigation system 118 to help the navigation system 118 track the end effector 140. In other words, the navigation system 118 may be able to better track the end effector 140 when the navigation system 118 has information about the type of end effector in use (e.g., a passive end effector may not move as compared to an active end effector which may move). The controller 128 may render the end effector type information 184 to the user interface 110 to enable a user to view the end effector type information 184. The controller 128 may compare the end effector type information 184 to information stored in the database 130 to authenticate the end effector 140. For example, the surgical plan may call for the use of an active end effector capable of resecting anatomical tissue, and the end effector type information 184 may specify that the end effector 140 is an active end effector that includes a surgical drill. The controller 128 may receive the end effector type information 184 and, since the end effector type information 184 matches the end effector type required by the surgical plan, the controller 128 may determine that the end effector 140 connected to the robotic arm 116 is the correct end effector. As another example, the surgical plan may call for the use of an active surgical drill, but the end effector type information 184 may specify that the end effector 140 is a passive instrument (e.g., a tool guide) that cannot resect anatomical tissue. As a result, when the controller 128 compares the end effector type information 184 to the stored data, the controller 128 may determine that the end effector 140 is not the correct end effector for the current step of the procedure. In such examples, the controller 128 may render a warning (e.g., a flashing light) to the display to notify the user that the incorrect end effector has been attached. Additionally or alternatively, the controller 128 may disable use of the robotic arm 116 and/or components thereof until the improper end effector 140 is removed.
[0087] The authentication information 188 may comprise information that enables the system 100 or components thereof (e.g., the processor 120 of the robot 114) to authenticate the end effector 140. The end effector type information 184 may be or comprise information associated with the manufacturing source, date of manufacturing, lot number, model number, serial number, recommended operating settings, operating parameters, combinations thereof, and/or the like. In some embodiments, the authentication information 188 may be accessed by the processor 168 and sent to the controller 128 of the robot 114. The controller 128 may compare the authentication information 188 to information stored in the database 130 to authenticate the end effector 140. For example, the surgical plan for a surgical procedure may call for the use of an end effector
manufactured by a first manufacturer, and the authentication information 188 may specify that the end effector 140 was manufactured by the first manufacturer. The controller 128 may receive the authentication information 188 and, since the authentication information 188 matches the surgical plan, the controller 128 may determine that the end effector 140 connected to the robotic arm 116 is an acceptable end effector for performing the surgical procedure. In some cases, the controller 128 may be able to control the end effector 140 once the end effector 140 has been authenticated. As another example, the surgical plan may call for the use of an end effector manufactured by the first manufacturer, but the authentication information 188 may specify that the end effector 140 was manufactured by a second, different manufacturer. As a result, when the controller 128 compares the authentication information 188 to the stored data, the controller 128 may determine that the end effector 140 is not acceptable to perform the current step of the procedure. In such examples, the controller 128 may render a warning (e.g., a flashing light) to the display to notify the user that the incorrect end effector has been attached. Additionally or alternatively, the controller 128 may disable use of the robotic arm 116 and/or components thereof until the improper end effector 140 is removed.
[0088] The calibration information 192 may comprise information about the dimensions of the end effector 140 and/or components thereof (e.g., the operative portion 180). The dimensions may be based on one or more measurements of the end effector 140 generated with one or more measurement systems. For example, the dimensions of the end effector 140 may be generated using a CMM. The CMM may capture the geometry of the end effector 140 based on sensing of discrete points on the surface of the end effector 140. In some embodiments, the measurements of the end effector 140 may be stored as the calibration information 192 in the memory 172. The calibration information 192 may be accessed by the processor 168 and sent to the controller 128. The processor 168 may send the information once the end effector 140 is coupled to the robotic arm 116 (e.g., via the tool changer 136). The controller 128 may receive the calibration information 192 and use the calibration information 192 along with the known pose of the robotic arm 116 to register the end effector 140 to the robot 114. The controller 128 may additionally or alternatively register the end effector 140 to any other coordinate system, and send such information to the navigation system 118 to enable the navigation system 118 to track the pose of the end effector 140.
[0089] The end effector usage information 194 may comprise information about a number of times the end effector 140 has been used. For example, the end effector usage information 194 may
comprise an integer number representative of the number of times the end effector 140 has connected to a robotic arm 116 and/or a component thereof (e.g., the tool changer 136) and/or the number of times the end effector 140 has been used in a surgery or surgical procedure. In some embodiments, the end effector usage information 194 may be updated and saved to the memory 172 once the end effector 140 has been connected to the tool changer 136. For example, the end effector usage information 194 may indicate that the end effector 140 has been used three times. When the robotic arm 116 moves to the tool stand and the end effector 140 is coupled with the distal end of the tool changer 136, or when the user manually attaches the end effector 140 to the tool changer 136, the processor 168 may access the memory 172 and update the end effector usage information 194 to indicate that the end effector 140 has been used four times. Additionally or alternatively, the processor 168 may send the end effector usage information 194 to one or more components of the system 100, such as to the user interface 110 so that the end effector usage information 194 can be rendered to a display and reviewed by a user (e.g., a physician, a member of surgical staff, etc.). In some embodiments, the end effector usage information 194 may be updated by the processor 168 after the end effector 140 has been used and returned to the tool stand. In other words, the memory 172 is updated after the end effector 140 has been used and the surgical procedure requiring the end effector 140 has concluded.
[0090] In some embodiments, the processor 168 may access the end effector usage information 194 and send the end effector usage information 194 to the controller 128, and the controller 128 may determine whether the end effector 140 has exceeded a predetermined number of uses. The predetermined number of uses may be or comprise a threshold value stored, for example, in the database 130. When the number of uses of the end effector 140 meets or exceeds the threshold value, the controller 128 may disable use of the end effector 140 such as by preventing the operative portion 180 of the end effector 140 from receiving power. In some embodiments, the controller 128 may cause the processor 168 to write instructions to the memory 172 that specify that the end effector 140 is not to be used again. Additionally or alternatively, the controller 128 may render a warning to the user interface 110 that notifies the user that the end effector 140 has exceeded the threshold number of uses. The threshold number of uses may be based on the specifications of the surgery or surgical procedure, the surgical plan, surgeon preference, combinations thereof, and/or the like.
[0091] The miscellaneous information 196 may comprise any other useful information associated with the end effector 140 and/or components thereof. The miscellaneous information 196 may comprise historical data associated with the end effector 140, such as the dates on which the end effector 140 was used, overall time of use of the end effector 140, combinations thereof, and/or the like.
[0092] It is to be understood that the above discussion of the memory 172 and the elements thereof (e.g., the end effector type information 184, the authentication information 188, etc.) is not limiting to the end effector 140, and other components of the system 100 may have such information stored in an erasable and programmable memory that is unique to that component. For example, the memory 152 of the add-on 132 may comprise an EEPROM or any similar erasable and programmable memory that stores information about the add-on 132.
[0093] The system 100 or similar systems may be used, for example, to carry out one or more aspects of the method 200 described herein. The system 100 or similar systems may also be used for other purposes.
[0094] Fig. 2 depicts a method 200 that may be used, for example, to calibrate and authenticate an end effector used during a surgery or surgical procedure.
[0095] One or more steps of the method 200 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 104 of the navigation system 118, the processor 120 of the robot 114, the processor 148 of the add-on 132, and/or the processor 168 of the end effector 140. A processor other than any processor described herein may also be used to execute one or more steps of the method 200. The at least one processor may perform one or more steps of the method 200 by executing elements stored in a memory such as the memory 106, the memory 122, the memory 152, and/or the memory 172. The elements stored in the memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 200. One or more portions of a method 200 may be performed by the processor executing any of the contents of memory, such as an image processing, a segmentation, a transformation, and/or a registration.
[0096] The method 200 comprises receiving a manufactured end effector (step 204). In some embodiments, the manufactured end effector may be similar to or the same as the end effector 140. [0097] The method 200 also comprises saving information associated with the end effector to a memory stored on a PCB of the end effector (step 208). The saved information may be or comprise
information such as the end effector type information 184, the authentication information 188, the end effector usage information 194, miscellaneous information 196, combinations thereof, and/or the like. In some embodiments, the step 208 may be repeated for additional or alternative end effectors that are to be used in the surgery or surgical procedure.
[0098] The method 200 also comprises measuring the end effector and generating measurement information (step 212). The end effector may be measured using any high accuracy measurement system, such as a CMM. The CMM may generate measurement information indicative of the dimensions of the end effector. In some embodiments, the measurement information may comprise information about the geometry of the end effector (e.g., the surface geometry, the curvature of one or more surfaces of the end effector, etc.).
[0099] The method 200 also comprises saving the measurement information to the memory (step 216). The measurement information may be saved to the memory 172 of the end effector. In some embodiments, the memory 172 may comprise an EEPROM or other programmable memory, and the processor 168 may write the measurement information to the EEPROM. In some embodiments, the measurement information may be stored as calibration information 192.
[0100] The method 200 also comprises determining that an interface of the end effector is connected to an adapter of a robotic arm (step 220). Once the EEPROM has been programmed with the end effector type information 184, the authentication information 188, the calibration information 192, the end effector usage information 194, the miscellaneous information 196, combinations thereof, and/or the like, the end effector 140 may be used during a surgery or surgical procedure. For example, during the course of the surgery or surgical procedure the end effector 140 may be connected to the tool changer 136. Upon connection, the processor 168 (or any other processor discussed herein) may determine that the end effector 140 has interfaced with the tool changer 136 (e.g., based on a signal generated when the end effector 140 mechanically couples with the tool changer 136).
[0101] The method 200 also comprises transmitting information stored on the memory and associated with the end effector to a navigation system and/or to a robotic controller (step 224). Once the end effector 140 couples to the tool changer 136, the controller 128 may determine that the end effector 140 is connected to the robotic arm 116 and request information from the memory 172. The processor 168 may access the memory 172 and send any of the information stored therein to the controller 128. The information may comprise the end effector type information 184, the
authentication information 188, the calibration information 192, the end effector usage information 194, the miscellaneous information 196, combinations thereof, and/or the like. Additionally or alternatively, the processor 168 may send the information to the navigation system 118. In some embodiments, the controller 128 or the navigation system 118 may perform authentication of the end effector 140 and register, based on the calibration information 192, the end effector 140 and the robotic arm 116.
[0102] The method 200 also comprises tracking the robotic arm as the robotic arm carries out a surgical task (step 228). The navigation system 118 may use one or more reference markers to track the pose of the robotic arm 116 as the robotic arm 116 performs a surgical task associated with the surgery or surgical procedure. For example, the robotic arm 116 may perform a step of drilling a vertebra of a patient for the insertion of a pedicle screw. The navigation system 118 may track the pose of the robotic arm 116 based on the movement of markers attached to the robotic arm 116 and, based on the registration, determine and track the pose of the end effector 140 as the drilling step is performed. In some embodiments, the navigation system 118 may send the pose information of the end effector 140 to the robot 114 to enable the controller 128 to more effectively control the robotic arm 116. In some embodiments, the navigation system 118 may send a signal to the controller 128 at various steps during the surgery or surgical procedure (e.g., when the end effector 140 is first connected, when the end effector 140 has completed the surgical task, when the end effector 140 has been moved to the tool stand, etc.).
[0103] The method 200 also comprises updating information in the memory (step 232). Once the end effector 140 has been used, the controller 128 may send a signal to the processor 168 to update the information stored in the memory 172 such as the end effector usage information 194. The updating of the end effector usage information 194 may comprise increasing an integer value representative of the number of times the end effector 140 has been used. In some embodiments, the end effector usage information 194 may be updated when the end effector 140 is connected to the tool changer 136 but before the end effector 140 is used in the surgical task. In other embodiments, the end effector usage information 194 may be updated after the end effector 140 is used to carry out the surgical task. For example, the end effector 140 may perform a drilling step, and the end effector 140 is then returned to the tool stand. Before the end effector 140 is decoupled from the tool changer 136, the controller 128 may instruct the processor 168 to write the updated number of uses to the memory 172. In some examples, the controller 128 may prevent the end
effector 140 from being decoupled from the tool changer 136 until the processor 168 confirms with the controller 128 (e.g., via a return signal) that the end effector usage information 194 has been updated.
[0104] The present disclosure encompasses embodiments of the method 200 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above. The present disclosure also encompasses embodiments of the method 200 that are performed with respect to other components of the system 100 other than the end effector, such as with respect to the add-on 132.
[0105] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 2 (and the corresponding description of the method 200), as well as methods that include additional steps beyond those identified in Fig. 2 (and the corresponding description of the method 200). 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. [0106] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.
[0107] Moreover, though the foregoing has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or
steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.
[0108] A set of examples are provided below:
[0109] Example 1: A surgical system (100), comprising: arobotic arm (116) including an adapter (136) on a distal end thereof; a navigation system (118) to track a pose of the robotic arm (116); and an end effector (140) comprising: an interface connectable to the adapter (136) of the robotic arm (116) to mechanically couple the end effector (140) and the robotic arm (116); a processor (104, 120, 148, 168); and a memory (106, 122, 152, 172) storing data thereon that, when processed by the processor (104, 120, 148, 168), enable the processor (104, 120, 148, 168) to: determine that the interface of the end effector (140) is connected to the adapter (136) of the robotic arm (116); and transmit information stored in the memory (106, 122, 152, 172) and associated with the end effector (140) to the navigation system (118), wherein the information transmitted to the navigation system (118) supports the navigation system (118) in tracking the pose of the robotic arm (116).
[0110] Example 2 : The surgical system of Example 1, wherein the memory (106, 122, 152, 172) comprises an electrically erasable programmable read-only memory (EEPROM).
[0111] Example 3 : The surgical system of any of Examples 1 to 2, wherein the information associated with the end effector (140) comprises information about a geometry of the end effector (140).
[0112] Example 4: The surgical system of Example 3, wherein the information about the geometry comprises information generated by a coordinate measuring machine (CMM).
[0113] Example 5: The surgical system of any of Examples 1 to 4, wherein the information associated with the end effector (140) comprises information about a number of uses of the end effector (140).
[0114] Example 6: The surgical system of Example 5, wherein the information about the number of uses of the end effector (140) is updated based on information sent from the navigation system (118) to the processor (104, 120, 148, 168).
[0115] Example 7: The surgical system of any of Examples 5 to 6, wherein the information about the number of uses of the end effector (140) is updated at a conclusion of a surgical procedure in which the end effector (140) was used.
[0116] Example 8: The surgical system of any of Examples 5 to 6, wherein the information about the number of uses of the end effector (140) is updated when the interface is connected to the adapter (136).
[0117] Example 9 : A system (100), comprising: a robotic arm (116); and an end effector (140) comprising: an operative portion (180) disposed on a distal end of the end effector (140); an interface on a proximal end opposite the distal end, the interface connectable to an adapter (136) of the robotic arm (116) to mechanically couple the end effector (140) and the robotic arm (116); a processor (104, 120, 148, 168); and a memory (106, 122, 152, 172) storing data thereon that, when processed by the processor (104, 120, 148, 168), enable the processor (104, 120, 148, 168) to: determine that the end effector (140) is connected to the robotic arm (116); and transmit, when the end effector (140) is connected to the robotic arm (116), information stored on the memory (106, 122, 152, 172) and associated with the end effector (140) to a robotic controller (128) that controls the robotic arm (116).
[0118] Example 10: The system of Example 9, wherein the information associated with the end effector (140), when processed by the robotic controller (128), indicates that the end effector (140) is an active end effector.
[0119] Example 11: The system of any of Examples 9 to 10, wherein the operative portion (180) of the active end effector is capable of resecting anatomical tissue.
[0120] Example 12: The system of Example 9, wherein the information associated with the end effector (140), when processed by the robotic controller (128), indicates that the end effector (140) is a passive end effector.
[0121] Example 13: The system of Example 12, wherein the operative portion (180) of the passive end effector comprises a tool guide.
[0122] Example 14: The system of any of Examples 9 to 13, wherein the information associated with the end effector (140) comprises information about a number of uses of the end effector (140). [0123] Example 15: The system of Example 14, wherein the number of uses of the end effector (140) is updated at a conclusion of a surgical procedure in which the end effector (140) was used. [0124] Example 16: The system of any of Examples 14 to 15, wherein the processor (104, 120, 148, 168) transmits a warning to the robotic controller (128) when an updated number of uses of the end effector (140) exceeds a threshold value.
[0125] Example 17: A device (140), comprising: an operative end (180); a processor (168); and a programmable memory (172) storing data thereon that, when processed by the processor (168), enable the processor (168) to: determine that the device (140) has been coupled with a robotic arm (116); and transmit information associated with the device (140) to a navigation system (118) of the robotic arm (116).
[0126] Example 18: The device of Example 17, wherein the information associated with the device (140) comprises calibration information.
[0127] Example 19: The device of Example 18, wherein the calibration information comprises information generated by a coordinate measuring machine (CMM).
[0128] Example 20: The device of any of Examples 17 to 19, wherein the information associated with the device (140) comprises authentication information, and wherein the authentication information, when processed by a robotic controller (128), enables the robotic controller (128) to control the operative end (180) of the device (140).
Claims
1. A surgical system (100), comprising: a robotic arm (116) including an adapter (136) on a distal end thereof; a navigation system (118) to track a pose of the robotic arm (116); and an end effector (140) comprising: an interface connectable to the adapter (136) of the robotic arm (116) to mechanically couple the end effector (140) and the robotic arm (116); a processor (104, 120, 148, 168); and a memory (106, 122, 152, 172) storing data thereon that, when processed by the processor (104, 120, 148, 168), enable the processor (104, 120, 148, 168) to: determine that the interface of the end effector (140) is connected to the adapter (136) of the robotic arm (116); and transmit information stored in the memory (106, 122, 152, 172) and associated with the end effector (140) to the navigation system (118), wherein the information transmitted to the navigation system (118) supports the navigation system (118) in tracking the pose of the robotic arm (116).
2. The surgical system of claim 1, wherein the memory (106, 122, 152, 172) comprises an electrically erasable programmable read-only memory (EEPROM).
3. The surgical system of any of claims 1 to 2, wherein the information associated with the end effector (140) comprises information about a geometry of the end effector (140).
4. The surgical system of claim 3, wherein the information about the geometry comprises information generated by a coordinate measuring machine (CMM).
5. The surgical system of any of claims 1 to 4, wherein the information associated with the end effector (140) comprises information about a number of uses of the end effector (140).
6. The surgical system of claim 5, wherein the information about the number of uses of the end effector (140) is updated based on information sent from the navigation system (118) to the processor (104, 120, 148, 168).
7. The surgical system of any of claims 5 to 6, wherein the information about the number of uses of the end effector (140) is updated at a conclusion of a surgical procedure in which the end effector (140) was used.
8. The surgical system of any of claims 5 to 6, wherein the information about the number of uses of the end effector (140) is updated when the interface is connected to the adapter (136).
9. A system (100), comprising: a robotic arm (116); and an end effector (140) comprising: an operative portion (180) disposed on a distal end of the end effector (140); an interface on a proximal end opposite the distal end, the interface connectable to an adapter (136) of the robotic arm (116) to mechanically couple the end effector (140) and the robotic arm (116); a processor (104, 120, 148, 168); and a memory (106, 122, 152, 172) storing data thereon that, when processed by the processor (104, 120, 148, 168), enable the processor (104, 120, 148, 168) to: determine that the end effector (140) is connected to the robotic arm (116); and transmit, when the end effector (140) is connected to the robotic arm (116), information stored on the memory (106, 122, 152, 172) and associated with the end effector (140) to a robotic controller (128) that controls the robotic arm (116).
10. The system of claim 9, wherein the information associated with the end effector (140), when processed by the robotic controller (128), indicates that the end effector (140) is an active end effector.
11. The system of any of claims 9 to 10, wherein the operative portion (180) of the active end effector is capable of resecting anatomical tissue.
12. The system of claim 9, wherein the information associated with the end effector (140), when processed by the robotic controller (128), indicates that the end effector (140) is a passive end effector.
13. The system of claim 12, wherein the operative portion (180) of the passive end effector comprises a tool guide.
14. The system of any of claims 9 to 13, wherein the information associated with the end effector (140) comprises information about a number of uses of the end effector (140).
15. The system of claim 14, wherein the number of uses of the end effector (140) is updated at a conclusion of a surgical procedure in which the end effector (140) was used.
16. The system of any of claims 14 to 15, wherein the processor (104, 120, 148, 168) transmits a warning to the robotic controller (128) when an updated number of uses of the end effector (140) exceeds a threshold value.
17. A device (140), comprising: an operative end (180); a processor (168); and a programmable memory (172) storing data thereon that, when processed by the processor (168), enable the processor (168) to: determine that the device (140) has been coupled with a robotic arm (116); and transmit information associated with the device (140) to a navigation system (118) of the robotic arm (116).
18. The device of claim 17, wherein the information associated with the device (140) comprises calibration information.
19. The device of claim 18, wherein the calibration information comprises information generated by a coordinate measuring machine (CMM).
20. The device of any of claims 17 to 19, wherein the information associated with the device (140) comprises authentication information, and wherein the authentication information, when processed by a robotic controller (128), enables the robotic controller (128) to control the operative end (180) of the device (140).
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363543850P | 2023-10-12 | 2023-10-12 | |
| US63/543,850 | 2023-10-12 |
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| WO2025079074A1 true WO2025079074A1 (en) | 2025-04-17 |
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| PCT/IL2024/050991 Pending WO2025079074A1 (en) | 2023-10-12 | 2024-10-10 | Systems for calibrating and authenticating end effectors |
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| WO (1) | WO2025079074A1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20230013550A1 (en) * | 2021-07-15 | 2023-01-19 | DePuy Synthes Products, Inc. | End effector identification in surgical robotic systems |
| US20230157774A1 (en) * | 2021-11-23 | 2023-05-25 | Mazor Robotics Ltd. | Multiple end effector interfaces coupled with different kinematics |
| WO2023102012A1 (en) * | 2021-12-01 | 2023-06-08 | Nuvasive, Inc. | Connector assemblies for connecting a robotic arm with a medical end effector |
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- 2024-10-10 WO PCT/IL2024/050991 patent/WO2025079074A1/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20230013550A1 (en) * | 2021-07-15 | 2023-01-19 | DePuy Synthes Products, Inc. | End effector identification in surgical robotic systems |
| US20230157774A1 (en) * | 2021-11-23 | 2023-05-25 | Mazor Robotics Ltd. | Multiple end effector interfaces coupled with different kinematics |
| WO2023102012A1 (en) * | 2021-12-01 | 2023-06-08 | Nuvasive, Inc. | Connector assemblies for connecting a robotic arm with a medical end effector |
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