Robotic spine surgery systems and methods

Abstract

To provide a robotic system and methods for performing spine surgery.SOLUTION: A robotic system 10 comprises a robotic manipulator with a tool 30 to hold a screw and to rotate the screw about a rotational axis. The screw is self-tapping and has a known thread geometry that is stored by a controller 32. A navigation system 12 tracks a position of a target site. Movement of the robotic manipulator is controlled to maintain the rotational axis of the surgical tool along a planned trajectory with respect to the target site based on the tracked position of the target site. In autonomous or manual modes of operation, the rotational rate of the screw about the rotational axis and / or an advancement rate of the screw linearly along the planned trajectory is controlled to be proportional to the known thread geometry stored in the memory.SELECTED DRAWING: Figure 1

Description

[Background technology]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This international application is a continuation of U.S. Nonprovisional Patent Application No. 16 / 184, filed November 8, 2019. This application claims priority to and benefit of US Pat. No. 3,376, the contents and entire disclosure of which are incorporated herein by reference. incorporated herein.

[0002] Robotic systems for performing surgical procedures on a patient's spine are well known. The suction system is currently utilized to place pedicle screws in a patient's spine.

[0003] If the patient requires surgery with pedicle screw placement, preoperative imaging and / or operative Intermediate imaging is used to visualize the patient's anatomy (in this case, the patient's spine) that requires treatment. The surgeon then has to provide a 3D image of the image and / or the 3D image generated from the image. For the D model, plan the locations where the pedicle screws should be placed. By specifying the desired pose in the image and / or 3D model, The position and orientation (i.e., posture) of each pedicle screw relative to the particular vertebra in which it is placed Once a plan is established, it is sent to the robotic system for execution. will be transferred.

[0004] Typically, a robotic system includes a robotic manipulator. The inserter is positioned above the patient and aligned to the desired orientation of the pedicle screws to be placed. The robot system positions the tool guide along the desired trajectory. The navigation system includes a robotic manipulator. The operator can place the tool guide along the desired trajectory according to the surgeon's plan. Determine the position of the tool guide relative to the patient's anatomy, such as: The navigation system includes a manipulator and a tracking device attached to the patient. The robotic system monitors the patient's movements during the surgical procedure to maintain the desired trajectory. Responds to patient movements during surgery by moving the tool guide as needed This can be done.

[0005] Once the tool guide is positioned to align with the desired trajectory, the robot The manipulator is controlled to maintain alignment. The surgeon then The surgeon positions the cannula adjacent to the vertebra through the guide. Insert the cannula into the vertebral column and drill pilot holes for the pedicle screws. The surgeon removes the drilling tool and inserts the pedicle screw using a pedicle screw driver. The screw is then screwed into place in the pilot hole. In this methodology, a robotic manipulator During drilling of the borehole or insertion of the pedicle screw, Robot manipulators are not widely used because they serve no purpose whatsoever. Summary of the Invention

[0006] In one embodiment, a robotic manipulator and a device coupled to the robotic manipulator are provided. and a surgical tool that rotates about an axis of rotation to place the implant in the patient's spine. A surgical robot system is provided. The robot controller is connected to the robot manipulator. and controlling the movement of the surgical tool to position the axis of rotation along a desired trajectory and By maintaining a desired trajectory and controlling the insertion of the implant into the patient's spine. The implant is placed in the desired position. The robot controller determines whether the implant is A surgical tool that positions the implant within the patient's spine until it is within a predetermined distance of the desired location and then the implant is placed in the desired position. The surgical tool is configured to control manual manipulation of the surgical tool until the surgical tool is fully engaged.

[0007] In another embodiment, a robotic manipulator and a and a surgical tool that rotates around a rotation axis, A method for placing an implant in a patient's spine is provided, the method comprising: moving an axis of rotation to a desired trajectory; and controlling the movement of the surgical tool to position the surgical tool along the path. Maintain the axis of rotation along the desired trajectory so that the implant is positioned in the desired location and guide the patient Controlling the insertion of the implant into the spine. Position the implant on the patient's spine until the implant is within a predetermined distance of the desired location. This triggers autonomous movement of the surgical tools, which then places the implant in the desired position. This includes controlling the manual manipulation of a surgical tool until the surgical tool is released.

[0008] In another embodiment, a robotic manipulator and a robotic manipulator coupled to the robotic manipulator are provided. and a skin incision tool for incising the skin of the patient. The skin tracker is attached to the patient's skin to track the patient's skin. Robot controller The robotic manipulator is coupled to the skin incision tool, and the movement of the skin incision tool relative to the haptic object is controlled. The haptic object controls the incision to be made at the desired location on the patient's skin. be defined.

[0009] In another embodiment, a robotic manipulator and a A skin incision tool and a skin tracker attached to the patient's skin to track the patient's skin. and a method for forming an incision in the skin of a patient using a surgical robotic system including a The method includes: moving a pointer while the skin tracker is attached to the patient; The method also includes identifying a desired incision location using a navigation system. tracking the movement of the desired location using a haptic object and a skin incision tool relative to the haptic object The haptic object is placed at a desired location on the patient's skin. The incision to be made is defined in a target coordinate system.

[0010] In another embodiment, a robotic manipulator and a robotic manipulator coupled to the robotic manipulator are provided. A surgical instrument that rotates around an axis of rotation to form a hole in the patient's spine to receive an implant. A surgical robotic system is provided, comprising: a robot controller; The surgical tool is coupled to a manipulator to control the motion of the surgical tool, rotating the axis of rotation along a desired trajectory. to position the spine, maintain the axis of rotation along a desired trajectory, and control the formation of a hole in the patient's spine. The implant is placed in the desired position by using a surgical tool. The drill that forms the lot hole and the implant head are integrated into this drill. and a reamer configured to form a seat for the head.

[0011] In another embodiment, a surgical tool for forming a hole to receive an implant is provided. The surgical tools include a drill to create a pilot hole for the implant. The reamer has a shaft with a proximal end and a distal end. The reamer extends proximally from the distal end. The reamer is integrated into the drill at a location on the shaft that is remote from the implant head. It is formed to form a groove.

[0012] In another embodiment, a robotic manipulator and a and a method for forming a hole in a patient's spine using a surgical tool that rotates around a rotation axis. The method includes controlling the motion of a surgical tool to rotate an axis of rotation along a desired trajectory. to position the spine, maintain the axis of rotation along the desired trajectory, and limit the formation of holes in the patient's spine. The method includes controlling the implant and placing it in the desired position. The holes are the pilot hole for the implant and the seal hole for the implant head. The pilot hole and at least a portion of the sheet are formed simultaneously.

[0013] In another embodiment, the navigation system, the robotic manipulator, and the rotation axis A surgical tool coupled to a robotic manipulator to rotate a central screw a surgical robotic system including: a screw that is self-tapping; The navigation system tracks the position of the target area. The robot controller is configured to control the robot manipulator and the navigation system. The robot controller is coupled to the control system and includes a memory that stores known thread forms. The troller follows a planned trajectory to the target site based on the tracked target site position. configured to control the motion of the robotic manipulator to maintain the axis of rotation along The robot controller also controls the rotation of the screw around the rotation axis at a certain rotation speed. and causes the screw to advance linearly at a certain forward speed along the planned trajectory. The surgical tool is configured to autonomously control the rotation speed and advancement speed, and the rotation speed and advancement speed are stored in memory. Proportional to a stored known thread form.

[0014] In another embodiment, the navigation system, the robotic manipulator, and the rotation axis A surgical tool coupled to a robotic manipulator to rotate a central screw A method for placing screws within a target site using a surgical robotic system including a The method includes holding a screw with a surgical tool, the tool The thread is self-tapping and has a known thread form. The method includes storing the shape in a memory of the robot controller. The method includes tracking the location of the target site using a tracking system. Based on the location of the site, the axis of rotation is adjusted to maintain the planned trajectory relative to the target site. The method includes controlling the movement of a surgical tool around a rotation axis. The screw rotates at a certain rotational speed and moves linearly at a certain forward speed along the planned trajectory. and autonomously controlling the movement of the surgical tool to advance the surgical tool, the rotation speed and the advancement speed. is proportional to a known thread form stored in memory.

[0015] In another embodiment, a surgical robotic system includes a robotic manipulator having a sensor. The surgical robotic system includes a surgical tool, and the surgical tool is connected to a robot manipulator, holds a screw, and rotates the screw around a rotation axis. The screw is self-tapping and has a known thread profile. The surgical robotic system has a configuration that tracks the position of the target site. The surgical robot system includes a robot controller. , the robot controller is connected to the robot manipulator and navigation system. The robot controller includes a memory coupled to the tracked thread profile and storing the known thread profiles. Based on the location of the target site, the surgical tool is rotated on a planned trajectory relative to the target site. The robot manipulator is configured to control the motion of the robot manipulator so as to maintain the rotation axis. The bot controller is configured to detect a force applied by a user using a sensor. The robot controller uses the force applied by the user to implant the screw into the target site. Based on this, the rotation speed of the screw around the axis of rotation or linearly along the planned trajectory The robot controller is configured to control one of the forward speeds of the screw and the forward speed of the screw. The advancement speed and rotation speed are adjusted to the force applied by the user and to the known thread profile stored in memory. The screw forward speed or rotation speed is autonomously controlled so that the speeds are proportional. It is composed of:

[0016] In another embodiment, a surgical robotic system is used to place the screws at the target site. The surgical robot system includes a robotic manipulator, a navigation system, and a The robot manipulator and the navigation system communicate with each other. The surgical robot system includes a robot controller. The robot controller rotates the screw around the axis of rotation. The surgical tool is coupled to a robotic manipulator for manipulating the robotic manipulator. The screw includes a sensor. The method includes holding the screw with a surgical tool. The screw is self-tapping and has a known thread form. The method includes storing the known thread forms in a memory of the robot controller. The method includes tracking the location of the target site using a navigation system. The method involves calculating the target location along a planned trajectory based on the tracked target location. The method includes controlling the movement of the surgical tool to maintain the axis of rotation. The method includes detecting a force applied by a user using a screw to insert a screw into the target site. The rotational speed of the screw around its axis of rotation based on the force applied by the user to embed it. or controlling one of the forward speeds of the screw linearly along the planned trajectory. This method involves combining a user-applied force with a known thread profile stored in memory. The forward speed or rotation speed of the screw is controlled autonomously so that the forward speed and rotation speed are proportional. This includes autonomous control of the other side of the degree. [Brief explanation of the drawings]

[0017] [Figure 1] FIG. 1 is a perspective view of a robotic surgical system. [Figure 2] FIG. 2 is a perspective view of a surgical robotic arm used in the system of FIG. 1. [Figure 3] FIG. 1 is a perspective view of a robotic surgical system used in combination with an imaging device to perform spinal surgery. [Figure 4] FIG. 1 is a partial perspective view of a robotic arm coupled to a surgical tool including a housing coupled to a drill. [Figure 5] FIG. 12 is a partial perspective view of a robotic arm coupled to a surgical tool coupled to a driver and a screw. [Figure 6] FIG. 10 is an elevational view of another surgical tool. [Figure 7] FIG. 10 illustrates drilling a pilot hole in the pedicle. [Figure 8] FIG. 10 shows how the pedicle screw is screwed into the pilot hole. [Figure 9A] FIG. 10 is a diagram showing current output versus depth, which can be used to verify that the drilling is according to the user's plan. [Figure 9B] FIG. 10 is a diagram showing current output versus depth, which can be used to confirm that pedicle screw insertion is according to the user's plan. [Figure 10A] FIG. 1 illustrates a skin incision tool attached to a robotic arm. [Figure 10B] FIG. 10 illustrates another skin incision tool attached to a robotic arm. [Figure 11] FIG. 1 shows a Jamshidi needle attached to a robotic arm. [Figure 12] 1 is a flowchart of sample steps performed during one surgery to place an implant in a desired location. [Figure 13] 1 is a flowchart of sample steps performed during one surgical procedure to make an incision. [Figure 14] FIG. 10 shows how the pedicle screw is screwed into the pilot hole. [Figure 15] 1 is a flowchart of sample steps performed during one surgery to place an implant in a desired location. DETAILED DESCRIPTION OF THE INVENTION

[0018] Referring to FIGS. 1 and 2, a surgical robot that can be used for various surgical procedures is shown. A spinal surgery system 10 is shown. Various surgical procedures are performed in spinal surgery, e.g., pedicle surgery. A spine in which a clew, other screw, or other type of implant is placed into the spine The robotic system 10 includes a localizer 14 and a navigation system 12 including a navigation system and a tracking device 16, and one or more displays 18 and a robot manipulator (e.g., a robot attached to a base 22 or a table, etc.). The robot arm 20 is rotatably connected to a base 22. a base link 24 and a plurality of ribs extending continuously from the base link 24 to a distal end 28. The arm link 26 connects multiple joints within the robot arm 20. Surgical tools used in performing spinal surgery generally, for example, The surgical tool 30 is attached to the distal end 28 of the robotic arm 20. It can be pivotally connected.

[0019] The robot controller 32 controls the robot arm 20 during the operation of the surgical tool 30. In one embodiment, the robot is configured to control or provide guidance to the surgeon. The robot controller 32 provides haptic feedback to the user via the robot arm 20. The robot arm 20 is controlled (for example, by controlling the motors for the joints) so as to This haptic feedback is designed to allow the surgeon to Constraining or inhibiting manual movement of the surgical tool 30 beyond a predetermined virtual boundary Such haptic feedback systems and associated tactile feedback that define virtual boundaries are useful. For example, a haptic object is disclosed in a patent application filed on February 21, 2006 entitled "Haptic Guidance." "Idence System And Method" by Quaid et al. Patent No. 8,010,180, and / or filed on December 21, 2012, Systems And Methods For Haptic Control O Otto et al., U.S. Patent Application Publication No. 2002 / 0022944, entitled "A Surgical Tool" No. 014 / 0180290, each of which is incorporated by reference in its entirety. In one embodiment, the robotic system 10 is Manufactured by MAKO Surgical Corp., Dardale, FL, USA The RIO™ Robotic Arm Interactive Orthopedic System is a

[0020] In some embodiments, the robotic arm 20 may be configured to It operates autonomously based on toolpaths and / or other predetermined motions. The desired motion may be defined during and / or prior to surgery. uses a combination of manual and autonomous control. For example, a user can manipulate a surgical tool 3 A manual mode is used in which the user applies a force to the robot arm 20 to cause movement of the robot arm 20, and a pendant mode is used in which the user applies a force to the robot arm 20 to cause movement of the robot arm 20. The robot arm 20 is controlled to follow the tool path autonomously by holding the tool. The robot system using both the Ro mode and the Ro botic System And Method For Transitionin Between Operating Modes,” Bowling et al. No. 9,566,122, which is incorporated herein by reference in its entirety. It will be incorporated into the specification.

[0021] The navigation system 12 locates various objects in the operating room with respect to the target coordinate system. Such an object can be, for example, a hand. a surgical tool 30, the target patient anatomy (e.g., one or more vertebrae), and / or The navigation system 12 calculates the coordinates of these objects in the target coordinate system. For the purpose of indicating relative position and orientation to the surgeon, and in some cases, the patient's anatomy related to the target morphology and with respect to the target coordinate system (e.g., as often done in surgical navigation). Movement of the surgical tool 30 relative to a defined virtual boundary (via a known coordinate system transformation) These objects are tracked for the purpose of controlling or constraining the

[0022] The surgical navigation system 12 includes a console that houses a navigation controller 36. The computer cart assembly 34 includes a navigation controller 36 and a robot The controllers 32 together form a control system for the robotic system 10. The navigation interface is in operative communication with the navigation controller 36 . The navigation interface is adjustably mounted on the computer cart assembly 34. The display 18 is attached to the computer. Input devices such as a keyboard and a mouse are used. to input information into the navigation controller 36 or to navigate in other ways. Certain aspects of the application controller 36 can be selected / controlled. Use of a finger (not shown) or other input device, including voice-activation It is also possible.

[0023] The localizer 14 communicates with a navigation controller 36. In the present invention, the localizer 14 is an optical localizer, and includes a camera unit (a sensing device). The camera unit includes an outer housing that houses one or more optical position sensors. In some embodiments, at least two optical sensors, and sometimes three or more optical sensors, are included. The optical sensor may be a separate charge-coupled device (CCD). The kit is mounted on an adjustable arm and places the optical sensor in an ideally clear, unobstructed area. It is placed within the field of view of the tracking device 16, which is described below. The mela unit has at least one degree of freedom by rotating around a revolute joint. In other embodiments, the camera unit is adjustable in more than two degrees of freedom. be.

[0024] The localizer 14 is a localizer in communication with the light sensor to receive signals from the light sensor. The localizer controller (not shown) may be wired or wireless. The navigation controller 36 communicates with the navigation controller 36 via a connection (not shown). One of the possible connections can be an IEEE1394 interface, and this IEEE13 The 94 interface is a serial interface for high-speed communication and isochronous real-time data transfer. The standard is a bus interface. The connection uses a company-specific protocol. In other embodiments, the light sensor communicates directly with the navigation controller 36. do.

[0025] Position and orientation signals and / or data are used for navigation purposes for tracking objects. The computer cart assembly 34, the display 18 and Localizer 14 were published on May 25, 2010, and are listed in the Surgery S U.S. Patent No. 7,725,162 to Malackowski et al., entitled "System" , which is incorporated herein by reference.

[0026] The robot controller 32 and the navigation controller 36 may be individually or jointly In total, one or more personal computers or laptops and data and memory suitable for storing computer readable instructions. ,Memory can be local memory, external memory, cloud-based memory, random access memory, RAM, non-volatile RAM (NVRAM), flash memory or other suitable form The robot controller 32 and the navigation controller The controllers 36 may each or together comprise one or more processors such as a microprocessor. These processors process instructions stored in memory. or processes algorithms stored in memory to perform the functions described herein. These processors can be any type of processor, Additionally or alternatively, the system may be a microprocessor or multiprocessor system. Specifically, the robot controller 32 and the navigation controller 36 each or a combination of one or more microcontrollers, field programmable gate arrays, (i) System-on-chip, discrete circuits, and / or functions described herein Other suitable hardware, software, or firmware capable of running The robot controller 32 and the navigation controller 36 can include , robotic manipulator, and computer cart assembly 34. and / or may be mounted in any other suitable location. The controller 32 and / or navigation controller 36 may include the following: The software is loaded with the signal received from the localizer 14. The signal is converted into data representing the position and orientation of the object being tracked.

[0027] Referring to FIG. 3, the navigation system 12, also referred to herein as a tracker, In the illustrated embodiment, the plurality of trackers 16 includes a plurality of tracking devices 16. In some cases, the tracker 16 is attached to a bone screen. In other cases, the bone is fixed to a part of the bone via a screw, bone pin, etc. The tracker 16 can be attached using clamps on other parts of the vertebrae. In alternative embodiments, the tracker 16 may be attached to other tissue types or portions of anatomy. The tracker 16 can be attached to the anatomy. The location of the tracker 16 may be determined by a registration technique such as point-based registration. In these registration techniques, a digital probe 73 (e.g., a probe having its own markers) can be used. Touch off on a bone landmark using the navigation pointer ( or touch on several points on the bone for surface-based registration. Conventional registration techniques are used to align the pose of the tracker 16 with the patient's anatomy, e.g., the anatomy of the patient being treated. It can be correlated to vertebra V.

[0028] Other types of registration are possible, for example, mechanical clamps attached to the spinous processes of vertebrae V. a tactile sensor (not shown) that identifies the shape of the spinous process to which the clamp is attached; The tracker 16 can then be used with the mechanical clamp that includes the spinous process. The shape of the tactile sensor can be matched to a 3D model of the spinous processes for registration. A known relationship between the vehicle and three or more markers on the tracking device 16 is Based on this known relationship, the patient's anatomy is pre-loaded into the controller 36. The position of the marker relative to the target can be determined.

[0029] The base tracker 16 also connects the base 22 to the surgical tool 30 to track its orientation. In other embodiments, a separate tracker 16 is attached to the surgical tool, e.g., during manufacture. The surgical tool 30 may be integrated into the surgical tool 30 and secured thereto, or may be attached to the surgical tool 30 in preparation for the surgical procedure. The surgical tool 30 may be attached separately. The working end of 30 is tracked by the base tracker 16 or another tracker. The working end can be the distal end of an attachment to the surgical tool 30. Accessories include drills, burrs, saws, electrocautery devices, screwdrivers, taps, and hand tools. It can be a surgical knife, Jamshidi needle, etc.

[0030] In the illustrated embodiment, tracker 16 is a passive tracker. In this embodiment, each tracker 16 reflects light from the localizer 14 to form an optical sensor. At least three passive tracking elements or markers are used to track the In another embodiment, tracker 16 is an active tracker. and may include a light emitting diode or LED that transmits light, such as infrared light, to the light sensor. Based on the received optical signals, the navigation controller 36 can perform conventional triangulation. Using quantum techniques, the relative position and orientation of the tracker 16 with respect to the localizer 14 can be determined. In some cases, more or fewer markers are used to generate data that show For example, if the tracked object can rotate around a line, Using two markers, you can measure the position of the markers at various positions around this line. The direction of this line can be determined by the above. Although the tracker 16 is described as utilizing optical tracking technology, it may alternatively also utilize Additionally, other tracking modalities such as electromagnetic tracking, radio frequency tracking, inertial tracking, and combinations thereof are considered. It should be appreciated that the object can be tracked using the property.

[0031] Also, if the surgical tool 30 inadvertently contacts the patient's skin outside the desired incision boundaries, It may be desirable to track the surface of the patient's skin to prevent penetration. For this purpose, active or passive markers with adhesive backings are available. The skin marker M is attached to the patient's skin to define a boundary relative to the patient's skin. The array of such markers M may be substantially a circumferential ring 74 (circular, rectangular, The outer ring 74 is positioned so that the surgical procedure can continue inside the ring 74 without interfering with the surgical procedure. (i.e., the ring can be placed in the patient's (placed on the skin). One suitable skin marker array is the Stryker Le ibinger GmbH&Co KG(BotzingerStraβe41, D-7 SpineMa is manufactured by SpineMatrix (9111 Freiburg, Germany). sk (registered trademark) tracker. Also, the application was filed on May 13, 2015, and vigation System For And Method Of Tracki ng The Position Of A Work Target”, See also U.S. Patent Application Publication No. 2015 / 0327948 to Choepp et al. is incorporated herein by reference in its entirety. Other suitable skin trackers may be used. Digital probes may also be used to map the skin surface and / or incision. However, once you have mapped it, you will need to digitize it further to see the skin. Although it cannot detect movement, the attached tracker array can detect movement of the patient's skin. It can be detected.

[0032] Prior to the start of a surgical procedure, additional data is loaded into the navigation controller 36 . Based on the position and orientation of the tracker 16 and the previously loaded data, the navigation The action controller 36 controls the movement of the surgical tool 30 relative to the tissue to which the working end is applied. The additional data determines the position of the working end and the orientation of the surgical tool 30. The position and / or orientation of the tracker 16 or its marker M relative to the working end of the tracker 16. The calibration data may include geometric data relating to the position of the sensor. The data is used to measure the position of a calibration probe or calibration divot on the tracker 16 of known geometry. can be used to track the position of the working end of the surgical tool 30, for example, by its own tracker or Determined pre-operatively or intra-operatively, such as by determining relative to a base tracker 16 The additional data can be used to align the tracker 16 with the patient's anatomy or a 3D model thereof. In some embodiments, the registration data may include transformation data associated with the rule. The navigation controller 36 transmits this data to the robot controller 3 2. The robot controller 32 then uses this data to Robots, as described in Nos. 8,010,180 or 9,566,122 arm 20, both of which are incorporated herein by reference. can be.

[0033] The navigation controller 36 also controls the surgical tool 30 relative to the target tissue. These image signals are displayed on the display 1. 8. Based on these signals, the display 18 allows the surgeon and staff to An image is generated that allows the relative position of the surgical tool 30 to be viewed with respect to the surgical site. The display 18, as discussed above, may be a touch screen display that allows for the entry of commands. It may include a screen or other input / output devices.

[0034] In the embodiment shown, the orientation of the surgical tool 30 is determined by the navigation system 12 to track the position of the base 22 via the base tracker 16 and the robot arm The joint encoder data from the joints of the 20 and the position of the surgical tool 30 and the robot arm 20 are By calculating the orientation of the surgical tool 30 based on known geometric relationships between the Finally, the localizer 14 and tracking device 16 can determine It allows for the determination of the orientation of the surgical tool 30 and the patient's anatomy, thus facilitating navigation. The surgical system 12 recognizes the relative relationship between the surgical tool 30 and the patient's anatomy. One such navigation system was released on September 24, 2013. The application was filed in 2013 and is entitled "Navigation System Including Opti Wu's US special issue entitled "Sensor-Based and Non-Optical Sensors" No. 9,008,757, which is incorporated herein by reference.

[0035] During surgery, for a particular surgical task, the user manually controls the robotic arm 20. Operate (e.g., move or cause movement of a robotic arm) , and manipulate the surgical tool 30 to perform drilling, cutting, sawing, reaming, implant insertion, and the like. When a user manipulates the surgical tool 30, The navigation system 12 may be configured to position the surgical tool 30 and / or the robotic arm 20. Tracking the position of the patient and providing haptic feedback (e.g., force feedback) to the user One or more locations that are registered (or mapped) to the subject's anatomy Move (or cause movement of) the surgical tool 30 beyond a certain virtual boundary. (which limits the user's ability to drill, cut, saw, etc.) with great accuracy and repeatability. Reaming, reaming, and / or implant placement may occur.

[0036] In one embodiment, the robotic arm 20 operates in a passive manner, allowing the surgeon to define a virtual boundary. Provides tactile feedback when attempting to move surgical tool 30 across. The feedback may be transmitted to one or more actuators (e.g., joint motors) in the robot arm 20. is generated by a flexible transmission such as a cable-driven transmission. The robot arm 20 provides haptic feedback. When not in use, the user is free to move the robot arm 20. In this regard, the present invention relates to a method for manufacturing a semiconductor device, as shown in U.S. Pat. No. 9,566,122, previously incorporated by reference herein. Similar to the robot arm 20, the robot arm 20 is operated by a user in a similar manner, but The robotic arm 20 operates in an active manner, for example, when a user applies force to the surgical tool 30. When a force is applied, the force / torque sensor measures this force and calculates the torque based on the measurement from the force / torque sensor. The robot arm 30 emulates the user's desired movements based on the robot arm. For a task, the robot arm 20 operates autonomously.

[0037] 4 and 5, a surgical tool is coupled to the distal end 28 of the robotic arm 20. More specifically, a coupling 40 is shown connecting the surgical tool 30 to the robot. The distal end 28 of the arm 20 is provided with a center axis A relative to the distal end 28. In FIG. 4, the surgical tool 30 is rotated around the vertebral Pilot for pedicle screws, other screws, or other types of implants The drill 42 is arranged to rotate around a rotation axis R. In FIG. 5, the surgical tool 30 is a pedicle screw PS or other implant. It is positioned along the axis of rotation R so that it rotates about the axis of rotation R to drive the runt. A driver 44 (eg, a screwdriver) is included.

[0038] The surgical tool 30 includes a housing 45. A drive system (e.g., a motor) drives the drill 4. 2, located in a housing 45 for driving a driver 44 or other accessories. The drive system can be variable speed. A handle 46 is provided on the housing 45 and has a grip. During a surgical procedure, a user grasps the grip and applies surgical tools 30 and / or or operate the robot arm 20.

[0039] Additionally, the housing 45 may be used to mount the drill 42, driver 44, or other accessory to the drive train. For removable mounting, include a collet 47 or other type of coupler. In some cases, a reducer 48 (see FIG. 5) is removably mounted on the collet 47. The reducer 48 may be used for certain accessories when directly connected to the drive train. A transmission or gear arrangement that reduces the rotational speed of an accessory compared to a A reducer is useful when a slower rotation speed is desired. Also, a trigger 49 may be provided. Advantageously, this trigger controls the speed of the drill 42 and / or driver 44, and the robot Initiate the movement of the arm 20 or align the rotation axis R to the desired trajectory (alignment The trigger 49 is used to trigger the robot arm 20 and / or the surgical tool. A signal for controlling the tool 30 is transmitted to a robot controller 32 (which may include a tool controller). It is possible to communicate with

[0040] In another embodiment shown in FIG. 6, one end of the coupling 40 is centered on an axis A. The other end of the coupling 40 supports the surgical tool 30 for rotation. The housing 45 may be fixed to the coupling 40 or may be Alternatively, it may be supported for rotation about the rotation axis R within the coupling 40. This allows the housing 45 to passively rotate within the coupling 40. At the same time, the coupling 40 allows the position of the housing 45 to be precisely controlled. axial movement of the housing 45 along the rotation axis R relative to the coupling 40 is restricted. A tracker (not shown) is attached to the housing 45 to determine the position of the housing 45. and / or orientation tracking, the rotation axis R and / or the The distal end of the attached attachment can be tracked. The rotating shaft 60 is supported for rotation within the a distal interface / collet 62 that couples to a torque driver such as a motor; A proximal interface that couples to a power source, such as a power source, a rotatable handle for manual rotation, etc. For example, a user may hold the handpiece 66 and operate the motor. Triggering the motor causes the motor to rotate through the rotating shaft 60 to the driver 44 and ultimately to the vertebrae. The driver 44 is positioned distally so that torque can be transmitted to the pedicle screw PS. Interface 62 / hand shown coupled to rotating shaft 60 and having an internal motor. Piece 66 is shown coupled to proximal interface 64. This configuration allows The user can feel direct torque feedback when inserting the pedicle screws. can be done.

[0041] Preoperative and / or intraoperative imaging may be used to assess the patient's anatomy (e.g., the patient's spine) The surgeon can visualize the images and / or the The 3D model created from the pedicle screw placement was used to plan the placement of the pedicle screws. This plan may, for example, specify the desired pose in an image and / or a 3D model. This allows the orientation of each pedicle screw PS relative to the specific vertebra V in which it is placed. This involves determining the location of the distinct vertebral arches with respect to a 3D model of the patient's anatomy. This may include creating a 3D model or positioning of the root screws PS. Once the plan is established, it is transferred to the robotic system 10 for execution.

[0042] The robot system 10 is connected to an imaging device 50 (e.g., a C-arm shown in FIG. 3). It can also be used to record any preoperative images, e.g., X-rays, CT scans, taken before surgery. or intraoperative imaging of the patient's anatomy in addition to, or instead of, MRI images. Intraoperative images from the imaging device 50 can be obtained by placing The actual position of the drill 42 or driver 44 relative to the desired orientation of the pedicle screw PS. A separate tracking device 16 can be used for each vertebra V to help determine the position of the vertebra. When placing a pedicle screw PS or other implant within a vertebra V, and the corresponding orientation of the drill 42 and / or driver 44 relative to the individual vertebrae V. can be tracked.

[0043] The robotic system 10 assesses the desired orientation of the pedicle screws PS and A virtual boundary (e.g., a haptic object), a predetermined tool, and a desired posture of the user's PS are Create a loop and / or other autonomous motion instructions to control the robot arm 20. The drill 42 and driver 44 of the surgical tool 30 are ultimately controlled by the user. The method of placing the pedicle screws PS according to the plan is controlled. This can be done, for example, by the surgeon. During surgery, the alignment of the trajectory of the surgical tool 30 with the desired orientation of the pedicle screw PS is For example, the desired orientation of the pedicle screw PS and the alignment of the axis of rotation R. This can include ensuring that the

[0044] In other embodiments, the user may plan the desired trajectory and / or screw placement during surgery. For example, the user may select a desired anatomical feature, e.g., a vertebra V. The drill 42 is placed at the desired insertion point, and the trajectory of the rotation axis R is confirmed to be in the desired direction by the digital The drill 42 can be oriented until the display 18 indicates this trajectory. Once satisfied, the user provides input to the control system (e.g., touchscreen, buttons, fonts, etc.). provide a foot pedal or other suitable device to set this trajectory as the desired trajectory to be maintained throughout the procedure. The surgical tool 3 can be rotated to maintain the axis of rotation R and stay along the desired trajectory. The haptic object created to constrain the movement of the 0 is the line shown in Figure 4. The line haptic object LH can be further 4. The starting point SP as described in 4. and the desired depth of the drill 42, pedicle screw PS, etc. The object may include a target point TP that defines the target position and an ejection point EP. It is also conceivable that this may include the shape, size, etc. of the object.

[0045] 7 and 8, one of the vertebrae V is shown. During a surgical procedure such as a spinal fusion procedure Next, the surgeon inserts one or more pedicle screws into the vertebral body 100 of vertebra V through the pedicle region. Before inserting the pedicle screw PS, the surgeon must 42 can be used to drill a pilot hole 102 in the vertebral body 100. In this embodiment, when a self-drilling, self-tapping bone screw is used, Lot holes can be excluded. For example, issued on December 29, 2009, "Self-drilling bone screw" by Stefan A See the teachings of U.S. Patent No. 7,637,929 to Uth, which is incorporated by reference. The entire contents of which are incorporated herein.

[0046] In one embodiment, before drilling begins, the robotic system 10 2, and the desired trajectory and alignment of the axis of rotation R of the surgical tool 30. and positioning the rotation axis R along a desired trajectory by autonomously taking the In this case, the robotic arm 20 is positioned along the desired trajectory but is also positioned along the vertebral body. 100 (as shown in FIG. 4) and spaced above the drill 42. Therefore, the drill 42 has not yet come into contact with the vertebral body 100. The proper positioning can be achieved by the user pulling the trigger of the surgical tool 30 or by other The motion can be initiated by providing an input to the control system that initiates the motion in a manner that In some cases, the tool center point (TCP) of the surgical tool 30 may first be aligned to the desired trajectory. A line providing a path is within a predetermined distance from the starting point SP of the tactile object LH (a predetermined starting sphere The TCP (e.g., center of gravity of the bar, center of the drill tip, etc.) is moved to the When within a predetermined distance from the starting point SP, the trigger is pulled (or alternatively the foot pedal is pressed). or moving another input), the robot arm 20 can autonomously move along a desired trajectory. The surgical tool 30 is aligned and positioned using the For example, a patent application filed on December 21, 2012 entitled "Systems and Me" thods For Haptic Control Of A Surgical T The teachings of U.S. Patent Application Publication No. 2014 / 0180290 to Otto et al., entitled "Ultra-High-Performance Microwave Cooling System," See the references herein, which are incorporated by reference in their entirety. The system 20 is configured to move the surgical tool 30 a fixed distance from the patient based on a preoperative plan. or to move the TCP to the nearest point in orbit. Once the surgical tool 30 is in the desired orientation, the robotic system 10 may Keep the rotation axis R on the path, i.e., in alignment with the line tactile object LH. To take the patient's position, the robotic arm 20 tracks the patient's movements and adjusts autonomously as needed. This effectively keeps the rotation axis R of the surgical tool 30 on the desired trajectory.

[0047] While the robotic system 10 holds the surgical tool 30 on the desired trajectory, the user , the surgical tool 30 is manually operated to move the vertebral body 100 along the line haptic object LH. 42 toward (or cause the drill to move) the pilot hole 1 In some cases, such as when using a passive robot arm 20, This means that the user can move the surgical tool in a way that deviates from the line haptic object LH and the desired trajectory. When the user tries to move the ball 30, the robot system 10 does not provide haptic feedback to the user. By providing the surgical tool 30 with the desired trajectory, the user can The user may use the robotic arm for unconstrained movement of the surgical tool 30. If the user wishes to return the surgical tool 20 to free mode, the user can move the surgical tool 20 until the insertion point EP is reached. The user can then pull the handle 30 back along the line haptic object LH and away from the patient. can.

[0048] The user then drills the pilot hole 102 to the desired depth. can be controlled by the user via a trigger or adapted to the patient's anatomy The control can be automatically based on the specific position of the drill 42. For example, The rotation speed of 2 can be set high (fast) during the initial drilling into the vertebral body V, Further drilling into vertebral body V can be slowed, and final drilling to final depth can be set even slower. Also, the control system One or more sensors S (e.g., one or more force sensors, force / torque sensors, torque sensors) in communication with the sensor 2 During line tactile guidance via sensors such as pressure sensors, light sensors, etc., Contact force can be monitored. If no significant contact / contact force is detected, this indicates that the surgery This means that the surgical tool 30 is passing through the soft tissue, so the control system Activating the motor or other power source (e.g., RF energy, ultrasonic motor, etc.) of the motor 30 If contact with bone is detected (e.g., optically, the sensed force When the voltage exceeds a predetermined threshold, the control system activates a motor or other power source. The user can also passively feel the touch / touch force to trigger the switch. The power source can be activated.

[0049] When the user has reached the desired depth of the pilot hole 102, e.g., the target point TP When the user reaches the desired trajectory, a virtual boundary ( For example, haptic objects) can also be presented via haptic feedback. Alternatively, a separate virtual boundary can be used to set the desired depth. The bot system 10 can autonomously drill the pilot hole 102 to a desired depth. In further cases, the robotic system 10 may initially drill autonomously. The final drilling can then be done manually, or vice versa. Once the pilot hole 102 is formed, the driver 44 is used to drive the pedicle screw. In some embodiments, the pilot hole 102 It may be unnecessary to place the pedicle screws PS by the robotic system 10. It can be placed over a guidewire or without any guidance. When using self-drilling or self-tapping bone screws, a pilot hole For example, the Self-drive Stefan Auth's patent entitled "Balling Bone Screw" See the teachings of US Pat. No. 7,637,929, which is incorporated herein by reference in its entirety. be absorbed.

[0050] The navigation system 12 is used to sequentially track each vertebra V separately, and the drill 42 One advantage of tracking the movement of the spinal cord is that the pedicle screws PS can be inserted close to the spinal cord 103. Therefore, the pedicle screws PS and their corresponding The placement of the pilot holes 102 is such that they avoid interaction with or damage to the spinal cord 103. It must be precisely aligned. Drilling too many holes 102 and / or drilling too deep can result in the pedicle screw The drill 42 used to drill the PS or pilot hole 102 is inserted into the spinal cord 103 As a result, the navigation system 12 may be used to Anatomy, specifically the anatomy as outlined in preoperative and / or intraoperative images By tracking the orientation of the drill 42 and / or driver 44 relative to the target shape, the spinal cord 1 You can avoid 03.

[0051] Specifically, with reference to FIG. 7, once drilling is complete, the drill 42 is removed from the vertebral body 100. The drill 42 is removed from the drive system via the collet 47, and the driver 44 is driven. The pedicle screw PS is connected to the pilot system (with or without a reducer 48). It is attached to the distal end of the driver 44 for placement in one of the holes 102. The line haptic object is also used to drive the pedicle screw PS. or create a new line tactile object with a new start point, target point, and exit point. This is created when installing the driver 44 and / or pedicle screws PS. In this case, the robot controller 32 is connected to the housing 45. The drill 42 and / or driver 44 may be RFID tagged so that the drill 42 and / or driver 44 can be identified. The housing 45 may include a tag or other identification device. communicate with the robot controller 32 to determine the attached accessories; Then, based on this information, the controller can The controller creates a new line tactile object and assigns access to the new line tactile object. You can determine the new line tactile object by accessing Similarly, the robot controller 32 determines the size of the pedicle screw PS to be attached. The pedicle screws PS also have RFID tags attached so that the type can be determined. and the driver 44 can have a similar reader. , the line tactile object is based on the driver 44 and / or pedicle screw PS The robotic arm 20 can be precisely controlled to perform the desired pedicle surgery on that particular pedicle. The implant is positioned at a desired location, e.g., a desired orientation and depth relative to the patient's anatomy. It can be placed.

[0052] Additionally, either RFID tags or other detection devices such as vision cameras Automatic detection of accessories via the control system allows the control system to Any surgical software that can be used in this case can be used as a driver since the driver 44 is connected to the It allows the user to proceed to the next screen related to Driver 44 and provides different prompts for the user. It can be used to give instructions, commands, etc. It can be used to give instructions, commands, commands, etc. Using the force device, advance the software and / or the next vertebra to be treated. 00 and / or change the (lateral) surface of the vertebral body 100 on which the surgery is being performed. This can also be based on the position of the surgical tool 30. The user must move the attached accessory TCP closer to one side of a particular vertebra V than the other. If manually placed, the software will automatically progress to accommodate one side of vertebra V. The selected vertebra V and the surgical side can be visually displayed on the display 18. or via audio input / output.

[0053] Again, the robotic system 10 controls the drill 42 in much the same way. While holding the surgical tool 30 on the desired trajectory, the user manually moves the surgical tool 30. Operate the driver 44 and the haptic object LH toward the vertebral body 100 along the line LH. Move the pedicle screw PS (or this driver and pedicle screw movement) The pedicle screw PS can be inserted into the pilot hole 102. In some cases, such as when using a passive robot arm 20, the robot system The system 10 moves the surgical tool 30 along the desired trajectory while the surgical tool 30 remains aligned with the desired trajectory. By constraining the user's movement for the surgical tool 30 to stay along Controlling the movement of the surgical tool 30. This allows the user to manipulate the surgical tool in a way that deviates from the desired trajectory. By providing tactile feedback to the user when attempting to move the tool 30, Therefore, even in such a case, the robot arm 20 can The device controls the insertion of the implant into the patient's spine so that the implant is positioned in the desired location. Next, the user inserts the pedicle screw PS into the pilot hole 102. The drive speed is controlled by the trigger. Controlled by the user via a controller or driver relative to the patient's anatomy and / or can be automatically controlled based on the specific position of the pedicle screw PS. For example, the rotational speed of the driver 44 may be set high during initial insertion into the vertebral body V. The insertion of the vertebral body V can be slowed down during further insertion, and the final insertion can be During the final embedding to the desired depth, the time can be set even slower.

[0054] When the user has reached the desired depth, the screw will be positioned along the desired trajectory. Virtual boundaries (e.g., line haptic objects) used to constrain the user's movement It can also be indicated through haptic feedback. A separate virtual boundary can also be used to indicate the desired In other cases, the robotic system 10 may set the depth of the pedicle. In a further case, the robot can autonomously insert the tube to the desired depth. The system 10 can autonomously drive the pedicle screws PS initially to the initial depth. After that, the final embedding to the final depth can be done manually, and The reverse can also be done. In one example, the pedicle screws PS are inserted from the final depth to a predetermined autonomously until within a distance (as determined by the navigation system 12) of At this point, the user should feel the pedicle screws 30 tighten. The pedicle screws PS can be manually embedded using a surgical tool 30. Either complete the procedure or use a separate tool (powered or manual) to insert the pedicle screw. The user completes the placement of the PS by the control system via the display 18. To be told how many rotations remain before the pedicle screw PS reaches its maximum depth and / or display 18 to indicate how further actuation of the pedicle screw PS The pedicle screen is designed to allow the user to easily visualize how much of the vertebra is needed. The PS, anatomy, and / or target points may be represented graphically.

[0055] In some procedures, all pilot holes are drilled first, and then all When the pedicle screws PS are driven into their desired positions, the pilot hose Between drilling the hole and driving the implant, the rotation axis R may deviate from the desired trajectory. In such cases, before placing each pedicle screw PS, First, insert the pedicle screw PS into the desired trajectory and position it with the surgical tool 30 in the manner previously described. By autonomously aligning with the rotation axis R, the rotation axis R can be moved along the desired trajectory. The movement of the surgical tool 30 can be controlled to effect placement.

[0056] In one alternative, the pedicle screws PS are inserted with the assistance of a robotic system 10. The robot controller 32 determines the rotation speed around the rotation axis R and the planned trajectory. The insertion is controlled so that the advancement speed along the pedicle screw is proportional to the thread form of the pedicle screw. For example, the thread form is determined by the length, thread diameter, thread depth, and head of the pedicle screw PS. The thread pitch P may include one or more of the following: thread size, thread pitch P. Indicates the starting position of the pedicle screw PS adjacent to the (target) site. In this case, linear Together with the planned trajectory specified by the haptic object LH, the target site is vertebra V and The threaded interface between the pedicle screw PS and the vertebral body 100 is shown. If the pedicle screw is not inserted correctly, the bone, screw PS, driver 4 4 or risk of damaging the surgical tool 30. Bone is probably the weakest material. Therefore, if the screw is not inserted correctly, it is most likely to be damaged. Improper insertion can result in, for example, a pedicle screw being inserted with insufficient rotation around the axis of rotation R. This can occur when the PS advances linearly along the trajectory LH. Bone material adjacent to the crest can become sheared and forced into the bone. In some cases, improper insertion may occur, for example, when the pedicle screw PS is not advanced along the trajectory LH. This can occur when the screw rotates around the rotation axis R in an insufficient state. The bone material adjacent to the threads is sheared and forced back along the threads, effectively In both cases, improper insertion can result in vertebral arch damage. The strength and amount of bone material securing the pedicle screw PS to the bone is reduced.

[0057] Figure 14 shows the vertebral body for insertion using position control to address this potential risk. Pedicle screw PS is shown with starting point Do adjacent to 100. Insert the screw. Position control for this purpose ensures that the appropriate depth position and angle or rotation position are maintained throughout the procedure. As shown in the above embodiment, a pilot hole is formed in the vertebral body 100. or may be self-drilling and self-removing so that no pilot holes are required. Surgery using tapping screws may be performed. Starting point D of the pedicle screw PS o is adjacent to the vertebral body 100, i.e., no part of the screw penetrates the vertebral body 100. Alternatively, the starting point Do may be set to a value that ensures adequate positional control throughout the procedure. To ensure safety, the implant may be spaced a certain distance from the vertebral body 100 as a safety margin. The insertion depth D is determined by the insertion of the pedicle screw PS into the vertebral body 100 along the trajectory LH. to a final depth Df as the planned depth to complete the insertion.

[0058] The robot controller 32 controls the rotation speed and the advancement speed along the trajectory LH to control the pedicle screen. The insertion of the pedicle screw PS is controlled in proportion to the thread pitch P of the pedicle screw PS. The PS pedicle screw has a known geometry and is designed for navigation. The thread pitch P is the number of threads per unit length. In a specific example, the pedicle screw shown in FIG. 14 has a diameter of 1 / 32 in. Other exemplary pedicle screws PS include , 8, 10, 14, 16 or other numbers of threads per inch. The relationship defined between the robot arm 20 and the pedicle screw PS and the robot system By having the known shape of the pedicle screw PS stored in the memory of the robot 10, The screw controller 32 controls the insertion of pedicle screws having a particular thread pitch. The system is configured to ensure proper rotational and forward speeds for the engine.

[0059] The thread profile of the PS pedicle screw can be adjusted preoperatively or intraoperatively by the robotic system. In one example, the pedicle screws PS can be stored in a library as part of the surgical plan. The corresponding thread form of the pedicle screw PS is selected as the pedicle screw PS. Once the plan is loaded for the intraoperative procedure, the robot The system 10 stores known thread forms in memory for immediate access. In the example, the operator can manually select different pedicle screws PS and manually inputting the thread form using a GUI associated with the operation of the robot system 10; The input thread form is retrieved from a database stored in memory. or the operator can select the offline screw associated with the selected pedicle screw PS. These examples can be derived from obtaining such information from the application specification. Either method stores the thread form in memory after operator input using a GUI. The robotic system 10 can then use the input thread profile to perform the thread forming process described herein. In yet another example, the robotic system 10 may implement the control techniques described herein. Any intended vertebral arch can be measured using a measurement tool that is directly or wirelessly connected to the Scan or measure the root screw PS, extract the thread form, and measure the thread form. can be transmitted to the memory of the robot system 10.

[0060] Pedicle screw thread pitch, angular or rotational position, and insertion depth or trajectory The relationship between the advance along the , θ is the angular position, D is the insertion depth in unit length, and pitch is the pedicle screw P The robot controller 32 uses this relationship to calculate the number of threads per unit length of S. For example, the first derivative with respect to time is The rate of change of the insertion position, i.e., the rotation speed δθ / δt, is It is equal to t multiplied by the pitch divided by 2π, which can be expressed as δθ / δt=δD / δt*(pitch / 2π) (Equation 1)

[0061] As described above, the robotic arm can be operated in an active manner, allowing the user to apply force to the surgical When a force is applied to a tool, the force / torque sensor measures this force. The robot emulates the user's desired movement based on measurements from the lux sensor. The controller 32 generates a torque proportional to the direction and magnitude of the applied force. The robot controller 20 may be configured to command the displacement of the robot arm 20. The Controller 32 measures the rotation and advancement speed of the pedicle screw PS relative to the thread pitch. and maintain a proportional relationship between them.

[0062] In one alternative, a method of placing an implant is provided, as shown in FIG. Figure 15 shows the placement of the implant in the desired position, such as placing a screw in the bone. 1 shows a flowchart of sample steps that may be performed in a surgical procedure for performing a vascular endoscopic procedure. In step 400, the anatomy is first prepared to receive the implant. Such preparation involves (1) making an incision in the patient (see also Figure 13), (2) assembling the wound with a retractor, and (3) drilling pilot holes in the anatomy; (4) retracting the tissue; This may involve several steps, such as cutting an internal thread into the anatomical form. In this procedure, it is not necessary to perform all the formation steps. For example, self-perforation, cell If capping screws are used, drill pilot holes or insert female screws. No separate threading step is required.

[0063] As shown in Figure 14, according to the surgical plan, the axis of rotation R is aligned with the planned trajectory LH. If the axis of rotation R is not properly aligned, or for any other reason, deviates from the desired trajectory, step 40 In step 2, the rotation axis R is aligned (positioned). 2, the robotic system 10 controls the movement of the surgical tool 30 to define a rotation axis R. This allows the robotic system 10 to autonomously move the surgical tool 30 along the desired trajectory. This can include inducing a movement to position the rotation axis R along a desired trajectory. Alternatively, the robot system 10 may continue to rotate until the rotation axis R is positioned along the planned trajectory LH. , allowing the user to apply force / torque to move the surgical tool 30 in manual mode The robotic system 10 may provide feedback (visual feedback) indicating proper alignment. In some examples, a visual, audible, and / or tactile sensation may be generated to the user. , the attractive haptic determines whether the tool position is on the trajectory LH up to a threshold distance defined by the attractive haptic. This is used to pull the tool 30 towards the planned trajectory LH so that it is close to the It can be done.

[0064] Once the rotation axis R is positioned on the desired trajectory, in step 404, the robot system 10 operates to maintain the axis of rotation R along a desired trajectory. It can include constraining 30 movements, whether autonomous or manual, The surgical tool 30 is used throughout the procedure until the implant is in the desired position. It remains aligned with the desired orbit.

[0065] Insertion of the implant into the patient's vertebra V is performed by carefully adjusting the implant to the desired position. In steps 406 and 408, the robot The surgical system 10 induces autonomous movement of the surgical tool 30 along a planned trajectory. The autonomous forward movement of the linear tool is controlled, while the rotation of the surgical tool around the rotation axis R is controlled. The autonomous control of forward and rotation is performed by the screw, defined by Equation 1 above. The autonomic control determined by the thread pitch is related to the pedicle scaffold. Ensure proper insertion of the rib and avoid causing damage to the surrounding bone tissue.

[0066] Autonomous control continues until completion of step 410, where the robotic system 10 The implant is placed in the desired position, i.e., final insertion depth according to the surgical plan.

[0067] Steps 400-410 may be commanded by the user in several alternatives. In a first example, the robotic system 10 is configured to run fully autonomously. That is, the user can command the robotic system 10 to perform an operation. The robotic system 10 then continues the operation without further user input until the operation is complete. In an alternative embodiment, the user may continue to initiate autonomous execution of the operation. Press and hold a button, footswitch, or other continuous input. If you provide continuous input through a control, for example, and the input stops, e.g., a button or The robot system 10 may be configured to pause execution of an operation when the stop switch is released. In cooperation with the autonomous control, the user may adjust the speed at which the operation is performed. In addition to buttons and foot switches, the user can also step through multiple discrete speeds. Additional functions are added so that the robot's speed can be commanded to increase or decrease. Additional speed controls may be provided. The control may include a set of controls, such as a yaw or other suitable controls.

[0068] In a further embodiment, the method includes a step of a user applying a force to a surgical tool, the force being a force / This includes using the robotic system 10 in an active manner where torque sensors are used to measure torque. The robot system determines the user's desired robot action based on measurements from the force / torque sensors. In this embodiment, the user controls the robotic system to emulate the motion of the robot. mode and command the execution of autonomous control operations to insert the implant. The robotic system 10 may convert signals indicative of inputs applied by a user into force / torque signals. The robot receives the force from the sensor and performs autonomous control at a speed proportional to the magnitude of the input force. The system 10 may be configured to detect when the user releases the control or by other means. Further configured to pause the execution of an operation if no force is input to the force / torque sensor It can be done.

[0069] In a further embodiment, the method includes the surgical tool 30 shown in FIGS. A trigger 49 capable of communicating a signal indicative of a user input to the robot controller 32. The robotic system 10 includes a trigger. During implant insertion, the rotation axis R is rotated according to the amount of pushing (operation) of 49. A mode in which the user controls either the rotation speed or the progression along the trajectory. In steps 406 to 410, the user For example, by variably depressing trigger 49 to control rotation or advancement speed. The robotic system provides input by controlling either forward speed or rotation speed. The screw responds to inputs by increasing the pitch of the thread in accordance with the relationship defined in Equation 1 above. Both aspects of the implant placement are maintained.

[0070] After step 410, with the implant in the desired position, step 412 Now, withdraw the tool from the implant. Just as when advancing the implant into the bone, Similarly, the user applies force to the surgical tool in a direction away from the vertebra V to increase the Alternatively, the robotic system 10 may command the implant to be extracted. Once deployed, the surgical tool can be autonomously withdrawn without further input from the user. The process described in steps 400-412 can be used to The procedure was performed anew to place the implants, and all implants were placed according to the surgical plan. This may continue until the

[0071] Partial facetectomy is performed using a surgical tool 30 to insert the head of the pedicle screw PS into the spinal wall. The amount of resection can be adjusted to suit the user's needs while providing a smooth bone surface to receive the implant. Based on the user's plan, i.e., by determining the position of the head in the 3D model A burr or pre-formed reamer 70 corresponding to the head shape can be defined. In some cases, the drill 42 may be used as a separate tool to remove material. To avoid this, a reamer can be incorporated into it, as shown in hidden lines in Figure 7. As a result, the drill 42 is drilled with a smaller profile drilling slot to form the pilot holes. shaft and more proximally forms a seat 72 for the head of the pedicle screw PS The reamer 70 is positioned to allow for the pilot hole 102 and the seat 72 to be fully opened. In the embodiment shown, the drill 42 is The drill has a drill shaft having a proximal end and a distal end, and a drill tip at the distal end. The reamer 70 is inserted into the target vertebral body to a desired depth, and the reamer 70 is then freed. It is spaced proximally from the drill tip so that it is located near the facet. The holes can be formed using the cutting function of a suitable drill and / or reamer. For example, forming a pilot hole and seat in the patient's spine to receive the implant. It is possible.

[0072] The robot controller 32 is used to drive the pedicle screw PS with the driver 44. To control the insertion of pedicle screws by measuring the torque associated with the movement. More specifically, the pedicle screw PS can be inserted into the vertebral body 100. The torque increases as the pedicle screw PS is placed deeper into the vertebral body 100. The force increases further as the end of the hole 102 is reached. The torque output of the actuator determines whether the pedicle screw PS has reached the desired depth and / or can indicate whether the end of the pilot hole 102 has been reached. The controller 32 monitors this torque (for example, via a torque sensor) flow, etc.) and controls the rotation of the driver 44 accordingly. For example, the driver 44 may be stopped when a threshold torque is reached.

[0073] 9A and 9B, the control system may be configured to control the torque output, e.g., current or other The measured force parameters were used to determine the force of the drill 42 or pedicle screw PS during insertion. This may be possible by having the tracking device 16 attached to the vertebra 100. This can be particularly useful in cases where a person inadvertently moves against the object, which may not otherwise be detected and may result in a puncture. For example, if the vertebra 100 is Using the preoperative and / or intraoperative images taken, bone mineral density (BMD) for the vertebrae 100 was calculated. ) volumetric map can be generated. Such BMD maps for robotic surgery The creation and use of the robot was filed on June 28, 2016. ms And Methods For Controlling A Tool Re Moving Material From A Workpiece" Octezuma de la Barrera et al., U.S. Patent Application Publication No. 2017 / 00 No. 00572, which is incorporated herein by reference. During drilling or screw drive, the control system evaluates the BMD map and creates a 3D model and the contact points of the drill 42 / pedicle screw PS to the bone according to the user's plan. i.e., at the current contact point if the drill / pedicle screw PS is according to the plan The control system can then adjust the current and pressure of the surgical tool 30 to predict the BMD. or predict the corresponding value of torque or interaction force (e.g., using a force / torque sensor) (and compare that value with the actual value measured to see if any discrepancies exceeding a threshold are found. If a discrepancy is found, the discrepancy is considered to be a reason to stop the surgery. This can be used to plan and update the plan. The current, torque and force profiles of the insertion of S are shown. The system 10 monitors the current, torque and force profile of the screw insertion. It can be shown that the pedicle screw follows the planned trajectory. The luke profile can be used to indicate the degree of osteoporosis in the bones.

[0074] An ultrasound transducer (not shown) is attached to the back of the patient's skin to measure the patient's Real-time images of the anatomy and progress of the surgical procedure can be generated. Use this to determine whether the pedicle screws PS are following the planned desired trajectory. The drill 42 or pedicle screw PS cuts the nerve or the medial or lateral cortical border. It is possible to determine whether or not the target is approaching any important structures, including the target.

[0075] Referring to FIG. 10A, one of the accessories of the surgical tool 30 is a scalpel, an electrocautery, a sharp The skin incision tool 80 may include other tools with tips. The drill 80 may be mounted similarly to the drill 42 and / or driver 44, or or a part of a separate end effector, which is attached to the coupling 40 The skin incision 1 may be connected to the back 81 in a manner similar to that previously described. Haptic guidance, i.e., using virtual boundaries (e.g., tactile objects), That is, when creating the incision, a virtual boundary can be used to define the location on the patient's skin. In one example, the digital printer can constrain the user's movements with respect to the desired incision. Lobe 73 is used to contact the desired incision location and create the associated boundary / haptic object. In another example, by digitizing and / or Preoperative methods allow the determination of a 3D skin model based on the orientation of the ring. The control system uses the desired plan of pedicle screw placement and calculates the pedicle screw placement based on this skin model. The location of the incision I can be determined using this.

[0076] Referring to FIG. 10B, other types of pointers similar to the digital probe 73 may also be used to measure the incision. Other types of pointers can be used to identify the desired location, such as the skin incision tool. The tool 80 may be attached to an end effector or other component to indicate the location of the incision. For example, a laser pointer LP can project visible light LT onto the patient's skin. The laser pointer, such as the one shown in FIG. 1, is first aligned with the desired trajectory and the rotation axis R of the skin incision tool 80. and then, by activating the laser pointer LP, the laser pointer is moved along the desired trajectory. An alternative form of skin incision tool 80 is shown in FIG. 10B and is arranged via a tool guide TG held in place by the robot arm. Tracking of the patient's skin is achieved via a skin tracker (e.g., ring 74). The trace also allows the navigation system 12 to generate a skin model (e.g., a surface model, a point cloud) ) and approximately determine the desired location of the incision I based on the intersection of the skin model and the desired trajectory. This allows the user to feel the sensation on the patient's skin through haptic feedback. The desired incision can be made at the desired location.

[0077] A tactile object is also provided to establish tactile feedback to guide the creation of the incision. It can be defined in a variety of ways (e.g., the V-shaped haptic object shown in Figure 10A). (See Object VH). The haptic object determines the width of the skin incision tool, the desired length of the skin incision, and and / or the desired depth of the incision. The depth can be controlled by the user within a maximum incision depth range, which is , the maximum incision depth programmed as part of the haptic object, or the skin incision The tool 80 guides a guide opening (not shown) in the tool guide TG of the end effector. A mechanical The stop can be determined by either

[0078] Referring to FIG. 11, one of the accessories of the surgical tool 30 is, for example, a Jamshidi It may include a wire insertion tool 90, such as a needle, a separate access cannula with a stylet, or the like. The wire insertion tool 90 can be attached in the same manner as the skin incision tool 80, or Or a part of a separate end effector and a mount (machine) that is attached to the coupling 40. The wire insertion tool 90 and the mount 91 can be fixedly connected to each other. If no relative movement is permitted between them, i.e., they are fixed to each other, The wire insertion tool 90 is guided by the line haptic object LH and inserted through the skin incision. I and reach a target point TP on a bone, for example, a vertebra. For example, when the tool guide TG is provided with a wire insertion tool 90, the interface between the wire insertion tool 90 and the base 91 is If relative axial sliding movement is permitted, the tool guide TG can be positioned in the desired direction. The wire insertion tool 90 can be positioned along the opening 93 of the tool guide TG. The relative distance to the target point TP, the length of the wire insertion tool 90, and Depending on the tool guide position, the wire insertion tool 90 may be used to insert the drill 42 and / or the driver. In the same manner as described above for the bar 44, the guide is guided through the line haptic object LH. It can be id.

[0079] FIG. 12 shows the placement of the implant in the desired position, such as placing a screw in the bone. 1 shows a flowchart of sample steps that may be performed in a surgical procedure for In step 200, the anatomy is first prepared to receive the implant. Such preparation involves (1) making an incision in the patient (see also Figure 13), (2) using a tissue retractor, and (3) placing a cannula within the retracted tissue; and (4) dissection. (5) drilling a pilot hole into the anatomical form; and (6) drilling a female thread into the anatomical form. It may include several steps such as:

[0080] If the axis of rotation R is not aligned to the desired trajectory, or for any other reason If the desired trajectory has been deviated from, step 202 aligns the rotation axis R. Specifically, in step 202, the robot system 10 rotates the rotation axis R along the desired trajectory. This controls the movement of the surgical tool 30 so as to position the axis of rotation R along the desired trajectory. a robotic system (10) for causing autonomous movement of a surgical tool (30) to be positioned along the may include:

[0081] Once the rotation axis R is positioned on the desired trajectory, in step 204, the robot system 10 operates to maintain the axis of rotation R along a desired trajectory. While the surgical tool 30 is being manually moved towards the spine, or while the user is While manually initiating the movement of the tool 30, the surgical tool 30 is aligned to the desired trajectory. By constraining the movement of the surgical tool 30 so that it remains in position, the surgical This may include controlling the manual operation of the tool 30.

[0082] Insertion of the implant into the patient's spine occurs in steps 206 and 208. In step 206, the robot system 10 The autonomous movement of the surgical tool 30 is controlled until the implant is within a predetermined distance of the desired position. The implant is then placed into the patient's spine in step 208. The user manually manipulates the surgical tool 30, and the robotic system 10 manipulates the implant to determine the location. The robot controls such manual manipulation of the surgical tool 30 until it is placed in the desired position. The implant system 10 may, for example, provide a tactile feel to indicate that the implant has reached the desired location. By generating such feedback to the user using the robot controller 32, Once the implant is in the desired position, the At step 210, the surgical tool 30 is withdrawn from the anatomy, removing all impingement. The surgery proceeds until the runt is placed.

[0083] FIG. 13 is a flow diagram of sample steps performed to form incision I in a patient's skin. In step 300, first, a skin tracker (e.g., ring 74) With the device attached to the patient, a pointer is used to identify the desired location for the incision. In the example, the pointer includes a digital probe 73, which is Identify the desired location of the incision by contacting the incision location and attaching the associated boundary / haptic object. In another example, a laser pointer LP can be used to The desired location of the incision can be identified.

[0084] In step 302, once the desired location of the incision I is identified, the skin (and the tissue for the incision I) is The desired location on the skin is tracked using the navigation system 12 in the manner described above. It is possible.

[0085] As the desired locations for the skin and incision I are tracked, the robotic system 10 In step 304, the skin incision tool is created with respect to the haptic object created for the incision. The haptic object can be used to control the movement of the control wheel 80. The target coordinate system is defined so that the incision is made at the desired location. The system 10 controls the manual operation of the skin incision tool 80 to manipulate the haptic object. This allows the user to control the movement of the skin incision tool 80 relative to the skin. While the skin incision tool 80 is being manually moved, or the user manually controls the movement of the skin incision tool 80, During the procedure, the haptic object is guided so that the skin incision tool 80 makes the incision I at the desired location. By constraining the movement of the skin incision tool 80 to a virtual boundary defined by the The robotic system 10 may be configured to allow the skin incision tool 80 to make the desired incision. The depth has been reached or the skin incision tool 80 has otherwise reached the desired limit for the incision I. By generating haptic feedback to the user indicating that a threshold has been reached, The movement of the skin incision tool 80 relative to the object can be constrained. Once positioned, the skin incision tool 80 is drawn from the anatomy in step 306. The operation continues until the bone is extracted and all incisions are made.

[0086] The systems and methods described herein include pedicle screws PS, other screws, fan screws, and It is understood that the present invention may be used to place a sniffer or other implant in a patient. Therefore, pedicle screws are mentioned throughout as an example. However, the same systems and methods described herein may be used to determine the patient's Any anatomical form can be treated and / or any implant can be placed in the patient, e.g. For example, they can be placed on the hip joint, knee, femur, tibia, face, shoulder, spine, etc. The robotic arm 20 can also be used to place cages for spinal implants, insert rods, and The robotic arm can be used to place or place other components in the discectomy. For other procedures, different end effectors may also be used. The end effector may be attached to a robot arm 30. The articulated arm also includes a stent for inserting the implant, i.e., inserting the implant. The articulated arm of the end effector facilitates placement in the desired position. Even if it is just a scaled down version of the robot arm 20 that is controlled in the same way to place the This may be a control mechanism for positioning the implant. The navigation system 12 is an optical navigation system with an optically based tracker. ultrasound navigation systems that track objects via ultrasound, which may include a a radio frequency navigation system that tracks objects via RF energy; and / or other modalities, such as electromagnetic navigation systems that track objects via electromagnetic signals. Other types of navigation systems may also be used. The use of stems is also contemplated. In some cases, the models described herein may be triangular meshes. volumetric models that use voxels or other types of 3D and / or 2D models It should also be understood that it may include

[0087] Several embodiments have been described above. The embodiments described are not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be in the nature of words of description rather than of limitation. Many modifications and variations are possible in light of the above teaching. and that the invention may be practiced otherwise than as specifically described. can.

Claims

1. 1. A surgical system comprising: a robotic manipulator, a navigation system, and one or more controllers; The robot manipulator comprises: a force sensor; a surgical tool coupled to the robotic manipulator and configured to hold a screw and rotate the screw about an axis of rotation, the screw having a known thread pitch; and Including, the navigation system is configured to track the position and orientation of a target anatomy; the one or more controllers are coupled to the robotic manipulator and the navigation system and include a memory that stores a value indicative of the known thread pitch; The one or more controllers: controlling the robotic manipulator based on the tracked position and orientation of the target anatomy to maintain the rotation axis of the surgical tool on a planned trajectory relative to the target anatomy; detecting a force applied by a user with the force sensor; controlling a rotational speed of the surgical tool to rotate the screw about the rotation axis and an advancement speed of the surgical tool to linearly advance the screw along the planned trajectory, the rotational speed and the advancement speed being based on a force applied by the user and proportional to a value indicative of the known thread pitch stored in the memory; configured to: Surgical system.

2. The surgical system of claim 1 , wherein the planned trajectory is defined by a linear haptic object.

3. The one or more controllers: constraining a rotation axis of the surgical tool onto the linear haptic object; generating haptic feedback in response to attempting to move the axis of rotation of the surgical tool in a manner that deviates from the linear haptic object; The surgical system of claim 2 , wherein the system is configured to perform the following steps to maintain the axis of rotation of the surgical tool on the planned trajectory.

4. 3. The surgical system of claim 2, wherein the one or more controllers are configured to control the robotic manipulator to generate haptic feedback in response to the screw reaching a planned insertion depth in the target anatomy.

5. 2. The surgical system of claim 1, wherein the one or more controllers are configured to detect, via the force sensor, that a force has been removed by the user, and in response, to pause linear advancement of the screw along the planned trajectory.

6. the surgical tool applies torque to drive the screw into the target anatomy; a torque sensor configured to detect torque applied by the surgical tool; the one or more controllers are configured to stop the surgical tool from driving the screw into the target anatomy in response to detecting that the torque has reached or exceeded a torque threshold. The surgical system of claim 1 .

7. The surgical system of claim 1 , further comprising a sensor configured to detect a contact force between the screw and the target anatomy.

8. 2. The surgical system of claim 1, wherein the one or more controllers are configured to control the robotic manipulator to autonomously move the surgical tool to position the axis of rotation along the planned trajectory.

9. 10. The surgical system of claim 1, wherein the one or more controllers are configured to utilize one or more sensors to determine an insertion profile of the screw, the insertion profile related to one or more of an insertion current, an insertion torque, and / or an insertion force of the screw.

10. 10. The surgical system of claim 9, wherein the one or more controllers are configured to utilize an insertion profile of the screw to determine whether the screw is following the planned trajectory.

11. the navigation system further includes a navigation controller, a display, and a tracker coupled to the target anatomy; the navigation controller is configured to output, on the display, graphical information indicating a relative spatial relationship between the screw and the target anatomy. The surgical system of claim 1 .

12. The surgical system of claim 1 , wherein the surgical tool includes a screwdriver.

13. The surgical system of claim 1 , wherein the force sensor is disposed on the surgical tool.

14. the rotational speed and the advancement speed are proportional to the number of flights per unit length of the screw according to the relationship [δθ / δt=δD / δt*P / 2π]; where δθ / δt is the rotational speed, δD / δt is the forward speed, and P is the number of flights per unit length of the screw. The surgical system of claim 1 .

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