Robot trajectory axis adjustment interface

Through the robotic arm and navigation system in the robotic surgery system, the movement of the tool guide is controlled by the controller and servo motor, which solves the problem of coaxial alignment of the tool with the planned trajectory during surgery and improves the orientation and position accuracy of the surgical tool.

CN120752003APending Publication Date: 2025-10-03ECENTIAL ROBOTICS
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Patent Information

Application Number
CN202380094724.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-12-22
Filing Date
2023-12-21
Publication Date
2025-10-03

AI Technical Summary

Technical Problem

Existing computer-assisted surgery systems have difficulty maintaining the coaxial alignment of the surgical tool with the pre-planned trajectory during the movement of the surgical tool, which affects the orientation and position accuracy of the tool.

Method used

A robotic surgical system is used, including a robotic arm, a handle, a tool guide and a navigation system. The movement of the tool guide is controlled by a positioning system to ensure that its longitudinal axis is coaxially aligned with the planned trajectory. The precise movement of the tool is achieved by cooperating with a controller and a servo motor.

Benefits of technology

This enables coaxial alignment of tools with pre-planned trajectories during surgery, improves the orientation and position accuracy of surgical tools, and enhances surgical visibility and accessibility.

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Abstract

A robotic surgical system including a robotic arm includes a grab handle (160), a tool guide (140), and a controller. The grab handle is supported by the mechanical arm, and the grab handle is provided with a first track button (162) and a second track button (164). The tool guide is supported by the grip. The controller has a memory storing at least one planned trajectory associated with a surgical procedure and a processor. The first trajectory button, when engaged, causes a processor of the controller to move the tool support away from the patient along a planned trajectory. The second trajectory button, when engaged, causes a processor of the controller to move the tool support along the planned trajectory toward the patient, thereby maintaining a longitudinal axis of the tool support substantially coaxially aligned with the planned trajectory.
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Description

Background Art

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

[0002] Therefore, there is a need for systems, devices, and methods that improve computer-assisted surgical systems, for example, by facilitating movement of a tool placed on 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 apparatus for a robotic surgical system are described. Some embodiments of the present invention provide a surgical robot and navigation system utilizing a positioning system that allows for controlled motion of a tool guide along a pre-planned trajectory, wherein a longitudinal axis of the tool guide and an associated surgical instrument secured therein remains coaxially aligned with the pre-planned trajectory throughout the motion. In some embodiments, the surgical robot may include a base, a robotic arm coupled to the base and configured to articulate relative to the base, and a handle and tool guide coupled to a distal end of the robotic arm.

[0004] In some embodiments, the present disclosure describes a robotic surgical system including a robotic arm, the robotic surgical system comprising: a handle supported by the robotic arm, the handle having a first trajectory button and a second trajectory button; a tool guide supported by the handle, the tool guide including a tool support, the tool support having a first end, a second end, a hole extending from the first end through the tool support to the second end, and a longitudinal axis extending from the first end through the center of the hole to the second end; a navigation system configured to track the position and orientation of the tool guide relative to the patient; and a controller connected to the navigation system, the handle, and the servo motor of the robotic arm, 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 the surgical procedure and processor-executable instructions that, when executed, cause the processor to receive the tool guide from the navigation system. relative to the position and orientation of the patient, and transmitting a first signal to at least one servo motor of the robotic arm, causing the robotic arm to position the tool support at a predetermined distance from the patient, with the longitudinal axis of the tool support substantially coaxially aligned with the at least one planned trajectory; wherein the first trajectory button, when engaged, is configured to transmit a second signal to the processor of the controller, causing the processor of the controller to drive the at least one servo motor of the robotic arm to move the tool support away from the patient along the at least one planned trajectory, while maintaining the longitudinal axis of the tool support coaxially aligned with the at least one planned trajectory; and the second trajectory button, when engaged, is configured to transmit a third signal to the processor of the controller, causing the processor of the controller to actuate the at least one servo motor of the robotic arm to move the tool support toward the patient along the at least one planned trajectory, while maintaining the longitudinal axis of the tool support coaxially aligned with the at least one planned trajectory.

[0005] In some embodiments, the robotic surgical system further includes a tool positioned in the tool support.

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

[0007] In some embodiments, the grip further includes first and second access buttons that, when engaged substantially simultaneously, are configured to transmit 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 has a tracking unit and a navigation array attached to the robotic arm, wherein the navigation system is configured to track the position and orientation of the tool guide using the navigation array and communicate the position and orientation of the tool guide to the controller.

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

[0010] In some embodiments, when engaged in a predetermined sequence, the first trajectory button and the second trajectory button are configured to transmit a fourth signal to a processor of the controller, causing the processor of the controller to actuate at least one servo mechanism of the robotic arm to move the tool guide from a current position to a new position, wherein the longitudinal axis of the tool guide is coaxially aligned with the second planned trajectory.

[0011] In some embodiments, the first track button and the second track button are positioned opposite each other on the grip.

[0012] The first access button and the second access button may be positioned opposite each other on the grip, with the first access button offset from the first track button.

[0013] In some embodiments, the grip further includes a body supporting the first track button, the second track button, the first access button, and the second access button, and the body of the grip includes a ridge positioned to separate the first track button and the second track button from the first access button and the second access button.

[0014] In some embodiments, the first track button and the second track button have a first color, and the first admission button and the second admission button have a second color different from the first color.

[0015] In some embodiments, the robotic surgical system further includes a safety signal generator having circuitry configured to monitor a predetermined position and detect extension from the first end, and the processor is programmed to require the safety signal generator to be pushed or otherwise selected with a second trajectory button in a predetermined sequence to cause the processor of the controller to actuate at least one servo mechanism of the robotic arm to move the tool support toward the patient along at least one planned trajectory.

[0016] In some embodiments, the robotic surgical system further includes a safety signal generator having circuitry configured to monitor a predetermined position and detect extension from the first end, and the processor is programmed to require pushing or otherwise selecting the safety signal generator with a first trajectory button in a predetermined sequence to cause the processor of the controller to actuate at least one servo mechanism 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 of assembling a surgical robotic system as described above, comprising:

[0018] A handle is attached to at least one arm segment of the robotic arm, the handle having a body supporting a first track button and a second track button.

[0019] 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 the handle to the distal end of the robotic arm.

[0020] In some embodiments, the method further includes attaching a tool guide to the handle, the tool guide having a tool support.

[0021] Another aspect of the present disclosure relates to a method comprising:

[0022] positioning a tool support supported by the robot arm at a predetermined position with a longitudinal axis of the tool support coaxially aligned with the planned trajectory;

[0023] causing a processor of a controller associated with the robotic arm to move the tool support in a first direction along the planned trajectory, maintaining a longitudinal axis of the tool support substantially coaxially aligned with at least one planned trajectory;

[0024] The processor of the controller is caused to move the tool support in a second direction along the at least one planned trajectory, maintaining a longitudinal axis of the tool support substantially coaxially aligned with the planned trajectory.

[0025] In some embodiments, the step of causing a processor of a controller associated with the robotic arm to move the tool guide in a first direction along a planned trajectory, keeping the longitudinal axis of the tool support substantially coaxially aligned with at least one planned trajectory is further defined as the processor receiving a signal from a first trajectory button on the robotic arm, thereby providing instructions to the processor to cause the processor to move the tool support in a first direction along the planned trajectory, keeping the longitudinal axis of the tool support substantially coaxially aligned with at least one planned trajectory.

[0026] In some embodiments, the first track button is supported by a body of a grip attached to the robotic arm, and the method further includes receiving a force on the first track button, whereby the first track button activates the signal in response to the force on the first track button.

[0027] Another object of the present disclosure relates to a method comprising:

[0028] receiving data indicative of a planned trajectory to be followed by a tool support coupled to the robotic arm;

[0029] configuring a processor of a controller associated with the robotic arm to move the tool support in a first direction along the planned trajectory, maintaining a longitudinal axis of the tool support substantially coaxially aligned with at least one planned trajectory;

[0030] The processor of the controller is configured to move the tool support in a second direction along at least one planned trajectory, maintaining a longitudinal axis of the tool support substantially coaxially aligned with the planned trajectory. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 A schematic diagram of a computer-assisted surgery system constructed in accordance with one embodiment of the present invention is shown, the system comprising a robotic base, a robotic arm, a handle attached to the robotic arm, and a tool guide attached to the handle;

[0032] Figure 2 is a schematic diagram of a surgical site according to an embodiment of the present disclosure, which shows Figure 1 a handle and a tool guide, wherein the tool is secured by the tool guide and aligned along a pre-planned trajectory adjacent to the surgical site;

[0033] Figure 3 It is constructed according to an embodiment of the present disclosure Figure 1 an exploded front perspective view of a handle and a tool guide;

[0034] Figure 4 It is constructed according to an embodiment of the present disclosure Figure 1 An exploded perspective view of the handle and tool guide;

[0035] Figure 5 The flowchart of a surgical procedure using a computer-assisted surgery system according to one embodiment of the present disclosure is shown. DETAILED DESCRIPTION

[0036] Before explaining at least one embodiment of the present disclosure in detail, it should be understood that the application of the present disclosure is not limited to the details of construction, experiments, exemplary data and / or arrangements of components set forth in the following description or illustrated in the accompanying drawings unless otherwise stated.

[0037] The systems and methods described in the present disclosure can be implemented in other embodiments or can be implemented or executed in various ways. In addition, it should be understood that the phraseology and terminology used herein are for descriptive purposes only and should not be considered as limiting.

[0038] The following detailed description refers to the accompanying drawings, in which the same reference numerals in different drawings may refer to the same or similar elements.

[0039] In the description herein, the terms "comprises," "includes," "has," and any other variations thereof are intended to cover a non-exclusive inclusion. For example, unless otherwise stated, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0040] 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 when A is true (or exists) and B is false (or does not exist), when A is false (or does not exist) and B is true (or exists), and when both A and B are true (or exist).

[0041] Additionally, "a" or "an" is used herein to describe elements and components of the embodiments. This is for convenience only and to provide a general sense of the inventive concept. This description should be understood to include one or more, and the singular includes the plural unless otherwise apparent. Furthermore, the term "plurality" is intended to mean "more than one" unless expressly stated otherwise.

[0042] As used herein, the term "substantially" means that the subsequently described event or circumstance occurs completely or to a substantial extent. As used herein, the qualifier "substantially" is intended to encompass not only the exact value, quantity, degree, orientation, or other defined characteristic or value, but also slight variations due to measurement error, control loop error, manufacturing tolerances, stresses applied to components, observer error, wear, and combinations thereof. For example, when describing the alignment of the longitudinal axis of a tool support substantially coaxially with at least one planned trajectory, the term "substantially" refers to alignment within a tracking tolerance.

[0043] Any reference herein to "one embodiment," "an embodiment," "some embodiments," "an example," "for example," or "an example" means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. For example, the phrases "in some embodiments" or "an example" appearing in different places in the specification do not necessarily refer to the same embodiment.

[0044] As used herein, a "circuit" may be an analog and / or digital component, or one or more appropriately programmed processors (e.g., microprocessors) and associated hardware and software, or hard-wired logic. In addition, a "component" may perform one or more functions. The term "component" may include hardware, such as a processor (e.g., microprocessor), a combination of hardware and software, and the like. Software may include one or more computer-executable instructions that, when executed by one or more components, cause the component to perform a specific function. It should be understood that the algorithms described herein may be stored on one or more non-transitory memories. Exemplary non-transitory memories may include random access memory, read-only memory, flash memory, and the like. Such non-transitory memories may be electrical-based, optical-based, and the like.

[0045] Referring now to the drawings, in particular Figure 1-Figure 4 , which shows an overview of an exemplary computer-assisted surgery system 100. The computer-assisted surgery system 100 can be provided with a robotic base 102 that supports a robotic arm 104. The robotic base 102 is depicted as a mobile base, but a fixed base is also contemplated. The robotic arm 104 includes a plurality of arm segments 105a, 105b, and 105c that are connected by rotatable or otherwise articulated joints and can be moved by actuating the joints. One of the arm segments 105 forms a distal end 107b of the robotic arm 104. In Figure 1 In the example shown, the arm segment 105c of the robotic arm 104 forms a distal end 107b. The robotic arm 104 also includes a proximal end 107a and a distal end 107b attached to and supported by the robot base 102. The robotic arm 104 can be adapted to move in all six degrees of freedom during a surgical procedure. The robotic arm 104 can be configured for incremental changes (e.g., in each of the six degrees of freedom) to ensure the necessary precision during surgery. The robotic arm 104 can actively move around joints to position the robotic arm 104 in a desired position relative to a patient (not shown), or the robotic arm 104 can be set and locked into position. For example, the present disclosure is contemplated to include tools used by a surgical robot, by a user with some degree of robotic assistance, and without involving a surgical robot or robotic assistance (e.g., once positioned and locked).

[0046] According to some embodiments of the present disclosure, a control unit or controller 106 can implement various features of the system 100 and the performance of the various methods disclosed herein. In some embodiments, the controller 106 can control the operation of the robotic arm 104 and the associated navigation system 120. In some embodiments, the control can include calibration of a relative coordinate system, generation of a planned trajectory, monitoring the positions of various units of the robotic base 102 and / or units functionally coupled thereto, enforcement of safety protocols or restrictions, and the like. The controller 106 can be one or more systems capable of embodying and / or executing the logic of the processes described herein. The controller 106 can 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 the logic can be implemented in a network environment, such as a distributed system using multiple computers and / or processors. In some embodiments, the planned trajectory can be based on the longitudinal axis of an implant to be positioned in a predetermined implant location within the patient's body. The predetermined implant location can include the position and orientation of the implant in 3D space within the patient's body. In these embodiments, the planned trajectory can coincide with the longitudinal axis of the implant extending from the predetermined implantation location in the patient.

[0047] Various embodiments of the present disclosure may operate with other computing systems, environments, and / or configurations suitable for use with the systems and methods of the present invention, including personal computers, server computers, laptops, or handheld devices, and multiprocessor systems configured to execute logic embodied in the form of software instructions and / or firmware as described herein. Other examples include mobile devices, programmable consumer electronics, network PCs, minicomputers, mainframe computers, distributed computing environments including any of the above systems or devices, and the like.

[0048] The controller 106 may include one or more processors 108 (hereinafter referred to as “processor 108”), one or more connectivity devices 110 (hereinafter referred to as “connectivity device 110”), one or more non-volatile memories 112 (hereinafter referred to as “memory 112”) that store processor executable code and / or software applications (such as application 111), and a system bus 113 that connects various components including the processor 108 to the memory 112.

[0049] In general, processor 108 refers to any computational processing unit or processing device, including but not limited to a single-core processor; a single processor with software multithreading execution capability; a multi-core processor; a multi-core processor with software multithreading execution capability; a multi-core processor using hardware multithreading technology; a parallel platform; and a parallel platform with distributed shared memory. Additionally or alternatively, processor 108 can 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 units referred to herein can utilize nanoscale architectures, such as molecular and quantum dot-based transistors, switches, and gates, to optimize space usage or enhance the performance of the computing devices of various aspects of the present invention. In some embodiments, processor 108 can also be implemented as a combination of computational processing units.

[0050] The external device 114 can be in communication with the controller 106. The external device 114 can be a touch screen display, a computing device, a remote server, etc., which is 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 from the controller 106, such as alarms. The communication between the external device 114 and the controller 106 can be wireless or wired. The illustrated external device 114 is shown as being attached to the robot base 102, however, in some embodiments, the external device 114 may 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.

[0051] The system 100 may also include a navigation system 120 that includes a tracking unit 122. The system 100 is capable of monitoring, tracking, and / or determining changes in the relative position and / or orientation of one or more portions of the robotic arm 104, a tool guide 140 attached to the robotic arm 104, and / or a tool inserted into the tool guide 140, and various portions of the patient's body B within a common coordinate system by utilizing various types of fiducials 123 (e.g., multi-degree-of-freedom optical, inertial, and / or ultrasonic sensing devices), the navigation system 120 (e.g., a machine vision system, a payload of a coupled device camera, a tracking sensor, a surface scanner, and / or a rangefinder), an anatomical computer model (e.g., a magnetic resonance imaging scan 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 while performing early steps of a surgical procedure), and the like. Tracking can be performed in a variety of ways, for example, using a stereo optical detector 127, an ultrasonic detector, a sensor configured to receive position information from an inertial measurement unit, and the like. In some embodiments, real-time tracking means a high frequency greater than 20 Hz (in some embodiments in the range of 100 to 500 Hz) with low latency (in some embodiments less than 5 milliseconds). Regardless of how the position and orientation data is collected, the position and orientation data can be transmitted between components (e.g., to the controller 106) via any suitable connection, for example, wired or wirelessly using a low-latency transmission protocol. The controller 106 can execute real-time control algorithms at a relatively high frequency with low additive latency to coordinate the motion of the robotic arm 104 of the system 100. The tracking unit 122 can 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.

[0052] The reference 123 of the navigation system 120 can be attached to the navigation array (e.g., the first navigation array 124, the second navigation array 126, and the optional navigation array 128 (and / or other navigation arrays)). The references 123 can be arranged in predetermined positions and oriented relative to each other. The references 123 can be aligned to be located in a plane of known orientation (e.g., a vertical plane, etc.) to enable the setting of a Cartesian reference frame. The references 123 can be positioned within the field of view of the navigation system 120 and can be identified in images captured by the navigation system 120. The references 123 can be disposable reflective navigation markers. Exemplary references 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 can be or can include inertial measurement units (IMUs), accelerometers, gyroscopes, magnetometers, other sensors, or combinations thereof. The sensors can transmit position and / or orientation information to the navigation system 120. In other embodiments, the sensor may be configured to transmit position and / or orientation information to an external controller, which may be, for example, controller 106 .

[0053] The first navigation array 124 can be attached to the patient, particularly in a fixed position and orientation relative to the bone to be cut. The second navigation array 126 can be mounted on the robotic arm 104, on the handle 160, or on the tool guide 140, and can be used to determine the position of the robotic arm 104 or its distal portion (indicative of the position of the tool guide 140). The structure and operation of the second navigation array 126 can vary depending on the type of navigation system 120 used. In some embodiments, the second navigation array 126 can include one or more spherical or other fiducials 123 for use with optical navigation systems, such as Figure 2A second navigation array 126 with a spherical fiducial 123 is shown. The navigation system 120 facilitates recording and tracking the position and / or orientation of the second navigation array 126, and by extension, the tool guide 140 and 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 can be collected, determined, or otherwise processed by the navigation system 120 using registration / navigation techniques to determine the coordinates of each navigation array and / or fiducial 123 within a coordinate system. These coordinates can be communicated to the controller 106, which uses the coordinates of each navigation array and / or fiducial 123 to calculate the position and orientation of the tool guide 140 in the coordinate system and 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, a second navigation array can be mounted on a base of a surgical robot, and the navigation system can 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, using the configuration of each servo mechanism to determine the position and orientation of the tool guide relative to the base.

[0054] According to aspects of the present invention, application 111 can configure controller 106 or its processor 108 to perform automatic control of the position of robotic arm 104. This control can be implemented at least in part by navigation system 120. In some embodiments, when controller 106 is functionally coupled to robotic arm 104, application 111 can configure controller 106 to perform the functions described in the present disclosure. In some embodiments, application 111 can be retained or stored in memory 112 as a set of computer-accessible instructions (e.g., computer-readable instructions, computer-executable instructions, or computer-readable computer-executable instructions). In some embodiments, the set of computer-accessible instructions can encode the methods of the presently disclosed inventive concepts. In some embodiments, application 111 can encode various forms (e.g., image segmentation) for computer vision tracking using navigation system 120. In some embodiments, application 111 can 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 such a set of computer-accessible instructions.

[0055] The memory 112 can be any available medium accessible to the controller 106, including, for example, but not limited to, volatile and non-volatile media, removable and non-removable media. In some embodiments, the 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, the memory 112 can store data (e.g., a set of tokens for a code buffer) and / or program modules, such as application programs 111 that are immediately accessible to the controller 106 and / or currently operating. In some embodiments, the memory can store an operating system (not shown), such as Windows operating system, Unix, Linux, Symbian, Android, Apple iOS operating system, Chromium, and substantially any operating system for wireless computing devices or wired computing devices. is a trademark of Apple Computer, Inc., registered in the U.S. and other countries. is a registered trademark of Cisco and is used under license by Apple Inc. and is a registered trademark or trademark of Microsoft Corporation in the United States and / or other countries. and OS is a registered trademark of Google Inc. is a registered trademark of Symbian Ltd. is a registered trademark of Linus Torvalds. is a registered trademark of The OpenGroup.

[0056] In some embodiments, the memory 112 may be a mass storage device that provides non-volatile storage of computer code (e.g., computer-executable instructions such as application programs 111), computer-readable instructions, data structures, program modules, and other data for the controller 106. For example, in some embodiments, the memory 112 may be a hard disk, a removable magnetic disk, a removable optical disk, a magnetic tape cassette or other magnetic storage device, a flash memory card, a CD-ROM, a digital versatile disk (DVD) or other optical storage, a random access memory (RAM), a read-only memory (ROM), an electrically erasable programmable read-only memory (EEPROM), etc.

[0057] In some embodiments, any number of program modules may optionally be stored on the memory 112, including, for example, an operating system and tracking software (not shown). In some embodiments, data and code (e.g., computer executable instructions, patient-specific trajectories, and patient anatomical data) may be retained and stored on the 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 Access, SQL Server, mySQL, PostgreSQL, etc. Further examples include membase databases and flat file databases. The database can be centralized or distributed across multiple systems.

[0058] is a registered trademark of IBM in the United States.

[0059] Access and SQL Server is a registered trademark or trademark of Microsoft Corporation in the United States and / or other countries.

[0060] are registered trademarks of Oracle Corporation and / or its affiliates.

[0061] is a registered trademark of MySQL AB in the U.S., the EU and other countries.

[0062] SQL and and logo are trademarks or registered trademarks of PostgreSQL Global Development Group in the United States and other countries.

[0063] In some embodiments, a user (e.g., a surgeon or other user or device) 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 reader 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 touch screen, gloves and other body coverings or wearable devices), a voice recognition device, a natural interface, and the like.

[0064] In some embodiments, external device 114 can be functionally connected to system bus 113 via interface 116. In some embodiments, controller 106 can be configured to have more than one external device 114. For example, in some embodiments, external device 114 can be a monitor, a liquid crystal display, or a projector. In addition, in addition to external device 114, some embodiments may include other output peripheral devices, which may include components that can be connected to controller 106 via interface 116, such as speakers (not shown) and printers (not shown). In some embodiments, a pointing device can be tethered to or wirelessly connected to controller 106 to receive input from a user. In some embodiments, any step and / or result of the method can be output to an output device such as external device 114 in any form. In some embodiments, the output can be any form of visual representation, including but not limited to text, graphics, animation, audio, tactile, etc.

[0065] In some embodiments, one or more cameras may be included or functionally coupled to the navigation system 120, which is functionally coupled to the system bus 113 via the input / output interface 115. This functional coupling may allow the one or more cameras to be coupled 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 include a frame grabber unit that may allow for the reception of imaging 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, where the frame grabber is an analog frame grabber, the processor 108 may provide analog-to-digital conversion functionality and decoder functionality to enable the frame grabber to manipulate the medical imaging data. Additionally, in some embodiments, the input / output interface 115 may include circuitry for collecting 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 may operate the frame grabber to receive imaging data, in accordance with various aspects described herein.

[0066] The system 100 can be provided with a safety signal generator 118, which is functionally coupled to the processor 108 via the input / output interface 115 and the system bus 113. The safety signal generator 118 can be provided with a circuit configured to monitor a predetermined location and detect the presence of a surgeon's body part within the predetermined area. For example, in some embodiments, the safety signal generator 118 can include a switch for connecting and disconnecting a connection in the electrical circuit, and the switch can be positioned within the predetermined area. For example, the switch can be a foot pedal actuated by the surgeon's foot.

[0067] While the system 100 can utilize tool guides of various shapes, sizes, and functions, the illustrated tool guide 140 has a hole 142 for holding, guiding, positioning, supporting, and / or locating at least one tool 150, such as a rotary tool. Advantageously, the tool guide 140 can be configured to guide, position, support, or locate a series of tools 150 for surgical procedures (e.g., spinal surgery) relative to the surgical site ST. The robotic arm 104 can be configured to assist a user (e.g., a surgeon) in guiding, positioning, supporting, or locating the tool 150 along at least one planned trajectory 180 using the tool guide 140. Figure 2 180b. Exemplary tools 150 include, but are not limited to, expanders with expander tips (e.g., pointed or blunt), probes, cutting instruments, taps, screws, and the like. The cutting instrument can be, for example, a drill bit, a saw blade, a burr, a reamer, a milling cutter, a scalpel blade, or any other tool that can cut bone or other tissue and is suitable for a particular surgical procedure. A locking mechanism (not shown) can be used to secure the tool in the tool guide 140. For example, the locking mechanism can be a sliding locking mechanism or other feature.

[0068] As will be explained below, in some embodiments, a signal transmitted 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., distally or toward the patient) along the planned trajectory 180, keeping the longitudinal axis 148 of the tool support 141 coaxially aligned with the at least one planned trajectory 180. A signal transmitted 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., proximally or away from the patient) along the at least one planned trajectory 180, keeping the longitudinal axis 148 of the tool support 141 coaxially aligned with the planned trajectory 180. In some embodiments, the signal includes instructions to the processor 108 to move the tool support in either the first direction or the second direction.

[0069] In some embodiments, tool guide 140 includes a tool support 141 having a bore 142 extending from a first side 144 of tool support 141 to a second side 146 of tool support 141, and having a longitudinal axis 148 extending through the center of bore 142. In some embodiments, tool support 141 can be a tube.

[0070] The handle 160 may be provided with a body 161 supporting a first track button 162, a second track button 164, a first admission button 166, and a second admission button 168. The ridge 169 (see FIG. Figure 2) may be formed in the body 161, separating the first and second track buttons 162 and 164 from the first and second admission buttons 166 and 168. The grip 160 may be provided with a connecting portion 170 (see FIG. Figure 3 ), the connecting portion is configured to connect the handle 160 and the tool guide 140. In the embodiment shown, the connecting portion 170 can be a male connector that is configured to receive a corresponding receiving portion 149 of the tool guide 140 (see Figure 4 The handle 160 may further be provided with a connector 172 (see Figure 4 ), which is configured to electrically connect the handle 160 to the robotic arm 104. The connector 172 of the handle 160 can be a male connector that is configured to receive a corresponding female connector on the distal end 107b of the robotic arm 104. One or more threaded connections or pins can be used to mechanically connect the handle 160 to the robotic arm 104.

[0071] The first track button 162 and the second track button 164 can be positioned adjacent to each other. Figure 3 As shown, the first track button 162 and the second track button 164 can be positioned on opposite sides of the body 161. The handle 160 can also be provided with a first access button 166 and a second access button 168, which are positioned adjacent to or opposite each other on the handle 160. The first track button 162, the second track button 164, the first access button 166 and the second access button 168 can be implemented in a variety of ways. For example, the first track button 162, the second track button 164, the first access button 166 and the second access button 168 can be implemented as mechanical switches, piezoelectric switches, proximity sensors, tactile control devices, graphical control elements on a touch screen, and combinations thereof, which provide a way for the user to trigger functions of the controller 106. The body can be cylindrical in shape.

[0072] The first track button 162, the second track button 164, the first access button 166 and the second access button 168 can be arranged on the handle to provide a visual and / or tactile means of identifying the buttons. For example, the first track button 162 and the second track button 164 can be placed opposite each other on the handle 160, and the first access button 166 and the second access button 168 are positioned opposite each other and offset 90 degrees from the first track button 162 and the second track button 164. This placement allows the user to identify the buttons by touch. In addition, the ridge 169 can be positioned between each group of buttons to further facilitate tactile identification of the buttons. In some embodiments, the first track button 162 and the second track button 164 can be configured to have a first color, and the first access button 166 and the second access button 168 can be configured to have a second color different from the first color to visually distinguish the groups of buttons from each other.

[0073] The controller 106 and the first trajectory button 162 can be configured to move the robotic arm 104 and, by extension, move the tool guide 140 toward the surgical site ST, while maintaining alignment of the longitudinal axis 148 of the tool support 141 of the tool guide 140 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 transmits an electrical signal (e.g., pushes or pulls) to the controller 106, causing the processor 108 of the controller 106 to transmit an electrical signal to the robotic arm 104 to adjust the position of the robotic arm 104, thereby moving the tool support 141 of the tool guide 140 toward the surgical site ST, while maintaining alignment of the longitudinal axis 148 of the tool support 141 of the tool guide 140 with the planned trajectory 180.

[0074] The controller 106 and the second trajectory button 164 can be configured to move the robotic arm 104, and by extension, the tool support 141 of the tool guide 140, away from the surgical site ST, while maintaining alignment of the longitudinal axis 148 of the tool guide 140 with the planned trajectory 180. For example, the second trajectory button 164 can be electrically connected to the controller 106 such that pressing the second trajectory button 164 transmits an electrical signal to the processor 108 of the controller 106, causing the processor 108 of the controller 106 to transmit an electrical signal to the robotic arm 104 to adjust the position of the robotic arm 104 to move the tool support 141 of the tool guide 140 away from the surgical site ST while maintaining alignment of the longitudinal axis 148 of the tool support 141 of the tool guide 140 with the planned trajectory 180.

[0075] The controller 106 and the first and second trajectory buttons 162, 164 can be configured to move the robotic arm 104 and, by extension, the tool support 141 of the tool guide 140 from a current position (e.g., on the planned trajectory 180a) to a next planned trajectory, such as the planned trajectory 180b. For example, the first and second trajectory buttons 162, 164 can be electrically connected to the controller 106 such that substantially simultaneous pressing or other selection of the first and second trajectory buttons 162, 164 transmits an electrical signal to the processor 108 of the controller 106, causing the processor 108 to transmit an electrical signal to the robotic arm 104 to move the robotic arm 104 from a current position (e.g., on the planned trajectory 180a) to a position on the next planned trajectory 180b. For example, during a surgical procedure, once anchor 190 is placed, the user can press the first trajectory button 162 and the second trajectory button 164 substantially simultaneously to move the tool guide 140 from the current position on the planned trajectory 180a to a position on the planned trajectory 180b, where the longitudinal axis 148 of the tool support 141 of the tool guide 140 is coaxially aligned with the planned trajectory 180a to begin placing the second anchor.

[0076] For example, during a surgical procedure, a user may insert a cannula 152 into the tool support 141 of the tool guide 140. Using the stored information about the cannula 152, the processor 108 of the system 100 may move the robotic arm 104 (and therefore the tool support 141 of the tool guide 140 and the cannula 152) so that the cannula 152 is at a predetermined distance from the patient's body B and / or anatomical structure. For example, the surgeon may use the second trajectory button 164 to move the tool 150 away from the patient along the trajectory 180 to improve visibility or access. 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 has been reached.

[0077] In some embodiments, the controller 106 can operate in a mode, referred to herein as an access mode, that allows manual positioning of the tool guide 140 by allowing and / or assisting the robotic arm 104 to move as directed by the user. For example, the first access button 166 and the second access button 168 can be configured to transmit a signal to the processor 108, which processes the signal and transmits the signal to the robotic arm 104 to sense the torque on the robotic arm 104 from the user placing a force on the robotic arm 104. The processor 108 determines the direction in which the user intends to move the robotic arm 104 and then actuates the servos within the robotic arm 104 to allow the user to freely move the robotic arm 104 in all directions, subject to safety limits. In the access mode, the processor 108 of the system 100 can be configured to activate the servos in the robotic arm 104 and sense the torque at the servos at each joint in the robotic arm 104 to determine the desired direction in which the user is attempting to move the robotic arm 104. The processor 108 can then be programmed to activate one or more servos to assist the user in moving the robotic arm 104 in the desired direction. The admission mode may be entered when both the first admission button 166 and the second admission button 168 are pressed in a predetermined sequence, eg, substantially simultaneously (eg, simultaneously, within 1 second, etc.), and then held simultaneously throughout the movement.

[0078] As described herein, some embodiments include a controller 106 that can control the operation of the robotic arm 104. The processor 108 of the controller 106 can be configured to execute an application 111 to control the robotic arm 104. In some embodiments, in response to execution by the processor 108, the application 111 can utilize trajectories (e.g., tip and tail coordinates) that can be planned and / or configured remotely or locally before and / or during the surgical procedure. Trajectories that have been planned before or during the 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 implement one or more methods described herein in the controller 106 to cause the robotic arm 104 to move according to one or more trajectories. It should be noted that for spinal surgery, there are multiple planned trajectories. Typically, there are six trajectories (three pairs of two trajectories, i.e., one trajectory for each vertebral body involved in the surgery). In some embodiments, four trajectories can be used to fuse two vertebral bodies together.

[0079] In some embodiments, the processor 108 of the controller 106 can use visual or audible alerts to communicate the status of the robotic arm 104 and / or other device being locked in place. For example, an LED or other visual device can be included on the handle 160 or the tool guide 140, and the controller 106 can be programmed to illuminate the LED to indicate the status of the robotic arm 104 and / or other device being locked in place.

[0080] 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.

[0081] In some embodiments, the processor 108 of the controller 106 can be programmed to enable a user (e.g., a surgeon or other user or device) to position a conventional surgical screw. In some embodiments, the processor 108 of the controller 106 can be programmed to enable a user to select the length and diameter of the surgical screw. In yet another aspect, the processor 108 of the controller 106 can be programmed to ensure that the relative position, size, and proportions of the screws are maintained on the external device 114 when in the graphical representation.

[0082] The tool guide 140 can be removably coupled to the handle 160, which is coupled to the robotic arm 104. It will be appreciated that there should be no gap between the tool guide 140 and the robotic arm 104. To facilitate coupling the tool guide 140 to the handle 160, the tool guide 140 can be configured to have a receiving portion 149 sized and shaped to receive a connecting portion 170 of the handle 160. The receiving portion 149 and connecting portion 170 are shown for illustrative purposes only and should not be considered limiting. The tool guide 140 and the handle 160 can be configured to have any receiving portion 149 and connecting portion 170 configured to securely couple the tool guide 140 and the handle 160. For example, the receiving portion 149 and connecting portion 170 can include at least one threaded connector, such as a screw, configured to securely couple the tool guide 140 and the handle 160.

[0083] Figure 5 shows a method that can be used with a computer-assisted surgery system (e.g., Figure 11. A workflow 200 of a surgical procedure (e.g., in accordance with a treatment plan) for use with a computer-assisted surgery system 100 (e.g., a computer-assisted surgery system 100) is shown. The system has a robotic arm 104, a controller 106, and a navigation system 120. For example, a surgical procedure may involve a patient's spine, such as placing screws in one or more pedicles of the patient's vertebrae. As a non-limiting example, the surgical procedure may employ drilling, tapping, and screwing techniques, such as may be required as part of a transforaminal lumbar interbody fusion (TLIF) procedure. The surgical procedure may require a range of tools. One example of a surgical procedure is posterior pedicle screw placement for posterior stabilization, which is often performed in conjunction with an interbody procedure (e.g., placement of a cage).

[0084] At step 201, the processor 108 of the controller 106 can be programmed to enable the user to locate the intended location of the surgical implant or tool. For example, at least one trajectory can be planned to approach the patient's anatomical structure. For example, each trajectory can be planned using imaging of the patient's anatomical structure that has been used to generate the anatomical computer model (e.g., a magnetic resonance imaging scan 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 when forming a guide hole that is subsequently used to facilitate the assembly of the anchor 190), etc. In some embodiments, the user can program the desired insertion point and trajectory for the surgical instrument to reach the desired anatomical target in or on the patient's body B. In some embodiments, the desired insertion point and trajectory can be planned on the anatomical computer model, which in some embodiments can be displayed on the external device 114. In some embodiments, the user can plan the trajectory and the 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 can 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 as a “planned trajectory”, such as planned trajectory 180 .

[0085] In some embodiments, the processor 108 of the controller 106 can be programmed to generate a display that follows the standardized workflow planned during step 201. For example, the surgeon can select the order in which the pedicle screws are to be inserted. Thus, after placing the first pedicle screw, for example, when the user presses the first trajectory button 162 and the second trajectory button 164 substantially simultaneously, the processor 108 causes the robotic arm 104 to move from the 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 the access mode by pressing the first access button 166 and the second access button 168 to move the robotic arm 104.

[0086] At step 202, a tool guide 140 (e.g., having a tool support 141, such as a connector or coupler, adapted to receive a plurality of tools 150 (e.g., sequentially different tools)) is supported (e.g., attached or mounted) to a handle 160, which is supported (e.g., mounted or attached) to the distal end 107b or other location on the robotic arm 104 of the computer-assisted surgery system 100. The tool guide 140 can be coupled to the handle 160, for example, via an end plate that is locked by a lever or other coupling means known in the art, such as screws, bolts, threaded connections, etc. In other embodiments, the tool guide 140 and the handle 160 can be integrally formed as a single structure. Prior to attaching the tool guide 140, a sterile drape (not shown) can be placed between the tool guide 140 and the handle 160 and extend to cover at least a portion of the handle 160 and / or the robotic arm 104.

[0087] In step 203, alignment of the tool guide 104 with the planned trajectory 180 is performed. In one example, after the tool guide 140 is connected to an active robotic arm, such as the robotic arm 104, a navigation 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 in the tool guide 140, with the tool 150 in the tool guide 140 being a reference tool, or with the initial tool 150 for the surgical procedure in the tool guide 140. In some embodiments, the robotic arm 104 is aligned with the planned trajectory only once (e.g., for each pedicle screw insertion procedure). Installation may only need to be performed once for the handle 160 and tool guide 140, but the installation and alignment steps may be repeated for each tool change and / or distal tip change for each tool 150 in the surgical procedure (e.g., for each tool 150 in the surgical procedure). A common cause of realignment is the detection of a deviation from the planned trajectory 180 due to forces exerted on the surgical system 100.

[0088] At step 204, a first tool 150 (e.g., such as a scalpel) holding a cutting instrument (e.g., a scalpel blade) is placed in the tool guide 140. The scalpel guide can be placed in the tool support 141 of the tool guide 140 to guide the scalpel holder (e.g., with the blade) and thereby allow the patient to be opened in a pre-planned trajectory given by the aligned (pre-planned) tool guide 140. Optionally, step 203 can be performed relative to the alignment of the first tool 150 (e.g., at a desired trajectory, position, and / or orientation). The robotic arm 104 can be navigated to a starting position (for systems with an active robotic arm) or can be guided to the starting position by a user (e.g., a surgeon) (for systems 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., a three-dimensional position). The cutting trajectory can be displayed on the external device 114 along with imaging of the patient's anatomy, etc. An incision is made in the patient to access the surgical site ST. The incision can be made manually by the surgeon. The incision can be made semi-autonomously, that is, controlled by at least partial robotic control (e.g., force assistance from the robot, the robot limiting movement beyond certain boundaries or within certain planes while otherwise providing manual control, determination to stay in a straight line, depth control, etc.). The incision can be made fully autonomously (e.g., fully controlled by the controller 106). Once the incision at the surgical site ST is completed, the patient's anatomical structures, such as the bone surface, can be approached. The navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the tool support 141 of the robotic arm 104 and / or the tool guide 140. For example, the position can include an incision boundary or an incision depth determination. The first tool 150 can be removed from the tool support 141 of the tool guide 140.

[0089] At step 206, a second tool 150 (e.g., a dilator) holding a cutting instrument (e.g., such as a sharp dilator tip (or, alternatively, a blunt dilator tip)) is placed in the tool support 141 of the tool guide 140 and secured in place. This allows initial access to the anatomy at the surgical site ST. Optionally, step 203 can be performed relative to the alignment of the second tool 150 (e.g., at a desired trajectory, position, and / or orientation). For example, the robotic arm 104 (and therefore the tool support 141 of the tool guide 140) can be returned to a storage position. An imaging of the patient's anatomy can be displayed on the external device 114. The second tool 150 is inserted into the patient to access the surgical site ST. As previously described, control of the second tool 150 can be performed manually, semi-automatically, or fully automatically. In some embodiments, the initial entry 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 determination indicating the location of the bone surface. The second tool 150 can be removed from the tool support 141 of the tool guide 140.

[0090] At step 208, a third tool 150 (e.g., such as a driving burr) holding a cutting instrument (e.g., such as a burr) is placed in the tool support 141 of the tool guide 140 and secured in place. The burr can be one of a variety of shapes, such as flat, round, or geometric, with geometric or non-geometric cutting structures. Furthermore, the burr can have a variety of configurations, such as slotted or non-slotted. Slotted burrs can have varying numbers of cutting slots. Optionally, step 203 can be performed relative to the alignment of the third tool 150 (e.g., at a desired trajectory, position, and / or orientation). For example, the robotic arm 104 (and therefore the tool support 141 of the tool guide 140) can 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 can be displayed on the external device 114. The burr is inserted into the patient to access the surgical site ST and generate a plane or other feature on the bone surface. The robotic arm 104 can be moved along the planned trajectory. The control of the rotating tool driving the burr can be performed manually, semi-automatically, or fully automatically. Once the decentralization procedure is completed, the navigation system 120 and / or the processor 108 of the controller 106 can store the position (e.g., three-dimensional position) of the tool support 141 of the robot arm 104 and / or the tool guide 140 in the memory 112. For example, the position may include a depth determination that indicates the position and / or contour of the decentralized bone surface. The third 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 to be assembled.

[0091] In step 210, a fourth tool 150 (e.g., such as a driving drill) holding a cutting instrument (e.g., such as a drill bit) is placed in the tool support 141 of the tool guide 140 and held in place. The drill bit can be one of a variety of diameters, lengths, and / or configurations, such as slotted or non-slotted. Optionally, step 203 can be performed relative to the alignment of the fourth tool 150 (e.g., at a desired trajectory, position, and / or orientation). For example, the robotic arm 104 (and therefore the tool guide 140) can be moved so that the fourth tool 150 reaches a storage position (e.g., a position on the bone surface). An imaging of the patient's anatomy can be displayed on the external device 114. The drill bit is inserted into the patient's body to enter the surgical site ST and a borehole is generated in the bone. The robotic arm 104 can move to achieve the planned trajectory 180. As previously described, the rotary tool driving the drill bit can be controlled manually, semi-automatically, or fully automatically. 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 determination indicating the drilling location. The fourth 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 to be assembled.

[0092] At step 212, a fifth tool 150 (e.g., such as a driving tap) holding a cutting instrument (e.g., such as a tap) is placed in 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., inserted into the borehole at step 214). Optionally, step 203 can be performed with respect to the fifth tool in alignment (e.g., at a desired trajectory, position, and / or orientation). For example, the robotic arm 104 (and therefore the 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 can be displayed on the external device 114. The tap is inserted into the patient's body to access the surgical site ST and create a thread in the drilled hole in the bone. The robotic arm 104 can be moved to and / or along a pre-planned trajectory. As previously described, the rotary tool driving the tap can be controlled manually, semi-automatically, or fully automatically. Once the tapping 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 determination indicating the location of the threaded 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 to be assembled.

[0093] In step 214, a sixth tool 150 (e.g., such as a screw) holding a cutting instrument (e.g., such as a screw) is placed in the tool support 141 of the tool guide 140 and fixed in place. The screw can be a pedicle screw of a predetermined screw size (e.g., inserted into a threaded borehole). Optionally, step 203 can be performed relative to the alignment of the sixth tool (e.g., at a desired trajectory, position, and / or orientation). For example, the robotic arm 104 (and therefore the tool support 141 of the tool guide 140) can be moved so that the sixth tool 150 reaches a storage position (e.g., a position on the bone surface). Imaging of the patient's anatomical structure can be displayed on the external device 114. The screw is inserted into the patient's body to enter the surgical site ST and is assembled in the drill hole of the bone. The robotic arm 104 can be moved to and / or along a pre-planned trajectory. As previously described, the control of the sixth tool 150 for driving the screw can be performed manually, semi-automatically, or fully automatically. Once the screw assembly 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 placement determination indicating the location of the pedicle screw. The sixth tool 150 can be removed from the tool support 141 of the tool guide 140.

[0094] When the surgical procedure includes multiple planned trajectories, such as a surgical procedure requiring the placement of multiple pedicle screws, the pedicle screw placed in step 214 may be a first pedicle screw placed along a first planned trajectory. After the first pedicle screw is placed, in step 215, the user may move the robotic arm 104 from its current position, which may be on the first planned trajectory, to a second planned trajectory for placement of a second pedicle screw by substantially simultaneously pressing the first trajectory button 162 and the second trajectory button 164. For example, the workflow 200 may be repeated starting from step 204 for the second pedicle screw.

[0095] When the tool holder 141 is aligned with the planned trajectory 180, in optional step 216, the user can move the robotic arm 104 and the tool guide 140 holding the tool 150 toward the patient by pushing or otherwise selecting the first trajectory button 162 on the grip 160. 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, by extension, the associated tool, is aligned with the pre-planned trajectory. Once the tool holder 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 access to the surgical site. In some embodiments, the first trajectory button 162 must be pressed or otherwise selected during the entire movement of the robotic arm 104.

[0096] In some embodiments, the system 100 may be programmed to require that the first trajectory button 162 and the safety signal generator 118 be pushed or otherwise selected in a predetermined order, e.g., simultaneously (concurrently), 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 may be programmed to require that the safety signal generator 118 be pressed or otherwise selected before the first trajectory button 162, and then the safety signal generator 118 and the first trajectory button 162 may be pressed or otherwise selected simultaneously before the robotic arm 104 and the tool guide 140 holding the tool 150 are moved toward the patient.

[0097] When the tool holder 141 is aligned with the planned trajectory 180, in optional step 218, the user can move the robotic arm 104 and the tool support 141 of the tool guide 140 holding the tool 150 away from the patient by pressing or otherwise selecting the second trajectory button 164 on the grip 160. 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 thus the associated 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 access to the surgical site ST. In some embodiments, the second trajectory button 164 must be pressed or otherwise selected during the entire movement of the robotic arm 104.

[0098] In some embodiments, the system 100 may be programmed to require that the second trajectory button 164 and the safety signal generator 118 be pressed or otherwise selected simultaneously before the robotic arm 104 and the tool guide 140 holding the tool 150 are moved away from the patient.

[0099] In optional step 220, the user can 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, away from the planned trajectory 180) by pressing or otherwise selecting the first and second access buttons 166, 168 substantially simultaneously and holding the first and second access buttons 166, 168 during movement of the robotic arm 104, subject to the safety constraints described above. Optional step 220 can be performed at any time during the surgical procedure, for example, to improve visibility and / or access to the surgical site ST. Upon releasing the first and / or second access buttons 166, 168, the processor 108 can be configured to move the robotic arm 104 to position the longitudinal axis 148 of the tool guide 140 and associate the tool 150 with the planned trajectory 180.

[0100] In optional step 222, the user may 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 substantially simultaneously pressing or otherwise selecting the first trajectory button 162 and the second trajectory button 164. Optional step 222 may be performed at any time during the surgical procedure when the tool support 141 is not aligned with the planned trajectory. For example, this may occur in step 220 when the surgeon may enter an access mode to move the robotic arm 104 around an obstacle by pressing the first access button 166 and the second access button 168, after which the user may substantially simultaneously press the first trajectory button 162 and the second trajectory button 164 to return the tool support 141 of the tool guide 140 to the planned trajectory 180 without obstructing the surgeon's view of the other portions of the robotic arm 104.

[0101] It will be appreciated that the presently described embodiments may also be applicable to other surgical procedures, such as cervical surgery.

[0102] As will be apparent from the foregoing description, the inventive concepts disclosed herein are well adapted to achieve the objectives and obtain the advantages mentioned herein, as well as those inherent in the inventive concepts disclosed herein. Although embodiments of the inventive concepts disclosed herein have been described for the purposes of this disclosure, it will be appreciated that numerous modifications may be readily conceived and made by those skilled in the art, all of which are within the scope and spirit of the inventive concepts disclosed herein.

Claims

1. A robotic surgery system comprising a robotic arm (104), the robotic surgery system comprising: a handle (160) supported by the robotic arm (104), the handle having a first track button (162) and a second track button (164); a tool guide (140) supported by a handle (160), the tool guide comprising a tool support (141) having a first end, a second end, a bore extending through the tool support (141) from the first end to the second end, and a longitudinal axis (148) extending from the first end through a center of the bore to the second end; a navigation system (120) configured to track the position and orientation of a tool guide (140) relative to the patient; and a controller (106) in communication with the navigation system (120), the grip (160), and the servo system of the robotic arm (104), 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 from the navigation system a position and orientation of the tool guide relative to the patient and transmit a first signal to at least one servo mechanism of the robotic arm, thereby causing the robotic arm (104) to position the tool support (141) at a predetermined distance from the patient, wherein a longitudinal axis (148) of the tool support is substantially coaxially aligned with the at least one planned trajectory; wherein the first trajectory button (162) is configured to transmit a second signal to the processor of the controller when engaged, causing the processor of the controller to actuate at least one servo mechanism of the robotic arm to move the tool support away from the patient along the at least one planned trajectory, thereby maintaining the longitudinal axis (148) of the tool support substantially coaxially aligned with the at least one planned trajectory, and the second trajectory button (164) is configured to transmit a third signal to the processor of the controller when engaged, causing the processor of the controller to actuate at least one servo mechanism of the robotic arm to move the tool support toward the patient along the at least one planned trajectory, thereby maintaining the longitudinal axis (148) of the tool support substantially coaxially aligned with the at least one planned trajectory.

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

3. The robotic surgery system according to claim 2, wherein: The non-transitory computer-readable memory of the controller (106) further stores safety limits associated with the surgical procedure, the safety limits being configured to limit movement of a tool (150) secured in the tool support (141) such that a predetermined distance limit between the tool and the patient's anatomy is maintained during the surgical procedure.

4. The robotic surgery system according to any one of claims 1 to 3, wherein: The handle (160) further includes a first access button (166) and a second access button (168), which are configured to transmit a fourth signal to the controller (106) when engaged substantially simultaneously, causing the controller to allow a user to manually move the robotic arm (104) in various directions.

5. The robotic surgery system according to any one of claims 1 to 4, wherein: The navigation system (120) has a tracking unit (122) and a navigation array (126) attached to the robotic arm (104), wherein the navigation system is configured to track the position and orientation of the tool guide (140) using the navigation array and transmit the position and orientation of the tool guide to the controller.

6. The robotic surgical system according to any one of claims 1 to 5, further comprising a sterile drape disposed between the tool guide (140) and the handle (160) and extending to cover the handle during a surgical procedure.

7. The robotic surgery system according to any one of claims 1 to 6, wherein: When engaged in a predetermined sequence, the first trajectory button (162) and the second trajectory button (164) are configured to transmit a fourth signal to a processor of the controller (106), causing the processor of the controller to actuate at least one servo mechanism of the robotic arm to move the tool guide (140) from a current position to a new position, wherein the longitudinal axis of the tool guide is coaxially aligned with a second planned trajectory.

8. The robotic surgery system according to any one of claims 1 to 7, wherein: The first track button (162) and the second track button (164) are positioned opposite each other on the grip (160).

9. The robotic surgery system according to claim 8 in combination with claim 4, wherein: The first access button (166) and the second access button (168) are positioned opposite each other on the grip (160), wherein the first access button is offset from the first track button.

10. The robotic surgery system according to claim 4, wherein: The grip (160) further includes a body (161) supporting the first track button (162), the second track button (164), the first access button (166) and the second access button (168), and wherein the body of the grip includes a ridge (169) positioned to separate the first track button and the second track button from the first access button and the second access button.

11. The robotic surgery system according to claim 4, wherein: The first track button (162) and the second track button (164) have a first color, and the first admission button (166) and the second admission button (168) have a second color different from the first color.

12. The robotic surgery system according to any one of claims 1 to 11, further comprising a safety signal generator having a circuit configured to monitor a predetermined position and detect the presence of a surgeon's body part within the predetermined area, and wherein The processor is programmed to require the second trajectory button (164) to be pushed or otherwise selected in a predetermined sequence to cause the controller (106) processor to actuate at least one servo mechanism of the robotic arm to move the tool support toward the patient along the at least one planned trajectory.

13. The robotic surgery system according to any one of claims 1 to 11, further comprising a safety signal generator having a circuit configured to monitor a predetermined position and detect the presence of a surgeon's body part within the predetermined area, and wherein The processor is programmed to require the first trajectory button (162) to be pushed or otherwise selected in a predetermined sequence to cause the controller (106) processor to actuate at least one servo mechanism of the robotic arm to move the tool support away from the patient along the at least one planned trajectory.

14. A method of assembling a surgical robot system according to any one of claims 1 to 13, comprising: A handle (160) is attached to at least one arm segment of a robotic arm (104), the handle having a body (161) supporting a first track button (162) and a second track button (164).

15. The method according to claim 14, wherein One of the arm segments (105c) of the robotic arm (104) forms a distal end (107b) of the robotic arm, and wherein the attaching step is further defined as attaching the handle (160) to the distal end (107b) of the robotic arm (104).

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