Robust landmark determination for navigated surgery

Abstract

A system and method are disclosed, which includes receiving location information including a plurality of acquired data points associated with the surface of a patient's anatomical features; determining a point cloud based on the plurality of data points; extracting points from the plurality of data points as indicating landmarks on the anatomical features; determining a boundary associated with the plurality of data points; and comparing the distance between the boundary and the landmark points with a predetermined threshold, wherein if the distance between the boundary and the landmark points is not within the predetermined threshold, the comparison generates an instruction requesting confirmation of the landmark points or a suggestion to acquire additional data points.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of U.S. Non - Provisional Patent Application No. 18 / 112,863, filed on February 22, 2023, the content of which is hereby incorporated by reference in its entirety.

Background Art

[0002] The detection of specific anatomical features of a patient (e.g., on the patient's bone, etc.) is beneficial when planning several surgical procedures. For example, in robotic or robot - assisted surgical procedures where a surgical robot can guide or control one or more surgical instruments (e.g., saw, drill, etc.), an accurate determination of the position and / or orientation of the bone is desirable. This is particularly true in so - called image - free techniques where a 3D model derived from imaging of the patient's bone is not created.

[0003] In image - free systems, instead of relying on preoperative images, a pointer and tracking system is used intraoperatively to acquire a predetermined anatomical landmark. Examples of such landmarks are anatomical lines or specific anatomical features. In the case of bone, the acquired bone landmarks are then used for navigation and an initial intraoperative plan is created that can be adjusted by the surgeon as needed. Using implant planning data, a cutting plane or tool trajectory for a robotic or robot - assisted surgical procedure is calculated, and this information is used to help the surgeon navigate the instrument to better position the implant and is desirably used to improve the patient's outcome.

[0004] In applications such as knee surgery (e.g., total knee arthroplasty, or uni-compartmental knee arthroplasty, or UKA) or hip surgery (e.g., hip arthroplasty), the bone markers to be acquired are well known. However, actual acquisition can be problematic. For example, the system may require the surgeon to indicate when the tip of the pointer or probe is close to a bone marker. Errors can be introduced in several ways, as will be discussed later, and may, for example, limit the accessibility of the bone. [Overview of the project] [Problems that the invention aims to solve]

[0005] Therefore, improved systems and methods are needed for use during surgical procedures. [Means for solving the problem]

[0006] A system and method are disclosed, which includes receiving location information including a plurality of acquired data points associated with the surface of a patient's anatomical features; determining a point cloud based on the plurality of data points; extracting points from the plurality of data points as indicating landmarks on the anatomical features; determining a boundary associated with the plurality of data points; and comparing the distance between the boundary and the landmark points with a predetermined threshold, wherein if the distance between the boundary and the landmark points is not within the predetermined threshold, the comparison generates an instruction requesting confirmation of the landmark points or a suggestion to acquire additional data points. [Brief explanation of the drawing]

[0007] [Figure 1A] This is a schematic diagram of a robotic surgical system. [Figure 1B] This is a schematic diagram of another robotic surgical system with a movable base cart. [Figure 2]This is a schematic diagram of a system with a controller configured to select robust marker points. [Figure 3A] This is a schematic diagram of a bone and multiple acquired points. [Figure 3B] This is a schematic diagram of Figure 3A, which contains the extracted marker points. [Figure 4A] This is another schematic diagram of the bone and multiple acquired points with extracted landmark points. [Figure 4B] This is a schematic diagram of Figure 4A from a different perspective. [Figure 4C] This is a schematic diagram of Figure 4A, which includes the newly extracted marker points. [Modes for carrying out the invention]

[0008] Figure 1A illustrates a robotic (e.g., robot-assisted) surgical system 100 that may be used with the systems and methods described herein, or after bone markers have been acquired. Instruments 102 (also referred to as surgical tools) may be controlled by the system. Examples of instruments include, for example, drill bits, saw blades, burrs, reamers, mills, knives, or any other instruments that can cut or deform (e.g., penetrate) bone or other tissue and are suitable for use in a given surgery (for example, a drill may be more suitable for one surgery, while a saw may be more suitable for another). The system 100 comprises a robotic arm 104 extending from a base 106 and terminating at an end effector 108 for attachment to instruments 102. The robotic arm 104 has a plurality of arm segments connected by rotatable joints, the movement of which may be controlled by a control system referred to herein as a controller 110.

[0009] The controller 110 may be used to actuate the robotic arm 104 (for example, by controlling the actuation of each joint), control its movement, and thus position the end effector 108, which results in the trajectory of the instrument 102. The controller 110 typically includes a power supply, an AC / DC converter, motion controllers for supplying power to the motors of the actuation units at each joint, fuses, a real-time control system interface circuit, and other components included in the surgical robot apparatus. The controller 110 is also configured to perform the systems and methods described herein with respect to the acquisition of bone markers. The controller 110 may also be configured to send warnings (such as instructions requesting confirmation of bone marker points or suggestions for acquiring additional data points). The controller 110 may also be configured to make decisions as described.

[0010] The end effector 108 may include an instrument mount or guide 112 configured to receive the instrument 102. Furthermore, this disclosure is also intended to include the use of such an instrument by a surgical robot, by a user with some degree of robot assistance, and, in some cases, possibly without the involvement of a surgical robot or robot assistance (for example, by using a controller configured to determine, based on data, the point of at least one bone marker).

[0011] While the exemplary embodiments and accompanying descriptions may refer to specific surgeries, the systems and methods described herein can be used in a variety of applications, including robotic surgery, robot-assisted surgery, and non-robot surgery, where computer-assisted instrument placement is desirable and precise adjustment of instrument positioning may be appropriate. Exemplary applications include knee surgery (e.g., total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA)), hip surgery (e.g., hip arthroplasty), shoulder surgery, spinal surgery, and other orthopedic surgeries. The teachings of this disclosure may be applied to such procedures. However, the systems and methods described herein are not limited to these applications.

[0012] The robot-assisted surgical system 100 may have multiple navigation features for determining the position and orientation in absolute space (with respect to all degrees of freedom in the three-dimensional coordinate system), thereby determining the trajectory of the instrument 102. For example, the robotic device as a whole may be said to have a global coordinate system 114, which can be defined in various ways, but generally uses the position of the base 106. The positions of various components may be determined, for example, by receiving position signals from encoders at each joint of the robotic arm 104, for example, or by calculation. For example, the movement of the end effector 108 may be restricted such that the sum of the joint positions defines the position of the end effector coordinate system 116 within the global coordinate system 114.

[0013] The position may be measured directly (for example, directly). The navigation array 118 may be mounted on the distal portion of the robot arm 104. The navigation array 118 may include one or more markers or sensors in a specific or geometric arrangement. For example, an optical navigation or tracking system may use a stereosensor to detect light-emitting diode (LED) or infrared (IR) light reflected or emitted from one or more optical markers fixed to the array. For example, if the markers are reflective elements, when detected by the stereosensor, the system can determine the three-dimensional position and orientation of the array by combining the relative arrangement of the elements within the sensor's field of view with the known geometric arrangement of the elements. Other examples of tracking systems include ultrasonic sensors, radio-frequency identification (RFID) sensors or other radio frequency (RF) tracking systems, and electromagnetic interference (EMI) tracking systems.

[0014] In some examples, the measured coordinate system 120 of array 118 may be used as the global coordinate system 114. A navigation array 122 (additionally or alternatively to array 118) may be mounted on the instrument 102 or end effector 108. The navigation array 122 may include one or more markers, for example, in a specific or geometric arrangement. The controller 110 may use the markers (for example, together with the navigation system) to determine the three-dimensional position of the end effector 108 and / or instrument 102.

[0015] The end-effector coordinate system 116 may be defined in different ways, but it may refer to the position and orientation of the end-effector 108 relative to the movement of the instrument 102. The array 122 can identify the positioning of the instrument 102. In this way, the array 122 may help provide complete positioning information (for example, of the instrument 102) that can be used by a controller (e.g., a surgical robot system, a surgeon, etc.).

[0016] A navigation (e.g., tracking) system comprising an array and a tracking unit 130 may be provided so that the relative posture or three-dimensional position and orientation of arrays 118 and / or 122, as well as any other navigation arrays present in the operating room, such as an array coupled to a patient's anatomical structure (not shown), an operating table (not shown), or a pointer (as described later), can be tracked and shared with the controller 110 and any additional planning systems. In some embodiments, the tracking unit 130 may include one or more navigation system cameras 132 capable of capturing the position of one or more markers in arrays 118 and / or 122.

[0017] The tracking unit 130 can measure relative movement between any coordinate systems in real time. Real time may mean, depending on the embodiment, high frequencies above 20 Hz, depending on the embodiment, in the range of 100 to 500 Hz with short latency, and depending on the embodiment, less than 5 milliseconds. Thus, the positional information captured from the array markers can identify the position of the component to which the array is connected in three-dimensional space, given the known and precise relationship between the array and the component. For example, the array 122 may be configured to identify the 3D position of a device 102, such as a tip, without being permanently connected to or fastened to the device.

[0018] In a similar manner to the array described above, further arrays (not shown) can be coupled to the patient or other structures in the surgical environment (e.g., an operating table) to help maintain tracking of the target anatomical structure, such as the femur, tibia, or pedicles of the spine. The patient coordinate system may be defined in different ways (e.g., using an array coupled to the patient) but may refer to the patient's position and orientation relative to the end effector 108 or instrument 102. A navigation system (e.g., a tracking unit 130) may track these objects for the purpose of displaying the relative position and orientation of the objects to the surgeon, and, optionally, for the purpose of controlling and / or restricting the manual manipulation of the instrument relative to virtual boundaries associated with the patient's anatomical structure.

[0019] FIG. 1B illustrates another embodiment of a system 100' that can be used with the surgical robot device 100'. The surgical system of FIG. 1B may be similar to the surgical system of FIG. 1A in that it may include a robotic arm 104 having a plurality of arm segments joined together by a plurality of joints and a sensor-equipped instrument 102. The robotic arm 104 may be coupled to a mobile cart at its base 106. Additionally, one or more navigation arrays 140 may be coupled to various parts of the robotic device 100. Although only a representative array 140 is shown, multiple arrays and navigation systems may be used as described above in connection with FIG. 1A. The external device 150 may communicate with a controller (not depicted). The device 150 may be a display, a computing device, a remote server, etc., configured to allow a surgeon or other user to directly input data into the controller. Such data may include patient information and / or surgical procedure information. The device 150 may display information from the controller, such as a warning or notification that the use of the instrument has been aborted (e.g., via a closed-loop command from the controller). The communication between the device 150 and the controller may be wireless (e.g., near-field communication (NFC), Wi-Fi, Bluetooth, Bluetooth LE, ZigBee, etc.) or wired (e.g., USB or Ethernet).

[0020] Referring to FIG. 2, in an image-free system, a pointer and a navigation (e.g., tracking) system can be used during surgery to obtain position information regarding a predetermined anatomical landmark. A controller (although the present disclosure contemplates embodiments without any robotic assistance, such as the controller 110 of FIG. 1A) may communicate with the navigation system and an optional display to prompt a user (e.g., a surgeon) to position a pointer (e.g., a probe) at various anatomical landmarks on the patient related to the surgical procedure. The controller may be configured to derive a robust estimate of the position of the anatomical landmark and extract the point of the landmark, as described below.

[0021] The pointer can be equipped with a tracker (such as array 122 in FIG. 1A). The tracker may be attached (e.g., integrally or removably) on the pointer. The navigation system and / or the controller can utilize the known fixed geometric relationships between the elements of the tracker to determine the exact three-dimensional position and orientation of the pointer. Examples of tracking systems include optical tracking systems with reflective markers, radio frequency (RF) tracking systems, electromagnetic interference (EMI) tracking systems, etc. The distance and orientation between the pointer tip and the tracker can be predetermined such that the 3D position of the tip can be determined and stored as a point. In a preferred embodiment, the tip of the pointer is placed in contact with the bone. The surgeon may actively indicate that the pointer is in a fixed position by means such as voice commands, pressing a foot pedal, or pressing a button on the pointer. Alternatively, the surgeon may passively indicate that the pointer is in a fixed position, such as by holding the position after the expiration of a timer in the controller. Alternatively, the surgeon can move the distal portion of the pointer body in a predetermined pattern (such as a circle) to trigger the acquisition of points (e.g., while maintaining the tip at a predetermined position).

[0022] Optionally, a second tracker having fixed geometric relationships can be coupled to a portion of the patient's anatomical structure or a surface in the operating room. The second tracker can use markers of the same type as the pointer. The second tracker can represent, for example, a global coordinate system relative to the patient. In some embodiments, the pointer tracker is dynamic (e.g., detected by moving at regular intervals), and the patient tracker is firmly attached to the patient's bone.

[0023] Bone landmarks (e.g., the anatomical location of a patient that the surgeon or other user is prompted to acquire) can be predetermined and stored in the controller. Different landmarks are used for different surgeries, as can be understood. The controller may prompt the surgeon or other user to select the type of surgery before displaying the landmarks to be acquired.

[0024] Exemplary applications include knee surgery, e.g., total knee arthroplasty (TKA) or unicompartmental knee arthroplasty (UKA), hip surgery, e.g., hip arthroplasty, shoulder surgery, and spinal surgery. For example, in hip arthroplasty, the landmarks may relate to the anterior superior iliac spine, the posterior superior iliac spine, or a set of points to establish an anterior pelvic (AP) plane coordinate system. In another example, the landmarks may relate to a set of individual points (e.g., the medial and lateral tibiae), or a line (e.g., the anterior surface of the femur), or a portion of a surface (e.g., several specific parts, or the entire articular surface of the femoral or tibial cartilage). In yet another example, in knee arthroplasty, the landmarks may relate to several portions of the femoral condyle surface (e.g., the distal and posterior portions of both the medial and lateral condyles).

[0025] The controller may be configured to require multiple acquisition points before determining a landmark point. For example, the controller may acquire multiple points and create a 3D point cloud. In the case of knee arthroplasty, the controller may be configured to extract a single point (e.g., the landmark point) from each point cloud (e.g., the distal point of the 3D point cloud for the distal portion of the condyle, and the posterior point for the posterior portion of the condyle). The accuracy of the procedure without imaging may be improved compared to a system in which the surgeon or other user is required to manually select a single landmark point. In some preferred embodiments, the landmark point is one of the points actually acquired by the surgeon (the controller is configured to extract one of the acquired points and consider it the landmark point). The controller may implement additional queries for the surgeon (e.g., validation and confirmation).

[0026] The controller can determine landmark points without using preoperative images such as computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, other three-dimensional (3D) images, 2D images integrated to provide 3D images (e.g., fluoroscopy), or 2D images such as X-rays.

[0027] Figure 3A is a schematic diagram of a bone and multiple acquired points. As can be understood, while every patient's bones are unique to some extent, given anatomical similarities, there may be anatomical locations (e.g., anatomical sites) of landmarks. A controller, such as those described herein, may receive input regarding the type of surgical procedure. The controller may determine that multiple acquired points associated with the surface of the patient's anatomical features are required. For example, in knee arthroplasty such as UKA, the surgeon may need to acquire the distal and / or posterior positions of the anatomical features as landmarks. The system may be used to acquire the locations of predetermined anatomical landmarks during surgery.

[0028] The tracked pointer may be positioned by the surgeon to make contact with the bone surface at an anatomical landmark. The surgeon may acquire multiple points, as described above, which, for example, actively or passively indicate that the pointer is in contact with bone. For each location where the pointer is indicated to be in contact with bone, the controller may determine location information for each location and store that location information as an acquired point. Preferably, multiple acquired points are stored. It can be understood that, despite the existence of multiple acquired points, the portion of the surface acquired by the surgeon may not be broad enough or properly located to encompass the actual most distal or most posterior features of the anatomical structure. As seen in Figure 3, the acquired points are not centered on the anatomical location of the landmark. This may occur due to insufficient coverage of the anatomical location of the landmark (e.g., coverage of the condylar surface), or it may be sufficient. Advantageously, the controller may be configured not only to extract points of the landmark but also to check their robustness and trigger potential warnings. Alternatively, points may be acquired using a non-contact method (e.g., a laser scanner or a white light scanner).

[0029] Referring to Figure 3B, the controller is configured to create a point cloud using the acquired points. The point cloud may represent the acquired surface patches. The controller may determine boundaries associated with multiple acquired points. The boundaries may be 2D boundaries such as border lines, or 3D boundaries such as planes or surface meshes. For example, the controller may assume that the surface of a bone is locally flat and determine a border line. The controller may determine the most fitting plane, project the point cloud onto that most fitting plane, and calculate the envelope of the projected points (e.g., using a standard convex hull determination algorithm or convex hull extraction algorithm) to determine the boundary (e.g., border line or plane). The controller can reconstruct a surface mesh from the point cloud (e.g., using a standard Delaunay triangulation algorithm or Poisson surface reconstruction algorithm). The controller can extract triangular surface boundaries from the surface mesh.

[0030] The controller may be configured to determine a landmark point; for example, the controller may extract one of the acquired points and consider it a landmark point (for example, in relation to the possible anatomical location of the landmark (e.g., anatomical place)). The controller may be configured to compare the distance between the boundary and the landmark point with a predetermined threshold. If the distance between the boundary and the landmark point is within the predetermined threshold, the landmark point is stored as a landmark point (it may be said to be robust). If the distance between the boundary and the landmark point is not within the predetermined threshold, the controller may be further configured to generate an instruction requesting confirmation of the landmark point or a suggestion to acquire additional data points.

[0031] In some embodiments, the boundary is a boundary line defined by the edges of the point cloud. The distance between the boundary line and a marker point may be outside a given threshold if that distance is below a threshold. For example, it is useful to check whether the most distal or most posterior point extracted from the point cloud is too close to the boundary line. If the distance to the boundary line is below a given threshold, the controller generates instructions such as a warning or a suggestion to acquire points over a larger anatomical area.

[0032] The controller may be further configured to receive location information including subsequent acquired data points, determine an updated point cloud based on multiple acquired points and subsequent acquired points, and determine an updated boundary line associated with the updated point cloud. If the distance between the updated boundary line and the landmark point is within a predetermined threshold, the landmark point is stored (and may be said to be robust). The controller can repeat this process (warning, receiving newly acquired points, updating the point cloud, updating the boundary line, comparing with a predetermined threshold, etc.) until the landmark point is stored as a landmark point. In other words, storing an extracted landmark point as a landmark point indicates sufficient coverage of the possible anatomical locations of the landmark.

[0033] In some cases, previously extracted landmark points may be replaced by subsequently acquired points (e.g., more distal or more posterior points (e.g., points better aligned with the desired anatomical landmark)). However, extracted landmark points do not necessarily have to be replaced as a result of the addition of subsequent acquired points. In fact, this process can confirm that the previously extracted landmark point was indeed the most distal or most posterior point, and thus ensure sufficient coverage of the possible anatomical locations of the landmark. While Figures 3A and 3B show boundary lines as borders, it should be understood that the boundary may be a plane.

[0034] The controller can use the stored markers as part of the coordinate system for intraoperative planning, such as for guiding the robotic arm.

[0035] Referring to Figure 4A, the landmark point is determined, for example, as described above with respect to substantially Figures 3A and 3B. During the process of acquiring a contact-based point, the surgeon should always keep the tip of the pointer tool in contact with the bone surface. However, for various reasons, this contact may not be maintained throughout the acquisition, or the surgeon may not realize that the tip of the pointer is actually in contact with another structure, such as soft tissue. In such cases, this can result in a false point, which will be called an outlier below. As can be understood, if an outlier is extracted as a landmark point, all subsequent use of the landmark point will inherit this error. As can be understood, if the surgeon uses a non-contact acquisition method (e.g., laser or white light scanner), the false point may correspond to noise, but still become an outlier as described herein.

[0036] Referring to Figure 4B, the marker point is not a point obtained from the bone surface. In other words, an outlier point was mistakenly selected as the marker point. Such a point is not, for example, the most distal or most posterior point of the femoral condyle in the context of UKA treatment.

[0037] To avoid this, in some embodiments, the boundary is determined as a plane. For example, a condylar surface is expected to have a smooth and continuous surface. A single point or portion of a point cloud separated from the plane may be an outlier. A single point or portion of a point cloud representing a local surface discontinuity may be an outlier. The controller may use an algorithm for determining the plane (e.g., a plane determination algorithm, e.g., least squares method). The plane defines a smooth surface containing acquired points that are implicitly connected to one another. The controller may be configured to determine whether a minimum point density is met.

[0038] Alternatively, the controller may be configured to determine a boundary, which is a surface mesh defined by the point cloud. The controller may determine a triangular mesh, for example, using a Poisson surface reconstruction algorithm. The controller may be configured to compare the surface location of a marker point with the surface locations of other points at multiple acquisition points. The controller may be configured to determine a watertight surface (e.g., a mesh) that interpolates all points as best as possible while maintaining smoothness.

[0039] Regardless of the boundary, the controller may be configured to ignore acquired points if the distance to the acquired point from the plane (or from the interpolated surface mesh) is greater than a predetermined threshold. The controller may be configured to ignore isolated clusters of acquired points. For example, clusters may represent structures that potentially belong to other anatomical features. The controller may be configured to determine the respective distance between a landmark point and each of the acquired points in a plurality of acquired points, and if the distance between the landmark point and each of the acquired points is not within a second predetermined threshold, the controller may be further configured to generate an instruction requesting confirmation of the landmark point, a suggestion to acquire additional points, or simply remove the landmark point.

[0040] The controller may be configured to determine a boundary which is a plane (or interpolated surface mesh) defined by the point cloud. The controller may be configured to compare the distance between the plane (or mesh) and the marker points with a predetermined threshold, and if the distance is greater than the threshold, the distance is not within the predetermined threshold.

[0041] Referring to Figure 4C, if the distance between the plane (or mesh) and the marker point is not within a predetermined threshold, the controller may be further configured to recalculate the plane defined by the point cloud by removing the marker point. If the distance between the plane (or mesh) and the marker point is not within a predetermined threshold, the controller may be further configured to extract a second point from multiple acquired points as indicating an anatomical feature marker.

[0042] If the distance between the boundary and the landmark point is not within a predetermined threshold, the controller may be further configured to generate an instruction requesting confirmation of the landmark point or a suggestion to acquire additional points. The controller may be further configured to receive positional information including subsequent acquired data points, determine an updated point cloud based on the multiple acquired points and subsequent acquired points, and determine an updated plane associated with the updated point cloud. If the distance between the updated plane and the landmark point is within a predetermined threshold, the landmark point is stored (and may be said to be robust). The controller may repeat this process (warning, receiving new acquired points, updating the point cloud, updating the plane, comparing with a predetermined threshold, etc.) until the landmark point is stored as a landmark point. In other words, storing an extracted landmark point as a landmark point indicates sufficient coverage of the possible anatomical locations of the landmark.

[0043] In some cases, previously extracted landmark points may be replaced by subsequently acquired points (e.g., more distal or more posterior points (e.g., points better aligned with the desired anatomical landmark)). However, extracted landmark points do not necessarily have to be replaced as a result of the addition of subsequent acquired points.

[0044] The controller may be configured to compare the acquisition order associated with the acquisition of multiple acquisition points. The controller can consider points in the order they were acquired and detect trends. For example, distance may increase (over acquisitions) as the pointer tool lifts off the surface. Analyzing this trend in the expansion of distance values ​​can help determine when lift-off has occurred, and further, which points are more likely to belong to the surface and which are more likely to be false. A large threshold may be used to detect lift-off with high confidence. Analyzing how the distance to the plane (or mesh) increases during acquisition can help determine precisely when the pointer is no longer in contact with the surface (e.g., at a finer level of detection).

[0045] In any of the embodiments described above, the controller may be configured to display feedback, such as specific messages, for efficiency (e.g., on display 150 (Figure 1B)). Additionally, the controller may be configured to display graphics, such as a user tutorial, if a potential liftoff occurs or if the bone acquisition range may be insufficient. The controller may be configured to display a pop-up or similar mechanism to prompt the surgeon for confirmation. The controller may be configured to allow the surgeon to proceed regardless of the robustness of the landmarks.

[0046] The systems and methods described herein may be used in a variety of applications, including robotic systems, robot-assisted systems, and non-robot systems for surgical approaches and / or surgery.

[0047] In one embodiment, the surgical system according to the present disclosure comprises a pointer, a navigation array attached to the pointer, a tracking system for detecting and tracking elements of the navigation array, and a controller having at least one processor, the processor being configured to receive data from the pointer, receive pointer position data from the tracking system to determine the three-dimensional position and orientation of the pointer, correlate the position data with a position on the patient's bone surface, store the patient position data as acquired points, determine a point cloud based on a plurality of acquired points, determine a boundary associated with the plurality of acquired points, extract a first acquired point from the plurality of acquired points as indicating an anatomical feature marker on the bone surface, compare the distance between the boundary and the marker point with a predetermined threshold, and store the extracted marker point if the distance between the boundary and the marker point is within the predetermined threshold. The system may further comprise a second navigation array fixed to the patient's bone (bone array) or the surgical surface. The controller may further be configured to transmit a warning if the marker point is not within the predetermined threshold. The controller may further be configured to transmit a suggestion to acquire more points if the marker point is not within the predetermined threshold.

[0048] In another embodiment, the surgical system according to the present disclosure comprises a display and a processor, the processor being configured to receive positional information including a plurality of acquired data points associated with the surface of a patient's anatomical features, to determine a point cloud based on the plurality of data points, to extract points from the plurality of data points as indicating landmarks on the anatomical features, to determine a boundary associated with the plurality of data points, and to compare the distance between the boundary and the landmark points with a predetermined threshold, and if the distance between the boundary and the landmark points is not within the predetermined threshold, the processor is further configured to generate an instruction requesting confirmation of the landmark points or a suggestion to acquire additional data points.

[0049] A boundary can be a boundary line defined by the edges of a point cloud. The distance between the boundary line and a marker point is not within a given threshold if that distance is less than a threshold. The processor may be further configured to receive positional information including acquired subsequent data points, determine an updated point cloud based on the multiple data points and subsequent data points, and determine an updated boundary line associated with the updated point cloud.

[0050] The boundary may be a plane defined by the point cloud. The distance between the plane and the landmark point is not within a predetermined threshold if the distance is greater than the threshold. If the distance between the plane and the landmark point is not within the predetermined threshold, the processor may be further configured to extract a second point from multiple data points as indicating an anatomical feature landmark. If the distance between the plane and the landmark point is not within the predetermined threshold, the processor may be further configured to recalculate the plane defined by the point cloud by removing the landmark point. The processor may be further configured to receive positional information including acquired subsequent data points, determine an updated point cloud based on the multiple data points and subsequent data points, and determine an updated plane associated with the updated point cloud.

[0051] The boundary may be a surface mesh defined by a point cloud.

[0052] The processor may be further configured to compare the surface position of a marker point with the surface positions of other data points in a plurality of data points. The processor may be further configured to determine the distance between the marker point and each of the data points in the plurality of data points, and if the distance between the marker point and each of the data points is not within a second predetermined threshold, the processor may be further configured to generate an instruction requesting confirmation of the marker point, or a suggestion to obtain additional data points, or to remove the marker point.

[0053] The processor may be further configured to compare the acquisition order associated with the acquisition of multiple data points.

[0054] In another embodiment, the method according to the present disclosure includes receiving location information including a plurality of acquired data points associated with the surface of a patient's anatomical feature; determining a point cloud based on the plurality of data points; extracting points from the plurality of data points to indicate landmarks on the anatomical feature; determining a boundary associated with the plurality of data points; comparing the distance between the boundary and the landmark points with a predetermined threshold; storing the landmark points if the distance between the boundary and the landmark points is within the predetermined threshold; and generating instructions requesting confirmation of the landmark points or suggestions for acquiring additional data points if the distance between the boundary and the landmark points is not within the predetermined threshold.

[0055] The boundary may be a boundary line defined by the edges of the point cloud, and the distance between the boundary line and the marker point is not within a predetermined threshold if that distance is less than the threshold.

[0056] The boundary may be a plane defined by a point cloud, and the distance between the plane and the marker point is not within a predetermined threshold if that distance is greater than the threshold.

[0057] This method may further include receiving location information including acquired subsequent data points, determining an updated point cloud based on multiple data points and subsequent data points, and determining an updated boundary associated with the updated point cloud.

[0058] If the distance between the plane and the point of the first landmark is not within a predetermined threshold, the method may further include ignoring the point of the first landmark and extracting a second point from a plurality of data points to represent an anatomical feature landmark, or removing the point of the first landmark and recalculating the plane defined by the point cloud.

[0059] This method may further include comparing the surface position of a marker point with the surface positions of other data points at multiple data points.

[0060] The method may further include determining the distance between a marker point and each of the data points in a plurality of data points, and if the distance between the marker point and each of the data points is not within a second predetermined threshold, it may further include generating an instruction to request confirmation of the marker point, generating an instruction to suggest that the user obtain additional data points, or removing the marker point.

[0061] [Implementation Method] (1) A surgical system, wherein the surgical system is The display and A processor is provided, and the processor is The system receives location information including multiple acquired data points associated with the surface of the patient's anatomical features. Based on the aforementioned multiple data points, a point cloud is determined, Points are extracted from the plurality of data points to represent the anatomical features and landmarks mentioned above. Determine the boundaries associated with the aforementioned plurality of data points, The distance between the boundary and the marker point is compared with a predetermined threshold, and if the distance between the boundary and the marker point is not within the predetermined threshold, the processor A surgical system further configured to generate instructions requesting confirmation of the aforementioned marker points, or suggestions for obtaining additional data points. (2) The surgical system according to Embodiment 1, wherein the boundary is a boundary line defined by the edges of the point cloud. (3) The surgical system according to Embodiment 2, wherein the distance between the boundary line and the point of the marker is not within the predetermined threshold if the distance is less than the threshold. (4) The processor is Receive location information including subsequent data points that have been acquired. Based on the aforementioned plurality of data points and the subsequent data points, the updated point cloud is determined. The surgical system according to embodiment 3, further configured to determine updated boundaries associated with the updated point cloud. (5) The surgical system according to Embodiment 1, wherein the boundary is a plane defined by the point cloud.

[0062] (6) The surgical system according to Embodiment 5, wherein the distance between the plane and the point of the marker is not within the predetermined threshold if the distance is greater than the threshold. (7) If the distance between the plane and the marker point is not within the predetermined threshold, the processor is further configured to extract a second point from the plurality of data points as indicating the marker on the anatomical feature, according to Embodiment 6. (8) If the distance between the plane and the marker point is not within the predetermined threshold, the processor is further configured to recalculate the plane defined by the point cloud by removing the marker point, according to Embodiment 6. (9) The processor is Receive location information including subsequent data points that have been acquired. Based on the aforementioned plurality of data points and the subsequent data points, the updated point cloud is determined. The surgical system according to embodiment 6, further configured to determine an updated plane associated with the updated point cloud. (10) The surgical system according to Embodiment 1, wherein the boundary is a surface mesh defined by the point cloud.

[0063] (11) The surgical system according to Embodiment 1, wherein the processor is further configured to compare the surface position of the marker point with the surface positions of other data points in the plurality of data points. (12) The processor It is further configured to determine the distance between the marker point and each of the data points in the plurality of data points, If the distance between the marker point and each of the data points is not within a second predetermined threshold, the processor Generate instructions requesting confirmation of the aforementioned marker points or suggestions for obtaining additional data points, or The surgical system according to embodiment 11, further configured to remove the aforementioned marker points. (13) The surgical system according to Embodiment 1, wherein the processor is further configured to compare the acquisition order associated with the acquisition of the plurality of data points. (14) Receiving location information including multiple acquired data points associated with the surface of the patient's anatomical features, Determining a point cloud based on the aforementioned multiple data points, Extracting points from the multiple data points to represent the aforementioned anatomical feature landmarks, Determining the boundaries associated with the aforementioned plurality of data points, The distance between the boundary and the marker point is compared with a predetermined threshold, If the distance between the boundary and the marker point is within the predetermined threshold, the marker point is stored. A method comprising: generating an instruction to request confirmation of the marker point, or a suggestion to obtain additional data points, if the distance between the boundary and the marker point is not within the predetermined threshold. (15) The method of Embodiment 14, wherein the boundary is a boundary line defined by the edges of the point cloud, and the distance between the boundary line and the marker point is not within the predetermined threshold if the distance is less than the threshold.

[0064] (16) The method of Embodiment 14, wherein the boundary is a plane defined by the point cloud, and the distance between the plane and the marker point is not within the predetermined threshold if the distance is greater than the threshold. (17) Receiving location information including subsequent data points that have been acquired, Determining an updated point cloud based on the aforementioned plurality of data points and the subsequent data points, The method of embodiment 14, further comprising determining updated boundaries associated with the updated point cloud. (18) If the distance between the plane and the point of the first marker is not within the predetermined threshold, Ignoring the first marker point and extracting a second point from the plurality of data points to represent the marker on the anatomical feature, or The method according to embodiment 14, wherein at least one of the following is performed: removing the first marker point and recalculating the plane defined by the point cloud. (19) The method of Embodiment 14, further comprising comparing the surface position of the marker point with the surface positions of other data points in the plurality of data points. (20) Determining the distance between the marker point and each of the data points in the plurality of data points, If the distance between the marker point and each of the data points is not within the second predetermined threshold, To generate an instruction requesting confirmation of the aforementioned marker point, To generate instructions that the user suggests obtaining additional data points, or The method of Embodiment 14, further comprising performing at least one of the following: removing the points of the marker.

Claims

1. A surgical system, wherein the surgical system is The display and A processor is provided, and the processor is The system receives location information including multiple acquired data points associated with the surface of the patient's anatomical features. Based on the aforementioned multiple data points, a point cloud is determined, Points are extracted from the plurality of data points to represent the anatomical features and landmarks mentioned above. Determine the boundaries associated with the aforementioned plurality of data points, The system is configured to compare the distance between the boundary and the marker point with a predetermined threshold, and if the distance between the boundary and the marker point is not within the predetermined threshold, the processor A surgical system further configured to generate instructions requesting confirmation of the aforementioned marker points, or suggestions for obtaining additional data points.

2. The surgical system according to claim 1, wherein the boundary is a boundary line defined by the edges of the point cloud.

3. The surgical system according to claim 2, wherein the distance between the boundary line and the marker point is not within the predetermined threshold if the distance is less than the threshold.

4. The aforementioned processor, Receive location information including subsequent data points that have been acquired. Based on the aforementioned plurality of data points and the subsequent data points, the updated point cloud is determined. The surgical system according to claim 3, further configured to determine updated boundary lines associated with the updated point cloud.

5. The surgical system according to claim 1, wherein the boundary is a plane defined by the point cloud.

6. The surgical system according to claim 5, wherein the distance between the plane and the point of the marker is not within the predetermined threshold if the distance is greater than the threshold.

7. The surgical system according to claim 6, wherein if the distance between the plane and the marker point is not within the predetermined threshold, the processor is further configured to extract a second point from the plurality of data points as indicating the marker on the anatomical feature.

8. The surgical system according to claim 6, wherein if the distance between the plane and the marker point is not within the predetermined threshold, the processor is further configured to recalculate the plane defined by the point cloud by removing the marker point.

9. The aforementioned processor, Receive location information including subsequent data points that have been acquired. Based on the aforementioned plurality of data points and the subsequent data points, the updated point cloud is determined. The surgical system according to claim 6, further configured to determine an updated plane associated with the updated point cloud.

10. The surgical system according to claim 1, wherein the boundary is a surface mesh defined by the point cloud.

11. The surgical system according to claim 1, wherein the processor is further configured to compare the surface position of the marker point with the surface positions of other data points in the plurality of data points.

12. The aforementioned processor, It is further configured to determine the distance between the marker point and each of the data points in the plurality of data points, If the distance between the marker point and each of the data points is not within a second predetermined threshold, the processor Generate instructions requesting confirmation of the aforementioned marker points or suggestions for obtaining additional data points, or The surgical system according to claim 11, further configured to remove the aforementioned marker points.

13. The surgical system according to claim 1, wherein the processor is further configured to compare the acquisition order associated with the acquisition of the plurality of data points.

14. Receiving location information including multiple acquired data points associated with the surface of the patient's anatomical features, Determining a point cloud based on the aforementioned multiple data points, Extracting points from the multiple data points to represent the aforementioned anatomical feature landmarks, Determining the boundaries associated with the aforementioned plurality of data points, The distance between the boundary and the marker point is compared with a predetermined threshold, If the distance between the boundary and the marker point is within the predetermined threshold, the marker point is stored. A method comprising: generating an instruction to request confirmation of the marker point, or a suggestion to obtain additional data points, if the distance between the boundary and the marker point is not within the predetermined threshold.

15. The method according to claim 14, wherein the boundary is a boundary line defined by the edges of the point cloud, and the distance between the boundary line and the marker point is not within the predetermined threshold if the distance is less than the threshold.

16. The method according to claim 14, wherein the boundary is a plane defined by the point cloud, and the distance between the plane and the marker point is not within the predetermined threshold if the distance is greater than the threshold.

17. Receiving location information including subsequent data points that have been acquired, Determining an updated point cloud based on the aforementioned plurality of data points and the subsequent data points, The method according to claim 14, further comprising determining an updated boundary associated with the updated point cloud.

18. If the distance between the plane and the point of the first marker is not within the predetermined threshold, Ignoring the first marker point and extracting a second point from the plurality of data points to represent the marker on the anatomical feature, or The method according to claim 14, wherein at least one of the following is performed: removing the first marker point and recalculating the plane defined by the point cloud.

19. The method according to claim 14, further comprising comparing the surface position of the marker point with the surface positions of other data points in the plurality of data points.

20. Determining the distance between the aforementioned marker point and each of the data points among the plurality of data points, If the distance between the marker point and each of the data points is not within the second predetermined threshold, To generate an instruction requesting confirmation of the aforementioned marker point, To generate instructions that the user suggests obtaining additional data points, or The method according to claim 14, further comprising performing at least one of the following: removing the marker point.

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