Robotic spinal surgery system and method with haptic interface

Abstract

Disclosed herein include technology including a robotic manipulator, including a surgical tool that interfaces with a screw and rotates the screw about an axis of rotation. A haptic device includes an actuator and a rotary interface coupled to the actuator, and the rotary interface is manually manipulatable by an operator's hand. One or more controllers control movement of the robotic manipulator to hold the axis of rotation of the surgical tool along a planned trajectory; autonomously control the surgical tool to rotate the screw about the axis of rotation at a rotational rate and to linearly advance the screw at an advancement rate in accordance with known thread geometry of the screw; obtain measurements indicative of a current interaction between the screw and the target site; and control the actuator of the haptic device to enable the rotary interface to mimic the current interaction between the screw and the target site.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and all benefits to U.S. Provisional Patent Application No. 63 / 001,019, filed on March 27, 2020, the entire disclosure of which is hereby incorporated by reference. Background Technology

[0003] Robotic surgical systems used to perform surgery in a patient's spine are well known. For example, robotic surgical systems are currently used to place pedicle screws in a patient's spine.

[0004] When a patient requires surgery involving the placement of pedicle screws, preoperative and / or intraoperative imaging is typically used to visualize the patient's anatomy – in this case, the spine. The surgeon then plans where to place the pedicle screws relative to the images and / or a 3D model created from the images. Planning involves, for example, determining the position and orientation (i.e., orientation) of each pedicle screw relative to the specific vertebra in which it will be placed by identifying the desired pose in the images and / or 3D model. Once the plan is established, it is transmitted to a robotic surgical system for execution.

[0005] Typically, robotic surgical systems include a robotic manipulator positioned above the patient and locating a tool guide along a desired trajectory aligned with the desired orientation of the pedicle screw to be placed. The robotic surgical system also includes a navigation system to determine the position of the tool guide relative to the patient's anatomy, allowing the robotic manipulator to place the tool guide along the desired trajectory according to the surgeon's plan. In some cases, the navigation system includes a tracking device attached to the manipulator and the patient, enabling the robotic surgical system to monitor and respond to patient movement during surgery by moving the tool guide as needed to maintain the desired trajectory.

[0006] Once the tool guide is aligned with the desired trajectory, the robotic manipulator is controlled to maintain alignment. The surgeon then positions the cannula via the tool guide and positions it adjacent to the vertebra. The surgeon inserts a conventional drilling tool into the cannula to drill a guide hole for the pedicle screw. The surgeon then removes the drilling tool and inserts the pedicle screw into the appropriate position within the guide hole using a pedicle screw driver. In this method, the robotic manipulator is somewhat underutilized because it plays a minimal or no role in drilling the guide hole or inserting the pedicle screw.

[0007] On the other hand, US 16 / 184,376, filed November 8, 2018, entitled "Robotic Spine Surgery System and Methods," discloses a technique by which a robotic system can be used to autonomously control a surgical tool to rotate a screw around a rotational axis at a certain rotational rate and linearly advance the screw along a planned trajectory at a certain advance rate. Although a robotic manipulator is used in this method, the surgeon no longer directly contacts or controls the flow of forces, energy, materials, and information involved in the interaction with tissue. This, in turn, can lead to the loss of tactile and sensory information that surgeons are accustomed to using to monitor and assess tissue interactions during surgery. Due to the lack of sensory input, the surgeon is unable to assess the process, which can lead to loss of confidence, emotional stress, reduced surgical efficiency, and an inability to react to unexpected situations that the robotic solution does not capture but that the surgeon could otherwise perceive. Summary of the Invention

[0008] A first aspect of this disclosure relates to a robotic surgical system comprising: a robotic manipulator; a surgical tool coupled to the robotic manipulator and configured to engage with a screw and rotate the screw about a rotation axis; a tactile device including an actuator and a rotary interface coupled to the actuator, the rotary interface being configured to be manually manipulated by an operator's hand; a navigation system configured to track the position of a target site; and one or more controllers coupled to the robotic manipulator, the tactile device, and the navigation system, the one or more controllers being configured to: control the robotic manipulator. The manipulator moves to maintain the axis of rotation of the surgical tool relative to the target site along a planned trajectory based on the position of the tracked target site; autonomously controls the surgical tool to rotate the screw around the axis of rotation at a certain rotational rate and linearly advance the screw along the planned trajectory at a certain advance rate, wherein the rotational rate and the advance rate are predetermined and proportional to the known thread geometry of the screw; obtains measurements indicating the current interaction between the screw and the target site; and based on the obtained measurements, controls the tactile device to enable the rotary interface to mimic the current interaction between the screw and the target site.

[0009] In some implementations, the rotary interface includes, but is not limited to, any one or more of the following: a knob, a wheel, a rotary switch, or a dial.

[0010] In some embodiments, the tactile device includes a linear interface instead of a rotary interface, such as, but not limited to, a linear button, a linear switch, a linear trigger, or a linear slider.

[0011] In some implementations, the one or more controllers mimic the current interaction between the screw and the target area by being configured to control the actuator of the tactile device.

[0012] In some implementations, the one or more controllers further mimic the current interaction between the screw and the target portion by being configured to provide resistance to the actuator to adjust the force required for the operator's hand to rotate the rotary interface, wherein the force required to rotate the rotary interface reflects the current force required to rotate the screw relative to the target portion.

[0013] In some embodiments, the one or more controllers are configured to resist mechanical movement of the interface using means different from or other than the actuator. For example, to influence the movement of the interface, the tactile device may utilize mechanical components, including but not limited to biasing mechanisms, stoppers, ratchet and / or gear systems; electrical components, such as, but not limited to, inductive, capacitive and / or resistive elements; magnetic components; electromagnetic components; electromechanical components; hydraulic components; and / or pneumatic components.

[0014] In some implementations, the one or more controllers further mimic the current interaction between the screw and the target portion by being configured to limit the range of motion of the interface.

[0015] In some embodiments, the one or more controllers are further configured to initiate an autonomous inspection mode, wherein the rotary interface, in the absence of the ability to control the surgical tool to rotate the screw, can be manually manipulated according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target site.

[0016] In some implementations, in response to a certain condition or command, the one or more controllers are further configured to initiate the autonomous inspection mode while autonomously controlling the surgical instruments.

[0017] In some implementations, in response to a certain condition or command, the one or more controllers are further configured to initiate the autonomous inspection mode after stopping or pausing the autonomous control of the surgical tool to stop the rotation of the screw.

[0018] In some implementations, in response to a certain condition or command, the one or more controllers are further configured to resume autonomous control of the surgical tool to rotate the screw after stopping or suspending autonomous control of the surgical tool to stop the rotation of the screw.

[0019] In some embodiments, the one or more controllers are further configured to activate a manual control mode, wherein the rotary interface is manually operable, having the capability to control either the rotation rate or the advance rate of the screw based on manual manipulation of the rotary interface by the operator; the one or more controllers are configured to control the surgical instrument to rotate the screw around the rotation axis at the rotation rate and advance the screw linearly along the planned trajectory at the advance rate in response to manual manipulation of the rotary interface to control either the rotation rate or the advance rate of the screw; and the rotary interface can be manually operated according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target site.

[0020] In some implementations, in response to a certain condition or command, the one or more controllers are further configured to initiate the manual control mode after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

[0021] In some implementations, in response to a certain condition or command, the one or more controllers are further configured to switch from the manual control mode to resume autonomous control of the surgical tool to rotate the screw.

[0022] In some implementations, the tactile device is configured to trigger the condition or the command.

[0023] In some embodiments, the robotic surgical system further includes sensors configured to obtain measurements indicating the current interaction between the screw and the target site, with one or more controllers coupled to the sensors.

[0024] In some embodiments, the one or more controllers are configured to: determine that a certain condition exists during the control of the screw; and, in response to determining that the condition exists, provide tactile feedback to the operator regarding the condition by controlling the actuator of the tactile device to prevent rotation of the rotary interface.

[0025] In some embodiments, the navigation system is further configured to: determine a position of the screw relative to an anatomical model of the target site that is registered to the target site, the navigation system including predetermined data indicative of an expected interaction between the screw and the anatomical model at a plurality of positions of the screw relative to the anatomical model; and obtain the measurement indicative of the current interaction between the screw and the target site based on the determined position of the screw relative to the anatomical model and the predetermined data.

[0026] In some embodiments, the rotation rate and the advancement rate are in accordance with a relationship proportional to the known thread geometry, wherein is the rotation rate, is the advancement rate, and pitch is the number of threads per unit length of the screw.

[0027] In some embodiments, the haptic device is further defined as a handheld pendant.

[0028] In some embodiments, the haptic device is a rotary interface, such as but not limited to a knob, a rotary switch, or a dial.

[0029] In some embodiments, any implant can be used in place of a screw, such as a spinal implant, such as a rod, an anchor, a spacer, a cage, or a plate.

[0030] In some embodiments, the screw is more specifically a self-tapping screw.

[0031] In some embodiments, the haptic device is remotely spaced apart from the robotic manipulator and the surgical tool.

[0032] In some embodiments, the haptic device is directly attached to the robotic manipulator or the surgical tool.

[0033] In some embodiments, the one or more controllers are further configured to receive input from the operator to selectively adjust one or more of: the resistance provided to the actuator; and a sensitivity of the ability of the rotary interface to control the surgical tool to rotate the screw.

[0034] In some embodiments, the robotic surgical system further comprises a display, and wherein the one or more controllers are further configured to initiate a simulated autonomous check mode, wherein the one or more controllers are configured to: simulate autonomous control of the surgical tool by rotating the screw about the rotation axis at the rotation rate and linearly advancing the screw along the planned trajectory at the advancement rate; display the simulated autonomous control of the surgical tool on the display; obtain a simulated current interaction between the screw and the target site; and based on the simulated current interaction, control the actuator of the haptic device to enable the rotation interface to mimic the simulated current interaction between the screw and the target site by being configured to provide resistance to the actuator to adjust a force required to rotate the rotation interface by the operator’s hand, wherein the force required to rotate the rotation interface reflects an simulated current force required to rotate the screw relative to the target site; wherein the rotation interface can be manually manipulated in accordance with the adjusted force without the ability to control the surgical tool to rotate the screw and without the ability to control the simulated autonomous control of the surgical tool to provide the operator with haptic feedback that reflects the simulated current force.

[0035] In some embodiments, the one or more controllers are further configured to initiate the simulated autonomous check mode prior to autonomously controlling the surgical tool.

[0036] In some embodiments, the robotic surgical system further comprises a display, and wherein the one or more controllers are further configured to initiate a simulated manual control mode in which the rotary interface is manually manipulatable without having the ability to control the rotation of the surgical tool screw and with the ability to control one of the rotation rate of the screw or the advancement rate of the screw during the simulated manual control of the surgical tool based on the operator manually manipulating the rotary interface, and wherein the one or more controllers are configured to: simulate manual control of the surgical tool by rotating the screw about the rotation axis at the rotation rate and linearly advancing the screw along the planned trajectory at the advancement rate in response to the rotary interface being manually manipulated to control one of the rotation rate of the screw or the advancement rate of the screw; display the simulated manual control of the surgical tool on the display; obtain a simulated current interaction between the screw and the target site; and based on the simulated current interaction, control the actuator of the haptic device to enable the rotary interface to mimic the simulated current interaction between the screw and the target site by being configured to provide resistance to the actuator to adjust a force required by the operator to rotate the rotary interface, wherein the force required to rotate the rotary interface reflects a simulated current force required to rotate the screw relative to the target site, and wherein the rotary interface is manually manipulatable in accordance with the adjusted force to provide haptic feedback to the operator that reflects the simulated current force.

[0037] In some embodiments, in response to a certain condition or command, the one or more controllers are further configured to initiate the simulated manual control mode after stopping or pausing autonomously controlling the surgical tool to stop rotation of the screw.

[0038] A second aspect of the present disclosure relates to a method of operating the robotic surgical system according to the first aspect of the present disclosure and optionally according to any one of the embodiments within the present section. The first and second aspects of the present disclosure are optionally implemented according to any one of the embodiments within the present section.

[0039] A third aspect of the present disclosure relates to a robotic surgical system comprising: a robotic manipulator; a surgical tool coupled to the robotic manipulator and configured to interface with a screw and rotate the screw about an axis of rotation; a haptic device comprising an actuator and a rotary interface coupled to the actuator, and the rotary interface is configured to be manually manipulatable by an operator’s hand; a navigation system configured to track a position of a target site; and one or more controllers coupled to the robotic manipulator, the haptic device, and the navigation system, and the one or more controllers are configured to: control movement of the robotic manipulator to maintain the axis of rotation of the surgical tool along a planned trajectory relative to the target site based on the tracked position of the target site; receive control input from the haptic device, wherein the rotary interface is manually manipulatable with the ability to control one of a rotation rate of the screw or an advancement rate of the screw based on the operator manually manipulating the rotary interface; in response to control input from the haptic device, control the surgical tool to rotate the screw about the axis of rotation at a rotation rate and to linearly advance the screw along the planned trajectory at an advancement rate, wherein the rotation rate and the advancement rate are predetermined and proportional to a known thread geometry of the screw; obtain a measurement indicative of a current interaction between the screw and the target site; and based on the obtained measurement, control the actuator of the haptic device to enable the rotary interface to mimic the current interaction between the screw and the target site.

[0040] A fourth aspect of the present disclosure relates to a method of operating the robotic surgical system according to the third aspect of the present disclosure and optionally according to any of the embodiments within this part. The third and fourth aspects of the present disclosure are optionally implemented according to any of the embodiments within this part.

[0041] A fifth aspect of the present disclosure relates to a robotic surgical system comprising: a robotic manipulator; a surgical tool coupled to the robotic manipulator and configured to rotate about an axis of rotation; a haptic device comprising an actuator and an interface coupled to the actuator, and the interface being configured to be manually manipulatable by an operator's hand; a navigation system configured to track a position of a target site; and one or more controllers coupled to the robotic manipulator, the haptic device, and the navigation system, and the one or more controllers being configured to: control movement of the robotic manipulator to maintain the axis of rotation of the surgical tool along a planned trajectory relative to the target site based on the tracked position of the target site; autonomously control the surgical tool to rotate the surgical tool about the axis of rotation at a rotation rate and to linearly advance the surgical tool along the planned trajectory at an advancement rate; obtain a measurement indicative of a current interaction between the surgical tool and the target site; and based on the obtained measurement, control the actuator of the haptic device to enable the rotational interface to mimic the current interaction between the surgical tool and the target site.

[0042] A sixth aspect of the present disclosure relates to a method of operating the robotic surgical system according to the fifth aspect of the present disclosure and optionally according to any one of the embodiments within this part. The fifth and sixth aspects of the present disclosure are optionally implemented according to any one of the embodiments within this part.

[0043] A seventh aspect of the present disclosure is directed to a simulation system comprising: a haptic device comprising an actuator and a rotary interface coupled to the actuator, and the rotary interface is configured to be manually manipulatable by an operator's hand; a display device; and one or more controllers coupled to the haptic device and the display device, and the one or more controllers are configured to provide a simulation on the display device, the simulation is configured to: provide a simulated surgical tool configured to interface with a simulated screw and rotate the simulated screw about a rotational axis along a simulated trajectory relative to a simulated target site; provide simulated control of the simulated surgical tool to rotate the simulated screw about the rotational axis at a rotational rate and to linearly advance the simulated screw along the simulated trajectory at an advancement rate, wherein the rotational rate and the advancement rate are predetermined and proportional to a known thread geometry of the simulated screw; obtain a simulated current interaction between the simulated screw and the simulated target site; and based on the simulated current interaction, control the haptic device to enable the rotary interface to mimic the simulated current interaction between the simulated screw and the simulated target site.

[0044] An eighth aspect of the present disclosure is directed to a method of operating the simulation system according to the seventh aspect of the present disclosure and optionally according to any of the embodiments within this section. The seventh and eighth aspects of the present disclosure are optionally implemented according to any of the embodiments within this section. BRIEF DESCRIPTION OF DRAWINGS

[0045] Figure 1 is a perspective view of a robotic surgical system according to one example.

[0046] Figure 2 is a perspective view of one example of a surgical robotic arm for use with Figure 1 the robotic surgical system of

[0047] Figure 3 is a perspective view of one example of a robotic surgical system used in conjunction with an imaging device to perform a spinal procedure.

[0048] Figure 4 is a partial perspective view of a surgical tool coupled to a robotic arm, wherein the surgical tool includes a housing coupled to a drill.

[0049] Figure 5 is a partial perspective view of a robotic arm coupled to a surgical tool coupled to a driver and a screw.

[0050] Figure 6 is an elevational view of an alternative surgical tool.

[0051] Figure 7 is an illustration of a pilot hole drilled in a pedicle according to one example.

[0052] Figure 8 is an illustration of a pedicle screw entering a vertebra according to one example.

[0053] Figure 9 is an illustration of a pedicle screw being set along a line haptics.

[0054] Figure 10 is Figure 1 a perspective view of an instance of a robotic surgical system of

[0055] Figure 11A is a table showing various operating modes including an autonomous inspection mode, a manual control mode, a simulated autonomous inspection mode, and a simulated manual control mode, as well as parameters of the haptics.

[0056] Figure 11B is a table showing various techniques for controlling insertion of a pedicle screw based on input from the haptics during the manual control mode.

[0057] Figure 11C is an illustration of a rotary interface of the haptics being manually manipulated from a home position to a non-home position.

[0058] Figure 12A is an illustration of the haptics providing haptic feedback to an operator while inserting a pedicle screw during the autonomous inspection mode.

[0059] Figure 12B is an illustration of the haptics providing haptic feedback to an operator while inserting a pedicle screw during the manual control mode.

[0060] Figure 13A and Figure 13B is an illustration showing a relationship of current output to depth, which can be used to verify that a drill hole and pedicle screw insertion are according to a plan of an operator.

[0061] Figure 14A is a perspective view of a robotic surgical system including haptics and showing a simulation of a pedicle screw being inserted according to one example.

[0062] Figure 14B is an illustration of the haptics providing haptic feedback to an operator while inserting a pedicle screw during the simulated autonomous inspection mode.

[0063] Figure 14C is an illustration of the haptics providing haptic feedback to an operator while inserting a pedicle screw during the simulated manual control mode.

[0064] Figure 15A This is a flowchart of a method for operating a robotic surgical system using a tactile device.

[0065] Figure 15B This is a flowchart of example steps for performing the self-checking mode.

[0066] Figure 15C This is a flowchart of example steps for performing manual control mode.

[0067] Figure 15D This is a flowchart of example steps for performing a simulated autonomous check mode.

[0068] Figure 15E This is a flowchart of example steps for performing a simulated manual control mode.

[0069] Figure 15F This is a flowchart illustrating example steps for autonomously controlling the insertion of a pedicle screw (PS) during surgical procedures. Detailed Implementation

[0070] I. System Overview

[0071] refer to Figure 1 and Figure 2 A surgical robotic system 10 is shown, which can be used for a variety of surgical procedures, including but not limited to spinal surgery, such as placing pedicle screws, other screws, or other types of implants in the spine. The robotic surgical system 10 includes a navigation system 12 comprising a locator 14 and a tracking device 16, one or more displays 18, and a robotic manipulator (e.g., a robotic arm 20 mounted to a base 22, a worktable, etc.). The robotic arm 20 includes a base link 24 rotatably coupled to the base 22 and a plurality of arm links 26 extending from the base link 24 to a distal end 28. The arm links 26 pivot / rotate about a plurality of joints in the robotic arm 20. For example, a surgical instrument for performing spinal surgery is shown generally at 30. The surgical instrument 30 is pivotally connected to the distal end 28 of the robotic arm 20. The arm links 26 may be mounted in series. Alternatively, the robotic arm 20 may include parallel arm links. Furthermore, any number of robotic arms 20 may be employed.

[0072] The robotic controller 32 is configured to provide control of the robotic arm 20 or guidance to a surgeon (referred to herein as an "operator") during manipulation of the surgical tool 30. In one example, the robotic controller 32 is configured to control the robotic arm 20 (e.g., by controlling its joint motors) to provide haptic feedback to the operator via the robotic arm 20. This haptic feedback helps to constrain or deter the operator from manually moving the surgical tool 30 outside of predetermined virtual boundaries associated with the surgical procedure. Such a haptic feedback system and related haptic objects that define the virtual boundaries are described in, for example, U.S. Patent No. 8,010,180 entitled "Haptic Guidance System And Method" to Quaid et al., filed February 21, 2006, and / or U.S. Patent Application Publication No. 2014 / 0180290 entitled "Systems And Methods For Haptic Control Of A Surgical Tool" to Otto et al., filed December 21, 2012, each of which is hereby incorporated by reference herein in its entirety. In one example, the robotic surgical system 10 is a RIO™ robotic arm interactive orthopedic system manufactured by MAKO Surgical Corp. of Lauderdale, FL.

[0073] In some examples, the robotic arm 20 autonomously acts to perform the surgical procedure based on a predetermined tool path and / or other predetermined movements. Such movements can be defined during the surgical procedure and / or prior to the procedure. In further examples, a combination of manual and autonomous control is utilized. For example, a robotic surgical system that employs both a manual mode in which the operator applies force to the surgical tool 30 to cause movement of the robotic arm 20 and a semi-autonomous mode in which the operator holds a suspended table to control the robotic arm 20 to autonomously follow a tool path is described in U.S. Patent No. 9,566,122 entitled "Robotic surgical system And Method For Transitioning Between Operating Modes" to Bowling et al., filed June 4, 2015, which is hereby incorporated by reference herein in its entirety.

[0074] The navigation system 12 is configured to track the movement of various objects in the surgical theater relative to a target coordinate system. Such objects include, for example, the surgical tool 30, a target anatomical structure of the patient (e.g., one or more vertebrae), and / or other objects. The navigation system 12 tracks these objects for the purpose of displaying their relative position and orientation in the target coordinate system to an operator, and in some cases for the purpose of controlling or constraining the movement of the surgical tool 30 relative to virtual boundaries associated with the patient’s anatomy and defined relative to the target coordinate system (e.g., via coordinate system transformations well known in surgical navigation).

[0075] The surgical navigation system 12 includes a computer cart assembly 34 that houses a navigation controller 36. The navigation controller 36 and the robotic controller 32 collectively form a control system of the robotic surgical system 10. A navigation interface is in operative communication with the navigation controller 36. The navigation interface includes a display 18 adjustably mounted to the computer cart assembly 34. Input devices such as a keyboard and mouse can be used to input information into the navigation controller 36 or otherwise select / control certain aspects of the navigation controller 36. Other input devices are contemplated, including a touch screen (not shown) or voice activation.

[0076] The localizer 14 is in communication with the navigation controller 36. In the illustrated example, the localizer 14 is an optical localizer and includes a camera unit (one example of a sensing device). The camera unit has a housing that houses one or more optical position sensors. In some examples, at least two optical sensors are employed, sometimes three or more. The optical sensors can be individual charge-coupled devices (CCDs). The camera unit is mounted on an adjustable arm to position the optical sensors to have a line of sight to the tracking device 16 discussed below that is ideally unobstructed. In some examples, the camera unit is adjustable in at least one degree of freedom by rotating about a rotary joint. In other examples, the camera unit is adjustable about two or more degrees of freedom.

[0077] The localizer 14 includes a localizer controller (not shown) that is in communication with the optical sensors to receive signals therefrom. The localizer controller is in communication with the navigation controller 36 by a wired or wireless connection (not shown). One such connection can be an IEEE 1394 interface, which is a serial bus interface standard for high-speed communications and synchronization of real-time data transfer. The connection can also use a company-specific protocol. In other examples, the optical sensors are in direct communication with the navigation controller 36.

[0078] Position and orientation signals and / or data are transmitted to the navigation controller 36 for the purpose of tracking objects. The computer cart assembly 34, the display 18, and the localizer 14 can be similar to those described in U.S. Patent No. 7,725,162, issued May 25, 2010, to Malackowski et al., entitled "Surgery System," which is hereby incorporated by reference.

[0079] The robot controller 32 and the navigation controller 36 can each or collectively include one or more personal computers or laptop computers; memory suitable for storing data and computer-readable instructions, such as local memory, external memory, cloud-based memory, random access memory (RAM), non-volatile RAM (NVRAM), flash memory, or any other suitable form of memory. The robot controller 32 and the navigation controller 36 can each or collectively include one or more processors, such as microprocessors, for processing instructions or for processing algorithms stored in memory to implement the functionality described herein. The processor can be any type of processor, microprocessor, or multi-processor system. Additionally or alternatively, the robot controller 32 and the navigation controller 36 can each or collectively include one or more microcontrollers, field programmable gate arrays, system on a chip, discrete circuits, and / or other suitable hardware, software, or firmware capable of implementing the functionality described herein. The robot controller 32 and the navigation controller 36 can be carried by the robotic manipulator, the computer cart assembly 34, and / or can be mounted to any other suitable location. The robot controller 32 and / or the navigation controller 36 are loaded with software as described below. The software converts signals received from the localizer 14 into data representing the position and orientation of tracked objects.

[0080] In addition to the robot controller 32, the surgical robotic system 10 can include any number of controllers to control components of the surgical robotic system 10. For example, the surgical robotic system 10 can include a tool controller configured to control the surgical tool 30. As another example, the surgical robotic system 10 can include a haptic device controller configured to control a haptic device of the surgical robotic system 10 (described in greater detail below). The controllers of the surgical robotic system 10 can be configured to individually or in combination implement the functionality of a surgical procedure. For example, the robot controller 32, the navigation controller 36, a localizer controller, a tool controller, and a haptic device controller can operate in combination to provide haptic feedback to an operator via a haptic device of the surgical robotic system 10. As another example, the robot controller 32 can operate individually to control the robotic arm 20. Accordingly, to embody these different configurations, the following description can refer to the robot controller 32 and the navigation controller 36 as being separate controllers, as being a single controller, or as being a combination of controllers. Figure 1The illustrated "one or more controllers 33." It will be understood that the "one or more controllers 33" includes any individual controller or any combination of controllers suitable to perform the referenced functions. The collective one or more controllers can also be considered a control system.

[0081] Furthermore, any steps within this specification performed by any one of the one or more controllers 33 described herein can operate according to control algorithms described herein, which can be implemented according to a finite sequence of steps for solving the tasks described herein.

[0082] With reference to Figure 3 The navigation system 12 includes a plurality of tracking devices 16, also referred to herein as trackers. In the illustrated example, the trackers 16 are coupled to individual vertebrae of the patient. In some cases, the trackers 16 are fixedly attached to segments of the bone via bone screws, bone pins, and the like. In other cases, clamps on the spinous processes or other portions of the spine can be used to attach the trackers 16. In further examples, the trackers 16 can be mounted to other tissue types or portions of the anatomy. The position of the trackers 16 relative to the anatomy to which they are attached can be determined by registration techniques such as point-based registration in which bone landmarks on the bone are outlined or a number of points on the bone are touched with a digitizing probe 73 (e.g., a navigation pointer that itself has markers) for surface-based registration. Conventional registration techniques can be employed to associate the pose of the trackers 16 with the patient's anatomy (e.g., the vertebrae V being treated).

[0083] Other types of registration are also possible, such as using a tracker 16 with a mechanical clamp that attaches to the spinous process of the vertebra V and has a tactile sensor (not shown) to determine the shape of the spinous process to which the clamp is attached. The shape of the spinous process can then be matched to a 3D model of the spinous process for registration. The known relationship between the tactile sensor and the three or more markers on the tracking device 16 is preloaded into the navigation controller 36. Based on this known relationship, the position of the markers relative to the patient's anatomy can be determined.

[0084] A base tracker 16 can be coupled to the base 22 to track the pose of the surgical tool 30. In other examples, a separate tracker 16 can be fixed to the surgical tool 30, for example integrated into the surgical tool 30 during manufacture, or can be separately mounted to the surgical tool 30 in preparation for the surgical procedure. In any case, the working end of the surgical tool 30 is tracked by means of the base tracker 16 or other trackers. The working end can be the distal end of an accessory of the surgical tool 30. Such accessories can include a drill, a drill bit, a saw, an electrical ablation device, a screw driver, a tap, a surgical knife, a Jamshidi needle, and the like.

[0085] In the illustrated example, the trackers 16 are passive trackers. In this example, each tracker 16 has at least three passive tracking elements or markers M to reflect light from the localizer 14 back to the optical sensors. In other examples, the trackers 16 are active trackers and can have light-emitting diodes or LEDs that transmit light, such as infrared light, to the optical sensors. Based on the received optical signals, the navigation controller 36 uses conventional triangulation techniques to generate data indicative of the relative position and orientation of the trackers 16 with respect to the localizer 14. In some cases, more or fewer markers can be employed. For example, in cases where the tracked object can rotate about a line, two markers can be used to determine the orientation of the line by measuring the position of the markers at various positions about the line. It will be appreciated that the localizer 14 and the trackers 16, although described above as utilizing optical tracking techniques, can alternatively or additionally utilize other tracking modalities, such as electromagnetic tracking, ultrasound, radio frequency tracking, inertial tracking, combinations thereof, and the like, to track the objects.

[0086] It can also be desirable to track the skin surface of the patient to ensure that the surgical tools 30 do not inadvertently contact or penetrate the patient's skin outside of any desired incision boundary. To this end, a skin-attached marker M, such as an active or passive marker with an adhesive backing, can be attached to the patient's skin to define a boundary associated with the patient's skin. An array of such markers M can be provided in a peripheral ring 74 (circular, rectangular, etc.) such that the surgical procedure continues within the ring 74 without substantially interfering with the ring 74 (i.e., the ring is placed on the patient's skin around the incision and the target vertebrae). One suitable array of skin markers is the SpineMask® tracker manufactured by Stryker Leibinger GmbH & Co. (KG, Bötzinger Straße 41, D-79111 Freiburg, Germany). See also U.S. Patent Application Publication No. 2015 / 0327948 entitled "Navigation System For And Method Of Tracking The Position Of A Work Target" to Schoepp et al., filed May 13, 2015, which is hereby incorporated by reference in its entirety. Other suitable skin trackers are also contemplated. A digitizing probe can also be used to map the skin surface and / or incision as well. However, once mapped, any movement of the skin will not be detected without further digitizing, whereas the attached array of trackers can detect movement of the patient's skin.

[0087] Prior to commencing a surgical procedure, additional data is loaded into the navigation controller 36. Based on the position and orientation of the trackers 16 and the previously loaded data, the navigation controller 36 determines the position of the working end of the surgical tool 30 and the orientation of the surgical tool 30 relative to the tissue against which the working end will be applied. The additional data can include calibration data, such as geometric data relating the position and / or orientation of the trackers 16 or their markers M to the working end of the surgical tool 30. Such calibration data can also be determined preoperatively or intraoperatively, such as by using a calibration probe or calibration divot on the tracker 16 having a known geometric shape to determine the position of the working end of the surgical tool 30, for example, relative to its own tracker or a base tracker 16. The additional data can include registration data, such as transformation data relating the trackers 16 to the patient’s anatomy or a 3D model thereof. In some instances, the navigation controller 36 forwards these data to the robotic controller 32. The robotic controller 32 can then use the data to control the robotic arm 20, as described in U.S. Patent Nos. 8,010,180 or 9,566,122, both of which are previously incorporated by reference herein.

[0088] The navigation controller 36 also generates image signals indicative of the relative position of the working end of the surgical tool 30 relative to the target tissue. These image signals are applied to the display 18. Based on these signals, the display 18 generates images that allow the operator and staff to view the relative position of the surgical tool 30 relative to the surgical site. The display 18 as described above can include a touchscreen or other input / output device that allows input of commands.

[0089] In the illustrated example, using the navigation system 12, the pose of the surgical tool 30 can be determined by tracking the position of the base 22 via the base tracker 16 and computing the pose of the surgical tool 30 based on joint encoder data from the joints of the robotic arm 20 and the known geometric relationship between the surgical tool 30 and the robotic arm 20. Ultimately, the localizer 14 and tracking devices 16 are able to determine the pose of the surgical tool 30 and the patient’s anatomy, so the navigation system 12 knows the relative relationship between the surgical tool 30 and the patient’s anatomy. One such navigation system is shown in U.S. Patent No. 9,008,757, entitled “Navigation System Including Optical And Non-Optical Sensors,” to Wu, filed September 24, 2013, which is hereby incorporated by reference herein.

[0090] In operation, for certain surgical tasks, the operator manually manipulates the robotic arm 20 (e.g., moves the robotic arm or causes it to move) to manipulate the surgical tool 30 to perform a surgical procedure on a patient, such as drilling, cutting, sawing, reaming, implant installation, etc. While the operator manipulates the surgical tool 30, the navigation system 12 tracks the position of the surgical tool 30 and / or the robotic arm 20 and provides haptic feedback (e.g., force feedback) to the operator to limit the operator’s ability to move the surgical tool 30 (or cause it to move) outside of one or more predetermined virtual boundaries that are registered (or mapped) to the patient’s anatomy, which results in highly accurate and repeatable drilling, cutting, sawing, reaming, and / or implant placement.

[0091] In one example, the robotic arm 20 is operated in a passive manner and haptic feedback is provided when the operator attempts to move the surgical tool 30 outside of the virtual boundaries. The haptic feedback is generated by one or more actuators (e.g., joint motors) in the robotic arm 20 and is transmitted to the operator via a flexible transmission such as a cable-driven transmission. When the robotic arm 20 does not provide haptic feedback, the robotic arm 20 is freely movable by the operator. In other examples, similar to that shown in U.S. Patent No. 9,566,122 (previously incorporated by reference herein), the robotic arm 20 is similarly manipulated by the operator, but the robotic arm 20 is operated in an active manner. For example, the operator applies a force to the surgical tool 30 that is measured by a force / torque sensor and the robotic arm 20 mimics the operator’s desired movement based on the measurements from the force / torque sensor. For other surgical tasks, the robotic arm 20 is operated autonomously.

[0092] Turning to Figure 4 and Figure 5 , one example of a surgical tool 30 is shown coupled to the distal end 28 of the robotic arm 20. More specifically, a coupling 40 is provided between the surgical tool 30 and the distal end 28 of the robotic arm 20 to allow the surgical tool 30 to rotate about an axis A relative to the distal end 28. In Figure 4 , the surgical tool 30 includes a drill 42 to drill a pilot hole for a pedicle screw, other screw, or other type of implant. The drill 42 is arranged to rotate about a rotation axis R. In Figure 5 , the surgical tool 30 includes a driver 44 (e.g., a screw driver) arranged along the rotation axis R to insert a pedicle screw PS or other implant by rotating about the rotation axis R. The surgical tool 30 includes a housing 45. A drive system (e.g., a motor) is located in the housing 45 to drive the drill 42, the driver 44, or other accessories. The drive system can have variable speed.

[0093] The housing 45 also includes a collet 47 or other type of coupler to releasably attach the drill 42, driver 44, or other accessories to the drive system. In some cases, a reduction gear 48 (see Figure 5 ) can be releasably attached to the collet 47 for use with certain accessories. The reduction gear 48 includes a transmission or gear arrangement that reduces the rate of rotation of the accessory compared to direct connection to the drive system. This is useful where slower rates of rotation are desired.

[0094] In another example shown in Figure 6 , one end of the coupling 40 supports the surgical tool 30 for rotation about the axis A. The other end of the coupling 40 supports the housing 45. The housing 45 can be fixed to the coupling 40, or can be supported for rotation within the coupling 40 about the rotation axis R. In other words, the housing 45 can be able to be passively rotated within the coupling 40. At the same time, however, the coupling 40 restricts axial movement of the housing 45 relative to the coupling 40 along the rotation axis R, so that the positioning of the housing 45 can be precisely controlled. A tracker (not shown) can be mounted to the housing 45 to track the position and / or orientation of the housing 45, and thereby the rotation axis R and / or the distal end of the accessory attached to the housing 45. A rotary shaft 60 is rotatably supported in the housing 45. The rotary shaft 60 has a distal interface / collet 62 coupled to an accessory (e.g., a driver 44 as shown) and a proximal interface / collet 64 coupled to a power source such as a torque source, e.g., a motor, a rotatable handle for manual rotation, etc. For example, the driver 44 is shown coupled to the distal interface 62 / rotary shaft 60.

[0095] The robotic surgical system 10 can include various components for controlling the drill 42 and / or driver 44. For example, in Figure 4 and Figure 5 , the surgical tool 30 includes a handle 46 that depends from the housing 45. The handle 46 can include a grip for being grasped by an operator to manipulate the surgical tool 30 and / or the robotic arm 20 during a surgical procedure. There can also be a trigger 49 to control the speed of the drill 42 and / or driver 44, to initiate movement of the robotic arm 20 to align the rotation axis R with a desired trajectory, etc. The trigger 49 can communicate signals to the robotic controller 32 and / or tool controller to control the robotic arm 20 and / or surgical tool 30.

[0096] In the example of Figure 6 , the surgical tool 30 includes a handpiece 66 with an internal motor for controlling the surgical tool 30 and drill 42. As shown, the handpiece 66 is coupled to the proximal interface 64 so that an operator can grasp the handpiece 66, trigger operation of the motor, and so that the motor delivers torque through the rotary shaft 60 to the driver 44 and ultimately to the pedicle screw PS.

[0097] Preoperative imaging and / or intraoperative imaging can be employed to visualize the anatomy of a patient in need of treatment, such as the patient’s spine. An operator can plan where to place pedicle screws PS relative to the images and / or relative to a 3D model created from the images. The planning includes determining the pose of each pedicle screw PS relative to the particular vertebra V in which they are to be placed, for example, by identifying the desired pose in the images and / or 3D model. This can include creating or positioning a separate 3D model of the pedicle screws PS relative to a 3D model of the patient’s anatomy. Once the plan is set, it is communicated to the robotic surgical system 10 for execution.

[0098] The robotic surgical system 10 can be used in cooperation with an imaging device 50 (e.g., a C-arm as shown Figure 3 intraoperative images of the patient’s anatomy in addition to or as an alternative to any preoperative images (e.g., X-ray, CT scan, or MRI images taken prior to the surgical procedure). The intraoperative images from the imaging device 50 can help determine the actual position of the drill 42 or driver 44 relative to the desired orientation of the pedicle screws PS that are placed in the patient’s spine. Separate tracking devices 16 can be employed on each vertebra V to individually track each vertebra V and the corresponding pose of the drill 42 and / or driver 44 relative to the individual vertebra V as the pedicle screws PS or other implants are placed into the vertebra V.

[0099] The robotic surgical system 10 evaluates the desired pose of the pedicle screws PS and creates virtual boundaries (e.g., haptic objects), predetermined tool paths, and / or other autonomous movement instructions that correspond to the desired pose of the pedicle screws PS to control movement of the robotic arm 20 such that the drill 42 and driver 44 of the surgical tool 30 are controlled in a manner that ultimately places the pedicle screws PS according to the operator’s plan. This can include, for example, ensuring that the trajectory of the surgical tool 30 is aligned with the desired pose of the pedicle screws PS, e.g., aligning the rotation axis R with the desired pose of the pedicle screws PS, during the surgical procedure.

[0100] In other instances, the operator can plan the desired trajectory and / or screw placement intraoperatively. For example, the operator can position the drill 42 at a desired entry point relative to the target anatomy (e.g., the vertebra V) and orient the drill 42 until the display 18 shows that the trajectory of the rotation axis R is in the desired orientation. Once the operator is satisfied with the trajectory, the operator can provide input (e.g., touch screen, button, foot pedal, etc.) to the control system to set that trajectory as the desired trajectory that will be maintained during the procedure. A haptic object created to constrain movement of the surgical tool 30 to maintain the rotation axis R along the desired trajectory can be, for example, a virtual sphere that is centered at the entry point and has a radius that is equal to the length of the drill 42. Figure 4The line haptics object LH is shown. The line haptics object LH can have a start point SP, a target point TP defining a desired depth of a drill 42, pedicle screw PS, etc., and an exit point EP as further described below. Other haptics object shapes, sizes, etc. are also contemplated.

[0101] Referring to Figure 7 and Figure 8 one of the vertebrae V is shown. During a surgical procedure, such as a spinal fusion surgical procedure, an operator can insert one or more pedicle screws PS into the vertebral body 100 of the vertebra V through a pedicle region. Prior to inserting the pedicle screw PS, the operator can employ a drill 42 to cut a pilot hole 102 in the vertebral body 100. In alternative examples, such as where a self-drilling, self-tapping bone screw is employed, the pilot hole can be excluded. See, e.g., the teachings in U.S. Patent No. 7,637,929 entitled "Self-drilling bone screw" issued to Stefan Auth on December 29, 2009, which is hereby incorporated by reference herein in its entirety.

[0102] In one example, prior to commencing drilling, the robotic surgical system 10 controls movement of the surgical tool 30 to place the rotational axis R of the surgical tool 30 along a desired trajectory in alignment with the desired orientation of the pilot hole 102 by autonomously aligning the rotational axis R of the surgical tool 30 with the desired trajectory. In this case, the robotic arm 20 can autonomously position the drill 42 along the desired trajectory, but leave a spacing (as indicated by the dashed line) above the vertebral body 100. Figure 4The surgeon can then manually manipulate the surgical tool 30 to move the drill bit 42 (or cause movement of the drill bit) along the line haptic object LH toward the vertebral body 100 to drill the pilot hole 102. In some cases, such as when a passive robotic arm 20 is used, the robotic surgical system 10 constrains movement of the surgical tool 30 to remain along the desired trajectory by providing haptic feedback to the operator if the operator attempts to move the surgical tool 30 in a manner that deviates from the line haptic object LH and the desired trajectory. If the operator desires to return the robotic arm 20 to a free mode, in which movement of the surgical tool 30 is unconstrained, the operator can pull the surgical tool 30 away from the patient along the line haptic object LH until the exit point EP is reached.

[0103] While the robotic surgical system 10 holds the surgical tool 30 on the desired trajectory, the operator can then manually manipulate the surgical tool 30 to move the drill bit 42 (or cause movement of the drill bit) along the line haptic object LH toward the vertebral body 100 to drill the pilot hole 102. In some cases, such as when a passive robotic arm 20 is used, the robotic surgical system 10 constrains movement of the surgical tool 30 to remain along the desired trajectory by providing haptic feedback to the operator if the operator attempts to move the surgical tool 30 in a manner that deviates from the line haptic object LH and the desired trajectory. If the operator desires to return the robotic arm 20 to a free mode, in which movement of the surgical tool 30 is unconstrained, the operator can pull the surgical tool 30 away from the patient along the line haptic object LH until the exit point EP is reached.

[0104] The operator then drills the guide hole 102 to the desired depth. The drilling speed can be controlled by the operator via trigger 49, or it can be automatically controlled based on the position of the drill 42 relative to the patient's anatomy. For example, the rotational rate of the drill 42 can be set high during initial drilling into the vertebral body V, but slowed down during further drilling into the vertebral body V, and set even slower during final drilling to the final depth. The control system can also monitor contact / contact force during online tactile guidance via one or more sensors S (e.g., one or more force sensors, force / torque sensors, torque sensors, pressure sensors, optical sensors, etc.) in communication with the robot controller 32. If no significant contact / contact force is detected, meaning that the surgical tool 30 is penetrating soft tissue, the control system avoids activating the motor or other power source (e.g., RF energy, ultrasonic motor, etc.) of the surgical tool 30. When contact with bone is detected (e.g., optically sensed force exceeding a predetermined threshold, etc.), the control system can activate the motor or other power source. The operator can also passively sense the contact / contact force and trigger a switch to activate the power source.

[0105] Virtual boundaries (e.g., tactile objects) used to constrain operator movement along a desired trajectory can also indicate via tactile feedback when the operator has reached the desired depth of the guide hole 102, such as reaching the target point TP. A separate virtual boundary can also be used to set the desired depth. In other cases, the robotic surgical system 10 can autonomously drill the guide hole 102 to the desired depth. In still other cases, the robotic surgical system 10 may initially drill autonomously, but then the final drilling can be completed manually, or vice versa. Once the guide hole 102 is created, the actuator 44 can be used to place the pedicle screw PS. In some instances, the guide hole 102 may be unnecessary, and the pedicle screw PS can be placed by a guide wire placed by the robotic surgical system 10 or without any guidance. For example, in cases involving self-drilling, self-tapping bone screws, the guide hole may be unnecessary. See, for example, the teachings in U.S. Patent No. 7,637,929, entitled “Self-drilling bone screw,” issued December 29, 2009, to Stefan Auth, which is hereby incorporated herein by reference in its entirety.

[0106] One advantage of using the navigation system 12 to continuously and individually track each vertebra V and the movement of the drill 42 is that the pedicle screw PS can be inserted very close to the spinal cord 103. Therefore, the placement of the pedicle screw PS and its corresponding guide hole 102 must be precisely aligned to avoid interaction with or damage to the spinal cord 103. If the operator drills the guide hole 102 at an improper angle and / or drills it too deep, the pedicle screw PS or the drill 42 used to drill the guide hole 102 may damage the spinal cord 103. Therefore, by using the navigation system 12 to track the posture of the drill 42 and / or the actuator 44 relative to the patient's anatomy (and specifically the anatomy outlined in the preoperative and / or intraoperative images), the spinal cord 103 can be avoided.

[0107] Once drilling is complete, the drill 42 is removed from the vertebral body 100 and disconnected from the drive system via the chuck 47. The driver 44 is then connected to the drive system (with or without a reducer 48).

[0108] A pedicle screw PS can be inserted with the assistance of a robotic surgical system 10. In one example, the robot controller 32 autonomously controls the insertion of the pedicle screw PS such that the rotational rate about the axis of rotation R and the advance rate along the planned trajectory are proportional to the thread geometry of the pedicle screw. The robot controller 32 can use a variety of methods to autonomously control the insertion of the pedicle screw PS.

[0109] For example, a pedicle screw PS can be inserted at a constant rotational or constant advance rate stored in the memory of the robotic surgical system 10 before surgery. In such an example, the advance rate and / or rotational rate can be stored in the memory of the robotic surgical system 10 before surgery. Alternatively, the advance rate and / or rotational rate can be input by the operator during surgery and stored in the memory of the robotic surgical system.

[0110] In another example, the robot controller 32 may follow a predetermined profile of rotational or propulsion rate. The predetermined profile of rotational or recommended rate may be based on any suitable variable, such as time or the location of the pedicle screw PS. For example, refer to... Figure 9 The insertion of the pedicle screw PS can be autonomously controlled based on the position of the actuator 44 and / or the pedicle screw PS relative to the patient's anatomy. In such an example, the rotation rate of the actuator 44 can be set high during initial installation into the vertebral body V, but can be slowed down during further installation into the vertebral body V, and can be set even slower during final implantation to the final depth.

[0111] Figure 9The initial position of the pedicle screw PS is shown when the robot controller 32 autonomously controls the surgical tool 30. As shown, the pedicle screw PS is adjacent to the target site (shown in this case as vertebra V), where the planned trajectory is represented by a linear tactile object LH. If the pedicle screw PS is not inserted correctly, the threaded interface between the pedicle screw PS and the vertebral body 100 risks damaging the bone, the screw PS, the actuator 44, or the surgical tool 30. Bone is likely the most fragile material and is therefore most likely to be damaged if the screw is not inserted correctly. For example, improper insertion may occur when the pedicle screw PS advances linearly along the trajectory LH but does not rotate sufficiently about the axis of rotation R. This could cause bone material to be sheared off adjacent to the thread and forced downward into the bone. In another example, improper insertion may occur, for instance, when the pedicle screw PS rotates insufficiently about the axis of rotation R and advances insufficiently along the trajectory LH, resulting in bone material actually being sheared off adjacent to the thread during drilling and forced back along the thread. In either example, improper insertion results in a reduction in the strength and extent to which the bone material secures the pedicle screw PS to the bone.

[0112] Figure 9 The insertion of the pedicle screw PS is also illustrated when the robot controller 32 autonomously controls the surgical tool 30. Position control for screw insertion ensures proper depth and angular or rotational position is maintained throughout the procedure. A guide hole may be prepared in the vertebral body 100, as shown in the example above, or the procedure may employ self-drilling and self-tapping screws, eliminating the need for a guide hole. The starting point Do of the pedicle screw PS is adjacent to the vertebral body 100, that is, before the screw penetrates any part of the vertebral body 100. In an alternative, the starting point Do may be spaced a certain distance from the vertebral body 100 as a safety margin to ensure proper position control throughout the procedure. The insertion depth D is advanced along the trajectory LH to a final depth Df, which is the planned depth, to complete the installation of the pedicle screw 100 in the vertebral body PS.

[0113] The robot controller 32 is configured to autonomously control the insertion of the pedicle screw PS such that the rotational rate and the advance rate along the trajectory LH are proportional to the thread geometry of the pedicle screw PS. Each pedicle screw PS has a known thread geometry stored in the memory of the robotic surgical system 10. For example, for each pedicle screw PS, the thread geometry may include any one or more of the pedicle screw PS length, thread diameter, thread depth, head size, and pitch P (which is defined as the number of threads per unit length). In a specific example, Figure 11AThe pedicle screw PS shown may have a pitch of 12 threads per inch. Other exemplary pedicle screw PS may have 8, 10, 14, 16, or other numbers of threads per inch. With the defined relationship between the robotic arm 20 and the pedicle screw PS, and the known geometry of the pedicle screw PS stored in the memory of the robotic surgical system 10, the robot controller 32 is configured to ensure appropriate rotational and advance speeds for insertion of the pedicle screw PS with a specific pitch.

[0114] The thread geometry of the pedicle screw PS can be stored in the memory of the robotic surgical system 10 before or during surgery. In one example, the pedicle screw PS is selected as part of the surgical plan, and the corresponding thread geometry of the pedicle screw PS is associated with and entered into the plan. Once the plan is loaded for intraoperative surgery, the robotic surgical system 10 will be aware of the thread geometry stored in memory for immediate access. In another example, the operator can manually select different pedicle screw PSs, or manually enter the thread geometry using a GUI associated with the operation of the robotic surgical system 10. The entered thread geometry can be obtained from a database stored in memory, or it can be derived from an operator who obtains this information from an offline specification associated with the selected pedicle screw PS. In any of these examples, the thread geometry can be stored in memory after the operator enters it using the GUI, allowing the robotic surgical system 10 to subsequently implement the control techniques described herein using the entered thread geometry. In yet another example, a measuring tool connected directly or wirelessly to the robotic surgical system 10 can be used to scan or measure any intended pedicle screw PS to extract the thread geometry and transfer the measured thread geometry to the memory of the robotic surgical system 10. Once the thread geometry of the pedicle screw PS is stored in the memory of the robotic surgical system 10, the pedicle screw PS can be virtually presented within the navigation system 12.

[0115] The relationship between the pedicle screw pitch, angle, or rotational position and the insertion depth or advancement along the trajectory depends on the equation θ = D. (Pitch / 2π), where θ is the angular position, D is the insertion depth per unit length, and the pitch is the number of threads per unit length of the pedicle screw PS. The robot controller 32 uses this relationship to control the installation of the pedicle screw PS. For example, taking the first derivative with respect to time, the rate of change of the angular position or rotational speed δθ / δt is equal to the rate of change of the insertion depth or advance rate δD / δt multiplied by the pitch and divided by 2π. This can be expressed as: δθ / δt = δD / δt Pitch / 2π (Equation 1).

[0116] The robotic surgical system 10 may include various attachments for preparing the anatomical structures for the pedicle screw PS. For example, one type of attachment for the surgical tool 30 may include a skin incision tool, such as a scalpel, an electrosurgical unit, or other tools with sharp tips. The skin incision tool may be mounted much like a drill 42 and / or a actuator 44, or it may be part of a separate end effector and connected to a base attached to the connector 40, and may form the skin incision in a tactilely guided manner in a manner similar to that previously described, i.e., when the incision is created, virtual boundaries (e.g., tactile objects) may be used to constrain the operator's movement relative to the desired incision in the patient's skin. In one example, a digitized probe may be used to locate the desired incision site and create an associated boundary / tactile object. In another example, a 3D skin model may be determined based on the pose of a skin tracker, by digitization and / or by preoperative methods, and the control system may use the desired plan for pedicle screw placement to determine the incision location based on the skin model.

[0117] Other types of pointers, similar to digital probes, can also be used to identify the desired location of the incision, such as laser pointers that can be mounted on a skin incision tool, end effector, or other component to project visible light onto the patient's skin to indicate the location of the incision. Such laser pointers can be used by first aligning the rotation axis R of the skin incision tool with the desired trajectory, and then activating the laser pointer to project light along the desired trajectory. An alternative form of skin incision tool is positioned using a tool guide held in place by a robotic arm. Because the patient's skin is tracked via a skin tracker, the navigation system 12 is also able to approximate the desired location of the incision based on a skin model (e.g., surface model, point cloud, etc.) and the intersection of the desired trajectory and the skin model, allowing the operator to make the desired incision at the desired location in the patient's skin using tactile feedback.

[0118] Tactile objects can be defined in various ways to establish tactile feedback to guide incision formation. They can be defined based on the width of the skin-cutting tool, the desired length of the skin incision, and / or the desired depth of the incision. The desired incision depth can also be controlled by the operator within a maximum incision depth, which can be determined by a maximum incision depth programmed into the tactile object or by a mechanical stop that can prevent the skin-cutting tool from sliding beyond a predetermined point through a guide opening (not shown) in the tool guide TG of the end effector.

[0119] One of the accessories for surgical tool 30 may include a thread insertion tool, such as a Jamshidi needle, another access cannula with a core needle, etc. The thread insertion tool may be mounted much like a skin incision tool, or it may be part of a separate end effector and fixedly attached to a base attached to connector 40. If relative movement between the thread insertion tool and the base is not permitted, i.e., they are fixed to each other, the thread insertion tool can be guided into the skin incision and to a target point on the bone (e.g., a vertebra). If relative axial sliding movement between the thread insertion tool and the base is permitted, such as when the base includes a tool guide with an opening, the tool guide can be positioned in a desired orientation and the thread insertion tool can be inserted along the opening in the tool guide. Depending on the relative distance to the target point, the length of the thread insertion tool, and the position of the tool guide, the thread insertion tool can be guided via the thread tactile object in the same manner as previously described for drill 42 and / or actuator 44.

[0120] Because the desired location of the skin and incision is tracked, the robotic surgical system 10 can control the movement of the skin-incision tool relative to a tactile object created for the incision. The tactile object is defined in a target coordinate system such that the incision is formed at the desired location in the patient's skin. In one example, the robotic surgical system 10 can control the movement of the skin-incision tool relative to the tactile object by controlling manual manipulation of the tool. This can be done by constraining the movement of the skin-incision tool relative to a virtual boundary defined by the tactile object as the operator manually moves or induces movement of the tool, such that the incision is formed at the desired location. The robotic surgical system 10 can constrain the movement of the skin-incision tool relative to the tactile object by generating tactile feedback to the operator indicating that the tool has reached the desired depth of the incision or otherwise reached the desired limit of the incision. Once the incision is formed at the desired location, the skin-incision tool is withdrawn from the anatomy, and the surgery continues until all incisions are formed. Skin incision techniques can be as described in U.S. patent application US 16 / 184,376, filed November 8, 2018, entitled "Robotic Spine Surgery System and Methods".

[0121] II. Haptic Feedback Technology

[0122] As described above, the robotic system 10 can be used to control the surgical tool 30 to rotate a screw along a planned trajectory. This document describes techniques used in conjunction with the robotic system 10 to provide surgeons with direct tactile "sensory" contact, touch, or control over the forces, energy, materials, and information flows involved when the robotic system 10 causes the surgical tool 30 to interact with tissue. Furthermore, the techniques described herein provide a technical solution to mimic the tactile and sensory information that surgeons are accustomed to (manually) monitoring and evaluating tissue interaction processes during surgery. The tactile techniques described herein restore the surgeon's ability to assess this process during robot-controlled surgery. The solution provides an elegant mechanism for providing tactile feedback using, for example, one degree of freedom (e.g., rotation) and an accompanying phenomenon (e.g., resistance). The tactile device may include an interface (e.g., a knob) that controls or mimics the interaction of the screw (or attachment) manipulated by the robotic arm 20 and / or the surgical tool 30. In some instances, the resistance of the interface is adjusted or amplified and can vary dynamically according to the interaction between the screw and the surrounding tissue into which it is inserted. In some instances, the robot rotates and advances the screw when the user manipulates the interface. The robotic system captures parameters of the screw insertion process using appropriate sensors. This sensor information is then converted and used to adjust feedback to the interface, giving the surgeon enhanced sensory acuity. This helps the surgeon understand the consistency of the screw insertion into the tissue and the quality of the gripping fit between the screw and the tissue. Furthermore, the tactile technology described in this paper increases surgeon confidence, reduces emotional stress, improves surgical efficiency, and provides surgeons with the ability to perceive and respond to unexpected situations that the robotic solution would otherwise be unable to capture.

[0123] The tactile technologies described herein can be used in a variety of medical applications. For example, while tactile technologies are involved in screw insertion procedures, they can also be used in a variety of other medical applications. As an example, during surgery involving a scalpel or syringe, the interface of the tactile device can provide tactile feedback to mimic the forces applied by the scalpel or syringe as it advances through different tissues. Tactile technologies can be used in surgeries involving soft tissue to prevent damage to the soft tissue. For example, during surgery involving the separation of soft tissue with a retractor, the interface of the tactile device can provide tactile feedback to mimic the forces (or tensions exerted by the soft tissue on the retractor) applied to the soft tissue by the retractor at the wound site, at the surgical opening, between bones in the joint space, or between bones during bone growth surgery (e.g., mandibular retraction). As another example, during surgery involving a tourniquet, the interface of the tactile device can provide tactile feedback to mimic the pressure applied to the soft tissue by the tourniquet. As yet another example, during surgery involving jacks used to open joint spaces, the interface of a tactile device can provide tactile feedback to mimic the force applied to the ligament by the jack (or the tension on the ligament in the jack), thereby aiding in the ligament balancing process.

[0124] A. Tactile devices

[0125] Refer to an example, such as Figure 10 As shown, the robotic surgical system 10 includes a tactile device 51 for controlling surgical tools 30. The tactile device 51 may include an interface 53 that can be manually manipulated by an operator's hand. In a non-limiting example, the tactile device 51 may be a handheld suspension table. Alternatively, the tactile device 51 may include units that can be placed on a surface, a tactile glove, or a physical design that mimics tools used in manual surgery (e.g., screw drivers). The tactile device 51 may be any other device configured to provide the surgeon with the capabilities described herein.

[0126] The term "device" in tactile device is not limited to any specific embodiment described herein. In practice, a tactile device can include any device configured to provide tactile (sensory) feedback to an operator, wherein the tactile response mimics conditions occurring in an environment remote from the tactile device. Such a device may consist of any one or more of the following components to provide appropriate tactile feedback: mechanical components, electrical components, electromechanical components, software, controllers, pneumatic components, and hydraulic components.

[0127] exist Figure 10In this embodiment, the haptic device 51 is directly attached to the robotic manipulator or surgical instrument 30 via the base 22. In other instances, the haptic device 51 may be attached to any other suitable component of the robotic surgical system 10, such as the computer cart assembly 34 or the navigation system 12. In yet another example, the haptic device 51 may be directly coupled to the robotic arm 20 or the surgical instrument 30, so that the haptic device 51 does not need to be held by the operator. The haptic device 51 may also be remotely spaced from the robotic manipulator and the surgical instrument 30, such as... Figure 10 As shown. In such examples, the haptic device 51 can be wirelessly coupled to the robotic surgical system 10. Alternatively, the haptic device 51 can be powered by a wire connected to the system 10, such as... Figure 10 As shown. In other instances, the haptic device 51 may be used as a stand-alone device that is not necessarily attached to the robotic surgical system 10. For example, the haptic device 51 may be used with a surgical system that does not include a robotic manipulator and / or navigation system 12.

[0128] The interface 53 of the tactile device 51 can move with a certain degree of freedom relative to the tactile device 51. In one example, the interface 53 is a rotary interface that can move with a certain degree of rotational freedom relative to the tactile device 51. In some examples, the rotary interface 53 can be a rotary knob, such as... Figure 10 As shown. The rotary interface 53 can also be a rotatable dial, ball, or wheel. Interface 53 can have configurations other than those specifically shown in the figures or described herein.

[0129] It may be desirable for the rotary interface 53 to allow the operator to correlate the rotational degrees of freedom of the rotary interface 53 with the rotational degrees of freedom of the screw or tool. However, the interface 53 of the tactile device 51 can be implemented using configurations other than the rotary interface 53. For example, the tactile device 51 may include a linear interface 53 that can be manually operated by the operator's hand. In some instances, the linear interface 53 may be a pivot, a button, a palm or finger trigger, a spring switch, a plunger, a compliance pad, or a slider. Furthermore, one or more controllers 33 may control the actuator 55 of the tactile device 51 to enable the linear interface 53 to mimic the current interaction between the screw and the target area. For example, in the instance where the linear interface 53 is a button, one or more controllers 33 may control the actuator 55 such that the operator applies a larger or smaller force to press the button based on the current interaction. In another example, where the linear interface 53 is a switch or plunger, one or more controllers 33 may control the actuator 55 of the tactile device 51 such that the operator applies a larger or smaller force to actuate the switch or plunger. In yet another example, the linear interface 53 is a slider that includes a mechanism configured to slide along a certain path. One or more controllers 33 can control the actuator 55 of the tactile device 51, allowing an operator to apply greater or lesser force to actuate the slider and / or control the actuator 55 to limit the linear displacement of the slider.

[0130] The robotic surgical system 10 provides tactile feedback to the operator via a tactile device 51. For example... Figure 10 As shown, the tactile device 51 may include an actuator 55, which may be controlled by one or more controllers 33. The actuator 55 is coupled to the interface 53 and configured to apply force to the interface 53. The actuator 55 may include a drive output drive shaft 68 coupled between the actuator 55 and the interface 53. One or more controllers 33 may control the actuator 55 so that the interface 53 can mimic the current interaction between the screw and the target area. In some instances, the interface 53 is used to directly control the surgical tool 30 and / or the actuator 44 to rotate the screw. Direct control via the tactile device 51 may also be combined with tactile feedback to mimic the current interaction between the screw and the target area. In these examples, the operator can correlate the degrees of freedom of the interface 53 with the degrees of freedom of the screw movement through perception.

[0131] Actuator 55 may be implemented as a motor, such as a brushed or brushless motor, a direct drive motor, an active actuator, a DC motor, an electric linear motor, a linear current controlled motor, a stepper motor, an electric rotary motor, a torque generator (a motor with a limited angular range), a spring-based actuator, a magnetic actuator, a hydraulic actuator, a pneumatic actuator, a manual mechanical actuator, a passive actuator (including magnetic powder brakes, friction brakes, damping resistance mechanisms, or friction generating mechanisms) or any combination thereof.

[0132] In some instances, the haptic device 51 may include safety features to prevent unintentional use of the robotic system 10 or the haptic device 51. For example, the haptic device 51 may include a user interface 57 (power switch) that needs to be pressed to manipulate the interface 53. Similarly, it may be necessary to press the user interface 57 to allow the haptic device 51 to transmit commands to the robotic surgical system 10. In another instance, it may be necessary to press and hold the interface 53 in the pressed position before it is manipulated. In yet another instance, the haptic device 51 may include one or more sensors, such as force sensors, temperature sensors, proximity sensors, optical sensors, and / or pressure sensors, to enable one or more controllers 33 to determine whether an operator's hand is in contact with the haptic device 51.

[0133] The tactile device 51 can be used in various operating modes, some of which are in Figure 11A The operating modes are described in the table (referred to as "Haptic Device Operating Modes"). As shown in the figure, these operating modes include, but are not limited to: "Autonomous Check Mode," "Manual Control Mode," "Simulated Autonomous Check Mode," and "Simulated Manual Control Mode." These names are provided for simplicity of understanding and description, and may therefore be used in any other appropriate convention. The functionality of these modes is to be fully understood based on the descriptions provided below.

[0134] refer to Figure 11A Column B of the table indicates that in each tactile device operating mode, one or more controllers 33 provide tactile feedback to the tactile device 51. In autonomous inspection mode and manual control mode, the tactile device 51 simulates the current interaction between the pedicle screw PS and the target site. In simulated autonomous inspection mode and simulated manual control mode, the tactile device 51 simulates the current interaction between a simulated pedicle screw and a simulated target site. Any of these modes can be initiated automatically by the robot system 10, manually by the operator, or upon any other command.

[0135] Furthermore, for any of the control modes described herein, the screw position and depth can be displayed on the display device.

[0136] B. Interactive Sensors

[0137] For any of the operating modes described herein, the robotic surgical system 10 may include one or more sensors coupled to one or more controllers 33 to obtain measurements indicating the current interaction between movable elements of the system (such as implants, screws, and / or the tools themselves) and the target site. For example, the robotic surgical system 10 may include a position sensor configured to sense the position of the pedicle screw PS relative to the target site and / or a rotary encoder configured to sense rotation of the actuator 44 of the surgical tool 30 or rotation of the pedicle screw PS. The robotic surgical system 10 may include a force sensor configured to sense the force exerted on the pedicle screw PS by the target site. The robotic surgical system 10 may include a torque sensor configured to sense the torque exerted on the pedicle screw PS by the target site and / or an electrical parameter sensor configured to sense electrical parameters generated by the actuator of the surgical tool 30, wherein the electrical parameters are proportional to the torque exerted on the surgical tool 30 by the current interaction between the screw and the target site. For example, in such instances, an increase in torque may indicate that the pedicle screw PS has contacted or will contact the cortical wall, while a rapid decrease in torque may indicate that the pedicle screw PS has breached the cortical wall and has reached the bottom. The robotic surgical system 10 may also include a proximity sensor configured to sense the proximity of the pedicle screw PS to a feature of the target site, a depth sensor configured to sense the depth of the pedicle screw PS within the target site, and a displacement sensor configured to sense the displacement of the pedicle screw PS relative to a feature of the target site.

[0138] In one implementation, navigation system 12 additionally or alternatively determines the current interaction between the pedicle screw PS and the target site. As previously described, preoperative and / or intraoperative imaging can be used to visualize the patient's anatomy. For example, preoperative images (e.g., X-ray, CT scan, or MRI images) can be used to create an anatomical (virtual) model of the patient's anatomy (specifically the target site). The anatomical model of the target site can be registered to the target site using any suitable registration method. Navigation system 12 can track the robot, tools, screws, and / or patient and determine the position of the pedicle screw PS relative to the anatomical model of the target site. Navigation system 12 may include predetermined data indicating the expected interaction between the pedicle screw PS and the anatomical model at multiple locations relative to the anatomical model. In one example, the data may be stored in a lookup table in memory for access by one or more controllers 33. Navigation system 12 may obtain measurements indicating the current interaction between the pedicle screw PS and the target site based on the determined state, position, orientation, and / or posture of the screw relative to the anatomical model and the predetermined data. The predetermined data may include bone mineral density data of vertebra V. Navigation system 12 can use bone mineral density data and the state of the screw relative to an anatomical model of the vertebral V to obtain indications of the relationship between the pedicle screw PS and the vertebral V, for example... Figure 12A The measured value of the current interaction at depth A is shown. The predetermined data may also include known data regarding the geometry of the screw, the tool, or any other characteristics relevant to defining the interaction.

[0139] Any combination of the above sensors (including navigation system 12) can be combined to implement sensing between the movable element and the target part.

[0140] C. Tactile interaction feedback

[0141] The controller 32 can be configured to provide physical feedback to the tactile device 51 to mimic the current interaction between the pedicle screw PS and the target site. As described below, the physical feedback can take various forms.

[0142] Any control mode described in this article, namely "autonomous check mode", "manual control mode", "simulated autonomous check mode" and "simulated manual control mode", can fully utilize any tactile interaction feedback technology described in this article.

[0143] To implement these technologies, the tactile device 51 may be equipped with one or more sensors 65, such as Figure 10As shown, features are used to sense the tactile device 51. For example, one or more sensors can detect any measurement related to the actuator 55, interface 53, any combination thereof, or any other feature. Such sensors 65 can be implemented as position or displacement sensors, incremental / absolute encoders, angle sensors, potentiometers, Hall effect sensors, inductive sensors, capacitive sensors, inertial sensors (such as accelerometers), velocity sensors, inclinometers, gyroscopes, force sensors, torque sensors, strain gauge sensors, or any combination or equivalent thereof.

[0144] In some embodiments, one or more controllers 33 are configured to modify or restrict the mechanical movement of the interface 53 using means different from or other than the actuator 55. For example, to influence the movement of the interface 54, the tactile device 51 may utilize mechanical components, including but not limited to biasing mechanisms, stoppers, ratchet and / or gear systems; electrical components, such as, but not limited to, inductive, capacitive and / or resistive elements; magnetic components; electromagnetic components; electromechanical components; hydraulic components; and / or pneumatic components.

[0145] In some embodiments, one or more controllers 33 are configured to prevent the ability to manually manipulate the interface 53. For example, one or more controllers 33 may determine that a certain condition exists during the control of the pedicle screw PS, and in response, may provide tactile feedback to the operator regarding said condition by controlling the actuator 55 of the tactile device 51 to prevent the ability to rotate the rotating interface 53. For example, said condition may include erroneous conditions that would prevent the ability to rotate the rotating interface 53. These stopping conditions include the pedicle screw PS reaching a desired depth, the pedicle screw PS being rotated a predetermined number of revolutions, the prediction of the contact point between the pedicle screw PS and the bone (as described in U.S. Patent Application Publication No. 2017 / 0000572, entitled "Robotic surgical systems And Methods For Controlling A Tool Removing Material From A Workpiece," filed June 28, 2016, by Moctezuma de la Barrera et al., which is hereby incorporated herein by reference), and / or the operator stopping based on subjective knowledge (e.g., the operator may set the amount of time to rotate each pedicle screw PS). Additionally, the conditions may include error conditions, such as malfunctions detected within the robotic surgical system 10. In some instances, instead of preventing rotation of the rotating interface 53, the robotic surgical system 10 may provide tactile feedback to the operator via vibration and / or pulses. For example, one or more controllers 33 may cause the tactile device 51 to vibrate when the pedicle screw PS has reached the desired depth.

[0146] Any of the aforementioned haptic technologies can be used individually or in combination in any of the modes or examples described herein or their equivalents. Furthermore, one or more controllers 33 can alter or modify any haptic technology in response to any condition, such as readings from interactive sensors, sensor 65 of the haptic device 51; changes or activation of control modes; or based on operator input. Additionally, any technologies described herein can be applied to the rotary or linear interface of the haptic device 51.

[0147] 1. Tactile feedback—resistance or torque

[0148] In one example, the physical feedback is the resistance applied to interface 53. Actuator 55 can adjust the force or torque required for the operator's hand to manipulate interface 53. The force required to manipulate rotating interface 53 can reflect the current force required to rotate the screw relative to the target location. Since interface 53 is coupled to actuator 55, actuator 55 can generate resistance to movement within the degrees of freedom of interface 53.

[0149] For example, refer to Figure 12A The current force required to rotate the pedicle screw PS is shown as F. PS The resistance provided to actuator 55 is shown as F. A And the force required to rotate the rotary interface 53 is shown as F. RI F RI It is shown as a dashed line because it is subjected to F when the operator manually manipulates the rotary interface 53. RI At different depths along trajectory LH, the current force F PS The change in the magnitude of the resistance F results in a change in the resistance F. A Heli F RI Change accordingly.

[0150] The controller 32 can control the actuator 55 to adjust, modify, amplify, or otherwise dynamically change the resistance. To this end, the controller 32 can modify the operating voltage, frequency, or current of the actuator 55. The resistance can be modeled or implemented as a spring force, damping force, impact force, etc. Furthermore, the resistance can be based on position, velocity, and / or acceleration parameters.

[0151] In some instances, the robotic surgical system 10 can be configured to receive input from an operator to selectively adjust the resistance F supplied to the actuator 55. A Additionally, the robotic surgical system 10 can be configured to receive input from the operator to selectively adjust the sensitivity of the interface 53's ability to control the rotation of the surgical tool 30 and the pedicle screw PS. In some instances, the resistance F A The sensitivity of interface 53 is related. For example, the resistance F A The larger the value, the higher the sensitivity of interface 53, and the lower the resistance F. AThe smaller the value, the lower the sensitivity of interface 53. Parameters that can be adjusted to modify the sensitivity of interface 53 include, but are not limited to: spring parameters, damping parameters, force parameters, the scaling factor between the rotational ratio of actuator 55 and interface 53, actuator parameters, the magnitude of the force, the direction of the force, the displacement limit or range of interface 53 for any given resistance, the resistance curve or slope, etc. For example, in an instance where interface 53 includes a spring and the spring parameters are adjusted, such spring parameters could be spring stiffness, where a greater spring stiffness requires a greater force to actuate interface 53. In such an instance, the spring can be formed of a compliant element, such that the spring stiffness can be modified by changing the material properties of the compliant element or by changing the geometry of the compliant element.

[0152] In one example, the resistance could be a restoring force, the magnitude of which is proportional to the magnitude of the deviation of interface 53 from its original position (zero detent) defined on interface 53 or between interface 53 and actuator 55. For example, the original position could be the position of interface 53 defined by the controller when a haptic mode is activated. In one example, the original position is defined as a static position relative to the haptic device 51. In another example, one or more controllers 33 could dynamically adjust the position of the original position based on any existing conditions, such as readings from interactive sensors, sensor 65 of the haptic device 51; changing or activating a control mode; completing a task; or based on operator input. Alternatively, the original position could be mechanically predefined, such as using a physical stop.

[0153] In some implementations, the resistance may yield to the movement of the interface 53. In other words, the resistance does not seek to restore the position of the interface 53 to any original position. The magnitude of the resistance may be small initially, and the magnitude of the resistance may increase as the interface 53 moves further from its original position.

[0154] In some instances, the resistance increases to a value necessary to communicate to the user that the screw PS has reached its limit relative to the target location. This might be suitable, for example, in cases where the screw is adjacent to the internal cortical wall of the vertebral body, thereby providing a constraint to avoid damaging the cortical wall. In one example, the resistance could be modeled as a barrier force effect with a high stiffness value. Alternatively, in such instances, the controller could direct the actuator 55 to impose mechanical constraints on the movement of the interface 53.

[0155] In many examples, resistance is applied to resist rotational motion. However, resistance can also be applied to resist linear motion. For example, linear motion can resist linear motion of interface 53. This linear motion can be the movement of a mechanism of interface 53 (such as a slider, button, etc.). Alternatively or additionally, linear motion can be an example of pushing the rotary interface 53 downward. In these examples, resistance resists pushing the rotary interface 53 downward.

[0156] Resistance can be provided in response to different conditions related to the current interaction between the pedicle screw (PS) and the target site. Any of these conditions can be detected by any of the aforementioned interactive sensors.

[0157] In one example, resistance is applied to interface 53 in response to the rotational position of the pedicle screw PS. The position of the screw PS relative to a reference point is determined. The resistance applied to interface 53 can be gradually increased or decreased until the screw has reached a designated position. In this example, the original position of interface 53 can be utilized. Interface 53 can be rotated away from the original position to command the screw to drive. When in a non-original position, resistance is applied to interface 53. However, once a certain position is reached, the resistance can be reduced to zero, and interface 53 can spring back to the original position. Alternatively, the resistance can be gradually reduced (until zero) as the screw gradually approaches the stated position.

[0158] In another example, resistance is applied to interface 53 in response to the insertion depth of the pedicle screw PS. In this example, the original position of interface 53 can be utilized. Interface 53 can be rotated away from the original position to command the screw to drive. When in a non-original position, resistance is applied to interface 53. However, once the insertion depth is reached, the resistance can be reduced to zero, and interface 53 can spring back to the original position. Alternatively, the resistance can be gradually reduced (until it becomes zero) as the screw gradually approaches the insertion depth.

[0159] In another example, resistance is applied to interface 53 in response to the rotational speed of the pedicle screw PS. In this example, the original position of interface 53 can be utilized. Interface 53 can be rotated away from the original position to command the screw to drive. When in a non-original position, the resistance can be gradually increased / decreased according to the screw's rotational speed.

[0160] In another example, resistance is applied to interface 53 in response to the torque applied to the pedicle screw PS by the target site or in response to the torque applied by the tool.

[0161] In another example, one or more controllers 33 may also provide tactile feedback to the operator via vibration and / or pulses. For example, one or more controllers 33 may adjust the vibration frequency and / or amplitude of the tactile device 51 based on the current force required to rotate the screw relative to the target area. In a more specific example, as the force required to rotate the screw relative to the target area increases, the vibration amplitude of the tactile device 51 may increase, and the vibration frequency of the tactile device 51 may decrease. Similarly, as the force required to rotate the screw relative to the target area decreases, the vibration amplitude of the tactile device 51 may decrease, and the vibration frequency of the tactile device 51 may increase.

[0162] Resistance can be implemented using any combination of the examples described herein or their equivalents.

[0163] 2. Haptic feedback - position

[0164] Interface 53 may employ feedback techniques other than resistance. In one example, the actuator 55 actively controls (moves) the position of interface 53 in response to the current interaction between the screw PS and the target area, providing feedback to the operator. Any of these conditions can be detected by any of the aforementioned interactive sensors.

[0165] In one example, the position of interface 53 is controlled in response to the rotational position of the pedicle screw PS. The position of interface 53 can be actively rotated by actuator 55 based on the real-time position of the screw. As the screw rotates, interface 53 will also rotate. In another example, the position of interface 53 can be moved to a fixed position or somewhere in between to inform the operator of any positional information related to the screw, such as maximum position or insertion depth. Interface 53 may include a graphical scale or markings to associate the interface position with the screw position.

[0166] In another example, the position of interface 53 is controlled in response to torque applied to the pedicle screw PS from the target site or in response to torque applied by a tool. The position of interface 53 can be actively moved by actuator 55 to indicate to the operator the various torque levels experienced by the screw. Interface 53 may include a graphical scale or markings to correlate interface position with screw torque.

[0167] In yet another example, the position of interface 53 is controlled in response to the rotational speed of the pedicle screw PS. The position of interface 53 can be actively moved by actuator 55 to indicate to the operator the various speed levels experienced by the screw. Interface 53 may include a graphical scale or markings to associate the interface position with tool or screw speed.

[0168] 3. Tactile feedback – range of motion

[0169] In another example, the control interface 53 is restricted in response to the current interaction between the screw PS and the target area to provide feedback to the operator. Any of these conditions can be detected by any of the aforementioned interactive sensors.

[0170] In one example, interface 53 is restricted to allow only rotation by an amount related to the amount the screw has turned. In another example, interface 53 is restricted to allow only rotation by an amount related to the depth to which the screw has been inserted. In yet another example, interface 53 is restricted to allow only rotation by an amount that indicates the position where the screw has reached a physical or virtual boundary.

[0171] In another implementation, when the interface 53 is rotating, its range of motion can be controlled to allow continuous rotation, such as any number of full 360-degree rotations. This may be suitable in certain control modes, as described below, such as when the tactile device 51 is used to allow a user to manually control screw insertion by controlling the rotation of the interface 53 to achieve a speed or force / torque for input control.

[0172] D. Self-inspection mode

[0173] One mode of the tactile device 51 is an autonomous inspection mode. During autonomous inspection mode, the robotic surgical system 10 provides tactile feedback to the operator to mimic the current interaction between the pedicle screw PS and the target site as the robotic system 10 autonomously inserts the screw PS. During autonomous inspection mode, the rotary interface 53 can adjust the force F according to... RI Manual manipulation to provide the operator with the current force F required to rotate the pedicle screw PS relative to the vertebral V. PS The tactile feedback. In other words, the autonomous inspection mode allows the operator to "feel" the screw interaction at any given time before, during, or after autonomous screw insertion.

[0174] like Figure 11A As shown in columns B and D of the table, tactile feedback is provided to the tactile device 51 for examination, but the tactile device 51 does not control the insertion of the surgical tool 30 or the actuator 44 during autonomous examination mode, because the robotic system 10 inserts the screw autonomously (see...). Figure 11A (Column D).

[0175] Figure 12A An example of the interaction between the pedicle screw (PS) and the target vertebral V during autonomous examination mode is provided. Figure 12A In this system, one or more controllers 33 autonomously control the insertion of a pedicle screw PS along a planned trajectory LH. In this case, the screw is self-tapping. Simultaneously, one or more controllers 33 control a tactile device 51 to mimic the current interaction between the pedicle screw PS and the vertebra V. For example, when the pedicle screw PS is inserted along the planned trajectory LH to depth A, one or more controllers 33 control the tactile device 51 to mimic the current interaction between the pedicle screw PS and the vertebra V at depth A. Therefore, the system 10 provides the operator with tactile sensations to experience the robotic system performing the screw PS insertion.

[0176] In one example, such as Figure 11AAs outlined in column F of the table, the autonomous inspection mode can be performed by the robotic system 10 simultaneously with / during active and autonomous screw insertion. In such an example, by initiating the autonomous inspection mode, the rotary interface 53 is controlled to be manually manipulated, allowing the operator to receive tactile feedback from the robotic surgical system 10 via the rotary interface 53 as the screw is autonomously inserted. In this example, the tactile inspection does not cease during autonomous screw insertion. As the screw PS continues to be autonomously inserted, the current interaction between the pedicle screw PS and the vertebra changes continuously with the insertion depth. Therefore, in this example, the resistance feedback to the rotary interface 53 can be varied to reflect the near real-time current interaction between the pedicle screw PS and the vertebra. The resistance update can be set according to any suitable time step, such as once every N seconds, once per N degrees of screw rotation, once per N mm of screw displacement, etc.

[0177] Alternatively, such as Figure 11A As outlined in column F of the table, an autonomous inspection mode can be initiated after one or more controllers 33 have stopped or paused autonomous control of the surgical tool 30 to stop rotation of the pedicle screw PS. In one example, the robotic system 10 stops or pauses autonomous control in response to an operator triggering the autonomous inspection mode. Alternatively, the robotic system 10 stops or pauses autonomous control in response to any other system command, such as a user-initiated stop autonomous movement. In any instance, the system 10 controls the tactile device 51 to mimic the interaction between the pedicle screw PS and the vertebrae present when the system 10 is stopped or paused. After executing the autonomous inspection mode, the operator can restart the autonomous control of the robotic system 10 to continue screw insertion.

[0178] In another example, such as Figure 11A As outlined in column F of the table, the robotic surgical system 10 can initiate an autonomous inspection mode before one or more controllers 33 autonomously control the surgical tool 30 to insert the pedicle screw PS. For example, an operator may be interested in tactile feedback on the pedicle screw PS before one or more controllers 33 autonomously control the surgical tool 30 to insert the pedicle screw PS. In such instances, the screw PS may be partially implanted based on manual insertion by the surgeon, followed by autonomous insertion. The existing interaction between the partially implanted screw PS and the target site can be reflected to the tactile device 51 for the surgeon to examine before initiating autonomous insertion.

[0179] In some examples, the activation of the autonomous inspection mode automatically initiates autonomous control of the surgical tool 30 via one or more controllers 33. Similarly, when the autonomous inspection mode is deactivated, one or more controllers 33 can deactivate the autonomous control of the surgical tool 30. Alternative instances of the autonomous inspection mode, their capabilities, and uses are envisioned.

[0180] E. Manual control mode

[0181] In manual control mode, the operator uses the tactile device 51 to control the surgical tool 30 to achieve purposes such as, but not limited to, inserting a pedicle screw PS. During manual control mode, one or more controllers 33 do not autonomously control the insertion of the pedicle screw PS (e.g., ...). Figure 11A (As shown in column D). Instead, the interface 53 of the tactile device 51 is manipulated to provide input to one or more controllers 33 to control the insertion of the pedicle screw PS. In response to the control input from the tactile device 51, one or more controllers 33 control the surgical tool to rotate the screw at a rotational rate about the rotation axis R and to advance the screw linearly along the planned trajectory LH at an advance rate.

[0182] The manual control mode can be used before or after any other tactile device modes described herein. In one example, the robot can autonomously insert a screw to the desired or predetermined torque peak, insertion depth, or screw rotation number. The remaining portion of the task can then be completed using the manual control mode.

[0183] 1. Manual control input

[0184] refer to Figure 11A In the table for manual control mode, column G indicates that one or more controllers 33 can be configured to determine or receive input control techniques that define how the haptic device 51 can be used as input.

[0185] refer to Figure 11B Examples of these input control techniques include, but are not limited to, using the haptic device 51 as a force or torque input, rotational position input, or rotational speed input. Input control techniques can be set according to the surgeon's preferences, specified by the system, or any combination thereof. The operator can use the user interface 57 of the haptic device 51. Figure 10 The input control technology can be selected either as shown in the diagram or by any other method, such as input to the display device 18.

[0186] In manual control mode, the tool is controlled to insert a screw in response to input from the tactile device 51. As described below, various output techniques exist for controlling the screw, which may be the same as or different from the techniques used for input control.

[0187] a. Force or torque input from the tactile device

[0188] refer to Figure 11B An exemplary input provided by the tactile device 51 is a force or torque input applied by the operator to the interface 53. For example... Figure 12B As shown, the operator can apply force F. inManually operate interface 53. The force F in Alternatively, it can be applied torque. One or more controllers 33 can obtain measurements of the force applied to interface 53 to determine the desired force for inserting the pedicle screw PS and control the insertion of the pedicle screw PS based on said desired force. The applied force or torque can represent the force or torque between the screw PS and the target site as desired by the operator.

[0189] For example, one or more controllers 33 may be based on a force F used to manually manipulate the rotary interface 53 from its original position P0 to a non-original position P1. in To determine the desired force for inserting the pedicle screw PS, such as Figure 11C As shown. In each of these examples, position P1 is only shown as one possible example of the many positions that interface 53 can be in relative to the original position. In one example, one or more controllers 33 can be configured to apply force F by the operator. in The force F is obtained by measuring or calculating the torque applied to the rotary interface 53. in The measured value. In another example, one or more controllers 33 may be configured to measure the force F applied by the operator. in The force F is obtained by determining the acceleration of the rotating interface 53. in The measured value.

[0190] The robotic surgical system 10 includes having Figure 4-6 In the example of the surgical tool 30 with trigger 49 shown, the operator can control the insertion of the pedicle screw PS by manually manipulating trigger 49 instead of the rotating interface 53 of the tactile device 51. In such an example, the operator can use force F in Pressing trigger 49 transmits a signal indicating operator input to one or more controllers 33.

[0191] Interface 53 may include a zero-lock position (original position P0), such that interface 53 returns to its original position when released by the operator after applying force. Therefore, the operator can apply a series of forces F without unnecessarily moving their hand. in The force is applied to the rotary interface 53. In another example, interface 53 can continue to rotate with unhindered degrees of freedom to allow interface 53 to rotate sufficiently to achieve the desired force. Thus, the rotary interface 53 provides a full 360-degree range of motion, allowing the operator to simulate rotating a screw with their hand.

[0192] b. Position input from the tactile device

[0193] In another example, one or more controllers 33 may obtain measurements of the position (or position change) of interface 53 to provide control input. For example, in an instance where an operator manually manipulates the rotating interface 53 from its original position P0 to position P1, one or more controllers 33 may determine the desired rotational position of the pedicle screw PS based on the positioning of position P1 relative to the original position P0. In some instances, one or more controllers 33 may obtain measurements of the rotation angle of the rotating interface 53 at position P1 relative to the original position P0. Any suitable sensor, such as an incremental or absolute encoder coupled to interface 53 and / or actuator 55, may be used to determine the position. The displacement of interface 53 relative to the original position P0 may also be used as input. Alternatively, the position of interface 53 relative to its full range of motion (e.g., 360 degrees) may be used as input, independent of the original position. The position may also take into account the cumulative rotation count of interface 53 relative to its full range of motion (e.g., 1 revolution and 1 / 2 revolution or 540 degrees).

[0194] In one example, interface 53 may include a zero-position (original position P0) such that interface 53 returns to the original position when released by the operator at the desired position. In another example, interface 53 may continue to rotate with unobstructed degrees of freedom to allow interface 53 to rotate sufficiently to achieve the desired position.

[0195] c. Speed ​​input from the tactile device

[0196] In yet another example, the input provided by the haptic device 51 is the velocity experienced by the interface 53 in response to operator manipulation. One or more controllers 33 may use any suitable sensing device (such as an inertial sensor, encoder, Hall effect sensor, etc.) to obtain a measurement of the velocity of the interface 53. For example, as Figure 11B As shown, assume that interface 53 is in its original position P0 at time T0, and the operator manually manipulates the interface to move to position P1 at time T1. One or more controllers 33 can determine the distance or displacement between P1 and P0 relative to the change in time T1-T0 to determine the velocity of interface 53. This distance or displacement can be linear or angular. One or more controllers 33 can utilize any suitable software or logic (such as integrators, differentiators, lookup tables, etc.) to calculate the velocity based on the sensed readings.

[0197] In one example, interface 53 may include a zero-position (original position P0) such that interface 53 returns to its original position when released by the operator. In another example, interface 53 may continue to rotate with unhindered degrees of freedom to allow interface 53 to rotate sufficiently to achieve the desired speed input.

[0198] The input control from the tactile device 51 can be any combination of force, position and / or speed.

[0199] 2. Manual control output

[0200] In response to a control input from the tactile device 51 utilizing any of the aforementioned input techniques (force, position, velocity), the system 10 is configured to control the insertion of a screw. (See reference) Figure 11B Tools can be controlled to drive screws using various output control techniques. These output control techniques include force, rotational position, insertion depth, and speed. These output control techniques are described in more detail below, and can be utilized in response to any input technique (force, position, speed).

[0201] One or more controllers 33 can be configured to determine or receive output control techniques that define how the tool should be operated in manual control mode (i.e., force, rotational position, insertion depth, and speed). The output control techniques can be set according to the surgeon's preferences, specified by the system, or any combination thereof. The operator can use the user interface 57 of the tactile device 51 (… Figure 10 The output control technology can be selected either as shown in the diagram or by any other method, such as input to the display device 18.

[0202] In all instances of output in manual control mode, the screw rotation and advance rate are determined by the pitch, according to the techniques described herein. Furthermore, for any of the examples described herein, the sensitivity of interface 53 can be varied to induce control of the tool. The sensitivity of interface 53 can be updated manually or automatically to account for bone density.

[0203] a. Tool force output control

[0204] In response to any input technology (force, position, speed), one or more controllers 33 can operate the tool to drive the screw PS based on force control.

[0205] In one example, the input position of interface 53 determines the force output to the screw by tool 30. The force output can be torque. In one example, the input position of interface 53 can determine a specific level of force or torque that the tool should apply to the screw, and tool 30 is controlled to apply the specified force or torque. In another example, the position of interface 53 can determine the maximum level of force or torque that the tool should apply to the screw, and the robot and tool 30 continue to insert the screw until the maximum force or torque is reached. In these examples, interface 53 may include a zero-lock position (original position P0) such that interface 53 returns to its original position when released by the operator.

[0206] In one example, the input speed of interface 53 determines the force output to the screw by tool 30. For example, increasing / decreasing the speed of interface 53 can cause an increase / decreasing of the torque applied to the screw by the tool. In this example, the user may need to rotate interface 53 faster and faster to achieve full screw insertion.

[0207] In yet another example, the input force or torque applied to interface 53 causes the tool to apply a force or torque output to drive the screw. In one example, the input force or torque of interface 53 may determine a specific force or torque level that the tool should apply to the screw, and tool 30 is controlled to apply the specified force or torque. Alternatively, the input force or torque of interface 53 may determine the maximum force or torque level that the tool should apply to the screw, and the robot and tool 30 continue to insert the screw until the maximum force or torque is reached.

[0208] b. Tool rotation position output control

[0209] In response to any input technique (force, position, velocity), one or more controllers 33 can operate the tool to drive the screw PS based on rotational position control. The rotational position can be defined as the rotational angle of the screw relative to a reference angle.

[0210] In one example, the input position of interface 53 causes the tool to rotate the screw PS to a certain position. Alternatively, the displacement of interface 53 causes the tool to rotate the screw PS according to the displacement.

[0211] In another example, the speed input of interface 53 causes the tool to rotate the screw PS to a certain position. Increasing / decreasing the input speed of interface 53 can also cause a change in the output position control. In this example, the user may need to rotate interface 53 faster and faster to achieve full screw insertion.

[0212] In another example, the force or torque input to interface 53 causes the tool to rotate the screw PS to a certain position. In one example, the input force or torque to interface 53 can determine a specific position to which the tool should drive the screw. Alternatively, the input force or torque to interface 53 can determine a maximum position to which the tool should drive the screw, and the robot and tool 30 continue inserting the screw until the maximum position is reached.

[0213] c. Tool insertion depth output control

[0214] In response to any input technique (force, position, speed), one or more controllers 33 can operate the tool to drive the screw PS to a specific insertion depth within the target area.

[0215] In one example, the input position of interface 53 causes the tool to rotate the screw PS to a specific insertion depth. Alternatively, the displacement of interface 53 causes the tool to rotate the screw PS according to the insertion depth.

[0216] In another example, the speed input of interface 53 causes the tool to rotate the screw PS to a specific insertion depth. Increasing / decreasing the input speed of interface 53 can also cause a change in the insertion depth. In this example, the user may need to rotate interface 53 faster and faster to achieve the full insertion depth.

[0217] In another example, the force or torque input to interface 53 causes the tool to rotate the screw PS to a specific insertion depth. In one example, the input force or torque to interface 53 can determine the specific insertion depth to which the tool should drive the screw. Alternatively, the input force or torque to interface 53 can determine the maximum specific insertion depth to which the tool should drive the screw, and the robot and tool 30 continue to insert the screw until the specific insertion depth is reached.

[0218] d. Tool speed output control

[0219] In response to any input technique (force, position, speed), one or more controllers 33 can operate the tool to drive the screw PS based on speed control. Speed ​​can be defined by the variation of the following with respect to time: the screw's rotation angle, the screw's linear insertion rate, the tool's rotational speed, or any combination thereof.

[0220] In one example, the input velocity of interface 53 causes the tool to rotate screw PS according to the corresponding velocity. Alternatively, the displacement of interface 53 causes the tool to rotate screw PS according to the corresponding velocity.

[0221] In another example, the speed input of interface 53 causes the tool to rotate screw PS according to a relevant speed. Increasing / decreasing the input speed of interface 53 can also cause a change in the output speed control. In this example, the user may need to rotate interface 53 faster and faster to achieve a certain speed.

[0222] In another example, the force or torque input to interface 53 causes the tool to rotate the screw PS according to a relevant speed. In one example, the input force or torque to interface 53 can determine a specific speed at which the tool should drive the screw. Alternatively, the input force or torque to interface 53 can determine a maximum speed at which the tool should drive the screw, and the robot and tool 30 continue inserting the screw until the maximum speed is reached.

[0223] e. The relationship between input and output

[0224] The above describes various input control techniques provided by the tactile device 51 and various output control techniques used to drive the tool. The relationship between the inputs of the tactile device 51 and the outputs of the tool can be defined according to various configurations described below. Any combination of the various configurations described below can be used to define the relationship between the inputs of the tactile device 51 and the outputs of the tool.

[0225] One or more controllers 33 can map the input of the tactile device 51 to a predetermined output of the tool, which may correspond to the tool's default settings. For example, the memory of one or more controllers 33 may include a lookup table, wherein the input of the tactile device 51 corresponds to a predetermined default output of the tool. In one such example, one or more controllers 33 may obtain a measurement of the interface 53 rotating 30 degrees. The one or more controllers 33 may then determine, based on the lookup table, that the pedicle screw PS should rotate at a rotational speed of 1.5 revolutions per second.

[0226] One or more controllers 33 can map inputs from the tactile device 51 to predetermined outputs of the tool, which can be based on various variables. For example, the predetermined output of the tool can be based on conditions of the tactile device 51 that can be detected by any of the aforementioned interactive sensors or sensors 65. For example, the predetermined output can be based on the insertion depth of the pedicle screw PS, the current force F required to rotate the pedicle screw PS, etc. PS And / or bone mineral density data of vertebra V. As another example, the predetermined output of the tool may be based on readings sensed by sensor 65 of the user interface 57 of the tactile device 51. For example, the user interface 57 may include a button that can be pressed for “sensitive” control or a slider that can be actuated to indicate the desired control sensitivity. The predetermined output may be based on the desired control sensitivity as sensed by sensor 65.

[0227] One or more controllers 33 can map the relationship between input and output based on any suitable mathematical function, such as a monotonic function, a linear function (e.g., a proportional function), an exponential function, a logarithmic function, a polynomial function, a root function, a power function, and a rational function. In one example, one or more controllers 33 can map the measured position to a desired insertion depth based on a linear function, such that the degree of rotation of the rotary interface 53 is proportional to the desired insertion depth. For example, for each degree of rotation of the rotary interface 53, one or more controllers 33 increase the desired insertion depth by 1 / 90 mm. In another example, one or more controllers 33 can map the measured position to a rotational speed based on a piecewise constant function (i.e., a floor function). In such an example, one or more controllers 33 may map the measured position to a desired rotational speed such that when the rotation interface 53 rotates between 1 degree and 180 degrees (inclusive), the one or more controllers 33 determine the desired rotational speed as 1 revolution per second, and when the rotation interface 53 rotates between 181 degrees and 360 degrees (inclusive), the one or more controllers 33 determine the desired rotational speed as 2 revolutions per second.

[0228] One or more controllers can map any input technique (force, position, speed) to the output control (force, rotational position, insertion depth, speed) of the tool based on the mapping relationship between the input of the tactile device 51 and the output of the tool.

[0229] like Figure 11B As shown in column D, force input can be mapped to rotational position output, insertion depth output, force output, or velocity output. For example, force input can be linearly mapped to rotational position output, allowing the measured value of force input (F) to be mapped to the rotational position output. in The measured values ​​are mapped to a proportional screw rotation. Similarly, the force input can be linearly mapped to the insertion depth output, force output, and speed output, so that the force input can be mapped to a proportional screw insertion depth, a proportional torque applied to the pedicle screw PS, and a proportional screw insertion speed.

[0230] like Figure 11B As shown in column D, position inputs can be mapped to rotational position outputs, insertion depth outputs, force outputs, or velocity outputs. For example, a position input can be linearly mapped to a rotational position output, such that a measurement of the position input (a measurement of position P1 or a measurement of the displacement between positions P1 and P0) is mapped to a proportional screw rotation. Similarly, a position input can be linearly mapped to insertion depth outputs, force outputs, and velocity outputs, such that a measurement of position P1 relative to the original position P0 is mapped to a proportional screw insertion depth, a proportional maximum torque level to be applied to the pedicle screw PS, and a proportional screw insertion speed.

[0231] like Figure 11B As shown in column D, velocity input can be mapped to rotational position output, insertion depth output, force output, or velocity output. For example, velocity input can be linearly mapped to rotational position output, such that a measurement of the velocity input (a measurement of the change in displacement between P1 and P0 relative to time T1-T0) can be mapped to a proportional screw rotation. Similarly, velocity input can be linearly mapped to insertion depth output, force output, and velocity output, such that velocity input can be mapped to a proportional screw insertion depth, a proportional torque applied to the pedicle screw PS, and a proportional screw insertion speed.

[0232] F. Simulation Mode

[0233] The technology associated with the aforementioned tactile device 51 already relates to intraoperative techniques utilizing physical robots to control and / or drive tools. However, it is conceivable to utilize the tactile device 51 to perform simulations, thereby providing operators with training or greater confidence in using robotic systems prior to performing actual surgical procedures. Reference Figure 11A The table and Figures 14A-14C Various simulation modes exist that can be used with the tactile device 51. These modes include a simulated autonomous inspection mode and a simulated manual control mode, and these modes are described in detail below.

[0234] The simulation mode can simulate the entire operating room conditions that may exist during surgery, including but not limited to the patient, robotic system, robotic manipulator, patient table, navigation system, tools, and screws. The simulation can alternatively simulate: screws and target sites; tools, screws, and target sites; or robotic manipulators, tools, screws, and target sites. Furthermore, a surgical plan, including target trajectory and insertion depth, can be provided in the simulation for reference.

[0235] The simulation can be performed on any suitable graphics display device, such as, but not limited to, one or more displays 18 of the robotic system 10 or displays outside the operating room. One or more controllers 33 can perform the simulation. Alternatively, the haptic device 51 can be connected to a simulation system separate from the robotic system 10, wherein the simulation system has its own control system.

[0236] The simulation mode described herein can be performed preoperatively or intraoperatively. For example, a surgeon may perform a simulation in the operating room just before commanding the physical robot controls. Alternatively, the simulation may be performed prior to the surgical procedure. In either case, the surgeon may set, confirm, or modify any operational parameters of system 10 experienced during the simulation. For example, the surgeon may set, confirm, or modify: surgical planning, such as pedicle screw size, insertion depth, and pedicle entry point location; tactile device operation or sensitivity; preferred control input technology for the tactile device (force / torque, position, velocity); tool operation, feed rate, linear advance rate, rotational speed, or sensitivity; preferred control output technology for the tool (force / torque, position, velocity); robot parameters, such as posture or orientation, etc.

[0237] As previously mentioned, preoperative and / or intraoperative imaging can be used to visualize the patient's anatomy. For example, preoperative images (e.g., X-rays, CT scans, or MRI images) can be used to create an anatomical model of the patient's anatomy (specifically, the target site). This virtual anatomical model can then be used for simulation. Furthermore, once the thread geometry of the pedicle screw PS is stored in the memory of the robotic surgical system 10, the selected pedicle screw PS can be virtually represented within the simulation.

[0238] During the execution of the simulation mode, one or more controllers 33 provide tactile feedback to the tactile device 51. The one or more controllers 33 are configured to control the actuator 55 of the tactile device 51 so that the rotary interface 53 can mimic the simulated current interaction between the pedicle screw PS and the target site. (Reference) Figure 14B and Figure 14C One or more controllers 33 can be configured to provide resistance F to actuator 55. A To adjust the force F required for the operator to rotate the rotary interface 53. RI To simulate the current interaction, the force required to rotate the rotary interface 53 reflects the simulated current force required to rotate the pedicle screw PS relative to the vertebral V (target site), such as... Figure 14C F in SPS As shown. Of course, the haptic device 51 can be controlled to provide haptic feedback using any technique other than resistance feedback (such as the force, position, or range of motion feedback techniques described above).

[0239] During the execution of the simulation mode, one or more controllers 33 may be configured to obtain simulated current interactions between the (simulated) pedicle screw PS and the (simulated) target site using various methods. For example, one or more controllers 33 may obtain virtual measurements corresponding to the simulated current interactions in the simulated coordinate system. The simulation system may track the simulated robot, tools, screws, and / or patient and determine the position of the simulated pedicle screw PS relative to the anatomical model of the target site. The simulation system may include predetermined data indicating the expected interactions between the simulated pedicle screw PS and the anatomical model at multiple locations relative to the anatomical model. In one example, the data may be stored in a lookup table in memory for access by one or more controllers 33. The simulation system may calculate parameters indicating the simulated current interactions between the pedicle screw PS and the target site based on the determined state, position, orientation, and / or posture of the screw relative to the anatomical model and the predetermined data. The predetermined data may include bone mineral density data of the vertebral V. The simulation system may use the bone mineral density data and the state of the screw relative to the anatomical model of the vertebral V to calculate or obtain parameters indicating the simulated current interactions between the pedicle screw PS and the vertebral V at various depths. The predetermined data may also include known data about the geometry of the screw, the tool, or any other characteristics related to the defined interaction.

[0240] 1. Simulated self-check mode

[0241] In one sense, the simulated autonomous inspection mode is a simulated version of the autonomous inspection mode. Therefore, any description of the autonomous inspection mode above can be incorporated into this document to understand the simulated autonomous inspection mode. During the simulated autonomous inspection mode, one or more controllers 33 (graphically) simulate autonomous control of the surgical tool 30, and the operator can use a tactile device 51 to tactilely sense the simulated autonomous insertion. The one or more controllers 33 simulate autonomous control of the surgical tool 30 by simulating rotation of the pedicle screw PS at a rotational rate around the rotation axis R and by simulating linear advancement of the pedicle screw PS along the planned trajectory LH at an advance rate. However, the robotic system does not physically control the operation of the tool. Instead, the one or more controllers 33 simulate autonomous control of the surgical tool 30 (e.g., Figure 11A (As shown in column E) to simulate autonomous insertion of the pedicle screw PS. During the simulated autonomous examination mode, the force F can be adjusted accordingly. RI However, the rotating interface 53 can be manually manipulated without the ability to control the rotation of the pedicle screw PS using the simulated surgical tool 30 and without the ability to control the simulated autonomous control of the surgical tool 30. Like the autonomous inspection mode, the simulated autonomous inspection mode can be executed before, during, or after stopping / pausing the simulated autonomous screw insertion.

[0242] 2. Simulate manual control mode

[0243] In one sense, the simulated manual control mode is a simulated version of the manual control mode. Therefore, any description of the manual control mode above can be incorporated into this document to understand the simulated manual control mode. In contrast to the manual control mode, during the simulated manual control mode, the interface 53 can be manually manipulated without the ability to control the (physical) surgical tool 30. Instead, one or more controllers 33 respond to the operator's manual manipulation of the interface 53 of the tactile device 51 (e.g., ...). Figure 11A (As shown in column E) and simulates manual control of the surgical tool 30. During the simulated manual control mode, one or more controllers 33 simulate manually controlling the surgical tool 30 in response to input from the tactile device 51. During the simulated manual control mode, one or more controllers 33 simulate controlling either the rotational rate or the advance rate of the pedicle screw PS. The operator manually manipulates the tactile device 51, and in response, one or more controllers 33 can simulate controlling either the rotational rate or the advance rate of the pedicle screw PS (e.g., as shown in column E) and simulate manual control of the surgical tool 30. Figure 11A (as shown in column G). For example, an operator can use any of the input techniques described above to manually manipulate interface 53. In response to control input, one or more controllers 33 control the output of the simulation tool based on any suitable output technique, such as the force, position, or velocity for simulated insertion of a pedicle screw PS. In this example, as... Figure 14C As shown, the user inputs force F. in An input force is applied to interface 53 to enable simulated manual control of screw insertion on display 18. The input force resists the (resistance) force F output by actuator 55. RI .

[0244] III. Methods for controlling robotic surgical systems

[0245] Now for reference Figure 15A The flowchart illustrates an example of a method for controlling the robotic surgical system 10. As shown, the flowchart illustrates the operation of various tactile device modes during surgery.

[0246] This flowchart illustrates a method for controlling a robotic surgical system 10 to insert or simulate the insertion of a pedicle screw PS. The method begins at step 200 and proceeds directly to step 202, which involves preparing an anatomical structure for receiving the pedicle screw PS. During step 202, various steps may be performed to prepare the anatomical structure for inserting the pedicle screw PS. These steps may include (1) forming an incision in the patient, (2) retracting the tissue with a tissue retractor, (3) placing a cannula in the retracted tissue, (4) drilling a guide hole 102 in the anatomical structure, and (5) tapping threads into the anatomical structure. It should be noted that step 202 need not include steps (1)-(5) above. For example, in alternative instances, steps (4) and (5) may be omitted because drilling the guide hole 102 and tapping threads into the anatomical structure may be excluded. Such instances include, for example, the use of self-drilling, self-tapping bone screws.

[0247] The method then proceeds to step 204, in which the pedicle screw PS interacts with the surgical tool 30. In some embodiments, the tool 30 is attached to the screw PS before interacting with the anatomical structure. Alternatively, any technique (including manual or robotic insertion) can be used to partially place the pedicle screw PS at a target site in the anatomical structure, after which the tool 30 interacts with the partially placed screw PS. More likely, the pedicle screw PS is attached to the distal end of the actuator 44 for placement in one of the guide holes 102. The original tactile object can be used to insert the pedicle screw PS, or a new tactile object with a new starting point, target point, and exit point can be created after attaching the actuator 44 and / or the pedicle screw PS. In this case, the drill 42 and / or the actuator 44 may have an RFID tag or other identification device, enabling one or more controllers 33 to identify which attachment is connected to the housing 45. The housing 45 may have a corresponding RFID reader, etc., communicating with one or more controllers 33 to read the tag and determine which attachment is attached. Based on this information, the controller can then create, access, or otherwise identify new line tactile objects. Similarly, the pedicle screw PS can also be equipped with an RFID tag, and the actuator 44 can have a similar reader, allowing one or more controllers 33 to also determine which size / type of pedicle screw PS is attached. Thus, the line tactile object can be based on the actuator 44 and / or the pedicle screw PS, enabling precise control of the robotic arm 20 to place that particular pedicle screw PS in a desired location, such as the desired orientation and depth relative to the patient's anatomy.

[0248] Additionally, in the case of automatic detection of attachments via RFID tags or other detection devices (such as vision cameras), the control system can advance any surgical software used with the robotic surgical system 10 to the next screen associated with the actuator 44, which may have different prompts, instructions, etc., to indicate to the operator that the actuator 44 is now connected. Voice recognition, posture sensing, or other input devices can be used to advance the software and / or change it to the next vertebra 100 to be treated and / or change the side of the vertebral body 100 from which the surgery is being performed. This can also be based on the position of the surgical instrument 30. For example, if the TCP of the attached attachment is manually positioned by the operator closer to one side of the vertebral V than the other, the software can be automatically advanced to that side corresponding to the vertebral V. The selected vertebral V and the side of surgery can be visually confirmed using the display 18 or via audio input / output.

[0249] In some surgeries, the axis of rotation R can be moved away from the desired trajectory between drilling the guide holes 102 and inserting the pedicle screws PS (such as when all the guide holes 102 are drilled first, and then all the pedicle screws PS are inserted into their desired positions). In this case, before placing each of the pedicle screws PS, the robotic surgical system 10 can first control the movement of the surgical tool 30 to place the axis of rotation R along the desired trajectory by autonomously aligning the axis of rotation R of the surgical tool 30 with the desired trajectory of each of the pedicle screws PS in the manner previously described.

[0250] The method proceeds to step 208, where, if the operator has not completed the surgical procedure during step 206, one or more controllers 33 determine which haptic device operating mode to select (step 206 will be described in more detail below). The haptic device operating mode can be selected in response to any situation or command. During step 210, the method determines whether the selected haptic device operating mode is currently being executed by one or more controllers 33. If the selected haptic device operating mode is not being executed by one or more controllers 33, the method first proceeds to step 212, where, if the haptic device operating mode is being executed, one or more controllers 33 terminate the currently executed haptic device operating mode. In response, the method proceeds to one of the following modes based on the selected haptic device operating mode: autonomous check mode, manual control mode, simulated autonomous check mode, or simulated manual control mode. If the selected haptic device operating mode has already been executed, the method continues to execute the selected haptic device operating mode. Therefore, during steps 208 and 210, one or more controllers 33 determine whether a situation prompts the activation of the haptic device operating mode or whether the operator commands the activation of the haptic device operating mode.

[0251] Therefore, any tactile device operating mode can be activated at any appropriate time in response to a certain situation or command. For example, in response to a certain situation or command, one or more controllers 33 can be configured to activate a manual control mode after stopping or pausing the autonomous control of the surgical tool 30 to stop the rotation of the pedicle screw PS (also in... Figure 11A (As indicated in column F). As another example, in response to a certain situation or command, one or more controllers 33 can be configured to initiate a manual control mode before autonomously controlling the surgical tool 30 (also in...). Figure 11A (As indicated in column F). In such instances, one or more controllers 33 can switch from manual control mode to resume autonomous control of the surgical tool to rotate the screw after stopping or pausing autonomous control of the surgical tool 30. As yet another example, in response to a certain condition or command, one or more controllers 33 can be configured to initiate a simulated autonomous inspection mode (also in...) before or after stopping or pausing autonomous control of the surgical tool. Figure 11A (As indicated in column F). As yet another example, in response to a certain situation or command, one or more controllers 33 can be configured to initiate a simulated manual control mode before or after stopping or suspending the autonomous control of the surgical tool (also in...). Figure 11A (Indicated in column F).

[0252] The ability to activate any tactile device operating mode at any suitable time provides the operator with the ability to customize surgery based on their preferences. For example, in a configuration where one or more controllers 33 activate a manual control mode after stopping or pausing autonomous control of the surgical tool 30, one or more controllers 33 can initially autonomously insert the pedicle screw PS to an initial depth (or vice versa) before the operator inserts the pedicle screw PS to the final depth during manual control mode. In such a configuration, the pedicle screw PS can be placed autonomously until it is within a predetermined distance of the final depth (as determined by the navigation system 12). At this point, the operator can manually complete the placement of the pedicle screw PS using the surgical tool 30, allowing the operator to more actively feel the tightening of the pedicle screw PS. The operator can also choose to use a separate tool (electric or manual) to complete the placement of the pedicle screw PS during manual control mode, rather than during autonomous control.

[0253] Other configurations also illustrate the operator's ability to customize surgery based on their preferences. For example, in one configuration, one or more controllers 33 initiate a simulated autonomous inspection mode before autonomously controlling the surgical tool 30. In such a configuration, the operator can visualize a simulation of the autonomous control of the surgical tool 30 on the display 18 before one or more controllers 33 initiate autonomous control to insert the pedicle screw PS. In another configuration, one or more controllers 33 initiate a simulated manual control mode before initiating a manual control mode to control the surgical tool 30. In such a configuration, the operator can visualize a simulation of the manual control of the surgical tool 30 on the display 18 before one or more controllers 33 initiate manual control mode to manually control the insertion of the pedicle screw PS.

[0254] Furthermore, the ability to activate any tactile device operating mode in response to a certain situation or command eliminates potential errors (e.g., collision with the spinal cord 103) and provides the operator with immediate control over the surgery. For example, in the above-described configuration where one or more controllers 33 initially autonomously insert the pedicle screw PS to the initial depth before the operator inserts it to the final depth during manual control mode, one or more controllers 33 can activate manual control mode in response to a certain situation or command. In an instance where the activation of manual control mode and the cessation of autonomous control are prompted by a situation, one or more controllers 33 may detect during autonomous control that the pedicle screw PS is within a predetermined distance of the final depth and transmit the situation to one or more controllers 33. The one or more controllers 33 are then prompted to activate manual control mode and cease autonomous control, allowing the operator to manually complete the placement of the pedicle screw PS. The predetermined distance to the final depth can be predetermined such that the pedicle screw PS does not contact the spinal cord 103. In an instance where the activation of manual control mode is commanded, the navigation system 12 can indicate the status of autonomous control to the operator. For example, the display 18 may indicate how many turns remain before the pedicle screw PS reaches its full depth, and / or the display 18 may graphically represent the pedicle screw PS, anatomical structures, and / or target points, allowing the operator to easily see how far the pedicle screw PS needs to be inserted further. One or more controllers 33 may also provide tactile feedback (e.g., vibration or pulse) to the operator via tactile device 51 to notify the operator that the pedicle screw PS has reached the predetermined depth. Once the operator determines that the pedicle screw PS is within the predetermined distance of the final depth, the operator may command one or more controllers 33 to activate manual control mode and stop autonomous control, allowing the operator to manually complete the placement of the pedicle screw PS.

[0255] Some exemplary situations that may prompt the activation of the tactile device's operating mode may include the pedicle screw PS reaching the desired depth, the pedicle screw PS potentially colliding with the spinal cord 103, and the pedicle screw PS being rotated a predetermined number of turns. In such instances, one or more controllers 33 may be configured to automatically select one of a self-checking mode, a manual control mode, a simulated self-checking mode, or a simulated manual control mode. In one such example, after one or more controllers 33 have autonomously controlled the surgical tool 30 to rotate the pedicle screw PS a predetermined number of turns, one or more controllers 33 may be configured to automatically select a manual control mode to allow the operator to manually complete the insertion of the pedicle screw PS.

[0256] The robotic surgical system 10 may include various components for commanding the activation of tactile device operating modes. For example, an operator can use tactile device 51 to command the activation of tactile device operating modes. Figure 10 As shown, the tactile device 51 may include a user interface 57. An operator can use the user interface 57 to select an operating mode of the tactile device by actuating the user interface 57 to transmit commands to one or more controllers 33. Alternatively, in some instances, the operator can press and rotate the interface 53 to select the operating mode of the tactile device. In the robotic surgical system 10, this includes... Figure 4-6 In the example of surgical tool 30, the operator can select the haptic device operating mode using trigger 49 or the user interface 59 of surgical tool 30. In other examples, the operator can select the haptic device operating mode via the user interface of computer cart assembly 34 (such as the keyboard 61 of computer cart assembly 34). The operator can also select the haptic device operating mode via the user interface 63 of base 22. It is conceivable that an individual other than the operator can command the activation of the haptic device operating mode. For example, a remote user can command the activation of the haptic device operating mode from a remote location using a remote user interface.

[0257] Figure 15B Exemplary steps of the autonomous inspection mode are illustrated. As shown, the autonomous inspection mode includes step 304 of obtaining a measurement indicating the current interaction between the pedicle screw PS and the target site; and step 306 of controlling the actuator of the tactile device based on the obtained measurement to enable the rotary interface 53 of the tactile device 51 to mimic the current interaction between the pedicle screw PS and the target site, which includes providing resistance F to the actuator 55 of the tactile device 51. A To adjust the force F required for the operator to rotate the rotary interface 53. RI Step 308, wherein the force F required to rotate the rotary interface 53 is... RI The current force F required to rotate the pedicle screw PS relative to the target site. PS; and in the absence of the ability to control the surgical instrument 30, according to the adjusted force F RI Manually manipulate the rotary interface 53 to provide the operator with the current force F required to rotate the pedicle screw PS relative to the target site. PS Step 310 of the tactile feedback.

[0258] Figure 15C Exemplary steps of the manual control mode are shown. As illustrated, the manual control mode includes: step 300, having the ability to manually manipulate the rotary interface 53 to control either the rotation rate or the advance rate of the pedicle screw PS based on the operator's manual manipulation of the rotary interface 53; step 302, in response to the rotary interface being manually manipulated to control either the rotation rate or the advance rate of the pedicle screw PS, controlling the surgical tool 30 to rotate the pedicle screw PS around the rotation axis at a rotational rate and advance the pedicle screw PS linearly along a planned trajectory at an advance rate; steps 304, 306, and 308 previously described; and step 304, 306, and 308, based on an adjusted force F. RI Manually manipulate the rotary interface 53 to provide the operator with the current force F required to rotate the pedicle screw PS relative to the target site. PS Step 311 of the tactile feedback.

[0259] Figure 15D Exemplary steps of a simulated autonomous inspection mode are shown. As shown, the simulated autonomous inspection mode includes step 312, which simulates autonomous control of the surgical tool 30 by simulating rotating the pedicle screw PS at a certain rotational rate around the rotation axis R and linearly advancing the screw along the planned trajectory LH at a certain advance rate; step 314, which displays the simulated autonomous control of the surgical tool 30 on the display 18; an example of step 304 (shown as step 304'), which obtains a measurement indicating the simulated current interaction between the pedicle screw PS and the target site; and an example of step 306 (shown as step 306'), which controls the actuator of the tactile device based on the obtained measurement to enable the rotation interface 53 of the tactile device 51 to mimic the simulated current interaction between the pedicle screw PS and the target site, including providing resistance F to the actuator 55. A To adjust the force F required for the operator to rotate the rotary interface 53. RI An example of step 308 (shown as step 308'), wherein the force F required to rotate the rotary interface 53 is... RI The simulated current force F required to rotate the pedicle screw PS relative to the target site is reflected. SPS ; and in the absence of the ability to control the rotation of the pedicle screw PS by the surgical tool 30 and the ability to control the surgical tool 30 through simulated autonomous control, based on the adjusted force FRI Manually manipulate the rotary interface 53 to provide the operator with a response that reflects the simulated current force F. SPS Step 316 of the tactile feedback.

[0260] Figure 15E Exemplary steps of a simulated autonomous inspection mode are shown. As shown, the simulated autonomous inspection mode includes steps 318: manually manipulating the rotating interface 53 without having the ability to control the rotation of the pedicle screw PS with the ability to control either the rotation rate or the advance rate of the pedicle screw PS based on the operator's manual manipulation of the rotating interface 53; simulating manual control of the surgical tool 30 by rotating the pedicle screw PS at a rotational rate about the rotation axis R and linearly advancing the pedicle screw PS along the planned trajectory LH at an advance rate in response to the manual manipulation of the rotating interface 53 to control either the rotation rate or the advance rate of the pedicle screw PS; step 322: displaying the simulated manual control of the surgical tool 30 on the display 18; the previously described step 304'; the previously described step 306', which includes the previously described step 308'; and adjusting the force F according to the situation without having the ability to control the rotation of the pedicle screw PS with the surgical tool 30. RI Manually manipulate the rotary interface 53 to provide the operator with a response that reflects the simulated current force F. SPS Step 324 of the tactile feedback.

[0261] refer to Figure 15A The dashed box illustrates step 214, where the surgical tool 30 is autonomously controlled to insert the pedicle screw PS. Step 214 can occur simultaneously with any of steps 206, 208, and 210, as well as in the autonomous inspection mode, following step 202, which prepares the anatomical structure, and step 204, which places the pedicle screw PS on the surgical tool 30. As previously described, during manual control mode, simulated autonomous inspection mode, and simulated manual control mode, one or more controllers 33 do not autonomously control the surgical tool 30. Therefore, if one or more controllers 33 initiate any of the manual control mode, simulated autonomous inspection mode, and simulated manual control mode, the one or more controllers 33 cease execution of step 214 and stop autonomous control of the surgical tool 30 (if the one or more controllers 33 autonomously control the surgical tool 30). However, step 214 can be performed at any time during any of steps 206, 208, and 210, or during autonomous inspection mode, and one or more controllers 33 can simultaneously initiate autonomous control of the surgical tool 30.

[0262] Step 214 of autonomously controlling surgical tools 30 Figure 15FFurther illustrated. As shown, the method includes a step 400 of tracking the position of a target site; a step 402 of placing the rotation axis R along a desired trajectory; a step 404 of controlling the movement of a robotic manipulator based on the tracked position of the target site to maintain the rotation axis R of the surgical tool 30 relative to the target site along a planned trajectory; and a step 406 of autonomously controlling the surgical tool 30 to rotate the pedicle screw PS around the rotation axis R at a certain rotational rate and linearly advance the pedicle screw PS along a planned trajectory LH at a certain advance rate, wherein the rotational rate and advance rate are predetermined and proportional to the known thread geometry of the pedicle screw PS.

[0263] During step 400, the location of the target site is tracked. An ultrasound transducer (not shown) may also be mounted on the dorsal side of the patient's skin to generate real-time images of the patient's anatomy and the progress of the surgery. Intraoperative images can be used to determine if the pedicle screw (PS) follows the planned expected trajectory or to determine if the drill 42 or pedicle screw (PS) is close to any critical structures, including nerves and medial or lateral cortical boundaries.

[0264] During step 402, the rotation axis R is aligned with the planned trajectory LH. If according to the surgical plan, such as... Figure 9 As shown, if the rotation axis R is not yet aligned with the planned trajectory LH, or if the rotation axis R has moved away from the desired trajectory for other reasons, then the rotation axis R is aligned in step 402. Specifically, in step 402, the robotic surgical system 10 controls the movement of the surgical tool 30 to place the rotation axis R along the desired trajectory. This may include the robotic surgical system 10 inducing autonomous movement of the surgical tool 30 to place the rotation axis R along the desired trajectory. Alternatively, the robotic surgical system 10 may enable an operator to move the surgical tool 30 by applying force / torque in manual mode until the rotation axis R is placed along the planned trajectory LH. The robotic surgical system 10 may generate feedback (visual, auditory, and / or tactile) to the operator to indicate proper alignment. In some examples, when the tool is positioned near the planned trajectory LH and separated by a threshold distance defined by an attractive tactile sensation, an attractive tactile sensation may be used to pull the tool 30 toward the planned trajectory LH.

[0265] During step 406, the robotic surgical system 10 induces autonomous movement of the surgical tool 30 to simultaneously control the tool's linear autonomous advancement along the planned trajectory LH, and also controls the tool's autonomous rotation about the rotation axis R. The autonomous control of advancement and rotation is related to the pitch defined by Equation 1 described above. This pitch-determined autonomous control ensures proper installation of the pedicle screw to avoid damage to surrounding bone tissue.

[0266] Step 214 can be commanded by the operator among several alternatives. In the first example, the robotic surgical system 10 can be configured to perform fully autonomously. That is, once the operator has commanded the robotic surgical system 10 to perform autonomous control of the surgical tool 30, the robotic surgical system 10 performs autonomous control without further operator input until the operation is complete. In an alternative instance, the operator can initiate autonomous execution of the operation and then provide continuous input, such as by pressing and holding a button, by pressing and holding a foot switch, or other continuous input control, such that if the input stops, for example, the button or foot switch is released, the robotic surgical system 10 pauses the operation. In conjunction with autonomous control, the operator can adjust the speed of the operation. In addition to the button or foot switch, additional controls can be provided so that the operator can command the robot speed to increase or decrease in a stepwise function with multiple discrete speeds. Additional speed controls may include a set of buttons, selectors, dials, or other suitable controls.

[0267] refer to Figure 15A If, during step 206, the robotic surgical system 10 determines whether the operation has ended, various methods can be used to determine that the operation has ended. For example, if the operator determines that all pedicle screws PS have been implanted to the desired depth, the operator can command the operation to end. As another example, if the operator subjectively determines that the operation has ended, the operator can command the operation to end. As yet another example, if one or more controllers 33 determine that all pedicle screw PS have been inserted to the desired depth, one or more controllers 33 can trigger the operation to end. However, in some instances, the operation does not end after the pedicle screw PS has been implanted to the desired depth. In such instances, the method can be repeated for another pedicle screw PS. Figure 15A The procedure is followed and continued until all pedicle screws (PS) have been implanted.

[0268] If the robotic surgical system 10 determines during step 206 that the operation has ended, the method proceeds to step 216, which determines whether the surgical tool 30 is inserted at the target site. During step 216, one or more controllers 33 may determine the position of the surgical tool 30 and whether it is inserted at the target site. If the robotic surgical system 10 determines that the surgical tool 30 is not inserted, the method proceeds to step 218, where the operation ends. If the robotic surgical system 10 determines that the surgical tool 30 is inserted, the method proceeds to step 220, which involves retracting the tool, before proceeding to step 218.

[0269] During step 220, the surgical tool 30 is withdrawn from the implant. Similar to pushing a pedicle screw PS into the bone, the operator can input force at the surgical tool 30 in a direction away from the vertebral V to command its withdrawal. Alternatively, the robotic surgical system 10 can autonomously withdraw the surgical tool 30 once the implant has been placed, without further operator input.

[0270] A partial vertebral articular surface resection can be performed using surgical tool 30 to provide a smooth bone surface for eventual reception of the head of the pedicle screw PS. The resection volume can be defined based on the operator's plan (i.e., by determining the position of the head in a 3D model). Material can be removed using a drill bit or pre-formed reamer 70 corresponding to the head shape. In some cases, the drill 42 can incorporate a reamer to avoid separate tools, such that the drill 42 has a smaller profile drill rod to create a guide hole, and more laterally positioned is the reamer 70 to create a support 72 for the head of the pedicle screw PS, so that at least a portion of the guide hole 102 and the support 72 can be formed simultaneously. In the example shown, the drill 42 has a drill rod with a proximal end and a distal end, and a drill tip at the distal end. The reamer 70 is proximally spaced from the drill tip so that once the drill 42 has been inserted to the desired depth in the target vertebral body, the reamer 70 is located near the vertebral articular surface. Any suitable drill and / or reamer can be used to cut features to create holes, such as guide holes and supports in the patient's spine to receive the implant.

[0271] It should be understood that the systems and methods described herein can be used to place pedicle screws (PS), other screws, fasteners, or other implants into a patient. Therefore, even though the pedicle screw PS is referred to as an example throughout, the same systems and methods described herein can be used to treat any patient's anatomy and / or place any implant into the patient, such as in the hip, knee, femur, tibia, face, shoulder, spine, etc. For example, the robotic arm 20 can also be used to place cages, placement rods, drive pins, implant threaded cups, or other components for spinal implants, and can be used in hip replacement surgery, discectomy, or other procedures. Different end effectors can also be attached to the robotic arm 20 to perform other procedures. In some cases, the end effector may also have an articulated arm to facilitate implant insertion, i.e., positioning the implant in a desired posture. The articulated arm of the end effector can be simply a miniature version of the robotic arm 20 controlled in the same way to place the implant, or it can be another mechanism controlled to position the implant.

[0272] Navigation system 12 may include an optical navigation system with an optics-based tracker, but may alternatively employ other modalities, such as an ultrasonic navigation system tracking an object via ultrasound, a radio frequency navigation system tracking an object via RF energy, and / or an electromagnetic navigation system tracking an object via electromagnetic signals. Other types of navigation systems are also envisioned. It should also be understood that the models described herein may include triangulated meshes, volumetric models using voxels, or, in some cases, other types of 3D and / or 2D models.

[0273] Several examples have been discussed in the preceding description. However, the examples discussed herein are not intended to be exhaustive or to limit this disclosure to any particular form. The terminology used is intended to be descriptive rather than restrictive in nature. In light of the above teachings, many modifications and variations are possible, and this disclosure can be practiced in ways other than those specifically described.

Claims

1. A robotic surgical system, the robotic surgical system comprising: Robotic manipulator; A surgical tool, which is coupled to the robotic manipulator and configured to engage with a screw and rotate the screw about a rotation axis; A tactile device, the tactile device including an actuator and a rotary interface coupled to the actuator, the rotary interface being configured to be manually operated by an operator's hand; A navigation system configured to track the position of a target location; as well as One or more controllers are coupled to the robot manipulator, the haptic device, and the navigation system, and the one or more controllers are configured to: The movement of the robotic manipulator is controlled to maintain the axis of rotation of the surgical tool relative to the target site along a planned trajectory based on the position of the tracked target site; The surgical tool is autonomously controlled to rotate the screw around the axis of rotation at a certain rotational rate and to advance the screw linearly along the planned trajectory at a certain advance rate, wherein the rotational rate and the advance rate are predetermined and proportional to the known thread geometry of the screw; Obtain a measurement indicating the current interaction between the screw and the target area; as well as Activate self-check mode, including: The one or more controllers are configured, based on obtained measurements, to control the actuator of the tactile device to adjust the force required by the operator's hand to rotate the rotary interface by providing resistance to the actuator, thereby enabling the rotary interface to mimic the current interaction between the screw and the target area, wherein the force required to rotate the rotary interface reflects the current force required to rotate the screw relative to the target area; and The rotary interface can be manually manipulated according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target site, without having the ability to control the surgical tool to rotate the screw.

2. The robotic surgical system of claim 1, wherein, in response to a certain condition or command, the one or more controllers are further configured to initiate the autonomous examination mode while autonomously controlling the surgical instruments.

3. The robotic surgical system of claim 1 or 2, wherein, in response to a certain condition or command, the one or more controllers are further configured to initiate the autonomous inspection mode after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

4. The robotic surgical system of claim 1 or 2, wherein, in response to a certain condition or command, the one or more controllers are further configured to resume autonomous control of the surgical tool to rotate the screw after stopping or suspending autonomous control of the surgical tool to stop the rotation of the screw.

5. The robotic surgical system as claimed in claim 1 or 2, wherein: The one or more controllers are further configured to activate a manual control mode, wherein the rotary interface is manually operable with the ability to control either the rotation rate of the screw or the advance rate of the screw based on the operator's manual manipulation of the rotary interface. The one or more controllers are configured to control the surgical tool to rotate the screw around the rotation axis at the rotation rate and advance the screw linearly along the planned trajectory at the advance rate in response to the rotary interface being manually manipulated to control either the rotation rate or the advance rate of the screw. and The rotary interface can be manually operated according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target area.

6. The robotic surgical system of claim 5, wherein, in response to a certain condition or command, the one or more controllers are further configured to initiate the manual control mode after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

7. The robotic surgical system of claim 6, wherein, in response to a certain condition or command, the one or more controllers are further configured to switch from the manual control mode to resume autonomous control of the surgical tool to rotate the screw.

8. The robotic surgical system of claim 2, wherein the tactile device is configured to trigger the condition or the command.

9. The robotic surgical system of claim 1 or 2, further comprising a sensor configured to obtain a measurement indicating the current interaction between the screw and the target site, the one or more controllers being coupled to the sensor.

10. The robotic surgical system of claim 5, wherein the one or more controllers are configured to: It is determined that a certain condition exists during the control of the screw; and In response to determining that the condition exists, tactile feedback about the condition is provided to the operator by controlling the actuator of the tactile device to prevent rotation of the rotary interface.

11. The robotic surgical system of claim 1 or 2, wherein the navigation system is further configured to: The navigation system determines the position of the screw relative to an anatomical model of the target site, the anatomical model being registered to the target site, and includes predetermined data indicating the expected interaction between the screw and the anatomical model at multiple locations relative to the screw; and The measurement value indicating the current interaction between the screw and the target site is obtained based on the determined position of the screw relative to the anatomical model and the predetermined data.

12. The robotic surgical system of claim 1 or 2, wherein the rotational rate and the propulsion rate are based on a relationship Proportioned to the known thread geometry, wherein It is the rotational speed, The feed rate is the feed rate, and the pitch is the number of threads per unit length of the screw.

13. The robotic surgical system of claim 1 or 2, wherein the tactile device is further defined as a handheld suspension platform, and the rotating interface is further defined as a knob.

14. The robotic surgical system of claim 1 or 2, wherein the tactile device is remotely spaced from the robotic manipulator and the surgical instruments.

15. The robotic surgical system of claim 1 or 2, wherein the tactile device is directly attached to the robotic manipulator or the surgical instrument.

16. The robotic surgical system of claim 1 or 2, wherein the one or more controllers are further configured to receive input from the operator to selectively adjust one or more of the following: The resistance provided to the actuator; and The rotary interface controls the sensitivity of the surgical tool's ability to rotate the screw.

17. The robotic surgical system of claim 1 or 2, wherein the robotic surgical system further includes a display, and wherein the one or more controllers are further configured to initiate a simulated autonomous examination mode, wherein the one or more controllers are configured to: The simulation autonomously controls the surgical tool by rotating the screw around the axis of rotation at the rotational rate and advancing the screw linearly along the planned trajectory at the advancing rate; The simulated autonomous control of the surgical instrument is displayed on the monitor; Obtain a simulated current interaction between the screw and the target area; as well as Based on the simulated current interaction, the actuator of the tactile device is controlled so that the rotary interface can mimic the simulated current interaction between the screw and the target area.

18. The robotic surgical system of claim 17, wherein the one or more controllers are further configured to initiate the simulated autonomous examination mode prior to autonomously controlling the surgical instruments.

19. The robotic surgical system of claim 1 or 2, wherein the robotic surgical system further includes a display, and wherein the one or more controllers are further configured to initiate a simulated manual control mode, wherein the one or more controllers are configured to: The control input is received in response to the rotary interface being manually manipulated to control either the rotation rate of the screw or the advance rate of the screw. The surgical tool is manually controlled in response to the control input by rotating the screw about the axis of rotation at the rotational rate and advancing the screw linearly along the planned trajectory at the advance rate. The display shows simulated manual control of the surgical instruments; Obtain the simulated current interaction between the screw and the target area; and Based on the simulated current interaction, the actuator of the tactile device is controlled so that the rotary interface can mimic the simulated current interaction between the screw and the target area.

20. The robotic surgical system of claim 19, wherein, in response to a certain condition or command, the one or more controllers are further configured to initiate the simulated manual control mode after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

21. A non-transient computer-readable storage medium storing computer instructions thereon, the computer instructions, when executed by a processor, implementing a method for controlling a robotic surgical system, the robotic surgical system including a robotic manipulator; and a surgical tool coupled to the robotic manipulator and configured to engage a screw and rotate the screw about a rotation axis. A tactile device, the tactile device including an actuator and a rotary interface coupled to the actuator and configured to be manually operated by an operator's hand; A navigation system configured to track the position of a target location; The method includes: and one or more controllers connected to the robot manipulator, the haptic device, and the navigation system. The movement of the robotic manipulator is controlled by the one or more controllers to maintain the axis of rotation of the surgical tool relative to the target site along a planned trajectory based on the position of the tracked target site; The surgical tool is autonomously controlled by one or more controllers to rotate the screw around the axis of rotation at a certain rotational rate and to advance the screw linearly along the planned trajectory at a certain advance rate, wherein the rotational rate and the advance rate are predetermined and proportional to the known thread geometry of the screw; The one or more controllers are used to obtain measurements indicating the current interaction between the screw and the target area; and Activate self-check mode, including: The method includes controlling the actuator of the tactile device with the one or more controllers and based on obtained measurements to adjust the force required for the operator's hand to rotate the rotary interface by providing resistance to the actuator with the one or more controllers, thereby enabling the rotary interface to mimic the current interaction between the screw and the target area, wherein the force required to rotate the rotary interface reflects the current force required to rotate the screw relative to the target area, and The rotary interface can be manually manipulated according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target site, without having the ability to control the surgical tool to rotate the screw.

22. The storage medium of claim 21, wherein the method further comprises, in response to a certain condition or command, simultaneously initiating the autonomous inspection mode with the one or more controllers.

23. The storage medium of claim 21 or 22, wherein the method further comprises, in response to a certain condition or command, initiating the autonomous inspection mode with the one or more controllers after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

24. The storage medium of claim 21 or 22, wherein the method further comprises, after stopping or suspending autonomous control of the surgical tool to stop rotation of the screw and in response to a certain condition or command, resuming autonomous control of the surgical tool to rotate the screw using the one or more controllers.

25. The storage medium of claim 21, wherein the method further comprises: The manual control mode is activated using the one or more controllers, wherein the rotary interface is manually operable with the ability to control either the rotation rate of the screw or the advance rate of the screw based on the operator's manual manipulation of the rotary interface. as well as In response to the rotary interface being manually manipulated to control either the rotation rate or the advance rate of the screw, the surgical tool is controlled by the one or more controllers to rotate the screw around the rotation axis at the rotation rate and advance the screw linearly along the planned trajectory at the advance rate. and The rotary interface is manually operable according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target area.

26. The storage medium of claim 25, wherein the method further comprises, in response to a certain condition or command, activating the manual control mode with the one or more controllers after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

27. The storage medium of claim 26, wherein the method further comprises switching from the manual control mode to autonomous control of the surgical tool to rotate the screw in response to a certain condition or command using the one or more controllers.

28. The storage medium of claim 22, wherein the method further comprises triggering the condition or the command with the tactile device.

29. The storage medium of claim 21 or 22, wherein the robotic surgical system includes a sensor, and the method further includes using the sensor to obtain a measurement indicating the current interaction between the screw and the target site, wherein the one or more controllers are coupled to the sensor.

30. The storage medium of any one of claims 25-28, wherein the method further comprises: The one or more controllers are used to determine that a certain condition exists during the control of the screw; as well as In response to determining the presence of the condition, the one or more controllers provide tactile feedback regarding the condition by controlling the actuator of the tactile device to prevent rotation of the rotary interface.

31. The storage medium of claim 21 or 22, wherein the method further comprises: The navigation system is used to determine the position of the screw relative to an anatomical model of the target site, the anatomical model being registered to the target site, and the navigation system includes predetermined data indicating the expected interaction between the screw and the anatomical model at multiple positions of the screw relative to the anatomical model; as well as The navigation system uses the determined position of the screw relative to the anatomical model and the predetermined data to obtain measurements indicating the current interaction between the screw and the target site.

32. The storage medium of claim 21 or 22, wherein the method further comprises receiving input from the operator using the one or more controllers to selectively adjust one or more of the following: The resistance provided to the actuator; and The rotary interface controls the sensitivity of the surgical tool's ability to rotate the screw.

33. The storage medium of claim 21 or 22, wherein the robotic surgical system further includes a display, and the method further includes initiating a simulated autonomous inspection mode using the one or more controllers, the simulated autonomous inspection mode including the one or more controllers: The simulation autonomously controls the surgical tool by rotating the screw around the axis of rotation at the rotational rate and advancing the screw linearly along the planned trajectory at the advancing rate; The simulated autonomous control of the surgical instrument is displayed on the monitor; Obtain a simulated current interaction between the screw and the target area; as well as Based on the simulated current interaction, the actuator of the tactile device is controlled so that the rotary interface can mimic the simulated current interaction between the screw and the target area.

34. The storage medium of claim 33, wherein the method further comprises activating the simulated autonomous examination mode with the one or more controllers before autonomously controlling the surgical instrument.

35. The storage medium of claim 21 or 22, wherein the robotic surgical system further includes a display, and the method further includes initiating a simulated manual control mode with the one or more controllers, the simulated manual control mode including the one or more controllers: The control input is received in response to the rotary interface being manually manipulated to control either the rotation rate of the screw or the advance rate of the screw. The surgical tool is manually controlled in response to the control input by rotating the screw about the axis of rotation at the rotational rate and advancing the screw linearly along the planned trajectory at the advance rate. The display shows simulated manual control of the surgical instruments; Obtain the simulated current interaction between the screw and the target area; and Based on the simulated current interaction, the actuator of the tactile device is controlled so that the rotary interface can mimic the simulated current interaction between the screw and the target area.

36. The storage medium of claim 35, wherein the method further comprises, in response to a certain condition or command, activating the simulated manual control mode with the one or more controllers after stopping or pausing autonomous control of the surgical tool to stop the rotation of the screw.

37. A robotic surgical system, the robotic surgical system comprising: Robotic manipulator; A surgical tool, which is coupled to the robotic manipulator and configured to engage with a screw and rotate the screw about a rotation axis; A tactile device, the tactile device including an actuator and a rotary interface coupled to the actuator, the rotary interface being configured to be manually operated by an operator's hand; A navigation system configured to track the position of a target location; as well as One or more controllers are coupled to the robot manipulator, the haptic device, and the navigation system, and the one or more controllers are configured to: The movement of the robotic manipulator is controlled to maintain the axis of rotation of the surgical tool relative to the target site along a planned trajectory based on the position of the tracked target site; The device receives control input from the tactile device, wherein the rotary interface is manually operable with the ability to control either the rotation rate of the screw or the advance rate of the screw based on the operator's manual manipulation of the rotary interface. In response to control input from the tactile device, the surgical tool is controlled to rotate the screw around the axis of rotation at a certain rotational rate and advance the screw linearly along the planned trajectory at a certain advance rate, wherein the rotational rate and the advance rate are predetermined and proportional to the known thread geometry of the screw; Obtain a measurement indicating the current interaction between the screw and the target area; as well as Activate self-check mode, including: The one or more controllers are configured, based on obtained measurements, to control the actuator of the tactile device to adjust the force required by the operator's hand to rotate the rotary interface by providing resistance to the actuator, thereby enabling the rotary interface to mimic the current interaction between the screw and the target area, wherein the force required to rotate the rotary interface reflects the current force required to rotate the screw relative to the target area; and The rotary interface can be manually manipulated according to an adjusted force to provide the operator with tactile feedback reflecting the current force required to rotate the screw relative to the target site, without having the ability to control the surgical tool to rotate the screw.

38. A non-transient computer-readable storage medium having stored thereon computer instructions that, when executed by a processor, implement the method of operating the surgical system as described in claim 37.

39. A simulation system, the simulation system comprising: A tactile device, the tactile device including an actuator and a rotary interface coupled to the actuator, the rotary interface being configured to be manually operated by an operator's hand; Display device; as well as One or more controllers are coupled to the haptic device and the display device, and the one or more controllers are configured to provide a simulation on the display device, the simulation being configured to: A simulated surgical tool is provided, wherein the simulated surgical tool is configured to engage with a simulated screw and rotate the simulated screw about a rotation axis along a simulated trajectory relative to a simulated target site; The simulated surgical tool is provided with simulated autonomous control to rotate the simulated screw around the axis of rotation at a certain rotational rate and to advance the simulated screw linearly along the simulated trajectory at a certain advance rate, wherein the rotational rate and the advance rate are predetermined and proportional to the known thread geometry of the simulated screw; Obtain the simulated current interaction between the simulated screw and the simulated target part; and Initiate the simulated self-check mode, including: The one or more controllers are configured, based on the simulated current interaction, to control the tactile device to mimic the simulated current interaction between the simulated screw and the simulated target area by providing resistance to the actuator to adjust the force required for the operator's hand to rotate the rotary interface, wherein the force required to rotate the rotary interface reflects the simulated current force required to rotate the simulated screw relative to the simulated target area, and The rotary interface can be manually manipulated by an adjusted force to provide the operator with tactile feedback reflecting the simulated current force required to rotate the simulated screw relative to the simulated target site, without the operator having the ability to control the simulated surgical tool to rotate the simulated screw or the ability to control the simulated autonomous control of the simulated surgical tool.

40. A method of operating the simulation system as described in claim 39.

Images