System and method for determining security layer of anatomical element

Abstract

Systems and methods for determining a security layer of an anatomical element are provided. Contact of a cutting tool to the anatomical element at the first surface may be detected, and dimensional information about the anatomical element may be received. A security layer of the anatomical element may be determined based on the dimensional information and the detected contact between the cutting tool and the anatomical element at the first surface.

Description

Background Art

[0001] The present disclosure relates generally to determining a safety layer or boundary, and more particularly to determining a safety layer of an anatomical element during a cutting procedure.

[0002] The surgical robot can assist a surgeon or other medical provider in performing surgical procedures, or can autonomously perform one or more surgical procedures. During such surgical procedures, surgical tools can be used on one or more anatomical elements. These tools can be directed and operated by the surgical robot and / or the surgeon or other medical provider. Summary of the invention

[0003] Exemplary aspects of the present disclosure include:

[0004] A system for determining a safety layer of an anatomical element according to at least one embodiment of the present disclosure, the system comprising: a processor; and a memory storing data for processing by the processor, the data when processed causing the processor to: detect that a cutting tool contacts the anatomical element at a first surface; receive dimensional information of the anatomical element; and determine the safety layer of the anatomical element based on the dimensional information and the detected contact between the cutting tool and the anatomical element at the first surface, wherein the cutting tool is prevented from moving beyond the safety layer.

[0005] Any of the aspects herein, wherein the memory stores further data for processing by the processor, which when processed causes the processor to: receive information describing a first pose corresponding to a moment in time when the cutting tool contacts the anatomical element.

[0006] Any aspect of the present invention, wherein determining the safety layer includes: determining a distance from the first posture to a second posture based on the dimensional information, the second posture corresponding to the time when the cutting tool destroys the anatomical element; and spacing the safety layer a predetermined distance from the second posture toward the first posture.

[0007] Any of the aspects herein, wherein the first pose is received from a robot operating the cutting tool.

[0008] Any of the aspects herein, wherein determining the security layer comprises: determining a second surface opposite to the first surface based on the dimensional information; and spacing the security layer a predetermined distance from the second surface toward the first surface.

[0009] Any of the aspects herein, wherein the predetermined distance is substantially constant throughout the security layer.

[0010] Any of the aspects herein, wherein the predetermined distance is variable throughout at least a portion of the security layer.

[0011] In any of the aspects herein, wherein spacing the security layer apart from the second surface by a predetermined distance comprises multiplying the distance between the second surface and the first surface by a predetermined safety factor.

[0012] Any of the aspects herein, wherein a sensor output is used to detect that the cutting tool contacts a portion of the anatomical element.

[0013] Any of the aspects herein, wherein the sensor output comprises the force measured by the force sensor in response to the cutting tool exerting a force on the force sensor, and wherein the cutting tool is detected to be contacting the anatomical element when the measured force exceeds a threshold force.

[0014] Any of the aspects herein, wherein the dimensional information comprises a three-dimensional model of the anatomical element.

[0015] Any of the aspects herein, wherein the memory stores further data for processing by the processor, the further data when processed causing the processor to: generate a notification when the cutting tool contacts the safety layer.

[0016] A system for determining a safety layer of an anatomical element according to at least one embodiment of the present disclosure, the system comprising: a sensor configured to measure parameters to generate a sensor output; a processor; and a memory storing data for processing by the processor, the data when processed causing the processor to: detect contact of a cutting tool with the anatomical element at a first surface using the sensor output received from the sensor; receive dimensional information of the anatomical element; determine the safety layer of the anatomical element based on the dimensional information and the detected contact between the cutting tool and the anatomical element at the first surface, wherein the cutting tool is prevented from moving beyond the safety layer; and generate a notification when the cutting tool contacts the safety layer.

[0017] Any of the aspects herein, wherein the memory stores further data for processing by the processor, which when processed causes the processor to: receive information describing a first pose corresponding to a moment in time when the cutting tool contacts the anatomical element.

[0018] Any aspect of the present invention, wherein determining the safety layer includes: determining a distance from the first posture to a second posture based on the dimensional data, the second posture corresponding to the time when the cutting tool destroys the anatomical element; and spacing the safety layer a predetermined distance from the second posture toward the first posture.

[0019] In any of the aspects herein, the system further comprises a robotic arm configured to orient the cutting tool, wherein the first pose is received from the robot.

[0020] Any of the aspects herein, wherein determining the security layer comprises: determining a second surface opposite to the first surface based on the dimensional data; and spacing the security layer a predetermined distance from the second surface toward the first surface.

[0021] Any of the aspects herein, wherein the sensor output comprises the force measured by the force sensor in response to the cutting tool exerting a force on the force sensor, and wherein the cutting tool is detected to be contacting the anatomical element when the measured force exceeds a threshold force.

[0022] Any of the aspects herein, wherein the dimensional information comprises a three-dimensional model of the anatomical element.

[0023] A system for determining a safety layer of an anatomical element according to at least one embodiment of the present disclosure, the system comprising: a robotic arm configured to hold and orient a cutting tool relative to the anatomical element; a processor; and a memory storing data for processing by the processor, the data when processed causing the processor to: cause the robotic arm to orient the cutting tool on a trajectory; detect when the cutting tool contacts the anatomical element at a first surface; receive dimensional information of the anatomical element; determine a safety layer of the anatomical element based on the dimensional information and the detected contact, wherein the cutting tool is prevented from moving beyond the safety layer; and cause the robotic arm to stop orienting the cutting tool on the trajectory when the cutting tool reaches the safety layer.

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

[0025] Any one or more of the features disclosed herein.

[0026] Any one or more of the features is generally disclosed herein.

[0027] Any one or more of the features generally disclosed herein may be combined with any one or more of the other features generally disclosed herein.

[0028] Any of the aspects / features / embodiments may be combined with any one or more of the other aspects / features / embodiments.

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

[0030] It should be understood that any feature described herein may be claimed in combination with any other feature described herein, regardless of whether the features are from the same described embodiment.

[0031] The details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the techniques described in the present disclosure will be apparent from the description and drawings, and from the claims.

[0032] The phrases "at least one", "one or more", and "and / or" are open expressions that have both connective and dissociative properties in operation. For example, 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" each mean only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element such as X, Y, and Z or a class of elements such as X1-Xn, Y1-Ym, and Z1-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., X1 and X2), and a combination of elements selected from two or more classes (e.g., Y1 and Zo).

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

[0034] The foregoing is a simplified overview of the present disclosure to provide an understanding of some aspects of the present disclosure. The present disclosure is neither a broad overview nor an exhaustive overview of the present disclosure and its various aspects, embodiments, and configurations. It is neither intended to determine the key or important elements of the present disclosure nor to delimit the scope of the present disclosure, but rather to present the selected concepts of the present disclosure in a simplified form as an introduction to the more detailed description presented below. As should be understood, other aspects, embodiments, and configurations of the present disclosure may utilize one or more of the features set forth above or described in detail below, either individually or in combination.

[0035] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art after considering the description of the embodiments provided below. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0037] Figure 1 is a block diagram of a system according to at least one embodiment of the present disclosure;

[0038] Figure 2A is an illustration of a cutting plane on an anatomical element according to at least one embodiment of the present disclosure;

[0039] Figure 2B is a detailed illustration of a cutting plane on an anatomical element according to at least one embodiment of the present disclosure;

[0040] Figure 3 is a schematic diagram of a cutting tool and a dissecting element according to at least one embodiment of the present disclosure;

[0041] Figure 4 is a graph of force versus depth according to at least one embodiment of the present disclosure; and

[0042] Figure 5 is a flow chart according to at least one embodiment of the present disclosure. DETAILED DESCRIPTION

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

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

[0045] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general-purpose microprocessor), graphics processing units (e.g., Nvidia GeForce RTX 2000 series processors, Nvidia GeForce RTX 3000 series processors, AMD Radeon RX 5000 series processors, AMD Radeon RX 6000 series processors, or any other graphics processing unit), application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Thus, the term "processor" as used herein may refer to any of the foregoing structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be fully implemented in one or more circuits or logic elements.

[0046] Before explaining any embodiment of the present disclosure in detail, it should be understood that the present disclosure is not limited to the construction details and component arrangements set forth in the following description or illustrated in the accompanying drawings in terms of its application. The present disclosure can have other embodiments and can be practiced or implemented in various ways. In addition, it should be understood that the wording and terminology used herein are for the purpose of description and should not be considered as restrictive. The use of "comprises", "including" or "having" and its variations herein is intended to cover the items listed thereafter and their equivalents, as well as additional items. In addition, the present disclosure can use examples to illustrate one or more aspects thereof. Unless otherwise expressly stated, the use or listing of one or more examples (which can be indicated by "for example", "by way of example", "such as" or similar language) is not intended to and does not limit the scope of the present disclosure.

[0047] The terms proximal and distal are used in this disclosure in their conventional medical sense, with proximal being closer to an operator or user of the system and farther away from an area of ​​surgical interest in or on the patient's body, and distal being closer to the area of ​​surgical interest in or on the patient's body and farther away from an operator or user of the system.

[0048] Robot-assisted surgery or autonomous robotic surgery enables autonomous surgical procedures, such as, for example, autonomous bone removal. When performing robotic or robot-assisted bone removal, one risk includes damaging the anatomical element on which cutting and removal are being performed. For example, in embodiments where the anatomical element includes anterior cortical bone, damage to such bone by a cutting instrument exposes the patient's spinal cord and / or nerves to damage caused by the cutting instrument. Therefore, it is desirable to have safety measures that mitigate this risk. Some methods for avoiding damage include detecting actual damage to the bone. However, detecting actual damage introduces risks to the patient because sensitive anatomical material is exposed to the cutting instrument during actual damage.

[0049] In at least one embodiment of the present disclosure, a predictive safety layer is used to provide an additional layer of safety based on a combination of detection of first contact between a cutting tool and an anatomical element (e.g., a bone) and dimensional information of the anatomical element (such as, for example, three-dimensional (3D) data). The system can use such information to stop the cutting tool before the cutting tool reaches a no-fly zone. More specifically, by combining information about the time and / or posture of first contact between the cutting tool and the anatomical element with the maximum depth allowed (taken from, for example, 3D data), an algorithm can be developed to allow the system to have another condition for stopping the cutting tool as a safety measure. Such an algorithm can, for example, tell the system to stop cutting after a distance L*0.8 (or any other safety factor) or after damage to the anatomical element has been detected (or whichever occurs first). The distance L can define the cutting length from the point where the cutting tool penetrates or first contacts the anatomical element to the point where the cutting tool breaks.

[0050] Embodiments of the present disclosure provide technical solutions to one or more of the following problems: (1) preventing damage to anatomical elements by cutting tools during cutting procedures; (2) protecting sensitive anatomical elements during cutting procedures; and (3) increasing patient safety.

[0051] First turn Figure 1 , a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 can be used to generate one or more safety measures and / or implement one or more other aspects of one or more of the methods disclosed herein. The system 100 includes a computing device 102, one or more imaging devices 112, a robot 114, a navigation system 118, one or more sensors 126, a database 130. And / or a cloud or other network 134. Systems according to other embodiments of the present disclosure may include more or fewer components than the system 100. For example, the system 100 may not include the imaging device 112, the robot 114, the navigation system 118, the one or more sensors 126, one or more components of the computing device 102, the database 130, and / or the cloud 134.

[0052] Computing device 102 includes processor 104, memory 106, communication interface 108, and user interface 110. Computing devices according to other embodiments of the present disclosure may include more or fewer components than computing device 102.

[0053] The processor 104 of the computing device 102 can be any processor described herein or any similar processor. The processor 104 can be configured to execute instructions stored in the memory 106, which can cause the processor 104 to perform one or more computing steps using or based on data received from the imaging device 112, the robot 114, the sensor 126, the navigation system 118, the database 130, and / or the cloud 134.

[0054] The memory 106 may be or include RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and / or instructions. The memory 106 may store information or data useful for completing any step of the method 500 or any other method described herein, for example. The memory 106 may store, for example, instructions and / or machine learning models that support one or more functions of the robot 114. For example, the memory 106 may store content (e.g., instructions and / or machine learning models) that, when executed by the processor 104, enables image processing 120, sensor processing 122, and / or security layer determination 124. In some embodiments, if provided as instructions, such content may be organized into one or more applications, modules, packages, layers, or engines.

[0055] Image processing 120 enables processor 104 to process image data of an image (received from, for example, imaging device 112, an imaging device of navigation system 118, or any imaging device) to, for example, identify information about anatomical element 200 (as shown in FIGS. 2 and 3 ). Figure 3 The identification information may be used to determine when the cutting tool has first contacted the anatomical element and / or the position of the cutting tool at the time of such contact. It should be understood that, alternatively or in addition, the first contact may be determined based on sensor output from one or more sensors 126, as described below.

[0056] The sensor processing 122 enables the processor 104 to process sensor output data (received from, for example, one or more sensors 126) for purposes such as determining first contact between the cutting tool 128 and the anatomical element 200. The sensor output may be received as a signal and may be processed by the processor 104 using the sensor processing 122 to output data such as, for example, force data, acceleration data, pose data, time data, etc.

[0057] The safety layer determination 124 enables the processor 104 to process inputs, such as information about the first contact between the cutting tool 128 and the anatomical element 200 and information about the anatomical element 200, for purposes such as generating a safety layer. The information about the first contact may include a pose of the cutting tool 128 and / or a timestamp corresponding to the time when the cutting tool 128 first contacts the anatomical element 200. The information about the anatomical element 200 may include a 3D model and / or a 2D image of the anatomical element 200, dimensional information about the anatomical element 200, a volume of the anatomical element 200, and / or a pose of the anatomical element 200 relative to the patient and / or the cutting tool 128. The processor 104 may output a safety layer or boundary that may limit or prevent the cutting tool 128 from traveling beyond the safety layer or boundary. The safety layer or boundary may advantageously prevent the cutting tool 128 from damaging the anatomical element by preventing the cutting tool 128 from drilling or cutting beyond the safety layer.

[0058] Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that may be processed by the processor 104 to perform the various methods and features described herein. Thus, while the various contents of the memory 106 may be described as instructions, it should be understood that the functionality described herein may be implemented using instructions, algorithms, and / or machine learning models. The data, algorithms, and / or instructions may cause the processor 104 to manipulate data stored in the memory 106 and / or received from or via the imaging device 112, the robot 114, the database 130, the sensor 126, and / or the cloud 134.

[0059] The computing device 102 may also include a communication interface 108. The communication interface 108 may be used to receive image data or other information from an external source (such as an imaging device 112, a robot 114, a navigation system 118, a sensor 126, a database 130, a cloud 134, and / or any other system or component that is not part of the system 100) and / or to transmit instructions, images, or other information to an external system or device (e.g., another computing device 102, an imaging device 112, a robot 114, a navigation system 118, a sensor 126, a database 130, a cloud 134, and / or any other system or component that is not part of the system 100). The communication interface 108 may include one or more wired interfaces (e.g., a USB port, an Ethernet port, a FireWire port) and / or one or more wireless transceivers or interfaces (configured to transmit and / or receive information, for example, via one or more wireless communication protocols such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, etc.). In some embodiments, the communication interface 108 may be used to enable the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time required to complete computationally intensive tasks or for any other reason.

[0060] The computing device 102 may also include one or more user interfaces 110. The user interface 110 may be or include a keyboard, a mouse, a trackball, a monitor, a television, a screen, a touch screen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 110 may be used for, for example, receiving a user selection or other user input for any step of any method described herein. Nevertheless, any required input for any step of any method described herein may be automatically generated by the system 100 (e.g., by another component of the processor 104 or the system 100) or received by the system 100 from a source outside the system 100. In some embodiments, the user interface 110 may be used to allow a surgeon or other user to modify the instructions to be executed by the processor 104 according to one or more embodiments of the present disclosure, and / or modify or adjust the settings of other information displayed on the user interface 110 or corresponding thereto.

[0061] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located near one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remote from one or more other components of the computing device 102.

[0062] The imaging device 112 may be operable to image anatomical features (e.g., bones, veins, tissues, etc.) and / or other aspects of the patient's anatomy and / or objects (such as cutting tools 128) to generate image data (e.g., image data depicting or corresponding to bones, veins, tissues, etc.). "Image data" as used herein refers to data generated or captured by the imaging device 112, including data in machine-readable form, graphical / visual form, and in any other form. In various examples, the image data may include data corresponding to the patient's anatomical features or a portion thereof, and / or an object (such as a cutting tool 128). The image data may be or include preoperative images, intraoperative images, postoperative images, or images taken independently of any surgical procedure. The imaging device 112 may be capable of taking 2D images or 3D images to generate image data. The imaging device 112 can be or include, for example, an ultrasound scanner (which may include, for example, physically separate transducers and receivers, or a single ultrasound transceiver), an O-arm, a C-arm, a G-arm, or any other device that utilizes X-ray based imaging (e.g., a fluoroscope, a CT scanner, or other X-ray machine), a magnetic resonance imaging (MRI) scanner, an optical coherence tomography (OCT) scanner, an endoscope, a microscope, an optical camera, a thermal imaging camera (e.g., an infrared camera), a radar system (which may include, for example, a transmitter, a receiver, a processor, and one or more antennas), or any other imaging device 112 suitable for obtaining images of anatomical features of a patient and / or an object (such as a cutting tool 128).

[0063] The sensor 126 may be configured to provide a sensor output. The sensor 126 may include a force sensor configured to detect a force applied to the robot arm 116 (e.g., whether via an end effector of the robot arm 116, a cutting tool 128 held by the end effector of the robot arm 116, or otherwise) or a force applied by the cutting tool 128 (e.g., whether held or supported by the robot 116 or by a user such as a surgeon or other medical provider). In other embodiments, the sensor 126 may alternatively or additionally include a position sensor, a proximity sensor, a magnetometer, or an accelerometer. In some embodiments, the sensor 126 may be a linear encoder, a rotary encoder, or an incremental encoder. In yet other embodiments, the sensor 126 may be an imaging sensor. Other types of sensors may also be used as the sensor 126.

[0064] The sensor output or output data from the sensor 126 may be provided to a processor of the robot 114, a processor 104 of the computing device 102, and / or a navigation system 118. The output data from the sensor 126 may also be used to determine when the cutting tool 128 initially contacts the anatomical element 200. For example, the output data may include force data that may be used by the processor 104 (or a processor of the robot 114) to determine when the cutting tool 128 contacts the anatomical element 200, as will be described in detail in the accompanying drawings. Figure 4 Described in more detail in .

[0065] It should be understood that in some embodiments, the sensor 126 may be a separate component from the robotic arm 116. In other embodiments, the sensor 136—which may be the same or similar to the sensor 126—may be integrated with the robot 114. In such embodiments, the sensor 136 may enable the processor 104 (or a processor of the robot 114) to determine the precise pose of the robotic arm 116 (and any object or element held by or secured to the robotic arm) in space. In other words, the sensor output or output data from the sensor 136 may be used to calculate the position of the robotic arm 116 (and therefore the cutting tool 128) in space relative to one or more coordinate systems.

[0066] Robot 114 may be any surgical robot or surgical robotic system. Robot 114 may be or include, for example, a Mazor X TM Stealth version of the robotic guidance system. The robot 114 can be configured to position the cutting tool 128 at one or more precise positions (e.g., location and orientation). The cutting tool 128 can be any tool capable of cutting, drilling, milling, and / or segmenting anatomical elements. The cutting tool 128 can be, for example, a drill bit. In some embodiments, the robot 114 can be configured to rotate the cutting tool 128 using, for example, one or more motors to rotate the cutting tool 128 and / or advance the cutting tool.

[0067] The robot 114 may be additionally or alternatively configured to manipulate any component (whether or not based on guidance from the navigation system 118) to complete or assist in surgical tasks. In some embodiments, the robot 114 may be configured to hold and / or manipulate anatomical elements during or in conjunction with a surgical procedure. The robot 114 may include one or more robot arms 116. In some embodiments, the robot arm 116 may include a first robot arm and a second robot arm, but the robot 114 may include more than two robot arms. In some embodiments, one or more of the robot arms 116 may be used to hold and / or manipulate a cutting tool 128. Each robot arm 116 may be positioned independently of the other robot arms. The robot arm 116 may be controlled in a single shared coordinate space or in a separate coordinate space.

[0068] The robot 114 together with the robot arm 116 can have, for example, one, two, three, four, five, six, seven or more degrees of freedom. In addition, the robot arm 116 can be positioned or positionable in any posture, plane and / or focus. The posture includes position and orientation. Therefore, the cutting tool 128, surgical tool or other object held by the robot 114 (or more specifically, by the robot arm 116) can be accurately positioned in one or more desired and specific positions and orientations.

[0069] In some embodiments, reference markers (i.e., navigation markers) may be placed on the robot 114 (including, for example, on the robot arm 116), the cutting tool 128, 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 may be used to track other components of the system (e.g., the cutting tool 128), and the system may operate without the use of the robot 114 (e.g., the surgeon manually manipulates the cutting tool 128 and / or one or more surgical tools, e.g., based on information and / or instructions generated by the navigation system 118).

[0070] During the operation, the navigation system 118 can provide navigation for the surgeon and / or the surgical robot. The navigation system 118 can be any known or future developed navigation system, including, for example, the Medtronic StealthStation TMS8 surgical navigation system or any subsequent product thereof. The navigation system 118 may include one or more cameras or other sensors for tracking one or more reference markers, navigation trackers, or other objects in the operating room or other rooms where part or all of the system 100 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system 118 may include one or more electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track the position and orientation (e.g., pose) of the imaging device 112, the robot 114 and / or the robot arm 116, the cutting tool 128, and / or one or more surgical tools (or more specifically, for tracking the pose of a navigation tracker attached directly or indirectly to one or more of the foregoing in a fixed relationship). The navigation system 118 may include a display for displaying one or more images from an external source (e.g., a computing device 102, an imaging device 112, or other source) or for displaying images and / or video streams from one or more cameras or other sensors of the navigation system 118. In some embodiments, the system 100 may operate without using the navigation system 118. The navigation system 118 can be configured to provide guidance to a surgeon or other user of the system 100 or components thereof, to the robot 114, or to any other element of the system 100 regarding, for example, the position of one or more anatomical elements, whether a tool is in an appropriate trajectory, and / or how to move a tool into an appropriate trajectory to perform a surgical task based on a preoperative or other surgical plan.

[0071] The database 130 may store information relating one coordinate system to another coordinate system (e.g., relating one or more robot coordinate systems to a patient coordinate system and / or a navigation coordinate system). The database 130 may additionally or alternatively store, for example, one or more surgical plans (including, for example, pose information about the target and / or image information about the patient's anatomical structure at and / or near the surgical site for use by the robot 114, the navigation system 118, and / or the computing device 102 or a user of the system 100); one or more images that may be used in conjunction with surgery performed by or with the assistance of one or more other components of the system 100; and / or any other useful information. The database 130 may be configured to provide any such information to the computing device 102 or any other device of the system 100 or any other device external to the system 100, whether directly or via the cloud 134. In some embodiments, database 130 can be or include a part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and / or another system for collecting, storing, managing, and / or transmitting electronic medical records including image data.

[0072] The cloud 134 can be or represent the Internet or any other wide area network. The computing device 102 can connect to the cloud 134 via the communication interface 108 using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 can communicate with the database 130 and / or an external device (e.g., a computing device) via the cloud 134.

[0073] The system 100 or a similar system may be used, for example, to implement one or more aspects of the method 500 described herein. The system 100 or a similar system may also be used for other purposes.

[0074] Figure 2A Anatomical element 200 and cutting plane 202 are shown. Figure 2B A cross-sectional view of an anatomical element at a cutting plane 202 is shown. In the illustrated embodiment, a cross-sectional view of an anatomical element 200 is shown, wherein the anatomical element 200 comprises a bone, and more specifically a vertebra. In other embodiments, the anatomical element 200 may be any bone, organ, or anatomical feature of a patient. As previously described, during the process of cutting the anatomical element 200 using the cutting tool 128, it may be desirable to stop the cutting tool 128 before damaging the anatomical element 200. The cutting plane 202 may define a first surface 204 and a second surface 206 opposite the first surface 204. In some embodiments, the second surface 206 may represent the beginning of a no-fly zone 208. In other words, the second surface 206 may be a surface where the cutting tool 128 may damage the anatomical element 200 and may enter or contact sensitive anatomical materials. For example, the anatomical element 200 may include a vertebra, the first surface 204 may correspond to the posterior cortex through which the cutting tool 128 first contacts the vertebra, the second surface 206 may correspond to the anterior cortex, and the no-fly zone 208 may correspond to the spinal cord and / or nerves. Therefore, it is not desirable for the cutting tool 128 to damage the anterior cortex and enter the no-fly zone 208, where the cutting tool 128 may damage the spinal cord and / or nerves. Therefore, embodiments of the present disclosure provide for determining a safety layer 210 to prevent the cutting tool 128 from damaging or contacting the second surface 206, and thus also prevent the cutting tool 128 from entering the no-fly zone 208.

[0075] It should be understood that in Figure 2B 2, cutting plane 202, second surface 206 (as represented by dashed lines), no-fly zone 208 (as represented by cross-hatching), and safety layer 210 are shown for illustration purposes. However, in some cases, cutting plane 202, second surface 206, no-fly zone 208, and / or safety layer 210 may be shown on a display or user interface (such as user interface 110).

[0076] Figure 32 is a schematic diagram of a cutting tool 128 contacting an anatomical element 200. As shown and previously described, the cutting tool 128 contacts the anatomical element 200 at a first surface 204. The cutting tool 128 can be advanced through the anatomical element 200 until the cutting tool 128 reaches a safety layer 210. The safety layer 210 can be determined based on information about the cutting tool 128 when the cutting tool 128 contacts the anatomical element 200 at the first surface 204 and dimensional information about the anatomical element 200 (such as, for example, a distance 212 between the first surface 204 and the second surface 206 (e.g., the distance "L" as previously described), the pose of the first surface 204 and / or the second surface 206, the volume of the anatomical element 200, the shape of the anatomical element 200, etc.). The distance 212 can define the cutting length from the point where the cutting tool penetrates or first contacts the anatomical element to the point where the cutting tool breaks. The dimensional information may include a 3D model of the anatomical element 200, a 2D image of the anatomical element 200, or information about the anatomical element 200 (whether in a machine-readable form or a human-readable form), such as dimensions (e.g., width, height, volume, etc.). As the cutting tool 128 advances toward the second surface 206, the safety layer 210 may stop the cutting tool 128 (whether by stopping a robotic arm (such as the robotic arm 116) from moving or by preventing a user (such as a surgeon) from advancing the cutting tool 128) and / or may generate a notification that the cutting tool 128 has reached the safety layer 210. In some cases, the cutting tool 128 may advance beyond the safety layer 210, and when the cutting tool 128 breaches the second surface 206, the cutting tool 128 may be stopped or a notification may be generated.

[0077] Figure 4A graph 218 of force 214 versus depth 216 is shown, which represents the force applied by the cutting tool 128, for example, on the sensor 126, and the cutting depth of the cutting tool 128. As shown, by measuring the force applied by the cutting tool 128, the first contact of the cutting tool 128 at the first surface 204 can be detected. It should be understood that in other embodiments, the first contact made by the cutting tool 128 can be measured in other ways, such as visual detection, using an electronic gyroscope and / or measuring conductivity. Conductivity can be used to measure the first contact by sensing the conductivity change between the different layers of the anatomical element 200. The conductivity change can be measured by sending an electronic pulse through the anatomical element 200 using a transceiver and a receiver and measuring the signal. As shown, when the cutting tool 128 contacts and / or is cutting through the first surface 204 and when the cutting tool 128 contacts and / or is cutting through the second surface 206, the force can increase. This is due to the higher bone density in the cortical region of the anatomical element 200 (e.g., a vertebra) and the lower bone density in the cancellous bone region of the anatomical element 200. Therefore, the first contact between the cutting tool 128 and the first surface 204 can be detected by monitoring the force applied by the cutting tool 128 (via, for example, sensor 126). In some cases, when the applied force meets or exceeds a threshold force, information about the first contact can be measured, recorded, and / or a notification indicating the first contact can be generated. For example, when the first contact is detected, the first pose of the cutting tool 128 can be measured and / or recorded. As shown in the diagrams shown (and also in Figures 2 and 3), the first pose of the cutting tool 128 can be measured and / or recorded. Figure 3 As further shown in FIG. 2 , the security layer 210 may be spaced apart from the second surface 206 toward the first surface 204 by a predetermined distance. The determination of this spacing will be described in further detail below.

[0078] Figure 5 A method 500 is depicted that may be used, for example, to determine a safety layer for an anatomical element.

[0079] Method 500 (and / or one or more steps thereof) may be performed or otherwise executed, for example, by at least one processor. The at least one processor may be the same or similar to processor 104 of computing device 102 described above. The at least one processor may be part of a robot (such as robot 114) or part of a navigation system (such as navigation system 118). Processors other than any processor described herein may also be used to perform method 500. The at least one processor may perform method 500 by executing elements stored in a memory (such as memory 106). The elements stored in the memory and executed by the processor may cause the processor to perform one or more steps of the functions shown in method 500. One or more portions of method 300 may be performed by a processor that executes any of the contents of the memory (such as image processing 120, sensor processing 122, and / or security layer determination 124).

[0080] Method 500 includes detecting that a cutting tool contacts an anatomical element (step 504). The cutting tool may be the same or similar to cutting tool 128, and the anatomical element may be the same or similar to anatomical element 200. Detecting when the cutting tool contacts the anatomical element may detect when the cutting tool contacts the anatomical element at a first surface, such as first surface 204. In some embodiments, the contact may be detected using a sensor, such as a sensor 126 configured to measure and generate a sensor output, and a processor, such as a processor 104 configured to perform sensor processing, such as sensor processing 122, to process the sensor output. The sensor processing enables the processor to process the sensor output data for purposes such as determining the first contact between the cutting tool and the anatomical element. The sensor output may be received as a signal and may be processed by the processor using sensor processing to output data, such as, for example, force data, acceleration data, posture data, time data, etc.

[0081] The sensor may include, for example, a force sensor configured to measure the force applied by the cutting tool. In such embodiments, the force sensor may be used to monitor force, and the detected contact (for example, the first contact between the cutting tool and the anatomical element) may correspond to the time when the measured force exceeds the threshold force. In some embodiments, artificial intelligence and training data (for example, historical cases) may be used to automatically determine the threshold force. In other embodiments, the threshold force may be or include or be based on the surgeon input received via the user interface. In other embodiments, the threshold force may be automatically determined using artificial intelligence, and thereafter may be checked and approved (or modified) by the surgeon or other users. In other embodiments, the contact may be optically detected by, for example, using an imaging device (such as an imaging device 112) or by measuring conductivity. In still other embodiments, the contact may be predicted based on a surgical plan, and the contact may be confirmed using a sensor, imaging and / or conductivity.

[0082] In some embodiments, the cutting tool is oriented and operated by a robot (such as robot 114) or a robot arm (such as robot arm 116). In such embodiments, the robot arm can automatically orient the cutting tool along the trajectory. In other embodiments, the robot arm can assist a user (such as, for example, a surgeon) in orienting and / or operating the cutting tool. In still other embodiments, the cutting tool can be oriented and / or operated by a user.

[0083] The method 500 also includes receiving dimensional information of the anatomical element (step 508). The dimensional information may be received from, for example, a communication interface (such as the communication interface 108), an imaging device, a user interface (such as the user interface 110), a memory (such as the memory 106), a database (such as the database 130), and / or a cloud (such as the cloud 134). The dimensional information may include, for example, a distance (such as the distance 212) between a first surface and a second surface (such as the second surface 206 opposite the first surface), a pose of the first surface and / or the second surface, a volume of the anatomical element, a shape of the anatomical element, etc. The dimensional information may also include a 3D model of the anatomical element, a 2D image of the anatomical element, or information about the anatomical element (whether in a machine-readable form or a human-readable form), such as a dimension (e.g., a width, a height, a volume, etc.). In embodiments where a 3D model or a 2D image is received, the processor may perform image processing (such as the image processing 120) to process the 3D model or the 2D image to measure and / or extract dimensional information about the anatomical element.

[0084] Method 500 also includes receiving information describing a first pose of the cutting tool (step 512). The first pose may correspond to the moment when the cutting tool contacts the anatomical element. In the case where the robot arm is configured to orient and / or operate the cutting tool or is configured to support a user to orient and / or operate the cutting tool, information describing the first pose may be received from the robot arm. In other cases, information describing the first pose may be determined from a 3D model or 2D image taken by, for example, an imaging device. In still other embodiments, information describing the first pose may be received from a navigation system (such as navigation system 118).

[0085] It should be understood that in some embodiments, method 500 may not include step 512 .

[0086] Method 500 also includes determining a safety layer for the anatomical element (step 516). Determining the safety layer may include using a processor to perform a safety layer determination (such as safety layer determination 124) to generate a safety layer. The safety layer determination enables the processor to process inputs, such as information about the first contact between the cutting tool and the anatomical element, input from a user (such as a surgeon or other medical provider), and information about the anatomical element for purposes such as generating a safety layer. Information about the first contact may include a first pose of the cutting tool and / or a timestamp corresponding to the time when the cutting tool first contacts the anatomical element. Input from the user may include a safety factor for determining the safety layer. Information about the anatomical element (as described in step 508 above) may include a 3D model and / or a 2D image of the anatomical element, dimensional information about the anatomical element, the volume of the anatomical element, and / or the pose of the anatomical element relative to the patient and / or the cutting tool. The processor may output a safety layer or boundary that may limit or prevent the cutting tool from traveling beyond the safety layer or boundary.

[0087] More specifically, in some embodiments, determining the safety layer can include determining a distance between a first pose (e.g., a pose of the cutting tool corresponding to the moment when the cutting tool contacts the anatomical element) and a second pose (e.g., a pose of the cutting tool corresponding to the time when the cutting tool destroys the anatomical element) based on the dimensional information. In such embodiments, the safety layer can be spaced a predetermined distance from the second pose toward the first pose. Such spacing can be determined by multiplying the distance (which can be the same or similar to distance 212) by a predetermined safety factor that can be received as input from a user. In some embodiments, the predetermined safety factor can be, for example, 0.8, but in other embodiments, the predetermined safety factor can be greater than or less than 0.8.

[0088] In other embodiments, determining the security layer may include: determining the second surface based on the dimensional information, and spacing the security layer from the second surface toward the first surface by a predetermined distance. In such embodiments, the predetermined distance may be substantially constant over the entire security layer. Alternatively, the predetermined distance may be variable over at least a portion of the entire security layer. In at least some embodiments, spacing the security layer from the second layer by a predetermined distance may include multiplying or adding a predetermined safety factor (whether a constant or a percentage) the distance between the second surface and the first surface. It should be understood that the predetermined safety factor may be received as an input from a user. In some embodiments, the predetermined safety factor may be, for example, 0.8, but in other embodiments, the predetermined safety factor may be greater than or less than 0.8.

[0089] Method 500 also includes generating a notification (step 520). When one or more conditions are met, such as when contact between a cutting tool and an anatomical element is detected, when a cutting tool encounters or exceeds a safety layer, and / or when a cutting tool destroys an anatomical element, a notification can be generated. The notification can warn the user of one or more conditions, and can also cause the cutting tool to pause or stop cutting, as described in the following steps 524. The notification can be a visual notification, an audible notification, or any type of notification communicated to the user. The notification can be communicated to the user via a user interface. In some embodiments, the notification can be automatically generated by a processor. In other embodiments, the notification can be automatically generated by any component of a system (such as system 100).

[0090] It should be understood that in some embodiments, method 500 may not include step 520 .

[0091] The method 500 also includes stopping the cutting tool (step 524). In embodiments where the cutting tool is automatically oriented and / or operated by a robotic arm, stopping the cutting tool may include causing the robotic arm to stop orienting the cutting tool on the trajectory and / or stopping operation of the cutting tool. In embodiments where the robotic arm can assist a user in orienting and / or operating the cutting tool and / or the user manually orients and / or operates the cutting tool, stopping the cutting tool may include preventing the user from advancing the cutting tool (whether by stopping the robotic arm from moving, warning and / or instructing the user to stop moving, etc.).

[0092] When the cutting tool has reached or passed through the safety layer, stopping the cutting tool (whether automatically or manually) can be triggered or occur. The safety layer enables the anatomical element to be automatically cut by the cutting tool to a position that is a safe distance away from the damaging anatomical element. Therefore, the safety layer can reduce the time required to perform a portion of the cutting procedure and can enable the cutting tool to be positioned in a safe position relative to the no-fly zone. In this case, the user may be able to manually direct and operate the cutting tool across the safety layer to complete the cutting procedure.

[0093] The present disclosure encompasses embodiments of method 500 that include more or fewer steps than those described above and / or one or more steps that are different than those described above.

[0094] As mentioned above, the present disclosure encompasses Figure 5 The method of all steps identified in (and the corresponding description of method 500), and including beyond Figure 5 The present disclosure also encompasses methods comprising one or more steps from one method described herein and one or more steps from another method described herein. Any correlation described herein may be or include registration or any other correlation.

[0095] The foregoing is not intended to limit the present disclosure to one or more forms disclosed herein. In the aforementioned specific embodiments, for example, for the purpose of simplifying the present disclosure, the various features of the present disclosure are grouped together in one or more aspects, embodiments and / or configurations. The features of the aspects, embodiments and / or configurations of the present disclosure may be combined in alternative aspects, embodiments and / or configurations other than those discussed above. The method of the present disclosure should not be interpreted as reflecting the following intention: the claims require more features than the features explicitly stated in each claim. On the contrary, as reflected in the following claims, aspects of the present invention are less than all the features of a single aforementioned disclosed aspect, embodiment and / or configuration. Therefore, the following claims are hereby incorporated into this specific embodiment, wherein each claim exists independently as a separate preferred embodiment of the present disclosure.

[0096] In addition, although the foregoing has included descriptions 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 present disclosure, for example, within the skill and knowledge of those skilled in the art after understanding the present disclosure. It is intended to obtain rights to include alternative aspects, embodiments and / or configurations, including alternative, interchangeable and / or equivalent structures, functions, ranges or steps of those claimed, regardless of whether such alternative, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and are not intended to be disclosed for any patentable subject matter.

Claims

1. A system for determining a safety layer of an anatomical element, the system include: processor; and a memory storing data for processing by the processor, the data, when processed, causing the processor to: detecting that a cutting tool contacts the anatomical element at a first surface; receiving dimensional information of the anatomical element; as well as A safety layer for the anatomical element is determined based on the dimensional information and the detected contact between the cutting tool and the anatomical element at the first surface, wherein the cutting tool is prevented from moving beyond the safety layer.

2. The system of claim 1 , wherein the memory stores further data for processing by the processor, the further data when processed causing the processor to: Information describing a first pose corresponding to a moment in time when the cutting tool contacts the anatomical element is received.

3. The system of claim 2, wherein determining the security layer include: determining a distance from the first pose to a second pose based on the dimensional information, the second pose corresponding to a time when the cutting tool destroys the anatomical element; and spacing the safety layer a predetermined distance from the second posture toward the first posture.

4. The system of claim 2, wherein the first pose is received from a robot operating the cutting tool.

5. The system of claim 1, wherein determining the security layer include: determining a second surface opposite to the first surface based on the dimensional information; and spacing the security layer a predetermined distance from the second surface toward the first surface.

6. The system of claim 5, wherein the predetermined distance is substantially constant throughout the security layer.

7. The system of claim 5, wherein the predetermined distance is variable throughout at least a portion of the security layer.

8. The system of claim 5, wherein the security layer is spaced a predetermined distance from the second surface. include: The distance between the second surface and the first surface is multiplied by a predetermined safety factor.

9. The system of claim 1, wherein a sensor output is used to detect that the cutting tool contacts a portion of the anatomical element.

10. A system according to claim 9, wherein the sensor output includes the force measured by the force sensor in response to the cutting tool applying a force on the force sensor, and wherein when the measured force exceeds a threshold force, the cutting tool is detected to be in contact with the anatomical element.

11. The system of claim 1, wherein the dimensional information comprises a three-dimensional model of the anatomical element.

12. The system of claim 1 , wherein the memory stores additional data for processing by the processor, the additional data when processed causing the processor to: A notification is generated when the cutting tool contacts the safety layer.

13. A system for determining a safety layer of an anatomical element, the system include: a sensor configured to measure a parameter to produce a sensor output; processor; and a memory storing data for processing by the processor, The data, when processed, causes the processor to: using a sensor output received from the sensor to detect contact of a cutting tool with the anatomical element at a first surface; receiving dimensional information of the anatomical element; determining a safety layer for the anatomical element based on the dimensional information and the detected contact between the cutting tool and the anatomical element at the first surface, wherein the cutting tool is prevented from moving beyond the safety layer; as well as A notification is generated when the cutting tool contacts the safety layer.

14. A system according to claim 13, wherein the memory stores further data for processing by the processor, the further data when processed causing the processor to: Information describing a first pose corresponding to a moment in time when the cutting tool contacts the anatomical element is received.

15. The system of claim 14, wherein determining the security layer include: determining a distance from the first pose to a second pose based on the dimensional data, the second pose corresponding to a time when the cutting tool destroys the anatomical element; and spacing the safety layer a predetermined distance from the second posture toward the first posture.

16. The system of claim 14, further comprising a robotic arm configured to orient the cutting tool, wherein the first pose is received from the robot.

17. The system of claim 13, wherein determining the security layer include: determining a second surface opposite to the first surface based on the dimensional data; and spacing the security layer a predetermined distance from the second surface toward the first surface.

18. A system according to claim 13, wherein the sensor output includes the force measured by the force sensor in response to the cutting tool applying a force on the force sensor, and wherein when the measured force exceeds a threshold force, the cutting tool is detected to be in contact with the anatomical element.

19. The system of claim 13, wherein the dimensional information comprises a three-dimensional model of the anatomical element.

20. A system for determining a safety layer of an anatomical element, the system include: a robotic arm configured to hold and orient a cutting tool relative to the anatomical element; processor; and a memory storing data for processing by the processor, the data, when processed, causing the processor to: orienting the cutting tool on the trajectory of the robotic arm; detecting when the cutting tool contacts the anatomical element at a first surface; receiving dimensional information of the anatomical element; determining a safety layer for the anatomical element based on the dimensional information and the detected contact, wherein the cutting tool is prevented from moving beyond the safety layer; as well as When the cutting tool reaches the safety layer, the robot arm is stopped to orient the cutting tool on the trajectory.

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