Dynamic implant-bone impingement color map user interface during intraoperative implant placement

Abstract

A method and system for generating a dynamic seating map during joint replacement surgery is disclosed. The method comprises tracking a spatial pose of a surgical tool relative to a patient's anatomy, determining a position of an implant based on the spatial pose of the surgical tool, mapping a prepared bone surface of the patient's anatomy, calculating distances between the implant and the prepared bone surface, and generating a real-time visualization of the distances on a user interface, wherein the visualization comprises a color-coded representation of implant-to-bone contact. The system may include a tracking device, a processor configured to perform the distance calculations, and a display device for presenting the real-time visualization to guide intraoperative implant placement.

Description

Attorney Docket No. 8178.6171WODYNAMIC IMPLANT-BONE IMPINGEMENT COLOR MAP USER INTERFACE DURING INTRAOPERATIVE IMPLANT PLACEMENTRELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 705,833, filed October 10, 2024, entitled "DYNAMIC IMPLANT-BONE IMPINGEMENT COLOR MAP USER INTERFACE DURING INTRAOPERATIVE IMPLANT PLACEMENT”, the contents of which are incorporated herein in their entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to surgical navigation systems and methods for joint replacement procedures. More particularly, the present disclosure relates to dynamic implant-bone impingement mapping user interfaces for intraoperative implant placement during joint arthroplasty.BACKGROUND

[0003] Joint replacement surgeries, such as total hip arthroplasty, total shoulder arthroplasty, and total knee arthroplasty, are common procedures performed to alleviate pain and restore function in patients with damaged or diseased joints. These procedures involve replacing damaged bone and cartilage with artificial implants designed to mimic the natural joint's structure and movement.

[0004] The success of joint replacement surgeries can depend on the accurate positioning and secure fixation of the implants within the patient's anatomy. Proper implant placement is crucial for achieving optimal joint function, stability, and longevity of the prosthetic components. However, achieving precise implant positioning may be challenging due to variations in patientAttorney Docket No. 8178.6171WO anatomy, limited visibility' during surgery, and the complex three-dimensional relationships between the implant and surrounding bone structures.

[0005] Traditionally, surgeons have relied on their experience, preoperative planning, and intraoperative visual and tactile feedback to guide implant placement. While these methods have been successful, they can be subject to variability and may not always result in optimal outcomes. As a result, there has been growing interest in developing advanced technologies to assist surgeons in achieving more accurate and consistent implant positioning.

[0006] Computer-assisted surgery and navigation systems have emerged as valuable tools in orthopedic procedures, offering the potential for improved precision and reproducibility in implant placement. These systems typically use various tracking technologies to monitor the position of surgical instruments and implants in relation to the patient's anatomy. However, many existing systems provide limited real-time feedback on the quality of implant seating and bone contact, which are critical factors in ensuring implant stability and long-term success.

[0007] There is a growing need for intuitive and real-time visualization tools that can provide surgeons with immediate feedback on implant positioning and bone contact during joint replacement procedures. Such tools could potentially enhance surgical decision-making, improve the consistency of implant placement, and ultimately lead to better patient outcomes.SUMMARY

[0008] In some examples, a method for generating a dynamic seating map during joint replacement surgery includes tracking a spatial pose of a surgical tool relative to a patient's anatomy; determining a position of an implant based on the spatial pose of the surgical tool; mapping a prepared bone surface of the patient's anatomy; calculating one or more distances between the implant and the prepared bone surface; and generating a real-time visualization ofAttorney Docket No. 8178.6171WO the one or more distances on a user interface, wherein the visualization comprises at least one of a color-coded or pattern-coded representation of implant-to-bone contact.

[0009] In some examples, mapping the prepared bone surface includes using a tracked tool to collect surface data points.

[0010] In some examples, calculating distances between the implant and the prepared bone surface includes constructing a bounding-box tree.

[0011] In some examples, generating the real-time visualization includes updating the representation at a predetermined frame rate as the surgical tool moves.

[0012] In some examples, the method includes calibrating the surgical tool to determine a spatial relationship between a tracking frame on the surgical tool and an implant attached to the surgical tool.

[0013] In some examples, determining the position of the implant is based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool.

[0014] In some examples, the joint replacement surgery’ is selected from the group consisting of total hip arthroplasty’, total shoulder arthroplasty, and total knee arthroplasty.

[0015] In some examples, a system for intraoperative implant placement guidance includes a tracking device configured to track a spatial pose of a surgical tool relative to a patient's anatomy; a process and a display device. The processor may be configured to determine a position of an implant based on the spatial pose of the surgical tool, map a prepared bone surface of the patient's anatomy, and calculate distances between the implant and the prepared bone surface. The display device may be configured to present a real-time visualization of the calculated distances, wherein the visualization comprises at least one of color-coded or pattern- coded representation of implant-to-bone contact.Attorney Docket No. 8178.6171WO

[0016] In some examples, the processor is further configured to construct a bounding-box tree data structure for efficient distance computations between the implant and the prepared bone surface.

[0017] In some examples, the system includes a calibration module configured to determine a spatial relationship between a tracking frame on the surgical tool and the implant attached to the surgical tool.

[0018] In some examples, the processor is configured to determine the position of the implant based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool.

[0019] In some examples, the display device is configured to update the representation at a predetermined frame rate as the surgical tool moves.

[0020] In some examples, the tracking device includes an optical tracking system with markers attached to the surgical tool and the patient's anatomy.

[0021] In some examples, the processor is further configured to register the tracked spatial poses to a pre-operative medical image of the patient's anatomy.

[0022] In some examples, a non-transitory computer-readable medium stores instructions that, when executed by a processor, cause the processor to perform operations for guiding implant placement during joint replacement surgery, the operations including receiving tracking data of a surgical tool's spatial pose relative to a patient's anatomy; determining a position of an implant based on the tracking data; accessing a map of a prepared bone surface of the patient's anatomy; calculating distances between the implant and the prepared bone surface; and generating a real-time visualization of the calculated distances for display on a user interface, wherein the visualization comprises at least one of a color-coded or pattern-coded representation of implant-to-bone contact.

[0023] In some examples, the operations include constructing a bounding-box tree data structure.Attorney Docket No. 8178.6171WO

[0024] In some examples, the operations include calibrating the surgical tool to determine a spatial relationship between a tracking frame on the surgical tool and the implant attached to the surgical tool.

[0025] In some examples, determining the position of the implant is based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool.

[0026] In some examples, generating the real-time visualization includes updating the representation at a predetermined frame rate as the surgical tool moves.

[0027] In some examples, the operations include registering the tracking data to a pre-operative medical image of the patient's anatomy.BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the examples of the disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings:

[0029] FIG. 1 depicts an operating theatre including an illustrative computer-assisted surgical system (CASS) in accordance with one or more features of the present disclosure.

[0030] FIG. 2A depicts illustrative control instructions that a surgical computer provides to other components of a CASS in accordance with one or more features of the present disclosure.

[0031] FIG. 2B depicts illustrative control instructions that components of a CASS provide to a surgical computer in accordance with one or more features of the present disclosure.

[0032] FIG. 2C depicts an illustrative implementation in which a surgical computer is connected to a surgical device in accordance with one or more features of the present disclosure.Attorney Docket No. 8178.6171WO

[0033] FIG. 3 depicts an illustrative flowchart for a method of tracking and positioning an implant during a surgical procedure in accordance with one or more features of the present disclosure.

[0034] FIG. 4 depicts an illustrative flowchart for a method of generating a visualization of distances between an implant and a bone surface in accordance with one or more features of the present disclosure.

[0035] FIG. 5 depicts an illustrative perspective view of a pelvis with a tracking array for use in surgical procedures in accordance with one or more features of the present disclosure.

[0036] FIG. 6 depicts an illustrative perspective view of a scapula with a tracking array for use in surgical procedures in accordance with one or more features of the present disclosure.

[0037] FIG. 7 depicts an illustrative tracking calibration setup for a surgical tool system in accordance with one or more features of the present disclosure.

[0038] FIG. 8 depicts an isometric view of a tracked insertion tool used in surgical procedures in accordance with one or more features of the present disclosure.

[0039] FIGS. 9 and 10 depict illustrative user interfaces for mapping bone-implant impingement in accordance with one or more features of the present disclosure.

[0040] FIG. 11 illustrates a block diagram of a data processing system in which one or more features of the present disclosure is implemented.DETAILED DESCRIPTION

[0041] This disclosure is not limited to the particular systems, devices and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or examples only and is not intended to limit the scope.

[0042] As used in this document, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one ofAttorney Docket No. 8178.6171WO ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the examples described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term ‘'comprising” means “including, but not limited to.”Definitions

[0043] For the purposes of this disclosure, the term “implant” is used to refer to a prosthetic device or structure manufactured to replace or enhance a biological structure. For example, in a total hip replacement procedure a prosthetic acetabular cup (implant) is used to replace or enhance a patients worn or damaged acetabulum. While the term “implant” is generally considered to denote a man-made structure (as contrasted with a transplant), for the purposes of this specification an implant can include a biological tissue or material transplanted to replace or enhance a biological structure.

[0044] For the purposes of this disclosure, the term "native" in this context refers to the original, natural anatomy of the patient before any surgical alterations.

[0045] For the purposes of this disclosure, the term “real-time” is used to refer to calculations or operations performed on-the-fly as events occur or input is received by the operable system. However, the use of the term “real-time” is not intended to preclude operations that cause some latency between input and response, so long as the latency is an unintended consequence induced by the performance characteristics of the machine.

[0046] For the purposes of this disclosure, the terms “distract,” “distracting,” or “distraction” are used to refer to displacement of a first point with respect to a second point. For example, the first point and the second point may correspond to surfaces of a joint. In some examples herein, ajoint may be distracted, i.e., portions of the joint may be separated and / or moved with respect to one another to place the joint under tension. In some examples, a first portion of the joint be a surface of a scapula and a second portion of the joint may be a surface of a humerusAttorney Docket No. 8178.6171WO such that separation occurs between the bones of the joint. In additional examples, a first portion of the joint may be a first portion of a humeral implant component or a humeral trial implant and a second portion of the joint may be a second portion of the humeral implant component or the humeral trial implant that is movable with respect to the first portion (e.g., a humeral component and a spacer). Accordingly, separation may occur between the portions of the humeral implant component or the humeral trial implant (i.e., intra-implant separation). Throughout the disclosure herein, the described examples may be collectively referred to as distraction of the joint.

[0047] Although much of this disclosure refers to surgeons or other medical professionals by specific job title or role, nothing in this disclosure is intended to be limited to a specific job title or function. Surgeons or medical professionals can include any doctor, nurse, medical professional, or technician. Any of these terms or job titles can be used interchangeably with the user of the systems disclosed herein unless otherwise explicitly demarcated. For example, a reference to a surgeon also could apply, in some examples to a technician or nurse.

[0048] The systems, methods, and devices disclosed herein are particularly well adapted for surgical procedures that utilize surgical navigation systems, such as the CORI® surgical navigation system. CORI is a registered trademark of SMITH & NEPHEW. INC. of Memphis, TN.CASS Ecosystem Overview

[0049] FIG. 1 provides an illustration of an example computer-assisted surgical system (CASS) 100, according to some examples. As described in further detail in the sections that follow, the CASS uses computers, robotics, and imaging technology' to aid surgeons in performing orthopedic surgery' procedures such as total knee arthroplasty' (TKA), unicondylar knee arthroplasty' (UKA), or total hip arthroplasty' (THA). For example, surgical navigation systems can aid surgeons in locating patient anatomical structures, guiding surgicalAttorney Docket No. 8178.6171WO instruments, and implanting medical devices with a high degree of accuracy. Surgical navigation systems such as the CASS 100 often employ various forms of computing technology to perform a wide variety of standard and minimally invasive surgical procedures and techniques. Moreover, these systems allow surgeons to more accurately plan, track and navigate the placement of instruments and implants relative to the body of a patient, as well as conduct pre-operative and intra-operative body imaging.

[0050] An Effector Platform 105 positions surgical tools relative to a patient during surgery. The exact components of the Effector Platform 105 will vary, depending on the example employed. For example, for a knee surgery, the Effector Platform 105 may include an End Effector 105B that holds surgical tools or instruments during their use. The End Effector 105B may be a handheld device or instrument used by the surgeon (e.g.. a CORI® hand piece or a cutting guide or jig) or. alternatively, the End Effector 105B can include a device or instrument held or positioned by a robotic arm 105 A. While one robotic arm 105 A is illustrated in FIG. 1, in some examples there may be multiple devices. As examples, there may be one robotic arm 105 A on each side of an operating table T or two devices on one side of the table T. The robotic arm 105 A may be mounted directly to the table T. be located next to the table T on a floor platform (not shown), mounted on a floor-to-ceiling pole, or mounted on a wall or ceiling of an operating room. The floor platform may be fixed or moveable. In one particular example, the robotic arm 105 A is mounted on a floor-to-ceiling pole located between the patient's legs or feet. In some examples, the End Effector 105B may include a suture holder or a stapler to assist in closing wounds. Further, in the case of two robotic arms 105 A, the surgical computer 150 can drive the robotic arms 105 A to work together to suture the wound at closure. Alternatively, the surgical computer 150 can drive one or more robotic arms 105A to staple the wound at closure.Attorney Docket No. 8178.6171WO

[0051] The Effector Platform 105 can include a Limb Positioner 105C for positioning the patient's limbs during surgery. One example of a Limb Positioner 105C is the SMITH AND NEPHEW SPIDER2 system. The Limb Positioner 105C may be operated manually by the surgeon or alternatively change limb positions based on instructions received from the Surgical Computer 150 (described below). While one Limb Positioner 105C is illustrated in FIG. 1, in some examples there may be multiple devices. As examples, there may be one Limb Positioner 105C on each side of the operating table T or two devices on one side of the table T. The Limb Positioner 105C may be mounted directly to the table T. be located next to the table T on a floor platform (not shown), mounted on a pole, or mounted on a wall or ceiling of an operating room. In some examples, the Limb Positioner 105C can be used in non-conventional ways, such as a retractor or specific bone holder. The Limb Positioner 105C may include, as examples, an ankle boot, a soft tissue clamp, a bone clamp, or a soft-tissue retractor spoon, such as a hooked, curved, or angled blade. In some examples, the Limb Positioner 105C may include a suture holder to assist in closing wounds.

[0052] The Effector Platform 105 may include tools, such as a screwdriver, light or laser, to indicate an axis or plane, bubble level, pin driver, pin puller, plane checker, pointer, finger, or some combination thereof.

[0053] Resection Equipment 110 (not shown in FIG. 1) performs bone or tissue resection using, for example, mechanical, ultrasonic, or laser techniques. Examples of Resection Equipment 110 include drilling devices, burring devices, oscillatory sawing devices, vibratory impaction devices, reamers, ultrasonic bone cutting devices, radio frequency ablation devices, reciprocating devices (such as a rasp or broach), and laser ablation systems. In some examples, the Resection Equipment 110 is held and operated by the surgeon during surgery. In other examples, the Effector Platform 105 may be used to hold the Resection Equipment 110 during use.Attorney Docket No. 8178.6171WO

[0054] The Effector Platform 105 also can include a cutting guide or jig 105D that is used to guide saws or drills used to resect tissue during surgery. Such cutting guides 105D can be formed integrally as part of the Effector Platform 105 or robotic arm 105 A or cutting guides can be separate structures that can be matingly and / or removably attached to the Effector Platform 105 or robotic arm 105 A. The Effector Platform 105 or robotic arm 105 A can be controlled by the CASS 100 to position a cutting guide or jig 105D adjacent to the patient's anatomy in accordance with a pre-operatively or intraoperatively developed surgical plan such that the cutting guide or jig will produce a precise bone cut in accordance with the surgical plan.

[0055] The Tracking System 115 uses one or more sensors to collect real-time position data that locates the patient's anatomy and surgical instruments. For example, for TKA procedures, the Tracking System may provide a location and orientation of the End Effector 105B during the procedure. In addition to positional data, data from the Tracking System 115 also can be used to infer velocity / acceleration of anatomy / instrumentation, which can be used for tool control. In some examples, the Tracking System 115 may use a tracker array attached to the End Effector 105B to determine the location and orientation of the End Effector 105B. The position of the End Effector 105B may be inferred based on the position and orientation of the Tracking System 115 and a known relationship in three-dimensional space between the Tracking System 115 and the End Effector 105B. Various types of tracking systems may be used in various examples of the present disclosure including, without limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration and tracking systems. Using the data provided by the tracking system 115, the surgical computer 150 can detect objects and prevent collision. For example, the surgical computer 150 can prevent the robotic arm 105A and / or the End Effector 105B from colliding with soft tissue.Attorney Docket No. 8178.6171WO

[0056] Any suitable tracking system can be used for tracking surgical objects and patient anatomy in the surgical theatre. For example, a combination of IR and visible light cameras can be used in an array. Various illumination sources, such as an IR LED light source, can illuminate the scene allowing three-dimensional imaging to occur. In some examples, this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging. In addition to the camera array, which in some examples is affixed to a cart, additional cameras can be placed throughout the surgical theatre. For example, handheld tools or headsets worn by operators / surgeons can include imaging capability that communicates images back to a central processor to correlate those images wi th images captured by the camera array. This can give a more robust image of the environment for modeling using multiple perspectives. Furthermore, some imaging devices may be of suitable resolution or have a suitable perspective on the scene to pick up information stored in quick response (QR) codes or barcodes. This can be helpful in identifying specific objects not manually registered with the system. In some examples, the camera may be mounted on the robotic arm 105 A.

[0057] In some examples, specific objects can be manually registered by a surgeon with the system preoperatively or intraoperatively. For example, by interacting with a user interface, a surgeon may identify the starting location for a tool or a bone structure. By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional model.

[0058] In some examples, certain markers, such as fiducial marks that identify individuals, important tools, or bones in the theater may include passive or active identifiers that can be picked up by a camera or camera array associated with the tracking system. For example, an IR LED can flash a pattern that conveys a unique identifier to the source of that pattern, providing a dynamic identification mark. Similarly, one- or two-dimensional optical codesAttorney Docket No. 8178.6171WO(barcode, QR code, etc.) can be affixed to objects in the theater to provide passive identification that can occur based on image analysis. If these codes are placed asymmetrically on an object, they also can be used to determine an orientation of an object by comparing the location of the identifier with the extents of an object in an image. For example, a QR code may be placed in a comer of a tool tray, allowing the orientation and identity of that tray to be tracked. Other tracking modalities are explained throughout. For example, augmented reality (AR) headsets can be worn by surgeons and other staff to provide additional camera angles and tracking capabilities. In this case, the infrared / time of flight sensor data, which is predominantly used for hand / gesture detection, can build correspondence between the AR headset and the tracking system of the robotic system using sensor fusion techniques. This can be used to calculate a calibration matrix that relates the optical camera coordinate frame to the fixed holographic world frame.

[0059] In addition to optical tracking, certain features of objects can be tracked by registering physical properties of the object and associating them with objects that can be tracked, such as fiducial marks fixed to a tool or bone. For example, a surgeon may perform a manual registration process whereby a tracked tool and a tracked bone can be manipulated relative to one another. By impinging the tip of the tool against the surface of the bone, a three- dimensional surface can be mapped for that bone that is associated with a position and orientation relative to the frame of reference of that fiducial mark. By optically tracking the position and orientation (pose) of the fiducial mark associated with that bone, a model of that surface can be tracked with an environment through extrapolation.

[0060] The registration process that registers the CASS 100 to the relevant anatomy of the patient also can involve the use of anatomical landmarks, such as landmarks on a bone or cartilage. For example, the CASS 100 can include a 3D model of the relevant bone or joint and the surgeon can intraoperatively collect data regarding the location of bony landmarks on theAttorney Docket No. 8178.6171WO patient's actual bone using a probe that is connected to the CASS. Bony landmarks can include, for example, the medial malleolus and lateral malleolus, the ends of the proximal femur and distal tibia, and the center of the hip joint. The CASS 100 can compare and register the location data of bony landmarks collected by the surgeon wi th the probe with the location data of the same landmarks in the 3D model. Alternatively, the CASS 100 can construct a 3D model of the bone or joint without pre-operative image data by using location data of bony landmarks and the bone surface that are collected by the surgeon using a CASS probe or other means. The registration process also can include determining various axes of a joint. For example, for a TKA the surgeon can use the CASS 100 to determine the anatomical and mechanical axes of the femur and tibia. The surgeon and the CASS 100 can identify the center of the hip joint by moving the patient's leg in a spiral direction (i.e., circumduction) so the CASS can determine where the center of the hip joint is located.

[0061] A Tissue Navigation System 120 (not shown in FIG. 1) provides the surgeon with intraoperative, real-time visualization for the patient's bone, cartilage, muscle, nervous, and / or vascular tissues surrounding the surgical area. Examples of systems that may be employed for tissue navigation include fluorescent imaging systems and ultrasound systems.

[0062] The Display 125 provides graphical user interfaces (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery. For example, the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions. The Display 125 may include, for example, one or more computer monitors. As an alternative or supplement to the Display 125, one or more members of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD). For example, in FIG. 1 the Surgeon 111 is wearing an AR HMD 155 that may, for example, overlay pre-operative image data onAttorney Docket No. 8178.6171WO the patient or provide surgical planning suggestions. In one example, a tracker array-mounted surgical tool could be detected by both the IR camera and an AR headset (HMD) using sensor fusion techniques without the need for any "intermediate" calibration rigs. This near-depth, time-of-flight sensing camera located in the HMD could be used for hand / gesture detection. The headset's sensor API can be used to expose IR and depth image data and carryout image processing using, for example, C++ with OpenCV. This approach allows the relationship between the CASS and the virtual coordinate frame to be determined and the headset sensor data (i.e.. IR in combination with depth images) to isolate the CASS tracker arrays. The image processing system on the HMD can locate the surgical tool in a fixed holographic world frame and the CASS IR camera can locate the surgical tool relative to its camera coordinate frame. This relationship can be used to calculate a calibration matrix that relates the CASS IR camera coordinate frame to the fixed holographic world frame. This means that if a calibration matrix has previously been calculated, the surgical tool no longer needs to be visible to the AR headset. However, a recalculation may be necessary if the CASS camera is accidentally moved in the workflow. Various example uses of the AR HMD 155 in surgical procedures are detailed in the sections that follow.

[0063] Surgical Computer 150 provides control instructions to various components of the CASS 100. collects data from those components, and provides general processing for various data needed during surgery. In some examples, the Surgical Computer 150 is a general-purpose computer. In other examples, the Surgical Computer 150 may be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPU) to perform processing. In some examples, the Surgical Computer 150 is connected to a remote server over one or more computer networks (e.g., the Internet). The remote server can be used, for example, for storage of data or execution of computationally intensive processing tasks.Attorney Docket No. 8178.6171WO

[0064] Various techniques generally known in the art can be used for connecting the Surgical Computer 150 to the other components of the CASS 100. Moreover, the computers can connect to the Surgical Computer 150 using a mix of technologies. For example, the End Effector 105B may connect to the Surgical Computer 150 over a wired (i.e., serial) connection. The Tracking System 1 15, Tissue Navigation System 120, and Display 125 can similarly be connected to the Surgical Computer 150 using wired connections. Alternatively, the Tracking System 115, Tissue Navigation System 120, and Display 125 may connect to the Surgical Computer 150 using wireless technologies such as, without limitation. Wi-Fi. Bluetooth®, Near Field Communication (NFC), or ZigBee.Robotic Arm

[0065] In some examples, the CASS 100 includes a robotic arm 105A that sen es as an interface to stabilize and hold a variety' of instruments used during the surgical procedure. For example, in the context of a hip surgery, these instruments may include, without limitation, retractors, a sagittal or reciprocating saw, the reamer handle, the cup impactor, the broach handle, and the stem inserter. The robotic arm 105 A may have multiple degrees of freedom (like a Spider device) and have the ability' to be locked in place (e.g., by a press of a button, voice activation, a surgeon removing a hand from the robotic arm, or other method).

[0066] In some examples, movement of the robotic arm 105 A may be effectuated by use of a control panel built into the robotic arm system. For example, a display screen may include one or more input sources, such as physical buttons or a user interface having one or more icons, that direct movement of the robotic arm 105 A. The surgeon or other healthcare professional may engage with the one or more input sources to position the robotic arm 105 A when performing a surgical procedure.

[0067] A tool or an end effector 105B attached or integrated into a robotic arm 105 A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a jointAttorney Docket No. 8178.6171WO tensioning device, or the like. In examples in which an end effector 105B is used, the end effector may be positioned at the end of the robotic arm 105 A such that any motor control operations are performed within the robotic arm system. In examples in which a tool is used, the tool may be secured at a distal end of the robotic arm 105 A, but motor control operation may reside within the tool itself.

[0068] The robotic arm 105 A may be motorized internally to both stabilize the robotic arm, thereby preventing it from falling and hitting the patient, surgical table, surgical staff, etc., and to allow the surgeon to move the robotic arm without having to fully support its weight. While the surgeon is moving the robotic arm 105 A, the robotic arm may provide some resistance to prevent the robotic arm from moving too fast or having too many degrees of freedom active at once. The position and the lock status of the robotic arm 105 A may be tracked, for example, by a controller or the Surgical Computer 150.

[0069] In some examples, the robotic arm 105A can be moved by hand (e.g., by the surgeon) or with internal motors into its ideal position and orientation for the task being performed. In some examples, the robotic arm 105 A may be enabled to operate in a "free" mode that allows the surgeon to position the arm into a desired position without being restricted. While in the free mode, the position and orientation of the robotic arm 105 A may still be tracked as described above. In one example, certain degrees of freedom can be selectively released upon input from user (e g., surgeon) during specified portions of the surgical plan tracked by the Surgical Computer 150. Designs in which a robotic arm 105 A is internally powered through hydraulics or motors or provides resistance to external manual motion through similar means can be described as powered robotic arms, while arms that are manually manipulated without power feedback, but which may be manually or automatically locked in place, may be described as passive robotic arms.Attorney Docket No. 8178.6171WO

[0070] A robotic arm 105 A or end effector 105B can include a trigger or other means to control the power of a saw or drill. Engagement of the trigger or other means by the surgeon can cause the robotic arm 105 A or end effector 105B to transition from a motorized alignment mode to a mode where the saw or drill is engaged and powered on. Additionally, the CASS 100 can include a foot pedal (not shown) that causes the system to perform certain functions when activated. For example, the surgeon can activate the foot pedal to instruct the CASS 100 to place the robotic arm 105 A or end effector 105B in an automatic mode that brings the robotic arm or end effector into the proper position with respect to the patient's anatomy in order to perform the necessary resections. The CASS 100 also can place the robotic arm 105A or end effector 105B in a collaborative mode that allows the surgeon to manually manipulate and position the robotic arm or end effector into a particular location. The collaborative mode can be configured to allow the surgeon to move the robotic arm 105 A or end effector 105B medially or laterally, while restricting movement in other directions. As discussed, the robotic arm 105 A or end effector 105B can include a cutting device (saw, drill, and burr) or a cutting guide or jig 105D that will guide a cutting device. In other examples, movement of the robotic arm 105 A or robotically controlled end effector 105B can be controlled entirely by the CASS 100 without any, or with only minimal, assistance or input from a surgeon or other medical professional. In still other examples, the movement of the robotic arm 105 A or robotically controlled end effector 105B can be controlled remotely by a surgeon or other medical professional using a control mechanism separate from the robotic arm or robotically controlled end effector device, for example using a joystick or interactive monitor or display control device.

[0071] A robotic arm 105 A may be used for holding the retractor. For example, the robotic arm 105 A may be moved into the desired position by the surgeon. At that point, the robotic arm 105 A may lock into place. In some examples, the robotic arm 105 A is provided with data regarding the patient's position, such that if the patient moves, the robotic arm can adjust theAttorney Docket No. 8178.6171WO retractor position accordingly. In some examples, multiple robotic arms may be used, thereby allowing multiple retractors to be held or for more than one activity to be performed simultaneously (e g., retractor holding & reaming).

[0072] The robotic arm 105 A may also be used to help stabilize the surgeon's hand while making a femoral neck cut. In this application, control of the robotic arm 105 A may impose certain restrictions to prevent soft tissue damage from occurring. For example, the Surgical Computer 150 tracks the position of the robotic arm 105 A as it operates. If the tracked location approaches an area where tissue damage is predicted, a command may be sent to the robotic arm 105 A causing it to stop. Alternatively, where the robotic arm 105 A is automatically controlled by the Surgical Computer 150. the Surgical Computer may ensure that the robotic arm is not provided with any instructions that cause it to enter areas where soft tissue damage is likely to occur. The Surgical Computer 150 may impose certain restrictions on the surgeon to prevent the surgeon from reaming too far into the medial wall of the acetabulum or reaming at an incorrect angle or orientation.

[0073] In some examples, the robotic arm 105 A may be used to hold a cup impactor at a desired angle or orientation during cup impaction. When the final position has been achieved, the robotic arm 105 A may prevent any further seating to prevent damage to the pelvis.

[0074] The surgeon may use the robotic arm 105 A to position the broach handle at the desired position and allow the surgeon to impact the broach into the femoral canal at the desired orientation. In some examples, once the Surgical Computer 150 receives feedback that the broach is fully seated, the robotic arm 105 A may restrict the handle to prevent further advancement of the broach.

[0075] The robotic arm 105A may also be used for resurfacing applications. For example, the robotic arm 105 A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g.,Attorney Docket No. 8178.6171WO guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 105 A may stabilize the surgeon's handpiece and may impose restrictions on the handpiece to prevent the surgeon from removing unintended bone in contravention of the surgical plan.

[0076] The robotic arm 105 A may be a passive arm. As an example, the robotic arm 105 A may be a CIRQ robot arm available from Brainlab AG. CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 9 81829, Munchen, FED REP of GERMANY. In one particular example, the robotic arm 105A is an intelligent holding arm as disclosed in U.S. Patent No. 10,426.571 to Krinninger et al., U.S. Patent No. 10.993,777 to Nowatschin et al.. U.S. Patent Application No. 15 / 561,048 to Nowatschin et al., and U.S. Patent No. 10,342.636 to Nowatschin et al., the entire contents of each of which is herein incorporated by reference.Surgical Procedure Data Generation and Collection

[0077] The various services that are provided by medical professionals to treat a clinical condition are collectively referred to as an "episode of care." For a particular surgical intervention, the episode of care can include three phases: pre-operative, intra-operative, and post-operative. During each phase, data is collected or generated that can be used to analyze the episode of care in order to understand various features of the procedure and identify patterns that may be used, for example, in training models to make decisions with minimal human intervention. The data collected over the episode of care may be stored at the Surgical Computer 150 or the Surgical Data Server 180 as a complete dataset. Thus, for each episode of care, a dataset exists that comprises all of the data collectively pre-operatively about the patient, all of the data collected or stored by the CASS 100 intra-operatively, and any postoperative data provided by the patient or by a healthcare professional monitoring the patient.

[0078] As explained in further detail, the data collected during the episode of care may be used to enhance performance of the surgical procedure or to provide a holistic understanding of theAttorney Docket No. 8178.6171WO surgical procedure and the patient outcomes. For example, the data collected over the episode of care may be used to generate a surgical plan. In one example, a high-level, pre-operative plan is refined intra-operatively as data is collected during surgery. In this way, the surgical plan can be viewed as dynamically changing in real-time or near real-time as new data is collected by the components of the CASS 100. In other examples, pre-operative images or other input data may be used to develop a robust plan preoperatively that is simply executed during surgery. In this case, the data collected by the CASS 100 during surgery may be used to make recommendations that ensure that the surgeon stays within the pre-operative surgical plan. For example, if the surgeon is unsure how to achieve a certain prescribed cut or implant alignment, the Surgical Computer 150 can be queried for a recommendation. In still other examples, the pre-operative and intra-operative planning approaches can be combined such that a robust pre-operative plan can be dynamically modified, as necessary or desired, during the surgical procedure. In some examples, a biomechanics-based model of patient anatomy contributes simulation data to be considered by the CASS 100 in developing preoperative, intraoperative, and post-operative / rehabilitation procedures to optimize implant performance outcomes for the patient.

[0079] Aside from changing the surgical procedure itself, the data gathered during the episode of care may be used as an input to other procedures ancillary to the surgery. For example, implants can be designed using episode of care data. Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. PatentNo. 10,064,686, filed August 15, 2011, and entitled "Systems and Methods for Optimizing Parameters for Orthopaedic Procedures"; U.S. Patent No. 10,102,309, filed July 20, 2012 and entitled "Systems and Methods for Optimizing Fit of an Implant to Anatomy"; and U.S. Patent No. 8,078,440, filed September 19, 2008 and entitled "Operatively Tuning Implants for Increased Performance,"Attorney Docket No. 8178.6171WO the entire contents of each of which are hereby incorporated by reference into this patent application.

[0080] Furthermore, the data can be used for educational, training, or research purposes. For example, using the network-based approach described below in FIG. 2C, other doctors or students can remotely view surgeries in interfaces that allow them to selectively view data as it is collected from the various components of the CASS 100. After the surgical procedure, similar interfaces may be used to "playback" a surgery for training or other educational purposes, or to identify the source of any issues or complications with the procedure.

[0081] Data acquired during the pre-operative phase generally includes all information collected or generated prior to the surgery. Thus, for example, information about the patient may be acquired from a patient intake form or electronic medical record (EMR). Examples of patient information that may be collected include, without limitation, patient demographics, diagnoses, medical histories, progress notes, vital signs, medical history information, allergies, and lab results. The pre-operative data may also include images related to the anatomical area of interest. These images may be captured, for example, using Magnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray, ultrasound, or any other modality known in the art. The pre-operative data may also comprise quality of life data captured from the patient. For example, pre-surgery patients use a mobile application ("app") to answer questionnaires regarding their current quality of life. In some examples, preoperative data used by the CASS 100 includes demographic, anthropometric, cultural, or other specific traits about a patient that can coincide with activity levels and specific patient activities to customize the surgical plan to the patient. For example, certain cultures or demographics may be more likely to use a toilet that requires squatting on a daily basis.

[0082] FIGS. 2 A and 2B provide examples of data that may be acquired during the intraoperative phase of an episode of care. These examples are based on the various components ofAttorney Docket No. 8178.6171WO the CASS 100 described above with reference to FIG. 1; however, it should be understood that other types of data may be used based on the types of equipment used during surgery and their use.

[0083] FIG. 2A shows examples of some of the control instructions that the Surgical Computer 150 provides to other components of the CASS 100, according to some examples. Note that the example of FIG. 2A assumes that the components of the Effector Platform 105 are each controlled directly by the Surgical Computer 150. In examples where a component is manually controlled by the Surgeon 111, instructions may be provided on the Display 125 or AR HMD 155 instructing the Surgeon 111 how to move the component.

[0084] The various components included in the Effector Platform 105 are controlled by the Surgical Computer 150 providing position commands that instruct the component where to move within a coordinate system. In some examples, the Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in FIG. 2A as "haptic" commands. For example, the End Effector 105B may provide a force to resist movement outside of an area where resection is planned. Other commands that may be used by the Effector Platform 105 include vibration and audio cues.

[0085] In some examples, the end effectors 105B of the robotic arm 105 A are operatively coupled with cutting guide 105D. In response to an anatomical model of the surgical scene, the robotic arm 105 A can move the end effectors 105B and the cutting guide 105D into position to match the location of the femoral or tibial cut to be performed in accordance with the surgical plan. This can reduce the likelihood of error, allowing the vision system and a processor utilizing that vision system to implement the surgical plan to place a cutting guide 105D at the precise location and orientation relative to the tibia or femur to align a cutting slot of the cutting guide with the cut to be performed according to the surgical plan. Then, a surgeon can use anyAttorney Docket No. 8178.6171WO suitable tool, such as an oscillating or rotating saw or drill to perform the cut (or drill a hole) with perfect placement and orientation because the tool is mechanically limited by the features of the cutting guide 105D. In some examples, the cutting guide 105D may include one or more pin holes that are used by a surgeon to drill and screw or pin the cutting guide into place before performing a resection of the patient tissue using the cutting guide. This can free the robotic arm 105 A or ensure that the cutting guide 105D is fully affixed without moving relative to the bone to be resected. For example, this procedure can be used to make the first distal cut of the femur during a total knee arthroplasty. In some examples, where the arthroplasty is a hip arthroplasty, cutting guide 105D can be fixed to the femoral head or the acetabulum for the respective hip arthroplasty resection. It should be understood that any arthroplasty that utilizes precise cuts can use the robotic arm 105 A and / or cutting guide 105D in this manner.

[0086] The Resection Equipment 110 is provided with a variety of commands to perform bone or tissue operations. As with the Effector Platform 105, position information may be provided to the Resection Equipment 110 to specify where it should be located when performing resection. Other commands provided to the Resection Equipment 110 may be dependent on the type of resection equipment. For example, for a mechanical or ultrasonic resection tool, the commands may specify the speed and frequency of the tool. For Radiofrequency Ablation (RFA) and other laser ablation tools, the commands may specify intensify and pulse duration.

[0087] Some components of the CAS S 100 do not need to be directly controlled by the Surgical Computer 150; rather, the Surgical Computer 150 only needs to activate the component, which then executes software locally specifying the manner in which to collect data and provide it to the Surgical Computer 150. In the example of FIG. 2A, there are two components that are operated in this manner: the Tracking System 115 and the Tissue Navigation System 120.

[0088] The Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery7. For monitors, the Surgical Computer 150 mayAttorney Docket No. 8178.6171WO provide instructions for displaying images, GUIs, etc. using techniques known in the art. The display 125 can include various portions of the workflow of a surgical plan. During the registration process, for example, the display 125 can show a preoperatively constructed 3D bone model and depict the locations of the probe as the surgeon uses the probe to collect locations of anatomical landmarks on the patient. The display 125 can include information about the surgical target area. For example, in connection with a TKA, the display 125 can depict the mechanical and anatomical axes of the femur and tibia. The display 125 can depict varus and valgus angles for the knee joint based on a surgical plan, and the CASS 100 can depict how such angles will be affected if contemplated revisions to the surgical plan are made. Accordingly, the display 125 is an interactive interface that can dynamically update and display how changes to the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.

[0089] As the workflow progresses to preparation of bone cuts or resections, the display 125 can depict the planned or recommended bone cuts before any cuts are performed. The surgeon 111 can manipulate the image display to provide different anatomical perspectives of the target area and can have the option to alter or revise the planned bone cuts based on intraoperative evaluation of the patient. The display 125 can depict how the chosen implants would be installed on the bone if the planned bone cuts are performed. If the surgeon 111 choses to change the previously planned bone cuts, the display 125 can depict how the revised bone cuts would change the position and orientation of the implant when installed on the bone.

[0090] The display 125 can provide the surgeon 111 with a variety of data and information about the patient, the planned surgical intervention, and the implants. Various patient-specific information can be displayed, including real-time data concerning the patient's health such as heart rate, blood pressure, etc. The display 125 also can include information about the anatomy of the surgical target region including the location of landmarks, the current state of theAttorney Docket No. 8178.6171WO anatomy (e.g., whether any resections have been made, the depth and angles of planned and executed bone cuts), and future states of the anatomy as the surgical plan progresses. The display 125 also can provide or depict additional information about the surgical target region. For a TKA, the display 125 can provide information about the gaps (e.g., gap balancing) between the femur and tibia and how such gaps will change if the planned surgical plan is carried out. For a TKA, the display 125 can provide additional relevant information about the knee joint such as data about the joint's tension (e.g., ligament laxity) and information concerning rotation and alignment of the joint. The display 125 can depict how the planned implants' locations and positions will affect the patient as the knee joint is flexed. The display 125 can depict how the use of different implants or the use of different sizes of the same implant will affect the surgical plan and preview how such implants will be positioned on the bone. The CASS 100 can provide such information for each of the planned bone resections in a TKA or THA. In a TKA, the CASS 100 can provide robotic control for one or more of the planned bone resections. For example, the CASS 100 can provide robotic control only for the initial distal femur cut, and the surgeon 111 can manually perform other resections (anterior, posterior and chamfer cuts) using conventional means, such as a 4-in-l cutting guide or jig 105D.

[0091] The display 125 can employ different colors to inform the surgeon of the status of the surgical plan. For example, un-resected bone can be displayed in a first color, resected bone can be displayed in a second color, and planned resections can be displayed in a third color. Implants can be superimposed onto the bone in the display 125, and implant colors can change or correspond to different types or sizes of implants.

[0092] The information and options depicted on the display 125 can vary' depending on the ty pe of surgical procedure being performed. Further, the surgeon 111 can request or select a particular surgical workflow display that matches or is consistent w ith his or her surgical plan preferences. For example, for a surgeon 111 who typically performs the tibial cuts before theAttorney Docket No. 8178.6171WO femoral cuts in a TKA, the display 125 and associated workflow can be adapted to take this preference into account. The surgeon 1 1 1 also can preselect that certain steps be included or deleted from the standard surgical workflow display. For example, if a surgeon 111 uses resection measurements to finalize an implant plan but does not analyze ligament gap balancing when finalizing the implant plan, the surgical workflow display can be organized into modules, and the surgeon can select which modules to display and the order in which the modules are provided based on the surgeon's preferences or the circumstances of a particular surgery. Modules directed to ligament and gap balancing, for example, can include pre- and postresection ligament / gap balancing, and the surgeon 111 can select which modules to include in their default surgical plan workflow depending on whether they perform such ligament and gap balancing before or after (or both) bone resections are performed.

[0093] For more specialized display equipment, such as AR HMDs, the Surgical Computer 150 may provide images, text, etc. using the data format supported by the equipment. For example, if the Display 125 is a holography device such as the Microsoft HoloLens™ or Magic Leap One™, the Surgical Computer 150 may use the HoloLens Application Program Interface (API) to send commands specifying the position and content of holograms displayed in the field of view of the Surgeon 111.

[0094] In some examples, one or more surgical planning models may be incorporated into the CASS 100 and used in the development of the surgical plans provided to the surgeon 111. The term "surgical planning model" refers to software that simulates the biomechanics performance of anatomy under various scenarios to determine the optimal way to perform cutting and other surgical activities. For example, for knee replacement surgeries, the surgical planning model can measure parameters for functional activities, such as deep knee bends, gait, etc., and select cut locations on the knee to optimize implant placement. One example of a surgical planning model is the LIFEMOD™ simulation software from SMITH AND NEPHEW, INC. In someAttorney Docket No. 8178.6171WO examples, the Surgical Computer 150 includes computing architecture that allows full execution of the surgical planning model during surgery (e.g., a GPU-based parallel processing environment). In other examples, the Surgical Computer 150 may be connected over a network to a remote computer that allows such execution, such as a Surgical Data Server 180 (see FIG. 2C). As an alternative to full execution of the surgical planning model, in some examples, a set of transfer functions are derived that simplify the mathematical operations captured by the model into one or more predictor equations. Then, rather than execute the full simulation during surgery, the predictor equations are used. Further details on the use of transfer functions are described in WIPO Publication No. 2020 / 037308. filed August 19, 2019, entitled "Patient Specific Surgical Method and System," the entirety of which is incorporated herein by reference.

[0095] FIG. 2B shows examples of some of the types of data that can be provided to the Surgical Computer 150 from the various components of the CASS 100. In some examples, the components may stream data to the Surgical Computer 150 in real-time or near real-time during surgery. In other examples, the components may queue data and send it to the Surgical Computer 150 at set intervals (e.g., every second). Data may be communicated using any format known in the art. Thus, in some examples, the components all transmit data to the Surgical Computer 150 in a common format. In other examples, each component may use a different data format, and the Surgical Computer 150 is configured with one or more software applications that enable translation of the data.

[0096] In general, the Surgical Computer 150 may serve as the central point where CASS data is collected. The exact content of the data will vary depending on the source. For example, each component of the Effector Platform 105 provides a measured position to the Surgical Computer 150. Thus, by comparing the measured position to a position originally specified by theAttorney Docket No. 8178.6171WOSurgical Computer 150 (see FIG. 2B), the Surgical Computer can identify deviations that take place during surgery.

[0097] The Resection Equipment 110 can send various types of data to the Surgical Computer 150 depending on the type of equipment used. Example data types that may be sent include the measured torque, audio signatures, and measured displacement values. Similarly, the Tracking Technology 115 can provide different types of data depending on the tracking methodology employed. Example tracking data types include position values for tracked items (e.g., anatomy, tools, etc.), ultrasound images, and surface or landmark collection points or axes. The Tissue Navigation System 120 provides the Surgical Computer 150 with anatomic locations, shapes, etc. as the system operates.

[0098] Although the Display 125 generally is used for outputting data for presentation to the user, it may also provide data to the Surgical Computer 150. For example, for examples where a monitor is used as part of the Display 125, the Surgeon 111 may interact with a GUI to provide inputs which are sent to the Surgical Computer 150 for further processing. For AR applications, the measured position and displacement of the HMD may be sent to the Surgical Computer 150 so that it can update the presented view as needed.

[0099] During the post-operative phase of the episode of care, various types of data can be collected to quantify the overall improvement or deterioration in the patient's condition as a result of the surgery. The data can take the form of. for example, self-reported information reported by patients via questionnaires. For example, in the context of a knee replacement surgery, functional status can be measured with an Oxford Knee Score questionnaire, and the post-operative quality of life can be measured with a EQ5D-5L questionnaire. Other examples in the context of a hip replacement surgery' may include the Oxford Hip Score, Harris Hip Score, and WOMAC (Western Ontario and McMaster Universities Osteoarthritis index). Such questionnaires can be administered, for example, by a healthcare professional directly in aAttorney Docket No. 8178.6171WO clinical setting or using a mobile app that allows the patient to respond to questions directly. In some examples, the patient may be outfitted with one or more wearable devices that collect data relevant to the surgery. For example, following a knee surgery, the patient may be outfitted with a knee brace that includes sensors that monitor knee positioning, flexibility, etc. This information can be collected and transferred to the patient's mobile device for review by the surgeon to evaluate the outcome of the surgery and address any issues. In some examples, one or more cameras can capture and record the motion of a patient's body segments during specified activities postoperatively. This motion capture can be compared to a biomechanics model to better understand the functionality of the patient's joints and better predict progress in recovery and identify any possible revisions that may be needed.

[0100] The post-operative stage of the episode of care can continue over the entire life of a patient. For example, the Surgical Computer 150 or other components comprising the CASS 100 can continue to receive and collect data relevant to a surgical procedure after the procedure has been performed. This data may include, for example, images, answers to questions, "normal" patient data (e.g., blood type, blood pressure, conditions, medications, etc.), biometric data (e.g., gait, etc.), and objective and subjective data about specific issues (e g., knee or hip joint pain). This data may be explicitly provided to the Surgical Computer 150 or other CASS component by the patient or the patient's physician(s). Alternatively, or additionally, the Surgical Computer 150 or other CASS component can monitor the patient's EMR and retrieve relevant information as it becomes available. This longitudinal view of the patient's recovery allows the Surgical Computer 150 or other CASS component to provide a more objective analysis of the patient's outcome to measure and track success or lack of success for a given procedure. For example, a condition experienced by a patient long after the surgical procedure can be linked back to the surgery through a regression analysis of various data items collectedAttorney Docket No. 8178.6171WO during the episode of care. This analysis can be further enhanced by performing the analysis on groups of patients that had similar procedures and / or have similar anatomies.

[0101] In some examples, data is collected at a central location to provide for easier analysis and use. Data can be manually collected from various CASS components in some instances. For example, a portable storage device (e.g., USB stick) can be attached to the Surgical Computer 150 into order to retrieve data collected during surgery. The data can then be transferred, for example, via a desktop computer to the centralized storage. Alternatively, in some examples, the Surgical Computer 150 is connected directly to the centralized storage via a Network 175 as shown in FIG. 2C.

[0102] FIG. 2C illustrates a "cloud-based" implementation in which the Surgical Computer 150 is connected to a Surgical Data Server 180 via a Network 175. This Network 175 may be, for example, a private intranet or the Internet. In addition to the data from the Surgical Computer 150. other sources can transfer relevant data to the Surgical Data Server 180. The example of FIG. 2C shows three additional data sources: the Patient 160, Healthcare Professional(s) 165, and an EMR Database 170. Thus, the Patient 160 can send pre-operative and post-operative data to the Surgical Data Server 180, for example, using a mobile app. The Healthcare Professional(s) 165 includes the surgeon and his or her staff as well as any other professionals working with Patient 160 (e.g., a personal physician, a rehabilitation specialist, etc.). It should also be noted that the EMR Database 170 may be used for both pre-operative and post-operative data. For example, assuming that the Patient 160 has given adequate permissions, the Surgical Data Server 180 may collect the EMR of the Patient pre-surgery. Then, the Surgical Data Server 180 may continue to monitor the EMR for any updates postsurgery.

[0103] At the Surgical Data Server 180, an Episode of Care Database 185 is used to store the various data collected over a patient's episode of care. The Episode of Care Database 185 mayAttorney Docket No. 8178.6171WO be implemented using any technique known in the art. For example, a SQL-based database may be used where all of the various data items are structured in a manner that allow s them to be readily incorporated in two SQL's collection of rows and columns. However, in other examples aNo-SQL database may be employed to allow- for unstructured data, while providing the ability to rapidly process and respond to queries. As is understood in the art, the term "NoSQL" is used to define a class of data stores that are non-relational in their design. Various types of No-SQL databases may generally be grouped according to their underlying data model. These groupings may include databases that use column-based data models (e.g.. Cassandra), document-based data models (e.g., MongoDB), key-value based data models (e.g.. Redis), and / or graph-based data models (e.g.. Allego). Any type of No-SQL database may be used to implement the various examples described herein and, in some examples, the different types of databases may support the Episode of Care Database 185.

[0104] Data can be transferred between the various data sources and the Surgical Data Server 180 using any data format and transfer technique known in the art. It should be noted that the architecture shown in FIG. 2C allows transmission from the data source to the Surgical Data Server 180, as well as retrieval of data from the Surgical Data Server 180 by the data sources. For example, as explained in detail below, in some examples, the Surgical Computer 150 may use data from past surgeries, machine learning models, etc. to help guide the surgical procedure.

[0105] In some examples, the Surgical Computer 150 or the Surgical Data Server 180 may execute a de-identification process to ensure that data stored in the Episode of Care Database 185 meets Health Insurance Portability and Accountability Act (HIPAA) standards or other requirements mandated by law. HIPAA provides a list of certain identifiers that must be removed from data during de-identification. The aforementioned de-identification process can scan for these identifiers in data that is transferred to the Episode of Care Database 185 forAttorney Docket No. 8178.6171WO storage. For example, the Surgical Computer 150 executes the de-identification process just prior to initiating transfer of a particular data item or set of data items to the Surgical Data Server 180. In some examples, a unique identifier is assigned to data from a particular episode of care to allow for re-identification of the data if necessary.

[0106] Although FIGS. 2A-C discuss data collection in the context of a single episode of care, it should be understood that the general concept can be extended to data collection from multiple episodes of care. For example, surgical data may be collected over an entire episode of care each time a surgery is performed with the CASS 100 and stored at the Surgical Computer 150 or at the Surgical Data Server 180. As explained in further detail below, a robust database of episode of care data allows the generation of optimized values, measurements, distances, or other parameters and other recommendations related to the surgical procedure. In some examples, the various datasets are indexed in the database or other storage medium in a manner that allows for rapid retrieval of relevant information during the surgical procedure. For example, a patient-centric set of indices may be used so that data pertaining to a particular patient or a set of patients similar to a particular patient can be readily extracted. This concept can be similarly applied to surgeons, implant characteristics, CASS component versions, etc.

[0107] Further details of the management of episode of care data are described in U.S. Patent No. 11,532,402, filed April 13, 2020, and entitled "METHODS AND SYSTEMS FOR PROVIDING AN EPISODE OF CARE," the entirety of which is incorporated herein by reference.Using the Point Probe to Acquire High-Resolution of Key Areas during Hip Surgeries

[0108] Use of the point probe is described in U.S. Patent No.9, 890, 744 entitled “Systems and Methods for Planning and Performing Image Free Implant Revision Surgery,’' the entirety7of which is incorporated herein by reference. Briefly, an optically tracked point probe may beAttorney Docket No. 8178.6171WO used to map the actual surface of the target bone that needs a new implant. Mapping is performed after removal of the defective or worn-out implant, as well as after removal of any diseased or otherwise unwanted bone. A plurality of points is collected on the bone surfaces by brushing or scraping the entirety of the remaining bone with the tip of the point probe. This is referred to as tracing or "painting” the bone. The collected points are used to create a three- dimensional model or surface map of the bone surfaces in the computerized planning system. The created 3D model of the remaining bone is then used as the basis for planning the procedure and necessary implant sizes. An alternative technique that uses X-rays to determine a 3D model is described in U.S. Patent No. 11,386,990 entitled "Three-Dimensional Selective Bone Matching” and U.S. Patent No. 11.259,874 entitled "Three-Dimensional Selective Bone Matching,” the entirety’ of each of which is incorporated herein by reference.

[0109] For hip applications, the point probe painting can be used to acquire high resolution data in key areas such as the acetabular rim and acetabular fossa. This can allow a surgeon to obtain a detailed view before beginning to ream. For example, the point probe may be used to identify the floor (fossa) of the acetabulum. As is well understood in the art, in hip surgeries, it is important to ensure that the floor of the acetabulum is not compromised during reaming so as to avoid destruction of the medial wall. If the medial wall were inadvertently destroyed, the surgery would require the additional step of bone grafting. With this in mind, the information from the point probe can be used to provide operating guidelines to the acetabular reamer during surgical procedures. For example, the acetabular reamer may be configured to provide haptic feedback to the surgeon when he or she reaches the floor or otherwise deviates from the surgical plan. Alternatively, the CASS 100 may automatically stop the reamer when the floor is reached or when the reamer is within a threshold distance.

[0110] As an additional safeguard, the thickness of the area between the acetabulum and the medial wall could be estimated. For example, once the acetabular rim and acetabular fossa hasAttorney Docket No. 8178.6171WO been painted and registered to the pre-operative 3D model, the thickness can readily be estimated by comparing the location of the surface of the acetabulum to the location of the medial wall. Using this knowledge, the CASS 100 may provide alerts or other responses in the event that any surgical activity is predicted to protrude through the acetabular wall while reaming.

[0111] The point probe may also be used to collect high resolution data of common reference points used in orienting the 3D model to the patient. For example, for pelvic plane landmarks like the ASIS and the pubic symphysis, the surgeon may use the point probe to paint the bone to represent a true pelvic plane. Given a more complete view of these landmarks, the registration software has more information to orient the 3D model.

[0112] The point probe may also be used to collect high-resolution data describing the proximal femoral reference point that could be used to increase the accuracy of implant placement. For example, the relationship between the tip of the Greater Trochanter (GT) and the center of the femoral head is commonly used as reference point to align the femoral component during hip arthroplasty. The alignment is highly dependent on proper location of the GT; thus, in some examples, the point probe is used to paint the GT to provide a high- resolution view of the area. Similarly, in some examples, it may be useful to have a high- resolution view of the Lesser Trochanter (LT). For example, during hip arthroplasty, the Dorr Classification helps to select a stem that will maximize the ability of achieving a press- fit during surgery to prevent micromotion of femoral components post-surgery and ensure optimal bony ingrow th. As is generated understood in the art, the Dorr Classification measures the ratio between the canal width at the LT and the canal width 10 cm below the LT. The accuracy of the classification is highly dependent on the correct location of the relevant anatomy. Thus, it may be advantageous to paint the LT to provide a high-resolution view of the area.Attorney Docket No. 8178.6171WO

[0113] In some examples, the point probe is used to paint the femoral neck to provide high- resolution data that allows the surgeon to better understand where to make the neck cut. The navigation system can then guide the surgeon as they perform the neck cut. For example, as understood in the art, the femoral neck angle is measured by placing one line down the center of the femoral shaft and a second line down the center of the femoral neck. Thus, a high- resolution view of the femoral neck (and possibly the femoral shaft as well) would provide a more accurate calculation of the femoral neck angle.

[0114] High-resolution femoral head neck data also could be used for a navigated resurfacing procedure where the software / hardware aids the surgeon in preparing the proximal femur and placing the femoral component. As is generally understood in the art, during hip resurfacing, the femoral head and neck are not removed; rather, the head is trimmed and capped with a smooth metal covering. In this case, it would be advantageous for the surgeon to paint the femoral head and cap so that an accurate assessment of their respective geometries can be understood and used to guide trimming and placement of the femoral component.Registration of Pre-operative Data to Patient Anatomy using the Point Probe

[0115] As noted above, in some examples, a 3D model is developed during the pre-operative stage based on 2D or 3D images of the anatomical area of interest. In such examples, registration between the 3D model and the surgical site is performed prior to the surgical procedure. The registered 3D model may be used to track and measure the patient’s anatomy and surgical tools intraoperatively.

[0116] During the surgical procedure, landmarks are acquired to facilitate registration of this pre-operative 3D model to the patient’s anatomy. For knee procedures, these points could comprise the femoral head center, distal femoral axis point, medial and lateral epicondyles, medial and lateral malleolus, proximal tibial mechanical axis point, and tibial A / P direction.Attorney Docket No. 8178.6171WOFor hip procedures these points could comprise the anterior superior iliac spine (ASIS), the pubic symphysis, points along the acetabular rim and within the hemisphere, the greater trochanter (GT), and the lesser trochanter (LT).

[0117] In a revision surgery, the surgeon may paint certain areas that contain anatomical defects to allow for better visualization and navigation of implant insertion. These defects can be identified based on analysis of the pre-operative images. For example, each pre-operative image is compared to a library of images showing “healthy” anatomy (i.e., without defects). Any significant deviations between the patient’s images and the healthy images can be flagged as a potential defect. Then, during surgery, the surgeon can be warned of the possible defect via a visual alert on the display 125 of the CASS 100. The surgeon can then paint the area to provide further detail regarding the potential defect to the Surgical Computer 150.

[0118] In some examples, the surgeon may use a non-contact method for registration of bony anatomy intra-incision. For example, laser scanning is employed for registration. A laser stripe is proj ected over the anatomical area of interest and the height variations of the area are detected as changes in the line. Other non-contact optical methods, such as white light interferometry or ultrasound, may alternatively be used for surface height measurement or to register the anatomy. For example, ultrasound technology may be beneficial where there is soft tissue between the registration point and the bone being registered (e.g., ASIS, pubic symphysis in hip surgeries), thereby providing for a more accurate definition of anatomic planes.Dynamic Intra-operative Seating Maps

[0119] The present disclosure relates to systems and methods for providing real-time feedback during joint replacement surgeries, such as total hip arthroplasty7and total shoulder arthroplasty7. More specifically, the disclosure pertains to generating a dynamic seating map system that can assist surgeons in achieving improved implant positioning and bone contact.Attorney Docket No. 8178.6171WOThe system for generating a dynamic seating map may include a tracking device for monitoring the spatial pose of a surgical tool relative to a patient's anatomy, a processor for determining the position of an implant based on the tracked spatial pose, and a display device (e.g., display 125) for presenting a real-time visualization of the distances between the implant and the prepared bone surface. The visualization may include a color-coded representation of implant- to-bone contact that provides surgeons with immediate feedback regarding the quality of implant seating. This real-time feedback may enhance surgical decision-making, potentially leading to improved consistency in implant placement and better patient outcomes. In some cases, the dynamic seating map system may be integrated with robotic surgery systems (e.g., CASS 100) for joint replacement to further enhance the precision and reproducibility of implant placement.

[0120] The positioning of an implant relative to a prepared bone surface can be an important factor in the success of a joint replacement surgery. When an implant impinges on the bone surface, it may result in excessive pressure on the surrounding tissues, potentially leading to pain, inflammation, and impaired j oint function. Furthermore, an implant that is too close to a prepared bone surface may cause bone resorption or implant loosening over time. Conversely, when an implant is positioned too far away from the prepared bone surface, it may result in inadequate fixation and stability. This may lead to micromotion between the implant and bone, potentially hindering osseointegration and compromising the long-term success of the implant. Additionally, an implant that is too far away from the bone surface may create gaps or voids that can become sites for debris accumulation or bacterial colonization, which each can increase the risk of infection or implant failure. Achieving the optimal distance between the implant and the prepared bone surface may improve load distribution, enhance implantAttorney Docket No. 8178.6171WO stability, and promote successful osseointegration. Each of these benefits may ultimately contribute to improved patient outcomes and implant longevity.

[0121] Referring to FIG. 3, a flowchart for a method 300 for tracking and positioning an implant during a surgical procedure is depicted in accordance with an example. The method 300 may include collecting 302 data from a tracking device (e.g., as utilized by tracking system 115) attached to the patient's anatomy. In some cases, the tracking device may be an optical tracking system with markers attached to the surgical tool and the patient's anatomy. Alternatively, any tracking system (e.g., EM tracking) may be utilized. The tracking device may be configured to track a spatial pose of a surgical tool relative to the patient's anatomy. The spatial pose may include the position and orientation of the surgical tool in three- dimensional space.

[0122] The method 300 may include correlating 304 the intraoperative coordinate frame with a surgical plan coordinate system. Such correlation 304 may be achieved using data collected from a point probe, as described herein. The point probe may be used to collect known landmarks on the patient's anatomy, which are used to align the intraoperative coordinate frame with the surgical plan coordinate system. In some cases, the processor may register tracking data (e.g., such as the tracked spatial poses) to a pre-operative medical image of the patient's anatomy. The registration process may involve using a probe to collect known landmarks and painting over a bone with the probe within distinct regions of the bone.

[0123] In some examples, the method 300 includes mapping 306 the prepared bone surface of the patient's anatomy. The mapping 300 may be performed using a tracked tool to collect surface data points as the surface is prepared to receive an implant. The tracked tool may be a surgical tool, such as a reamer or a handpiece, that is equipped with a tracking frame. Because the 3D shape of the tool and its position relative to the bone are known via the tracking system, the 3D model of the bone may be updated as the bone is being removed. Alternatively, the boneAttorney Docket No. 8178.6171WO may be prepared with a conventional (e g., non-tracked) tool prior to mapping the prepared bone surface (e g., using a point probe and / or depth mapping camera). The processor may access a map of the prepared bone surface of the patient's anatomy. The map may be used to guide the placement of the implant and to calculate distances between the implant and the bone surface.

[0124] The method 300 may include calibrating 308 the tracking of an insertion tool. In some cases, the calibration 308 is configured to determine a spatial relationship between a tracking frame on a surgical tool and the implant attached to the surgical tool. The calibration 308 may involve collecting a known point on the tool with a probe. The calibration data obtained from this step may be used to accurately track the position of the implant during the surgery.

[0125] The method may include tracking 310 the insertion tool during implant installation. A tracking device may be configured to monitor / track 310 the spatial pose of the insertion tool relative to the patient's anatomy in real-time. In some cases, the tracking device may comprise an optical tracking system with markers attached to the surgical tool and the patient's anatomy.

[0126] In some examples, the method 300 includes determining 312 the location of the implant based on the location of the insertion tool and the calibration data. The processor may be configured to determine 312 the location of the implant based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool. The determination 312 may provide real-time feedback on the positioning of the implant relative to the bone surface during a surgical procedure.

[0127] Referring to FIG. 4, a flowchart for a method 400 for generating a dynamic boneimplant impingement map is depicted in accordance with an example. The method 400 may include determining 402 the position of an insertion. The determination 402 may be made by a processor, which receives tracking data of the surgical tool's spatial pose relative to theAttorney Docket No. 8178.6171WO patient's anatomy. The processor may use this data, along with calibration data, to update 404 the position of an attached implant, as described above in reference to FIG. 3.

[0128] In some cases, the method 400 may include constructing 406 a bounding-box tree for efficient distance computations between the implant and the prepared bone surface. A bounding-box tree may be generated by recursively partitioning a set of geometric objects (e.g., the implant or bone surface) or points into a hierarchical structure. An initial bounding box may be generated that encompasses all objects in the set. The box may be divided into smaller boxes, each containing a subset of the objects. The division process may continue until a predetermined condition is met, such as a maximum tree depth or a minimum number of obj ects per box. At each level of the tree, the bounding boxes may be split along different axes to create child nodes. The resulting tree structure allows for efficient spatial queries and distance computations by enabling rapid elimination of large portions of the search space. In some cases, the bounding-box tree may be balanced to optimize search performance, and various splitting strategies may be employed to adapt the tree structure to the specific characteristics of the data set.

[0129] The method 400 may include calculating 408 distances between the implant and the prepared bone surface. The processor may use the bounding-box tree data structure and the position of the implant to calculate 408 the distances. Calculating 408 the distances may include looping over all the points on the surface of the bone and querying the bounding boxes within the bounding-box tree that correspond to the implant to determine the closest distance to a triangle on the bone. Each closest distance may be stored in an array.

[0130] The method 400 may include generating 410 a real-time visualization of the calculated distances for display on a user interface. The visualization may include a color-coded representation of implant-to-bone contact to provide surgeons with immediate feedback regarding the quality7of implant seating. Alternative visualizations include, but are not limitedAttorney Docket No. 8178.6171WO to, pattern-coded representations, three-dimensional modeled representations, and topographical representations. The visualization may be updated in real time at a predetermined frame rate as the surgical tool moves, providing real-time feedback on the positioning of the implant relative to the bone surface. In some examples, the processor may be configured to generate a real-time visualization of the calculated distances for display on a user interface.

[0131] The methods described herein may be applied in surgical procedures in the hip or shoulder, among other joints. FIGS. 5 and 6 depict tracked patient anatomy in illustrative joints according to some examples. Referring to FIG. 5, a tracked pelvis 500 is depicted. Tracking the pelvis 504 may be performed in some surgical procedures such as total hip arthroplasty. As shown in FIG. 5. a tracking frame 502 is attached to the pelvis 504 is. The tracking frame 502 may be a structure (e.g., an optical tracking system) with multiple markers arranged in a specific geometric configuration. The markers may be used for, for example, optical tracking during a surgical procedure. The tracking frame 502 may be affixed to, for example, the iliac wing of the pelvis 504. In some examples, the tracking frame 502 may be attached to the pelvis 504 using a variety of attachment methods. For example, the tracking frame 502 may be attached to the pelvis 504 using screws, clamps, adhesive, or other suitable attachment methods.

[0132] Referring to FIG. 6, a tracked scapula 600 is depicted. Tracking the scapula 604 may be performed in some surgical procedures such as total shoulder arthroplasty. As shown in FIG. 6, a tracking frame is attached to the scapula 604. The tracking frame 602 may be a structure with multiple markers arranged in a specific geometric configuration. The markers may be used for, for example, optical tracking during surgical procedures. The tracking frame 602 may be securely fastened to the scapula 604, likely in a position that does not interfere with the surgical site while still allowing clear line-of-sight for tracking cameras. For example, the tracking frame 602 may be attached to the scapula 604 at the coracoid tip. In some examples, theAttorney Docket No. 8178.6171WO tracking frame 602 may be attached to the scapula 604 using a variety of attachment methods. For example, the tracking frame 602 may be attached to the scapula 604 using screws, clamps, adhesive, or other suitable attachment methods.

[0133] Referring to FIG. 7, a tracking calibration setup 700 is depicted, which may be used in surgical procedures utilizing an impactor 702 such as total hip arthroplasty. The tracking calibration setup 700 may include an impactor 702, a point probe 704, and a tracking frame 706. The impactor 702 may be utilized for implant insertion. The tracking frame 706 may be a structure with multiple markers arranged in a specific geometric configuration for optical tracking. The tracking frame 706 may be securely fastened to the impactor 702 in a position that does not interfere with the surgical site while still allowing clear line-of-sight for tracking cameras.

[0134] In some examples, the tracking calibration setup 700 may be used to calibrate a surgical tool to determine a spatial relationship between the tracking frame 706 on the surgical tool and an implant attached to the surgical tool. In some examples, calibration may involve touching a known point on the surgical tool, such as the impactor 702, with a tip of the point probe 704. The calibration data may be used to accurately track the position of the implant during the surgical procedure. A calibration module executed by the surgical computer, or some other computing device.

[0135] Referring to FIG. 8, a tracked insertion tool 800 is depicted, which may be used in surgical procedures such as a total shoulder arthroplasty. The tracked insertion tool 800 may include an insertion tool 802 and a tracking frame 806. The insertion tool 802 may be a surgical tool used for implant insertion. The tracking frame 806 may be a structure with multiple markers arranged in a specific geometric configuration. The markers may be used for, for example, optical tracking during surgical procedures. The tracking frame 806 may be securelyAttorney Docket No. 8178.6171WO fastened to the insertion tool 802 in a position that does not interfere with the surgical site while still allowing clear line-of-sight for tracking cameras.

[0136] In some examples, the tracked insertion tool 800 may be used to determine a position of an implant based on the spatial pose of the surgical tool. This determination may be made by a processor, which receives tracking data of the surgical tool's spatial pose relative to the patient's anatomy. The processor may use this data, along with calibration data, to determine the position of the implant.

[0137] Referring to FIG. 9, a user interface 900 is depicted, which may be used during total hip arthroplasty procedures. The user interface 900 may display a real-time visualization of the distances between an implant and a prepared bone surface. The visualization may include a color-coded representation 902 of implant-to-bone contact to provide a surgeon with immediate feedback on the quality of implant seating. The color-coded representation 902 may be updated in real-time to provide real-time feedback on the positioning of the implant relative to the bone surface.

[0138] In some examples, the user interface 900 may include a 3D model of the patient's anatomy, such as a pelvis and an acetabular cup. The 3D model may be color-coded to indicate the level of contact between the implant and the bone surface. For example, areas of the model where the implant is in close contact with the bone surface may be colored green, while areas where the implant is not in contact with the bone surface may be colored red. This color-coding may provide a visual indication of the quality of implant seating to assist a surgeon in making adjustments to an implant position during a surgical procedure.

[0139] In some cases, the user interface 900 may be configured to update the color-coded representation at a predetermined frame rate as the surgical tool moves. The real-time updating may provide the surgeon with immediate feedback on the positioning of the implant relative toAttorney Docket No. 8178.6171WO the bone surface. The frame rate may be selected based on the specific requirements of the surgical procedure, the patient's anatomy, and / or other factors.

[0140] In some examples, alternative and / or additional visualizations of the distances between the implant and the prepared bone surface may be displayed. For example, shaded representations, three-dimensional modeled representations, and / or topographical representations may be visualized. In another example, a cutaway side view 906 illustrating the contact between the implant and the prepared surface in a particular plane may be visualized. In some examples, a plane may be selectable. For example, a user may select a plane from a series of parallel planes and / or rotate the plane around an axis. In another example, the user may select a plane on a 3D model of the implant and / or prepared bone surface.

[0141] In some examples, the user interface 900 may include one or more options 904 for inputting surgical tool parameters. For example, a user may input values identifying the tool and / or the implant to the system to aid in tracking.

[0142] In some examples, the user interface 900 may be configured to display additional information related to the surgical procedure. This additional information may include numerical values for the inclination and anteversion angles of the acetabular cup. the diameter of the cup, the press fit of the implant, and other relevant data. This information may assist the surgeon in making adjustments to the implant position and orientation during the surgical procedure.

[0143] In some examples, the user interface 900 may display numerical values for the leglength and offset changes. These values may be calculated based on the position and orientation of the implant, the patient's anatomy, and other relevant factors. The leg-length and offset changes may be displayed in real-time as the surgical tool moves to provide the surgeon with immediate feedback on the potential postoperative leg length and hip offset. This real-timeAttorney Docket No. 8178.6171WO feedback may assist the surgeon in making adjustments to the implant position and orientation during the surgical procedure and potentially improve the outcome of the surgery.

[0144] Referring to FIG. 10, a user interface 1000 is depicted, which may be used during total shoulder arthroplasty procedures. The user interface 1000 may display one or more real-time visualizations of the distances between an implant and a prepared bone surface. This visualization may include a color-coded representation of implant-to-bone contact to provide a surgeon with immediate feedback on the quality of implant seating. The representation(s) may be updated in real-time as the surgical tool moves to provide real-time feedback on the positioning of the implant relative to the bone surface.

[0145] In some examples, the user interface 1000 may include a 3D model 1002 of the patient's anatomy, such as a scapula. The 3D model 1002 may be color-coded to indicate the level of contact between the implant and the bone surface. For example, areas of the model where the implant is in close contact with the bone surface may be colored green, while areas where the implant is not in contact with the bone surface may be colored red. The color-coding may provide a visual indication of the quality of implant seating to assist the surgeon in making adjustments to the implant position during the surgical procedure.

[0146] In some cases, the user interface 1000 may be configured to update the color-coded representation at a predetermined frame rate as the surgical tool moves. This real-time updating may provide the surgeon with immediate feedback on the positioning of the implant relative to the bone surface. The frame rate may be selected based on the specific requirements of the surgical procedure, the patient's anatomy, and / or other factors.

[0147] In some examples, the user interface 1000 may be configured to display additional information related to the surgical procedure. This additional information may include numerical values for the arm length and lateralization changes in shoulder procedures. These values may be calculated based on the position and orientation of the implant, the patient'sAttorney Docket No. 8178.6171WO anatomy, and / or other relevant factors. The arm length and lateralization changes may be displayed in real-time as the surgical tool moves to provide the surgeon with immediate feedback on the potential postoperative arm length and shoulder offset. This real-time feedback may assist the surgeon in making adjustments to the implant position and orientation during the surgical procedure and potentially improve the outcome of the surgery.

[0148] In some examples, the 3D model of surfaces used in the dynamic seating map system may take various forms. For instance, the 3D model may be a mesh with vertices and triangles, a point cloud, an implicit representation, a voxel-based representation, or any other suitable 3D model. The choice of 3D model may depend on various factors, such as the specific requirements of the surgical procedure, the computational resources available, the desired level of detail, and / or other relevant factors.

[0149] In some examples, the source of the 3D model used in the dynamic seating map system may be derived from various imaging techniques. For example, portions of the 3D model may be derived from computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, ultrasound images, X-ray images, or other suitable imaging techniques. The choice of imaging technique may depend on various factors, such as the specific requirements of the surgical procedure, the patient's anatomy, the desired level of detail, and / or other relevant factors. Regardless of the imaging modality used, the bone may be segmented out to create the 3D model. In some examples, portions of the 3D model may be derived from atlas models. As described herein, in some examples, portions of the 3D model may be derived from tracking information (e.g., associated with a point probe or tracked surgical tool).

[0150] In some cases, the color map provided by the dynamic seating map system may be used to guide the application of impaction force during the surgical procedure. For instance, the color map may indicate areas where the implant is not in full contact with the bone, which may imply that additional impaction force is needed in those areas to achieve complete seating.Attorney Docket No. 8178.6171WOConversely, the color map may indicate areas where the implant is in full contact with the bone, which may imply that no additional impaction force is needed in those areas. This feedback may assist the surgeon in applying the impaction force in a targeted and efficient manner and potentially minimize the risk of fracture and / or other complications.

[0151] While the examples provided herein primarily refer to shoulder and hip procedures, a person of ordinary skill in the art may apply the methods and systems described to other implant-based procedures as well. A dynamic seating map system, with real-time visualization capabilities and color-coded and / or pattern-coded representations, may be adapted for use in various orthopedic surgeries involving implant placement. For example, the system may be applied to knee arthroplasty, spinal fusion procedures, dental implant surgeries, or even small joint replacements in the hand or foot. The underlying principles of tracking spatial poses, mapping prepared bone surfaces, calculating distances, and generating real-time visualizations may be tailored to the specific anatomical requirements and implant designs of particular surgical procedures. This versatility may allow surgeons across various specialties to benefit from the enhanced precision and real-time feedback offered by the dynamic seating map system and potentially improve outcomes in a wide range of implant-based surgeries.ExamplesExample 1: Hip ApplicationTable 1Attorney Docket No. 8178.6171WO

[0152] Table 1 presents an example color-coding scheme used in the dynamic seating map interface for a hip implant application during a total hip arthroplasty procedure. The colorcoding scheme is designed to visually represent the distance between the implant surface and the bone surface. Table 1 delineates four distinct distance ranges, each associated with a specific color to provide real-time feedback on the implant seating quality.

[0153] A distance of less than 0.5 mm is indicated by a gray color, signifying very close proximity or contact between the implant and bone. This color indicates that the implant is well-seated on the bone, which may be correlated with increases in the implant’s longevity and the patient’s postoperative recovery.

[0154] The range from 0.5 mm to 2 mm is represented by white, which suggests minimal separation and potentially acceptable seating. More particularly, this color indicates that the implant is close to the bone surface but may require minor adjustments to achieve optimal seating.

[0155] A green color is used for distances between 2 mm and 5 mm. which may indicate a moderate level of seating that could require attention. This color indicates that the implant is not fully seated on the bone, and the surgeon may need to apply additional impaction force or make other adjustments to improve the seating.

[0156] Finally, any distance greater than 5 mm is shown in beige, which corresponds to the natural color of bone. This may be used to highlight areas where the implant is not seated properly and may require significant adjustment. This color indicates that the implant is far from the bone surface, and the surgeon may need to reposition the implant or make otherAttorney Docket No. 8178.6171WO significant adjustments to achieve optimal seating. Some of these areas may correspond to portions of the bone outside of the coverage area of the implant.Example 2: Shoulder ApplicationTable 2

[0157] Table 2 presents an example color-coding scheme used in the dynamic seating map interface for a shoulder implant application during a total shoulder arthroplasty procedure. The color-coding scheme is designed to visually represent the distance between the implant surface and the bone surface. Table 2 delineates two distance ranges, each associated with a specific color to provide real-time feedback on the implant seating quality.

[0158] A distance of less than 0.5 millimeters is indicated by the color red, suggesting a zone of concern where the implant is potentially too close to the bone surface. The surgeon may need to reposition the implant or make other adjustments to prevent potential complications.

[0159] Conversely, a distance range from 0.5 millimeters to 3 millimeters is represented by the color green, signifying an acceptable range of contact where the implant is properly seated against the bone. In this example, this color indicates that the implant is well-seated on the bone, which is crucial for the implant’s longevity and the patient's postoperative recovery.Example Data Processing System

[0160] FIG. 11 illustrates a block diagram of an example data processing system 1100 in which examples are implemented. The data processing system 1100 is an example of a computer, such as a server or client, in which computer usable code or instructions implementing theAttorney Docket No. 8178.6171WO process for illustrative examples of the present disclosure are located. In some examples, the data processing system 1 100 may be a server computing device. For example, the data processing system 1100 may be implemented in a server or another similar computing device operably connected to a surgical system 100 as described above. The data processing system 1100 may be configured to, for example, transmit and receive information related to a patient and / or a related surgical plan with the surgical system 100. The data processing system 1100 may further be configured to process and store information associated with the CASS 100, such as determining distances between a surface the bone and an implant and generating a visualization based on the distances in real-time, as described herein.

[0161] In the depicted example, the data processing system 1100 may employ a hub architecture including a north bridge and memory controller hub (NB / MCH) 1101 and south bridge and input / output (I / O) controller hub (SB / ICH) 1102. A processing unit 1103, a main memory 1104, and a graphics processor 1105 may be connected to the NB / MCH 1101. The graphics processor 1105 may be connected to the NB / MCH 1101 through, for example, an accelerated graphics port (AGP).

[0162] In the depicted example, a network adapter 1106 connects to the SB / ICH 1102. An audio adapter 1107, a keyboard and mouse adapter 1108, a modem 1109. a read only memory (ROM) 1110, a hard disk drive (HDD) 1111, an optical drive (e.g., CD or DVD) 1112, a universal serial bus (USB) ports and other communication ports 1113, and PCI / PCIe devices 1114 may connect to the SB / ICH 1102 through a bus system 1116. The PCI / PCIe devices 1114 may include Ethernet adapters, add-in cards, and / or PC cards for notebook computers. The ROM 1110 may be, for example, a flash basic input / output sy stem (BIOS). The HDD 1111 and the optical drive 1112 may use an integrated drive electronics (IDE) or serial advanced technology7attachment (SATA) interface. A super I / O (SIO) device 1115 may be connected to the SB / ICH 1102.Attorney Docket No. 8178.6171WO

[0163] An operating system may run on the processing unit 1103. The operating system may coordinate and provide control of various components within the data processing system 1 100. As a client, the operating system may be a commercially available operating system. An object- oriented programming system, such as the Java™ programming system, may run in conjunction with the operating system and provide calls to the operating system from the object-oriented programs or applications executing on the data processing system 1100. As a server, the data processing system 1100 may be an IBM® eServer™ System* running the Advanced Interactive Executive operating system or the Linux operating system. The data processing system 1100 may be a symmetric multiprocessor (SMP) system that includes a plurality of processors in the processing unit 1103. Alternatively, a single processor system may be employed.

[0164] Instructions for the operating system, the object-oriented programming system, and applications or programs are located on storage devices, such as the HDD 1111. and are loaded into the main memory’ 1104 for execution by the processing unit 1103. The processes for examples described herein may be performed by the processing unit 1103 using computer usable program code, which can be located in a memory such as, for example, main memory 1104, ROM 1110, or in one or more peripheral devices.

[0165] A bus system 1116 may comprise one or more busses. The bus system 1116 may be implemented using any ty pe of communication fabric or architecture that provides for a transfer of data between different components or devices attached to the fabric or architecture. A communication unit such as the modem 1109 or the network adapter 1106 may include one or more devices that can be used to transmit and receive data.

[0166] Those of ordinary' skill in the art will appreciate that the hardware depicted in FIG. 11 may vary' depending on the implementation. Other internal hardware or peripheral devices, such as flash memory', equivalent non-volatile memory7, or optical disk drives may be used inAttorney Docket No. 8178.6171WO addition to or in place of the hardware depicted. Moreover, the data processing system 1100 can take the form of any of a number of different data processing systems, including but not limited to, client computing devices, server computing devices, tablet computers, laptop computers, telephone or other communication devices, personal digital assistants, and the like. Essentially, data processing system 1100 can be any known or later developed data processing system without architectural limitation.

[0167] While various illustrative examples incorporating the principles of the present teachings have been disclosed, the present teachings are not limited to the disclosed examples. Instead, this application is intended to cover any variations, uses, or adaptations of the present teachings and use its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which these teachings pertain.

[0168] In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative examples described in the present disclosure are not meant to be limiting. Other examples may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that various features of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein.

[0169] The present disclosure is not to be limited in terms of the particular examples described in this application, which are intended as illustrations of various features. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope ofAttorney Docket No. 8178.6171WO the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only and is not intended to be limiting.

[0170] With respect to the use of substantially any plural and / or singular terms herein, those having skill in the art can translate from the plural to the singular and / or from the singular to the plural as is appropriate to the context and / or application. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0171] It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (for example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” et cetera). While various compositions, methods, and devices are described in terms of “comprising” various components or steps (interpreted as meaning “including, but not limited to”), the compositions, methods, and devices also can “consist essentially of’ or “consist of’ the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups.

[0172] In addition, even if a specific number is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of "two recitations," without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, et cetera). In those instances where a convention analogous to “at leastAttorney Docket No. 8178.6171WO one of A, B, or C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, '‘a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B, and C together, et cetera). It will be further understood by those within the art that virtually any disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, sample examples, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or "A and B.”

[0173] In addition, where features of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group.

[0174] As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera. As will also be understood by one skilled in the art all language such as “up to,” “at least,” and the like include the number recited and refer to ranges that can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 cells refers to groups having 1, 2, or 3 cells. Similarly, a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth.Attorney Docket No. 8178.6171WO

[0175] The term “about,” as used herein, refers to variations in a numerical quantity that can occur, for example, through measuring or handling procedures in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of compositions or reagents; and the like. Typically, the term “about” as used herein means greater or lesser than the value or range of values stated by 1 / 10 of the stated values, e.g., ±10%. The term “about” also refers to variations that would be recognized by one skilled in the art as being equivalent so long as such variations do not encompass known values practiced by the prior art. Each value or range of values preceded by the term “about” is also intended to encompass the example of the stated absolute value or range of values. Whether or not modified by the term “about.” quantitative values recited in the present disclosure include equivalents to the recited values, e.g., variations in the numerical quantity of such values that can occur, but would be recognized to be equivalents by a person skilled in the art.

[0176] Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed examples.

Claims

Attorney Docket No. 8178.6171WOCLAIMSWhat is claimed is:

1. A method for generating a dynamic seating map during joint replacement surgery, comprising: tracking a spatial pose of a surgical tool relative to a patient's anatomy; determining a position of an implant based on the spatial pose of the surgical tool; mapping a prepared bone surface of the patient's anatomy; calculating one or more distances between the implant and the prepared bone surface; and generating a real-time visualization of the one or more distances on a user interface, wherein the visualization comprises at least one of a color-coded or pattern-coded representation of implant-to-bone contact.

2. The method of claim 1, wherein mapping the prepared bone surface comprises using a tracked tool to collect surface data points.

3. The method of claim 1, wherein calculating distances between the implant and the prepared bone surface comprises constructing a bounding-box tree.

4. The method of claim 1, wherein generating the real-time visualization comprises updating the representation at a predetermined frame rate as the surgical tool moves.

5. The method of claim 1, further comprising calibrating the surgical tool to determine a spatial relationship between a tracking frame on the surgical tool and an implant attached to the surgical tool.Attorney Docket No. 8178.6171WO6. The method of claim 5, wherein determining the position of the implant is based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool.

7. The method of claim 1, wherein the joint replacement surgery is selected from the group consisting of total hip arthroplasty, total shoulder arthroplasty, and total knee arthroplasty.

8. A system for intraoperative implant placement guidance, comprising: a tracking device configured to track a spatial pose of a surgical tool relative to a patient's anatomy; a processor configured to: determine a position of an implant based on the spatial pose of the surgical tool, map a prepared bone surface of the patient's anatomy, and calculate distances between the implant and the prepared bone surface; and a display device configured to present a real-time visualization of the calculated distances, wherein the visualization comprises at least one of a color-coded or pattern-coded representation of implant-to-bone contact.

9. The system of claim 8, wherein the processor is further configured to construct a bounding-box tree data structure for efficient distance computations between the implant and the prepared bone surface.Attorney Docket No. 8178.6171WO10. The system of claim 8, further comprising a calibration module configured to determine a spatial relationship between a tracking frame on the surgical tool and the implant attached to the surgical tool.

11. The system of claim 10, wherein the processor is configured to determine the position of the implant based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool.

12. The system of claim 8. wherein the display device is configured to update the representation at a predetermined frame rate as the surgical tool moves.

13. The system of claim 8. wherein the tracking device comprises an optical tracking system with markers attached to the surgical tool and the patient's anatomy.

14. The system of claim 13, wherein the processor is further configured to register the tracked spatial poses to a pre-operative medical image of the patient's anatomy.

15. A non-transitory computer-readable medium storing instructions that, when executed by a processor, cause the processor to perform operations for guiding implant placement during joint replacement surgery, the operations comprising: receiving tracking data of a surgical tool's spatial pose relative to a patient's anatomy; determining a position of an implant based on the tracking data; accessing a map of a prepared bone surface of the patient's anatomy; calculating distances between the implant and the prepared bone surface; andAttorney Docket No. 8178.6171WO generating a real-time visualization of the calculated distances for display on a user interface, wherein the visualization comprises at least one of color-coded or pattern-coded representation of implant-to-bone contact.

16. The non-transitory computer-readable medium of claim 15, wherein the operations further comprise constructing a bounding-box tree data structure.

17. The non-transitory computer-readable medium of claim 15. wherein the operations further comprise calibrating the surgical tool to determine a spatial relationship between a tracking frame on the surgical tool and the implant attached to the surgical tool.

18. The non-transitory computer-readable medium of claim 17. wherein determining the position of the implant is based on the calibrated spatial relationship and the tracked spatial pose of the surgical tool.

19. The non-transitory computer-readable medium of claim 15, wherein generating the realtime visualization comprises updating the representation at a predetermined frame rate as the surgical tool moves.

20. The non-transitory computer-readable medium of claim 19, wherein the operations further comprise registering the tracking data to a pre-operative medical image of the patient's anatomy.

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