Surgical robot controller with suction volume for hip joint procedures

Abstract

This invention provides a surgical robot and related methods for use in total hip arthroplasty (THA) procedures. [Solution] In some cases, the surgical robot includes a robotic arm for holding surgical instruments and a controller coupled to the robotic arm, the controller being programmed to detect the position of the surgical instrument in at least one adsorption volume, which corresponds to a planned trajectory of the surgical instrument for a THA procedure and is partially defined by a point and an axis extending from the point, and to provide assistance for the movement of the surgical instrument in the direction toward the at least one adsorption volume while the surgical instrument is in the at least one adsorption volume during the THA procedure.

Description

[Technical Field]

[0001] The present invention relates, in general, to devices, systems, and methods for use in robot-assisted surgical procedures. More specifically, the present invention relates to computer-assisted devices, systems, and methods for performing robot-assisted bone preparation, trialing, and implant placement during total hip arthroplasty (THA) surgical procedures. Various specific implementations use an adsorption volume-based approach to guide the user in THA surgical procedures. [Background technology]

[0002] Hip arthroplasty or hip replacement is a surgical procedure used to replace and reconstruct the surface of a hip joint damaged by disease or injury, such as arthritis or a hip fracture. A total hip arthroplasty (THA) device replaces both the acetabulum and the femoral head, which collectively constitute the hip joint. The acetabular implant forms a replacement joint surface that is fixed to the acetabulum and interfaces with a femoral implant fixed to the end of the femur. The femoral implant is pivotably coupled to the acetabular implant, thereby reconstructing the hip joint. An exemplary acetabular implant is disclosed, for example, in U.S. Patent Application No. 17 / 024,876, filed on 18 September 2020 (published as U.S. Patent Application Publication No. 2022 / 0087823(A1)), which is incorporated by reference as if fully described herein.

[0003] Robotic surgical systems, including computer-aided navigation, have become well-established technologies in the operating room, including their use in arthroplasty procedures. Computer-aided navigation systems provide surgeons with computerized visualizations of how surgical instruments or other devices orienting themselves relative to a patient correlate to the orientation of the patient's anatomical structures in medical images, and how those orientations correlate to the preoperative surgical plan. Camera tracking systems for computer-aided surgical navigation typically use a set of tracking cameras to track the orientation of a reference element on a surgical instrument, which may be coupled to a surgical robot and positioned by the surgeon during surgery, relative to a patient reference element (or "dynamic reference base," DRB) fixed to the patient. A computer model of the actual instrument is associated with the reference element so that the computer model can be superimposed onto a aligned image of the patient's anatomical structures. The camera tracking system uses the relative orientation of the reference element to determine how the actual instrument orients relative to the patient, and how the computer model of the actual instrument orients correspondingly as an overlay on the medical image. This allows surgeons to use real-time visual feedback of relative posture to navigate surgical instruments during surgical procedures on patients.

[0004] As described above, the robotic system may be used in arthroplasty procedures. The robotic system (or “robot” or “surgical robot”) has a serial arm to which an end effector is attached. The surgeon (or “user”) can perform the surgical procedure while holding the end effector or any instruments coupled thereto and viewing it in real time on a navigation system (e.g., a standalone display or an augmented reality (AR) headset), and can receive various types of relevant feedback and information associated with a defined plan and / or progress for the surgical procedure.

[0005] The serial arm can be moved to a suitable position for surgical procedures via computer-guided control, according to the surgeon's requests, which may be provided, for example, via a foot pedal, touch screen, or AR interaction. The passive robotic structure allows the surgeon to perform each movement precisely during the procedure.

[0006] Various workflows may be available for use with the system. Such workflows may incorporate preoperative scans or images of the patient (e.g., X-rays or computed tomography (CT)). Other workflows may be image-free or may not require any preoperative images. Some workflows may incorporate the acquisition of intraoperative information about the patient's anatomical structure. In one example, the surgeon may measure key bone parameters using a camera tracking system and appropriate tracked instruments to capture points on the patient's anatomical structure. Later, this information, and other intraoperative information, can be used to plan the position and orientation of implants relative to the patient's anatomical structure and to navigate the robot and surgical instruments during the surgical procedure.

[0007] In some workflows, a surgeon may firmly attach a reference element to one or more bones, the reference element containing a criterion that is detected by a tracking camera for computer-aided navigation. The reference element enables the navigation system to track the bone's position. The reference element may be positioned on the bone and oriented so that it can be seen by the navigation system's tracking camera. Once positioned, the reference element is attached to the bone (e.g., pelvis or femur) using a fixation structure (e.g., screw pins, "alligator" jaws). Each position and orientation of the reference element remains firmly fixed to the bone throughout the procedure.

[0008] Another step in various workflows is to locate the patient within the tracking space of the navigation system. Patient locatement may involve matching the patient's anatomical structure to a corresponding numerical representation of the bone, such as a three-dimensional (3D) model of the bone. The bone representation may be constructed, for example, from a set of CT images (CT workflow) or a set of fluorescence images, or based on a general bone model (no-image workflow).

[0009] While current surgical approaches offer sophisticated techniques in robotic and navigation-assisted surgery, current approaches to bone preparation, trial placement, and implant placement may have drawbacks, for example, in total hip arthroplasty (THA) procedures. [Overview of the Initiative]

[0010] A first aspect of the present disclosure provides a surgical robot for use in a total hip arthroplasty (THA) procedure, the robot comprising a robotic arm for holding a surgical instrument and a controller coupled to the robotic arm, the controller being programmed to detect the position of the surgical instrument in at least one suction volume corresponding to a planned trajectory of the surgical instrument for a THA procedure and partially defined by a point and an axis extending from the point, and to provide assistance for the movement of the surgical instrument in a direction toward the at least one suction volume while the surgical instrument is in the at least one suction volume during a THA procedure.

[0011] Another aspect of the present disclosure provides a method for controlling a surgical robot during a total hip arthroplasty (THA) procedure, the method comprising detecting the position of a surgical instrument in at least one suction volume, which corresponds to a planned trajectory of the surgical instrument for the THA procedure and is partially defined by a point and an axis extending from the point, and providing assistance for the movement of the surgical instrument toward the at least one suction volume while the surgical instrument is in the at least one suction volume during the THA procedure.

[0012] According to a particular embodiment, at least one adsorption volume comprises a plurality of adsorption volumes having separate associated adsorption forces.

[0013] According to a particular embodiment, the first adsorption volume has a smaller adsorption force than the second adsorption volume, and the second adsorption volume is a sub-volume of the first adsorption volume.

[0014] According to a particular embodiment, the points and axes define the centerlines of both the first adsorption volume and the second adsorption volume.

[0015] According to certain embodiments, the operator must apply greater force to remove the surgical instrument from the second adsorption volume than from the first adsorption volume.

[0016] According to certain embodiments, the controller is configured to align and fix surgical instruments along a planned trajectory in at least one operating mode.

[0017] According to a particular embodiment, the surgical instrument includes at least one of a reamer or an impactor.

[0018] According to certain embodiments, the controller is further programmed to progressively guide the axis of the surgical instrument from the tip (e.g., distal end) of the surgical instrument to the axis of the adsorption volume.

[0019] According to a particular embodiment, progressive guidance includes providing tactile feedback to guide the tip of a surgical instrument to a point, and then providing tactile feedback to guide the axis of the surgical instrument to the axis of the adsorption volume, the axis of the adsorption volume being aligned with the planned trajectory of the surgical instrument for the THA procedure.

[0020] According to certain embodiments, the controller is configured to operate in multiple modes during a THA procedure, and the controller automatically switches between operating modes in response to detecting that the surgical instrument is aligned with a planned trajectory of the surgical instrument for the THA procedure. In certain embodiments, the automatic switching is performed without requiring additional user interaction (e.g., via a command interface). In certain embodiments, the operating modes include a free mode, a constrained mode, and the like. In certain embodiments, the constrained mode includes a hinge sub-mode, a linear sub-mode, and the like.

[0021] According to certain embodiments, at least one of the operating modes includes a hinge haptic control mode that restricts the degrees of freedom of the surgical instrument and allows rotation about its axis.

[0022] According to certain embodiments, at least one of the plurality of operating modes includes a linear guidance haptic control mode that restricts the degrees of freedom of the surgical instrument and allows translation along an axis.

[0023] According to certain embodiments, at least one suction volume has a substantially conical shape.

[0024] According to certain embodiments, the robot further includes a navigation system for maintaining alignment of the surgical instrument along a planned trajectory for the THA procedure.

[0025] According to certain embodiments, the controller aligns (e.g., snaps) the surgical instrument with a planned trajectory for a THA procedure such that the tip of the surgical instrument coincides with a point that defines an initial reaming position, and is configured to control the reaming portion of the THA procedure by restricting the axial movement of the surgical instrument when the tip reaches a final point that defines a final reaming position distal to the initial reaming position. In some cases, after aligning the surgical instrument with the planned trajectory, the surgical instrument may rotate freely about an axis or pivot freely about a point. In further cases, after the axial movement of the surgical instrument is restricted, the surgical instrument may rotate freely about the axis or pivot freely about the point.

[0026] In some examples, the controller restricts movement of the surgical instrument after reaching a final destination such that no further movement is permitted even if the user actuates the tool (e.g., the reamer rotates but the instrument is fixed and thus does not allow further reaming depth). In certain examples, the controller snaps the center point of a volume to an end (e.g., tip) of a tool (e.g., a reamer) to define an initial reaming position. At the initial reaming position, the controller enables the user to pivot / rotate the instrument about that point to allow reaming, which removes tissue linearly, and after reaming, reaches a second center point (final center point), and the controller restricts the axial movement of the surgical instrument (e.g., still allowing rotation / pivoting about the point).

[0027] According to certain embodiments, the surgical robot further includes an end effector for holding a surgical instrument and enabling attachment of a separate surgical instrument for a THA procedure.

[0028] According to certain embodiments, the system includes a surgical robot, and the system further includes a reference element on the surgical instrument and a user interface that enables the user to monitor the position of the surgical instrument during a THA procedure as partially indicated by the reference element.

[0029] These and other aspects, advantages and notable features of the present invention will become apparent from the following detailed description, which, together with the accompanying drawings in which similar parts are indicated by similar reference numerals throughout, discloses embodiments of the present invention. [Brief explanation of the drawing]

[0030] The aspects of this disclosure are shown as examples and are not limited by the accompanying drawings. In the drawings, [Figure 1] This is a top view of a surgical system positioned in a surgical room during a surgical procedure, which includes a camera tracking system for computer-assisted navigation during a surgical procedure and a surgical robot for robot assistance, according to some embodiments of the present disclosure. [Figure 2] Figure 1 shows a camera tracking system and surgical robot positioned relative to a patient, according to some embodiments of this disclosure. [Figure 3] Further illustrations show the camera tracking system and surgical robot of Figures 1 and 2, which are configured according to some embodiments of the present disclosure. [Figure 4] A block diagram of a surgical system, including an extended reality headset, a computer platform, an imaging device, and a surgical robot, configured to operate according to some embodiments of the present disclosure, is shown. [Figure 5] This disclosure shows flowcharts of the workflow between the intraoperative portions of total hip arthroplasty (THA) surgery according to several embodiments of this disclosure. [Figure 6] A flowchart of the patient preparation process before alignment, according to some embodiments of this disclosure, is shown. [Figure 7] The radiographic tilt angles measured in the coronal plane of a patient according to some embodiments of this disclosure are shown. [Figure 8] The following are the radiographic version angles measured relative to the patient's coronal plane according to some embodiments of this disclosure. [Figure 9] The present disclosure shows different diagrams of landmarks and axes for aligning the functional pelvic plane (FPP) and anterior pelvic plane (APP) of a patient, according to several embodiments of this disclosure. [Figure 10] This flowchart provides a workflow for robot-assisted preparation of one or more bones, such as the acetabulum, by reaming before implant placement during total hip arthroplasty (THA) surgery. [Figure 11] This disclosure provides perspective views of surgical robots, arms, end effectors, and parts of reamers according to several embodiments of this disclosure, as well as of their specific movements permitted in force-controlled operating modes. [Figure 12] This disclosure provides some embodiments of surgical robots, arms, end effectors, and parts of reamers, as well as perspective views of their specific movements permitted in point rotation control operating modes. [Figure 13] This disclosure provides perspective views of surgical robots, arms, end effectors, and parts of reamers according to several embodiments of this disclosure, as well as of their specific movements permitted in axial rotation control operating modes. [Figure 14] This disclosure provides perspective views of surgical robots, arms, end effectors, and parts of reamers according to several embodiments of this disclosure, as well as of their specific movements permitted in translational control operating modes. [Figure 15] This disclosure provides perspective views of surgical robots, arms, end effectors, and parts of reamers according to several embodiments of this disclosure, as well as of their specific movements permitted in translational / rotational control operating modes. [Figure 16] The present disclosure provides some reamers according to several embodiments, and perspective views of their particular movements permitted in translational / rotational control modes. [Figure 17] This provides a flowchart illustrating the workflow for robotic trials of the acetabular shell during THA surgery using various implementations. [Figure 18] This document provides flowcharts illustrating the workflow for robotic placement of acetabular shell implants during total hip arthroplasty (THA) surgery using various implementations. [Figure 19] This provides perspective views of surgical instruments and adsorption volumes to assist in performing THA surgery through various implementations. [Figure 20] This is a magnified perspective view of a portion of a surgical instrument interacting with an adsorption volume, using various implementations. [Figure 21] This is another enlarged perspective view of a portion of a surgical instrument interacting with an adsorption volume, with various implementations. [Figure 22] This is a perspective view of a robotic arm holding a surgical instrument in its first operating mode, with various implementations. [Figure 23] This is a perspective view of a robotic arm holding surgical instruments in a second operating mode, with various implementations. [Figure 24] This flowchart illustrates the process in various implementations. [Figure 25] This flowchart illustrates the process in various implementations.

[0031] Please note that the disclosed drawings are not necessarily to scale. The drawings are intended to show only typical aspects of the disclosure and should therefore not be considered to limit the scope of the disclosure. In the drawings, similar numbers represent similar elements across drawings. [Modes for carrying out the invention]

[0032] This disclosure should be understood to be limited to the details of the configuration and its use for the arrangement of components described herein or shown in the drawings. The teachings of this disclosure may be used and practiced in other embodiments and may be practiced or performed in a variety of ways. Also, it should be understood that the expressions and terminology used herein are for illustrative purposes only and should not be considered limiting. The use of “including,” “comprising,” or “having,” and variations thereof herein, means to include the items listed thereafter and their equivalents, as well as additional items. Unless otherwise specified or limited, the terms “mounted,” “connected,” “attached,” “supported,” and “coupled,” and variations thereof, are used broadly and include both direct and indirect mounting, connection, attachment, support, and coupling. Furthermore, “connected” and “coupled” are not limited to physical or mechanical connection or coupling.

[0033] The following considerations are presented to enable those skilled in the art to construct and use embodiments of the present disclosure. Various modifications to the embodiments shown will be readily apparent to those skilled in the art, and the principles of this specification may be applied to other embodiments and uses without departing from the embodiments of the present disclosure. Accordingly, embodiments are not intended to be limited to those shown, but should be given the broadest scope consistent with the principles and features disclosed herein. The following detailed description should be read with reference to the drawings, and similar elements in different figures have similar reference numerals. The drawings are not necessarily to scale and depict selected embodiments, and are not intended to limit the scope of embodiments. Those skilled in the art will recognize that the embodiments provided herein are within the scope of embodiments and have many useful alternatives.

[0034] This application is related to (1) U.S. Patent Application No. 15 / 180,126 (U.S. Patent No. 10,842,453) filed on 13 June 2016, (2) U.S. Patent Application No. 15 / 157,444 (U.S. Patent Publication No. 2016 / 0256225) filed on 18 May 2016, (3) U.S. Patent Application No. 18 / 743,685 (Reference No. ROBOT.143.0005 / IDR-24-008), and (4) U.S. Patent Application No. 18 / 743,388 (Reference No. ROB (5) U.S. Patent Application No. 18 / 743,647 (reference number ROBOT.143.0004 / IDR-23-149), (6) U.S. Patent Application No. 18 / 743,615 (reference number ROBOT.143.0003 / IDR-23-151), and (7) U.S. Patent No. 10,058,394 (U.S. Patent Application No. 14 / 815,198), all of which are incorporated herein by reference.

[0035] Robotic surgical systems and associated workflows may offer improved outcomes in surgical procedures, such as total hip arthroplasty (THA), compared to more conventional approaches. For example, a robotic surgical system may provide additional precision and force assistance when preparing the acetabulum and additional precision and alignment when trialing and placing implants. In certain embodiments, including implant position preparation, implant trialing, and / or implant placement, the surgical robot may be configured to provide suction force-based (or tactile) feedback to guide the user through the THA procedure. In certain implementations, a robotic controller coupled to a robotic arm is programmed to detect the position of a surgical instrument within at least one suction volume corresponding to a planned trajectory of the surgical instrument for the THA procedure. The at least one suction volume can be partially defined by a point and an axis extending from the point. The robotic controller is also programmed to provide suction force to move the surgical instrument toward at least one suction volume while the surgical instrument is within at least one suction volume during the THA procedure. As described in U.S. Patent No. 10,058,394 ("Robot Arm and Methods of Use," issued August 28, 2018, incorporated in its entirety), the movement of a surgical instrument's suction base may be controlled via a robotic arm, for example, in an end effector. More specifically, a controller may move the robotic arm and / or end effector and control one or more motors that are operable to provide guidance and / or resistance to the user of the surgical instrument during a THA procedure. Aspects of the disclosed embodiments are discussed below.

[0036] Figure 1 is a top view of a surgical system 10 positioned in a surgical room or operating room during a surgical procedure. The system 10 includes a camera tracking system 200 for computer-assisted navigation during surgery and may further include a surgical robot 100 for robot assistance, according to several embodiments. Figure 2 shows the camera tracking system 200 and surgical robot 100 positioned relative to the patient, according to several embodiments. Figure 3 further shows the camera tracking system 200 and surgical robot 100 configured according to several embodiments. Figure 4 shows a block diagram of the surgical system 10, including an extended reality (XR) headset 150, a computer platform 400, an imaging device 420, and a surgical robot 100, configured to operate according to several embodiments.

[0037] The camera tracking system 200 (Figures 1-4) may include an intraoperative imaging system that may include separate imaging modalities. These imaging modalities may include one or more of the following: fluoroscopy, 2D radiography, and cone-beam computed tomography (CBCT). Fluoroscopy is a medical imaging technique that displays a series of X-ray images on a monitor that closely resemble X-ray motion. 2D radiography is an imaging technique that uses X-rays to view the internal structure of opaque objects with heterogeneous structures, such as the human body. CBCT (or cone-beam 3D imaging or C-arm CT) is a medical imaging technique consisting of X-ray computed tomography, in which X-rays diverge to form a cone. The camera tracking system 200 may include an integrated or detachable navigation array having (1) three-dimensional (3D) images (e.g., CT, CBCT, MCT, PET, angiography, MRI, ultrasound, etc.), (2) two-dimensional (2D) images (e.g., fluoroscopy, digital radiography, ultrasound, etc.), and (3) tracking markers (e.g., NIR retroreflection, NIR LED, visible light, etc.) that are calibrated to the image space of the 2D and 3D images.

[0038] The system 10, including the surgical robot 100, may include (1) the use of aligned 2D and / or 3D images for surgical planning, navigation, and guidance in various workflows (e.g., intraoperative 3D, intraoperative 2D, preoperative 3D to 2D, and intraoperative 3D to 2D), and (2) a camera tracking system 200 capable of tracking markers (e.g., NIR retroreflection, NIR LED, visible, etc.). In some cases, as described herein, the dynamic reference base (DRB) (or patient reference array) 116 may (1) be firmly attached to a patient anatomical structure, and (2) include an array of tracking markers (e.g., NIR retroreflection, NIR LED, visible, etc.).

[0039] The XR headset 150 may be configured to augment real-world scenes with computer-generated XR images while worn by personnel in an 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, light from the real-world scene from being directly seen by the user 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. Therefore, the term XR headset encompasses either or both AR headsets and VR headsets.

[0040] Continuing to refer to Figures 1-4, the surgical robot 100 may include, for example, one or more robotic arms 102, 104, a display 110, an end effector 112 including, for example, a guide tube 118, and an end effector reference element 114 which may include one or more tracking criteria. A patient reference element (or DRB) 116 (shown in Figure 1) has multiple tracking criteria and is fixed directly to the patient 210. For example, a navigated pelvic DRB marker array may be positioned in or out of an incision with the help of cortical pins drilled into the pelvic bone. In some embodiments, the DRB is oriented to be visible by a tracking camera 204 (e.g., a stereoscopic tracking camera) mounted on a camera tracking system 200 and / or an XR headset 150. The reference element 170 is attached to or formed on instruments, surgical tools, surgical implant devices, etc.

[0041] The camera tracking system 200 includes tracking cameras 204 which may be spaced apart to provide a stereo camera configured to have partially overlapping fields of view. The camera tracking system 200 may have any preferred configuration of arms 202 for moving, oriented and supporting the tracking cameras 204 at desired positions and may include at least one processor capable of tracking the positions of individual references and the orientation of an array of references of reference elements.

[0042] As used herein, the term “posture” refers to the position (e.g., along three orthogonal axes, e.g., x, y, and z axes) and / or rotation angle (e.g., around three orthogonal axes) of a reference (e.g., DRB) relative to another reference (e.g., monitoring reference) and / or a defined coordinate system (e.g., camera coordinate system, navigation coordinate system, etc.). Thus, posture may be defined based solely on the multidimensional position of the reference relative to another reference and / or a defined coordinate system, based solely on the multidimensional rotation angle of the reference relative to another reference and / or a defined coordinate system, or based on a combination of multidimensional position and multidimensional rotation angle. Accordingly, the term “posture” is used, for example, to refer to the position, rotation angle, or combination thereof of the instrument reference element 170, the patient reference element 116, etc.

[0043] The tracking camera 204 may include an infrared camera (e.g., a bifocal or stereophotogrammetry camera) capable of operating to identify a single reference (e.g., a monitoring reference) and active and passive tracking references relative to a reference element, which can be formed or mounted on, for example, a patient 210 (e.g., a patient reference element or DRB 116), an end effector 112 (e.g., an end effector reference element 114), an XR headset 150 worn by a surgeon 120 and / or surgical assistant 126, in a given measured volume of the camera coordinate system while visible from the viewpoint of the tracking camera 204. The tracking camera 204 may scan a given measured volume and detect light emitted from or reflected from the reference to identify and determine the position of individual references and the orientation of the reference element in three dimensions. For example, an active reference element may include an infrared emission reference activated by an electrical signal (e.g., an infrared light-emitting diode, LED), and a passive reference element may include a retroreflective reference that reflects infrared light emitted by an illuminator on a tracking camera 204 or other suitable device (e.g., reflects incident IR radiation in the direction of the incident light).

[0044] The XR headset 150 may include tracking cameras (e.g., separated stereo cameras) capable of tracking the position of monitoring references and the orientation of reference elements within the field-of-view (FOV) 152 and 154 of the XR camera headset, respectively. Thus, as shown in Figure 1, the position of monitoring references and the orientation of reference elements on various objects, such as the instrument reference element 170 and the patient reference element 116, can be tracked while they are within the FOVs 152 and 154 of the XR headset 150, and / or the FOV 212 of the tracking camera 204.

[0045] Figures 1 and 2 show potential configurations for the placement of the camera tracking system 200 and the surgical robot 100 in an operating room environment. Computer-assisted navigation robotic surgery may be provided by the camera tracking system 200 controlling the surgical robot 100, an XR headset 150 for displaying surgical procedure navigation information, and / or other displays 34, 36, and 110.

[0046] The camera tracking system 200 may operate using tracking information and other information provided by multiple XR headsets 150, such as inertial tracking information and optical tracking information (frames of tracking data). The XR headsets 150 may operate to display visual information and to play audio information to the wearer. This information may come from a local source (e.g., a surgical robot 100), an imaging device 420 (Figure 4), a remote source (e.g., a patient medical image database), and / or other electronic devices. The camera tracking system 200 may track references with 6 degrees of freedom (6DOF) around three axes of a 3D coordinate system and rotation angles around each axis. The XR headsets 150 may also operate to track hand posture and gestures to enable gesture-based interaction with "virtual" buttons and interfaces displayed through the XR headsets 150, and may also interpret hand or finger pointing or gestures as various defined commands. Additionally, the XR headset 150 may have a digital color camera sensor with a magnification of 1 to 10 times, referred to as a digital magnifier. In some embodiments, one or more of the XR headsets 150 are minimal XR headsets that display local or remote information but include fewer sensors and are therefore lighter.

[0047] The “outside-to-inside” machine vision navigation bar 206 supports a tracking camera 204 and may include a color camera. The machine vision navigation bar generally does not move as frequently or quickly as the XR headset 150, which is positioned above the wearer's head, and therefore has a more stable view of the environment. The patient reference element (or DRB) 116 is generally firmly attached to the patient 210 with a pitch and roll that is stable against gravity. This localized, precise patient reference 116 can serve as a common reference frame for other tracked elements, such as the reference element 114 on the end effector 112, the instrument reference element 170, and the reference element on the XR headset 150.

[0048] In some embodiments, at the end of the end effector 112, the instrument is connected to perform actions such as excision, reaming, and implant placement.

[0049] The surgical robot 100 can be positioned near or next to the patient 210, as shown in Figures 1 and 2. The robot 100 can be positioned at any suitable location near the patient 210, depending on the area of ​​the patient 210 receiving the surgical procedure. The camera tracking system 200 may be separate from the robot system 100 and may be positioned at the feet of the patient 210. This position allows the tracking camera 200 to have a direct line of sight to the surgical area 208, for example, the hip area (Figure 2). In the configuration shown in Figure 1, the surgeon 120 may be positioned opposite the robot 100 but still able to operate the end effector 112 and display 110. The surgical assistant 126 may also be positioned opposite the surgeon 120, with access to both the end effector 112 and display 110. If desired, the positions of the surgeon 120 and the assistant 126 may be reversed. An anesthesiologist 122, a nurse, or a scrub technician may operate equipment that can be connected to display information from the camera tracking system 200 on the display 34 (Figure 1).

[0050] Regarding other components of the robot 100, the display 110 may be mounted on the surgical robot 100 or at a remote location. The end effector 112 may be coupled to the robot arm 104 and controlled by at least one motor. The upper arm 102 may further couple the arm 104 to the support column 312 of the robot 100. In some embodiments, the end effector 112 includes a guide tube 118 (e.g., Figure 11) configured to receive and orient a surgical instrument, tool, or implant used to perform a surgical procedure on a patient 210. For example, the end effector 112 is adapted to receive a surgical instrument or a portion thereof (e.g., through the guide tube 118), removably couple to the instrument, and manipulate the instrument by translating and rotating it, etc. In some other embodiments, the end effector 112 includes a passive structure for guiding a saw blade (e.g., a sagittal saw) along a defined cutting plane.

[0051] As used herein, the term “end effector” is used interchangeably with the terms “end effector” and “effector element.” The term “apparatus” is used in a non-limiting manner and interchangeably with “tool” and “implant,” and can generally refer to any type of device that may be used in a surgical procedure according to the embodiments disclosed herein. The more general term device can also refer to structures such as end effectors. Exemplary instruments, tools, and implants include, but are not limited to, reamer structures, drills, screwdrivers, saws, dilators, retractors, probes, implant inserters, and implant devices such as shells and trial shells, screws, spacers, intervertebral fixators, plates, and rods. Although generally shown with the guide tube 118, it will be understood that the end effector 112 may be replaced with any suitable instrument for use in a surgical procedure. In some embodiments, the end effector 112 may have any known structure for bringing the movement of a surgical instrument in a desired manner.

[0052] The surgical robot 100 is operable to control the translation and orientation of the end effector 112. The robot 100 can move the end effector 112 along the x, y, and z axes under computer control, for example. The end effector 112 can be configured to selectively rotate about one or more of the x, y, and z axes, as well as the Z-frame axis, so that one or more of the Euler angles associated with the end effector 112 (e.g., roll, pitch, and / or yaw) can be selectively computer controlled. In some embodiments, selective control of the translation and orientation of the end effector 112 and associated surgical instruments can enable the performance of medical procedures with significantly improved accuracy compared to conventional robots that utilize a 6-degree-of-freedom robotic arm including only a rotation axis. For example, the surgical robot 100 may be used to operate on a patient 210, the robotic arm 104 can be positioned over the patient's body, and the end effector 112 is selectively angled with respect to the z-axis toward the patient's body.

[0053] In some exemplary embodiments, the XR headset 150 can be controlled to dynamically display an updated graphic representation of the pose of the surgical instrument, so that a user, for example, a surgeon 120, can always be aware of the pose of the surgical instrument during the procedure.

[0054] In some further embodiments, the surgical robot 100 may be operable to correct the path of a surgical instrument guided by the robotic arm 104 if the surgical instrument deviates from a selected, pre-planned, or defined trajectory. The surgical robot 100 may also be operable to allow stopping, correcting, and / or manual control of the movement of the end effector 112 and / or the surgical instrument. Thus, during use, the surgeon 120 or other user may use the surgical robot 100 as part of a computer-assisted navigated surgical procedure and have the option to stop, correct, or manually control the autonomous or semi-autonomous movement of the end effector 112 and / or the surgical instrument.

[0055] Reference or criterion elements can be formed on or connected to robot arms 102 and / or 104, end effectors 112 (e.g., end effector element 114 in Figure 2), and / or surgical instruments (e.g., instrument element 170) to enable tracking of posture in a defined coordinate system, such as three orthogonal axes and six degrees of freedom (DOF) along rotation around those axes. Reference elements 114, 116, and 170 enable each of the marked objects (e.g., end effector 112, patient 210, and surgical instrument, respectively) to be tracked by a tracking camera 200, and the tracked posture can be used to provide guidance to be navigated during the surgical procedure and / or to control the movement of the surgical robot 100 to guide the end effector 112 and / or the instrument operated by the end effector 112. The instrument operated by the end effector 112 may include, for example, a reamer 124 or inserter adapted for inserting an implant.

[0056] Referring to 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 electrical components of the surgical robot 100, including but not limited to a battery, a power distribution module, a platform interface board module, and a computer. The camera tracking system 200 may include a display 36, a tracking camera 204, an arm 202 (Figure 1), a computer housed in the cabinet 330, and other components.

[0057] In computer-assisted navigation surgery, vertical 2D scan slices of the patient's anatomical structure are displayed, such as axial, sagittal, and / or coronal views, enabling user visualization of the patient's anatomical structure along with the relative orientation of surgical instruments. An XR headset or other display may be controlled to display one or more 2D scan slices of the patient's anatomical structure along with a 3D graphical model of the anatomical structure. The 3D graphical model may be generated, for example, from a 3D scan of the patient by a CT scanner, and / or based on a baseline model of the anatomical structure that is not necessarily formed from the patient's scan.

[0058] Exemplary surgical system Figure 4 shows a block diagram of a surgical system 10, according to several embodiments, which includes a surgical robot 100 and a computer platform 400 configured to operate as described herein, including, in particular, a camera tracking system 200, an imaging device 420, and an XR headset 150.

[0059] 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 of 2D and / or 3D images. The XR headset 150 provides a human interface for performing navigated surgical procedures. The XR headset 150 may be configured to provide functions including, but not limited to, one or more of the following via a computer platform 400: identification of hand gesture-based commands and display of XR graphical objects on the XR headset 150's display device 438 and / or another display device. The display device 438 may include a video projector, a flat panel display, and the like. The user can view XR graphical objects as overlays anchored to specific real-world objects viewed through a see-through display screen. The XR headset 150 may additionally or alternatively be configured to display video streams from one or more cameras mounted on the XR headset 150 and other cameras on the display device 438.

[0060] The electrical components of the XR headset 150 may include multiple cameras 430, a microphone 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 cameras 430 of the XR headset 150 may be visible light-capturing cameras, near-infrared-capturing cameras, or a combination of both.

[0061] Camera 430 may be configured to operate as a gesture sensor 434 by tracking the hand gestures of an identified user performed within the field of view of camera 430. Alternatively, the gesture sensor 434 may be a proximity sensor and / or touch sensor that senses hand gestures performed in close proximity to the gesture sensor 434 and / or physical contact, such as a tap on the sensor 434 or its housing. The attitude sensor 436, for example, an IMU, may include a multi-axis accelerometer, a tilt sensor, and / or other sensors 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 electrical components may be housed in a head-mounted component housing or in another housing configured to be worn at other locations such as the waist or shoulder.

[0062] As described above, the surgical system 10 includes a camera tracking system 200 which may be connected to a computer platform 400 for motion processing and may provide other motion functions, including a navigation controller 404 and / or an XR headset controller 410. The surgical system 10 may further include a surgical robot 100. The navigation controller 404 may be configured to provide the operator with visual navigation guidance for moving and positioning the surgical tool relative to the patient's anatomical structure, for example, based on a surgical plan from a surgical planning function that defines where a surgical procedure is performed using a surgical tool on an anatomical structure, and based on the orientation of the anatomical structure determined by the camera tracking system 200. The navigation controller 404 may be further configured to generate navigation information based on the target orientation of the surgical tool, the orientation of the anatomical structure, and the orientation of the surgical tool and / or the end effector 112 of the surgical robot 100. 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 tools and / or end effectors 112 of the surgical robot 100 should move to perform surgical procedures according to a defined surgical plan.

[0063] The electrical components of the XR headset 150 may be operably connected to the electrical components of the computer platform 400 via a wired / wireless interface 440. The electrical components of the XR headset 150 may be operably connected, for example, via the computer platform 400, or directly connected to various imaging devices 420, such as C-arm imaging devices, O-arm imaging devices, other imaging devices, patient image databases, and / or other medical devices via the wired / wireless interface 440.

[0064] The surgical system 10 may include an XR headset controller 410, which is at least partially located within the XR headset 150, the computer platform 400, and / or another system component connected via wired cables and / or wireless communication links. Various functions may be provided by software executed by the XR headset controller 410. The XR headset controller 410 is configured to receive information from the camera tracking system 200 and the navigation controller 404 and to generate XR images based on the information for display on the display device 438.

[0065] The XR headset controller 410 can be configured to operationally process frames of tracking data from camera 430 (tracking camera), signals from microphone 432, and / or information from attitude sensor 436 and gesture sensor 434 to generate information for display as an XR image on display device 438 and / or for display on other display devices for user viewing. Thus, the XR headset controller 410, as shown as a circuit block within the XR headset 150, should be understood as operationally connected to the other shown components of the XR headset 150, but not necessarily residing in a common housing or being separately transportable by the user. For example, the XR headset controller 410 may additionally or alternatively reside within a computer platform 400, which may consequently reside within the cabinet 330 of the camera tracking system 200, the cabinet 106 of the surgical robot 100, and so on.

[0066] Exemplary patient positioning workflow In some embodiments of the present disclosure, the system 10, for example, a computer platform 400, may perform one of several available workflows to position a patient to the surgical system 10 before surgical intervention. The workflow may further include isolating a target area for surgical treatment from a non-target surgical area. In one example, the target surgical area may include the acetabulum, and the non-target surgical area may include the femur.

[0067] In one embodiment, the workflow may be an image-less workflow in which preoperative images are not used. Instead, information regarding the patient's anatomical structure in the operating room (OR) may be obtained by the surgeon using the system to measure key parameters of the patient's bone, as described herein. For example, the computer platform 400 of system 10 operates to identify the location of landmarks on the bone (e.g., points, axes, and / or surfaces) and to align the locations simultaneously with or after identification. The locations can be used to define reference planes (e.g., anterior pelvic plane (APP) and / or functional pelvic plane (FPP)), which are used to plan implants and to navigate robots and surgical instruments for THA surgical procedures.

[0068] In some embodiments, the only preoperative use case related to an image-less workflow may be an initial patient assessment. The surgeon may assess the patient's mobility and health status using sensors (e.g., sensors manufactured by Globus Medical and attached to the leg), physical movement, and / or clinical surveys to determine whether a total hip arthroplasty (THA) is recommended. The collected data may then be stored and processed by the system before being analyzed by the surgeon to facilitate the final decision. The data may then be reused by an application (e.g., a surgical planning application by Globus Medical) to establish the most appropriate implant surgical plan.

[0069] Figure 5 shows a flowchart of the image-free workflow between the intraoperative portions of a total hip arthroplasty (THA) according to some embodiments of the present disclosure. In some embodiments, after positioning the patient on the operating table (step 500), some of the actions considered above and below may be performed during step 600 for patient positioning and before another step 700 for intraoperative computer-navigated surgery. In the case of hip joint, the patient's pelvis or acetabulum is positioned in the tracking coordinate system of the camera tracking system 200. As shown in Figure 1, the pelvis or acetabulum is positioned in the optical coordinate system. In one embodiment, positioning is performed in an image-free modality without using medical images such as X-ray or CT images from an imaging device. In other embodiments, as described herein, positioning is performed using one or more preoperative X-ray and / or CT images.

[0070] Figure 6 shows a flowchart of the patient preparation process before alignment according to some embodiments of the present disclosure.

[0071] The patient preparation process may begin with the patient being positioned on the operating table in a lateral or supine position. The patient's body is prepared for positioning. Optionally, in step 3000, an EKG / ECG patch electrode is attached to or near the distal end of the patient's femur. The EKG / ECG patch electrode may be positioned at or slightly below the center of the patella. In some embodiments, the patch position coincides with the anatomical axis of the femur. This patch may be used in a later stage to obtain the most distal point of the femur under draping. This patch may also be used to track the femur in space (e.g., when the patient's leg is moved during surgery) and to assist in measuring the patient's leg length. However, in some embodiments, this action (step 3000) is skipped.

[0072] In some embodiments, the EKG / ECG patch electrode includes an adhesive patch that is removable and attachable to the patient. In some embodiments, the patch may be black or dark in color to be more visible to the tracking camera. In other embodiments, the patch and patch electrode are not visible to the tracking camera because they are under a drape. The geometric shape of the patch (nipple-like) helps the surgeon to always touch a single point on or adjacent to the distal portion of the femur (anterior patellar region) using a stylus / instrument that is traceable by the tracking camera. This ensures that the surgeon always collects the same point for measuring leg length or medial-lateral offset.

[0073] In step 3002, the patient's body is draped. Next, depending on the surgeon's technique, the navigated pelvic DRB is positioned inside (steps 3006-3008) or outside (step 3004) the incision using cortical pins drilled into the pelvic bone. In some embodiments, the DRB is oriented to be visible to a tracking camera, such as a camera tracking system 200 (Figure 1) or a stereoscopic tracking camera mounted on an XR headset 150 (Figure 1). In one embodiment, the operation of positioning the DRB inside the incision includes tracking and navigating access to the articular space using the system (step 3006) and positioning a reference element inside the incision. In another embodiment, the reference element is positioned outside the incision (step 3004), and the system does not necessarily need to be used to track and navigate access to the articular space.

[0074] After positioning a reference element or DRB inside or outside the incision, data points and axes can be collected on the patient's anatomical structure by using the pelvic DRB coordinate system as a spatial reference, with the assistance of a navigated instrument. In addition, as shown in Figures 7-8, two pelvic reference planes can be established for planning implant placement by measuring angular deviations such as tilt and rotation of the acetabular cup implant.

[0075] Figure 7 shows the radiographic inclination angle measured in the coronal plane of a patient according to some embodiments of the present disclosure. In some embodiments, the surgeon can determine the center of rotation of the acetabulum by palpating or painting the surface of the patient's acetabular cavity using a navigated instrument. Figure 8 shows the radiographic rotation angle (version angle) measured relative to the coronal plane of a patient according to some embodiments of the present disclosure. The two pelvic reference planes (or coronal plane or frontal plane), the anterior pelvic plane (APP) and the functional pelvic plane (FPP) are determined or defined using different landmarks and axes, as shown in Figure 9 and described in more detail below.

[0076] In this specification, the user interface and related operations are described as being performed in a specific order, but it should be understood that they may be performed in other orders within the scope of the disclosed embodiments. Furthermore, it is not necessary for all of the user interface and / or described operations to be performed. Instead, fewer operations may be performed, still within the disclosed embodiments. In addition, additional alignment approaches may include image-based workflows and image-less workflows. Combinations of these alignment approaches are also possible according to various disclosed embodiments.

[0077] During patient orientation procedures, markers used to orient the patient's anatomical structures can be extracted using either single-point palpation acquisition or surface painting (resulting in a point cloud of locations). Figure 9 shows different views of markers and axes for orienting the patient's FPP and APP according to several embodiments of this disclosure. The markers and axes used to orient the APP plane and the FPP plane are described in detail in U.S. Patent Application No. 18 / 430,077 (reference number ROBOT.134.0002), which is already incorporated herein by reference.

[0078] Furthermore, U.S. Patent Application No. 18 / 430,077 (Reference No. ROBOT.134.0002) discloses a process for aligning the pelvic acetabulum of a patient (including painting the acetabular cavity) according to various embodiments of this disclosure. For example, to define the origins of the APP and FPP, the rotational center of the pelvic acetabulum can be determined after removing the patient's femoral head from the acetabular cavity. The acetabular fossa may be made accessible by cutting the femoral neck and removing the femoral head from the acetabular fossa. In some embodiments, a cork screw instrument may be used to remove the femoral head from the acetabular fossa.

[0079] Next, the surface of the acetabular cavity can be painted using a navigated instrument (e.g., a stylus). For example, a surgeon can palpate the surface of the acetabular cavity using a navigated instrument (e.g., a stylus) while a tracking camera continuously measures the position of a ball on the end of the stylus. This process provides a cluster of points of measured positions (locations). Simultaneously, the tracking camera can also monitor and track the posture of the patient DRB116 attached to the pelvis so that the posture of the stylus can be tracked relative to the posture of the patient DRB. Alternatively, the surgeon may then measure a predefined number or proportion of points by palpating them one by one. Based on these points and the tracking data of the stylus and the patient DRB116, the rotational center of the acetabular cavity is determined. Furthermore, based on these points, the surface of the acetabular cavity can be aligned to the system, or a 3D model can be generated or modified based on these points. Next, the acetabular fossa shape can be reproduced by the system (e.g., in a 3D model) based on the measured points, using, for example, other algorithms for outlier removal and surface fitting.

[0080] While certain image-less approaches are described herein and in U.S. Patent Application No. 18 / 430,077 (Reference No. ROBOT.134.0002), other exemplary methods for performing image-less and image-based pelvic alignment to the tracking coordinate system (e.g., optical coordinate system) of a tracking system are already incorporated herein by reference. These methods may also be used, for example, to determine the intrinsic center of acetabular rotation, derive or define the FPP, and derive or define the APP. Alignment allows a navigation system or robotic system to track any navigated instrument or end effector 112, or any tool attached to the end effector 112, relative to the pelvis, which is tracked by a patient dynamic reference base 116 attached to the pelvis. The various alignment methods described herein can be combined in accordance with the various embodiments disclosed.

[0081] For example, in a method that does not use images, the APP is derived by touching various known points (e.g., the left and right anterior superior iliac spines (ASIS) or the pubic symphysis) with the navigated instrument, or by the physician aligning a plane or axis defined by the navigated instrument along or parallel to the APP. Once the center of rotation and the APP are determined, the system (either the navigation system or a combined navigation and robotic system 100) has sufficient information to align the acetabulum in the coordinate system of the camera tracking system 200 (e.g., the optical coordinate system). In both of the exemplary methods described above, the tracking system also tracks the navigated instrument (e.g., a stylus) while constantly monitoring and tracking the posture of the patient DRB 116 attached to the pelvis, for the purpose of aligning the pelvis with respect to the patient DRB 116, at least in the tracking coordinate system of the camera tracking system 200, so that the posture of the instrument can be tracked relative to the posture of the patient DRB.

[0082] Several exemplary image-based examples involve the use of preoperative CT images. In one such exemplary image-based approach to patient registration, as described in U.S. Patent Application No. 18 / 743,388 (reference number ROBOT.143.0002 / IDR-23-131), preoperative CT images and intraoperative fluoroscopy images are merged to exclude non-target surgical areas, and the location of the target surgical area is registered based on the merged CT and fluoroscopy images. In another exemplary image-based approach to patient registration, as described in U.S. Patent Application No. 18 / 743,615 (reference number ROBOT.143.0003 / IDR-23-151), preoperative CT and intraoperative point cloud data acquired via a navigated instrument are merged, and the location of the target surgical area is registered based on the merged CT images and point cloud data.

[0083] Other exemplary image-based registration approaches can be performed without first acquiring preoperative CT images. In one such exemplary approach to patient registration, intraoperative fluoroscopic images are acquired to identify the APP and FPP. The FPP and APP images are merged, excluding the non-target surgical area, and the location of the target surgical area is registered based on the merged APP and FPP fluoroscopic images, as described in U.S. Patent Application No. 18 / 743,647 (reference number ROBOT.143.0004 / IDR-23-149).

[0084] In a further exemplary image-based approach for patient registration, intraoperative fluoroscopic images are acquired, and intraoperative point cloud data is acquired using a navigated instrument. The FPP is identified in the intraoperative fluoroscopic images, and input from the navigated instrument regarding the location of the target surgical area is acquired. A set of markers for the identified FPP is validated using input from the navigated instrument, and the location of the target surgical area is registered based on the identified FPP image and input from the navigated instrument, as described in U.S. Patent Application No. 18 / 743,685 (reference number ROBOT.143.0005 / IDR-24-008).

[0085] Computer-assisted navigation systems provide surgeons with computerized visualizations of how surgical instruments or other devices used to position a patient correlate to the patient's anatomical structure in medical images, and how those positions correlate to preoperative surgical planning.

[0086] Robotic reaming workflow According to embodiments of the present disclosure, a surgical system 10 including a surgical robot 100, such as those shown in Figures 1 to 4, can be used to perform various workflows for robot-assisted surgical procedures. Referring to Figure 10, one such workflow 800 may include preparing one or more bones, such as the acetabulum, for implant placement during a total hip arthroplasty (THA) procedure.

[0087] Preparation of the acetabulum may include reaming the acetabular cavity. The objective of the reaming workflow 800 may be to guide the reamer 124 into the patient's original acetabulum and expand its diameter to prepare the acetabular cavity for placement of an acetabular implant or "shell". In some cases, the surgeon may use the reamer to modify the position of the natural acetabular center according to a predefined surgical plan. The surgeon can perform the planned surgical procedure by holding an instrument, e.g., a navigated reamer structure with an attached reamer, and observing the procedure steps occurring on a navigation system or XR headset 150. The end effector 112 facilitates the precise execution of the intended function of each instrument, e.g., the reamer 124 in the workflow 800. In any robotic movement, the movement enable switch must be engaged to enable the robotic movement.

[0088] Referring to workflow 800, in step 802, the sterile reamer structure 130 may be inserted into the end effector 112, for example, into the guide tube 118. Alternatively, a sterile end effector-integrated navigation reamer structure may be used. The reamer structure may also be a navigational surgical instrument and may include one or more instrument reference elements 170 that are attached to or formed on the instrument, as described elsewhere in this specification. The instrument reference elements 170 may be used, for example, to track the orientation of the instrument, i.e., the reamer, relative to another reference and / or defined coordinate system, using a camera tracking system 200, a computer platform 400, and a display which may include an XR headset 150 as described above herein.

[0089] In step 804, the power system may be connected to supply power to the robot 100 and other components of system 10. The system may be powered on and a self-test may be performed. In step 806, the components of the system, including, for example, the robot 100, may then be positioned in close proximity to the operating table and stabilized on the floor. The robot 100 may then be draped to maintain the sterility of the field.

[0090] Steps 808-834, which are further described below, are sub-steps that collectively provide the process of preparing the patient's acetabular cavity for implantation of an acetabular prosthesis or shell, for example, by reaming the acetabulum.

[0091] In step 808, a hemispherical acetabular reamer 124 of appropriate size may be coupled to a reamer structure 130 or driver. The reamer size, for example, the diameter, may be selected according to a defined plan for the surgical procedure, or at least in part based on the patient's anatomical structure.

[0092] In step 810, the surgeon can input or confirm the size of the selected reamer in the system 10. In certain embodiments, such input may be provided, for example, via a touch screen or XR interaction using the XR headset 150. The surgeon can then bring the robotic arm into position for surgery by providing input commands, for example, by pressing a foot pedal or by interacting with the touch screen or XR headset 150.

[0093] In the first stage of the robot-assisted reaming workflow 800, the reamer is inserted into the patient's soft tissue to access the target surgical area. To perform the insertion, in step 812, the surgeon selects either a force-controlled or tactile-controlled mode from several defined operating modes (or "operating control modes").

[0094] Each operating mode may be defined at least in part by the movement of the robotic arm, e.g., translation along the X, Y, and Z axes, and rotation around each of these axes relative to a defined coordinate system, which are permitted or restricted while a particular operating mode is involved. In this way, the computer platform (e.g., computer platform 400) is adapted to selectively control the translation and orientation, e.g., posture, of the navigated surgical instrument based on the defined operating modes in order to perform steps in the workflow as described herein. In certain embodiments, the operating modes may be defined by the surgeon, for example, by selection or activation by the surgeon. This may be, for example, via a touch screen or XR interaction. In other embodiments, the operating modes may be defined by the system 10 as an automatic response to predefined conditions, such as the proximity of one particular navigated instrument, implant, or patient anatomical feature to another navigated instrument, implant, or patient anatomical feature. Each operating mode may be further defined by whether the mode is used in conjunction with navigation guidance or whether it can be used without navigation guidance, for example, whether it can be used for manual operation of the device.

[0095] Referring back to step 812, in force control mode, translation of the reamer along the X, Y, and Z axes is permitted. Roll, yaw, and pitch of the reamer, i.e., rotation around the X, Y, and Z axes respectively, are also possible. Thus, in force control mode, the user may translate the instrument along any one or more of the X, Y, and Z axes, as shown in Figure 11, and rotate the instrument around any one or more of the X, Y, and Z axes, in order to gain access to a surgical target area, e.g., the acetabular cavity. The robotic arm may provide six active degrees of freedom (DOF). However, due to the axis of symmetry of the reamer structure 130 defined by the instrument rotation axis, only five DOF are required to fully define the position and orientation of the reamer structure in the defined coordinate system. Navigation guidance is not required in force control mode. Translation and orientation of the reamer 124 are controlled by the surgeon by directly or indirectly applying force and torque to the end effector and / or instrument. In certain embodiments, these forces and torques may be applied directly to the end effector 112 or the reamer structure 130, while in other embodiments, the forces and torques may be measured by force and torque sensors incorporated into a tactile control device and correspond to force and torque control commands applied to the end effector.

[0096] In step 814, with the force control mode engaged, the user inserts the reamer 124 into the patient's original acetabulum. Due to the size constraints of the original acetabulum relative to the reamer 124, the center 132 of the reamer 124 is often located lateral to the original center 134 of the acetabulum.

[0097] For example, using the computer platform 400, when the proximity of the reamer 124 to the acetabulum is detected, the system can move from the insertion phase to the alignment phase. In the alignment phase, the desired or defined reamer trajectory is identified for final reaming.

[0098] In step 816, to perform alignment, the surgeon selects a rotation control mode from several defined motion modes (or “motion control modes”). A rotation control mode may be defined by restricting the translation of the reamer along the X, Y, and Z axes (e.g., the center point 132 of the reamer 124), while allowing rotation of the reamer 124 about the X, Y, and Z axes, i.e., roll, yaw, and pitch. In particular, in point rotation control mode, rotation about the Y and Z axes is permitted around a fixed, hardcoded point located at the center 132 of the reamer. In axial rotation control mode, rotation is permitted about a trajectory defined by the rotation axis of the reamer (e.g., the X axis) and within the working space of the robot arm. In the example in Figure 12, as shown in Figure 13, pitch and yaw are permitted in point rotation control mode, and roll about the X axis is permitted in axial rotation control mode. The rotation is under the surgeon's control, and no navigation guidance is required while in rotation control mode.

[0099] In step 818, the user operates the rotation of the reamer in rotation control mode to align the reamer structure 130 with a desired, i.e., defined or planned reamer trajectory 136 (shown in Figure 14). In some embodiments, the computer platform 400 may operate to identify the desired reamer trajectory 136 and display it, for example, on a display or on an XR headset 150 to guide the surgeon.

[0100] In step 820, the surgeon selects a translational control mode from several defined operating modes. The translational control mode is defined by allowing translation of the reamer along the X, Y, and Z axes, while restricting rotation around the roll axis X, yaw axis Y, and pitch axis Z. Thus, translation can occur while maintaining the orientation of the instrument (e.g., the reamer) previously achieved in step 818. The translation of the reamer is initiated by the user and assisted by navigation guidance provided by the computer platform 400.

[0101] In step 822, the user activates the translation of the reamer in translation control mode to translate the reamer along a desired translational trajectory 128 (Figure 14) without correcting the orientation of the reamer. The translation proceeds along the desired translational trajectory 128 until the center 132 of the reamer is colocalized with the original center of the acetabulum 134 and the reamer is aligned with the reamer trajectory 136.

[0102] For example, using a computer platform 400, once the completion of alignment is detected, the system can move from the alignment phase to the reaming phase. In the reaming phase, the acetabulum is reamed along a reamer trajectory 136 from its original center 134 to the planned center of the acetabular prosthesis 138 (Figures 14 and 16).

[0103] In step 824, the surgeon selects a translation / rotation control mode from several defined operating modes. The translation / rotation control mode is defined by allowing the instrument to rotate around the fixed center point 132 of the reamer 124 and translate along a defined reamer trajectory 136, based on navigation guidance provided by the computer platform 400 and when operated by the surgeon 120.

[0104] In step 826, once the surgeon is satisfied with the trajectory, the rotation of the reamer 124 around the reamer center 132 can be actuated by the surgeon 120, for example, by pulling a trigger on the reamer structure. The translation of the reamer along the defined reamer trajectory 136 (Figure 16), guided by the computer platform 400, can be initiated by the surgeon directly or indirectly applying force to the end effector, as previously described. As the reamer 124 rotates around the reamer center 132 and translates along the defined reamer trajectory 136 toward the planned center 138 of the shell, the bone is cut to prepare the acetabulum to receive the shell. The rotation of the reamer around the center point 132 (for example, as shown in Figure 12) during reaming can be useful in achieving a smooth prepared surface within the acetabular cavity without leaving irregularities such as relatively high or low points along the surface. When the center point 132 of the reamer 124 reaches the planned center point 138 of the shell, the computer platform acts to stop the reaming process, so that the center 132 of the reamer 124 does not pass the planned center point 138 of the shell as it translates along the reamer trajectory 136. In this way, the system 10 realizes a surgical procedure plan with the assistance of navigation guidance from the computer platform 400 to locate the position and orientation of the reamer 124 relative to the patient's anatomical structure.

[0105] In step 828, following reaming, the surgeon selects a rotational control mode in a manner similar to that in step 816. As described above, the rotational control mode may be defined by restricting the translation of the reamer (e.g., the center point 132 of the reamer 124) along the X, Y, and Z axes, while allowing rotation of the reamer 124 around the roll, yaw, and pitch, i.e., the X, Y, and Z axes.

[0106] In step 830, the surgeon rotates the reamer structure to the desired reamer alignment to facilitate easy removal from the patient. In step 832, the surgeon selects a force control mode in the same manner as in step 812. In step 834, the surgeon guides the reamer structure out of the joint space in force control mode. As described above, navigation guidance is not required for steps 830 and 834, which are performed in rotation control mode and force control mode. In step 836, the surgeon removes the reamer structure from the end effector 112, completing workflow 800.

[0107] In certain embodiments, steps 802-836 described herein can be performed as a single-step reaming step, as shown in workflow 800 (Figure 10). In other embodiments, one or more steps, for example, one or more of steps 812-834, can be performed iteratively as desired to achieve an acetabular surface that is satisfactorily prepared for the execution of steps 900 and 1000 as described herein. In other embodiments, certain steps of workflow 800 may be performed iteratively. For example, in one embodiment, only the alignment steps, including steps 816-822, can be performed iteratively to achieve the desired alignment, and then the reaming step can be repeated once. In another embodiment, each of the insertion and alignment steps can be performed a single iteration, followed by iterative execution of steps 824 and 826 in the reaming step. Any combination of single and multiple iterations can be used as needed to achieve the desired result.

[0108] Robot-based trial workflow A trial placement or trial is an optional workflow 900 shown in Figure 17, which may be performed using a surgical system 10 including a surgical robot 100 (Figures 1-4) to assist the surgeon, as per specific embodiments of this disclosure. The purpose of the trial may include evaluating the fit of the shell in the acetabulum, which may be prepared according to workflow 800 as described herein, and evaluating the interaction between the femoral components, liner, and shell. Workflow 900 helps to ensure that the shell positioning actually matches the preoperative plan and that the shell is fully seated in the prepared acetabulum.

[0109] Referring to workflow 900, a trial shell and an inserter structure are provided. Similar to the reamer structure 130, the inserter structure may be a navigated surgical instrument and may include one or more instrument reference elements 170 that are attached to or formed on the instrument, as described elsewhere in this specification. The instrument reference elements 170 may be used to track the orientation of the instrument, i.e., the inserter, relative to another reference and / or defined coordinate system, for example, using a display which may include a camera tracking system 200, a computer platform 400, and / or an XR headset 150 as described above herein. In step 902, the trial shell is attached to the inserter structure, and in step 904, the inserter structure is inserted into the end effector 112, for example, into the guide tube 118. Alternatively, a sterile end effector-integrated navigated inserter structure may be used.

[0110] In step 906, the user selects a force-controlled operating mode in the same manner as in step 812 of workflow 800. The force-controlled modes used in workflow 900 are defined in the same manner as described for workflow 800. Thus, with the surgical robot 100 in force-controlled mode, translation of the injector along the X, Y, and Z axes is possible. Roll, yaw, and pitch of the injector, i.e., rotation around each of the X, Y, and Z axes, is also possible. Thus, in force-controlled mode, the user may translate the instrument along any one or more of the X, Y, and Z axes, and may rotate the instrument around any one or more of the X, Y, and Z axes to gain access to the surgical area, without requiring navigation guidance. The translation and orientation of the injector are controlled by the surgeon by directly or indirectly applying force and torque to the end effector and / or instrument.

[0111] In step 908, the user uses force control mode to position the intubator structure within the patient's acetabulum. This movement brings the trial shell, attached to the navigated intubator, into the patient's previously prepared acetabulum (e.g., via workflow 800).

[0112] In step 910, the user selects a rotation control mode from several defined operating modes. The rotation control mode may be defined in the same manner as described above with respect to step 816, for example, while translation of the inserter along the X, Y, and Z axes is restricted, roll, yaw, and pitch, i.e., rotation of the inserter about the X, Y, and Z axes, is permitted. The rotation is under the surgeon's control, and no navigation guidance is required while in rotation control mode.

[0113] In step 912, the user rotates the insertor structure to achieve the desired alignment and trajectory for inserting the shell. In some embodiments, the computer platform 400 may operate to identify the defined insertion trajectory and display it, for example, on a display or on the XR headset 150 to guide the surgeon.

[0114] In step 914, the user selects a translation control mode from several defined operating modes. The translation control mode may be defined in the same manner as described above with respect to step 820, for example, by constraints on rotation around the roll, yaw, and pitch axes X, Y, and Z, and by allowing translation of the inserter along the X, Y, and Z axes. Thus, translation may occur while maintaining the orientation of the instrument (e.g., the inserter) previously achieved in step 912. Translation of the inserter may be initiated by the user or assisted by navigation guidance provided by the computer platform 400.

[0115] In step 916, the user translates the inserter structure along the insertion axis. This step is similar to step 822 of workflow 800 and the example in Figure 14.

[0116] In step 918, the user may optionally evaluate whether any adjustments are needed, for example, in the planned trajectory or alignment of the inserter, and these adjustments may be made before proceeding to step 920. This evaluation may be assisted by visualization and / or navigation guidance from the computer platform 400, which may be displayed, for example, on a display or on the XR headset 150.

[0117] In step 920, the user may strike the trial shell to seat it in the prepared acetabulum. In step 922, the surgeon may verify that the trial shell is properly seated. For example, the trial shell may include a reference element that allows its tracking as described herein, and visualization to the user on a display or on the XR headset 150. In some embodiments, the surgeon may, for example, examine the display or the XR headset 150 to visually confirm whether the trial shell is properly seated. In other embodiments, other verification steps may be possible.

[0118] In step 924, the surgeon may disengage the trial shell from the insertor. In step 926, the surgeon may select a force control mode in the manner defined above with respect to step 906. In step 928, the user guides the insertor out of the joint space.

[0119] As described above, the trial workflow 900 in Figure 17 is optional and may or may not be performed after the reaming workflow 800 (Figure 10) and before the implant placement workflow 1000 (Figure 18), depending on several factors, including a predefined surgical plan and / or the surgeon's judgment. In either case, if workflow 900 is performed, the THA surgery may proceed to workflow 1000 following its conclusion.

[0120] Implant Placement Workflow Figure 18 shows a workflow 1000 for robot-assisted acetabular prosthesis (or "shell") placement in a particular embodiment of the present disclosure, using a surgical system 10 including a surgical robot 100 (Figures 1-4) to assist the surgeon.

[0121] Referring to workflow 1000, in embodiments where workflow 1000 optionally follows workflow 900, the surgeon begins in step 1002 by removing any trial components, such as the trial shell and liner, from the navigated inserter. In embodiments where workflow 1000 follows immediately after acetabular preparation, for example via workflow 800, step 1002 may be omitted.

[0122] In step 1004, the user can attach or insert a shell or implant into the insertor structure, and in step 1006, the insertor structure can be inserted into the end effector 112.

[0123] In an optional step 1008, in a particular embodiment, the user may teach the system 10 the location of one or more fixed openings within the shell, such as screw holes, using a alignment workflow that may be, for example, CT-based. In embodiments in which the locations of the fixed openings are aligned to the system 10 in step 1008, the computer platform 400 may be adapted to provide navigation guidance that enables robot-assisted placement of screws later in the workflow 1000 during implant placement (see step 1034 discussed below).

[0124] In step 1010, the user selects a force-controlled operating mode in the same manner as in steps 812 and 906 in workflows 800 and 900, respectively. The force-controlled mode used in workflow 1000 is defined in the same manner as described for workflows 800 and 900. Thus, with the surgical robot 100 in force-controlled mode, translation of the injector along the X, Y, and Z axes is possible. Roll, yaw, and pitch of the injector, i.e., rotation around each of the X, Y, and Z axes, is also possible. Thus, in force-controlled mode, the user may translate the instrument along any one or more of the X, Y, and Z axes, and may rotate the instrument around any one or more of the X, Y, and Z axes to gain access to the surgical area, without requiring navigation guidance. The translation and orientation of the injector are controlled by the surgeon by directly or indirectly applying force and torque to the end effector and / or instrument.

[0125] In step 1012, the user uses force control mode to position the insertor structure within the patient's acetabulum. This movement brings the shell implant, which is attached to the navigated insert, into the patient's previously prepared acetabulum (e.g., via workflow 800).

[0126] In step 1014, the user selects a rotation control mode from several defined operating modes. The rotation control mode may be defined in the same manner as described above with respect to steps 816 and 910, for example, translation of the inserter along the X, Y, and Z axes may be restricted, but roll, yaw, and pitch, i.e., rotation of the inserter about the X, Y, and Z axes, may be permitted. The rotation is under the surgeon's control, and no navigation guidance is required while in rotation control mode.

[0127] In step 1016, the user rotates the inserter structure to achieve the desired alignment and trajectory for inserting the shell. In some embodiments, the computer platform 400 may operate to identify the defined insertion trajectory and display it, for example, on a display or on the XR headset 150 to guide the surgeon.

[0128] In step 1018, the user selects a translation control mode from several defined operating modes. The translation control mode can be defined in the same manner as described above for steps 820 and 914, for example, by constraints on rotation around the roll, yaw, and pitch axes X, Y, and Z, and by allowing translation of the inserter along the X, Y, and Z axes. Thus, translation can occur while maintaining the orientation of the instrument (e.g., the inserter) previously achieved in step 1016. Translation of the inserter may be initiated by the user or assisted by navigation guidance provided by the computer platform 400.

[0129] In step 1020, the user translates the inserter structure along the insertion axis. This step is similar to steps 822 and 916 of workflows 800 and 900, respectively, and is similar to the example in Figure 14.

[0130] In step 1022, the user may optionally evaluate whether any adjustments are needed, for example, in the planned trajectory or alignment of the inserter, and these adjustments may be made before proceeding to step 1024. This evaluation may be assisted by visualization and / or navigation guidance from the computer platform 400, which may be displayed, for example, on a display or on the XR headset 150.

[0131] Once the trajectory and alignment of the inserter, and the planned position of the implant, are determined to be satisfactory, in step 1024, the user may strike the shell to seat it in the prepared acetabulum. In step 1026, the surgeon may verify that the implant is properly positioned and seated in a manner similar to that described herein with respect to step 922 of workflow 900.

[0132] In step 1028, the surgeon may disengage the shell from the insertor. In step 1030, the surgeon may select a force control mode in the manner defined above with respect to step 1010. In step 1032, the user guides the insertor out of the joint space.

[0133] Following the removal of the inserter in step 1032, the user may optionally place one or more screws in step 1034 to enhance the fixation of the shell within the acetabulum. As described above with respect to step 1008, in certain embodiments where the fixing opening in the shell is pre-aligned to the system 10, the computer platform 400 may operate to provide navigation guidance for the robotic placement of screws in the fixing opening in the shell. In other embodiments where the fixing opening in the shell is not pre-aligned to the system 10 (i.e., the optional step 1008 is omitted), the screws can be placed without the benefit of navigation guidance and / or robotic assistance. In yet another embodiment, screw placement 1034 may be omitted entirely, as it is an optional step.

[0134] Following the removal of the inserter in step 1032, and following the placement of the screws (if implemented) in step 1034, the liner may be inserted into the shell in step 1036.

[0135] Furthermore, following the removal of the inserter in step 1032, the surgical robot 10 may be removed from the surgical field in step 1038. In certain embodiments, step 1038 may be performed in parallel with one or more of steps 1034 and / or 1036.

[0136] Workflows 800, 900, and 1000 for robot-assisted acetabular preparation and prosthesis placement offer several advantages compared to previous methods. For example, workflow 800, assisted by system 10 including a surgical robot 100, provides additional precision and force assistance when preparing the acetabulum compared to conventional methods. Trial and prosthesis placement using workflows 900 and 1000 provides improved precision and alignment. Certain embodiments also provide useful confirmation of screw position before drilling when used in combination with CT-based alignment workflows.

[0137] Control based on adsorption volume A specific implementation provides a surgical robot with a controller programmed to use an adsorption volume-based control protocol in a total hip arthroplasty (THA) procedure. In a particular case, the surgical robot controller is configured to detect the position of a surgical instrument within one or more surgical volumes and to provide guidance (e.g., adsorption force) for the movement of the surgical instrument toward the adsorption volume. In various implementations, the adsorption volume is partially defined by a point and an axis extending from that point.

[0138] In certain cases, when a surgical instrument (e.g., instrument tip) is detected by the navigation system within a first (e.g., "low-suction") volume, the surgical robot controller provides (e.g., via the robot arm) (relatively) low assistance by generating forces and torques that are added to the forces and torques applied by the user. This assistance helps guide the surgical instrument (e.g., instrument tip) onto a planned acetabular trajectory and align the surgical instrument axis with the planned trajectory. In some cases, within the "low-suction" volume, the robot's forces and torques are of the same magnitude order as the forces and torques applied by the user, but remain within a range of magnitudes that the user can override if necessary. Thus, the user may feel low suction toward the planned acetabular trajectory, but can still move the center of the surgical instrument out of the "low-suction" volume by applying appropriate forces and torques in the opposite direction and intensity to the robot assistance.

[0139] Proximity-based adsorption control can also be performed within a second (or third, or additional) volume (e.g., a "high adsorption" volume or a "higher adsorption" volume). In these cases, when a surgical instrument (e.g., instrument tip) leaves the "low adsorption" volume and is detected by the navigation system within the "high adsorption" volume, the robot controller (e.g., robot arm) generates high assistance in the form of force and torque torquesole, which has a higher intensity than the force and torque torquesole applied by the user, to move the instrument center (instrument tip) onto the planned acetabular trajectory and align the instrument axis with the planned acetabular trajectory. In physics, force torquesole is defined as a vector containing the intensities of three forces applied along three orthogonal directions in 3D space and the intensities of torques applied around the same three directions. In some of these cases, the user feels a strong adsorption of the instrument toward the planned acetabular trajectory.

[0140] In yet another case, the robot controller is configured to operate in a fixed mode when the surgical instrument is aligned with a planned acetabular trajectory, for example, when the surgical instrument is aligned with a point and / or axis of the trajectory. In certain such cases, the robot controller does not allow movement of the surgical instrument in at least one degree of freedom (DoF) when it is aligned with the planned acetabular trajectory. In this sense, the robot controller fixes the surgical instrument on the planned acetabular trajectory until the user (or another command control) disables the operating mode.

[0141] As described in U.S. Patent No. 10,058,394 ("Robot Arm and Methods of Use," issued August 28, 2018, incorporated in its entirety), the suction force and / or resistance to the movement of a surgical instrument may be controlled via a robotic arm, for example, in an end effector. More specifically, a controller (or a group of controllers, such as one or more microcontrollers) may be programmed to move the robotic arm and / or end effector and control one or more motors that are operable to provide guidance to the user of the surgical instrument via suction force and / or resistance during a THA procedure. Feedback from one or more tracking systems, such as one that relies on reference element 170 described herein, can enable precise tracking of the position of the surgical instrument in space and enable real-time surgical guidance via tactile feedback.

[0142] Figure 19 shows examples of surgical instruments 1200 and acetabular regions 1210 including a planned acetabular center 1220, with various implementations. In some cases, the surgical instrument 1200 includes a reamer, an impactor, or another surgical instrument described herein. In some cases, the surgical instrument 1200 is similar to the reamer 124 described herein, for example, including a center 132. The surgical instrument 1200 is coupled to a robotic arm 104, for example, via an end effector 112. Figures 20 and 21 show enlarged perspective views of the distal end (or tip) 1230 of the instrument 1200, in this example, the distal end 1230 of a reamer 124 for reaming the acetabular region 1210. As described herein, the teachings of various embodiments can be applied to different types of surgical instruments 1200, such as the distal end of an impactor, reamer, etc.

[0143] Figures 19–21 also show separate adsorption volumes 1240, 1250, and 1260 for use in guiding the surgical instrument 1200, according to separate implementations herein. In some examples, two adsorption volumes 1240 and 1250 are shown, but one or more adsorption volumes can be used to perform the beneficial control functions described herein. For example, a single adsorption volume can be used to control the surgical instrument 1200 during a THA procedure, or two, three, four, or more adsorption volumes can be used to control the surgical instrument 1200 during a THA procedure. Figure 20 shows an exemplary configuration including an additional adsorption volume 1260 within adsorption volume 1240, having a smaller radius than the adsorption volume 1250 shown in Figures 19 and 21. In certain implementations, adsorption volume 1260 is used together with both adsorption volumes 1240 and 1250. For efficient explanation, the adsorption volume 1240 can be considered as the first adsorption volume, and the adsorption volumes 1250 and 1260 can be considered as the second adsorption volume, or the second and third adsorption volumes, respectively.

[0144] It is understood that the adsorption volumes 1240, 1250, and 1260 are defined by a set of coordinates and / or the perimeter of the coordinates having a center point, axis, or other reference point related to the target position for the THA procedure. For example, the adsorption volumes 1240, 1250, and 1260 can be defined based on the planned acetabular center 1220 (e.g., the center of the implant placed in the acetabular region 1210). The adsorption volumes 1240, 1250, and 1260 can be systematized in program code (e.g., in a separate processor of the navigation controller 404 or computer platform 400, as shown in Figure 4) and can be defined by coordinates associated with the tracked position of the surgical instrument 1200 (e.g., three-dimensional coordinates in surgical space) (e.g., reference element 170, as shown by Figures 11, 14, and 19). In other words, the suction volumes 1240, 1250, and 1260 are not necessarily visible to the operator (e.g., surgeon) during the THA procedure, but provide guidance via control functions in the robotic arm 104. In certain implementations, the suction volumes 1240, 1250, and 1260 provide tactile feedback (or guidance) to the user during the THA procedure. In additional implementations, for example, when an XR headset 150 (Figure 1) is used, the suction volumes 1240, 1250, and 1260 can be overlaid on a display visible to the user during the THA procedure. In such cases, the periphery, centerline, and / or points defining the suction volumes 1240, 1250, and 1260 can be visually displayed to the user during the THA procedure to assist in guiding the surgical instrument 1200 to the target position.

[0145] As described herein, the adsorption volumes 1240, 1250, and 1260 are partially defined by a point (e.g., the acetabular center 1220) and an axis (A) extending from point 1220. In certain cases, point 1220 and axis (A) define the centerlines (CL) of both the first adsorption volume 1240 and the second adsorption volumes 1250 and / or 1260. In certain implementations, at least one of the adsorption volumes has a substantially conical shape, for example, having a larger radius at a distance further from point 1220 than at a distance closer to point 1220. In some cases, the conical adsorption volume is cut off by a plane (P) intersecting point 1220. In additional implementations, the volume may have a substantially tubular shape, for example, as shown in the adsorption volume 1250 in Figure 19, such that the radius of volume 1250 is substantially consistent along axis (A).

[0146] In certain embodiments, the navigation controller 404 (or other controllers and / or microcontrollers in the computer platform 400) is configured to: i) detect the position of the surgical instrument 1200 in at least one of the adsorption volumes 1240, 1250, and 1260 during a THA procedure; and ii) provide an adsorption force while the surgical instrument 1200 is within the adsorption volumes 1240, 1250, and 1260 to guide its movement toward the adsorption volumes 1240, 1250, and 1260. In certain cases, the controller 404 provides guidance (or an adsorption force) for the movement of the surgical instrument 1200 toward a planned trajectory for the THA procedure. For example, the controller 404 can provide an adsorption force to move the surgical instrument 1200 toward an axis (A) and / or point (e.g., 1220) defining the planned trajectory. In a particular example, if the user does not apply force to the surgical instrument 1200 while it is within the suction volumes 1240, 1250, and 1260, the navigation controller 404 provides sufficient suction force to move the surgical instrument 1200 toward a planned trajectory (e.g., toward axis (A) and / or point 1220). In a particular example, the controller 404 is configured to allow movement of the surgical instrument 1200 in multiple directions (e.g., via the end effector 112 and / or robotic arm 104), but to provide greater assistance for movement toward a planned trajectory (e.g., axis (A) and / or point 1220). In various implementations, directional assistance is based in part on the shape and size of the suction volumes 1240, 1250, and 1260. For example, the controller 404 may be configured to assist movement in directions that are radially inward toward axis (A) and / or axially inward toward the acetabular center 1220. That is, when the surgical instrument 1200 enters the suction volumes 1240, 1250, and 1260, the controller 404 activates the motor or other limiter in the robot arm 104 and / or end effector 112 to provide a suction force (e.g., tactile guidance) in a radially inward direction (towards axis (A)) and / or to guide axial movement along axis (A) toward the acetabular center 1220.When the surgical instrument 1200 moves from one side of axis (A) to the other side of axis (A) through the adsorption volumes 1240, 1250, and 1260, it is understood that the controller 404 responds by adjusting the assistance back in the direction that guides the surgical instrument 1200 toward axis (A).

[0147] In certain implementations, separate adsorption volumes may have separate associated adsorption forces. For example, a first adsorption volume, such as adsorption volume 1240, may have a smaller adsorption force than a second adsorption volume, such as adsorption volume 1250 (or 1260). As described herein, in certain cases, the second (or third) adsorption volumes 1250, 1260, etc., may be sub-volumes of the first adsorption volume 1240. In this sense, when a surgical instrument 1200 enters the first adsorption volume 1240, the user encounters an adsorption force that induces movement in the direction toward the planned trajectory (e.g., radially toward axis (A) and / or axially toward point 1220). In certain cases, the adsorption force within a given adsorption volume is substantially consistent, and as a result, the user feels approximately the same amount of adsorption force while the surgical instrument 1200 is within the adsorption volume, regardless of its distance from axis (A) and / or point 1220. In other cases, the suction force within a given adsorption volume is progressive, and as a result, the user feels a greater suction force for movement toward the planned trajectory (e.g., toward axis (A) and / or point 1220) as the surgical instrument 1200 approaches the planned trajectory. In various embodiments where the second (or third) adsorption volumes 1250, 1260 are sub-volumes of the first adsorption volume 1240, the user feels a greater suction force for movement toward the planned trajectory (e.g., toward axis (A) and / or point 1220) as the surgical instrument 1200 enters the second (or third) adsorption volumes 1250, 1260. In these cases, the user (or operator) must apply a greater force to remove the surgical instrument 200 from the second (or third) adsorption volumes 1250, 1260 than from the first adsorption volume 1240. As described herein, any adsorption volume may have a substantially consistent or progressive suction force.

[0148] According to a particular embodiment, a controller (e.g., a navigation controller 404 or other controllers and / or microcontrollers in the computer platform 400) places the tip (e.g., distal end) 1230 of the surgical instrument 1200 at point 1220, and the axis (A) of the surgical instrument 1200. si The surgical instrument 1200 is further programmed to progressively guide the 1230 to the axis (A) of the adsorption volume 1240. In various embodiments, progressively guiding the surgical instrument 1200 is to provide tactile feedback to guide the tip 1230 of the surgical instrument 1200 to point 1220, and then the axis (A) of the surgical instrument 1200. si The method includes providing tactile feedback to guide the tip 1230, then the axis (A) of the adsorption volume 1240. As described herein, the tactile feedback may include providing greater adsorption force for the movement of the surgical instrument 1200 toward the point 1220 and the axis (A) of the adsorption volume 1240. In some cases, the tip 1230, then the axis (A) of the surgical instrument 1200 si Incremental guidance of the surgical instrument helps to efficiently draw the surgical instrument into its planned trajectory. For example, for the operator, first align two points, e.g., tip 1230 with point 1220, and then each axis consisting of multiple points (e.g., A and A) si It may be easier to align the axes (e.g., A and A). The controller 404 first aligns the tip 1230 with point 1220, and then aligns the axes (e.g., A and A). si To align the adsorption volumes, the system can be configured to provide instructions (e.g., via the display 110 and / or interface 440) and / or inductive adsorption. As also described herein, the axes (A) of the adsorption volumes 1240, 1250, and 1260 are aligned with the planned trajectory of the surgical instrument 1200 for the THA procedure.

[0149] In additional implementations, providing haptic feedback (e.g., from the navigation controller 404 or other controllers and / or microcontrollers in the computer platform 400) may include providing the user with other haptically detectable outputs to assist in guiding the surgical instrument 1200 toward a planned trajectory. For example, additional or alternative haptic feedback may include vibrating the end effector 112 and / or robotic arm 104 in response to the user's movement of the surgical instrument 1200 toward a direction away from the planned trajectory. In these cases, while the surgical instrument 1200 is in the suction volume 1240, 1250, etc., the controller initiates vibration of the end effector 112 and / or robotic arm 104 in response to the user moving the surgical instrument toward axis (A) and / or point 1220. This vibration feedback may be added to or alternative to suction for movement via the motorized and / or limiter-based approaches described herein. In various additional embodiments, auditory feedback may be provided to the user in addition to or alternative to the haptic feedback described herein. For example, the XR headset 150 may play auditory feedback to the user, which may include one or more patterns of tones or verbal feedback representing specific movements of the surgical instrument 1200.

[0150] As described herein, in certain implementations, the controller 404 (or other controllers and / or microcontrollers in the computer platform 400) is configured to operate in multiple modes during THA procedures. In some cases, the controller 404 is configured to automatically switch between operating modes in response to detecting that the surgical instrument 1200 is aligned with a planned trajectory of the surgical instrument for the THA procedure (e.g., point 1220 and axis A). In certain embodiments, the automatic switching is performed without requiring additional user interaction (e.g., via the command interface 440 or other interfaces such as the GUI on the display 110).

[0151] In certain embodiments, the operating modes include a free mode, a constrained mode, etc. In certain embodiments, the constrained mode includes a hinge sub-mode, a fixed sub-mode, etc. FIG. 22 shows an example of the hinge sub-mode or the hinge haptic control mode), and FIG. 23 shows the linear guidance mode. According to certain embodiments, the hinge haptic control mode shown in FIG. 22 limits the degrees of freedom of the surgical instrument 1200 to allow rotation about its axis (A si ). In these implementations, the position of the tip 1230 is fixed (e.g., aligned with point 1220), and the axis (A si ) of the surgical instrument 1200 is fixed to the axis (A), such that the surgical instrument 1200 is configured to rotate about the axis (A) as indicated by θ R .

[0152] According to certain embodiments, another operating mode includes a linear guidance haptic control mode (FIG. 23) that limits the degrees of freedom of the surgical instrument 1200 to allow translation along the axis (A). In these cases, when the axis (A si ) of the surgical instrument 1200 is aligned with the axis (A), the user can translate the surgical instrument 1200 along the axis (A) and can also rotate it about the axis (A) as indicated by θ R .

[0153] In a specific implementation, as shown in the process flow diagram of Figure 24, the controller 404 uses multiple adsorption volumes 1240, 1250, and 1260 to perform part of the THA procedure. P1300: During THA procedure, the position of the surgical instrument 1200 within the first adsorption volume 1240 is detected. P1310: Provides an adsorption force for the movement of the surgical instrument 1200 in a direction toward the first adsorption volume 1240 (for example, radially toward axis (A) and / or linearly toward point 1220), P1320: Detects the position of the surgical instrument 1200 within the second adsorption volume 1250 and 1260 within the first adsorption volume 1240. P1330: Can be configured to control the movement of the surgical instrument 1200 in the direction toward the second adsorption volumes 1250, 1260 (e.g., radially toward axis (A) and / or linearly toward point 1220) by providing a greater adsorption force. Optional implementations (shown by dashed lines) may also include: P1340: For example, snap the surgical instrument 1200 for the THA procedure to a planned trajectory (e.g., axis A and point 1220) with a relatively maximum suction force. In these cases, snapping the surgical instrument 1200 to the planned trajectory can be performed with a higher suction force than in P1330, and includes providing sufficient suction force that, in certain cases, would require the user to apply a deliberately strong force to move the surgical instrument from the planned trajectory. In some cases, step 1340 is performed when the position of the surgical instrument is within a threshold distance or threshold percentage deviation from the planned trajectory, e.g., within X centimeters of axis (A) and / or point 1220, and / or within Y percent deviation from axis (A) and / or point 1220. In certain implementations, snapping may be enabled or disabled via a setting for the THA procedure.

[0154] According to additional specific implementations, referring to the flowchart in Figure 25 and the schematic diagram in Figure 20, the controller 404 controls the reaming portion of the THA procedure. P1400: The surgical instrument 1200 is configured to be controlled to align (e.g., snap) with a planned trajectory for the THA procedure (e.g., axis A and point 1220) so that the tip 1230 of the surgical instrument 1200 coincides with point 1220 (planned acetabular center). In these cases, the planned acetabular center 1220 defines both the planned center point of the acetabulum 138 and the initial reaming position for reaming the acetabular cavity. P1410: Constrains the axial movement (e.g., along axis A) of the surgical instrument 1200 when the tip 1230 reaches the final point 1420 which defines the final reaming position. The final reaming position is understood to define the position where the surgical instrument 1200 will be located when the reaming process is complete. In various embodiments, as shown in Figure 20, the final reaming position 1420 is distal to the initial reaming position 1220. In certain cases, the final reaming position (or final point) 1420 is related to the acetabular center point 138, as well as the size of the implant. In other words, the final reaming position (or point) 1420 is predetermined (or pre-selected) based on the planned acetabular center point / implant size. In certain examples, the final reaming position 1420 is axially offset from the acetabular center point 138 by the radius of the acetabular implant or shell.

[0155] In some cases, after aligning the surgical instrument 1200 with a planned trajectory (e.g., axis A and point 1220), the surgical instrument 1200 is free to rotate around axis (A) or pivot freely around point 1220. In further cases, the surgical instrument 1200 is free to rotate around axis (A) or pivot freely around point 1420 after its axial movement is constrained. In some examples, the controller 404 constrains the movement of the surgical instrument 1200 after it has reached its final destination (point 1420), and as a result, no further movement is permitted even if the user operates the instrument 1200. In these cases, the reamer can rotate freely (e.g., via operation by the user), but the instrument 1200 is fixed and therefore does not allow for further reaming depth along axis (A). As described in the exemplary implementations herein, in certain examples, the controller 404 snaps the planned center point 1220 of the acetabulum to the end (e.g., tip) 1230 of the surgical instrument (e.g., reamer) 1200, defining an initial reaming position. At the initial reaming position 1220, the controller 404 allows the user to pivot / rotate the instrument around point 1220, enabling reaming to linearly remove tissue, and after reaming, reaching a second center point (final center point) 1420, where the controller constrains axial movement of the surgical instrument (e.g., still allowing rotation / pivot around point 1420).

[0156] According to certain embodiments, as described herein, the position of the surgical instrument 1200 can be tracked via one or more reference elements 170, and a user interface such as a display 110 and / or 440 can enable a user (e.g., a surgeon, technician, assistant, etc.) to monitor the position of the surgical instrument 1200 in the surgical space during a THA procedure. The surgical robot may include a navigation system (controller 404) for tracking the reference elements 170 and providing input to a controller 404 to perform the functions described herein, as well as for providing feedback to the user via the display 110 and / or user interface 440.

[0157] In contrast to conventional THA procedures, the approaches and systems disclosed herein can enable greater precision in positioning surgical instruments at multiple stages of the surgery. Furthermore, the approaches and systems disclosed herein can enhance the efficiency of THA procedures by effectively guiding surgical instruments along planned trajectories. The disclosed approaches and systems are also configured to limit user errors in reaming and / or implant placement by guiding the movement and / or operation of surgical instruments in a manner that deviates from planned trajectories.

[0158] Postoperative evaluation examples Similar to the methods used for preoperative patient assessment, system 10 may be used by surgeons to perform postoperative patient assessments to evaluate the quality of the THA surgery and the patient's benefit. The workflow may include, for example, an assessment of the patient's mobility using data collected from physical movement and sensor feedback (e.g., attached to the leg), which can be compared with clinical surveys to confirm the patient's health status. All collected postoperative information can be automatically compared with preoperative information by the system.

[0159] Further Definitions and Embodiments In the above description of various embodiments of the concept of the present invention, it should be understood that the terms used herein are for the purpose of describing only specific embodiments and are not intended to limit the concept of the present invention. Unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as generally understood by those skilled in the art in the field to which the concept of the present invention belongs. Terms such as those defined in commonly used dictionaries should be interpreted as having the same meaning in the context of this specification and related art, and should not be interpreted in the ideal or overly formal sense as explicitly defined herein.

[0160] When an element is referred to as “connected,” “combined,” “responding,” or a variation thereof to another element, it can be directly connected, combined, or responding to the other element, or an intervening element may exist. In contrast, when an element is referred to as “directly connected,” “directly combined,” “directly responding,” or a variation thereof to another element, no intervening element exists. Similar numbers refer to similar elements throughout. Furthermore, as used herein, “combined,” “connected,” “responding,” or a variation thereof may include being combined, connected, or responding wirelessly. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural form unless otherwise explicitly indicated by the context. Well-known functions or structures may not be described in detail for the sake of brevity and / or clarity. The term “and / or” includes any combination of one or more of the related enumerated items.

[0161] In this specification, terms such as first, second, third, etc., may be used to describe various elements / operations, but it will be understood that these elements / operations should not be limited by these terms. These terms are used solely to distinguish one element / operation from another. Thus, a first element / operation in some embodiments may be called a second element / operation in other embodiments without departing from teaching the concepts of the invention. The same reference numbers or reference numerals indicate the same or similar elements throughout this specification.

[0162] As used herein, “comprise,” “comprising,” “comprises,” “include,” “including,” “includes,” “have,” “has,” “having,” or variations thereof are open-ended and include one or more described features, integers, elements, processes, components, or functions, but do not preclude the existence or addition of one or more other features, integers, elements, processes, components, functions, or groups thereof. Furthermore, as used herein, the general abbreviation “eg,” derived from the Latin phrase “exempli gratia,” may be used to introduce or specify a general example or a number of examples of the previously mentioned items, and is not intended to limit such items. The general abbreviation “ie,” derived from the Latin phrase “id est,” may be used to specify a particular item from a more general enumeration.

[0163] Exemplary embodiments are described herein with reference to block diagrams and / or flowcharts of computer implementation methods, devices (systems and / or devices) and / or computer program products. It is understood that blocks in block diagrams and / or flowcharts, and combinations of blocks in block diagrams and / or flowcharts, can be implemented by computer program instructions implemented by one or more computer circuits. These computer program instructions may be provided to processor circuits of general-purpose computer circuits, dedicated computer circuits, and / or other programmable data processing circuits for manufacturing machines, such that instructions executed via the processor of a computer and / or other programmable data processing device convert and control transistors, values ​​stored in memory locations, and other hardware components in such circuits to implement functions / operations specified in block diagram and / or flowchart blocks or a plurality of blocks, thereby forming means (functions) and / or structures for implementing functions / operations specified in block diagrams and / or flowchart blocks.

[0164] These computer program instructions can also be stored on a tangible computer-readable medium, which can instruct a computer or other programmable data processing device to function in a particular way, such as to generate a product containing instructions that implement a function / operation specified in a block or more blocks of a flowchart and / or block diagram. Accordingly, embodiments of the concept of the present invention may be embodied in software (including firmware, resident software, microcode, etc.) running on a processor such as a hardware and / or digital signal processor, which can be collectively called “circuits,” “modules,” or variations thereof.

[0165] Furthermore, it should be noted that in some alternative implementations, the functions / operations described in a block may occur in a different order than that shown in the flowchart. For example, two consecutively shown blocks may actually be executed substantially simultaneously, or blocks may sometimes be executed in reverse order depending on the functions / operations involved. Moreover, the function of a given block in a flowchart and / or block diagram may be separated into multiple blocks, or the functions of two or more blocks in a flowchart and / or block diagram may be at least partially integrated. Finally, without departing from the scope of the concept of the present invention, other blocks may be added / inserted between shown blocks, and / or blocks / operations may be omitted. Furthermore, while some diagrams include arrows on the communication path to indicate the main direction of communication, it should be understood that communication may occur in the opposite direction to the depicted arrows.

[0166] Many variations and modifications can be made to the embodiments without substantially departing from the principles of the concept of the present invention. All such variations and modifications are intended to be included herein within the scope of the concept of the present invention. Accordingly, the above disclosed subject matter should be considered as illustrative and not restrictive, and the accompanying examples of embodiments are intended to cover all such modifications, enhancements, and other embodiments that fall within the spirit and scope of the concept of the present invention. Accordingly, to the maximum extent permitted by law, the scope of the concept of the present invention should be determined by the broadest permissible interpretation of this disclosure, including the following examples of embodiments and their equivalents, and is not limited or restricted by the above detailed description.

Claims

1. A surgical robot for use in total hip arthroplasty (THA) procedures, wherein the robot is A robotic arm for holding surgical instruments, A controller coupled to the robot arm, The position of the surgical instrument in at least one adsorption volume, which corresponds to the planned trajectory of the surgical instrument for the THA procedure and is partially defined by a point and an axis extending from the point, is detected. A controller programmed to provide assistance for moving the surgical instrument toward the at least one adsorption volume while the surgical instrument is within the at least one adsorption volume during the THA procedure, A surgical robot equipped with [a specific feature / ability].

2. The surgical robot according to claim 1, wherein the at least one adsorption volume comprises a plurality of adsorption volumes having separate associated adsorption forces.

3. The surgical robot according to claim 2, wherein the first adsorption volume has a smaller adsorption force than the second adsorption volume, and the second adsorption volume is a sub-volume of the first adsorption volume.

4. The surgical robot according to claim 3, wherein the point and the axis define the centerlines of both the first adsorption volume and the second adsorption volume.

5. The surgical robot according to claim 3, wherein the operator must apply a greater force than that applied to the first suction volume in order to remove the surgical instrument from the second suction volume, and the controller is configured to align and fix the surgical instrument with the planned trajectory in at least one operating mode.

6. The surgical robot according to claim 1, wherein the surgical instrument includes at least one of a reamer or an impactor.

7. The surgical robot according to claim 1, wherein the controller is further programmed to progressively guide the tip of the surgical instrument to the point and the axis of the surgical instrument to the axis of the adsorption volume.

8. The surgical robot according to claim 7, wherein progressive guidance includes providing tactile feedback to guide the tip of the surgical instrument to the point, and then providing tactile feedback to guide the axis of the surgical instrument to the axis of the adsorption volume, the axis of the adsorption volume being aligned with the planned trajectory of the surgical instrument for the THA procedure.

9. The surgical robot according to claim 8, wherein the controller is configured to operate in multiple modes during the THA procedure, and the controller automatically switches between the operating modes in response to detecting that the surgical instrument is aligned with the planned trajectory of the surgical instrument for the THA procedure.

10. The surgical robot according to claim 9, wherein at least one of the operating modes includes a hinge tactile control mode that restricts the degrees of freedom of the surgical instrument and allows it to rotate around its axis.

11. The surgical robot according to claim 9, wherein at least one of the plurality of operating modes includes a linear induced tactile control mode to limit the degrees of freedom of the surgical instrument and enable translation along the axis.

12. The surgical robot according to claim 1, wherein the at least one adsorption volume has a substantially conical shape.

13. The surgical robot according to claim 1, further comprising a navigation system for maintaining the alignment of the surgical instruments along the planned trajectory for the THA procedure.

14. The aforementioned controller, Align the surgical instrument with the planned trajectory for the THA procedure such that the tip of the surgical instrument coincides with the point defining the initial reaming position. The reaming portion of the THA procedure is controlled by restricting the axial movement of the surgical instrument when the tip reaches the final point that defines the final reaming position distal to the initial reaming position. After aligning the surgical instrument with the planned trajectory, the surgical instrument rotates freely around the axis or pivots freely around the point. The surgical robot according to claim 1, wherein the surgical instrument, after its axial movement is constrained, can freely rotate about the axis or pivot freely about the point.

15. The surgical robot according to claim 1, further comprising an end effector for holding the surgical instrument, the end effector enabling the attachment of a separate surgical instrument for the THA procedure.

16. A method for controlling a surgical robot during total hip arthroplasty (THA) is, the earlier method is, To detect the position of the surgical instrument in at least one adsorption volume, which corresponds to the planned trajectory of the surgical instrument for the THA procedure and is partially defined by a point and an axis extending from the point, A method comprising providing assistance for the movement of the surgical instrument toward the at least one adsorption volume while the surgical instrument is within the at least one adsorption volume during the THA procedure.

17. The at least one adsorption volume comprises a plurality of adsorption volumes having separate associated adsorption forces, wherein the first adsorption volume has a smaller adsorption force than the second adsorption volume, and the second adsorption volume is a sub-volume of the first adsorption volume. The aforementioned point and the aforementioned axis define the centerlines of both the first adsorption volume and the second adsorption volume, The operator must apply greater force to remove the surgical instrument from the second adsorption volume than from the first adsorption volume. The method according to claim 16, further comprising aligning and fixing the surgical instrument with the planned trajectory in at least one operating mode.

18. The method according to claim 16, wherein the controller is further programmed to progressively guide the tip of the surgical instrument to the point and the axis of the surgical instrument to the axis of the adsorption volume.

19. The progressive guidance includes providing tactile feedback to guide the tip of the surgical instrument to the point, and then providing tactile feedback to guide the axis of the surgical instrument to the axis of the adsorption volume, wherein the axis of the adsorption volume is aligned with the planned trajectory of the surgical instrument for the THA procedure, and the method is The method according to claim 18, further comprising automatically switching between operating modes in response to detection that the surgical instrument is aligned with the planned trajectory of the surgical instrument for the THA procedure.

20. At least one of the aforementioned operating modes is A hinge tactile control mode that restricts the degrees of freedom of the surgical instrument and allows rotation around its axis, or The method according to claim 19, comprising a linear induced tactile control mode that restricts the degrees of freedom of the surgical instrument and enables translation along the axis.

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