Craniotomy planning system

Abstract

A cranial surgery planning system includes at least one network interface connectable to obtain radiological patient images generated by a radiological image scanner, a display device, at least one processor, and at least one memory storing program code executed by the at least one processor. Operations include obtaining, by the at least one network interface, a first radiological patient image of a cranial structure of a patient along a first plane and a second radiological patient image of the cranial structure of the patient along a second plane angularly offset from the first plane. Operations further include merging the first radiological patient image and the second radiological patient image into an image coordinate system. Operations further include obtaining a surgical trajectory plan defining an entry point on a skull of the patient and a target point in a brain of the patient captured in the merged first radiological patient image and the second radiological patient image.

Description

Technical Field

[0001] This disclosure relates to medical devices, and more specifically to robotic surgical systems and related methods and apparatus. Background Technology

[0002] Various medical procedures in cranial surgery require precise three-dimensional positioning of surgical instruments within the patient's body to achieve optimal treatment. Robotic surgical platforms are being introduced to assist surgeons in positioning surgical instruments and performing surgical procedures within the patient. These platforms may include a robot coupled to an end effector element, configured to control the movement and positioning of the end effector relative to the body. The end effector may be a surgical tool catheter, such as a drill catheter, or it may be the surgical tool itself.

[0003] There is a need for a robotic surgical platform that provides precise positioning of surgical instruments relative to the body's three-dimensional location for optimized treatment. Improved positioning accuracy minimizes human and robotic errors while allowing for rapid and efficient surgical procedures. The ability to perform procedures on the patient using the robotic surgical platform and computer software can enhance the entire surgical protocol and patient outcomes. Summary of the Invention

[0004] Some embodiments of this disclosure relate to a cranial surgery planning system, which includes at least one network interface connectable to obtain radiographic patient images generated by a radiographic imaging scanner, a display device, at least one processor, and at least one memory storing program code executed by the at least one processor. The processor is configured to perform operations including obtaining a first radiographic patient image of the patient's cranial structure along a first plane via the at least one network interface, and obtaining a second radiographic patient image of the patient's cranial structure along a second plane offset at an angle to the first plane. The operations also include merging the first and second radiographic patient images into an image coordinate system. The operations further include obtaining a surgical trajectory plan defined as an entry point on the patient's skull and a target point in the patient's brain captured in the merged first and second radiographic patient images.

[0005] Some additional embodiments of this disclosure relate to operations that combine a first radiological patient image and a second radiological patient image into an image coordinate system, which may include generating a three-dimensional graphical representation of a cranial structure captured in the first radiological patient image and the second radiological patient image in an image coordinate system.

[0006] Some additional embodiments of this disclosure relate to operations for obtaining a surgical trajectory plan, which may include receiving user-specified entry points on the patient's skull and target points in the patient's brain, defined relative to an image coordinate system. The user-specified entry and target points are then stored in the surgical trajectory plan.

[0007] Some additional embodiments of this disclosure relate to operations for obtaining a surgical trajectory plan, which may include receiving a user-specified target point in the patient's brain defined relative to an image coordinate system. The operation includes generating a set of preset trajectories based on the target point and a knowledge base of craniotomy procedures, and receiving a user selection of one of the preset trajectories. The operation further includes determining an entry point on the patient's skull based on the selected preset trajectory, and generating a surgical trajectory plan based on the target point and the user-specified determined entry point.

[0008] Other craniotomy planning systems, methods, and computer program products according to embodiments of the subject matter of the present invention will be apparent or will become apparent to those skilled in the art after reading the following figures and detailed description. All such craniotomy planning systems, methods, and computer program products are intended to be included in this specification, within the scope of the subject matter of the invention, and protected by the appended claims. Furthermore, all embodiments disclosed herein are intended to be implementable individually or in any manner and / or in combination. Attached Figure Description

[0009] The accompanying drawings, which are included and constitute a part of this application and are intended to further illustrate this disclosure, show certain non-limiting embodiments of the inventive concept. In the drawings:

[0010] Figure 1 The camera base is shown;

[0011] Figure 2 The patient stabilization base is shown;

[0012] Figure 3 A robot base station is shown;

[0013] Figure 4 The control panel located at the rear of the robot base station is shown.

[0014] Figure 5 The connector panel located at the rear of the robot base station is shown.

[0015] Figure 6 The five axes of motion of the robot arm are shown;

[0016] Figure 7 A collar located at the distal end of the lower arm is shown;

[0017] Figure 8 The components of the camera base are shown;

[0018] Figure 9 A 3-pin mounting adapter is shown;

[0019] Figure 10 The Leksell frame base adapter is shown;

[0020] Figure 11 The CRW frame base adapter is shown;

[0021] Figure 12 Interchangeable guide end effectors are shown;

[0022] Figure 13 This illustrates the motion of the interchangeable guide end effector as it moves from one trajectory to the next.

[0023] Figure 14 The verification probe is shown;

[0024] Figure 15 The trajectory probe is shown;

[0025] Figure 16 The navigation biopsy needle is shown;

[0026] Figure 17 The end effector conduit is shown;

[0027] Figure 18 An electrode drive fixture is shown;

[0028] Figure 19 A 2.5mm hex screwdriver is shown;

[0029] Figure 20 A skull drill was shown;

[0030] Figure 21 The skull drill stopper is shown;

[0031] Figure 22 The boundary marker probe is shown;

[0032] Figure 23 An adjustable drill guide for the skull is shown;

[0033] Figure 24 The front portion of the dynamic reference base of the skull is shown;

[0034] Figure 25 The posterior portion of the dynamic reference base of the skull is shown;

[0035] Figure 26 The cranial joint movement arm is shown;

[0036] Figure 27The kinematic support located on the motion arm of the skull joint is shown;

[0037] Figure 28 Two versions of the frame reference array are shown;

[0038] Figure 29 The intraoperative CT registration and fixation device is shown;

[0039] Figure 30 The perspective registration and fixing device is shown;

[0040] Figure 31 The positioning of the navigation camera relative to the operating room table is shown, thus providing a patient reference point in the field of view of the navigation camera;

[0041] Figure 32 The image shows pressing the laser button to align with the navigation camera;

[0042] Figure 33 The markings attached to the marking post are shown;

[0043] Figure 34 An example of merging images in a skull application is shown;

[0044] Figure 35 This shows the image coordinate system window in the skull application;

[0045] Figure 36 The planning window for skull applications is shown;

[0046] Figure 37 This demonstrates the patient's immobilization and stability;

[0047] Figure 38 An example of an ICT registration fixture attached to a cranial joint motion arm is shown;

[0048] Figure 39 An example of image acquisition and registration in a skull application is shown;

[0049] Figure 40 An example of image acquisition and registration using the Leksell framework in a skull application is shown;

[0050] Figure 41 An example of trajectory coordinates in a skull application is shown;

[0051] Figure 42 An example of CRW locator benchmark detection in skull applications is shown;

[0052] Figure 43 An example of the calculated frame loop coordinates and arc coordinates obtained for each planned trajectory in a skull application is shown;

[0053] Figure 44 An example of an image applied to the skull after the removal of the ICT registration fixation device and clamps is shown;

[0054] Figure 45 An example of an image in the skull application for monitoring markers of devices or implants during monitoring procedures is shown;

[0055] Figure 46 An example of verifying the accuracy of implant placement in a skull application is shown; and

[0056] Figures 47 to 50 A flowchart is shown of operations that can be performed by a craniotomy planning system configured according to the implementation scheme. Detailed Implementation

[0057] The following discussion is provided to enable those skilled in the art to implement and use embodiments of this disclosure. Various modifications to the illustrated embodiments will be apparent to those skilled in the art, and the principles herein can be applied to other embodiments and applications without departing from the embodiments of this disclosure. Therefore, embodiments are not intended to be limited to those shown, but should have the broadest scope consistent with the principles and features disclosed herein. Refer to the accompanying drawings, in which similar elements have similar reference numerals. The drawings are not necessarily drawn to scale, depict selected embodiments, and are not intended to limit the scope of embodiments. Those skilled in the art will recognize that the examples provided herein have many useful alternative forms and fall within the scope of embodiments.

[0058] System Overview

[0059] According to some embodiments of this disclosure, the cranial surgery planning system, also known as the Excelsius GPS cranial module, comprises five main components: a robot base station (shown below), a camera base (shown below), a patient stabilization base (shown below), instruments, and a cranial software module.

[0060] Figure 1 The camera base is shown.

[0061] Figure 2 The patient stabilization base is shown.

[0062] Figure 3A robotic base station is shown. The robotic base station is the main control center for a cranial surgery planning system (e.g., ExcelsiusGPS). Monitor 300 allows surgeons to plan surgery in real time and visualize anatomical structures, instruments, and implants. Monitor 300 can be a high-resolution flat-panel touchscreen liquid crystal display (LCD) located on a vertical column 302. Monitor 300 can be adjusted to the desired position using both hands. An external mouse can be used with monitor 300. The mouse is not intended for use in sterile areas.

[0063] The optional wireless tablet can be used as a second touchscreen monitor for operation planning and software control. The main monitor 300 remains active at all times during use. Users can lock the tablet's usage if needed. A tablet compartment is provided for storing the tablet. The tablet is not intended for use in sterile areas.

[0064] Figure 4 The control panel located at the rear of the robot base station is shown. This panel is used to display and control the system power supply and general positioning functions.

[0065] Control panel functions in Figure 4 As shown in the image.

[0066]

[0067]

[0068] Figure 5 The connector panel located at the rear of the robot base station is shown. This panel contains external connection ports for various devices.

[0069] Connector panel function in Figure 5 As shown in the image.

[0070]

[0071] The system includes four casters with integrated stabilizers. The stabilizers are used to secure the system and ensure it does not move during use.

[0072] A robotic arm, including the upper and lower arms, is attached to a vertical column of a cranial surgery planning system (e.g., an Excelsius GPS robotic base station). This configuration allows for a variety of movements.

[0073] Cranial surgery planning systems (e.g., ExcelsiusGPS) can employ advanced drive control systems and high-performance servo drives to accurately position and control a 5-axis robotic arm in the operating room environment. Figure 6 The five axes of motion of the robot arm are shown.

[0074] Figure 7A collar located at the distal end of the lower arm is shown. It is a load sensing component that allows the user to guide the positioning of the robotic arm.

[0075] To initiate movement, squeeze the ring of the collar on opposite sides with your thumb and forefinger. While squeezing, apply a light force in the desired direction of movement. The robotic arm will then move in the desired direction. If the plan is active, the arm can be moved manually in any direction or along a trajectory, but not exceeding the desired depth.

[0076] The camera base is movable and adjustable to position the camera for viewing the operating area and optical markings. Figure 8 The parts of the camera base are shown.

[0077] The following table describes how Figure 8 The camera base function of the parts shown.

[0078]

[0079] See Figure 2 The patient stabilizing base is a portable base that can be rigidly fixed to the floor, such as at the head of an operating room table. It includes wheels, a base, a vertical column, and an upper arm. The vertical column and upper arm are adjustable, allowing for various surgical configurations.

[0080] The patient is positioned on the operating room (OR) table, and a patient fixation device (such as a stereotactic frame or Mayfield system) is attached to the patient. The base is positioned, and the upper arm is attached to the patient fixation device. The base is characterized by mechanisms for retracting wheels and securing the base to the floor. This prevents accidental patient movement. This design allows access via intraoperative imaging systems such as fluoroscopic C-arms or CT scanners.

[0081] The patient stabilization base includes adapters that attach to the upper arm. These adapters directly connect the base to a specific patient fixation device. A 3-pin fixation adapter can be used to attach the base to a 3-pin fixation device (e.g., Mayfield). Alternatively, if the user wishes to position the patient using a stereotactic frame, a Leksell frame base adapter or a CRW frame base adapter can be attached to the base. Each adapter has additional features for attaching a craniosynostotic motion arm to facilitate various registration methods.

[0082] Figure 9 A 3-pin mounting adapter is shown.

[0083] Figure 10 The Leksell frame base adapter is shown.

[0084] Figure 11 The CRW frame base adapter is shown.

[0085] Now let's discuss the apparatus used in this article.

[0086] Figure 12 Interchangeable guided end effectors are shown. Interchangeable guided end effectors serve as interfaces between robotic arms and system-specific surgical instruments. They allow for rigid connection via sterile drapes to provide precise positioning of instruments placed within their catheters. The end effector is supplied as a separate component and is sterilized by the user prior to use. Care must always be taken when manipulating or transporting the end effector, as it contains sensitive electronics.

[0087] The interchangeable guided end effector is wirelessly powered by the robotic arm. This power is used to drive a moving marker used by the camera to identify the position and orientation of the end effector. A green status LED illuminates when the end effector is powered on and capable of movement. The LED turns off when the arm's movement is stopped.

[0088] Interchangeable guide end effectors can be attached to a variety of catheters. When attached to a catheter, various instruments can be inserted through the catheter along a desired trajectory, including electrode drive clamps, drill bits with or without drill stops, drill guides, and biopsy needles.

[0089] The interchangeable guided end effector includes a safety switch. The safety switch has two positions: "on" and "off". When "on", the robot arm cannot move; when "off", the robot arm can move. For safety, when the switch is in the "on" position, the instrument can only be inserted through the end effector. The switch cannot be "off" until the instrument is removed from the end effector. This ensures that no movement of the robot arm occurs when the instrument is inserted through the end effector.

[0090] To switch from "on" to "off", slide the safety switch release device from left to right. To switch from "off" to "on", pull out the safety switch release device and then slide it from right to left.

[0091] An electrosurgical unit (ESU) may be used during procedures that comply with the guidelines below:

[0092] 1. The maximum peak voltage in the electric cutting mode is 900Vpk.

[0093] 2. The maximum peak voltage in electrocoagulation mode is 4500Vpk.

[0094] 3. The powered ESU probe should not come into contact with the metal end effector itself, but should only come into contact with the probe or scraper.

[0095] 4. If a probe is used, it must be correctly positioned in the electrode-driven feeder. The electrode-driven feeder must be correctly mounted on the end effector using an electrode-driven clamp.

[0096] 5. If a scraper is used, it must be inserted through the end effector conduit. The end effector conduit is electrically isolated and must be properly installed in the end effector quick release mechanism.

[0097] A cranial surgery planning system (e.g., ExcelsiusGPS) robotic arm positions interchangeable guided end effectors to guide instruments along a desired trajectory. The surgeon manually inserts the instruments and implants via the end effectors, aligning them with the desired trajectory for accurate placement.

[0098] The robotic arm can be moved only by repeatedly pressing the collar or foot switch. The arm can be moved manually by the user in Wrist mode or automatically to the selected trajectory in Trajectory mode.

[0099] In Wrist mode, the arm can be manually moved to any location within its range.

[0100] In Trajectory mode, the arm automatically moves from its current position to the next trajectory when it is ready, or it can be moved manually along the selected trajectory.

[0101] When moving from one trajectory to the next, the arm moves outward along the current trajectory to a safe distance (200mm) from the surgical site, then moves to the new trajectory, and then moves downward along the current trajectory to the anatomical structure.

[0102] The arm moves automatically when the end effector is moved from its current position (either on the initial trajectory or on the current trajectory) to a new trajectory. Once the end effector has moved to the new trajectory, it can be moved up and down along the path of the trajectory to the desired depth.

[0103] Figure 13 The movement of interchangeable guide end effectors is shown as they move from one track to the next. Tracks 1, 2, and 3 are automatic movements. Track 4 is manual and optional.

[0104] The robotic arm's automatic movement can be stopped by the user, stopped by the system, or prevented. To stop movement at any time, press the emergency stop button located on the base station. Movement stops if the end effector detects a force greater than 50 N (11 lbs) in the direction opposite to the movement. The end effector detects a force greater than 100 N (22 lbs) in any direction. Movement is also stopped in Trajectory mode when the patient reference element (such as the Skull Dynamic Reference Base (CDRB) or Frame Reference Array (FRA)) or the end effector is not in the camera's view. Movement is prevented when the safety switch in the interchangeable guided end effector is turned on. When a trajectory is selected, arm movement is only allowed in Trajectory mode.

[0105] If the robotic arm cannot reach a safe starting position due to its current location, an error message appears indicating that the trajectory is out of reach. A new trajectory must be used, or the base must be repositioned.

[0106] For new trajectories, a loop is used to clear the selected trajectory and the position of the robotic arm to the cleanup location. The loop provides the user with the flexibility to move the arm around obstacles.

[0107] To reposition the base, the stabilizer on the caster disengages, the base station moves to the desired position, and the stabilizer re-engages. Registration is unaffected because the patient reference has not yet moved relative to the patient.

[0108] Before use, confirm that the robotic arm can be moved using wrist mode and the arm position button on the control panel.

[0109] Navigational surgical instruments may include navigational biopsy needles and navigational probes, such as verification probes and trajectory probes.

[0110] The navigation probe has an array of optical markers parallel or perpendicular to the instrument axis. The navigation probe is used to indicate anatomical structures.

[0111] Figure 14 The verification probe is shown.

[0112] Figure 15 The trajectory probe is shown.

[0113] Figure 16 A navigation biopsy needle is shown. A navigation biopsy needle is a navigational instrument that can be used manually or via an interchangeable guide end effector. When the biopsy needle is passed through the end effector, a unique array pattern defined by reflective markers determines the distal end position. This array is tracked by a camera, and the distal end position is projected onto a monitor. A depth stop can be added to prevent the needle from being inserted beyond the desired depth.

[0114] Non-navigation surgical instruments may include end effector catheters, electrode drive clamps, 2.5mm hex screwdrivers, skull drills, skull drill stoppers, landmark probes, and skull adjustable drill guides.

[0115] Figure 17 The end effector conduit is shown.

[0116] Figure 18 An electrode drive fixture is shown.

[0117] Figure 19 A 2.5mm hex screwdriver is shown.

[0118] Figure 20 A skull drill is shown.

[0119] Figure 21 The skull drill stopper is shown.

[0120] Figure 22 The boundary probe is shown.

[0121] Figure 23 An adjustable drill guide for the skull is shown.

[0122] Non-navigational surgical instruments used with Excelsius GPS include end effector catheters, electrode-driven clamps, skull drill stops, 2.5mm hex screwdrivers, skull drills, landmark probes, and adjustable skull drill guides. Auxiliary instruments, including electrode drivers, skull drills, biopsy needles, catheters, and probes, can be inserted via end effector catheters that are plugged into interchangeable guide end effectors. When using a drill, a drill stop is provided to prevent drilling beyond the desired depth.

[0123] To insert the end effector guide tube into the interchangeable guide end effector, loosen the quick-release mechanism, then align the tube alignment feature with the alignment pin on the end effector. Tighten the quick-release mechanism and check the tube to ensure it is securely connected.

[0124] Now let's discuss the monitor tag holder.

[0125] A monitor mark holder is a stand-alone device that holds a reflective mark. It serves to alert the user if the skull dynamic reference base or frame reference array has moved. The monitor mark holder is attached to a patient fixation device, such as a stereotactic frame base. Navigation is not required, but additional safety measures are needed to monitor movement and confirm that the patient reference (CDRB or FRA) remains fixed in optical space.

[0126] Now let's discuss registration devices such as CDRB, craniosynostosis motor arm, and FRA.

[0127] Registration instruments are used in the patient registration process. Patient registration is the process of establishing a correlation between virtual patient anatomy obtained from patient images and physical patient anatomy in the operating room.

[0128] Figure 24 The front part of the dynamic reference base of the skull is shown.

[0129] Figure 25 The posterior portion of the dynamic reference base of the skull is shown.

[0130] The skull dynamic reference base (CDRB) serves as a patient reference and a fixed reference point for establishing all navigation tracking references in optical space. The CDRB comprises an array body, notch, screws, kinematic supports, and alignment pins. The CDRB has a unique array pattern (configuration of tracking marker posts) that allows it to be recognized by the system. The CDRB has a notch that is used for device validation. The distal end of the navigation device is placed in the notch of the CDRB and held in front of the optical camera to validate the device in use.

[0131] Figure 26 The skull joint movement arm is shown.

[0132] Figure 27 The kinematic support located on the motion arm of the skull joint is shown.

[0133] The CDRB is mounted to the craniosynostotic articulator via CDRB screws and a kinematic support. It has several connectors that are locked or unlocked by tightening or loosening a locking knob, allowing for quick adjustments. The kinematic support and CRDB alignment pins allow for intraoperative removal and replacement of the CDRB without loss of registration.

[0134] Figure 28 Two versions of the frame reference array are shown.

[0135] When using a stereo frame during procedures, the Frame Reference Array (FRA) is an alternative to the CDRB. The FRA functions to establish fixed reference points in optical space for all navigation tracking references. Two FRAs are available; one is compatible with the Leksell stereo frame, and the other is compatible with the CRW stereo frame. The FRA consists of an array body with a verification notch and attachment features for easy attachment to their associated Leksell or CRW frame base.

[0136] Now we will discuss registration and fixation devices, such as intraoperative CT registration and fixation devices and fluoroscopic registration and fixation devices.

[0137] Figure 29 The intraoperative CT registration and fixation device is shown.

[0138] The intraoperative CT (ICT) registration and fixation device comprises a registration and fixation unit and an ICT registration clamp, allowing the use of any intraoperative CT image with a cranial surgery planning system (e.g., Excelsius GPS skull module). The ICT registration clamp and registration and fixation unit are assembled prior to use by engaging a star gear and snapping the two components together. The intraoperative registration and fixation unit is positioned near the surgical site using the ICT registration clamp with a cranial articulated motion arm. This reference is automatically detected in the intraoperative image and used to register the patient's anatomy with a patient reference, which is tracked by the camera throughout the procedure. Reflection markers are detected by the camera. Once the registration is transferred to the patient reference, the ICT registration and fixation unit is removed to provide access to the surgical site.

[0139] Figure 30 The perspective registration and fixing device is shown.

[0140] The fluoroscopic registration fixation device allows the use of any intraoperative fluoroscopic image. The fluoroscopic fixation device is attached to the fluoroscope's image intensifier using an integrated clamp. The fixation device should be positioned so that the camera sees the reflection markers in all intended fluoroscope positions: anterior / posterior (AP), lateral, etc.

[0141] Now let's discuss the system settings for this article.

[0142] Insert the camera cable from the cable retainer into the connector panel on the base station.

[0143] Move the camera to the OR stage and engage the wheel brake by activating the lever located on the wheel. Aim the camera to view the surgical field.

[0144] Figure 31 The positioning of the navigation camera relative to the OR station is shown, thus providing a patient reference point within the navigation camera's field of view.

[0145] The laser button located on the positioning handle of the camera is pressed and held to activate the camera's alignment laser, and the position is adjusted so that the laser point is centered in the surgical field.

[0146] Figure 32 The image shows pressing the laser button to align the laser with the navigation camera.

[0147] Next, position the robot's base station. Position the outriggers on flat ground at a comfortable distance from the operator's feet. The foot switch is IPX68 rated and can be used in areas where liquids may be present. Insert the foot switch cable into the connector panel. The foot switch allows the arm to move along its active trajectory, similar to the action of a collar on the forearm.

[0148] The robotic base station is positioned next to the patient at a comfortable distance from the surgeon. The robotic arm is moved using a loop around a planned trajectory, ensuring the arm reaches all positions before engaging the stabilizer.

[0149] Press the stabilizer engagement button on the control panel to lower the stabilizer onto the casters. The button illuminates when the stabilizer is engaged.

[0150] This paper discusses attaching end effectors to a robotic arm. Interchangeable guided end effectors are attached to the robotic arm via a bonding plate on a custom-designed drape. Magnetic aids facilitate positioning and self-alignment of the end effectors. The end effectors are equipped with grippers suitable for the drapes, allowing the drapes to be removed and reattached up to three times during the procedure without damaging the drapes.

[0151] The brackets on the end effector open and are placed on the engagement plate by aligning the V-groove with the alignment ball. The brackets on both sides of the end effector are pressed, and the handle is pressed down to lock into place.

[0152] To remove the end effector from the robot arm, pull the handle upwards to release the spring and side bracket.

[0153] Figure 33 The markings attached to the marking posts are shown. Attach disposable reflective markings to each marking post of each instrument assembly. Ensure the markings are fully aligned with the post.

[0154] The procedure for using skull applications follows the workflow.

[0155] Figure 47 A flowchart illustrates the operations that can be performed by a craniotomy planning system configured according to the implementation scheme. See also Figure 47 The cranial surgery planning system includes at least one network interface connectable to obtain radiographic patient images generated by a radiographic imaging scanner, a display device, at least one processor, and at least one memory storing program code executed by the at least one processor. The processor is configured to perform operations including 4700, obtaining a first radiographic patient image of the patient's cranial structure along a first plane via the at least one network interface, and obtaining a second radiographic patient image of the patient's cranial structure along a second plane offset at an angle to the first plane. The operations also include 4702, merging the first and second radiographic patient images into an image coordinate system. The operations further include 4704, obtaining a surgical trajectory plan defined by an entry point on the patient's skull and a target point in the patient's brain captured in the merged first and second radiographic patient images.

[0156] In some implementations, the first and second radiological patient images are angularly offset within a range of 90° and 30°.

[0157] In some implementations, the operations performed by the cranial surgery planning system also include generating a set of preset trajectories based on a knowledge base of target points and cranial surgery procedures by displaying a graphical representation of the trajectory as an overlay on a first radiographic patient image and a second radiographic patient image. The operations also include receiving a user selection of one preset trajectory from the preset trajectories by receiving a user selection of one of the graphical representations of the displayed trajectory.

[0158] First, merge the images after importing them and select the images in the skull application. Merging is the process of registering two or more image sets of the same patient anatomy together. This can be any combination of CT or MR image sets. To import and select images, click "Add Image" on the "Merge" page to open the "Image Sets" dialog box, which will be shown below. Images can be loaded from a USB drive, hard drive, or network. To view images on a USB drive, insert the USB drive into the USB port on the connector panel. To load images, select the hard drive or USB drive icon and select the desired patient images. Select the desired images from the "Local" image list and then identify the master image. Merge all images into the master image to ensure that the examination and registration images refer to the same coordinate system. Select all images for the case to continue merging.

[0159] Figure 48 A flowchart illustrates the operations that can be performed by a craniotomy planning system configured according to the implementation scheme. See also Figure 48 In some implementations, operation 4702 merges the first radiological patient image and the second radiological patient image into an image coordinate system. This operation includes 4800 generating a three-dimensional graphical representation of the cranial structure captured in the first radiological patient image and the second radiological patient image in an image coordinate system.

[0160] Figure 34 This example illustrates merging images in a skull application. To merge images, select two images for merging: a master image and another image. The software automatically merges the selected images into the master image. Automatic merging using different view modes can be implemented by clicking one of the image icons. Overlay the images to determine the quality of the merge, and adjustments can be made using the arrows on each image. Once the first image is registered to the master image, the second image can be registered to the first image, not the master image. All images should be registered to the master image.

[0161] Next, define the coordinate system. Once the images are merged into the main image coordinate system, the user can identify the anterior commissure (AC) and posterior commissure (PC) anatomical landmarks in the defined image coordinate system. The user can skip this step and select the standard XYZ coordinate system by clicking "Use scancoordinates".

[0162] To set the image coordinates, align the red dot displayed on each of the four images with AC or PC anatomical landmarks as needed. Once aligned, click "Set AC" or "Set PC". The green dot indicates the patient's position on the image. The AC / PC coordinates can be adjusted using the adjustment arrows.

[0163] Figure 35 The image coordinate system window is shown in the skull application.

[0164] Next, plan the trajectory. You can choose a preset trajectory, plan a new trajectory, or limit a new preset trajectory. Figure 36 The planning window for skull applications is shown.

[0165] Figure 49 A flowchart illustrates the operations that can be performed by a craniotomy planning system configured according to the implementation scheme. See also Figure 49 Operation 4704 is used to obtain a surgical trajectory plan for an entry point on the skull and a target point in the brain of the patient, defined in a merged first and second radiographic patient image. This operation includes 4900, receiving user-specified entry points on the skull and target points in the brain of the patient, defined relative to an image coordinate system. The operation also includes 4902, storing the user-specified entry and target points in the surgical trajectory plan.

[0166] Figure 50 A flowchart illustrates the operations that can be performed by a craniotomy planning system configured according to the implementation scheme. See also Figure 50 Operation 4704 is used to obtain a surgical trajectory plan defined by an entry point on the patient's skull and a target point in the patient's brain captured in a merged first and second radiographic patient image. This operation includes 5000, receiving a user-specified target point in the patient's brain defined relative to an image coordinate system. The operation also includes 5002, generating a set of preset trajectories based on the target point and a knowledge base of cranial surgical procedures. The operation further includes 5004, receiving a user selection of one of the preset trajectories. The operation further includes 5006, determining an entry point on the patient's skull based on the selected preset trajectory. The operation further includes 5008, generating a surgical trajectory plan based on the target point and the user-specified determined entry point.

[0167] In some implementations, operation 5008 is used to generate a surgical trajectory plan based on user-specified target points and determined entry points, the operation including defining the target points and entry points in the surgical trajectory plan as positions relative to the image coordinate system.

[0168] In some implementations, operation 5008 is used to generate a surgical trajectory plan based on user-specified target points and determined entry points, the operation including defining the target points and entry points in the surgical trajectory plan as positions relative to a first radiological patient image and a second radiological patient image.

[0169] In some embodiments, operation 4704 is used to obtain a surgical trajectory plan defined by an entry point on the patient's skull and a target point in the patient's brain captured in a merged first and second radiographic patient image. This operation includes displaying a graphical surgical instrument representing the physical surgical instruments used during the patient's craniotomy procedure. The operation also includes controlling the angular orientation and position of the displayed graphical surgical instrument relative to the entry point on the patient's skull and the target point in the patient's brain, captured in the merged first and second radiographic patient images, in response to receiving user input. The operation also includes storing indications of the angular orientation and position of the graphical surgical instrument in the surgical trajectory plan.

[0170] When a preset trajectory is selected, the surgeon plans its trajectory and the location of the surgical implant on the patient's images. The trajectory is defined by the entry point on the patient's skull and the target point in the brain. Users can create and compare trajectories on all co-registered MR and CT image sets as part of a case.

[0171] Preset trajectories are available for surgeons to select when creating new trajectories. Preset trajectories, or "presets," are defined in the image coordinate system. The system's default preset coordinates are derived from published literature. The software provides citations for the source of each default preset. A pop-up display allows selection of trajectories from previous cases, literature, or previous patients. Select the desired trajectory. Once selected, the preset trajectory can be viewed on the patient image.

[0172] When selecting a new track, users can manually plan the target and entry points on any images already added to the case, either starting from a preset track or an empty track.

[0173] To create a new track, select the "+" button. Name the track and define its color and width before setting the target and entry points. Click "Set Target" or "Set Entry" to define the target and entry points, respectively. To adjust the target and entry points, click "Modify Target" or "Modify Entry," respectively. Select the "+" button to add more tracks.

[0174] When defining a new preset trajectory, users can save the planned trajectory as a custom preset trajectory for future use. The preset trajectory is defined by the coordinates of the target point and the angle of entry in the image coordinate system. Target coordinates are entered in millimeters (mm) or as a percentage of the distance from AC to PC. The sagittal and coronal angles of entry are also entered.

[0175] Next, the patient is positioned by securing him to the patient fixation device and stabilizing him. Figure 37 The patient's immobilization and stability were demonstrated.

[0176] To secure the patient to a patient fixation device, the patient fixation hardware is attached to the patient. Support fixation systems include the Leksell frame, CRW frame, or 3-pin fixation devices such as the Mayfield cranial clamp.

[0177] To stabilize the patient, adjust the OR table to the required height for the procedure. Disconnect the OR table from power to prevent any unintended movement during the procedure. Position the patient stabilization base so that the distal end of the upper arm is at the upper edge of the operating table. The base positioning should be optimized to avoid obstructing operating room personnel and to allow access for any intraoperative imaging systems that will be used during the procedure. Attach the corresponding fixation adapter to the patient fixation hardware. Attach the adapter to the distal end of the base. Once the desired positioning of the patient and base is achieved, tighten all adjustment knobs on the base and pull the wheel retractor handle to lock it in place.

[0178] Next, the patient's position is registered by selecting a method, validation curves, and a patient registration method. Registration is the process of aligning the physical patient with the surgical plan.

[0179] In some embodiments, the operations performed by the cranial surgery planning system further include determining the occurrence of a first condition when the marker tracking camera can track reflective markers on a cranial fluoroscopic registration fixation device, and determining the occurrence of a second condition when the marker tracking camera can track dynamic reference base markers attached to the end effector of the robotic arm and / or surgical robot. The operations further include, while both the first and second conditions continue to occur, allowing the execution of operations to obtain a first radiographic patient image of the patient's cranial structure along a first plane, and a second radiographic patient image of the patient's cranial structure along a second plane angled away from the first plane.

[0180] In some embodiments, the operations performed by the craniotomy planning system further include, after attaching a registration fixation device including a reference to the patient's cranial structure, obtaining a first radiographic patient image of the patient's cranial structure and the reference along a first plane, and obtaining a second radiographic patient image of the patient's cranial structure and the reference along a second plane offset at an angle to the first plane.

[0181] In some embodiments, the operation performed by the cranial surgery planning system also includes registering the position of a reference on the registration frame with the position of a reference captured in the first and second radiographic patient images. This operation further includes displaying a three-dimensional graphical representation of the registration fixation device superimposed on a three-dimensional graphical representation of the cranial structure captured in the first and second radiographic patient images, based on the registration of the position on the reference on the registration frame with the position of the reference captured in the first and second radiographic patient images.

[0182] In some embodiments, the registration fixation device also includes a reflective marker. Additionally, the operation performed by the cranial surgery planning system includes receiving the position of the reflective marker tracked by the camera tracking system relative to an optical coordinate system. This operation also includes registering the position of a reference on the registration frame in the image coordinate system with the position of the reflective marker in the optical coordinate system.

[0183] In some embodiments, the operations performed by the craniotomy planning system further include, after attaching the registration and fixation device to the patient's cranial structure, obtaining a first radiographic patient image of the patient's cranial structure and the registration and fixation device along a first plane, and obtaining a second radiographic patient image of the patient's cranial structure and the registration and fixation device along a second plane that is angularly offset from the first plane.

[0184] There are four methods that can be used for patient registration:

[0185] Intraoperative CT (ICT) registration

[0186] ·CT-fluoroscopy registration

[0187] Leksell frame registration

[0188] • CRW frame registration.

[0189] Choose the desired patient registration method to follow the correct workflow for that registration method.

[0190] Device validation steps are used for all registration methods. The device must be assembled before validation. Each device is validated as follows:

[0191] 1. Place the end of the device to be validated within the validation notch in the interchangeable guide end effector, CDRB, or FRA.

[0192] 2. Ensure the instrument is visible and remains stable.

[0193] 3. A pop-up display appears on the verification device page to indicate the verification progress.

[0194] Once verification is complete, the verification status will be indicated on the screen. If verification has failed (indicated by a red circle with an X), it must be repeated until it succeeds (indicated by a green circle).

[0195] Intraoperative computed tomography (ICT) registration is discussed below.

[0196] When using ICT registration, attach the patient reference to the patient fixation hardware before registration. If using a Leksell frame for patient fixation, the Leksell FRA or CDRB can be used as the patient reference. If using a CRW frame for patient fixation, the CRW FRA or CDRB can be used as the patient reference. If using a 3-pin fixation device, the CDRB must be used as the patient reference. When using an FRA, attach the FRA to the frame base. When using a CDRB, attach the craniosynostosis motion arm to the fixation adapter, and then attach the CDRB to the arm. Attach a disposable reflective marker to the marker post of the patient reference. Position the reflective marker on the CDRB in the camera direction. Care should be taken with the initial placement of the patient reference to avoid interfering with the surgical procedure.

[0197] A monitoring marker retainer can be rigidly attached to a patient fixation device to track the relative distance to a patient reference, thereby monitoring for unintended displacement of the patient reference during the procedure. A disposable reflective marker is attached to a marker post on the retainer.

[0198] To align the ICT registration fixture, place the ICT registration clamp on the registration fixture and rotate it 90° to secure it. Press the locking pin from below and rotate the pin 90° until the pin is in place to secure the fixture.

[0199] Attach the ICT registration clamp to the cranial joint motion arm. Adjust the arm so that the metal reference in the registration fixation device is as close as possible to the surgical site, while keeping the optical markers visible to the camera, such as... Figure 38 As shown. Figure 38 An example of an ICT registration fixture attached to the cranial articulation arm is shown. Only the metal reference embedded in the fixture needs to be in the 3D image (non-reflective marker). Importantly, the ICT registration fixture should not move between image acquisition and the performance of anatomical landmark checks. To remove the ICT registration fixture, rotate it out of the cranial articulation arm.

[0200] The user is prompted to confirm the surgical site settings used for ICT image acquisition. This ensures all navigation items are visible to the camera. After ICT registration settings are complete, a snapshot is taken to record the patient reference points and the location of the ICT.

[0201] Intraoperative CT imaging systems are used to acquire CT images containing patient anatomy and the ICT registration and fixation device. Images can be loaded from a USB drive or hard drive. If images are transmitted via Ethernet, they automatically appear on the hard drive when the transmission is complete.

[0202] Detect ICT references. Seven ICT references are displayed in the right sidebar of the skull application. Each reference includes a view showing a combination of three orthogonal planes centered on the detected reference. Accurately detected references should appear as circles in the skull application. Clicking on any reference in the right sidebar centers that reference in the viewport and allows the user to modify its position in any 2D view. After optimizing the fit between the detected ICT references and the nominal ICT reference interval, the software displays the residual reference registration error. Lower values ​​indicate more accurate registration.

[0203] ICT images must be merged into the image coordinate system. This is achieved by merging the image into the main image or into any other image that has already been merged into the main image.

[0204] After confirming the ICT baseline, the user is prompted to transfer the registration from the ICT to the patient reference array to complete the registration.

[0205] The following section discusses computed tomography (CT) fluoroscopic registration.

[0206] When setting up CT-lens registration, the fluoroscopic registration fixture is attached to the image intensifier on the C-arm. Turn the knob on the clamp clockwise until tightened. Ensure that the patient reference is visible to the camera after the C-arm is in the proper position.

[0207] A monitoring marker retainer can be rigidly attached to a patient fixation device to track the relative distance to a patient reference, thereby monitoring for unintended displacement of the patient reference during the procedure. A disposable reflective marker is attached to a marker post on the retainer.

[0208] To select a CT image and patient reference, the user must first select the 3D image and patient reference to be used for registration. Select "Register 3D Image" from the drop-down menu in the right-hand column. All CT images merged into the master image coordinate system are available for registration. The patient reference for registration is displayed in the lower half of the right-hand column. Click on the selected patient reference to cycle through all available patient references.

[0209] To acquire and register images, two fluoroscopic images of the patient are obtained (one anterior-posterior (AP) image and one lateral image). The lateral image can be acquired as a true lateral view or at any angle of at least 30° to the AP image. The user should select the lateral image angle to maximize the patient content in the image and minimize metallic artifacts from the patient fixation hardware.

[0210] The following four conditions must be met before acquiring perspective images:

[0211] 1. The patient reference point is visible through the camera.

[0212] 2. The perspective registration and fixing device is attached to the C-arm and is visible through the camera.

[0213] 3. The connection between the cranial surgery planning system (e.g., the Excelsius GPS system) and the C-arm is active.

[0214] 4. The C-arm is stationary.

[0215] When ready for image capture, each indicator light on the right sidebar turns green. When all four indicator lights are green, intraoperative fluoroscopic images are acquired until all desired images are captured. Figure 39 An example of image acquisition and registration in a skull application is shown.

[0216] When acquiring images, users can assign them as AP images or lateral images, or they can delete images. Once the desired AP and lateral images are selected, click the "Run" button in the right sidebar to run the registration algorithm.

[0217] When verifying registration, visual verification is performed before navigation. Digitally reconstructed radiographs (DRR) created from CT images and fluoroscopic images are alternated to confirm correct registration. A merge scale (1 to 10) is used to confirm image registration. A score of 6-10 indicates good image alignment. For scores of 5 or less, the images are checked again before proceeding, landmark checks are performed, or images are retaken. Click the "Next" button to complete.

[0218] The following section discusses Leksell frame registration.

[0219] Figure 40 An example of image acquisition and registration using the Leksell framework in a skull application is shown.

[0220] When acquiring and importing images from the Leksell frame, the Leksell CT locator is attached to the Leksell frame base. CT images of the patient are acquired using the frame and the attached frame locator. Ensure the entire frame locator is visible in the CT images. CT images can be acquired preoperatively or intraoperatively, provided that the rigid connection between the frame base and the patient is maintained from CT image acquisition until the surgery is performed.

[0221] To perform patient reference attachment, remove the locator and attach the FRA to the frame base. Attach a disposable reflective marker to the marker post on the patient reference.

[0222] A monitoring marker retainer can be rigidly attached to a patient fixation device to track the relative distance to a patient reference, thereby monitoring for unintended displacement of the patient reference during the procedure. A disposable reflective marker is attached to a marker post on the retainer.

[0223] When performing Leksell locator benchmark detection, two slices of the CT image are extracted, and a frame detection algorithm is executed on each slice in the software to detect intersections with the locator pattern. The user must confirm and / or modify the detected intersection positions (one at a time) by clicking on points in the list on the right sidebar. After all benchmarks are placed, frame registration is calculated.

[0224] When performing Leksell image merging, the CT images must be merged into the master image coordinate system. This is done by merging the images into the master image or into any other image that has already been merged into the master image. The software requires user confirmation of the image merging.

[0225] The frame loop coordinates and arc coordinates calculated for each trajectory in the planned trajectory can be obtained. Without using a robotic arm, the coordinates can be used to align the Leksell loops and arcs with the selected trajectory.

[0226] Figure 41An example of trajectory coordinates in a skull application is shown.

[0227] The Cosman-Roberts-Wells (CRW) framework registration is discussed below.

[0228] When acquiring and importing images from a CRW frame, first attach the CRW locator to the CRW frame base.

[0229] Acquire CT images of the patient using the attached frame and frame locator. Ensure the entire frame locator is present in the CT images. CT images can be acquired preoperatively or intraoperatively, provided that the rigid connection between the frame base and the patient is maintained from CT image acquisition until the surgery is performed.

[0230] Remove the locator and attach the FRA to the frame base. Attach the disposable reflective marker to the marker post of the patient reference.

[0231] A monitoring marker retainer can be rigidly attached to a patient fixation device to track the relative distance to a patient reference, thereby monitoring for unintended displacement of the patient reference during the procedure. A disposable reflective marker is attached to the marker post of the monitoring marker retainer.

[0232] When detecting CRW locator references, a slice of the CT image is extracted, and a frame detection algorithm is performed on the slice in the software to detect intersections with the locator pattern. The user must verify and / or modify the detected intersection positions (one at a time). After all references are placed, frame registration is calculated.

[0233] Figure 42 An example of CRW locator benchmark detection in skull applications is shown.

[0234] When merging CRW images, the CT images must be merged into the master image coordinate system. This is achieved by merging the image into the master image or into any other image that has already been merged into the master image. The software requires user confirmation of the image merging.

[0235] Then, the calculated frame loop coordinates and arc coordinates are obtained for each planned trajectory. If a robotic arm is not used, the coordinates can be used to align the CRW loop and arc with the selected trajectory.

[0236] Figure 43 An example of the calculated frame loop coordinates and arc coordinates obtained for each planned trajectory in a skull application is shown.

[0237] Next, check the landmarks to verify the registration. After registration is complete, a landmark check or verification should be performed to ensure that the registration was successfully calculated. Using a verification probe or trajectory probe, contact the anatomical landmarks and verify that the corresponding positions are displayed on the system monitor. This process can be repeated using, for example, 2-3 landmarks.

[0238] Monitor markers are registered by pointing the calibration probe or trajectory probe at, but not touching, the monitor marker. When activated, the monitor marker box turns green. Monitor markers can be used to provide additional verification when the patient reference remains stationary during surgery. If the monitor marker indicates significant movement of the patient reference, an anatomical landmark check is performed. If the landmark check is satisfactory, the monitor marker is re-registered. If the landmark check fails, the patient is re-registered.

[0239] If using the ICT registration method, remove the ICT registration fixtures and clamps before proceeding. Figure 44 An example of an image applied to the skull after the removal of the ICT registration fixation device and clamps is shown.

[0240] Next, navigate the selected trajectory.

[0241] The skull application's navigation page allows users to visualize the navigated instrument and trajectory alignment relative to the patient's anatomy, based on the planned trajectory. The robotic arm precisely aligns interchangeable guided end effectors with the planned trajectory.

[0242] To activate the trajectory plan, select the desired trajectory on the right side of the screen. The trajectory plan is active when the trajectory marker is highlighted and the robotic arm can be moved via the loop or by pressing the foot switch. The robotic arm first moves upward to clear obstacles in the surgical field, then moves along the trajectory, and subsequently moves downward along the trajectory. Once it is moving along the trajectory, the robotic arm moves up / down along the trajectory but will not move off the trajectory unless the trajectory plan is deselected.

[0243] The device or implant is then inserted to the desired depth based on the current trajectory. Monitor the monitoring markers during the procedure. If the monitoring markers indicate significant movement of the patient reference, perform an anatomical landmark check. If the landmark check is satisfactory, re-register the monitoring markers. If the landmark check fails, re-register the patient.

[0244] Figure 45 An example of an image is shown in the skull application of a monitoring marker used to monitor instruments or implants during surgery.

[0245] If the Leksell or CRW frame registration method is used, frame coordinates are calculated to display the Leksell or CRW frame coordinates in the skull application.

[0246] If the active patient reference is the FRA, a registration transfer from the FRA to the CDRB can be performed. This is helpful if it is necessary to remove the FRA from the frame base during the procedure.

[0247] Next, the accuracy of the selected trajectory is verified using at least one postop image.

[0248] The accuracy of implant placement can be verified by acquiring postoperative CT images, merging them into the main image coordinate system, and identifying the implant in the postoperative images.

[0249] After acquiring postoperative images, the CT images are imported to the hard drive and merged into the master image coordinate system. A trajectory is selected to create a virtual guide object representing the implant. Up to four contact points are defined along each implant. Once the contact points are defined, the software reports the Euclidean distance (in millimeters (mm)) between each contact point and the target location, as well as the shortest distance between each contact point and the planned trajectory. The total angle between the planned trajectory and the detected guide object is displayed in degrees.

[0250] Figure 46 An example of verifying the accuracy of implant placement in a skull application is shown.

[0251] In some embodiments, the cranial surgery planning system includes a surgical robot having a robot base, a robotic arm coupled to the robot base, and an end effector coupled to the robotic arm, the end effector being configured to guide the movement of surgical instruments. The cranial surgery planning system also includes a camera tracking system configured to output tracking information indicating the position of a reflective marker on the surgical robot and the position of the reflective marker on a registration and fixation device attached to the patient's cranial structure. At least one processor performs operations to acquire a first patient image and a second patient image of the patient, and tracks the pose of the end effector relative to the cranial structure captured in the first and second patient images based on the tracking information from the camera tracking system.

[0252] In some implementations, at least one processor performs operations to receive a surgical trajectory plan and control the movement of at least one motor, which is operatively connected to move the robotic arm relative to the robot base based on the surgical trajectory plan.

[0253] In some implementations, the operations performed by the cranial surgery planning system also include determining the target pose of the end effector based on the surgical trajectory plan. This operation further includes generating steering information based on the target pose planned for the surgical trajectory and the current tracking pose of the end effector, indicated by tracking information, which indicates the position where the end effector needs to be moved relative to the patient's cranial structures.

[0254] In some implementations, the operations performed by the cranial surgery planning system also include controlling the movement of at least one motor based on steering information to guide the movement of the end effector, so that the end effector is positioned in a target pose relative to the patient's cranial structure.

[0255] Further definitions and implementation plans :

[0256] In the above description of the various embodiments of this disclosure, aspects of this disclosure can be illustrated and described by way of example in any of a number of patentable classes or contexts, including any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof. Therefore, aspects of this disclosure can be implemented entirely in hardware, entirely in software (including firmware, resident software, microcode, etc.), or in a combination of software and hardware, all of which may herein be generally referred to as “circuit,” “module,” “component,” or “system.” Furthermore, aspects of this disclosure can take the form of a computer program product, including one or more computer-readable media on which computer-readable program code is embodied.

[0257] Any combination of one or more computer-readable media may be used. A computer-readable medium can be a computer-readable signal medium or a computer-readable storage medium. A computer-readable storage medium can be, for example, but not limited to, electronic, magnetic, optical, electromagnetic, or semiconductor systems, devices, or apparatuses, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of computer-readable storage media will include the following: portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), suitable optical fiber with a repeater, portable optical disc read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination of the foregoing. In the context of this document, a computer-readable storage medium can be any tangible medium that can contain or store programs used by or in conjunction with an instruction execution system, device, or apparatus.

[0258] Computer-readable signal media may include, for example, propagated data signals in baseband or as part of a carrier wave, wherein computer-readable program code is specifically embodied. Such propagated signals may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. Computer-readable signal media may be any computer-readable medium that is not a computer-readable storage medium and is capable of transmitting, propagating, or transmitting a program for use by or in conjunction with an instruction execution system, device, or apparatus. The program code embodied on the computer-readable signal medium may be transmitted using any suitable medium, including but not limited to wireless, wired, fiber optic cable, RF, etc., or any suitable combination thereof.

[0259] Computer program code used to perform the operations of various aspects of this disclosure may be written in any combination of one or more programming languages, including: object-oriented programming languages ​​such as Java, Scala, Smalltalk, Eiffel, JADE, Emerald, C++, C#, VB.NET, Python, etc.; traditional procedural programming languages ​​such as the "C" programming language, Visual Basic, Fortran2003, Perl, COBOL 2002, PHP, ABAP; dynamic programming languages ​​such as Python, Ruby, and Groovy; or other programming languages. The program code may be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet service provider) or in a cloud computing environment, or provided as a service such as Software as a Service (SaaS).

[0260] Various aspects of this disclosure are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of this disclosure. It should be understood that each block in the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via a processor of the computer or other programmable instruction execution apparatus, create mechanisms for implementing the functions / actions specified in one or more blocks of the flowchart illustrations and / or block diagrams.

[0261] These computer program instructions may also be stored in a computer-readable medium, which, when executed, instruct a computer, other programmable data processing device, or other means to function in a particular manner, such that when stored in a computer-readable medium, the instructions produce an article of writing including the instructions, which, when executed, cause the computer to perform the functions / actions specified in one or more boxes of a flowchart and / or block diagram. The computer program instructions may also be loaded onto a computer, other programmable instruction execution device, or other means to cause a series of operational steps to be performed on the computer, other programmable device, or other means, thereby producing a computer-implemented process, such that the instructions, which execute on the computer or other programmable device, provide a process for performing the functions / actions specified in one or more boxes of a flowchart and / or block diagram.

[0262] It should be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the invention. Unless otherwise specified, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. It should also be understood that terms such as those defined in common dictionaries should be interpreted as having the meaning consistent with their meaning in the context of this specification and the relevant field, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0263] The flowcharts and block diagrams in the accompanying drawings illustrate the architecture, functionality, and operation of possible specific implementations of systems, methods, and computer program products according to various aspects of this disclosure. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of code comprising one or more executable instructions for implementing a specified logical function. It should also be noted that in some alternative implementations, the functions indicated in the blocks may not occur in the order shown in the drawings. For example, depending on the functions involved, two blocks shown consecutively may actually execute substantially simultaneously, or these blocks may sometimes execute in reverse order. It should also be noted that each block in the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, may be implemented by a system based on dedicated hardware that performs the specified function or action, or by a combination of dedicated hardware and computer instructions.

[0264] The terminology used herein is for descriptive purposes only and is not intended to limit the scope of this disclosure. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should also be understood that the terms “comprising” and / or “including” as used in this specification define the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more associated listed items. Throughout the description of the accompanying drawings, similar reference numerals denote similar elements.

[0265] The corresponding structures, materials, actions, and equivalents of any means or steps plus functional elements in the following claims are intended to include any disclosed structures, materials, or actions to perform the function in combination with other elements protected by the claims, as specifically claimed. The description in this disclosure is presented for illustrative and descriptive purposes and is not intended to be exhaustive or to limit the disclosure to the forms disclosed. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of this disclosure. Aspects of this disclosure have been selected and described in order to best explain the principles and practical application of this disclosure and to enable others skilled in the art to understand this disclosure with various modifications suitable for the particular intended use.

Claims

1. A cranial surgery planning system, the cranial surgery planning system comprising: A surgical robot having a robot base, a robot arm connected to the robot base, and an end effector connected to the robot arm, the end effector being configured to guide the movement of surgical instruments; At least one network interface, the at least one network interface being capable of connecting to obtain radiological patient images generated by a radiological image scanner; Display device; At least one processor; as well as At least one memory, the at least one memory storing program code, the program code being executed by the at least one processor to perform operations, thereby A first radiographic patient image of the patient's cranial structure is obtained along a first plane via the at least one network interface, and a second radiographic patient image of the patient's cranial structure is obtained along a second plane offset at an angle to the first plane. The first and second radiological patient images obtained by the radiological image scanner are merged into a three-dimensional medical image of the patient in the image coordinate system. The display device alternately displays the first radiological patient image and a corresponding merged digitally reconstructed radiographic (DRR) image from the three-dimensional medical image for manual verification by the user. A surgical trajectory plan is obtained, which is defined by the entry point on the skull and the target point in the brain of the patient captured in the merged first and second radiological patient images. The at least one processor performs operations to receive the surgical trajectory plan and control the movement of at least one motor, the at least one motor being operatively connected to move the robotic arm relative to the robotic base based on the surgical trajectory plan.

2. The cranial surgery planning system of claim 1, wherein the first radiological patient image and the second radiological patient image are angularly offset within a range of 90° and 30°.

3. The cranial surgery planning system of claim 1, wherein the first radiological patient image and the second radiological patient image are merged into the image coordinate system, and the at least one processor performs an operation to: A three-dimensional graphical representation of the cranial structure is generated in the image coordinate system captured in the first and second radiological patient images.

4. The cranial surgery planning system of claim 1, wherein, in order to obtain a surgical trajectory plan defined in the combined first and second radiological patient images of the patient, specifically the entry point on the skull and the target point in the brain of the patient, the at least one processor performs operations to: Receive user-specified entry point on the patient's skull and target point in the patient's brain, defined relative to the image coordinate system; and The user-specified entry point and target point are stored in the surgical trajectory plan.

5. The cranial surgery planning system of claim 1, wherein, in order to obtain a surgical trajectory plan defined in the combined first and second radiological patient images of the patient, specifically the entry point on the skull and the target point in the brain of the patient, the at least one processor performs operations to: Receive user-specified target point in the patient's brain relative to the image coordinate system; A set of preset trajectories is generated based on the knowledge base of the target points and craniotomy procedures. Receive a user selection of one of the preset trajectories from the preset trajectories; The entry point on the patient's skull is determined based on one of the preset trajectories selected from the preset trajectories; as well as The surgical trajectory plan is generated based on the user's specification of the target point and the determined entry point.

6. The cranial surgery planning system of claim 5, wherein the at least one processor performs operations to: By displaying the graphical representation of the trajectory as an overlay on the first and second radiological patient images, a set of preset trajectories is generated based on the target points and a knowledge base of craniotomy procedures; and The user selection of a preset trajectory is received by receiving a user selection of an image representation in the displayed graphical representation of the trajectory.

7. The cranial surgery planning system of claim 5, wherein, in order to generate the surgical trajectory plan based on the user specification of the target point and the determined entry point, the at least one processor performs operations to: The target point and the entry point in the surgical trajectory plan are defined as their positions relative to the image coordinate system.

8. The cranial surgery planning system of claim 5, wherein, in order to generate the surgical trajectory plan based on the user specification of the target point and the determined entry point, the at least one processor performs operations to: The target point and the entry point in the surgical trajectory plan are defined as positions relative to the first radiological patient image and the second radiological patient image.

9. The cranial surgery planning system of claim 1, wherein, in order to obtain a surgical trajectory plan defined in the entry point on the skull of the patient and the target point in the brain of the patient captured in the combined first and second radiological patient images, the at least one processor performs operations to: The graphic surgical instruments are shown, representing the physical surgical instruments to be used during the cranial surgical procedure in the patient. In response to receiving user input, the angular orientation and position of the displayed graphic surgical instrument relative to the entry point on the patient's skull and the target point in the patient's brain captured in the merged first and second radiographic patient images are controlled. as well as The graphic surgical instrument stores the angular orientation and position indications in the surgical trajectory plan.

10. The cranial surgery planning system of claim 1, wherein the at least one processor performs operations to: The occurrence of the first condition is determined when the marker tracking camera is able to track the reflected marker on the skull fluoroscopic registration fixation device, and the occurrence of the second condition is determined when the marker tracking camera is able to track the dynamic reference base marker attached to the end effector of the robotic arm and / or surgical robot; and When both the first and second conditions continue to occur, operations are permitted to be performed to obtain a first radiographic patient image of the patient's cranial structure along a first plane, and a second radiographic patient image of the patient's cranial structure along a second plane that is angularly offset from the first plane.

Images