Computer-assisted pelvic surgical navigation

Abstract

The present disclosure relates to a system for computer-aided navigation during a surgical procedure, the system comprising a computer platform operative to identify a set of locations at which a navigation instrument is palpation a landmark defined on a surface of a pelvic bone of a patient. Other operations determine the center of rotation of the pelvic acetabulum of the patient based on the identified set of positions at which the navigation instrument is palpation the landmark. The operation is based on the identified set of positions at which the navigation instrument is palpation the landmark, and the orientation of the patient's anterior pelvic plane (APP) and / or functional pelvic plane (FPP) is determined based on the determined center of rotation of the pelvic acetabulum.

Description

Technical Field

[0001] The present disclosure relates to medical devices and systems, and more particularly to a surgical navigation system for pelvic surgery. Background Art

[0002] Computer-assisted surgical navigation systems have become a well-established technology in the operating room, which is used to provide surgeons with a computerized visualization of the relationship between the pose of a surgical instrument or other device relative to a patient-set pose and the pose of a medical image relative to the patient's anatomy, as well as the relationship between those poses and a preoperative surgical plan. A camera tracking system for computer-assisted surgical navigation typically uses a set of tracking cameras to track the pose of a reference element on a surgical instrument relative to a patient reference element (also referred to as a "dynamic reference base" (DRB)) attached to the patient, and the surgical instrument is positioned by the surgeon during the surgery. A computer model of the real instrument is associated with the reference element, so that the computer model can be overlaid on a registered image of the patient's anatomy. The camera tracking system uses the relative pose of the reference element to determine how the real instrument is posed relative to the patient and how the computer model of the real instrument is correspondingly posed, as overlaid on the medical image. Thus, the surgeon can use the real-time visual feedback of the relative pose to navigate the surgical instrument during the surgical procedure of the patient.

[0003] A robotic system for knee replacement can be used, which has a serial arm, and a passive structure for guiding a saw blade is mounted on the serial arm. For example, a sagittal saw can be attached to the end of the passive structure to guide the cutting plane. The system enables the surgeon to hold the sagittal saw and cut the bone while viewing various types of relevant feedback and information associated with the surgical procedure planning and / or progress on a navigation system (e.g., a stand-alone display or an augmented reality (AR) headset).

[0004] The serial arm can be moved to a suitable position for the surgery by computer-guided control, for example, in accordance with a request from the surgeon that can be provided via a foot pedal, a touch screen, AR interaction, etc. The passive structure allows the surgeon to precisely remove the bone in the cutting plane. The progress of bone removal can be measured by camera tracking of fiducials of reference elements attached to the bone and the sagittal saw.

[0005] There are various workflows available for the system. Some workflows require pre-operative scans or images of the patient (e.g., x-rays, computed tomography (CT)). On the other hand, image-free workflows do not require any pre-operative images. To obtain intraoperative information about the patient's anatomy, the surgeon uses a camera tracking system and appropriate tracking instruments to measure key parameters of the bone to acquire points on the patient's anatomy. Subsequently, this information is used to plan the implant position and orientation for the patient's anatomy and to navigate the robot and surgical instruments during the surgical procedure.

[0006] Some workflows include having the surgeon rigidly attach a reference element to one or more bones, where the reference element includes fiducials detected by a tracking camera for computer-aided navigation. The reference element allows the bone position to be tracked by the navigation system. The reference element can be positioned on the bone in such a way that it is attached to the bone (e.g., the pelvis or femur and tibia, depending on the surgical procedure being performed) using a fixation structure (e.g., screw pins, "alligator clip" bite) and oriented such that they can be seen by the tracking camera of the navigation system. The position and orientation of the reference element must remain rigidly fixed relative to the bone.

[0007] Another step in the various workflows is to register the patient in the tracking space of the navigation system. Patient registration can include matching the patient's anatomy to a digital representation of the corresponding bone (usually a 3D model of the bone). The bone representation can be constructed from a set of CT images (CT workflow) or based on a generic bone model (image-free workflow).

[0008] Although current surgical procedures provide precise computer-aided navigation once the patient's bone landmarks have been properly registered for tracking, the current registration procedures should be improved to be more automated and to provide more accurate assisted navigation during the surgical procedure. SUMMARY OF THE INVENTION

[0009] Some embodiments of the present disclosure relate to a system for computer-aided navigation during a surgical procedure. The system includes a computer platform that is operative to identify a set of positions at which a navigation instrument is contacting landmarks defined on the surface of the patient's pelvic bone, femur, or both. Other operations determine the center of rotation of the patient's pelvic acetabulum based on the identified set of positions at which the navigation instrument is palpating the landmarks. The operation determines the orientation of the patient's anterior pelvic plane (APP) and / or functional pelvic plane (FPP) based on the identified set of positions (at which the navigation instrument is palpating the landmarks) and based on the determined center of rotation of the pelvic acetabulum.

[0010] Some other corresponding embodiments of the present disclosure relate to a computer program product that includes a non-transitory computer-readable medium storing instructions that are executable by at least one processor to perform operations for computer-aided navigation during a surgical procedure. The operations identify a set of positions at which a navigation instrument is palpating landmarks defined on the surface of a patient's pelvic bone. Other operations determine a center of rotation of the patient's pelvic acetabulum based on the identified set of positions at which the navigation instrument is palpating landmarks. The operations determine an orientation of the patient's anterior pelvic plane (APP) and / or functional pelvic plane (FPP) based on the identified set of positions (at which the navigation instrument is palpating landmarks) and based on the determined center of rotation of the pelvic acetabulum.

[0011] After reviewing the following drawings and the detailed description, other systems, computer program products, and related methods for computer-aided navigation during a surgical procedure in accordance with embodiments of the subject matter of the present invention will become apparent to those skilled in the art. All such additional systems, computer program products, and methods are intended to be included in this specification, within the scope of the subject matter of the present invention, and are protected by the appended claims. Additionally, all embodiments disclosed herein are intended to be implementable separately or in any manner and / or combination in combination. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Aspects of the present disclosure are illustrated by way of example and are not limited by the drawings. In the drawings:

[0013] Figure 1 is a top view of a surgical system arranged during a surgical procedure in a surgical operating room, the surgical system including a camera tracking system for computer-aided navigation during a surgical procedure and may further include a surgical robot for robotic assistance;

[0014] Figure 2 illustrates a camera tracking system and a surgical robot positioned relative to a patient;

[0015] Figure 3 further illustrates a camera tracking system and a surgical robot configured in accordance with some embodiments;

[0016] Figure 4 illustrates a block diagram of a surgical system configured to operate, the surgical system including an extended reality headset, a computer platform, an imaging device, and a surgical robot;

[0017] Figure 5 illustrates a spherical tip stylet constructed in accordance with some embodiments of the present disclosure;

[0018] Figure 6 Shows a user interface that is displayed to guide a user through condylar surface registration by using spherical tip palpation according to some embodiments of the present disclosure;

[0019] Figure 7 Shows a schematic diagram of an operation for defining and then translating an offset acquisition surface of a bone toward the surface of the bone along a local normal vector based on the radius of a sphere to define an acquisition surface of the bone according to some embodiments of the present disclosure;

[0020] Figure 8 Shows a flowchart of an imageless workflow during the intraoperative portion of a total hip arthroplasty (THA) surgery according to some embodiments of the present disclosure;

[0021] Figure 9 Shows a flowchart of a patient preparation process before registration according to some embodiments of the present disclosure;

[0022] Figure 10A Shows a radiographic tilt angle measured in the coronal plane of a patient according to some embodiments of the present disclosure;

[0023] Figure 10B Shows a radiographic torsion angle measured relative to the coronal plane of a patient according to some embodiments of the present disclosure;

[0024] Figure 11 Shows different views of landmarks and axes for registration of a functional pelvic plane (FPP) and an anterior pelvic plane (APP) of a patient according to some embodiments of the present disclosure;

[0025] Figure 12 Shows a flowchart for registering the APP and FPP of a patient according to some embodiments of the present disclosure;

[0026] Figures 13A to 13C Shows an example of registering the APP and / or FPP using a tracking marker plane of a navigation instrument according to some embodiments of the present disclosure;

[0027] Figure 14 Shows an example of registering the APP and / or FPP using an axis of a navigation instrument and a tracking camera including an inertial measurement unit (IMU) according to some embodiments of the present disclosure;

[0028] Figure 15 Shows a flowchart of an operation for measuring the leg length and offset of a patient according to some embodiments of the present disclosure;

[0029] Figure 16 Shows a flowchart for registering the pelvic acetabulum of a patient according to some embodiments of the present disclosure;

[0030] Figure 17 Illustrates the operation of mapping the acetabular cavity with a navigation instrument according to some embodiments of the present disclosure;

[0031] Figure 18 Illustrates a user interface for a planning view that displays a graphical representation of a generic bone with extracted (e.g., registered) landmarks (shown as bright spots), and a graphical representation of a surface that has been acquired through a palpation operation;

[0032] Figure 19 Illustrates a flowchart of operations that may be performed by a computer platform of a system for computer - assisted navigation during a surgical procedure according to some embodiments of the present disclosure;

[0033] Figure 20 Illustrates a flowchart of additional or alternative operations that may be performed by a computer platform of a system for computer - assisted navigation during a surgical procedure on a patient according to some embodiments of the present disclosure;

[0034] Figure 21 Illustrates a schematic diagram of operations for acquiring femoral and / or tibial features according to some embodiments of the present disclosure; and

[0035] Figure 22 Illustrates a schematic diagram of the structure and operation of a second method of operation that may be used to acquire femoral and / or tibial features. DETAILED DESCRIPTION

[0036] It should be understood that the present disclosure is not limited in its application to the construction details and component arrangements shown in the present description or illustrated in the drawings. The teachings of the present disclosure can be used and practiced in other embodiments and practiced or carried out in various ways. Further, it should be understood that the wording and terminology used herein are for the purpose of description and should not be regarded as limiting. The use of "comprising", "including", or "having" and their variants herein is intended to include the items listed hereinafter and their equivalents as well as additional items. Unless otherwise specified or limited, the terms "mounted", "connected", "attached", "supported", and "coupled" and their variants are used broadly and include direct and indirect mounting, connecting, attaching, supporting, and coupling. Further, "connected" and "coupled" are not limited to physical or mechanical connection or coupling.

[0037] The following discussion is provided to enable a person skilled in the art to make and use the embodiments of the present disclosure. Various modifications to the illustrated embodiments will be apparent to those skilled in the art, and the principles herein may be applied to other embodiments and applications without departing from the embodiments of the present disclosure. Accordingly, the embodiments are not intended to be limited to the embodiments shown, but rather should have the broadest scope consistent with the principles and features disclosed herein. Read the following detailed description with reference to the accompanying drawings, in which like elements in different drawings have like reference numerals. The drawings are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the embodiments. Those skilled in the art will recognize that the examples provided herein have many useful alternative forms and fall within the scope of the embodiments.

[0038] A first set of embodiments of the present disclosure relates to a system for computer-assisted navigation during surgery that utilizes the operation of a navigation spherical tip stylet that is used to contact the surface of a bone as the stylet traverses the bone. For example, according to various embodiments disclosed herein, the bone can be continuously contacted through a process called "surface mapping," which refers to the user preferably touching (e.g., tapping) the ball at various surface positions on the bone in a zigzag manner, and / or refers to the user preferably touching and then dragging the ball in a zigzag manner while maintaining contact with the bone surface, while tracking the stylet such that the acquisition surface of the bone can be defined. The bone can also be continuously contacted through palpation, i.e., by repeatedly lifting and contacting various surface positions while the navigation spherical tip stylet preferably traverses the bone in a zigzag manner. For the purposes of this application, the phrases "mapping," "surface mapping," and palpation will be used interchangeably to mean contacting the bone either continuously or intermittently. Before describing these embodiments in detail, reference Figures 1 to 4 describes the various components of a system that can be used with and / or for performing the embodiments.

[0039] In addition to, in combination with, or as an alternative to the first set of embodiments, a second set of embodiments of the present disclosure that can be used relates to a system for computer-assisted navigation during surgery that includes a computer platform operable to identify a set of positions at which a navigation instrument palpates landmarks defined on the surface of a patient's pelvic bone. The computer platform is also operable to determine the center of rotation of the pelvic acetabulum based on the identified set of positions at which the navigation instrument palpates the landmarks, and to determine the orientation of the anterior pelvic plane (APP) and / or the functional pelvic plane (FPP) based on the identified set of positions at which the navigation instrument palpates the landmarks and based on the determined center of rotation of the pelvic acetabulum.

[0040] The first set of embodiments is discussed below.

[0041] Figure 1 It is a top view of a surgical system arranged in a surgical operating room during a surgical procedure. According to some embodiments, the system includes a camera tracking system 200 for computer-aided navigation during surgery and may also include a surgical robot 100 for robotic assistance. Figure 2 Shows the camera tracking system 200 and the surgical robot 100 positioned relative to a patient according to some embodiments. Figure 3 Further shows the camera tracking system 200 and the surgical robot 100 configured according to some embodiments. Figure 4 Shows a block diagram of a surgical system configured to operate according to some embodiments, the surgical system including an extended reality (XR) headset 150, a computer platform 400, an imaging device 420, and a surgical robot 100.

[0042] The XR headset 150 may be configured to enhance the real-world scene with computer-generated XR images when worn by a person in the operating room. The XR headset 150 may be configured to provide an augmented reality (AR) viewing environment by displaying computer-generated XR images on a see-through display screen that allows light from the real-world scene to pass through for combined viewing by the user. Alternatively, the XR headset 150 may be configured to provide a virtual reality (VR) viewing environment by preventing or substantially preventing the user from directly viewing light from the real-world scene while the user is viewing computer-generated AR images on the display screen. The XR headset 150 may be configured to provide both AR and VR viewing environments. Thus, the term XR headset may be referred to as an AR headset or a VR headset.

[0043] Reference Figures 1 to 4 , the surgical robot 100 may include, for example, one or more robotic arms 104, a display 110, an end effector 112 such as including a guide tube 114, and an end effector reference element that may include one or more tracking fiducials. The patient reference element 116 (DRB) has a plurality of tracking fiducials and is directly fixed to the patient 210 (e.g., fixed to the patient's bone, such as the pelvis, femur, or tibia). The reference element 170 is attached to or formed on an instrument, a surgical tool, a surgical implant device, etc.

[0044] The camera tracking system 200 includes tracking cameras 204, which may be spaced-apart stereo cameras configured with partially overlapping fields of view. The camera tracking system 200 may have any suitable configuration of an arm 202 to move, orient, and support the tracking cameras 204 in a desired position and may include at least one processor operable to track the position of individual fiducials and the orientation of a fiducial array of a reference element.

[0045] As used herein, the term "pose" refers to the position (e.g., along three orthogonal axes) and / or rotational angles (e.g., about three orthogonal axes) of a reference (e.g., a DRB) relative to another reference (e.g., a monitoring reference) and / or relative to a defined coordinate system (e.g., a camera coordinate system, a navigation coordinate system, etc.). Thus, the definition of pose can be based solely on the multi-dimensional position of a reference relative to another reference and / or relative to a defined coordinate system, solely on the multi-dimensional rotational angles of a reference relative to another reference and / or relative to a defined coordinate system, or on a combination of multi-dimensional position and multi-dimensional rotational angles. Thus, the term "pose" is used to refer to position, rotational angle, or a combination thereof.

[0046] The tracking camera 204 can include, for example, an infrared camera (e.g., a bifocal or stereophotogrammetric camera) that is operable to identify, for example, active and passive tracking references and reference elements for a single reference (e.g., a monitoring reference), where the reference element can be formed on or attached to the patient 210 (e.g., a patient reference element, DRB, etc.), the end effector 112 (e.g., an end effector reference element), the XR headset 150 worn by the surgeon 120 and / or the surgical assistant 126, etc. within a given measurement volume of the camera coordinate system and be visible from the perspective of the tracking camera 204. The tracking camera 204 can scan the given measurement volume and detect light emitted or reflected from the references in order to identify and determine the positions of the individual references and the pose of the reference element in three dimensions. For example, an active reference element can include an infrared emission reference (e.g., an infrared light-emitting diode (LED)) activated by an electrical signal, and a passive reference element can include a retroreflective reference (e.g., they reflect incident IR radiation back in the direction of the incident light) that reflects infrared light emitted, for example, by an illuminator on the tracking camera 204 or other suitable device.

[0047] The XR headsets 150 can each include a tracking camera (e.g., spaced-apart stereo cameras) that can track the position of the monitoring reference and the pose of the reference element within the XR camera headset fields of view (FOVs) 152 and 154, respectively. Thus, as Figure 1 shown, when within the FOVs 152 and 154 of the XR headsets 150 and / or the FOV 600 of the tracking camera 204, the position of the monitoring reference and the pose of the reference element on various objects can be tracked.

[0048] Figure 1 and Figure 2Shows a possible configuration for placing the camera tracking system 200 and the surgical robot 100 in an operating room environment. Computer-assisted navigation surgery can be provided by a camera tracking system that controls the XR headset 150 and / or other displays 34, 36, and 110 to display surgical procedure navigation information. The surgical robot 100 is optional during computer-assisted navigation surgery.

[0049] The camera tracking system 200 can operate using tracking information and other information provided by multiple XR headsets 150, such as inertial tracking information and optical tracking information (tracking data frames). The XR headset 150 operates to display visual information and can play audio information to the wearer. This information can come from local sources (e.g., the surgical robot 100 and / or other medical devices), imaging device 420( Figure 4 ), and remote sources (e.g., a patient medical image database) and / or other electronic devices. The camera tracking system 200 can track fiducials in six degrees of freedom (6DOF) of the three axes of a 3D coordinate system and the rotation angle about each axis. The XR headset 150 can also operate to track hand gestures and postures to enable gesture-based interaction with "virtual" buttons and interfaces displayed through the XR headset 150, and can also interpret the pointing or posture of a hand or finger as various defined commands. Additionally, the XR headset 150 can have a digital color camera sensor with a magnification factor of 1x to 10x, known as a digital magnifier. In some embodiments, one or more of the XR headsets 150 are simplified XR headsets that display local or remote information but include fewer sensors and are thus lighter.

[0050] The "outside-in" machine vision navigation bar supports the tracking camera 204 and can include a color camera. The machine vision navigation bar generally has a more stable view of the environment because it does not move as frequently or quickly as the XR headset 150 when positioned on the wearer's head. The patient reference element 116 (DRB) is typically rigidly attached to the patient in a pitch and roll that is stable relative to gravity. This local rigid patient reference 116 can be used as a common reference for a reference frame relative to other tracking elements, such as the reference element on the end effector 112, the instrument reference element 170, and the reference element on the XR headset 150.

[0051] In some embodiments, at the end of the end effector, an instrument is connected to perform operations such as resection, reaming, broaching, drilling, and screw placement.

[0052] If present, a surgical robot (also referred to as a "robot") can be positioned near or beside patient 210. Robot 100 can be positioned at any suitable location near patient 210, depending on the area of patient 210 undergoing a surgical procedure. Camera tracking system 200 can be separate from robot system 100 and positioned at the foot of patient 210. This position gives tracking camera 200 a direct line of sight to surgical area 208. In the configuration shown, surgeon 120 can be located opposite robot 100 but still be able to manipulate end effector 112 and display 110. Surgical assistant 126 can be located opposite surgeon 120 and still have access to end effector 112 and display 110. If desired, the positions of surgeon 120 and assistant 126 can be interchanged. An anesthesiologist 122, nurse, or scrub technician can operate a device that can be connected to display information from camera tracking system 200 on display 34.

[0053] Regarding other components of robot 100, display 110 can be attached to surgical robot 100 or in a remote location. End effector 112 can be coupled to robot arm 104 and controlled by at least one motor. In some embodiments, end effector 112 includes a guide tube 114 that is configured to receive and direct surgical instruments, tools, or implants for performing a surgical procedure on patient 210. In some other embodiments, end effector 112 includes a passive structure that guides a saw blade (e.g., a sagittal saw) along a defined cutting plate.

[0054] As used herein, the term "end effector" can be used interchangeably with the term "effector element". The term "instrument" is used in a non-limiting manner and can be used interchangeably with "tool" and "implant" to generally refer to any type of device that can be used during a surgical procedure in accordance with the embodiments disclosed herein. The more general term "device" can also refer to structures such as end effectors. Example instruments, tools, and implants include, but are not limited to: drills, screwdrivers, saws, dilators, retractors, probes, implant inserters, and implant devices such as screws, spacers, intervertebral fusion devices, plates, rods, etc. Although typically shown as having guide tube 114, it should be understood that end effector 112 can be replaced with any suitable instrument adapted for use in a surgical operation. In some embodiments, end effector 112 can include any known structure for effecting movement of a surgical instrument in a desired manner.

[0055] Surgical robot 100 is operable to control the translation and orientation of end effector 112. The robot 100 can move the end effector 112 under computer control along, for example, the x-axis, y-axis, and z-axis. The end effector 112 can be configured to selectively rotate about one or more of the x-axis, y-axis, and z-axis and the Z-frame axis such that one or more of the Euler Angles (e.g., roll, pitch, and / or yaw) associated with the end effector 112 can be selectively controlled by a computer. In some embodiments, compared to traditional robots that utilize, for example, a 6DOF robotic arm that only includes axes of rotation, the selective control of the translation and orientation of the end effector 112 can allow medical procedures to be performed with significantly increased precision. For example, surgical robot 100 can be used to operate on patient 210, and robotic arm 104 can be positioned above the body of patient 210, where the end effector 112 is selectively angled relative to the z-axis toward the body of patient 210.

[0056] In some example embodiments, the XR headset 150 can be controlled to dynamically display an updated graphical indication of the pose of the surgical instrument such that the user can know the pose of the surgical instrument at all times during the surgical procedure.

[0057] In some additional embodiments, surgical robot 100 can be operated to correct the path of a surgical instrument guided by robotic arm 104 when the surgical instrument deviates from a selected, pre-planned trajectory. Surgical robot 100 can be operated to allow stopping, modifying, and / or manually controlling the movement of end effector 112 and / or the surgical instrument. Thus, in use, a surgeon or other user can use surgical robot 100 as part of a computer-assisted navigation surgical procedure and have the option to stop, modify, or manually control the autonomous or semi-autonomous movement of end effector 112 and / or the surgical instrument.

[0058] References to fiducials can be formed on and / or connected to robotic arms 102 and / or 104, end effector 112 (e.g., Figure 2 end effector element 114 therein) and / or surgical instrument (e.g., instrument element 170) to enable tracking of the pose in a defined coordinate system (e.g., 6DOF such as along 3 orthogonal axes) and rotation about the axes. The fiducial elements enable each marked object (e.g., end effector 112, patient 210, and surgical instrument) to be tracked by tracking camera 200, and the tracked poses can be used to provide navigation guidance during the surgical procedure and / or to control the movement of surgical robot 100 for guiding end effector 112 and / or the instrument manipulated by end effector 112.

[0059] Reference Figure 3, the surgical robot 100 may include a display 110, an upper arm 102, a lower arm 104, an end effector 112, a vertical column 312, casters 314, a table 318, and a ring 324 that uses light to indicate status and other information. The cabinet 106 may house the electronic components of the surgical robot 100, including but not limited to batteries, power distribution modules, platform interface board modules, and computers. The camera tracking system 200 may include a display 36, tracking cameras 204, an arm 202, a computer housed in the cabinet 330, and other components.

[0060] In computer-assisted navigation surgery, vertical 2D scan slices of the patient's anatomy, such as axial, sagittal, and / or coronal views, are displayed to enable the user to visualize the patient's anatomy along the relative pose of the surgical instrument. An XR headset or other display can be controlled to display one or more 2D scan slices of the patient's anatomy and a 3D graphical model of the anatomy. The 3D graphical model can be generated, for example, from a 3D scan of the patient by a CT scanning device, and / or can be generated based on a baseline model of the anatomy that does not have to be formed from a scan of the patient.

[0061] Example surgical system :

[0062] Figure 4 A block diagram of a surgical system according to some embodiments is shown, the surgical system including an XR headset 150, a computer platform 400, an imaging device 420, and a surgical robot 100 configured to operate.

[0063] The imaging device 420 may include a C-arm imaging device, an O-arm imaging device, other imaging devices, and / or a patient image database (2D and / or 3D images). The XR headset 150 provides an improved human-machine interface for performing the navigated surgical procedure. The XR headset 150 may be configured to provide functions, for example, via the computer platform 400, including but not limited to any one or more of the following: recognition of gesture-based commands, display of XR graphical objects on the display device 438 of the XR headset 150 and / or another display device. The display device 438 may include a video projector, a flat panel display, etc. The user may view the XR graphical object as an overlay anchored to a specific real-world object viewed through the perspective display screen. The XR headset 150 may additionally or alternatively be configured to display a video stream from cameras mounted to one or more XR headsets 150 and other cameras on the display device 438.

[0064] The electronic components of the XR headset 150 may include multiple cameras 430, microphones 432, a gesture sensor 434, an attitude sensor (e.g., an inertial measurement unit (IMU)) 436, a display device 438, and a wireless / wired communication interface 440. The camera 430 of the XR headset 150 may be a visible light capture camera, a near-infrared capture camera, or a combination of both.

[0065] The camera 430 may be configured to operate as the gesture sensor 434 by tracking recognized user gestures performed within the field of view of the camera 430. Alternatively, the gesture sensor 434 may be a proximity sensor and / or a touch sensor that senses gestures performed near the gesture sensor 434 and / or senses physical contact, such as tapping the gesture sensor 434 or its housing. The attitude sensor 436 (e.g., IMU) may include a multi-axis accelerometer, a tilt sensor, and / or another sensor that can sense the rotation and / or acceleration of the XR headset 150 along one or more defined coordinate axes. Some or all of these electronic components may be housed within the headset component housing or may be housed within another housing configured to be worn elsewhere (such as on the hip or shoulder).

[0066] As described above, the surgical system includes a camera tracking system 200 that may be connected to a computer platform 400 for operative processing and may provide additional operative functions including a navigation controller 404 and / or an XR headset controller 410. The surgical system may include a surgical robot 100. The navigation controller 404 may be configured to provide visual navigation guidance to an operator to move and position a surgical tool relative to the patient anatomy based on a surgical plan (e.g., from a surgical planning function) that defines where on the anatomy to perform a surgical procedure using the surgical tool and based on the attitude of the anatomy determined by the camera tracking system 200. The navigation controller 404 may also be configured to generate navigation information based on the target attitude of the surgical tool, the attitude of the anatomy, and the attitude of the end effector of the surgical tool and / or the surgical robot 100. The navigation information may be displayed via the display device 438 of the XR headset 150 and / or another display device to indicate where the surgical tool and / or the end effector of the surgical robot 100 should move to perform the surgical procedure according to the defined surgical plan.

[0067] The electronic components of the XR headset 150 may be operatively connected to the electronic components of the computer platform 400 via the wired / wireless interface 440. The electronic components of the XR headset 150 may be operatively connected to or directly connected to various imaging devices 420, such as a C-arm imaging device, an O-arm imaging device, other imaging devices, a patient image database, and / or other medical devices via the wired / wireless interface 440, for example, via the computer platform 400.

[0068] The surgical system may include an XR headset controller 410 that resides at least in part within the XR headset 150, computer platform 400, and / or another system component connected via a wired cable and / or wireless communication link. Software executed by the XR headset controller 410 provides various functions. The XR headset controller 410 is configured to receive information from the camera tracking system 200 and navigation controller 404 and generate XR images based on that information for display on the display device 438.

[0069] The XR headset controller 410 may be configured to operatively process tracking data frames from the camera 430 (tracking camera), signals from the microphone 1620, and / or information from the attitude sensors 436 and pose sensors 434 to generate information for display as an XR image on the display device 438 and / or for image display on other display devices for viewing by the user. Thus, the XR headset controller 410, illustrated as a circuit block within the XR headset 150, should be understood to be operatively connected to the other illustrated components of the XR headset 150 but not necessarily to reside within a common housing or be otherwise portable by the user. For example, the XR headset controller 410 may reside within the computer platform 400, which in turn may reside within the cabinet 330 of the camera tracking system 200, the cabinet 106 of the surgical robot 100, etc.

[0070] Bone surface acquisition by palpation (“painting”) using a spherical tip stylet:

[0071] Various embodiments relate to acquiring specific landmarks on bone by a process of palpating the bone surface using a tracked spherical tip stylet to register the patient's anatomy in an algorithm for computer-assisted navigation during surgery. The position of the bone landmark can be acquired and registered by a single touch of the tracked spherical tip stylet. The surface of the bone can be acquired and registered by, for example, multiple individual touches of the tracked spherical tip stylet by tapping and / or by touching and then maintaining contact with the surface while moving the ball along the surface (e.g., “painting” the surface while being tracked). Defined landmarks (e.g., the most distal point and posterior point) can be extracted, and other measurements of the bone surface can be performed, and simultaneously registered for computer-assisted navigation. The surface of the bone can be defined (recreated) based on a point cloud acquired by moving the ball of the tracked spherical tip stylet over the surface of the bone.

[0072] Figure 5 A spherical tip stylet 500 constructed in accordance with some embodiments of the present disclosure is shown. Refer to Figure 5, the spherical tip stylus 500 includes a ball 610 at the tip, which is connected to a reference element 602 of an array having a datum 504 through an interconnecting member 612. The datum 504 can be of any shape, such as a disc, a sphere, etc., can be of any color, and can be passive to reflect light or active to emit light.

[0073] The tip shape can have a significant impact on how easily and precisely a user can move the tip over the bone. It has been determined that a ball (spherical) tip slides more easily and consistently over the bone surface, but the radius of the tip needs to be considered when defining the position of the surface. The larger the ball radius, the easier the sliding ability, but the more difficult it is to access certain areas of the patient's bone (e.g., acetabular cartilage or the acetabular fossa of the pelvis).

[0074] A user (e.g., a surgeon) can manipulate the ball 610 of the spherical tip stylus 500 to sweep over the surface of the bone or cartilage. In doing so, the camera tracking system 200 can measure the position of the ball 610 during continuous operation and output a point cloud of positions. Alternatively, the user can subsequently measure a sufficient number of points by touching points one by one with the ball 610 of the spherical tip stylus 500 tracked by the camera tracking system 200.

[0075] The user can be guided by display and / or audible instructions generated by a software application (e.g., an algorithm for computer-aided navigation) to acquire a defined surface area of one or more bones. Figure 6 A user interface is shown on a display device as guiding a user through registration of the condylar surface 700 by using a spherical tip stylus 500 according to some embodiments of the present disclosure. Although reference Figure 6 shows the condylar surface, it should be noted that a similar process can be performed and similar information can be determined / identified for the patient's pelvis.

[0076] The user interface displays markers 702 to indicate that the user should use the spherical tip stylus 500 to palpate the distal condyle so that the system defines the surface of the distal condyle and registers the surface in an algorithm for computer-aided navigation during surgery.

[0077] The positions (points) acquired by the camera tracking system 200 correspond to the center of the ball 610 during user acquisition. These positions can be used to define an offset acquisition surface of the bone. Then, based on the radius of the ball 610, the offset acquisition surface can be translated to correspond to the actual surface of the bone. For some of these operations, the system can use a surface matching algorithm.

[0078] Figure 7A schematic diagram of an operation for defining and then translating an offset acquisition surface 810 of a bone 820 toward the surface of the bone 820 along a local normal vector based on the radius of a sphere 610 is shown. Refer to Figure 7 , in one exemplary embodiment, the operation includes acquiring the position of the center 800 of the sphere when the sphere 610 is used to palpate the surface of the bone 820. The positions of the center 800 of the sphere 610 are then connected together mathematically to define the offset acquisition surface 810 of the bone 820, which is offset from the true bone surface by a distance corresponding to the radius 802 of the sphere 610. To match the offset acquisition surface 810 to the true bone surface, the operation determines the local normal vector to the true bone surface for each acquired position of the center 800 of the sphere 610. The operation then translates each acquired position of the center 800 of the sphere 610 along the normal vector toward the bone 820 by a distance corresponding to the radius 802 of the sphere 610. These operations enable the surface to be defined in a manner that is agnostic to the orientation of the spherical tip stylet 500 (e.g., when not perpendicular to the palpation surface). Then, the acquisition surface of the bone corresponding to the true bone surface can be defined by connecting the translated positions together mathematically.

[0079] Landmarks associated with a surgical procedure (e.g., the most posterior condylar point and the most distal condylar point of the femur; the most distal point on the tibial plateau; etc.) can be extracted for planning and computer-assisted navigation. Based on this acquisition surface, a registration algorithm can then match the patient anatomy to a 3D model of the bone and / or identify additional landmarks for use in planning and computer-assisted navigation.

[0080] According to some embodiments, these operations can be generalized. Figure 19 A flowchart of operations that can be performed by a computer platform of a system for computer-assisted navigation during a surgical procedure is shown, according to some embodiments of the present disclosure.

[0081] Refer to Figure 19, the operation may include identifying 11000 the position of the fiducial 504 of the reference element 602 on the spherical tip stylet 500 in images obtained from the tracking camera 204 having at least partially overlapping fields of view, the tracking camera imaging the spherical tip stylet 500 with a ball 610 thereon, the spherical tip stylet palpating (contacting) the surface of the bone 820. The operation determines 11002 the position of the center 800 of the ball 610 based on the position of the fiducial 504 of the reference element 602. The operation defines 11004 the offset acquisition surface 810 of the bone based on mathematically connecting the positions of the center 800 of the ball 610. The operation determines 11006 the local normal vector 804 of the offset acquisition surface 810 for the position of the center 800 of the ball 610. The operation translates 11008 the offset acquisition surface 810 of the bone 820 along the local normal vector 804 by the radius 802 of the ball 610 towards the surface of the bone 820 to define the acquisition surface of the bone 820, which ideally precisely corresponds to the true surface of the bone 820.

[0082] The operation of translating 11008 the offset acquisition surface 810 of the bone 820 along the local normal vector 804 by the radius 802 of the ball 610 towards the surface of the bone 820 to define the acquisition surface of the bone 820 may include: translating 11010 the position of the center 800 of the ball 610 along the local normal vector 804 by the radius 802 of the ball 610 towards the surface of the bone 820 to define a first set of positions of the acquisition surface of the bone 820. The operation may then mathematically connect 11012 the positions of the acquisition surface of the bone 820 to define the acquisition surface of the bone 820.

[0083] As will be further explained in detail below, the operation may further include registering 11014 the acquisition surface of the bone 820 in an algorithm for computer-aided navigation during surgery, and / or displaying 11016 a graphical representation of the acquisition surface of the bone 820 in a planning view for computer-aided navigation during surgery.

[0084] Some additional embodiments relate to operations for detecting and processing outlier positions that do not correspond to the position where the ball 610 palpates (contacts) the bone 820. During measurement of the bone surface, it may be difficult or unnecessary to maintain contact with the bone surface. However, in the absence of operations for detecting and processing such outlier positions, these outlier positions may result in the acquisition of many irrelevant points, such as when the ball 610 moves towards the bone 820 to contact and / or away from the bone 820 for repositioning. In some embodiments, operations are used to process the acquired positions and prevent the use of outlier positions that are spaced apart from the bone surface when defining the offset acquisition surface or the acquisition surface of the bone. Outlier positions can be identified based on a comparison with other determined positions. For example, when positions are connected and a planar or curved path is produced, any position that deviates from the plane or the path by at least a threshold distance can be marked as an outlier position.

[0085] Operations for identifying and processing outliers may include, when defining the offset acquisition surface 11004 of the bone 820 based on the positions that mathematically connect the centers 800 of the balls 610, identifying outlier positions of the centers 800 of the balls 610 among the positions of the centers 800 of the balls 610, where the balls 610 do not palpate the surface of the bone 820. Then, the operation can define the offset acquisition surface 11004 of the bone 820 based on the positions that mathematically connect the centers 800 of the balls 610 and not based on the outlier positions of the centers 800 of the balls 610 (where the balls 610 do not palpate the surface of the bone).

[0086] The operation of identifying outlier positions of the centers 800 of the balls 610 among the positions of the centers 800 of the balls 610 (where the balls 610 do not palpate the surface of the bone 820) may include: identifying outlier positions of the centers 800 of the balls 610 from other positions of the centers 800 of the balls 610 that are within a second threshold distance in the direction along the offset acquisition surface 810, based on outlier positions of the centers 800 of the balls 610 that have at least a first threshold distance in the direction along the local normal vector 804 to the offset acquisition surface 810, where the balls 610 do not palpate (contact) the surface of the bone 820.

[0087] Example operations for acquiring femoral and / or tibial features and axes are now described, and these operations can be similarly performed to acquire pelvic features and axes. Figure 21 A schematic diagram of operations for acquiring femoral and / or tibial features according to some embodiments of the present disclosure is shown. Although reference Figure 21 Example femoral and / or tibial features are acquired, but similar operations / steps can be performed to acquire / identify other features of the patient (e.g., features of the pelvis).

[0088] Reference Figure 21, the acquisition of features and other landmarks on the anterior and distal surfaces of the femur and tibial plateau by palpation can be performed with the spherical tip stylet 500. For example, these areas are naturally exposed, such as for the femur, or can be easily accessed, such as through excessive flexion of the joint, which provides easy access to approximately 75% of the tibial plateau. However, the posterior portion of the condylar surface is difficult to acquire by palpation with an appropriate level of usability. From a clinical perspective, it may be necessary to acquire the posterior condylar aspect to determine the posterior condylar axis 910, which is an option for setting the internal rotation and / or external rotation of the femoral component during planning.

[0089] The procedures disclosed herein can be used to acquire the posterior portion of the condylar surface using the Whiteside line 920 and / or the supracondylar axis 900 of the femur.

[0090] In this method of operation, two acquisition steps are used. In one step, the landmarks on the anterior and distal surfaces of the femur are acquired, and partial registration of the femur is performed. The acquisition of the tibial plateau and the complete registration of the tibia are performed. Tibial resection is performed. Then, in another step, the acquisition of the posterior surface of the femoral condyle is performed.

[0091] For this method of operation, in Figure 19 the context of, the acquisition surface of the bone can define the anterior and distal surfaces of the femur palpated by the sphere 610. The corresponding operations for one of the steps can include: acquiring the position of the tibial plateau based on the positions of the anterior and distal surfaces of the femur defined by the acquisition surface of the bone (e.g., Figure 19 11000 to 11008 in Figure 19 ). The position of the tibia in the tracking space can be registered based on the acquired position of the tibial plateau (e.g.,

[0092] 11014 in Figure 22 ). The corresponding operations for the other step can include: after tibial resection, operating to identify the position of the fiducial 504 of the reference element 602 on the spherical tip stylet 500 in other images obtained from the tracking camera 204, which images the spherical tip stylet 500 with the sphere 610 that palpates (contacts) the posterior surface of the femoral condyle. This operation determines the position of the center of the sphere 610 based on the position of the fiducial of the reference element, and defines an offset acquisition surface of the posterior surface of the femoral condyle based on mathematically connecting the positions of the center of the sphere 610. This operation determines the local normal vector of the offset acquisition surface of the posterior surface of the femoral condyle for the position of the center of the sphere 610, and translates the offset acquisition surface of the posterior surface of the femoral condyle towards the posterior surface of the femoral condyle along the local normal vector based on the radius of the sphere 610 to define the acquisition surface of the posterior surface of the femoral condyle.

[0092] A second method of operation can use the tibia registered with its reference element 520 as a navigation instrument to acquire the posterior condylar axis. Figure 22A schematic diagram showing the structure and operation of a second method of operation that can be used to acquire femur and / or tibia features. In Figure 22 , the virtual plane 1002 is illustrated as being attached to the femur and determined using landmarks such as the mechanical axis and the superior distal aspect of the femur. Another virtual plane 1004 is illustrated as being attached to the tibia and determined by landmarks such as the mechanical axis and the proximal geometry. Another virtual plate 1000 extends perpendicular to the virtual plane 1002 through the tibia to intersect the virtual plane 1004. The intersection of the virtual plane 1000 and the virtual plane 1004 is illustrated as occurring at position 1010, which corresponds to acquiring the posterior condylar axis using the registered tibia.

[0093] Corresponding operations may include acquiring the position of the tibial plateau based on the position of the anterior and distal surfaces of the femur defined by the acquisition surface of the bone (e.g., Figure 19 11000 to 11008 in Figure 19 ). The position of the tibia in the tracking space can be registered based on the acquired position of the tibial plateau (e.g.,

[0094] 11014 in

[0095] ). When the ball 610 palpates the femur, the operation identifies the position of the fiducial of the tibial reference element 520 attached to the tibia and the position of the fiducial of the femoral reference element 510 attached to the femur in the image obtained from the tracking camera 204. The operation acquires the position of the posterior condylar axis based on the registered position of the tibia and based on the positions of the fiducials of the identified tibial reference element 520 and femoral reference element 510.

[0096] The operation of acquiring the position of the posterior condylar axis based on the registered position of the tibia and based on the positions of the fiducials of the identified tibial reference element 520 and femoral reference element 510 may include determining a distal femoral plane that will be virtually attached to the femur and pass through the posterior surface of the femoral condyle. The operation can acquire the position of the tibial plateau based on the position of the anterior and distal surfaces of the femur defined by the acquisition surface of the bone and based on the position of the fiducial of the identified tibial reference element 520. The operation can determine a proximal tibial plane that is virtually attached to the tibia and determine the posterior condylar axis based on the movement of the position of the fiducial of the tracking tibial reference element 520 relative to the position of the fiducial of the femoral reference element 510 when the tibia rotates relative to the femur.

[0097] The second set of embodiments is now discussed below.

[0098] In these embodiments, the above-described systems and embodiments (along with additional / alternative embodiments discussed below) are used to assist in total hip arthroplasty surgery. For example, the systems and embodiments can be used to prepare bone (e.g., pelvic acetabulum and femur) and place corresponding implants within a patient.

[0099] Certain landmarks and / or planes can be used to register or determine a patient's orientation within the 3D space of the operating room. For example, as part of a computer-assisted navigation workflow during surgery, the system can record or determine the orientation of a patient's anterior pelvic plane (APP) and / or functional pelvic plane (FPP) to determine the patient's orientation on the operating table during total hip arthroplasty (THA) surgery.

[0100] The system can provide computer-assisted navigation throughout the continuum of care (pre-operative, intra-operative, and post-operative). Thus, the system can be configured to perform multiple workflows. Some workflows use scans of the patient (X-rays, computed tomography (CT)) obtained during pre-operative steps.

[0101] In some embodiments of the present disclosure, the system performs an image-free workflow in which pre-operative images are not used. Information regarding a patient's anatomy within the operating room (OR) can be obtained by a surgeon using the system to measure key parameters of the patient's bone. For example, the computer platform of the system operates to identify the location of landmarks (e.g., points, axes, and / or surfaces) on the bone and register the location either simultaneously with or after the identification. The location can be used to define a reference plane (e.g., APP and / or FPP), which in turn is used to plan the implant and navigate robotic and surgical instruments for the THA surgical procedure.

[0102] In some embodiments, the only pre-operative usage associated with the image-free workflow can be an initial patient assessment. A surgeon can evaluate a patient's mobility and health status with the help of sensors (e.g., a sensor attached to the leg manufactured by Globus Medical), physical exercise, and / or clinical surveys to determine whether THA is recommended. The data collected can then be stored and processed by the system for ease of final decision-making before being analyzed by the surgeon. Subsequently, the data can be reused by an application (e.g., Globus Medical's surgical planning application) to determine the most appropriate implant surgical plan.

[0103] Figure 8 A flowchart of an image-free workflow during the intra-operative portion of a THA surgery in accordance with some embodiments of the present disclosure is shown.

[0104] In some embodiments, after the patient is positioned on the operating table (step 2000), some of the operations discussed above and below can be performed during step 2002 to register the patient and before another step 2004 for intraoperative computer-navigated surgery. In terms of the hip, the patient's pelvis or acetabulum is registered in the tracking coordinate system of the camera tracking system 200. As Figure 1 shown, the pelvis or acetabulum is registered in the optical coordinate system. In one embodiment, registration is performed in an image-free mode without using any medical images (such as X-ray or CT images) from an imaging device.

[0105] Figure 9 A flowchart of a patient preparation process before registration according to some embodiments of the present disclosure is shown.

[0106] The patient preparation process can start with the patient positioned in a lateral or supine position on the OR table. The patient's body is prepared for registration.

[0107] Optionally, in step 3000, EKG / ECG patch electrodes are attached to the distal end of the patient's femur. The EKG / ECG patch electrodes can be placed at or slightly below the center of the patella. In some potentially preferred embodiments, the patch position is aligned with the anatomical axis of the femur. The patch can be used to collect the most distal point under the drape of the femur at a subsequent stage. The patch can be used to track the femur in space (e.g., when the patient's leg moves during surgery) and can also be used to assist in measuring the patient's leg length. However, in some embodiments, this operation (step 3000) is skipped.

[0108] In some embodiments, the EKG / ECG patch electrodes include adhesive patches removably attached to the patient. In some preferred embodiments, the patches can be black or dark-colored for better visibility to the tracking camera. In other embodiments, the patch electrodes are not visible to the tracking camera when they are under the drape. The patch is invisible to the camera (it is under the patient's drape). The geometry of the patch (such as papillary) will help the surgeon always touch a single point on the distal part (anterior patellar region) of the femur with a navigation stylet / instrument that can be tracked by the tracking camera. This ensures that the physician always collects the same point to measure leg length or medio-lateral offset.

[0109] In step 3002, the patient's body is draped. Then, depending on the surgeon's technique, with the help of cortical pins drilled into the pelvic bone, the navigated pelvic dynamic reference base (DRB) marker array (also referred to herein as the reference element) is placed inside the incision (steps 3006 to 3008) or outside the incision (step 3004). In some embodiments, the DRB is oriented for mounting on the camera tracking system (e.g.,Figure 1 The tracking camera (e.g., a stereo tracking camera) on the camera tracking system 200) or the head-mounted headset (e.g., Figure 1 the XR head-mounted headset 150) is visible.

[0110] In one embodiment, the operation of placing the reference element within the incision includes using the system to track and navigate to the access to the joint space (step 3006), and then placing the reference element within the incision simultaneously.

[0111] In an alternative embodiment, the reference element is placed outside the incision (step 3004), and the system does not necessarily need to be used to track and navigate to the access to the joint space.

[0112] After the reference element has been placed within or outside the incision, data points and axes can be collected on the patient's anatomy with the assistance of a navigation instrument and using the pelvic DRB coordinate system as a spatial reference. In addition, two pelvic reference planes can be established to plan the placement of the implant by measuring angular deviations, such as Figures 10A to 10B the tilt angle and the twist angle of the acetabular cup implant as shown.

[0113] Figure 10A shows the radiographic tilt angle measured in the coronal plane of the patient according to some embodiments of the present disclosure. In some embodiments, the surgeon can use the navigation instrument to palpate or map the surface of the patient's acetabular cavity to determine the center of rotation of the acetabulum, for example, as discussed in more detail below.

[0114] Figure 10B shows the radiographic twist angle measured relative to the coronal plane of the patient according to some embodiments of the present disclosure.

[0115] The two pelvic reference planes (or coronal planes or frontal planes) are referred to as the anterior pelvic plane (APP) and the functional pelvic plane (FPP). They are determined or defined using different landmarks and axes, as Figure 11 shown and described in more detail below.

[0116] It should be understood herein that although the user interface and the associated operations are described as being performed in a specific order, they can be performed in other orders while still within the disclosed embodiments (all embodiments disclosed in the present disclosure). In addition, not all of the user interfaces and / or the described operations need to be performed. Instead, fewer operations can be performed while still within the disclosed embodiments.

[0117] During the patient registration process, single-point palpation collection or surface mapping (generating a point cloud of positions) can be used to extract landmarks for registering the patient's anatomy.

[0118] Figure 11 Shows different views of landmarks and axes for registration of the functional pelvic plane (FPP) and the anterior pelvic plane (APP) for a patient, according to some embodiments of the present disclosure.

[0119] The landmarks and axes for registering the APP and FPP planes are described in Figure 12 and Figure 15 in more detail. In some embodiments, the computer platform guides the surgeon to touch these landmarks for the computer platform to acquire or identify.

[0120] Figure 12 Shows a flowchart for registering the APP and FPP of a patient, according to some embodiments of the present disclosure.

[0121] For APP plane registration, the accessibility of the landmarks can depend on the patient position selected on the OR table (i.e., supine or lateral position).

[0122] If the patient is in the supine position on the OR table, a navigation instrument (in this case a stylet) can be used to acquire or identify (step 6002) the left anterior superior iliac spine (ASIS), acquire or identify (step 6004) the right ASIS, and acquire or identify (step 6006) the pubic symphysis. These landmarks (i.e., left ASIS, right ASIS, and pubic symphysis) can then be used to determine the orientation of the patient's APP.

[0123] Alternatively, if the patient is in the supine or lateral position, one of two navigation instruments discussed in more detail below can be used to establish the APP (step 6008).

[0124] For FPP plane registration, in the supine or lateral position, one of the following navigation instruments can be used to establish (step 6010) the coronal plane. For example, by acquiring or identifying the inferior - superior axis, left - right axis, and / or anterior - posterior axis of the patient.

[0125] The operation workflows of two navigation instruments that can be used to establish the APP (step 6008) or establish the coronal plane (step 6010) are described below.

[0126] Figures 13A to 13C Shows an example of registering (i.e., establishing) the APP and / or FPP using the tracking marker plane of a navigation instrument, according to some embodiments of the present disclosure.

[0127] The first design (at Figures 13A to 13C) can be a completely passive navigation device 1100. The navigation device 1100 can include a reference 1160 on a reference element of the navigation device 1100. These references 1160 can form a navigation device tracking marker plane, which is a plane formed by the intersection of these references 1160. It should be noted that although Figures 13A to 13C Four fiducials are shown in FIG, but any number of fiducials may be used to form a navigation instrument tracking marker plane.

[0128] like Figures 13B to 13C As shown, the instrument can be positioned by the surgeon so that the plane of the reference is parallel to the APP or FPP of the patient's pelvis. Once the plane is parallel to the APP or FPP, the surgeon can trigger capture of the plane through the system (e.g., by depressing a foot pedal); thereby, the APP and / or FPP is established using the navigation instrument.

[0129] In some embodiments, the tracking marker plane is positioned parallel to the APP or FPP while the navigation instrument palpates the patient's landmarks.

[0130] Figure 14 An example of registering an APP and / or FPP using the axes of a navigation instrument and a tracking camera with a built-in inertial measurement unit (IMU) is shown according to some embodiments of the present disclosure.

[0131] This second design (in Figure 14 ) may include: (1) a passive and tracked registration rod (or bar) 1210 that is attached to or forms part of the navigation apparatus 1200, and the tracked registration rod 1210 can be used by the surgeon to identify the longitudinal axis of the patient (i.e., the inferior-superior axis) by aligning the rod 1210 to be parallel to the inferior-superior axis of the patient; and (2) an active inertial measurement unit (IMU) sensor that measures a gravity vector that can be used to identify the anterior-posterior axis of a patient in the supine position or the left-right axis of a patient in the lateral position. This can be determined because the gravity vector may be perpendicular to the coronal plane when the patient is supine on the OR table. Alternatively, the gravity vector may be parallel to the coronal plane when the patient is lateral.

[0132] In some embodiments, the tracked registration rod can be maintained parallel to the inferior-superior axis of the patient while palpating the patient's landmarks.

[0133] Alternatively, the data collected from the IMU may be provided by the same navigation apparatus 1200 or another device in the system, such as another device with an IMU sensor (e.g., a tracked power tool such as a drill, hand-held saw, etc.), another camera, an XR headset (e.g., Figure 1 XR headset 150) etc.

[0134] Figure 15 A flowchart showing operations for measuring a patient's leg length and offset according to some embodiments of the present disclosure.

[0135] After APP and / or FPP plane registration, the hip joint space and the distal portion of the femur can be contacted (step 9014) (see Figure 15 the left side of Figure 15 to collect (step 9016) the initial or preoperative leg length and the positioning offset of the medial-lateral femur. As

[0136] shown on the right side of Figure 9 , two points can be collected or identified to determine the position of the femur relative to the pelvis.

[0137] Optionally, for the first measurement or a measurement prior to the measurements discussed below, the system can guide the surgeon to create a landmark (step 9002) on the patient's proximal femur. The landmark can correspond to a landmark defined by the surgeon, such as a cross-section on the bone anatomy, which can allow the computer platform to create a line in 3D space relative to the patch (e.g., the patch placed in

[0138] step 3000 of

[0139] Once the patch is also identified (step 9010). Figure 9 In step 9004, the femur can be positioned at a known location. For example, the system can guide the surgeon to position the patient's femur at a specific location known to the system.

[0140]

[0141] Figure 16 A flowchart showing operations for registering a patient's pelvic acetabulum according to some embodiments of the present disclosure.

[0142] To define the APP and FPP origins, the system guides the surgeon to remove (step 10002) the patient's femoral head from the acetabular cavity, thereby determining the pelvic acetabular rotation center. The acetabular cavity can be made accessible by cutting the femoral neck and removing the femoral head from the acetabular cavity. In some embodiments, a corkscrew instrument can be used to remove the femoral head from the acetabular cavity. The surface of the acetabular cavity can then be mapped (step 10004) using a navigation instrument (e.g., a stylet).

[0143] Figure 17 An operation of mapping the acetabular cavity 1302 with the navigation instrument 1300 according to some embodiments of the present disclosure is shown. The surgeon uses the navigation instrument 1300 (e.g., a stylet) to palpate the surface of the acetabular cavity 1302, and the tracking camera measures the position of the ball at the end of the stylet in a continuous manner and provides a point cloud for the measured positions (localizations). At the same time, the tracking camera can also monitor and track the pose of the patient DRB 116 attached to the pelvis, such that the pose of the stylet can be tracked relative to the pose of the patient DRB. Alternatively, the surgeon can subsequently measure a predetermined number or percentage of points by palpating one by one. Based on these points and the tracking data of the stylet and the patient DRB, the rotation center of the pelvic acetabulum is determined. Additionally, based on these points, the surface of the acetabular cavity can be registered in the system, and / or a 3D model can be generated or modified based on these points.

[0144] Next, the system can recreate (e.g., in a 3D model) the acetabular cavity shape based on the measured point cloud and using other algorithms, e.g., for outlier removal and surface fitting.

[0145] Optionally, the deepest point in the acetabular fossa can be identified or acquired (step 10006) to provide information about the maximum acetabular reaming depth. For example, the ball of the stylet can be pressed into the acetabular fossa, and the identified deepest point can be acquired or identified by the system as the deepest point in the acetabular fossa. Alternatively, when mapping the acetabular cavity with the navigation instrument, the deepest point in the acetabular fossa can be determined as the deepest point among the points identified or acquired during the mapping of the acetabular cavity. In some embodiments, step 10006 can be the final step for the surgeon in a non-image workflow for registering the patient.

[0146] In a manner similar to the preoperative patient assessment, the postoperative patient assessment can be performed by the surgeon to evaluate the quality of the THA surgery and the benefits to the patient. The workflow can include patient mobility assessment, e.g., using data collected from physical exercise and sensor feedback (e.g., attached to the leg), and it can be compared with a clinical survey to confirm the patient's health status. All collected postoperative information can be automatically compared by the system with the preoperative information.

[0147] Figure 18A user interface for a planning view is shown, which displays a graphical representation of a bone with extracted (e.g., registered) landmarks (shown as bright spots), and a graphical representation of the surface that has been acquired through a palpation operation. Although the image represents the knee, a similar image can be used to display the pelvis, where its acetabulum is shown and landmarks are acquired.

[0148] Bone palpation operations can acquire and extract landmarks in many ways, and they can vary based on whether the operation is for a computer-assisted navigation program (e.g., robotic) or a manual navigation program, and whether the operation is for a non-image or CT-based program.

[0149] For example, in a patient registration workflow for a computer-assisted navigation program or a manual navigation program with non-image or CT-based images, bone palpation operations can be used to acquire and extract landmarks.

[0150] In a workflow for displaying a 3D model of a bone for a computer-assisted navigation program: for a non-image process, a generic bone model can have dimensions updated based on landmarks acquired and extracted through bone palpation operations; or for a CT-based image process, a reconstructed 3D model of the patient's anatomy can be generated based on preoperative CT images and landmarks acquired and extracted through bone palpation operations.

[0151] In a workflow for displaying a 3D model of a bone for a manual navigation program: for a non-image process, a generic bone model may not have dimensions updated based on landmarks acquired and extracted through bone palpation operations; or for a CT-based image process, a reconstructed 3D model of the patient's anatomy can be generated based on preoperative CT images and may or may not be based on landmarks acquired and extracted through bone palpation operations.

[0152] In a workflow for displaying a navigation instrument together with a bone model for a computer-assisted navigation program: for a non-image process, no navigation instrument can be displayed together with the 3D bone model; or for a CT-based image process, a navigation saw blade can be displayed together with the 3D bone model.

[0153] In a workflow for displaying a 3D model of a bone for a manual navigation program, for non-image or CT-based image processing, navigation guidance can be displayed together with the 3D bone model to guide the user in inserting a cut block locator pin.

[0154] Figure 20 A flowchart of additional or alternative operations performed by a computer platform (e.g., Figure 4 computer platform 400) of a system for computer-assisted navigation during a surgical procedure on a patient is shown according to some embodiments of the present disclosure.

[0155] In some embodiments, a computer platform is operable to identify a set of locations at which a navigation instrument (e.g., the stylus of Figure 5 or the navigation instrument of Figures 13A to 14 ) is palpating landmarks defined on the surface of a patient's pelvic bone. For example, this operation can be similar to the operations / steps 6002 to 6010 of Figure 12 , the operations / steps 9006 and 9010 of Figure 15 , and the operations / steps 10004 to 10006 of Figure 16 . Figure 5 the stylus of Figures 13A to 14 the navigation instrument) is palpating landmarks defined on the surface of a patient's pelvic bone. For example, this operation can be similar to Figure 12 the operations / steps 6002 to 6010, Figure 15 the operations / steps 9006 and 9010, and Figure 16 the operations / steps 10004 to 10006.

[0156] The computer platform is also operable to determine, based on the identified set of locations at which the navigation instrument is palpating landmarks, the center of rotation of the patient's pelvic acetabulum. For example, the center of rotation of the pelvic acetabulum can be performed similar to at least a portion of the operations / steps performed with reference to Figure 16 . Figure 16 performed with reference to

[0157] The computer platform is further operable to determine, based on the identified set of locations at which the navigation instrument is palpating landmarks and based on the determined center of rotation of the pelvic acetabulum, the orientation of the patient's anterior pelvic plane (APP) and / or functional pelvic plane (FPP). For example, these operations can be performed similar to the operations of Figure 12 . Figure 12 performed with reference to

[0158] In some embodiments, to determine the orientation of the APP, the landmarks are defined as the right ASIS, left ASIS, and pubic symphysis of the patient's pelvic bone. Alternatively, in some embodiments, to determine the orientation of the APP based on the identified set of locations at which the navigation instrument is palpating landmarks, the computer platform is further operable to identify the inferior - superior axis, left - right axis, and / or anterior - posterior axis of the patient's pelvic bone.

[0159] In some embodiments, to determine the orientation of the FPP based on the identified set of locations at which the navigation instrument is palpating landmarks, the computer platform is further operable to identify the inferior - superior axis, left - right axis, and / or anterior - posterior axis of the patient's pelvic bone. For example, the identification of the inferior - superior axis, left - right axis, and / or anterior - posterior axis of the patient's pelvic bone can be performed similarly to that described with reference to Figure 14 . In some embodiments, when determining the center of rotation of the pelvic acetabulum, the landmarks are defined as the deepest point of the acetabular fossa of the pelvic bone. Figure 14 described with reference to

[0160] In some embodiments, when the navigation instrument is palpating landmarks, the inferior - superior axis is identified by a rod on the navigation instrument that is parallel to the inferior - superior axis.

[0161] In some embodiments, the computer platform is also operable to identify another location at which the navigation instrument is palpating the deepest point on the acetabular fossa. The computer platform is also operable to determine a maximum acetabular reaming depth based on the identified another location at which the navigation instrument is palpating the deepest point on the acetabular fossa.

[0162] In some embodiments, the orientation of the APP and / or FPP and the center of rotation of the pelvic acetabulum are determined without using preoperative images.

[0163] In some embodiments, the computer platform is also operable to register the determined orientation of the APP and / or FPP in an algorithm for computer-assisted navigation during surgery. Additionally, in some embodiments, the computer platform is also operable to display a graphical representation of the determined orientation of the APP and / or FPP in a planning view for computer-assisted navigation during surgery.

[0164] In some embodiments, after determining the orientation of the APP and / or FPP based on the identified set of locations at which the navigation instrument is palpating landmarks and based on the determined center of rotation of the pelvic acetabulum, the computer platform further operates to identify a first location separate from the set of locations at which the navigation instrument is palpating the proximal femoral trochanteric region at least near the exit point of the femoral anatomical axis. In these embodiments, the computer platform is also operable to identify a second location separate from the set of locations at which the navigation instrument is palpating the distal portion of the femur at which an electrocardiogram (EKG) patch electrode is located on the patient. Additionally, in some embodiments, the computer platform is also operable to determine the length of the patient's leg and the medio-lateral femoral positioning offset based on the identified first location and the identified second location.

[0165] Additionally, in these embodiments, after the patient's femur is placed in a known position, the identification of another location separate from the set of locations is performed at which the navigation instrument is palpating the proximal femoral trochanteric region at least near the exit point of the femoral anatomical axis.

[0166] In some embodiments, the navigation instrument includes a spherical tip stylet. For example, the spherical tip stylet can correspond to Figure 5A spherical tip stylet. The computer platform is operable to identify a set of positions at which the navigation instrument is palpating a landmark by identifying the position of a fiducial of a reference element on the spherical tip stylet in images obtained from a tracking camera having at least partially overlapping fields of view, the tracking camera imaging the spherical tip stylet with a ball thereon that is palpating the surface of a bone. Additionally, the computer platform is operable to: identify the set of positions by determining the position of the center of the ball based on the position of the fiducial of the reference element; define an offset acquisition surface of the bone based on mathematically connecting the positions of the centers of the balls; determine a local normal vector of the offset acquisition surface for the position of the center of the ball; and translate the offset acquisition surface of the bone towards the surface of the bone along the local normal vector based on the radius of the ball to define an acquisition surface of the bone.

[0167] In some embodiments, the computer platform is further operable to determine a center of rotation of the pelvic acetabulum of a patient based on the identified set of positions at which the navigation instrument is palpating a landmark including the interior of the acetabular cavity of the patient, and to determine a starting point of the APP and / or FPP based on the center of rotation of the pelvic acetabulum of the patient. In these embodiments, the determination of the center of rotation of the pelvic acetabulum of the patient may be performed after the femoral head of the patient's femur has been removed from the acetabular cavity. Additionally or alternatively, the computer platform is further operable to generate a model of the shape of the acetabular cavity based on the identified set of positions at which the navigation instrument is palpating a landmark including the interior of the acetabular cavity of the patient.

[0168] In some embodiments, the computer platform is further operable to register at least one of the determined orientation of the APP, the determined orientation of the FPP, and the determined center of rotation of the pelvic acetabulum in an algorithm for computer-assisted navigation during a surgical procedure.

[0169] In some embodiments, the orientation of the patient's APP and / or FPP is also determined based on the gravity vector of the built-in inertial measurement unit (IMU) of the system's tracking camera.

[0170] As described above and generally speaking, there can be at least two different methods of registering the pelvis without an image to the tracking coordinates (e.g., an optical coordinate system) of a tracking system. In both methods, for example, the center of rotation of the acetabulum is determined based on touching multiple points on the inner acetabulum with a navigation instrument / probe 1100 or by palpation with continuous surface point plotting without lifting the navigation instrument / probe 1100. In the first method, the FPP is derived by the physician aligning a plane or axis defined by the navigation instrument along the FPP or parallel to the FPP. Once the center of rotation and the FPP are determined, the system (navigation system or combined navigation and robotic system 100) has sufficient information to register the acetabulum in the coordinate system (e.g., an optical coordinate system) of the camera tracking system 200. The registration may allow the navigation system or robotic system to track any navigation instrument or end effector or any tool attached to the end effector relative to the pelvis, as tracked by the patient dynamic reference base 116 attached to the pelvis.

[0171] In a second embodiment, the APP is derived by touching different known points (e.g., left ASIS and right ASIS and the pubic symphysis) with the navigation instrument or by the physician aligning a plane or axis defined by the navigation instrument along the APP or parallel to the APP. Once the center of rotation and the APP are determined, the system (navigation system or combined navigation and robotic system 100) has sufficient information to register the acetabulum in the coordinate system (e.g., an optical coordinate system) of the camera tracking system 200.

[0172] In both of the above methods, the tracking system can continuously monitor and track the pose of the patient DRB 116 attached to the pelvis while also tracking the navigation instrument 1100, such that the pose of the instrument can be tracked relative to the pose of the patient DRB, at least for the purpose of registering the pelvis relative to the patient DRB 116 in the tracking coordinate system of the camera tracking system 200.

[0173] Further definitions and embodiments :

[0174] In the above description of various embodiments of the inventive concept, it should be understood that the terms used herein are for the purpose of describing particular embodiments only and are not intended to limit the inventive concept. Unless otherwise defined, 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 the inventive concept pertains. It should also be understood that terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of this specification and the relevant art, and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0175] When an element is referred to as being "connected", "coupled", "responsive" or variations thereof to another element, the element can be directly connected, coupled or responsive to the other element or intervening elements may be present. In contrast, when an element is referred to as being "directly connected", "directly coupled", "directly responsive" or variations thereof to another element, no intervening elements are present. Throughout, like numbers refer to like elements. Additionally, as used herein, "coupled", "connected", "responsive" or variations thereof can include wireless coupling, connection or response. As used herein, the singular forms "a", "an" and "the" are intended to also include the plural forms unless the context clearly dictates otherwise. Well-known functions or constructions may not be described in detail for the sake of brevity and / or clarity. The term "and / or" includes any and all combinations of one or more of the associated listed items.

[0176] It should be understood that although the terms "first", "second", "third", etc. may be used herein to describe various elements / operations, these elements / operations are not to be limited by these terms. These terms are only used to distinguish one element / operation from another. Thus, a first element / operation in some embodiments may be referred to as a second element / operation in other embodiments without departing from the teachings of the inventive concept. Throughout the specification, like reference numerals or like reference indicators denote the same or similar elements.

[0177] As used herein, the terms "comprising", "including", "having" or variations thereof are open-ended and include one or more of the stated features, integers, elements, steps, components or functions but do not preclude the presence or addition of one or more other features, integers, elements, steps, components, functions or groups thereof. Additionally, as used herein, the common abbreviation "e.g.", which is derived from the Latin phrase "exempli gratia", can be used to introduce or specify one or more general examples of a previously mentioned item and is not intended to limit such item. The common abbreviation "i.e.", which is derived from the Latin phrase "id est", can be used to specify a particular item from a more general recitation.

[0178] This document describes example embodiments with reference to block diagrams and / or flowchart illustrations of computer-implemented methods, apparatus (systems and / or devices), and / or computer program products. It should be understood that the blocks of the block diagrams and / or flowchart illustrations, and combinations of blocks in the block diagrams and / or flowchart illustrations, can be implemented by computer program instructions executed by one or more computer circuits. These computer program instructions can be provided to a processor circuit of a general-purpose computer circuit, a special-purpose computer circuit, and / or other programmable data processing circuits to produce a machine such that the instructions executed via the computer and / or other programmable data processing devices transform and control transistors, values stored in memory locations, and other hardware components within such circuits to implement the functions / actions specified in the block diagrams and / or one or more flowchart blocks, and thereby create means (functions) and / or structures for implementing the functions / actions specified in the block diagrams and / or flowchart blocks.

[0179] These computer program instructions can also be stored in a tangible computer-readable medium, and these computer program instructions can direct a computer or other programmable data processing device to operate in a specific manner such that the instructions stored in the computer-readable medium produce an article of manufacture that includes instructions for implementing the functions / actions specified in the block diagrams and / or one or more flowchart blocks. Accordingly, embodiments of the inventive concept can be embodied in hardware and / or software (including firmware, resident software, microcode, etc.), which runs on a processor such as a digital signal processor, and the processor can be collectively referred to as "circuits", "modules", or their variants.

[0180] It should also be noted that in some alternative specific implementations, the functions / actions indicated in the blocks may not occur in the order indicated in the flowchart. For example, two consecutively shown blocks may actually be executed substantially simultaneously, or the blocks may sometimes be executed in the reverse order, depending on the functions / actions involved. Additionally, the function of a given block of the flowchart and / or block diagram can be divided into multiple blocks, and / or the functions of two or more blocks of the flowchart and / or block diagram can be at least partially integrated. Finally, other blocks can be added / inserted between the shown blocks, and / or blocks / operations can be omitted, without departing from the scope of the inventive concept. Moreover, although some of the illustrations in the diagrams include arrows on communication paths to indicate the primary communication direction, it should be understood that communication can occur in a direction opposite to the depicted arrows.

[0181] Many variations and modifications can be made to the embodiments without substantially departing from the principles of the inventive concept. All such variations and modifications are intended to be included within the scope of the inventive concept herein. Accordingly, the subject matter disclosed above should be considered illustrative and not restrictive, and the appended exemplary embodiments are intended to cover all such modifications, enhancements, and other embodiments that fall within the spirit and scope of the inventive concept. Thus, to the maximum extent permitted by law, the scope of the inventive concept will be determined by the broadest permissible interpretation of this disclosure, which includes the following exemplary embodiments and their equivalents, and should not be limited or restricted by the foregoing detailed description.

Claims

1. A system for computer - assisted navigation during a surgical procedure, the system comprising a computer platform operable to: Identify a set of locations on the surface of a patient's pelvic bone, at which a navigation instrument palpates when a tracking system tracks the navigation instrument; Determine a center of rotation of the patient's pelvic acetabulum based on the identified set of locations; While the tracking system tracks the navigation instrument, use the navigation instrument to determine the orientation of the patient's anterior pelvic plane (APP) and / or functional pelvic plane (FPP); Register the pelvis in the coordinate system of the tracking system based on the determined APP or FPP and the determined center of rotation of the pelvic acetabulum.

2. The system according to claim 1, wherein, in order to determine the orientation of the APP, the computer platform records the position of the right anterior superior iliac spine, the position of the left anterior superior iliac spine, and the position of the pubic symphysis of the patient's pelvic bone based on the tracking of the navigation instrument by the tracking system.

3. The system according to claim 1, wherein, in order to determine the orientation of the FPP, the computer platform is further operable to: Identify the inferior - superior axis, left - right axis, and / or anterior - posterior axis of the patient's pelvic bone based on the tracking of the navigation instrument by the tracking system.

4. The system according to claim 3, wherein the computer platform identifies the inferior - superior axis by recording the attitude of the navigation instrument when a rod located on the navigation instrument is parallel to the inferior - superior axis.

5. The system according to claim 1, wherein, in order to determine the orientation of the APP, the computer platform is further operable to: Record the attitude of the navigation instrument when the navigation instrument identifies the inferior - superior axis, left - right axis, and / or anterior - posterior axis of the patient's pelvic bone.

6. The system according to claim 1, wherein when identifying a set of locations on the surface of the patient's pelvic bone, the computer platform is operable to continuously track the attitude of the navigation instrument and a patient - dynamic reference base attached to the pelvis.

7. The system according to claim 1, wherein the computer platform is further operable to: Identify another location at which the navigation instrument is in contact with the deepest point on the acetabular fossa; and Determine a maximum acetabular reaming depth based on the identified another location.

8. The system according to claim 1, wherein the orientation of the APP and / or the FPP and the center of rotation of the pelvic acetabulum are determined without using preoperative images.

9. The system according to claim 1, wherein the computer platform is further operable to: Display a graphical representation of the determined orientation of the APP and / or the FPP in a planning view for computer - assisted navigation during a surgical procedure.

10. The system according to claim 1, the computer platform is further operable to: Identify a first location separate from the set of locations, at which the navigation instrument palpates the proximal greater trochanter region that is at least close to the exit point of the femoral anatomical axis. Identify a second location separate from the set of locations at which a known location of the distal portion of the femur is palpated by the navigation instrument; and Determine the length of the patient's leg and the mediolateral femoral positioning offset based on the identified first location and the identified second location.

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