Robot trajectory axis adjustment interface

Abstract

A robotic surgery system including a robotic arm, the system comprising: a handgrip (160), a tool guide (140), and a controller. The handgrip is supported by the robotic arm and has a first trajectory button (162) and a second trajectory button (164). The tool guide is supported by the handgrip. The controller has a memory and a processor, the memory storing at least one planned trajectory associated with a surgical procedure. The first trajectory button, when actuated, causes the controller's processor to move a tool support along the planned trajectory away from a patient. The second trajectory button, when actuated, causes the controller's processor to move the tool support along the planned trajectory toward a patient while maintaining a longitudinal axis of the tool support substantially coaxially aligned with the planned trajectory.

Description

[Technical Field]

[0001] A computer-assisted surgery system may include a robotic arm, a controller, and a navigation system. Robotic or robot-assisted surgery has many associated advantages, particularly with regard to the precise placement of surgical tools and implants. For example, in robotic spine surgery, a trajectory for a tool or set of tools attached to a robotic arm via a tool guide is pre-planned based on a surgical plan. During surgery, the robotic arm moves the tool guide and, in conjunction with it, moves the tools placed or attached to the tool guide to and along the pre-planned trajectory, positioning the tool guide and tools at a pre-planned distance from the patient. During surgery, the surgeon may want to adjust the distance of the tool from the patient, for example, to improve visibility or accessibility. However, it is important that the tool maintain its orientation on the pre-planned trajectory.

[0002] Therefore, there is a need for systems, devices, and methods that improve computer-assisted surgery systems, for example, by facilitating movement of a tool placed or attached to a tool guide while maintaining the orientation of the tool on a pre-planned trajectory. Summary of the Invention

[0003] Systems, methods, and devices for robotic surgical systems are described. Some embodiments of the present invention provide a surgical robot and a navigation system that utilizes a positioning system that enables controlled movement of a tool guide along a preplanned trajectory, where the longitudinal axis of the tool guide and associated surgical instrument secured to the tool guide are maintained substantially coaxially aligned with the preplanned trajectory throughout the movement. In some embodiments, the surgical robot can include a base, a robotic arm coupled to the base and configured to articulate relative to the base, and a handgrip and tool guide coupled to a distal end of the robotic arm.

[0004] In some embodiments, the present disclosure describes a robotic surgery system including a robotic arm, a handgrip supported by the robotic arm and having a first trajectory button and a second trajectory button, a tool guide supported by the handgrip, the tool guide having a first end, a second end, an aperture extending through the tool support from the first end to the second end, and a longitudinal axis extending through a center of the aperture from the first end to the second end, a navigation system configured to track the position and orientation of the tool guide relative to a patient, and a controller in communication with servos of the robotic arm, the navigation system, and the handgrip, the controller having a non-transitory computer-readable memory and a processor, the non-transitory computer-readable memory configured to store at least one planned trajectory associated with a surgical procedure and, when executed, cause the processor to receive from the navigation system the position and orientation of the tool guide relative to the patient and control the at least one servo of the robotic arm. to cause the robotic arm to position the tool support a predetermined distance from the patient with a longitudinal axis of the tool support substantially coaxially aligned with the at least one planned trajectory, wherein the first trajectory button, when operated, is configured to pass a second signal to the processor of the controller causing the processor to actuate at least one servo of the robotic arm to move the tool support away from the patient along the at least one planned trajectory while keeping the longitudinal axis of the tool support substantially coaxial with the at least one planned trajectory, and the second trajectory button, when operated, is configured to pass a third signal to the processor of the controller causing the processor to actuate at least one servo of the robotic arm to move the tool support toward the patient along the at least one planned trajectory while keeping the longitudinal axis of the tool support substantially coaxial with the at least one planned trajectory.

[0005] In some embodiments, the robotic surgical system further comprises a tool disposed within the tool support.

[0006] In some embodiments, the non-transitory computer-readable memory of the controller further stores a safety limit associated with the surgical procedure, the safety limit configured to restrict movement of a tool secured within the tool support such that a predetermined distance limit is maintained between the tool and the patient's anatomical structure during the surgical procedure.

[0007] In some embodiments, the hand grip further comprises a first admittance button and a second admittance button that, when actuated substantially simultaneously, are configured to pass a fourth signal to the controller, causing the controller to allow a user to manually move the robotic arm in various directions.

[0008] In some embodiments, the navigation system includes a tracking unit and a navigation array attached to the robotic arm, and the navigation system is configured to track the position and orientation of the tool guide using the navigation array and pass the position and orientation of the tool guide to the controller.

[0009] In some embodiments, the robotic surgical system further comprises a sterile drape positioned between the tool guide and the handgrip and extending to cover the handgrip during the surgical procedure.

[0010] In some embodiments, the first trajectory button and the second trajectory button, when operated in a predetermined sequence, are configured to pass a fourth signal to the controller processor, causing the controller processor to activate at least one servo of the robot arm to move the tool guide from its current position to a new position in which the longitudinal axis of the tool guide is coaxially aligned with the second planned trajectory.

[0011] In some embodiments, the first trajectory button and the second trajectory button are located opposite each other on the hand grip.

[0012] The first admittance button and the second admittance button may be located opposite each other on the handgrip, with the first admittance button offset from the first trajectory button.

[0013] In some embodiments, the hand grip further comprises a body supporting the first trajectory button, the second trajectory button, the first admittance button, and the second admittance button, the body of the hand grip comprising ridges positioned to separate the first trajectory button and the second trajectory button from the first admittance button and the second admittance button.

[0014] In some embodiments, the first trajectory button and the second trajectory button are provided having a first color, and the first admittance button and the second admittance button are provided having a second color different from the first color.

[0015] In some embodiments, the robotic surgery system further includes a safety signal generator with circuitry configured to monitor a predetermined position and detect the presence or absence of a part of the surgeon in a predetermined area, and the processor is programmed to request that the safety signal generator be pressed or otherwise selected in a predetermined sequence along with the second trajectory button to cause the controller processor to actuate at least one servo of the robotic arm to move the tool support toward the patient along at least one planned trajectory.

[0016] In some embodiments, the robotic surgery system further includes a safety signal generator with circuitry configured to monitor a predetermined location and detect the presence or absence of a part of the surgeon in the predetermined area, and the processor is programmed to request that the safety signal generator be pressed or otherwise selected in a predetermined sequence along with the first trajectory button, causing the controller processor to actuate at least one servo of the robotic arm to move the tool support away from the patient along at least one planned trajectory.

[0017] Another object of the present disclosure is a method for assembling the above-mentioned robotic surgical system, comprising the steps of: Attaching a hand grip to at least one arm segment of the robotic arm, the hand grip having a body supporting a first trajectory button and a second trajectory button.

[0018] In some embodiments, one of the arm segments of the robotic arm forms a distal end of the robotic arm, and the attaching step is further defined as attaching a hand grip to the distal end of the robotic arm.

[0019] In some embodiments, the method further comprises attaching a tool guide to the hand grip, the tool guide having a tool support.

[0020] Another aspect of the present disclosure relates to a method including: Positioning the tool support supported by the robot arm in a predetermined position so that the longitudinal axis of the tool support is coaxial with the planned trajectory. and causing a processor of a controller associated with the robotic arm to move the tool support in a first direction along the planned trajectories while maintaining the longitudinal axis of the tool support substantially coaxially aligned with the at least one planned trajectory. causing the controller processor to move the tool support in a second direction along the at least one planned trajectory while maintaining the longitudinal axis of the tool support substantially coaxial with the planned trajectory.

[0021] In some embodiments, the step of instructing a processor of a controller associated with the robot arm to move the tool guide in a first direction along the planned trajectory while keeping the longitudinal axis of the tool support substantially coaxial with the at least one planned trajectory is further defined as the processor receiving a signal from a first trajectory button on the robot arm, thereby instructing the processor to move the tool support in a first direction along the planned trajectory while keeping the longitudinal axis of the tool support substantially coaxial with the at least one planned trajectory.

[0022] In some embodiments, the first trajectory button is supported by a body of a hand grip attached to the robotic arm, and the method further includes receiving a force on the first trajectory button, whereby the first trajectory button initiates a signal in response to the force on the first trajectory button.

[0023] Another object of the present disclosure relates to a method comprising: Receiving data indicative of a trajectory to be followed by a tool support connected to the robotic arm. Configuring a processor of a controller associated with the robotic arm to move the tool support in a first direction along the planned trajectory while maintaining a longitudinal axis of the tool support substantially coaxial with the at least one planned trajectory. Configuring the processor of the controller to move the tool support in a second direction along at least one planned trajectory while keeping the longitudinal axis of the tool support substantially coaxial with the planned trajectory. [Brief explanation of the drawings]

[0024] [Figure 1]1 shows a schematic diagram of a computer-assisted surgery system including a robotic base, a robotic arm, a handgrip attached to the robotic arm, and a tool guide attached to the handgrip constructed in accordance with one embodiment of the present invention.

[0025] [Figure 2] 2 is a diagrammatic view of a surgical site taken across a patient's vertebrae, showing the hand grip and tool guide of FIG. 1 and a tool secured by the tool guide and aligned along a pre-planned trajectory adjacent the surgical site, according to an embodiment of the present invention.

[0026] [Figure 3] FIG. 2 is an exploded front perspective view of the hand grip and tool guide of FIG. 1 configured in accordance with one embodiment of the present disclosure.

[0027] [Figure 4] FIG. 2 is an exploded rear perspective view of the hand grip and tool guide of FIG. 1 configured in accordance with one embodiment of the present disclosure.

[0028] [Figure 5] 1 illustrates a workflow of a surgical procedure employing a computer-assisted surgery system according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0029] Before describing at least one embodiment of the present disclosure in detail, it is to be understood that, unless otherwise indicated, the present disclosure is not limited in its application to the details of construction, experiments, exemplary data, and / or arrangement of components set forth in the following description or illustrated in the drawings.

[0030] It is to be understood that the systems and methods described in this disclosure are capable of other embodiments or of being practiced or carried out in various ways, and that the phraseology and terminology used herein is for the purpose of description only and should not be regarded as limiting.

[0031] The following detailed description refers to the accompanying drawings, in which: The use of the same reference numbers in different drawings may indicate the same or similar elements.

[0032] As used herein, "comprises," "comprising," "includes," "including," "has," "having," or variations thereof are intended to be non-exclusive inclusions. For example, unless otherwise specified, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to only those elements and may include other elements not expressly listed or inherent in the process, method, article, or apparatus.

[0033] Furthermore, unless expressly stated to the contrary, "or" refers to an inclusive "or" rather than an exclusive "or." For example, condition A or B is satisfied by any of the following: A is true (or exists) and B is false (or does not exist), A is false (or does not exist) and B is true (or exists), and both A and B are true (or exist).

[0034] Furthermore, the terms "a" or "an" are used in describing elements and components of the embodiments herein. This is merely used for convenience and to give a general sense of the inventive concept. The description should be interpreted to include one or more, and the singular also includes the plural unless the context clearly dictates otherwise. Furthermore, the use of the term "plurality" means "more than one" unless expressly stated to the contrary.

[0035] As used herein, the term "substantially" means that a described event or circumstance occurs entirely or to a significant extent. As used herein, the modifier "substantially" is intended to include not only an exact value, amount, degree, orientation, or other modified characteristic or value, but also slight variations due to measurement error, control loop error, manufacturing tolerances, stresses on various parts or components, observer error, wear, and combinations thereof. For example, when describing that the longitudinal axis of a tool support is substantially coaxially aligned with at least one planned trajectory, the term "substantially" refers to alignment within tracking tolerances.

[0036] As used herein, references to "one embodiment," "an embodiment," "some embodiments," "one example," "for example," or "an example" mean that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in some embodiments" or "one example" in various places in the specification are not necessarily all referring to the same embodiment.

[0037] As used herein, a circuit may be analog and / or digital components, or hardware and software in association with one or more appropriately programmed processors (e.g., microprocessors), or hardwired logic. Also, a "component" may perform one or more functions. The term "component" may include hardware, such as a processor (e.g., a microprocessor), a combination of hardware and software, and / or the like. Software may include one or more computer-executable instructions that, when executed by one or more components, cause the components to perform a particular function. It should be understood that the algorithms described herein may be stored in one or more non-transitory memories. Examples of non-transitory memories include random access memory, read-only memory, flash memory, etc. Such non-transitory memories may be electrical, optical, and / or the like.

[0038] Referring to the drawings, and particularly to FIGS. 1-4, an exemplary computer-assisted surgery system 100 is shown. The computer-assisted surgery system 100 may include a robotic base 102 supporting a robotic arm 104. While the robotic base 102 is shown as a movable base, a fixed base is also contemplated. The robotic arm 104 includes multiple arm segments 105a, 105b, and 105c connected by rotatable or other joints and can be moved by actuating these joints. One of the arm segments 105 forms the distal end 107b of the robotic arm 104. In the example shown in FIG. 1, the arm segment 105c of the robotic arm 104 forms the distal end 107b. The robotic arm 104 further includes a proximal end 107a attached to and supported by the robotic base 102, and a distal end 107b. The robotic arm 104 may be adapted to move in all six degrees of freedom during a surgical procedure. The robotic arm 104 may be configured to make incremental changes (e.g., in each of six degrees of freedom) to ensure the precision required during surgery. The robotic arm 104 may actively move about joints to position the robotic arm 104 in a desired position relative to a patient (not shown), or may set and lock the robotic arm 104 in a predetermined position. For example, the present disclosure is contemplated to include use of tools by a surgical robot, use of tools by a user with some degree of robotic assistance, and use of tools without the involvement of a surgical robot or robotic assistance (e.g., once positioned and locked).

[0039] A control unit or controller 106 enables various functions of the system 100 and the execution of various methods disclosed herein, according to some embodiments of the present disclosure. In some embodiments, the controller 106 can control the operation of the robotic arm 104 and associated navigation system 120. In some embodiments, control can include calibrating a relative coordinate system, generating a planned trajectory, monitoring the positions of various units of the robotic base 102 and / or units operatively coupled thereto, implementing safety protocols or restrictions, etc. The controller 106 can be a system capable of embodying and / or executing logic of the processes described herein. The controller 106 may include circuitry configured to execute logic embodied in the form of software instructions and / or firmware. In some embodiments, the logic described herein can be executed in a standalone environment, such as on the controller 106, and / or implemented in a network environment, such as a distributed system employing multiple computers and / or processors. In some embodiments, the planned trajectory can be determined based on the longitudinal axis of an implant to be placed at a predetermined implant location within a patient body. The predetermined implant location can include the location and orientation in three-dimensional space where the implant will be placed within the patient body. In these embodiments, the planned trajectory may coincide with the longitudinal axis of the implant projected from a predetermined implant location within the patient.

[0040] Various embodiments of the present disclosure may operate in conjunction with other computing systems, environments, and / or configurations suitable for use with the systems and methods of the present invention. These systems and configurations include personal computers, server computers, laptop or handheld devices, and multiprocessor systems configured to execute logic embodied in the software instructions and / or firmware described herein. Other examples include mobile devices, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments that include any of the above systems or devices, and the like.

[0041] The controller 106 may include one or more processors 108 (hereinafter, "processors 108"), one or more communication devices 110 (hereinafter, "communication devices 110"), one or more non-transitory memories 112 (hereinafter, "memory 112") that store processor executable code and / or software applications such as applications 111, and a system bus 113 that couples various components, including the processors 108, to the memory 112.

[0042] In general, processor 108 refers to any computing processing unit or processing device, including, but not limited to, a single-core processor, a single processor with software multithreading execution capabilities, a multi-core processor, a multi-core processor with software multithreading execution capabilities, a multi-core processor with hardware multithreading technology, a parallel platform, and a parallel platform with distributed shared memory. Additionally or alternatively, processor 108 may be an integrated circuit, an application-specific integrated circuit (ASIC), a digital signal processor (DSP), a field-programmable gate array (FPGA), a programmable logic controller (PLC), a complex programmable logic device (CPLD), discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. The processors or processing devices referred to herein may utilize nanoscale architectures, such as molecular and quantum dot-based transistors, switches, and gates, to optimize space utilization and improve performance of computing devices capable of implementing various aspects of the present invention. In some embodiments, processor 108 may be implemented as a combination of computing processing units.

[0043] The external device 114 can communicate with the controller 106. The external device 114 can be a touchscreen display, a computing device, a remote server, or the like, and can be configured to allow a surgeon or other user to input data directly into the controller 106. Such data can include patient information and / or surgical procedure information. The external device 114 can display information (e.g., alerts) from the controller 106. Communication between the external device 114 and the controller 106 can be wireless or wired. While the illustrated external device 114 is attached to the robot base 102, in some embodiments, the external device 114 need not be attached to the robot base 102. For example, the external device 114 can be located in the operating room but not attached to the robot base 102.

[0044] The system 100 may also include a navigation system 120 including a tracking unit 122. The system 100 can monitor, track, and / or determine changes in the relative positions and / or orientations of one or more portions of the robotic arm 104, the tool guide 140 attached to the robotic arm 104, and / or tools inserted in the tool guide 140, and various portions of the patient's body B within a common coordinate system by utilizing various types of reference points 123 (e.g., multi-degree-of-freedom optical, inertial, and / or ultrasonic sensing devices), the navigation system 120 (e.g., machine vision systems, charge-coupled device cameras, tracker sensors, surface scanners, and / or range finders), anatomical computer models (e.g., magnetic resonance imaging scans of the lower lumbar region of the spine), data from previous surgical procedures and / or previously performed surgical techniques (e.g., data recorded by the system 100 during performance of an initial phase of a surgical procedure), and the like. Tracking can be performed in various ways, such as using a stereo optical detector 127, an ultrasonic detector, a sensor configured to receive position information from an inertial measurement unit, and the like. Real-time tracking refers to tracking high frequencies, in some embodiments above 20 Hz, in some embodiments in the range of 100-500 Hz, with low latency, in some embodiments less than 5 milliseconds. Regardless of the collection method, position and orientation data can be transferred between components (e.g., to the controller 106) via any suitable connection, such as wired or wirelessly using a low-latency transfer protocol. The controller 106 may execute real-time control algorithms at a reasonably high frequency with low additional latency to coordinate the movement of the robotic arm 104 of the system 100. The tracking unit 122 may also include a camera or use a stereo optical detector 127 to detect, for example, characteristics of a tool guide 140 attached to the robotic arm 104.

[0045] The reference points 123 of the navigation system 120 may be attached to the navigation arrays (e.g., the first navigation array 124, the second navigation array 126, and the optional navigation array 128 (and / or other navigation arrays)). The reference points 123 may be positioned at predetermined locations and orientations relative to one another. The reference points 123 may be aligned to lie in a plane of known orientation (e.g., a vertical plane) to enable the establishment of a Cartesian coordinate system. The reference points 123 may be positioned within the field of view of the navigation system 120 and identified in images captured by the navigation system 120. The reference points 123 may be disposable reflective navigation markers. Exemplary reference points 123 include infrared reflectors, light-emitting diodes (LEDs), spherical reflective markers, flashing LEDs, augmented reality markers, etc. The first navigation array 124, the second navigation array 126, and the optional navigation array 128 may be or include inertial measurement units (IMUs), accelerometers, gyroscopes, magnetometers, other sensors, or combinations thereof. These sensors may transmit position and / or orientation information to navigation system 120. In other embodiments, these sensors may be configured to transmit position and / or orientation information to an external controller (e.g., controller 106).

[0046] The first navigation array 124 may be attached to the patient at a fixed position and orientation, particularly relative to the bone being cut. The second navigation array 126 may be attached to the robotic arm 104, the handgrip 160, or the tool guide 140 and may be used to determine the position of the robotic arm 104 or a distal portion thereof (indicating the position of the tool guide 140). The structure and operation of the second navigation array 126 may vary depending on the type of navigation system 120 used. In some embodiments, the second navigation array 126 may include one or more spherical or other reference points 123 for use with an optical navigation system (e.g., the second navigation array 126 with spherical reference points 123 shown in FIG. 2). The navigation system 120 facilitates registration and tracking of the position and / or orientation of the second navigation array 126, and thus the position and / or orientation of the tool guide 140, as well as the relative distance of the tool guide 140 to other objects in the operating room (e.g., the patient, the surgeon, etc.). The position and / or orientation data is collected, determined, or otherwise processed by the navigation system 120 using registration / navigation techniques to determine the coordinates of each navigation array and / or reference point 123 within a coordinate system. These coordinates are communicated to the controller 106, which uses the coordinates of each navigation array and / or reference point 123 to calculate the position and orientation of the tool guide 140 within the coordinate system, as well as the position of the tool guide 140 relative to the patient to facilitate articulation of the robotic arm 104. The second navigation array need not be fixed relative to the tool guide. For example, the second navigation array may be attached to the base of a surgical robot, and the navigation system may be configured to determine the position and orientation of the tool guide relative to the patient based on the first and second navigation arrays and a kinematic model of the robotic arm that uses the configuration of each servo to determine the position and orientation of the tool guide relative to the base.

[0047] The application 111 can configure the controller 106 or its processor 108 to perform automated control of the position of the robotic arm 104 in accordance with aspects of the present invention. Such control can be achieved, at least in part, by the navigation system 120. In some embodiments, when the controller 106 is operatively coupled to the robotic arm 104, the application 111 can configure the controller 106 to perform functions described in this disclosure. In some embodiments, the application 111 can be retained or stored in the memory 112 as a group of computer-accessible instructions (e.g., computer-readable instructions, computer-executable instructions, or computer-readable computer-executable instructions). In some embodiments, the group of computer-accessible instructions can encode methods of the inventive concepts disclosed herein. In some embodiments, the application 111 can encode various formats (e.g., image segmentation) for performing computer vision tracking using the navigation system 120. In some embodiments, application 111 may be a compiled instance of such computer-accessible instructions stored in memory 112, a linked instance of such computer-accessible instructions, a compiled and linked instance of such computer-executable instructions, or other executable instance of a group of computer-accessible instructions.

[0048] Memory 112 is any available medium accessible to controller 106, including, but not limited to, both volatile and nonvolatile, removable and non-removable media. In some embodiments, memory 112 includes computer-readable media in the form of volatile memory, such as random access memory (RAM), and / or non-volatile memory, such as read-only memory (ROM). In some embodiments, memory 112 may store data (e.g., groups of tokens used for code buffers) and / or program modules, such as applications 111, that are immediately accessible to and / or currently being operated on by controller 106. In some embodiments, memory may store an operating system (not shown), such as a Windows operating system, Unix, Linux, Symbian, Android, Apple iOS operating system, Chromium, and virtually any operating system for wireless or tethered computing devices. Apple® is a trademark of Apple Computer, Inc., registered in the U.S. and other countries. iOS® is a registered trademark of Cisco Systems, Inc., used under license from Apple Inc. Microsoft® and Windows® are either registered trademarks or trademarks of Microsoft Corporation in the United States and / or other countries. Android® and Chrome® operating systems are registered trademarks of Google Inc. Symbian® is a registered trademark of Symbian Ltd. Linux® is a registered trademark of Linus Torvalds. UNIX® is a registered trademark of The Open Group.

[0049] In some embodiments, memory 112 may be a mass storage device capable of providing non-volatile storage of computer code (e.g., computer-executable instructions such as application 111), computer-readable instructions, data structures, program modules, and other data for controller 106. For example, in some embodiments, memory 112 may be a hard disk, a removable magnetic disk, a removable optical disk, a magnetic cassette or other magnetic storage device, a flash memory card, a CD-ROM, a digital versatile disk (DVD) or other optical storage device, random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), etc.

[0050] In some embodiments, any number of program modules, such as, for example, an operating system and tracking software (not shown), may optionally be stored in memory 112. In some embodiments, data and code (e.g., computer-executable instructions, patient-specific trajectories, and patient anatomical data) may be maintained and stored on memory 112. In some embodiments, the data and / or code may be stored in any one or more databases known in the art. Examples of such databases include DB2®, Microsoft® Access, Microsoft® SQL Server, Oracle®, mySQL, PostgreSQL, etc. Additionally, membase and flat file databases may also be included. Databases may be centralized or distributed across multiple systems.

[0051] DB2 (registered trademark) is a registered trademark of IBM Corporation in the United States.

[0052] Microsoft®, Microsoft® Access®, and Microsoft® SQL Server® marks are either registered trademarks or trademarks of Microsoft Corporation in the United States and / or other countries.

[0053] Oracle® is a registered trademark of Oracle Corporation and / or its affiliates.

[0054] MySQL® is a registered trademark of MySQL AB in the United States, the European Union and other countries.

[0055] PostgreSQL® and the PostgreSQL® logo are trademarks or registered trademarks of PostgreSQL Global Development Group in the United States and other countries.

[0056] In some embodiments, a user (e.g., a surgeon, other user, or equipment) can use an input device (not shown) to input commands and information into the controller 106 via the external device 114. Examples of such input devices include, but are not limited to, a keyboard, a pointing device (e.g., a mouse), a microphone, a joystick, a scanner (e.g., a barcode scanner), a reading device such as a radio frequency identification (RFID) reader or a magnetic stripe reader, a gesture-based input device such as a tactile input device (e.g., a touchscreen, a glove or other body covering, or a wearable device), a voice recognition device, or a natural interface.

[0057] In some embodiments, external device 114 may be operatively connected to system bus 113 via interface 116. In some embodiments, controller 106 may be configured with multiple external devices 114. For example, in some embodiments, external device 114 may be a monitor, LCD display, or projector. Further, in some embodiments, in addition to external device 114, other output peripherals may be included, which may include components such as speakers (not shown) or a printer (not shown), connectable to controller 106 via interface 116. In some embodiments, a pointing device may be wired or wirelessly connected to controller 106 to receive input from a user. In some embodiments, any step and / or result of a method may be output in any format to an output device, such as external device 114. In some embodiments, the output may be any format of visual representation, including, but not limited to, text, graphics, animation, audio, tactile, etc.

[0058] In certain embodiments, one or more cameras are integrated into or operatively coupled to the navigation system 120. The navigation system 120 is operatively coupled to the system bus 113 via the input / output interface 115. Such operative coupling may couple the one or more cameras to other functional elements of the controller 106. In one embodiment, the input / output interface 115, at least a portion of the system bus 113, and the memory 112 may embody a frame grabber unit capable of receiving image data acquired by at least one of the one or more cameras. In some embodiments, the frame grabber may be an analog frame grabber, a digital frame grabber, or a combination thereof. In some embodiments, if the frame grabber is an analog frame grabber, the processor 108 may provide analog-to-digital conversion and decoder functionality to enable the frame grabber to operate with medical image data. Additionally, in some embodiments, the input / output interface 115 may include circuitry for acquiring analog signals received from at least one of the one or more cameras. In some embodiments, in response to execution by the processor 108, the application 111 can operate a frame grabber to receive imaging data in accordance with various aspects described herein.

[0059] The system 100 may be provided with a safety signal generator 118 operatively coupled to the processor 108 via the input / output interface 115 and the system bus 113. The safety signal generator 118 may be provided with circuitry configured to monitor a predetermined location and detect the presence or absence of a part of the surgeon in a predetermined area. For example, in some embodiments, the safety signal generator 118 may include a switch for making and breaking connections in an electrical circuit that may be located within the predetermined area. For example, the switch may be a foot pedal that may be actuated by the surgeon's foot.

[0060] While the system 100 can utilize tool guides of various shapes, sizes, and functions, the illustrated tool guide 140 has an opening 142 for holding, guiding, positioning, supporting, and / or positioning at least one tool 150, such as a rotary tool. Advantageously, the tool guide 140 can be configured to guide, position, support, or position a series of tools 150 relative to the surgical site ST for use in a surgical procedure, such as spinal surgery. The robotic arm 104 can be configured to assist a user (e.g., a surgeon) in using the tool guide 140 to guide, position, support, or position the tools 150 along at least one planned trajectory 180. Two planned trajectories 180a and 180b are shown in FIG. 2 by way of example. Exemplary tools 150 include, but are not limited to, dilators with dilator tips (e.g., sharp or blunt), probes, cutting instruments, taps, screws, etc. Cutting instruments can include, for example, drills, saw blades, burrs, reamers, mills, scalpels, or other instruments capable of cutting bone or other tissue and suitable for a particular surgical procedure. The tool can be secured to the tool guide 140 using a locking mechanism (not shown), which may be, for example, a slider lock mechanism or other feature.

[0061] As described below, in some embodiments, a signal passed from the first trajectory button 162 to the processor 108 of the controller 106 associated with the robotic arm 104 causes the processor 108 to move the tool support 141 in a first direction (e.g., distal or toward the patient) along the at least one planned trajectory 180 while keeping the longitudinal axis 148 of the tool support 141 coaxially aligned with the at least one planned trajectory 180. A signal passed from the second trajectory button 164 to the processor 108 of the controller 106 causes the processor 108 to move the tool support 141 in a second direction (e.g., proximal or away from the patient) along the at least one planned trajectory 180 while keeping the longitudinal axis 148 of the tool support 141 coaxially aligned with the planned trajectory 180. In some embodiments, the signal includes an instruction to the processor 108 to move the tool support in the first direction or the second direction.

[0062] In some embodiments, tool guide 140 includes a tool support 141 having an opening 142 extending from a first surface 144 of the tool support 141 to a second surface 146 of the tool support 141, and has a longitudinal axis 148 extending through a center of opening 142. In some embodiments, tool support 141 may be a tube.

[0063] The hand grip 160 may include a body 161 supporting a first trajectory button 162, a second trajectory button 164, a first admittance button 166, and a second admittance button 168. The body 161 may include a ridge 169 (see FIG. 2 ) formed thereon that separates the first and second trajectory buttons 162 and 164 from the first and second admittance buttons 166 and 168. The hand grip 160 may include a connecting portion 170 (see FIG. 3 ) at a distal portion of the body 161 that is configured to connect the hand grip 160 to the tool guide 140. In the illustrated embodiment, the connecting portion 170 may be a male connector configured to receive a corresponding receptacle 149 (see FIG. 4 ) on the tool guide 140. The hand grip 160 may further include a connector 172 (see FIG. 4 ) configured to electrically connect the hand grip 160 to the robotic arm 104. The connector 172 of the hand grip 160 may be a male connector configured to receive a corresponding female connector on the distal end 107b of the robotic arm 104. One or more threaded connections or pins may be used to mechanically connect the hand grip 160 to the robotic arm 104.

[0064] The first trajectory button 162 and the second trajectory button 164 can be positioned adjacent to each other. Alternatively, as shown in FIG. 3, the first trajectory button 162 and the second trajectory button 164 can be positioned on opposite sides of the body 161. The hand grip 160 can also include a first admittance button 166 and a second admittance button 168 positioned adjacent to each other or on opposite sides of the hand grip 160. The first trajectory button 162, the second trajectory button 164, the first admittance button 166, and the second admittance button 168 can be implemented in a variety of ways. For example, the first trajectory button 162, the second trajectory button 164, the first admittance button 166, and the second admittance button 168 can be implemented as mechanical switches, piezoelectric switches, proximity sensors, tactile control devices, graphical control elements on a touchscreen, and combinations thereof to provide a user with a way to trigger functions on the controller 106. The body can be cylindrical.

[0065] The first trajectory button 162, the second trajectory button 164, the first admittance button 166, and the second admittance button 168 can be positioned on the handgrip to provide a means for visually and / or tactilely identifying the buttons. For example, the first trajectory button 162 and the second trajectory button 164 can be positioned opposite each other on the handgrip 160, and the first admittance button 166 and the second admittance button 168 can be positioned opposite each other and offset 90 degrees from the first trajectory button 162 and the second trajectory button 164. This positioning allows a user to identify the buttons by touch. Additionally, ridges 169 can be positioned between the buttons to further facilitate tactile identification of the buttons. In some embodiments, the first trajectory button 162 and the second trajectory button 164 are provided having a first color, and the first admittance button 166 and the second admittance button 168 are provided having a second color that is different from the first color, allowing the sets of buttons to be visually distinguished from one another.

[0066] The controller 106 and the first trajectory button 162 can be configured to move the robotic arm 104, and thus the tool guide 140, toward the surgical site ST while keeping the longitudinal axis 148 of the tool support 141 of the tool guide 140 aligned with the planned trajectory 180. For example, the first trajectory button 162 can be electrically connected to the controller 106, such that pressing the first trajectory button 162 sends an electrical signal (e.g., pushes or pulls) to the controller 106, causing the processor 108 of the controller 106 to send an electrical signal to the robotic arm 104 to adjust the position of the robotic arm 104 and move the tool support 141 of the tool guide 140 toward the surgical site ST while keeping the longitudinal axis 148 of the tool support 141 of the tool guide 140 aligned with the planned trajectory 180.

[0067] The controller 106 and the second trajectory button 164 can be configured to move the robotic arm 104, and therefore the tool support 141 of the tool guide 140, away from the surgical site ST while keeping the longitudinal axis 148 of the tool guide 140 aligned with the planned trajectory 180. For example, the second trajectory button 164 is electrically connected to the controller 106, and pressing the second trajectory button 164 sends an electrical signal to the processor 108 of the controller 106, which then passes an electrical signal to the robotic arm 104 to adjust the position of the robotic arm 104 so as to move the tool support 141 of the tool guide 140 away from the surgical site ST while keeping the longitudinal axis 148 of the tool support 141 of the tool guide 140 aligned with the planned trajectory 180.

[0068] The controller 106 and the first trajectory button 162 and the second trajectory button 164 may be configured to move the robotic arm 104, and thus the tool support 141 of the tool guide 140, from a current position (e.g., on planned trajectory 180 a) to a next planned trajectory, such as planned trajectory 180 b. For example, the first trajectory button 162 and the second trajectory button 164 may be electrically connected to the controller 106 such that pressing or selecting the first trajectory button 162 and the second trajectory button 164 substantially simultaneously passes an electrical signal to the processor 108 of the controller 106, which in turn passes an electrical signal to the robotic arm 104 to move the robotic arm 104 from a current position (e.g., on planned trajectory 180 a) to a position on the next planned trajectory 180 b. For example, during a surgical procedure, after placing anchor 190, the user can press first trajectory button 162 and second trajectory button 164 approximately simultaneously to move tool guide 140 from its current position on planned trajectory 180a to a position on planned trajectory 180b where the longitudinal axis 148 of tool support 141 of tool guide 140 is coaxially aligned with planned trajectory 180b, and begin placing a second anchor.

[0069] For example, during a surgical procedure, a user may insert a cannula 152 into a tool support 141 of a tool guide 140. The processor 108 of the system 100 may use stored information about the cannula 152 to move the robotic arm 104 (and thus the tool support 141 and cannula 152 of the tool guide 140) so that the cannula 152 reaches a position that is a predetermined distance from the patient's body B and / or anatomical structures. The surgeon may use the second trajectory button 164 to move the tool 150 away from the patient along the trajectory 180, for example, to improve visibility or accessibility. When the first trajectory button 162 is used to move the tool 150 back toward the patient along the trajectory 180, the processor 108 of the system 100 may stop the robotic arm 104 when a safety limit is reached.

[0070] In some embodiments, the controller 106 can operate in a mode referred to herein as an admittance mode, in which the tool guide 140 can be manually positioned by allowing and / or assisting the movement of the robotic arm 104 according to user instructions. For example, the first admittance button 166 and the second admittance button 168 can be configured to send a signal to the processor 108. The processor 108 processes the signal and sends it to the robotic arm 104 to detect torque on the robotic arm 104 resulting from the user applying a force to the robotic arm 104. The processor 108 determines the direction in which the user wants the robotic arm 104 to move and then activates servos within the robotic arm 104 to allow the user to freely move the robotic arm 104 in any direction within safety limits. In admittance mode, the processor 108 of the system 100 may be configured to actuate servos in the robotic arm 104 and sense the torque of the servos at each joint of the robotic arm 104 to determine a desired direction in which a user intends to move the robotic arm 104, and the processor 108 may then be programmed to actuate one or more servos to assist the user in moving the robotic arm 104 in the desired direction. The admittance mode may be initiated when both the first admittance button 166 and the second admittance button 168 are pressed in a predetermined order, for example, substantially simultaneously (e.g., simultaneously, within one second, etc.), and then held simultaneously throughout the movement.

[0071] As described herein, some embodiments include a controller 106 that can control the movement of the robotic arm 104. The processor 108 of the controller 106 can be configured to execute an application 111 for controlling the robotic arm 104. In some embodiments, the application 111, in response to execution by the processor 108, can utilize trajectories (e.g., leading and trailing coordinates) that can be planned and / or configured remotely or locally before and / or during a surgical procedure. Trajectories planned before or during a surgical procedure may be referred to herein as “planned trajectories,” such as planned trajectories 180a and 180b. In additional or alternative aspects, in response to execution by the processor 108, the application 111 can be configured to execute one or more methods described herein in the controller 106 to move the robotic arm 104 according to one or more trajectories. It should be noted that in spinal surgery, multiple trajectories are planned. Typically, six trajectories (three sets of two trajectories, one for each vertebral body being operated on) will be used. In some embodiments, four trajectories may be used to fuse two vertebral bodies.

[0072] In some embodiments, the processor 108 of the controller 106 can communicate when the robotic arm 104 and / or other device is locked in place using a visual or audio alert. For example, the hand grip 160 or tool guide 140 can be provided with an LED or other visual device, and the controller 106 can be programmed to illuminate the LED to indicate when the robotic arm 104 and / or other device is locked in place.

[0073] In some embodiments, the processor 108 of the controller 106 may be programmed to continuously control the position of the tool guide 140 relative to the patient's anatomy.

[0074] In some embodiments, the processor 108 of the controller 106 can be programmed to allow a user (e.g., a surgeon, another user, or equipment) to position conventional surgical screws. In some embodiments, the processor 108 of the controller 106 can be programmed to allow a user to select the length and diameter of the surgical screws. In yet another aspect, the processor 108 of the controller 106 can be programmed to maintain the relative position, size, and scale of the screws in the graphical display on the external device 114.

[0075] The tool guide 140 can be removably coupled to a hand grip 160 coupled to the robotic arm 104. As can be appreciated, there should be no play between the tool guide 140 and the robotic arm 104. To facilitate coupling of the tool guide 140 to the hand grip 160, the tool guide 140 can be provided with a receiver 149 sized and shaped to receive a connection portion 170 of the hand grip 160. The receiver 149 and connection portion 170 are shown for illustrative purposes only and should not be considered limiting. The tool guide 140 and the hand grip 160 can be provided with any receiver 149 and connection portion 170 configured to securely couple the tool guide 140 and the hand grip 160. For example, the receiver 149 and connection portion 170 can include at least one threaded connection, e.g., a screw, configured to securely couple the tool guide 140 and the hand grip 160.

[0076] FIG. 5 illustrates a workflow 200 of a surgical procedure (e.g., based on a treatment plan) that may be employed in a computer-assisted surgery system (e.g., the computer-assisted surgery system 100 including the robotic arm 104, controller 106, and navigation system 120 of FIG. 1 ). For example, the surgical procedure may involve the patient's spine, such as placing screws into one or more pedicles of the patient's vertebrae. As a non-limiting example, the surgical procedure may employ drill, tap, and screw techniques, such as those required as part of a transforaminal lumbar interbody fusion (TLIF). The surgical procedure may require a range of tools. One example of a procedure is posterior pedicle screw placement for posterior stabilization, which is often performed in conjunction with interbody surgery (e.g., cage placement).

[0077] In step 201, the processor 108 of the controller 106 may be programmed to allow a user to identify intended locations for surgical implants or tools. For example, at least one trajectory for accessing the patient's anatomy may be planned. For example, each trajectory may be planned using imaging of the patient's anatomy (e.g., a magnetic resonance imaging scan of the lower lumbar spine) used to create the anatomical computer model, data from previous surgical procedures and / or previously performed surgical techniques (e.g., data recorded by the system 100 when forming pilot holes used later to facilitate placement of anchors 190), etc. In some embodiments, a user may program a desired insertion point and trajectory for a surgical instrument to reach a desired anatomical target within or on the patient's body B. In some embodiments, the desired insertion point and trajectory may be planned on the anatomical computer model and, in some embodiments, displayed on the external device 114. In some embodiments, the user may plan the trajectory and desired insertion point (if any) on a computed tomography scan (hereinafter referred to as a "CT scan") of the patient. In some embodiments, the CT scan may be an isocentric C-arm scan, an O-arm scan, or an intraoperative CT scan, as known in the art. However, in some embodiments, any known 3D image scan may be used in accordance with embodiments of the invention described herein. The at least one trajectory planned as described in step 201 may be referred to throughout this specification as a "planned trajectory," e.g., planned trajectory 180.

[0078] In some embodiments, the processor 108 of the controller 106 may be programmed to generate a display that follows the standardized workflow planned in step 201. For example, the surgeon may select the order of pedicle screw insertion. Thus, for example, after the first pedicle screw is placed, if the user presses both the first trajectory button 162 and the second trajectory button 164 substantially simultaneously, the processor 108 moves the robotic arm 104 from its current position to the next planned trajectory for inserting the second pedicle screw. The current position of the robotic arm 104 may be on the planned trajectory for placing the first pedicle screw, or the surgeon may have entered admittance mode by pressing both the first admittance button 166 and the second admittance button 168 to move the robotic arm 104.

[0079] In step 202, a tool guide 140 having a tool support 141, such as a connector or coupler adapted to accept multiple tools 150 (e.g., different tools sequentially), is supported (e.g., attached or mounted) on a hand grip 160, which is supported (e.g., mounted or attached) at the distal end 107b or other location of the robotic arm 104 of the computer-assisted surgery system 100. The tool guide 140 may be coupled to the hand grip 160 via an end plate secured by, for example, a lever or other coupling means known in the art, such as a screw, bolt, or threaded connection. In other embodiments, the tool guide 140 and the hand grip 160 may be integrally formed as a unitary structure. Prior to attachment of the tool guide 140, a sterile drape (not shown) may be placed between the tool guide 140 and the hand grip 160 and extended to cover at least a portion of the hand grip 160 and / or the robotic arm 104.

[0080] In step 203, the tool guide 140 is aligned to the planned trajectory 180. In one example, after connecting the tool guide 140 to an active robotic arm, such as the robotic arm 104, a navigational assessment using the controller 106 and associated navigation system 120 can be performed to ensure alignment of the tool guide 140. Alignment can be performed with no tool 150 attached to the tool guide 140, with the tool 150 being a reference tool within the tool guide 140, or with the initial tool 150 of the surgical procedure attached to the tool guide 140. In some embodiments, the robotic arm 104 is aligned to the planned trajectory only once (e.g., for each pedicle screw insertion procedure). While the hand grip 160 and tool guide 140 may only need to be attached once, the attachment and alignment procedures may be repeated for each tool exchange and / or distal end exchange for each tool 150 in a surgical procedure (e.g., for each tool 150 in a surgical procedure). A common reason for realignment is when a deviation from the planned trajectory 180 is detected due to forces applied to the surgical system 100 .

[0081] In step 204, a first tool 150 (e.g., a scalpel, etc.) holding a cutting instrument (e.g., a scalpel blade, etc.) is placed in the tool guide 140. Placing the scalpel guide in the tool support 141 of the tool guide 140 guides the scalpel holder (e.g., with a blade) to incise the patient along a pre-planned trajectory imparted by the aligned (pre-planned) tool guide 140. Optionally, step 203 may be performed with respect to the alignment (e.g., desired trajectory, position, and / or orientation) of the first tool 150. The robotic arm 104 may navigate to a start position (in a system with an active robotic arm) or be guided by a user (e.g., a surgeon) to a start position (in a system with a passive arm with an active tool guide). The navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position). The cutting trajectory may be displayed on the external device 114, such as along with an image of the patient's anatomy. An incision is made in the patient to access the surgical site ST. The incision may be made manually by the surgeon. The incision may be made semi-autonomously, i.e., controlled by at least partial robotic control (e.g., robotic force assistance, robotic constraints against movement beyond certain boundaries or planes, while otherwise providing manual control, determining straightness, depth control, etc.). The incision may also be made fully autonomously (e.g., fully controlled by the controller 106). Once the incision at the surgical site ST is complete, the patient's anatomical structures, such as bone surfaces, become accessible. The navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the robotic arm 104 and / or the tool support 141 of the tool guide 140. For example, this position may include determining the incision boundary or incision depth. The first tool 150 may be detached from the tool support 141 of the tool guide 140.

[0082] In step 206, a second tool 150 (e.g., a dilator) holding a cutting instrument (e.g., a sharp dilator tip (or, alternatively, a blunt dilator tip)) is placed on the tool support 141 of the tool guide 140 and secured in place. This allows initial access to the anatomy of the surgical site ST. Optionally, step 203 may be performed with respect to the alignment (e.g., a desired trajectory, position, and / or orientation) of the second tool 150. For example, the robotic arm 104 (and the tool support 141 of the tool guide 140) may be returned to a saved position. An image of the patient's anatomy may be displayed on the external device 114. The second tool 150 is inserted into the patient to access the surgical site ST. Control of the second tool 150 can be manual, semi-autonomous, or fully autonomous, as described above. In some embodiments, the initial access is a dilation procedure. Once the dilation procedure is complete, the navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the robotic arm 104 and / or the tool support 141 of the tool guide 140. For example, the position can include a depth measurement indicating the location of the bone surface. The second tool 150 can be removed from the tool support 141 of the tool guide 140.

[0083] In step 208, a third tool 150 (e.g., for driving the burr), which holds a cutting instrument (e.g., a burr), is placed on the tool support 141 of the tool guide 140 and secured in place. The burr may be any of a variety of shapes, e.g., flat, circular, or geometric, and may have geometric or non-geometric cutting features. Additionally, the burr may have a variety of configurations, e.g., grooved or non-grooved. A grooved burr may have a different number of cutting grooves. Optionally, step 203 may be performed with respect to the alignment (e.g., desired trajectory, position, and / or orientation) of the third tool 150. For example, the robotic arm 104 (and thus the tool support 141 of the tool guide 140) may be moved so that the third tool 150 reaches a stored position (e.g., a position on the bone surface). An image of the patient's anatomy may be displayed on the external device 114. The burr is inserted into the patient to access the surgical site ST and create a flat or other feature on the bone surface. The robotic arm 104 may move along a planned trajectory. Control of the rotary tool driving the burr may be manual, semi-autonomous, or fully autonomous. Once the cortical bone removal procedure is complete, the navigation system 120 and / or the processor 108 of the controller 106 may store the position (e.g., three-dimensional position) of the robotic arm 104 and / or the tool support 141 of the tool guide 140 in the memory 112. For example, the position may include a depth measurement indicating the location and / or contour of the bone surface where the cortical bone was removed. The third tool 150 may be detached from the tool support 141 of the tool guide 140. As will be appreciated, in some embodiments, this step may be omitted depending on the type of screw being installed.

[0084] In step 210, a fourth tool 150 (e.g., for driving a drill bit, etc.) holding a cutting instrument (e.g., a drill bit, etc.) is placed on the tool support 141 of the tool guide 140 and held in place. The drill bit may be of any of a variety of diameters, lengths, and / or configurations (e.g., fluted or non-fluted). Optionally, step 203 may be performed with respect to the alignment (e.g., desired trajectory, position, and / or orientation) of the fourth tool 150. For example, the robotic arm 104 (and tool guide 140) may be moved so that the fourth tool 150 reaches a stored position (e.g., a position on a bone surface). An image of the patient's anatomy is displayed on the external device 114. The drill bit is inserted into the patient to access the surgical site ST and drill a hole in the bone. The robotic arm 104 moves to achieve the planned trajectory 180. Control of the rotary tool driving the drill bit can be manual, semi-autonomous, or fully autonomous, as described above. Once the drilling procedure is complete, the navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the robotic arm 104 and / or the tool support 141 of the tool guide 140 in the memory 112. For example, the position can include a depth measurement indicating the location of the hole. The fourth tool 150 can be removed from the tool support 141 of the tool guide 140. As will be appreciated, in some embodiments, this step can be omitted depending on the type of screw being installed.

[0085] In step 212, a fifth tool 150 (e.g., for driving the tap), which holds a cutting instrument (e.g., a tap), is placed on the tool support 141 of the tool guide 140 and secured in place. The tap can be selected based on a predetermined screw size (e.g., the screw size to be inserted into the hole in step 214). Optionally, step 203 can be performed with respect to the alignment (e.g., a desired trajectory, position, and / or orientation) of the fifth tool. For example, the robotic arm 104 (and tool guide 140) can be moved so that the fifth tool 150 reaches a stored position (e.g., a position on the bone surface). An image of the patient's anatomy is displayed on the external device 114. The tap is inserted into the patient to access the surgical site ST and create a thread in the bone hole. The robotic arm 104 can be moved to and / or along a pre-planned trajectory. Control of the rotary tool driving the tap can be manual, semi-autonomous, or fully autonomous, as described above. Once the tapping procedure is complete, the navigation system 120 and / or processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the robotic arm 104 and / or the tool support 141 of the tool guide 140 in the memory 112. For example, the position can include a depth determination indicating the location of the tapped hole. The fifth tool 150 can be removed from the tool support 141 of the tool guide 140. It will be appreciated that in some embodiments, this step can be omitted depending on the type of screw being installed.

[0086] In step 214, a sixth tool 150 (e.g., for tightening the screw) holding a cutting instrument (e.g., a screw, etc.) is placed on the tool support 141 of the tool guide 140 and secured in place. The screw may be a pedicle screw of a predetermined screw size (e.g., one to be inserted into a tapped hole). Optionally, step 203 may be performed with respect to the alignment (e.g., a desired trajectory, position, and / or orientation) of the sixth tool. For example, the robotic arm 104 (and thus the tool support 141 of the tool guide 140) may be moved so that the sixth tool 150 reaches a memorized position (e.g., a position on a bone surface). An image of the patient's anatomy may be displayed on the external device 114. The screw is inserted into the patient to access the surgical site ST and placed in the bone hole. The robotic arm 104 may move to and / or along a pre-planned trajectory. Control of the sixth tool 150, which drives the screw, may be manual, semi-autonomous, or fully autonomous, as described above. Upon completion of the screw placement procedure, the navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the robotic arm 104 and / or the tool support 141 of the tool guide 140. For example, the position can include placement determination information indicating the location of the pedicle screw. The sixth tool 150 can be detached from the tool support 141 of the tool guide 140.

[0087] If the surgical procedure includes multiple planned trajectories (e.g., a surgical procedure requiring the placement of multiple pedicle screws), the pedicle screw in step 214 may be the first pedicle screw placed along the first planned trajectory. After the first pedicle screw is placed, in step 215, the user can move the robotic arm 104 from its current position on the first planned trajectory to a second planned trajectory for placing a second pedicle screw by substantially simultaneously pressing the first trajectory button 162 and the second trajectory button 164. Workflow 200 can be repeated for the second pedicle screw, for example, from step 204.

[0088] Once the tool support 141 is aligned with the planned trajectory 180, in optional step 216, the user can press or select a first trajectory button 162 on the hand grip 160 to move the robotic arm 104 and the tool guide 140 holding the tool 150 toward the patient. During this movement, the processor 108 of the system 100 is programmed to move the robotic arm 104 so that the longitudinal axis 148 of the tool support 141 of the tool guide 140, and therefore the tool, remains aligned with the pre-planned trajectory. Once the tool support is aligned with the planned trajectory 180, optional step 216 can be performed at any time during the surgical procedure, for example, to improve visibility and / or accessibility of the surgical site ST. In some embodiments, the first trajectory button 162 must be pressed or selected throughout the entire movement of the robotic arm 104.

[0089] In some embodiments, the system 100 can be programmed to require that the first trajectory button 162 and the safety signal generator 118 be pressed or otherwise selected in a predetermined sequence, such as simultaneously, in a predetermined sequence, or a combination thereof, before the robotic arm 104 and the tool guide 140 holding the tool 150 are moved toward the patient. In some embodiments, the system 100 can be programmed to require that the safety signal generator 118 be pressed or otherwise selected before the first trajectory button 162 is pressed, and then both the safety signal generator 118 and the first trajectory button 162 are pressed or otherwise selected simultaneously before the robotic arm 104 and the tool guide 140 holding the tool 150 are moved toward the patient.

[0090] Once the tool support 141 is aligned with the planned trajectory 180, in optional step 218, the user can press or otherwise select the second trajectory button 164 on the hand grip 160 to move the robotic arm 104 and the tool support 141 of the tool guide 140 holding the tool 150 away from the patient. During this movement, the system 100 is programmed to move the robotic arm 104 so that the longitudinal axis 148 of the tool support 141 of the tool guide 140, and therefore the tool 150, remains aligned with the planned trajectory 180. Optional step 216 can be performed at any time during the surgical procedure, for example, to improve visibility and / or accessibility of the surgical site ST. In some embodiments, the second trajectory button 164 must be pressed or selected throughout the entire movement of the robotic arm 104.

[0091] In some embodiments, the system 100 may be programmed to require that the second trajectory button 164 and the safety signal generator 118 be simultaneously pressed or selected before the robotic arm 104 and the tool guide 140 holding the tool 150 move away from the patient.

[0092] In optional step 220, the user can substantially simultaneously press or select the first admittance button 166 and the second admittance button 168 and hold the first admittance button 166 and the second admittance button 168 while the robotic arm 104 is moving to move the robotic arm 104 and the tool support 141 of the tool guide 140 holding the tool 150 in various directions (including, but not limited to, directions away from the planned trajectory 180), subject to the safety limits described above. Optional step 220 can be performed at any time during the surgical procedure to, for example, improve visibility and / or accessibility to the surgical site ST. Upon releasing the first admittance button 166 and / or the second admittance button 168, the processor 108 can be configured to move the robotic arm 104 to position the longitudinal axis 148 of the tool guide 140 to associate the tool 150 with the planned trajectory 180.

[0093] In optional step 222, the user can move the robotic arm 104 and the tool support 141 of the tool guide 140 holding the tool 150 from a current position away from the planned trajectory to the planned trajectory 180 by pressing or otherwise selecting the first trajectory button 162 and the second trajectory button 164 substantially simultaneously. Optional step 222 can be performed at any time during a surgical procedure if the tool support 141 is not aligned with the planned trajectory. For example, this may occur when the surgeon enters admittance mode by pressing both the first admittance button 166 and the second admittance button 168 to move the robotic arm 104 around an obstacle, as described above in step 220, and then the user presses the first trajectory button 162 and the second trajectory button 164 substantially simultaneously to move the tool support 141 of the tool guide 140 back to the planned trajectory 180, without other portions of the robotic arm 104 obscuring the surgeon's view.

[0094] As will be appreciated, the embodiments described herein are applicable to other surgical procedures, such as cervical procedures.

[0095] From the foregoing, it is apparent that the inventive concepts disclosed herein are well adapted to carry out the objects and obtain the advantages set forth herein, as well as those inherent therein. While embodiments of the inventive concepts disclosed herein have been described for purposes of this disclosure, it will be understood that many modifications may be made, and will be readily suggested to those skilled in the art, which modifications will be within the scope and spirit of the inventive concepts disclosed herein.

Claims

1. A robotic surgery system including a robotic arm (104), a hand grip (160) supported by the robotic arm (104) and having a first trajectory button (162) and a second trajectory button (164); a tool guide (140) supported by the hand grip (160), the tool guide (140) comprising a tool support (141) having a first end, a second end, an opening extending through the tool support (141) from the first end to the second end, and a longitudinal axis (148) extending through a center of the opening from the first end to the second end; a navigation system (120) configured to track the position and orientation of the tool guide (140) relative to the patient; a controller in communication with servos of the robotic arm, the navigation system, and the handgrip, the controller having a non-transitory computer readable memory and a processor, the non-transitory computer readable memory storing at least one planned trajectory associated with a surgical procedure and processor-executable instructions that, when executed, cause the processor to receive a position and orientation of the tool guide relative to the patient from the navigation system and pass a first signal to at least one servo of the robotic arm to cause the robotic arm to position the tool support at a predetermined distance from the patient with a longitudinal axis of the tool support substantially coaxially aligned with the at least one planned trajectory; and the first trajectory button (162), when actuated, is configured to pass a second signal to the controller processor causing the controller processor to actuate at least one servo of the robotic arm to move the tool support along the at least one planned trajectory away from the patient while keeping the tool support longitudinal axis (148) substantially coaxial with the at least one planned trajectory; and the second trajectory button (164), when actuated, is configured to pass a third signal to the controller processor causing the controller processor to actuate at least one servo of the robotic arm to move the tool support along the at least one planned trajectory toward the patient while keeping the tool support longitudinal axis (148) substantially coaxial with the at least one planned trajectory.

2. The robotic surgical system of claim 1 , further comprising a tool (150) disposed within the tool support (141).

3. 3. The robotic surgical system of claim 2, wherein the non-transitory computer-readable memory of the controller further stores safety limits associated with the surgical procedure, the safety limits configured to restrict movement of a tool secured to the tool support such that a predetermined distance limit between the tool and a patient's anatomical structure is maintained during the surgical procedure.

4. 4. The robotic surgery system of claim 1, wherein the hand grip further comprises a first admittance button and a second admittance button configured to, when actuated substantially simultaneously, pass a fourth signal to the controller, causing the controller to allow a user to manually move the robotic arm in various directions.

5. 5. The robotic surgery system of claim 1, wherein the navigation system includes a tracking unit and a navigation array attached to the robot arm, the navigation system being configured to track the position and orientation of the tool guide using the navigation array and pass the position and orientation of the tool guide to the controller.

6. 6. The robotic surgical system of claim 1, further comprising a sterile drape positioned between the tool guide and the hand grip and extending to cover the hand grip during a surgical procedure.

7. 7. The robotic surgery system of claim 1, wherein the first trajectory button and the second trajectory button, when operated in a predetermined sequence, are configured to pass a fourth signal to the processor of the controller, causing the processor of the controller to activate at least one servo of the robot arm to move the tool guide from a current position to a new position in which the longitudinal axis of the tool guide is coaxially aligned with a second planned trajectory.

8. 8. The robotic surgical system of claim 1, wherein the first trajectory button (162) and the second trajectory button (164) are located opposite each other on the hand grip (160).

9. 10. The robotic surgical system of claim 8, including the configuration of claim 4, wherein the first admittance button (166) and the second admittance button (168) are positioned opposite each other on the hand grip (160), and the first admittance button is offset from the first trajectory button.

10. 5. The robotic surgical system of claim 4, wherein the hand grip further comprises a body supporting the first trajectory button, the second trajectory button, the first admittance button, and the second admittance button, the body of the hand grip comprising a ridge positioned to separate the first and second trajectory buttons from the first and second admittance buttons.

11. 5. The robotic surgical system of claim 4, wherein the first trajectory button (162) and the second trajectory button (164) are provided with a first color, and the first admittance button (166) and the second admittance button (168) are provided with a second color different from the first color.

12. 12. The robotic surgery system of claim 1, further comprising a safety signal generator having circuitry configured to monitor a predetermined position and detect the presence or absence of a part of a surgeon in the predetermined area, wherein the processor is programmed to request that the safety signal generator be pressed or otherwise selected in a predetermined sequence along with the second trajectory button to activate at least one servo of the robot arm to move the tool support toward the patient along the at least one planned trajectory.

13. 12. The robotic surgery system of claim 1, further comprising a safety signal generator having circuitry configured to monitor a predetermined position and detect the presence or absence of a part of a surgeon in the predetermined area, wherein the processor is programmed to request that the safety signal generator be pressed or otherwise selected in a predetermined sequence along with the first trajectory button to activate at least one servo of the robotic arm to move the tool support away from the patient along the at least one planned trajectory.

14. 14. A method of assembling a robotic surgical system according to any one of claims 1 to 13, comprising attaching to at least one arm segment of a robotic arm (104) the hand grip (160) having a body (161) supporting a first trajectory button (162) and a second trajectory button (164).

15. 15. The method of claim 14, wherein one of the arm segments of the robot arm forms a distal end of the robot arm, and the attaching step is further defined as attaching the hand grip to the distal end of the robot arm.

16. The method of claim 14 or claim 15, further comprising attaching a tool guide (140) having a tool support to the hand grip (160).

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