JP6970154B2 - Surgical robot automation with tracking markers - Google Patents

Description

[Cross-reference of related applications]
This application is a partial continuation of US Patent No. 15 / 609,334 (published as US Patent Application No. 2017-02585535) filed on May 31, 2018, which is May 2016. This is a partial continuation application of US Patent Application No. 15 / 157,444 (published as US Patent Application No. 2016-02562225) filed on 18th, which was filed on April 11, 2016 in the United States. This is a partial continuation application of Patent Application No. 15 / 095,883 (published as US Patent Application No. 2016-0220320), which is a US Patent Application No. 14/062, filed on October 24, 2013. It is a partial continuation application of No. 707 (published as US Patent Application No. 2014-0275955), which is the US Patent Application No. 13 / 924,505 filed on June 21, 2013 (US Patent No. 9). , 782,229), which claims priority over provisional application No. 61 / 662,702 (extinguished) filed June 21, 2012, and 2013. Claims priority over provisional application No. 61 / 800,527 (extinguished) filed on March 15, 2014. The application also claims priority to provisional application No. 62 / 583,851 filed on 21 November 2017. All of the applications identified above are incorporated herein by reference in their entirety for all purposes.

The present disclosure displays surgical navigation of surgical implants modified to fit the anatomical structure of a particular patient, and a graphic representation of the modified surgical implants superimposed on the patient's anatomical structure. Related to that.

Spinal fusion is a surgical procedure used to correct spinal deformities. Accompanied by fusing the painful parts of the spine to limit exercise to relieve painful symptoms. Spinal fusion surgery is to treat abnormal spinal curvature (spine kyphosis, abnormal kyphosis), degenerative disc disease, spondylolisthesis, trauma that causes spinal nerve compression, and vertebral instability caused by infection or tumor. Most widely used.

Fusion surgery involves the placement of instruments with rods and screws, as well as bone grafts between the vertebrae. During surgery, the surgeon corrects the spinal deformity so that the radiographic parameters of both the sagittal and coronal planes are within clinically acceptable values. During surgery, the surgeon uses a rod to secure the modified spine in place. The rod needs to fit the shape of the spine and therefore needs to be bent accordingly.

Currently, when performing rod placement in open surgery, the rod can be pushed into the slot of the screw head in a situation where the surgeon can see the whole thing. The exposed surgical site allows the surgeon to ensure that the rod is properly bent and fits into the screw head. This also allows the surgeon to make adjustments on the fly. Open surgery allows easy access and wide field of view for the procedure, but recovery and healing times are longer than minimally invasive surgery (MIS). With MIS treatment, access to the spine is gained through several small incisions. When utilizing the MIS procedure, the insertion guide penetrates each incision from each screw. Under the skin, there is a section cut into a screw mount for the rod to pass as the surgeon passes it axially through the tissue. This process can be compared to threading a series of needle holes. However, unlike threads, the rod is rigid and it is difficult to find the path of the bent rod when the surgical structure consists of multiple levels.

In the MIS procedure, the surgeon can use a position recognition system to locate and track a particular object in three dimensions (3D). In robot-assisted surgery, certain objects, such as surgical instruments and / or surgical implants, need to be tracked with a high degree of accuracy as the instrument is positioned and moved by the robot or physician.

Position recognition systems based on infrared signals can use active and / or passive sensors or markers to track objects. In a passive sensor or marker, the tracked object can include a passive sensor, such as a reflective spherical ball, which is placed at the strategic location of the tracked object. The infrared transmitter sends a signal, and the reflective spherical ball reflects the signal to help determine the three-dimensional position of the object. In an active sensor or marker, the tracked object includes an active infrared transmitter such as a light emitting diode (LED) and thus produces its own infrared signal for 3D detection.

With either active or passive tracking sensors, the time required for the system to receive one or more infrared cameras, digital signals, known positions, distances, response signals of active and / or passive sensors, Based on information from other known variables, or combinations thereof, or information to them, the 3D position of the active and / or passive sensor is geometrically resolved.

Insertion of the spinal cord rod during minimally invasive surgery can be difficult because the rod needs to be positioned invisibly through the screw head tulip. Surgical navigation techniques will provide the surgeon with visibility while placing the bent rod through the tulips in the MIS procedure. Therefore, there is a need to enable surgical navigation of bent rods with navigation arrays attached to the rods in a known fashion, and the shape of the bent rods needs to be known.

To meet this and other needs, devices, systems, and methods for navigating surgical implants are provided.

According to one embodiment, the surgical navigation system includes a computer, a camera, a display, a surgical implant with an implant tracker, and a detection tool with a tool tracker associated with the surgical implant. The computer may be configured to determine the shape of the surgical implant by receiving data associated with the location of the detection tool as the detection tool moves along the outer surface of the surgical implant.

According to one embodiment, the surgical robot system for use in robot-assisted surgery is a computer, a robot arm, a camera, a display, a surgical implant with an implant tracker, and a tool tracker associated with the surgical implant. Includes detection tools with. The computer may be configured to move the robot arm to a target location in the patient's anatomy to insert a surgical implant. The computer may be configured to determine the shape of the surgical implant by receiving data associated with the location of the detection tool as the detection tool moves along the outer surface of the surgical implant.

FIG. 1 is a bird's-eye view of possible locations of robotic systems, patients, surgeons, and other healthcare professionals during a surgical procedure. FIG. 2 shows a robotic system, including positioning of a surgical robot and a camera with respect to a patient, according to one embodiment. FIG. 3 shows a surgical robot system according to an exemplary embodiment. FIG. 4 shows a portion of a surgical robot according to an exemplary embodiment. FIG. 5 shows a block diagram of a surgical robot according to an exemplary embodiment. FIG. 6 shows a surgical robot according to an exemplary embodiment. 7A-7C show end effectors according to exemplary embodiments. FIG. 8 shows the surgical instrument and the end effector before and after inserting the surgical instrument into the guide tube of the end effector according to the embodiment. 9A-9C show portions of the end effector and robot arm according to an exemplary embodiment. FIG. 10 shows a dynamic reference array, an imaging array, and other components according to an exemplary embodiment. FIG. 11 shows a registration method according to an exemplary embodiment. 12A-12B show embodiments of an image pickup apparatus according to an exemplary embodiment. FIG. 13A shows a portion of a robot, including a robot arm and an end effector, according to an exemplary embodiment.

FIG. 13B is an enlarged view of the end effector, on which a plurality of tracking markers are firmly anchored, as shown in FIG. 13A.

FIG. 13C is a tool or instrument, according to one embodiment, on which a plurality of tracking markers are firmly immobilized.
FIG. 14A is an alternative version of the end effector with the first configuration movable tracking marker.

FIG. 14B is the end effector shown in FIG. 14A with a second configuration movable tracking marker.

FIG. 14C shows a template for tracking markers in the first configuration of FIG. 14A.

FIG. 14D shows a template for tracking markers in the second configuration of FIG. 14B.
FIG. 15A shows an alternative version of an end effector with only a single tracking marker immobilized on it. FIG. 15B shows the end effector of FIG. 15A with an instrument placed via a guide tube. FIG. 15C shows the end effector of FIG. 15A with the instrument in two different positions and shows the resulting logic for determining whether the instrument is located inside or outside the guide tube. FIG. 15D shows the end effector of FIG. 15A, where the instrument is in the guide tube at two different frames and at a distance relative to a single tracking marker on the guide tube. FIG. 15E shows the end effector of FIG. 15A with respect to the coordinate system. FIG. 16 is a block diagram of a method of navigating and moving a robot end effector to a desired target trajectory. Also, FIGS. 17A and 17B show instruments for inserting expandable implants with fixed and movable tracking markers in contraction and expansion positions, respectively. Also, FIGS. 18A and 18B show instruments for inserting articulated implants with fixed and movable tracking markers in insertion and tilt positions, respectively. FIG. 19A shows an embodiment of a robot that includes replaceable or alternative end effectors.

FIG. 19B shows an embodiment of a robot coupled with an instrument-style end effector.
20A-20B show surgical implants consistent with the principles of the present disclosure. FIG. 21 shows an exemplary embodiment of a system for tracking surgical implants that is consistent with the principles of the present disclosure. FIG. 22 shows an exemplary method for tracking surgical implants that is consistent with the principles of the present disclosure. 23A-23C show exemplary embodiments for determining the geometry of spinal implants that are consistent with the principles of the present disclosure.

It is to be understood that this disclosure is not limited in its application to the configuration details and component arrangements described in the description of this specification or shown in the drawings. The teachings of the present disclosure may be used, practiced, practiced in various ways, or practiced in other embodiments. It should also be understood that the expressions and terms used herein are for illustration purposes only and should not be considered limiting. The use of "include", "comprising" or "having" and variations thereof herein include the items listed below and their equivalents as well as additional items. Means. Unless otherwise specified or limited, the terms "mounted", "connected", "supported" and "coupled" and theirs. Deformations are widely used and include both direct and indirect attachment, connection, support and coupling. Further, "connected" and "coupled" are not limited to physical or mechanical connections or connections.

The following discussion is presented to allow one of ordinary skill in the art to create and use embodiments of the present disclosure. Various changes to the illustrated embodiments will be readily apparent to those of skill in the art and the principles herein may apply to other embodiments and applications without departing from the embodiments of the present disclosure. can. Accordingly, embodiments are not intended to be limited to the embodiments shown, and should be given the broadest scope consistent with the principles and features disclosed herein. The following detailed description should be read with reference to the drawings, and similar elements in different figures have similar reference numbers. Drawings that are not necessarily on scale indicate the selected embodiment and do not limit the scope of the embodiment. Those skilled in the art will recognize that the examples provided herein have many useful alternatives and fall within the scope of the embodiments.

Referring here to the drawings, FIGS. 1 and 2 show a surgical robot system 100 according to an exemplary embodiment. The surgical robot system 100 includes, for example, a surgical robot 102, one or more robot arms 104, a base 106, a display 110, an end effector 112 including a guide tube 114, and one or more tracking. Includes marker 118 and. The surgical robot system 100 can include a patient tracking device 116 that also includes one or more tracking markers 118 adapted to be fixed directly to the patient 210 (eg, to the bone of the patient 210). The surgical robot system 100 can also use, for example, a camera 200 arranged on the camera stand 202. The camera stand 202 can have any suitable configuration for moving, orienting, and supporting the camera 200 in the desired position. The camera 200 can identify any suitable camera, or, for example, an active and passive tracking marker 118, which is within a given measurement volume visible from the viewpoint of the camera 200, one or the other. It may include a camera such as a plurality of infrared cameras (eg, a bifocal camera or a stereoscopic photography camera). The camera 200 can scan a given measurement volume, detect the light coming from the marker 118, and identify and determine the three-dimensional position of the marker 118. For example, the active marker 118 can include an infrared emitting marker (eg, an infrared light emitting diode (LED)) that is actuated by an electrical signal, and the passive marker 118 is, for example, an illuminator or other suitable device on the camera 200. Can include infrared-reflecting retroreflective markers (eg, they reflect incident IR irradiation in the direction of incident light) emitted by.

In addition, FIGS. 1 and 2 show possible configurations of the surgical robot system 100 in an operating room environment. For example, the robot 102 can be placed near the patient 210 or next to the patient 210. Although depicted near the patient 210's head, it will be appreciated that the robot 102 can be placed at any suitable location near the patient 210, depending on the area of the patient 210 undergoing surgery. The camera 200 may be separated from the robot system 100 and placed on the foot of the patient 210. This position allows the camera 200 to have a visual direct line of sight to the surgical area 208. Again, it is believed that the camera 200 can be placed at any suitable position with a line of sight to the surgical area 208. In the configuration shown, the surgeon 120 is located on the opposite side of the robot 102, but can still operate the end effector 112 and the display 110. The surgeon assistant 126 can also be placed on the opposite side of the surgeon 120 so that both the end effector 112 and the display 110 can be accessed. If necessary, the positions of the surgeon 120 and the assistant 126 may be reversed. The traditional area for the anesthesiologist 122 and the nurse or operating room technician 124 remains unobstructed by the positions of the robot 102 and the camera 200.

With respect to other components of the robot 102, the display 110 can be attached to the surgical robot 102, and in another exemplary embodiment, the display 110 is separated from the surgical robot 102 and together with the surgical robot 102. Placed in the operating room or in a remote location. The end effector 112 may be coupled to the robot arm 104 and controlled by at least one motor. In an exemplary embodiment, the end effector 112 is a guide tube 114 capable of receiving and orienting a surgical instrument 608 (discussed further herein) used to perform surgery on a patient 210. Can be included. The term "end effector" as used herein is used interchangeably with the terms "end effector" and "effectuator element". Although generally indicated by the guide tube 114, it will be appreciated that the end effector 112 can be replaced with any suitable instrument suitable for surgical use. In some embodiments, the end effector 112 can include any known structure for performing the movement of the surgical instrument 608 in the desired manner.

The surgical robot 102 can control the translation and orientation of the end effector 112. The robot 102 can, for example, move the end effector 112 along the x, y, and z axes. The end effector 112 is of the x-axis, y-axis, and z-axis (so that one or more of the Euler angles (eg, roll, pitch, and / or yaw) associated with the end effector 112 can be selectively controlled). It can be configured to selectively rotate one or more, and around the z-frame axis. In some exemplary embodiments, the selective control of translation and orientation of the end effector 112 is significantly improved compared to, for example, a conventional robot utilizing a robotic arm with 6 degrees of freedom containing only the axis of rotation. Allows the execution of medical procedures with the accuracy given. For example, the surgical robot system 100 is used to operate on the patient 210, the robot arm 104 is positioned above the patient 210's body, and the end effector 112 is selected with respect to the z-axis towards the patient 210's body. Is angled.

In some exemplary embodiments, the position of the surgical instrument 608 can be dynamically updated so that the surgical robot 102 is always aware of the position of the surgical instrument 608 during surgery. .. As a result, in some exemplary embodiments, the surgical robot 102 can quickly move the surgical instrument 608 (unless the doctor desires) to the desired position without the further help of the doctor. In some further embodiments, the surgical robot 102 can be configured to modify the path of the surgical instrument 608 if the surgical instrument 608 deviates from a selected pre-planned trajectory. In some exemplary embodiments, the surgical robot 102 may be configured to allow stopping, modification, and / or manual control of the end effector 112 and / or the surgical instrument 608. Thus, in use, in an exemplary embodiment, the physician or other user can operate the system 100 and stop, modify, or manually control the autonomous movement of the end effector 112 and / or the surgical instrument 608. Have the option to do. Further details of the Surgical Robot System 100, including the control and movement of the Surgical Instrument 608 by the Surgical Robot 102, can be found in the co-pending US Patent Application No. 13 / 924,505, which is in its entirety by reference. Incorporated in the specification.

The robotic surgical system 100 comprises one or more tracking markers 118 configured to track the movement of the robot arm 104, the end effector 112, the patient 210, and / or the surgical instrument 608 in three dimensions. Can be done. In an exemplary embodiment, a plurality of tracking markers 118 are attached (otherwise fixed) to the outer surface of the robot 102, such as on the base 106 of the robot 102, on the robot arm 104, or on the end effector 112. However, it is not limited to this. In an exemplary embodiment, at least one of the plurality of tracking markers 118 can be attached to the end effector 112 or otherwise secured. The one or more follow-up markers 118 may be further attached (or otherwise immobilized) to the patient 210. In an exemplary embodiment, multiple follow-up markers 118 are placed on the patient 210 away from the surgical area 208 to reduce the possibility of obscuring by the surgeon, surgical tool, or other part of the robot 102. Can be placed. In addition, one or more tracking markers 118 can be further attached (or otherwise secured) to a surgical tool 608 (eg, screwdriver, dilator, implant inserter, etc.). Therefore, the tracking marker 118 allows each of the marked objects (eg, end effector 112, patient 210, and surgical tool 608) to be tracked by the robot 102. In an exemplary embodiment, the system 100 is placed in, for example, an end effector 112, a surgical instrument 608 (eg, a tube 114 of the end effector 112) using tracking information collected from each of the marked objects. The orientation and position of the patient 210 and the relative position of the patient 210 can be calculated.

The marker 118 can include a radiation opaque or optical marker. The marker 118 can have a suitable shape including a sphere, a spheroid, a cylinder, a cube, a rectangular parallelepiped, and the like. In an exemplary embodiment, the one or more markers 118 may be optical markers. In some embodiments, the positioning of one or more tracking markers 118 on the end effector 112 may maximize the accuracy of position measurement by functioning to confirm or confirm the position of the end effector 112. can. Further details of the surgical robot system 100, including control, movement and tracking of the surgical robot 102 and the surgical instrument 608, can be found in co-pending US Patent Application No. 13 / 924,505, in its entirety. Incorporated herein by reference.

An exemplary embodiment comprises one or more markers 118 coupled to a surgical instrument 608. In an exemplary embodiment, for example, these markers 118 coupled to the patient 210 and the surgical instrument 608, as well as the marker 118 coupled to the end effector 112 of the robot 102, are conventional infrared light emitting diodes (LEDs), or Optorak® diodes that can be tracked using a commercially available infrared optical tracking system such as Optorak® can be included. Optitrak® is known from Northern Digital Inc. of Waterloo, Ontario, Canada. Is a registered trademark of. In another embodiment, the marker 118 can include a conventional reflective sphere that can be tracked using a commercially available optical tracking system such as Polaris Spectra. Polaris Spectra is described by Northern Digital, Inc. Is a registered trademark of. In an exemplary embodiment, the marker 118 coupled to the end effector 112 is an active marker comprising an infrared light emitting diode that can be turned on and off, and the marker 118 coupled to the patient 210 and the surgical instrument 608 is Includes passively reflecting spheres.

In an exemplary embodiment, the light emitted from and / or reflected by the marker 118 can be detected by the camera 200 and used to monitor the position and movement of the marked object. In an alternative embodiment, the marker 118 may include a radio frequency and / or an electromagnetic reflector or receiver, and the camera 200 may include or replace a radio frequency and / or an electromagnetic receiver. can.

Similar to the surgical robot system 100, FIG. 3 shows a surgical robot system 300 and a camera stand 302 in a docked configuration according to an exemplary embodiment of the present disclosure. The surgical robot system 300 controls a display 304, an upper arm 306, a lower arm 308, an end effector 310, a vertical column 312, a caster 314, a cabinet 316, a tablet drawer 318, a connector panel 320, and the like. Includes a robot 301 that includes a panel 322 and a ring of information 324. The camera stand 302 can include a camera 326. These components will be described in a larger scale with reference to FIG. FIG. 3 shows a surgical robot system 300 in a docked configuration in which the camera stand 302 is nested with the robot 301, for example when not in use. Those skilled in the art will appreciate that the camera 326 and the robot 301 can be separated from each other and placed in any suitable position during the surgical procedure, eg, as shown in FIGS. 1 and 2.

FIG. 4 shows a base 400 consistent with an exemplary embodiment of the present disclosure. The base 400 may be part of the surgical robot system 300 and may include a cabinet 316. The cabinet 316 can accommodate specific components of the surgical robot system 300 including, but not limited to, a battery 402, a power distribution module 404, a platform interface board module 406, a computer 408, a handle 412, and a tablet drawer 414. .. The connections and relationships between these components are described in more detail with reference to FIG.

FIG. 5 shows a block diagram of a particular component of an exemplary embodiment of a surgical robot system 300. The surgical robot system 300 can include a platform subsystem 502, a computer subsystem 504, a motion control subsystem 506, and a tracking subsystem 532. The platform subsystem 502 can further include a battery 402, a power distribution module 404, a platform interface board module 406, and a tablet charging station 534. The computer subsystem 504 may further include a computer 408, a display 304, and a speaker 536. The operation control subsystem 506 can further include a drive circuit 508, a motor 510, 512, 514, 516, 518, a ballast 520, 522, 524, 526, an end effector 310, and a controller 538. The tracking subsystem 532 can further include a position sensor 540 and a camera converter 542. The system 300 can also include a foot pedal 544 and a tablet 546.

The input power is supplied to the system 300 via a power source 548 which may be supplied to the power distribution module 404. The power distribution module 404 is configured to receive input power and generate different power supply voltages provided to other modules, components, and subsystems of the system 300. The power distribution module 404 can be configured to supply different voltages to the platform interface module 406, but the voltage is such that the computer 408, display 304, speaker 536, eg power motors 512, 514, 516, 518 and end effectors. To provide to other components such as the driver 508 of the 310, the motor 510, the ring 324, the camera converter 542, and other components for the system 300 (eg, fans for cooling electrical components in cabinet 316). Can be done.

The power distribution module 404 may also power other components, such as the tablet charging station 534, which may be located within the tablet drawer 318. The tablet charging station 534 may communicate wirelessly or by wire with the tablet 546 to charge the table 546. Tablet 546 is consistent with the present disclosure and can be used by the surgeons described herein.

The power distribution module 404 may be connected to a battery 402 that acts as a temporary power source when the power distribution module 404 does not receive power from the input power 548. At other times, the power distribution module 404 can serve to charge the battery 402 as needed.

Other components of the platform subsystem 502 can also include a connector panel 320, a control panel 322, and a ring 324. The connector panel 320 can function to connect different devices and components to the system 300 and / or related components and modules. The connector panel 320 can include one or more ports that receive lines or connections from different components. For example, the connector panel 320 relates to a ground terminal port for grounding the system 300 to other equipment, a port for connecting the foot pedal 544 to the system 300, and a tracking subsystem 532 (position sensor 540, camera converter 542, camera stand 302). Can have a port to connect to a camera 326 and can include). The connector panel 320 may also include other ports that allow USB, Ethernet®, HDMI® communication to other components such as the computer 408.

The control panel 322 can provide various buttons or indicators that control the operation of the system 300 and / or provide information about the system 300. For example, the control panel 322 engages with a button for powering on or off the system 300, a button for raising or lowering the column 312, and a caster 314 to prevent the system 300 from being physically moved. The stabilizers 520-526 designed to fit can include buttons for raising or lowering. In the event of an emergency, other buttons may stop the system 300, but this removes all motor power and applies mechanical braking to stop all operations. The control panel 322 can also have a line power indicator for the battery 402 or an indicator that informs the user of a particular system condition such as charge status.

The ring 324 can be a visual indicator that alerts the user of the system 300 to different modes in which the system 300 is operating and certain warnings to the user.

The computer subsystem 504 includes a computer 408, a display 304, and a speaker 536. The computer 504 includes an operating system for operating the system 300 and software. The computer 504 can receive and process information from other components (eg, tracking subsystem 532, platform subsystem 502, and / or motion control subsystem 506) in order to display the information to the user. Further, the computer subsystem 504 may also include a speaker 536 that provides audio to the user.

The tracking subsystem 532 can include a position sensor 504 and a converter 542. The tracking subsystem 532 can accommodate a camera stand 302 that includes the camera 326 described with respect to FIG. The position sensor 504 may be a camera 326. The tracking subsystem can track the location of specific markers located on different components and / or instruments of the system 300 used by the user during surgery. This tracking may be performed in a manner consistent with the present disclosure, each including the use of infrared technology for tracking the location of active or passive elements such as LEDs or reflective markers. The location, orientation, and placement of structures with these types of markers may be provided to the computer 408 shown to the user on the display 304. For example, a surgical instrument 608 that has these types of markers and is tracked in this way (which can be called the navigation space) is shown to the user in relation to a three-dimensional image of the patient's anatomy. May be done.

The motion control subsystem 506 can be configured to physically move the vertical column 312, the upper arm 306, and the lower arm 308, or to rotate the rotary end effector 310. Physical movement can be done through the use of one or more motors 510-518. For example, the motor 510 can be configured to vertically lift or lower the vertical column 312. As shown in FIG. 3, the motor 512 can be configured to laterally move the upper arm 308 around the engagement point with the vertical column 312. The motor 514 can be configured to laterally move the lower arm 308 around the point of engagement with the upper arm 308, as shown in FIG. Motors 516 and 518 can be configured to move the end effector 310, one controlling the roll and one controlling the tilt, thereby moving the end effector 310 at multiple angles. Can be provided. These movements are placed on the end effector 310 and are activated by engaging the load cells in order for the user to move the system 300 in a desired manner, a controller that controls these movements via the load cells. Can be achieved by 538.

Further, the system 300 allows the user to indicate on the display 304 (which can be a touch screen input device) the location of a surgical instrument or component on a three-dimensional image of the patient's anatomy on the display 304. , Vertical columns 312, upper arm 306, and lower arm 308 can be provided for automatic movement. The user can initiate this automatic movement by stepping on the foot pedal 544 or some other input means.

FIG. 6 shows a surgical robot system 600 according to an exemplary embodiment. It can include a surgical robot system 600, an end effector 602, a robot arm 604, a guide tube 606, an instrument 608, and a robot base 610. The instrument tool 608 can be attached to a tracking array 612 containing one or more tracking markers (such as the marker 118) and have an associated orbit 614. The orbit 614 represents a travel path (eg, a path through which the instrument tool 608 is inserted into the patient) configured to move the instrument tool 608 when positioned or anchored through the guide tube 606. Can be done. In an exemplary operation, the robot base 610 is configured to electronically communicate with the robot arm 604 and the end effector 602, and the surgical robot system 600 moves the user (eg, a surgeon) when operating on the patient 210. Support. The surgical robot system 600 may be consistent with the surgical robot systems 100 and 300 described above.

The tracking array 612 may be mounted on the instrument 608 to monitor the position and orientation of the instrument tool 608. The tracking array 612 may be attached to the instrument 608 or may include a tracking marker 804. As best shown in FIG. 8, the tracking marker 804 may be, for example, a light emitting diode and / or other type of reflection marker (eg, the marker 118 described elsewhere herein). The tracking device may be one or more gaze devices associated with the surgical robot system. As an example, the tracking device may be one or more cameras 200, 326 associated with the surgical robot system 100, 300, to the robot arm 604, the robot base 610, the end effector 602, and / or the patient 210. In connection with this, the tracking array 612 may be tracked for a defined region or relative orientation of the instrument 608. The tracking device may be consistent with the structures described in connection with the camera stand 302 and tracking subsystem 532.

7A, 7B and 7C show a top view, a front view and a side view of the end effector 602 according to an exemplary embodiment, respectively. The end effector 602 can include one or more tracking markers 702. The tracking marker 702 may be a light emitting diode or other type of active and passive marker, such as the tracking marker 118 described above. In an exemplary embodiment, the tracking marker 702 is an active infrared emitting marker activated by an electrical signal (eg, an infrared light emitting diode (LED)). Therefore, the tracking marker 702 may be active so that the infrared marker 702 is visible to the cameras 200 and 326, or may be inactive so that the infrared marker 702 is not visible to the cameras 200 and 326. Thus, when the marker 702 is active, the end effector 602 is controlled by systems 100, 300, 600, and when the marker 702 is deactivated, the end effector 602 is locked in place and the systems 100, 300, Some 600 cannot move.

The marker 702 is placed on or inside the end effector 602 so that the marker 702 is visible by one or more cameras 200, 326, or other tracking devices associated with the surgical robot systems 100, 300, 600. May be done. The camera 200, 326 or other tracking device can track the end effector 602 as it moves to a different position and viewing angle following the movement of the tracking marker 702. The location of the markers 702 and / or end effector 602 may also be indicated on displays 110, 304 associated with the surgical robot systems 100, 300, 600, such as display 110 shown in FIG. 2 and / or display 304 shown in FIG. good. The displays 110, 304 allow the user to ensure that the end effector 602 is in the desired position for the robot arm 604, the robot base 610, the patient 210, and / or the user.

For example, as shown in FIG. 7A, a marker 702 is placed around the surface of the end effector 602, placed away from the surgical area 208, and tracked towards robots 102, 301 and cameras 200, 326. The device can see at least three markers 702 through the range of general orientation of the end effector 602 with respect to the tracking devices 100, 300, 600. For example, such distribution of the marker 702 makes it possible for the tracking device to monitor the end effector 602 as it is moved and rotated within the surgical area 208.

Further, in an exemplary embodiment, the end effector 602 can include an infrared (IR) receiver capable of detecting when the external cameras 200 and 326 are ready to read the marker 702. Upon this detection, the end effector 602 can illuminate the marker 702. The duty cycle of the marker 702, which may be a light emitting diode, needs to be synchronized with the external cameras 200 and 326 by the IR receiver detecting that the external cameras 200 and 326 are ready to read the marker 702. I can tell you that. It can also allow lower power consumption by the robotic system as a whole, whereby the marker 702 is illuminated only at the appropriate time instead of being continuously illuminated. Further, in an exemplary embodiment, the marker 702 can be powered off to prevent interference with other navigation tools such as different types of surgical instruments 608.

FIG. 8 shows one type of surgical instrument 608 containing a tracking array 612 and a tracking marker 804. The tracking marker 804 may be, but is not limited to, any type described herein, including light emitting diodes or reflective spheres. The marker 804 may be monitored by tracking devices associated with the surgical robot systems 100, 300, 600 and may be one or more line-of-sight cameras 200, 326. The cameras 200 and 326 can track the position of the instrument 608 based on the position and orientation of the tracking array 612 and the marker 804. A user, such as the surgeon 120, has the tracking array 612 and the marker 804 fully recognized by the tracking device or camera 200, 326 and displays the instrument 608 and the marker 804, eg, on the display 110 of an exemplary surgical robot system. The instrument 608 can be pointed to do so.

The method by which the surgeon 120 places the instrument 608 in the guide tube 606 of the end effector 602 and adjusts the instrument 608 is apparent in FIG. The hollow tubes or guide tubes 114, 606 of the end effectors 112, 310, 602 are sized and configured to receive at least a portion of the surgical instrument 608. The guide tubes 114, 606 are configured to be oriented by the robot arm 104 so that the insertion and trajectory of the surgical instrument 608 can reach the desired anatomical target within or on the body of the patient 210. The surgical instrument 608 may include at least a portion of a substantially cylindrical instrument. Although the screwdriver is exemplified as a surgical tool 608, it will be appreciated that any suitable surgical tool 608 may be positioned by the end effector 602. As an example, the surgical instrument 608 may include one or more guide wires, cannulas, retractors, drills, reamers, screwdrivers, insertion tools, removal tools and the like. Hollow tubes 114, 606 are shown as having a cylindrical shape as a whole, but those skilled in the art would find guide tubes 114, 606 any suitable suitable for accommodating surgical instruments 608 and accessing the surgical site. Can have different sizes and configurations.

9A-9C also show a portion of the end effector 602 and the robot arm 604 according to an exemplary embodiment. The end effector 602 can further include a body 1202 and a clamp 1204. Clamp 1204 can include a handle 1206, a ball 1208, a spring 1210, and a lip 1212. The robot arm 604 can further include a recess 1214, a mounting plate 1216, a lip 1218, and a magnet 1220.

The end effector 602 can mechanically interface and / or engage with the surgical robot system and robot arm 604 via one or more couplings. For example, the end effector 602 can engage the robot arm 604 via a positioning coupling and / or a reinforcing coupling. These couplings allow the end effector 602 to be secured to the robot arm 604 outside the flexible and sterile barrier. In an exemplary embodiment, the positioning coupling may be a magnetic kinematic mount and the reinforced coupling may be a five-bar overcenter clamping link mechanism.

With respect to the positioning coupling, the robot arm 604 can include a non-magnetic material, one or more recesses 1214, a lip 1218, and a mounting plate 1216, which may be a magnet 1220. Magnets 1220 are mounted under each of the recesses 1214. The portion of the clamp 1204 contains a magnetic material and is attracted by one or more magnets 1220. The magnetic attraction of the clamp 1204 and the robot arm 604 causes the balls 1208 to sit in their respective recesses 1214. For example, the ball 1208 shown in FIG. 9B sits in the recess 1214, as shown in FIG. 9A. This seat can be thought of as a magnetically assisted kinematic coupling. The magnet 1220 can be configured to have sufficient strength to support the full weight of the end effector 602, regardless of the orientation of the end effector 602. The positioning coupling is any style of kinematic mount that uniquely limits 6 degrees of freedom.

With respect to the reinforcing coupling, the portion of the clamp 1204 can be configured to be a fixed ground link, such a clamp 1204 can function as five rod-shaped link mechanisms. The closing clamp handle 1206 may secure the end effector 602 to the robot arm 604 when the lip 1212 and the lip 1218 engage the clamp 1204 to secure the end effector 602 and the robot arm 604. When the clamp handle 1206 is closed, the spring 1210 may be stretched or stressed while the clamp 1204 is in the locked position. The locking position may be a position that provides a link mechanism past the center. If there is no force applied to the clamp handle 1206 to release the clamp 1204, the linkage will not open. Therefore, in the locked position, the end effector 602 can be firmly fixed to the robot arm 604.

The spring 1210 may be a curved beam with tension. The spring 1210 can be made of a material that exhibits high stiffness and high yield strain, such as unused PEEK (polyetheretherketone). The link mechanism between the end effector 602 and the robot arm 604 may provide a sterile barrier between the end effector 602 and the robot arm 604 without interfering with the fastening of the two couplings.

The reinforcing coupling may be a link mechanism with a plurality of spring members. Reinforcing couplings can be latched by a cam or friction-based mechanism. The reinforcing coupling may be a sufficiently strong electromagnet that assists in fixing the end effector 102 to the robot arm 604. Reinforcing couplings slide the interface between the end effector 602 and the robot arm 604 and are completely separated from the end effector 602 and / or the robot arm 604 secured by a threading mechanism, overcenter link mechanism, or cam mechanism. It may be the color of.

With reference to FIGS. 10 and 11, specific enrollment procedures are performed to track the object and target anatomy of patient 210, both in the navigation space and in the imaging space, before or during the surgical procedure. May be good. To perform such registration, the registration system 1400 can be used as shown in FIG.

To track the location of the patient 210, the patient tracking device 116 includes a patient fixation device 1402 that is secured to the rigid anatomical structure of the patient 210, and a dynamic reference base (DRB) 1404 is attached to the patient fixation device 1402. It may be fixedly attached. For example, the patient fixation device 1402 may be inserted into the opening 1406 of the dynamic reference base 1404. The dynamic reference base 1404 can include a marker 1408 that looks like a tracking device such as tracking subsystem 532. These markers 1408 may be reflective spheres such as optical markers or tracking markers 118, as described herein above.

The patient fixation device 1402 is attached to the rigid anatomy of the patient 210 and may remain attached during the surgical procedure. In an exemplary embodiment, the patient fixation device 1402 is attached to a rigid area of the patient 210, eg, a bone located away from the target anatomy to be surgically operated. To track the target anatomy, the dynamic reference base 1404 temporarily registers on or near the target anatomy to register the dynamic reference base 1404 at the location of the target anatomy. Through the use of registered fixtures that are placed, it is associated with the target anatomy.

The registration fixture 1410 is attached to the patient fixation device 1402 using the pivot arm 1412. The pivot arm 1412 is attached to the patient fixation device 1402 by inserting the patient fixation device 1402 into the opening 1414 of the registration fixture 1410. The pivot arm 1412 is attached to the registration fixture 1410, for example, by inserting the knob 1416 into the opening 1418 of the pivot arm 1412.

The pivot arm 1412 can be used to place the registration fixture 1410 over the target anatomy, and its position can be positioned using the tracking marker 1420 and / or reference 1422 on the registration fixture 1410. It can be determined in the image space and the navigation space. Registration fixture 1410 can include a set of markers 1420 visible in the navigation space (eg, marker 1420 may be detectable by tracking subsystem 532). The tracking marker 1420 may be an optical marker visible in infrared light, as described herein above. The registration fixture 1410 can also include an aggregate of reference points 1422 visible in the imaging space (eg, a three-dimensional CT image), such as a bearing ball. As described in more detail with reference to FIG. 11, a registration fixture 1410 can be used to associate the target anatomy with the dynamic reference base 1404, thereby making an image of the anatomy. You can overlay the depiction of objects in the navigation space. The dynamic reference base 1404, located away from the target anatomy, serves as a reference point, which allows the registration fixture 1410 and / or the pivot arm 1412 to be removed from the surgical area.

FIG. 11 provides an exemplary method 1500 for registration according to the present disclosure. Method 1500 can begin at step 1502 and import a graphic representation (or image) of the target anatomy into systems 100, 300, 600, such as computer 408. This graphic display may be a three-dimensional CT or fluoroscopic scan of the target anatomy of patient 210, including a registered fixture 1410 and a detectable reference imaging pattern 1420.

In step 1504, the image pickup pattern of the reference point 1420 is detected, registered in the image pickup space, and stored in the computer 408. Optionally, at this point in step 1506, the graphic display of the registration fixture 1410 can be overlaid on the image of the target anatomy.

In step 1508, by recognizing the marker 1420, the navigation pattern of the registration fixture 1410 is detected and registered. The marker 1420 may be an optical marker recognized in the navigation space by infrared light by the tracking subsystem 532 via the position sensor 540. Therefore, the position, orientation, and other information of the target anatomy is registered in the navigation space. Therefore, the registration fixture 1410 can be recognized both in the image space by using the reference point 1422 and in the navigation space by using the marker 1420. In step 1510, the registration of the registration fixture 1410 in the image space is transferred to the navigation space. This transfer is performed, for example, by using the relative position of the imaging pattern of reference 1422 compared to the position of the navigation pattern of marker 1420.

In step 1512, the registration of the navigation space of the registration fixture 1410 (registered in the image space) is further transferred to the navigation space of the dynamic registration array 1404 attached to the patient fixation device 1402. Therefore, since the navigation space is associated with the image space, it is possible to remove the registration fixture 1410 and use the dynamic reference base 1404 to track the target anatomy of both the navigation space and the image space. can.

In steps 1514 and 1516, the navigation space may be overlaid on the image space and objects using markers recognizable in the navigation space (eg, surgical instruments 608 with optical markers 804). Objects can be tracked through a graphic representation of the surgical instrument 608 on an image of the target anatomy.

Also, FIGS. 12A-12B show imaging device 1304 that can be used with robotic systems 100, 300, 600 to acquire pre-surgery, intra-surgery, post-surgery, and / or real-time image data of patient 210. Any suitable subject can be imaged for any suitable procedure using imaging system 1304. The imaging system 1304 can be any imaging device such as an imaging device 1306 and / or a C-arm 1308 device. It may be desirable to obtain patient 210 x-rays from several different locations without the need for frequent manual repositioning of patient 210 as required by the x-ray system. As shown in FIG. 12A, the imaging system 1304 may be in the form of a C-arm 1308 comprising an elongated C-shaped member terminating at the opposite distal end 1312 of the "C" shape. The C-shaped member 1130 can further include an x-ray source 1314 and an image receptacle 1316. The space within the C-arm 1308 of the arm can provide room for the physician to diagnose a patient with virtually no interference from the x-ray support structure 1318. As shown in FIG. 12B, the imaging system is a gantry housing 1324 mounted on a support structure imager support structure 1328, such as a wheeled moving cart 1330 that includes a wheel 1332 that can surround an image capture unit (not shown). Can include a fixed and movable imaging device 1306 with reference to. The image capture units are arranged approximately 180 degrees from each other and have an x-ray source and / or emission unit attached to a rotor (not shown) for tracking the image capture unit, and an x-ray receiver and / or image receiver. Can include parts and parts. The image capture unit may be operable so as to rotate 360 degrees during image acquisition. The image capture unit can rotate around a center point and / or an axis, allowing image data of the patient 210 to be acquired from multiple directions or in multiple planes. Although specific imaging systems 1304 are exemplified herein, it will be appreciated that any suitable imaging system may be selected by one of ordinary skill in the art.

Referring now to FIGS. 13A-13C, the surgical robot systems 100, 300, 600 are end effectors 112, 602, surgical instruments 608, and / or patient 210 (eg, patient tracking device 116) for a desired surgical area. ) Depends on accurate positioning. In embodiments shown in FIGS. 13A-13C, with reference to, tracking markers 118, 804 are fixedly attached to a portion of instrument 608 and / or end effector 112.

FIG. 13A shows a portion of a surgical robot system 100 that includes a base 106, a robot arm 104, and a robot 102 that includes an end effector 112. Other elements not shown, such as displays, cameras, etc., may also be present as described herein. FIG. 13B shows an enlarged view of an end effector 112 having a guide tube 114 and a plurality of tracking markers 118 firmly anchored to the end effector 112. In this embodiment, a plurality of tracking markers 118 are attached to the guide tube 112. FIG. 13C shows an instrument 608 (in this case, probe 608A) having a plurality of tracking markers 804 firmly anchored to the instrument 608. As described elsewhere herein, the instrument 608 may include suitable surgical instruments such as guidewires, cannulas, retractors, drills, reamers, screwdrivers, insertion tools, removal tools, etc. Not limited to them.

When tracking an instrument 608, an end effector 112, or another object tracked in 3D, the array of tracking markers 118, 804 may be fixedly attached to a part of the tool 608 or the end effector 112. The tracking markers 118, 804 are preferably attached so that the markers 118, 804 do not interfere (eg, do not interfere with surgery, visibility, etc.). Markers 118, 804 may be anchored to the instrument 608, the end effector 112, or other objects to be tracked, for example using an array 612. Typically, three or four markers 118, 804 are used with the array 612. The array 612 can include straight sections, crosspieces, and may be asymmetric such that the markers 118, 804 are in different relative positions and positions. For example, as shown in FIG. 13C, a probe 608A with a 4-marker tracking array 612 is shown, and FIG. 13B shows an end effector 112 with a different 4-marker tracking array 612.

In FIG. 13C, the tracking array 612 functions as the handle 620 of the probe 608A. Therefore, the four markers 804 are attached to the handle 620 of the probe 608A and are separated from the shaft 622 and the tip 624. Tracking by stereoscopic photogrammetry of these four markers 804 allows the instrument 608 to be tracked as a rigid body, with tracking systems 100, 300, 600 tipped while probe 608A is moved forward of tracking cameras 200, 326. The position of the 624 and the orientation of the shaft 622 can be accurately determined.

Markers 118, such as each tool 608, end effector 112, to allow automatic tracking of one or more tools 608, end effector 112, or other objects (eg, multiple rigid bodies) tracked in 3D. 804s are asymmetrically placed at known marker spacing. The reason for the asymmetric alignment is to clarify which markers 118, 804 correspond to a particular position on the rigid body, whether the markers 118, 804 are viewed from the front or back, that is, mirrored. be. For example, if the markers 118, 804 were placed in a square on the tool 608 or the end effector 112, it is unknown to the systems 100, 300, 600 which marker 118, 804 corresponds to which corner of the square. .. For example, in the case of probe 608A, it is unclear which marker 804 is closest to shaft 622. Therefore, it is unknown how the shaft 622 extended from the array 612. Therefore, each array 612, and thus each tool 608, end effector 112, or other object being tracked, must have a unique marker pattern so that it can be distinguished from the other tool 608 or other objects being tracked. Must be. The asymmetry and unique marker pattern is that the systems 100, 300, 600 detect individual markers 118, 804 and check the marker spacing against the saved template, which tool 608, end effector 112. , Or makes it possible to determine if it represents another object. The detected markers 118, 804 can then be automatically sorted and assigned to each tracked object in the correct order. Without this information, it is important, for example, the alignment of the tool tip 624 and the shaft 622, unless the user manually specifies which position and position on which detected markers 118, 804 correspond to which position on each rigid body. Rigid body calculations will not be possible to extract various geometric information. These concepts are generally known to those of skill in the art of 3D optical tracking methods.

Referring now to FIGS. 14A-14D, an alternative version of the end effector 912 with the movable tracking markers 918A-918D is shown. In FIG. 14A, an array with mobile tracking markers 918A-918D is shown in the first configuration, and in FIG. 14B, the mobile tracking markers 918A-918D are shown in a second configuration tilted relative to the first configuration. .. FIG. 14C shows templates for tracking markers 918A-918D, for example, as seen by cameras 200 and 326 in the first configuration of FIG. 14A. FIG. 14D shows templates for tracking markers 918A-918D, for example, as seen by cameras 200 and 326 in the second configuration of FIG. 14B.

In this embodiment, four marker array tracking is intended, but not all markers 918A-918D are in a fixed position with respect to the rigid body, instead one or more array markers 918A-918D are tested, eg. It is possible to provide up-to-date information about the rigid body to be tracked without interrupting the process for automatic detection and sorting of markers 918A-918D adjusted and tracked in.

When tracking any tool such as the guide tube 914 connected to the end effector 912 of the robot system 100, 300, 600, the main purpose of the tracking array is to update the position of the end effector 912 in the camera coordinate system. Is. When using a fixation system, for example, as shown in FIG. 13B, the array 612 of reflection markers 118 is fixedly extended from the guide tube 114. Since the tracking marker 118 is fixedly connected, the marker position information in the camera coordinate system also provides the exact position of the centerline, tip and tail of the guide tube 114 in the camera coordinate system. Normally, information about the position of the end effector 112 from such an array 612, and information about the position of the target orbit from another tracked source, moves the guide tube 114 to align with the orbit and orbits the tip. It is used to calculate the required movement that must be entered for each axis of the robot 102 to move to a particular position along the vector.

In some cases, the desired trajectory is in an awkward or unreachable position, but can be reached if the guide tube 114 can be swiveled. For example, if the guide tube 114 is pivotable upwards beyond the limits of the pitch (wrist up / down angle) axis, a very steep trajectory pointing away from the base 106 of the robot 102 may be reachable, but if. , The guide tube 114 may not be reachable if attached parallel to the plate connecting it to the end of the wrist. To reach such a trajectory, the base 106 of the robot 102 can be moved or different end effectors 112 with different guide tube attachments can be replaced with working end effectors. Both of these solutions can be time consuming and cumbersome.

As best shown in FIGS. 14A and 14B, if the array 908 does not have one or more of the markers 918A-918D in a fixed position, instead one or more of the markers 918A-918D adjust, swivel, If it can be pivoted or moved, the robot 102 can provide updated information about the object being tracked without interrupting the detection and tracking process. For example, one of the markers 918A-918D may be fixed in place and the other markers 918A-918D may be mobile. Two of the markers 918A-918D may be fixed in place and the other markers 918A-918D may be mobile. Three of the markers 918A-918D may be fixed in place and the other markers 918A-918D may be mobile. Alternatively, all of the markers 918A to 918D may be movable.

In the embodiments shown in FIGS. 14A and 14B, the markers 918A, 918B are fixedly connected directly to the base 906 of the end effector 912, and the markers 918C, 918D are fixedly connected to the tube 914. Similar to the array 612, the array 908 can be provided to attach the markers 918A-918D to the end effector 912, instrument 608, or other object to be tracked. However, in this case, the array 908 is composed of a plurality of separate components. For example, the markers 918A, 918B may be connected to the base 906 by a first array 908A and the markers 918C, 918D may be connected to the guide tube 914 by a second array 908B. The marker 918A may be attached to the first end of the first array 908A and the marker 918B may be separated into linear distances and secured to the second end of the first array 908A. The first array 908 is substantially linear, while the second array 908B has a curved or V-shaped configuration, each root end connected to a guide tube 914 from which it is V-shaped. It branches to the distal end and has a marker 918C at one distal end and a marker 918D at the other distal end. Although specific configurations are exemplified herein, it will be appreciated that other asymmetric designs including arrays 908A, 908B of different numbers and types and markers 918A-918D of different arrangements, numbers, and types are contemplated. ..

The guide tube 914 may be movable, pivotable, or pivotable with respect to the base 906, for example, across a hinge 920 or other connector to the base 906. Therefore, the markers 918C, 918D are movable so that when the guide tube 914 is pivoted, swiveled, or moved, the markers 918C, 918D are also pivoted, swiveled, or moved. As best shown in FIG. 14A, the guide tube 914 has a longitudinal axis 916 that is substantially normal or vertically aligned so that the markers 918A-918D have the first configuration. Referring here to FIG. 14B, the guide tube 914 is pivoted so that the longitudinal axis 916 is angled with respect to the vertical direction so that the markers 918A-918D have a second configuration different from the first configuration. , Turn, or move.

In contrast to the embodiments described in FIGS. 14A-14D, the guide tube 914 and arm 104 (eg, wrist attachment) with all four markers 918A-918D fixedly attached to the guide tube 914. ), And if the swivel is adjusted by the user, the robot systems 100, 300, 600 cannot automatically detect that the orientation of the guide tube 914 has changed. Robot systems 100, 300, 600 track the position of the marker array 908 and assume inaccurate robot axis movements, assuming that the guide tube 914 is attached to the wrist (robot arm 104) in the previous orientation. calculate. One or more markers 918A-918D (eg, two markers 918C, 918D) are fixed and held on tube 914 and one or more markers 918A-918D (eg, two markers 918A, 918B) are fixed and held. By holding the swivel across the swivel, new positions can be automatically detected and the correct robot movement is calculated based on the detection of new tools or end effectors 112, 912 on the end of the robot arm 104.

One or more markers 918A-918D are configured to be moved, pivoted, swiveled, etc. according to any suitable means. For example, markers 918A-918D can be moved by hinges 920 such as clamps, springs, levers, slides, toggles, or to move markers 918A-918D individually or in combination, or arrays 908A, 908B individually or. Any part for moving in combination, for moving any part of the end effector 912 to another part, or for moving any part of the tool 608 to another part. It may be moved by other suitable mechanism.

As shown in FIGS. 14A and 14B, the array 908 and guide tube 914 simply loosen the clamps or hinges 920, moving a portion of the arrays 908A, 908B relative to the other portions 908A, 908B to move the hinge 920. It may be readjusted and configured so that the guide tube 914 is oriented in a different position. For example, the two markers 918C, 918D are fixedly interconnected with the tube 914, and the two markers 918A, 918B are fixedly interconnected to the base 906 of the end effector 912 attached to the robot arm 104 via the hinge 920. obtain. The hinge 920 is in the form of a clamp such as a wing nut that can be loosened and tightened to allow the user to quickly switch between the first configuration (FIG. 14A) and the second configuration (FIG. 14B). There may be.

Cameras 200 and 326 detect markers 918A-918D, for example, in one of the templates identified in FIGS. 14C and 14D. If the array 908 is in the first configuration (FIG. 14A) and the tracking cameras 200 and 326 detect markers 918A-918D, the markers tracked will match array template 1 as shown in 14C. If array 908 is the second configuration (FIG. 14B) and tracking cameras 200 and 326 detect the same markers 918A-918D, the markers tracked will match array template 2 as shown in FIG. 14D. Array template 1 and array template 2 are recognized by systems 100, 300, 600 as two different tools with a spatial relationship uniquely defined between the guide tube 914, markers 918A-918D, and robot attachment. Thus, the user can adjust the position of the end effector 912 between the first and second configurations without notifying the systems 100, 300, 600 of the change, the system 100, 300, 600 being a robot. Appropriately adjust the movement of 102 so that it is in orbit.

In this embodiment, there are two assembly positions where the marker array matches a unique template that allows the systems 100, 300, 600 to recognize the assembly as two different tools or two different end effectors. At any position on the swivel between or outside these two positions (ie, Array Template 1 and Array Template 2 shown in FIGS. 14C and 14D, respectively), markers 918A-918D do not match either template and the system. 100, 300, 600 do not detect the existing array even though the individual markers 918A-918D are detected by the cameras 200 and 326, and the markers 918A-918D are temporarily out of sight of the cameras 200 and 326. The result is the same as if it was blocked. It will be appreciated that other array templates may be present for other configurations that identify, for example, different instruments 608 or other end effectors 112, 912 and the like.

In the described embodiment, two separate assembly positions are shown in FIGS. 14A and 14B. However, it will be appreciated that there are multiple discrete positions on swivel joints, straight joints, swivel and straight joint combinations, pegboards, or other assemblies. Here, unique marker templates can be created by adjusting the positions of one or more markers 918A-918D in the array to each other, where each discrete position matches a particular template and is known to be different. Defines a unique tool 608 or end effectors 112, 912 with the attributes of. Further, although exemplified for the end effector 912, it will be appreciated that the movable fixed markers 918A-918D may be used with any suitable instrument 608 or other object to be tracked.

When using an external 3D tracking system 100, 300, 600 to track a complete rigid array of three or more markers attached to the robot's end effector 112 (eg, as shown in FIGS. 13A and 13B), the camera The 3D position of each section of the robot 102 in the 200,326 coordinate system can be directly tracked or calculated. The geometric orientation of the joint with respect to the tracker is known by design, the linear or angular position of the joint is known from the encoder of each motor of the robot 102 and of all moving parts from the end effector 112 to the base 116. Completely define the 3D position. Similarly, if the tracker is attached to the base 106 of the robot 102 (not shown), the robot 102 from the base 106 to the end effector 112 will be based on the known joint geometry and the joint position from the encoder of each motor. It is also possible to track or calculate the 3D position of each section.

In some situations, it may be desirable to track the position of all segments of the robot 102 from less than three markers 118 fixedly attached to the end effector 112. Specifically, when the tool 608 is introduced into the guide tube 114, it may be desirable to track only one additional marker 118 to track the complete rigid body motion of the robot 902.

Here, with reference to FIGS. 15A-15E, an alternative version of the end effector 1012 with only a single tracking marker 1018 is shown. The end effector 1012 may be similar to the other end effectors described herein and may include a guide tube 1014 extending along the longitudinal axis 1016. A single tracking marker 1018 similar to the other tracking markers described herein can be firmly secured to the guide tube 1014. This single marker 1018 serves the purpose of adding the missing degrees of freedom to enable full rigid body tracking and / or as a surveillance marker that ensures that the robot and camera positioning assumptions are valid. Can serve a functioning purpose.

The single tracking marker 1018 may be attached to the robotic end effector 1012 as an extension of rigidity to the end effector 1012 that projects in any convenient direction and does not obstruct the surgeon's view. The tracking marker 1018 can be anchored in any other suitable position on the guide tube 1014 or end effector 1012. When attached to the guide tube 1014, the tracking marker 1018 may be positioned between the first and second ends of the guide tube 1014. For example, in FIG. 15A, the single tracking marker 1018 extends forward from the guide tube 1014 and is on a thin shaft 1017 located above the longitudinal midpoint of the guide tube 1014 and below the inlet of the guide tube 1014. Shown as a reflective sphere attached to the end. This position not only allows the marker 1018 to be totally visible by the cameras 200 and 326, but also does not obstruct the view of the surgeon 120 and does not collide with other tools or objects in the vicinity of the surgery. Further, the guide tube 1014 having the marker 1018 at this position allows the marker array on any tool 608 introduced into the guide tube 1014 to be seen at the same time as the single marker 1018 on the guide tube 1014 is visible. Designed.

As shown in FIG. 15B, when a snug-fitting tool or instrument 608 is placed within the guide tube 1014, the instrument 608 is mechanically constrained in four of the six degrees of freedom. That is, the instrument 608 cannot be rotated in any direction except for the longitudinal axis 1016 of the guide tube 1014, and the instrument 608 translates in any direction other than along the longitudinal axis 1016 of the guide tube 1014. I can't. In other words, the instrument 608 can only translate and rotate along the centerline of the guide tube 1014. If two more parameters are known, such as (1) the rotation angle around the longitudinal axis 1016 of the guide tube 1014 and (2) the position along the guide tube 1014, the position of the end effector 1012 in the camera coordinate system is perfect. Defined in.

Next, as shown in FIG. 15C, the system 100, 300, 600 is such that the tool 608 is actually placed inside the guide tube 1014 and instead is not outside the guide tube 1014, but somewhere in the field of view of the cameras 200, 326. You should be able to know when you are in. The tool 608 has a longitudinal axis or centerline 616 and an array 612 with a plurality of tracked markers 804. Rigid body calculations can be used to determine where the centerline 616 of the tool 608 is located in the camera coordinate system, based on the tracking position of the array 612 on the tool 608.

_{A fixed normal (vertical) distance DF} from the single marker 1018 to the centerline or longitudinal axis 1016 of the guide tube 1014 is fixed, geometrically known, and traces the position of the single marker 1018. be able to. Therefore, the detection distance _{D D} from the tool center line 616 to the single marker 1018, if it matches the known fixed distance _{D F} from the guide tube centerline 1016 to single marker 1018, the tool 608 into the guide tube 1014 Determined that there is (matches the centerlines 616 and 1016 of the tool 608 and the guide tube 1014), or that this distance _DD is present at some point in the locus of a position that may coincide with the fixed distance _DF. can. For example, as shown in FIG. 15C, the detection distance D _D in the normal direction from the tool center line 616 to the single marker 1018, at the two positions, the both data frames represented by a transparent tool 608 (tracking Marker coordinates) coincides with _{the fixed distance DF} from the guide tube centerline 1016 to the single marker 1018. Therefore, additional consideration may be needed to determine when the tool 608 is placed within the guide tube 1014.

Referring now to FIG. 15D, the tool 608 is used with respect to a single sphere 1018 in space to satisfy the condition that the tool 608 is moving in the guide tube 1014 using programmed logic. be moved by some minimum distance remains detection distance D _D from the tool center line 616 to a single marker 1018 is fixed to the correct length, it is possible to find a frame of tracking data. For example, the first frame F1 can be detected by the tool 608 in the first position and the second frame F2 can be detected by the tool 608 in the second position (ie, linear with respect to the first position). Will be moved to). The marker 804 on the tool array 612 can move from the first frame F1 to the second frame F2 by more than a given amount (eg, more than 5 mm total). Even in this movement, the detection distance D _D from the tool center line vector C 'to a single marker 1018 is substantially the same in both the first frame F1 and second frame F2.

Logically, the surgeon 120 or the user could place the tool 608 inside the guide tube 1014 and slightly rotate or slide it into the guide tube 1014, the system 100, 300, 600 would be the tool. It can be detected that the 608 is in the guide tube 1014 from five markers (four markers 804 on the tool 608 plus a single marker 1018 on the guide tube 1014). Knowing that the tool 608 is inside the guide tube 1014, it is possible to calculate all six degrees of freedom that determine the position and orientation of the robotic end effector 1012 in space. Without the single marker 1018, where the guide tube 1014 is located along the tool centerline vector C'and where the guide tube 1014 is located, even though it is certain that the tool 608 is inside the guide tube 1014. It is unclear how it rotates with respect to the centerline vector C'.

As highlighted in FIG. 15E, the single marker 1018 is tracked together with the four markers 804 on the tool 608, so that the guide tube 1014 and the tool 608 centerline vector C'and the single marker 1018 and the centerline vector C You can build a normal vector by'. This normal vector is a known orientation with respect to the robot's forearm (oriented parallel to that segment in this example) distal to the wrist and intersects the centerline vector C'at a particular fixed position. Has orientation. For convenience, as shown in FIG. 15E, three mutually orthogonal vectors k', j', i'can be configured to define the rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors, k'is composed of the centerline vector C', the second vector j'is composed of the normal vector passing through the single marker 1018, and the third. The vector i'is a vector product of the first and second vectors k'and j'. The robot's joint positions with respect to these vectors k', j', i'are known to be zero for all joints and are fixed, so using rigid body calculations, these when the robot is in the home position. The position of any part of the robot with respect to the vectors k', j', i'can be determined. While the robot is moving, the position of the tool marker 804 (while the tool 608 is in the guide tube 1014) and the position of the single marker 1018 are detected by the tracking system and the angle / linear position of each joint is known from the encoder. For example, the position and orientation of any part of the robot can be determined.

In some embodiments, it may be useful to fix the orientation of the tool 608 with respect to the guide tube 1014. For example, the end effector guide tube 1014 may be oriented to a specific position around its axis 1016 to allow machining or implant positioning. The orientation of anything attached to the tool 608 inserted into the guide tube 1014 can be seen from the tracked marker 804 on the tool 608, but an additional tracking marker 1018 (or in other embodiments) on the guide tube 1014. Without the multiple tracking markers), the direction of rotation of the guide tube 1014 itself in the camera coordinate system is unknown. The marker 1018 essentially provides a "clock position" of −180 ° to + 180 ° based on the orientation of the marker 1018 with respect to the centerline vector C'. Thus, the single marker 1018 can provide additional degrees of freedom to allow full rigid body tracking and / or serve as a surveillance marker that ensures that the robot and camera positioning assumptions are valid. be able to.

FIG. 16 is a block diagram of method 1100 for navigating and moving an end effector 1012 (or any other end effector described herein) of robot 102 to a desired target trajectory. Another use of the single marker 1018 on the robot end effector 1012 or guide tube 1014 is part of method 1100 that allows automatic safe movement of the robot 102 without a full tracking array attached to the robot 102. In this method 1100, the tracking system and the robot's coordinate system are registered together without the tracking cameras 200 and 326 moving relative to the robot 102 (ie, they are in a fixed position), and the position of the guide tube 1014. And works when the robot 102 is calibrated so that the orientation can be accurately determined in the robot's Cartesian coordinate system based only on the coded position of each robot axis.

In this method 1100, both the tracker and the robot's coordinate system must be registered, which means that a coordinate conversion from the tracking system's Cartesian coordinate system to the robot's Cartesian coordinate system is required. For convenience, this coordinate transformation can be a 4x4 parallel traveling matrix and rotation matrix well known in the field of robotics. This conversion is called the Tcr and refers to "conversion-from camera to robot". Once this transformation is known, a new frame of tracking data received as x, y, z coordinates in vector form can be multiplied by a 4x4 matrix for each marker being tracked, and the resulting x, y, z coordinates are robots. It is in the coordinate system of. To obtain the Tcr, the robot's full tracking array is tracked while it is fixedly attached to the robot at a known position in the robot's coordinate system, and then the known rigid body method calculates the transformation of the coordinates. Used for. It is clear that any tool 608 inserted into the guide tube 1014 of the robot 102 can provide the same rigid body information as the fixedly mounted array when the additional marker 1018 is also read. That is, the tool 608 only needs to be inserted at an arbitrary position in the guide tube 1014 at an arbitrary rotation in the guide tube 1014. It does not need to be inserted in a fixed position and orientation. Therefore, it is possible to determine the Tcr by inserting any tool 608, including the tracking array 612, into the guide tube 1014 and reading the tool array 612 and the single marker 1018 on the guide tube 1014. At the same time, the current position of the guide tube 1014 in the robot's coordinate system can be determined from the encoders on each axis.

The logic for navigating and moving the robot 102 to the target trajectory is provided in method 1100 of FIG. It is assumed that the transformation Tcr was previously stored before entering loop 1102. Thus, prior to entering loop 1102, in step 1104, after the robot base 106 has been fixed, one or more frames of the tool tracking data inserted into the guide tube while the robot is stationary are stored. Will be done. In step 1106, the conversion of the robot guide tube position from the camera coordinates to the robot coordinates Tcr is calculated from this static data and the previous calibration data. The Tcr should be valid as long as the cameras 200 and 326 do not move with respect to the robot 102. If the cameras 200, 326 move against the robot 102 and need to reacquire the Tcr, the systems 100, 300, 600 prompt the user to insert the tool 608 into the guide tube 1014, which is then required. Calculations can be performed automatically.

In the flowchart of Method 1100, each frame of the collected data is a snapshot of the tracked position of DRB1404 on the patient 210, the tracked position of the single marker 1018 on the end effector 1014, and the position of each robot axis. Consists of. From the position of the robot axis, the position of the single marker 1018 on the end effector 1012 is calculated. This calculated position is compared to the actual position of marker 1018 recorded from the tracking system. If the values match, it can be assured that the robot 102 is in a known position. The transformation Tcr is applied to the tracked position of the DRB 1404 so that the target of the robot 102 is provided with respect to the robot's coordinate system. The robot 102 may then be instructed to move to reach the target.

After steps 1104 and 1106, the loop 1102 receives the rigid body information of the DRB 1404 from the tracking system, steps 1108, converts the target tip and trajectory from image coordinates to tracking system coordinates, and the target tip and trajectory in camera coordinates. Includes step 1112 to convert from to robot coordinates (apply Tcr). Loop 1102 further includes step 1114 to receive a single drift marker position for the robot from the tracking system and step 1116 to convert the single drift marker from tracking system coordinates to robot coordinates (apply storage Tcr). including. Loop 1102 also includes step 1118 to determine the current position of a single robot marker 1018 in the robot coordinate system from forward kinematics. The information from steps 1116 and 1118 is used to determine if the drift marker coordinates from the converted tracked position match the calculated coordinates that are less than a predetermined tolerance (step 1120). .. If yes, proceed to step 1122 to calculate and apply robot movement to targets x, y, z and orbits. If no, proceed to step 1124, pause, request full array insertion into guide tube 1014 before continuing processing, and recalculate Tcr after the array has been inserted in step 1126. Then, steps 1108, 1114 and 1118 are repeated.

This method 1100 has an advantage over a method in which continuous monitoring of a single marker 1018 is omitted to confirm the position. Without the single marker 1018, it is possible to use Tcr to locate the end effector 1012 and send the end effector 1012 to the target position, but the robot 102 is actually in the expected location. Cannot be confirmed. For example, if the cameras 200 and 326 hit and the Tcr is no longer valid, the robot 102 will move to the wrong position. For this reason, the single marker 1018 provides safety value.

Theoretically, for a given fixed position of the robot 102, the tracking cameras 200 and 326 remain unmoved because the single tracked marker 1018 is a single point rather than an array. , It is possible to move to a new position. In such a case, the systems 100, 300, 600 do not detect any error because the calculated position of the single marker 1018 matches the tracked position. However, when the robot axis moves the guide tube 1012 to a new position, the calculated position and the tracked position do not match and the safety check becomes effective.

The term "monitoring marker" can be used, for example, with reference to a single marker in a fixed position with respect to DRB1404. In this example, if the DRB1404 is abutted or otherwise removed, the relative position of the surveillance marker will change, alerting the surgeon 120 that there may be a navigation problem. Similarly, in the embodiments described herein, using a single marker 1018 on the robot's guide tube 1014, the systems 100, 300, 600 will see if the cameras 200, 326 have moved relative to the robot 102. Can be checked continuously. If the tracking system's coordinate system is lost in the robot's coordinate system due to the camera 200, 326 hitting, malfunctioning, robot malfunction, etc., the systems 100, 300, 600 will be the user. Can be warned and corrected. Therefore, this single marker 1018 can also be considered as a monitoring marker for the robot 102.

In the case of a full array permanently attached to the robot 102 (eg, multiple tracking markers 702 on the end effector 602 shown in FIGS. 7A-7C), such a function of a single marker 1018, such as a robot surveillance marker, is , Cameras 200 and 326 are not required to be in a fixed position with respect to the robot 102, and Tcr is not required as it is updated at each frame based on the tracked position of the robot 102. The reason for using the single marker 1018 instead of the complete array is that the complete array is bulkier, which impedes the surgeon's visibility and access to the surgical area 208 than the single marker 1018. , Because the line of sight to the full array is more easily blocked than the line of sight to the single marker 1018.

Here, with reference to FIGS. 17A-17B and 18A-18B, an instrument 608 such as implant holders 608B, 608C containing both fixed and movable tracking markers 804, 806 is shown. Implant holders 608B, 608C may have a handle 620 and an outer shaft 622 extending from the handle 620. The shaft 622 may be positioned substantially perpendicular to the handle 620 or in any other suitable orientation as shown. The inner shaft 626 can extend through the outer shaft 622 having a knob 628 at one end. Implants 10 and 12 are connected to the shaft 622 at the other end at the tip 624 of the implant holders 608B, 608C using a typical connection mechanism known to those of skill in the art. The knob 628 can be rotated, for example, to expand or articulate implants 10, 12. U.S. Pat. Nos. 8,709,086 and 8,491,659, incorporated herein by reference, describe expandable fusion devices and mounting methods.

When tracking a tool 608 such as the implant holders 608B, 608C, the tracking array 612 is movable with one or more fixed markers 804 that constitute the array 612 or are otherwise attached to the implant holders 608B, 608C. A combination of markers 806 can be included. The navigation array 612 can include at least one or more (eg, at least two) fixed position markers 804 that are located at known positions with respect to the implant holder instruments 608B, 608C. These fixed markers 804 cannot move in any direction with respect to the geometry of the instrument and are useful in defining where the instrument 608 is in space. In addition, there is at least one marker 806, which can be attached to the array 612 or the instrument itself, which can move within a predetermined boundary relative to the fixed marker 804 (eg, sliding, rotating, etc.). Systems 100, 300, 600 (eg, software) relate the position of the movable marker 806 to a particular position, orientation, or other attribute of the implant 10 (eg, the expandable interbody interbody shown in FIGS. 17A-17B). Spacer height, angle of interbody spacer with joints shown in FIGS. 18A-18B). Thus, the system and / or the user can determine the height or angle of implants 10, 12 based on the position of the movable marker 806.

In the embodiments shown in FIGS. 17A-17B, four fixed markers 804 are used to define the implant holder 608B and a fifth movable marker 806 is slid within a predetermined path to implant height (eg, eg). Feedback can be provided to the contracted or expanded position). FIG. 17A shows the expandable spacer 10 at its initial height, and FIG. 17B shows the expanded spacer 10 with the movable marker 806 translated into different positions. In this case, it is believed that the movable marker 806 approaches the fixed marker 804 when the implant 10 is expanded, but this movement may be reversed or otherwise different. The amount of linear translation of the marker 806 corresponds to the height of the implant 10. Although only two positions are shown, it is possible to have this as a continuous function, whereby any predetermined extended height can be correlated with a particular position of the movable marker 806.

Referring here to FIGS. 18A-18B, four fixed markers 804 are used to define the implant holder 608C and a fifth movable marker 806 is a predetermined route to provide feedback for the implant joint angle. It is configured to slide within. FIG. 18A shows the spacer 12 with the joint in its initial linear state, and FIG. 18B shows the spacer 12 in the joint-operated state at a certain offset angle in which the movable marker 806 has been moved to a different position. The linear translation of the marker 806 corresponds to the joint angle of the implant 12. Although only two positions are shown, it is possible to have this as a continuous function, whereby any given joint angle can be correlated with a particular position of the movable marker 806.

In these embodiments, the movable marker 806 slides continuously to provide feedback on the attributes of implants 10, 12 based on position. It is also possible that there may be a well-thought-out position where there must be a movable marker 806 that can provide further information about the implant attributes. In this case, the careful configuration of all markers 804,806 correlates with the particular geometry of implant holders 608B, 608C and implants 10,12 at a particular orientation or height. In addition, any movement of the movable marker 806 can be used for other variable attributes of any other type of navigated implant.

Although illustrated and described with respect to the linear movement of the movable marker 806, the movable marker 806 should not be limited solely to sliding. There may be applications in which the rotation or other movement of the marker 806 may be useful in providing information about implants 10, 12. The relative change in position between the set of fixed markers 804 and the movable marker 806 can be relevant information about implants 10, 12 or other devices. Further exemplified by expandable and articulated implants 10, 12, the instrument 608 includes other medical devices and spacers, cages, plates, fasteners, nails, screws, rods, pins, wire structures, sutures, anchors. It can work with materials such as clips, staples, stents, bone grafts, biologics and cement.

Here, with reference to FIG. 19A, it is assumed that the robot end effector 112 is interchangeable with other types of end effectors 112. Further, it is believed that each end effector 112 can perform one or more functions based on the desired surgical procedure. For example, an end effector 112 with a guide tube 114 may be used to guide the instrument 608 as described herein. Further, the end effector 112 can be replaced, for example, with a different or alternative end effector 112 that controls a surgical device, instrument, or implant.

The alternative end effector 112 may include one or more devices or instruments coupled to the robot and controlled by the robot. As a non-limiting example, the end effector 112 shown in FIG. 19A may be a retractor (eg, one or more retractors disclosed in US Pat. Nos. 8,992,425 and 8,968,363), or It can include one or more mechanisms for inserting or installing surgical devices such as: It includes expandable intervertebral fusion devices (such as the expandable implants exemplified in US Pat. Nos. 8,845,734, 9,510,954, and 9,456,903), stand-alone intervertebral space. Fusion devices (such as implants as exemplified in US Pat. Nos. 9,364,343 and 9,480,579), expandable osteotomy devices (US Pat. Nos. 9,393,128 and 9, Bone orthodontic implants exemplified by 173,747), spacers with joints (implants exemplified by US Pat. No. 9,259,327), facet prostheses (eg, US Pat. No. 9,539,031). Devices such as), vertebral angioplasty devices (such as the device exemplified by US Pat. No. 9,486,253), spinous spacers (such as implants exemplified by US Pat. No. 9,592,082), Inflatable products, fasteners including multi-axis screws, unilateral screws, pedicle screws, post-screws, etc., bone fixation plates, rod constructs and modification devices (such as the devices exemplified by US Pat. No. 8,882,803), Artificial and natural discs, motion storage devices, implants, and spinal cord stimulators (such as those exemplified in US Pat. No. 9,440,076), as well as other surgical devices. The end effector 112 is one or more directly or indirectly coupled to the robot to provide bone cement, bone grafts, living cells, pharmaceuticals, or other deliverables to surgical targets. Can include instruments. The end effector 112 can also include one or more instruments designed for performing discectomy, kyphosis, vertebral suture, dilation, or other surgical procedures.

The end effector itself and / or the implant, device or instrument can include one or more markers 118 so that the location and location of the markers 118 can be identified in three dimensions. It is believed that the marker 118 may include the active or passive markers 118 described herein that are directly or indirectly visible to the camera 200. Thus, for example, one or more markers 118 placed on the implant 10 can provide tracking of the implant 10 before, during and after the implant.

As shown in FIG. 19B, the end effector 112 can include an instrument 608 coupled to the robot arm 104 or a portion thereof (eg, the instrument 608 is the robot arm 104 by the coupling mechanism shown in FIGS. 9A-9C. Can be coupled to), which can be controlled by the robot system 100. Therefore, in the embodiment shown in FIG. 19B, the robot system 100 can insert the implant 10 into the patient and expand or contract the expandable implant 10. Therefore, the robot system 100 can be configured to assist the surgeon or operate partially or completely independently. Therefore, it is envisioned that the robot system 100 can control each alternative end effector 112 for its particular function or surgical procedure.

With reference to FIGS. 20A-22C, surgical navigation may be used to track a bent spinal rod during minimally invasive surgery (MIS). One problem that can exist is that it can be difficult to insert the spinal cord rod into the MIS because the rod needs to be positioned invisibly through the screw head tulip. Surgical navigation techniques will provide the surgeon with visibility while placing the bent rod through the tulips in the MIS procedure. To enable surgical navigation, the navigation array must be attached to the rod in a known manner and the shape of the bent rod should be known.

By having a mounting point with a known orientation, such as a keyed hexagon located at the end of the rod, it can be attached to the tracking array itself, with the rod mentioned above inside the patient's body, the camera and the surgeon. Rod navigation is allowed while the is not directly visible.

Information about the shape of the rod can be determined preoperatively by planning the software. It can be determined intraoperatively by navigating the screw head to determine the rod shape, as is done when using an automated rod bender system. It can also be determined by the navigation wand used to scan the shape of the bent rod.

The present disclosure provides a patient-specific bent rod within the MIS by providing a tracking array that monitors the position of the rod to ensure alignment with the pedicle screw while using the minimum incision entry point. Can be tracked. The present disclosure may also enable a rod geometry detection tool that allows rapid generation of CAD models of bent rods, which in turn enable anatomical on-display of robotic surgical systems. It can be overlaid on the structure and displayed graphically.

The automatic rod bending device described in other disclosures, such as US Provisional Patent Application No. 62 / 583,851 (incorporated herein by reference), automatically adjusts the rod to match the desired attachment point. Can be used to bend. The desired attachment point may be the location of the screw head after insertion, or the location of the screw head after realignment application. Surgical planning and / or navigation can be used to establish a set of points where rods need to be interconnected. The splines can then be fitted to the points, the points can be connected by straight lines or curves, or other methods can be used to establish the rod shape. Once the rod shape is defined, the automatic rod bender can generate a physically bent rod and the software can generate and hold a CAD file representing the geometry of the bent rod. Like other tracked tools with CAD representation, the navigation system is a bent rod overlaid on the patient's anatomy, and anatomical planned or tracked screws. Render the CAD representation of the bent rod overlaid on the position. Surgical planning software allows the user to rotate and translate the bent rod image and rearrange it against the anatomy and planned screws to determine if the fit is correct. You can check. When navigating, the current or extrapolated position of the bent rod can also be tracked against the anatomy and planned threads.

Navigation of a bent rod may include attaching a tracker to the rod. Since the rod is non-linear, the attachment point needs to be in a known orientation so that the rod can be traced as a rigid body with 6 degrees of freedom. A mounting mechanism to the end of the rod may be used that allows the tracker to be mounted in one possible way. One possible configuration for this mounting mechanism is a hexagon with a keyway. The tracking array can have a male connection boss that inserts into a female connection socket, and the keyway ensures that the tracker is mounted in one direction (FIGS. 20A-21, described in more detail below). See). Other possible configurations include, but are not limited to, a "T" keyway, a notched cylinder, a heart shape, a bean shape, or a notched n-sided polygon.

20A-20B show exemplary embodiments of the present disclosure. 20A-20B show two views of the attachment point 2002 of the rod 2004 after bending. The first figure (FIG. 20A) shows the front of the attachment point 2002. The central recess or keyway 2006 of the inner channel 2008 ensures that there is a proper alignment of the tracker connection with the rod 2004 due to the asymmetrical nature of the inner channel 2008. The second figure (FIG. 20B) shows the rod 2004 and the attachment point 2002 from the side. The depth of the attachment point can be seen as a notch 2010 along the rear of the hexagon. The notch 2010 may be configured as a mounting point to which the tracking array is mounted, ensuring a secure connection between the tracker and the rod 2004 and ensuring a fixed locking position along the direction of the shaft.

FIG. 21 shows an exemplary embodiment of a system 2100 for tracking a bent rod according to the principles of the present disclosure. The system 2100 may include a rod 2004 with attachment points 2002 and a tracker (or tracking array) 2102 with connection points 2104. The connection point 2104 may engage the keyway 2006 on the rod to insert the tracker 2102 into the rod 2002. The tracker 2102 may have a corresponding piece on the connection point 2104 that attaches to the hexagonal keyway 2006. The tracker 2102 is locked in the keyway 2006 and wound around the notch 2010. Clamping the tracker 2102 around the rod attachment point 2002 helps ensure that the rod 2004 is secured to the tracker 2102.

FIG. 22 shows an exemplary method 2200 for tracker mounting and registration consistent with the principles of the present disclosure. At step 2202, the automatic rod flexor or manual rod flexor can bend the rod to fit the pedicle screw head implanted in the patient.

At step 2204, the orientation of the rod with respect to the keyway is determined to track the bent rod. Keyway orientation can be recorded in several ways. In one exemplary method, the rod is positioned within the rod bender so that the system recognizes the orientation of the rod during the bending process. In another exemplary method, the keyway may be inscribed in the end of the rod by an automatic rod bending device. In another exemplary method, keyway orientation can be detected by detecting the shape of the rod through optical detection, laser scanning or other means. After the rod is bent, the CAD file can be imported into the navigation system through a connection with a computer associated with the automatic rod bending device. The surgeon may then attach the tracker to the rod and secure it via a clip mounted within the notch 2010. Markers on the tracker can be pre-calibrated so that the orientation of the tracker at its connection is known. The bent rod tracker is tracked simultaneously with the tracking array on the patient, allowing the position of the bent rod tracker connector to be recognizable to the patient's anatomy. The rod is provided with its fixation point by a bent rod tracker connector and extends as directed by the orientation of the keyway connector.

At step 2206, the bent rod is navigated. Upon navigating, the surgeon grasps the shaft of the bent rod tracker, inserts the rod through the incision into the surgical site, manipulates the rod through the incision and screw eyelet, and of one or more tracking cameras. Steer the rod while keeping the tracking array in sight. Manipulating the tracker and rod to follow the rod's curvature helps to minimize the incision size.

At step 2208, the rod bent relative to the patient's anatomy can be displayed on the display of the robot system. While maneuvering the rod under navigation, the rod may be visible to the inserted pedicle screw in an overlay on the anatomy. The surgeon can visualize how the position of the rod, especially the tip, changes with respect to the screw eyelet as it advances.

At step 2210, as the rod is steered through the screw head, the surgeon may lock the screw to the rod by inserting and tightening the screw lock cap using a driver collinearly inserted into each screw. The surgeon may remove the tracker from the end of the rod before or after the rod is placed and the screw is locked to the rod.

In an exemplary embodiment, the geometry of the bent rod can be determined, but it can be unknown prior to surgery and can be bent automatically or manually during surgery. Once the geometry of the rod is determined, a CAD model can be generated to visualize the rod on its anatomy. The geometry of the rod can be determined by detecting the curvature using a tracked tool as shown in FIGS. 23A-C.

FIG. 23A shows a system 2300 for determining the geometry of the rod. The system 2300 may include a tracked tool 2302 with a rod 2004 and a foot 2304 and a navigation array 2306. The navigation array 2306 may be recognizable for tracking the camera for navigation purposes.

To determine the geometry of the rod, the rod can be fixed to the table so that it remains in the camera's coordinate system. Alternatively, as described in connection with FIG. 21, the tracker 2102 can be attached to the end of the rod 2004, and the rod 2004 and the tool 2302 are as long as both the tracker 2102 and the navigation array 2306 remain visible to the tracking camera. , Can move freely with respect to each other. The user may move the tool 2302 along the outer surface of the rod 2004. The end of the tool 2302 has a V-shaped or semi-circular notch and one end has an open foot 2308 or surrounds the rod so that the foot can be freely pressed against the rod. As such, it may have a foot 2310 that is ring-shaped and requires the end of the rod to pass through the opening. The tool 2302 can calibrate the position of the center of the circular opening, or the position of the notch where it is known where the center of the rod is relative to the navigation array 2306 of the tool 2302.

The user may move the tool 2302 along the rod 2004 and record the shape of the bent rod. If the foot 2304 of the tool 2302 is a hole through which the rod 2004 passes, the rod 2304 can clog in the hole if there is a sharp curve. One way to avoid this situation is to flatten the cross section of the hole, as well as the washer. The tool 2302 may move over the length of the rod and the data related to its curvature is recorded continuously or unit by unit. This data is used to generate a CAD model.

In FIG. 23A, the foot 2304 on the tool 2302 can move the tool 2302 and the navigation array 2306 on the rod while in contact with the rod. The system can detect rod positions at intervals along its length and record the geometry of the rod for navigation. The foot 2304 may be a U-shaped socket 2308, as shown in FIG. 23B, or, as shown in FIG. 23C, a foot having a hole 2310 through which the rod passes.

Although the robots and related systems described herein are generally described with reference to spinal applications, robotic systems are configured to be used in other surgical applications. Other surgical procedures include traumatic surgery or other orthopedic surgery (eg, placement of intramedullary nails, plates, etc.), cranial, nerve, cardiothoracic, vascular, colonic rectal, oncology, dentistry and other surgery. And treatment, but not limited to these.

Although some embodiments of the invention are disclosed in the specification above, many modifications and other embodiments of the invention are assumed to be relevant to the invention and are described in the description and related drawings above. Enjoy the benefits of the teachings presented. Accordingly, it is understood that the invention is not limited to the particular embodiments disclosed above, but that many modifications and other embodiments are intended to be included within the appended claims. The features of one embodiment can be combined or further envisioned to be combined with or used with the features of the different embodiments described herein. In addition, certain terms are used herein and in the claims below, but they are used only in a comprehensive and descriptive sense to cover the inventions described and the claims below. It is not used for limiting purposes. The entire disclosure of each patent and gazette cited herein is incorporated by reference in its entirety as if each such patent or patent gazette was individually incorporated herein by reference. Various features and advantages of the present invention are described in the claims below.

Claims (18)

Surgical navigation system
With a computer
With the camera
With the display
Surgical implants with implant trackers and
A detection tool with a tool tracker associated with the surgical implant,
Equipped with
The computer is configured to determine the shape of the surgical implant by receiving data associated with the location of the detection tool as the detection tool moves along the outer surface of the surgical implant. ,
The surgical implant is a rod containing a attachment point, the attachment point has a hexagonal keyway and a notch, and the surgical implant is configured to bind to the implant tracker. ,
The implant tracker includes a connection point attached to the hexagonal keyway, the wound on the notches of the surgical implant, the surgical navigation system. The surgical navigation system of claim 1, wherein the camera is configured to track the surgical implant. The surgical navigation system according to claim 2, wherein the display is configured to display a graphic display of the surgical implant in relation to the patient's anatomy. The surgical navigation system of claim 3, wherein the display is configured to show the shape of the surgical implant as determined by the computer. The surgical navigation system of claim 1, wherein the implant tracker comprises one or more optical sensors configured to be recognized by the camera. The surgical navigation system of claim 5, wherein the tool tracker comprises one or more optical sensors configured to be recognized by the camera. The portion of the rod is configured to be found acceptable to pedicle the screw, surgical navigation system according to claim 1. The surgical navigation system of claim 1, wherein the detection tool comprises a U-shaped foot. The surgical navigation system of claim 1, wherein the detection tool comprises a foot having a through hole. Robot-assisted surgery A surgical robot system for use in surgery, said system.
With a computer
With the robot arm
With the camera
With the display
Surgical implants with implant trackers and
A detection tool with a tool tracker associated with the surgical implant,
Equipped with
The computer is configured to move the robot arm to a target location in the patient's anatomy to insert the surgical implant, where the detection tool is along the external surface of the surgical implant. As it travels, it is configured to determine the shape of the surgical implant by receiving data associated with the location of the detection tool.
The surgical implant is a rod containing a attachment point, the attachment point has a hexagonal keyway and a notch, and the surgical implant is configured to bind to the implant tracker. ,
The implant tracker includes a connection point attached to the hexagonal keyway, the wound on the notches of surgical implants, surgical robot system. 10. The surgical robot system of claim 10 , wherein the camera is configured to track the surgical implant. 11. The surgical robot system of claim 11 , wherein the display is configured to display a graphic display of the surgical implant in relation to the anatomical structure of the patient. 12. The surgical robot system of claim 12 , wherein the display is configured to display the shape of the surgical implant as determined by the computer. 10. The surgical robot system of claim 10 , wherein the implant tracker comprises one or more optical sensors configured to be recognized by the camera. 14. The surgical robot system of claim 14, wherein the tool tracker comprises one or more optical sensors configured to be recognized by the camera. The portion of the rod is configured to be found acceptable to pedicle the screw, surgical robotic system of claim 10. 10. The surgical robot system of claim 10 , wherein the detection tool comprises a U-shaped foot. 10. The surgical robot system of claim 10 , wherein the detection tool comprises a foot having a through hole.

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