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WO2025151691A1 - Système et méthode pour déterminer un risque de conflit fémoro-acétabulaire chez des patients avec une prothèse de hanche à l'aide d'une modélisation basée sur une image - Google Patents

Système et méthode pour déterminer un risque de conflit fémoro-acétabulaire chez des patients avec une prothèse de hanche à l'aide d'une modélisation basée sur une image

Info

Publication number
WO2025151691A1
WO2025151691A1 PCT/US2025/011032 US2025011032W WO2025151691A1 WO 2025151691 A1 WO2025151691 A1 WO 2025151691A1 US 2025011032 W US2025011032 W US 2025011032W WO 2025151691 A1 WO2025151691 A1 WO 2025151691A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
spinopelvic
computer
implant
impingement
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/011032
Other languages
English (en)
Other versions
WO2025151691A9 (fr
Inventor
Alessandro NAVACCHIA
Elizabeth A. DUXBURY
Nathan A. NETRAVALI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smith and Nephew Orthopaedics AG
Smith and Nephew Inc
Original Assignee
Smith and Nephew Orthopaedics AG
Smith and Nephew Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith and Nephew Orthopaedics AG, Smith and Nephew Inc filed Critical Smith and Nephew Orthopaedics AG
Publication of WO2025151691A1 publication Critical patent/WO2025151691A1/fr
Publication of WO2025151691A9 publication Critical patent/WO2025151691A9/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

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    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A—HUMAN NECESSITIES
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    • A61B34/25—User interfaces for surgical systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
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    • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/50—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
    • A—HUMAN NECESSITIES
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    • A61B2034/101—Computer-aided simulation of surgical operations
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    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
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    • A61B2034/105—Modelling of the patient, e.g. for ligaments or bones
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/374—NMR or MRI
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A61B2090/3762—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/34—Acetabular cups

Definitions

  • Typical total hip arthroplasty (THA) planning currently consists of templating a two-dimensional frontal x-ray of the patient’s joint or using a computed tomography (CT) scan from the patient to correctly size and position implant components on the patient’s anatomy.
  • CT computed tomography
  • One of the objectives of THA is to restore normal hip function, which includes both mobility and stability. Individual patients may present varying levels of spinopelvic mobility. Limited motion at the spinopelvic joint often results in compensation at the hip, thereby increasing the range of motion at the hip and increasing the risk of impingement.
  • patients may exhibit different types of limitations to spinopelvic mobility (i.e., different spinopelvic conditions) that influence the risk of impingement differently.
  • spinopelvic mobility i.e., different spinopelvic conditions
  • patients exhibiting a “stuck standing” pelvis position may be more prone to anterior ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 implant impingement
  • patients exhibiting a “stuck sitting” pelvis position may be more prone to posterior implant impingement.
  • Dislocation which is often driven by impingement, is one of the leading causes for revision surgery. The risk of impingement depends on the post-operative mobility of the patient.
  • a computer-implemented method includes receiving, by one or more processors, a three-dimensional model of a human anatomy comprising a spinopelvic joint; receiving, by the one or more processors, input related to a spinopelvic condition of a patient; modifying, by the one or more processors, the three-dimensional model ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • PT-6083-WO-PCT/D031202 based on the input related to the spinopelvic condition of the patient and a placement of an implant; performing, by the one or more processors, at least one simulation of one or more activities with the modified three-dimensional model; and displaying, by the one or more processors, an impingement analysis on a display device based on the at least one simulation.
  • the method further includes determining, by the one or more processors, at least one of a sacral slope or a lumbar lordosis of the patient based on the input; and classifying, by the one or more processors, the spinopelvic condition of the patient based on at least one of the sacral slope or the lumbar lordosis in a plurality of positions, wherein modifying the three-dimensional model is further based on the spinopelvic condition.
  • the three-dimensional model of the human anatomy includes a plurality of segments and a plurality of joints, wherein the plurality of segments are interconnected by the plurality of joints.
  • classifying the spinopelvic condition of the patient further includes classifying, based on a combination of a seated sacral slope and a standing sacral slope, a spinopelvic balance condition of the patient.
  • classifying the spinopelvic condition of the patient further includes classifying, based on a combination of a standing lumbar lordosis and a flex- seated lumbar lordosis, a spinopelvic balance condition of the patient.
  • classifying the spinopelvic condition of the patient further includes classifying, based on a combination of a standing lumbar lordosis and a relaxed-seated lumbar lordosis, a spinopelvic balance condition of the patient.
  • classifying the spinopelvic condition of the patient further includes classifying a spinopelvic mobility condition of the patient.
  • the spinopelvic mobility condition of the patient is selected from the group consisting of fused, stiff, hypermobile, and normal. ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • performing the at least one simulation of the one or more activities with the modified three-dimensional model further includes simulating a rotation of a stem of the implant about an axis until impingement between the stem and a cup or liner of the implant occurs.
  • the computer-implemented method further includes simulating a plurality of rotations of the stem and generating a range of motion profile for the plurality of rotations, wherein the range of motion profile indicates angles that can be reached by the stem without impingement with respect to the cup or liner.
  • displaying the impingement analysis includes visualizing a graphical representation of a minimum distance to impingement in reference to each of the one or more activities.
  • the computer-implemented method further includes generating an optimal placement of the implant based on the at least one simulation of one or more activities with the modified three-dimensional model.
  • generating an optimal placement of the implant includes determining a jump distance for the at least one simulation of one or more activities and selecting the optimal placement to maximize the jump distance.
  • a system for impingement analysis includes an input device; a display device; at least one processor; and a non-transitory, computer-readable medium comprising instructions.
  • FIG. 1 depicts an operating theatre including an illustrative computer-assisted surgical system (CASS) in accordance with an embodiment.
  • FIG. 2A depicts illustrative control instructions that a surgical computer provides to other components of a CASS in accordance with an embodiment.
  • FIG. 2B depicts illustrative control instructions that components of a CASS provide to a surgical computer in accordance with an embodiment.
  • FIG. 2C depicts an illustrative implementation in which a surgical computer is connected to a surgical data server via a network in accordance with an embodiment.
  • FIG.3A illustrates example imagery in accordance with an embodiment.
  • FIG. 9C illustrates an example visualization of series of sweeps in a range of motion profile in accordance with an embodiment.
  • FIG. 10 depicts an illustrative user interface for evaluating joint kinematic information in accordance with an embodiment.
  • FIG. 11 depicts an illustrative user interface for evaluating impingement in accordance with an embodiment.
  • FIG. 12 depicts an illustrative user interface that can be interacted with to visualize simple preset motions in one or two directions.
  • FIG. 13 illustrates a block diagram of an exemplary data processing system in which embodiments are implemented. ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • first point and the second point may correspond to surfaces of a joint.
  • a joint 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.
  • 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 humerus such that separation occurs between the bones of the joint.
  • 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 embodiments may be collectively referred to as distraction of the joint.
  • 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 embodiment 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 105A. While one robotic arm 105A is illustrated in FIG.1, in some embodiments there may be multiple devices. As examples, there may be one robotic arm 105A on each side of an operating table T or two devices on one side of the table T. The robotic arm 105A 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.
  • a floor platform not shown
  • mounted on a floor-to-ceiling pole or mounted on a wall or ceiling of an operating room.
  • 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.
  • 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, ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 vibratory impaction devices, reamers, ultrasonic bone cutting devices, radio frequency ablation devices, reciprocating devices (such as a rasp or broach), and laser ablation systems.
  • 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 embodiments of the present invention including, without ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 limitation, Infrared (IR) tracking systems, electromagnetic (EM) tracking systems, video or image based tracking systems, and ultrasound registration and tracking systems.
  • IR Infrared
  • EM electromagnetic
  • the surgical computer 150 can detect objects and prevent collision.
  • the surgical computer 150 can prevent the robotic arm 105A and/or the End Effector 105B from colliding with soft tissue.
  • Any suitable tracking system can be used for tracking surgical objects and patient anatomy in the surgical theatre.
  • 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 embodiments, this can include stereoscopic, tri-scopic, quad-scopic, etc. imaging.
  • additional cameras can be placed throughout the surgical theatre.
  • handheld tools or headsets worn by operators/surgeons can include imaging capability that communicates images back to a central processor to correlate those images with images captured by the camera array. This can give a more robust image of the environment for modeling using multiple perspectives.
  • 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.
  • the camera may be mounted on the robotic arm 105A.
  • 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.
  • a processor may track that tool or bone as it moves through the environment in a three-dimensional model.
  • ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202
  • 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.
  • an IR LED can flash a pattern that conveys a unique identifier to the source of that pattern, providing a dynamic identification mark.
  • one- or two-dimensional optical codes 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 corner of a tool tray, allowing the orientation and identity of that tray to be tracked. Other tracking modalities are explained throughout. For example, in some embodiments, augmented reality (AR) headsets can be worn by surgeons and other staff to provide additional camera angles and tracking capabilities.
  • AR augmented reality
  • 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 the 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 with the probe with the location data of the same landmarks in the 3D model.
  • 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.
  • 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.
  • a Tissue Navigation System 120 (not shown in FIG.
  • the Display 125 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. [0070]
  • 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, in one embodiment, the Display 125 overlays image information ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • the Display 125 may include, for example, one or more computer monitors.
  • one or more members of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD).
  • AR Augmented Reality
  • FIG.1 the Surgeon 111 is wearing an AR HMD 155 that may, for example, overlay pre-operative image data on the patient or provide surgical planning suggestions.
  • 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.
  • 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.
  • the Surgical Computer 150 is a ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 general-purpose computer.
  • 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.
  • 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.
  • Various techniques generally known in the art can be used for connecting the Surgical Computer 150 to the other components of the CASS 100.
  • the computers can connect to the Surgical Computer 150 using a mix of technologies.
  • the End Effector 105B may connect to the Surgical Computer 150 over a wired (i.e., serial) connection.
  • the Tracking System 115, Tissue Navigation System 120, and Display 125 can similarly be connected to the Surgical Computer 150 using wired connections.
  • 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.
  • the CASS 100 includes a robotic arm 105A that serves as an interface to stabilize and hold a variety of instruments used during the surgical procedure.
  • 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 105A 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).
  • movement of the robotic arm 105A may be effectuated by use of a control panel built into the robotic arm system.
  • a display screen may ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • PT-6083-WO-PCT/D031202 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 105A.
  • the surgeon or other healthcare professional may engage with the one or more input sources to position the robotic arm 105A when performing a surgical procedure.
  • a tool or an end effector 105B attached or integrated into a robotic arm 105A may include, without limitation, a burring device, a scalpel, a cutting device, a retractor, a joint tensioning device, or the like.
  • the end effector may be positioned at the end of the robotic arm 105A such that any motor control operations are performed within the robotic arm system.
  • the tool may be secured at a distal end of the robotic arm 105A, but motor control operation may reside within the tool itself.
  • the robotic arm 105A 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 105A, 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 105A may be tracked, for example, by a controller or the Surgical Computer 150.
  • 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.
  • the robotic arm 105A 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 105A may still be tracked as described above.
  • certain degrees of freedom can be selectively released upon input from user (e.g., surgeon) during specified portions of the ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 surgical plan tracked by the Surgical Computer 150.
  • a robotic arm 105A 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 105A or end effector 105B to transition from a motorized alignment mode to a mode where the saw or drill is engaged and powered on.
  • the CASS 100 can include a foot pedal (not shown) that causes the system to perform certain functions when activated.
  • the surgeon can activate the foot pedal to instruct the CASS 100 to place the robotic arm 105A 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 105A or end effector 105B medially or laterally, while restricting movement in other directions.
  • the robotic arm 105A 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.
  • movement of the robotic arm 105A 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.
  • the movement of the robotic arm 105A 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 ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • a robotic arm 105A may be used for holding the retractor.
  • the robotic arm 105A may be moved into the desired position by the surgeon. At that point, the robotic arm 105A may lock into place.
  • the robotic arm 105A is provided with data regarding the patient's position, such that if the patient moves, the robotic arm can adjust the retractor position accordingly.
  • 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).
  • the robotic arm 105A may also be used to help stabilize the surgeon's hand while making a femoral neck cut.
  • control of the robotic arm 105A may impose certain restrictions to prevent soft tissue damage from occurring.
  • the Surgical Computer 150 tracks the position of the robotic arm 105A as it operates. If the tracked location approaches an area where tissue damage is predicted, a command may be sent to the robotic arm 105A causing it to stop.
  • the robotic arm 105A 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.
  • the robotic arm 105A 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 105A may prevent any further seating to prevent damage to the pelvis.
  • ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202
  • the surgeon may use the robotic arm 105A 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.
  • the robotic arm 105A may restrict the handle to prevent further advancement of the broach.
  • the robotic arm 105A may also be used for resurfacing applications. For example, the robotic arm 105A may stabilize the surgeon while using traditional instrumentation and provide certain restrictions or limitations to allow for proper placement of implant components (e.g., guide wire placement, chamfer cutter, sleeve cutter, plan cutter, etc.). Where only a burr is employed, the robotic arm 105A 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. [0084] The robotic arm 105A may be a passive arm.
  • the robotic arm 105A may be a CIRQ robot arm available from Brainlab AG.
  • CIRQ is a registered trademark of Brainlab AG, Olof-Palme-Str. 9 81829, Ober, FED REP of GERMANY.
  • the robotic arm 105A is an intelligent holding arm as disclosed in U.S. Patent Application No.15/525,585 to Krinninger et al., U.S. Patent Application No.15/561,042 to Nowatschin et al., U.S. Patent Application No. 15/561,048 to Nowatschin et al., and U.S. Patent No.
  • Surgical Procedure Data Generation and Collection The various services that are provided by medical professionals to treat a clinical condition are collectively referred to as an "episode of care.”
  • 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 ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 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.
  • a dataset exists that includes 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 post- operative data provided by the patient or by a healthcare professional monitoring the patient.
  • 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 the surgical procedure and the patient outcomes.
  • the data collected over the episode of care may be used to generate a surgical plan.
  • a high-level, pre-operative plan is refined intra-operatively as data is collected during surgery.
  • 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.
  • pre-operative images or other input data may be used to develop a robust plan preoperatively that is simply executed during surgery.
  • 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.
  • Example data-driven techniques for designing, sizing, and fitting implants are described in U.S. Patent No. 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," the entire contents of each of which are hereby incorporated by reference into this patent application.
  • the data can be used for educational, training, or research purposes. For example, using the network-based approach described below in FIG.
  • the pre-operative data may also comprise quality of life data captured from the patient.
  • pre-surgery patients use a mobile application ("app") to answer questionnaires regarding their current quality of life.
  • 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.
  • FIGS. 2A and 2B provide examples of data that may be acquired during the intra-operative phase of an episode of care. These examples are based on the various components of 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.
  • 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 embodiments. 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.
  • PT-6083-WO-PCT/D031202 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.
  • the end effectors 105B of the robotic arm 105A are operatively coupled with cutting guide 105D.
  • the robotic arm 105A 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.
  • 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.
  • a surgeon can use any 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.
  • 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.
  • the Surgical Computer 150 provides the Display 125 with any visualization that is needed by the Surgeon 111 during surgery. For monitors, the Surgical Computer 150 may 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.
  • 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.
  • the display 125 in connection with a TKA, 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.
  • 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 LIFEMODTM simulation software from SMITH AND NEPHEW, INC.
  • 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).
  • 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).
  • 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. ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • 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.
  • the components may stream data to the Surgical Computer 150 in real-time or near real-time during surgery.
  • 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.
  • the components all transmit data to the Surgical Computer 150 in a common format.
  • 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.
  • 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 the Surgical Computer 150 (see FIG. 2B), the Surgical Computer can identify deviations that take place during surgery. [0105]
  • 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.
  • the Tracking Technology 115 can provide different types of data depending on the tracking methodology employed.
  • 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.
  • 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.
  • functional status can be measured with an Oxford Knee Score questionnaire
  • post-operative quality of life can be measured with a EQ5D-5L questionnaire.
  • 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.
  • the post-operative stage of the episode of care can continue over the entire life of a patient.
  • the Surgical Computer 150 or other ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 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.
  • 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.
  • 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.
  • 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 may be implemented using any technique known in the art.
  • a SQL-based database may be used where all of the various data items are structured in a manner that allows them to be readily incorporated in two SQL's collection of rows and columns.
  • a No-SQL database may be employed to allow for unstructured data, while providing the ability to rapidly process and respond to queries.
  • the term "No-SQL" is used to define a class of data stores that are non-relational in their design.
  • 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 embodiments ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 described herein and, in some embodiments, the different types of databases may support the Episode of Care Database 185.
  • column-based data models e.g., Cassandra
  • document-based data models e.g., MongoDB
  • key-value based data models e.g., Redis
  • graph-based data models e.g., Allego
  • 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 embodiments, the Surgical Computer 150 may use data from past surgeries, machine learning models, etc. to help guide the surgical procedure. [0113] In some embodiments, 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 Health Insurance Portability and Accountability Act
  • 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 for storage.
  • 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.
  • a unique identifier is assigned to data from a particular episode of care to allow for re-identification of the data if necessary.
  • 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.
  • 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.
  • a robust database of episode of care data allows the generation of optimized values, measurements, ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 distances, or other parameters and other recommendations related to the surgical procedure.
  • 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.
  • 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. [0115] 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. Methods of Assessing Impingement Risk in Implant Patients [0116] Planning applications may include varying forms of spinopelvic consideration combined with an impingement analysis.
  • Some example systems allow the user to manually input parameters measured on standing and relaxed-seated lateral x-rays. These measurements may be used to align the 3D bone models. The user may switch between standing and sitting positions. Starting from one of these two positions, the user may manually set the joint to a desired position. In some embodiments, when implant or bone impingement are present, the impinging areas in the 3D models are highlighted in a particular color, such as red.
  • Other example systems may use spinopelvic information within their planning software. For each patient, spinopelvic imagery may be collected. The imagery may include a CT scan and a set of lateral x-rays (e.g., standing, flexed-seated, and step-up). FIG.
  • FIG. 3A illustrates example lateral x-rays 301-303 in accordance with an embodiment.
  • the x-rays ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 may be used to take pelvis and spine measurements 304-306.
  • the measurements 304-306 may be used to position a CT-derived 3D model in the poses of the x-rays (e.g., standing, flexed-seated, and step-up).
  • FIG.3B illustrates example poses of the 3D model in accordance with an embodiment. The poses may be tested for impingement.
  • Further example systems may measure spinopelvic mobility on standing and relaxed-seated lateral x-rays.
  • a 3D model may be aligned to a standing position using the pelvic tilt measured on the lateral x-ray. Additional activities of daily life (e.g., walking, sitting down, lacing shoes, etc.) may be simulated. It should be noted that in current systems the spinopelvic mobility measurements do not affect the activities of daily life motion and impingement is only detected and visualized by running the activity animation. The systems may be improved by using the spinopelvic mobility of the patient to condition activity of daily life simulations that are used to quantify risk of implant-on-implant impingement.
  • the method includes receiving 405 a computer model of the human anatomy, receiving 410 input related to a spinopelvic condition of the patient (e.g., one or more of a spinopelvic balance and a spinopelvic mobility), classifying 415 the spinopelvic condition of the patient based on the input, conditioning 420 the computer model based on the spinopelvic condition, performing 425 at least one simulation of one or more activities of daily living with the computer model, analyzing 430 ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 impingement in the at least one simulation, and outputting 435 hip joint kinematic information based on the at least one simulation and/or the impingement analysis.
  • a spinopelvic condition of the patient e.g., one or more of a spinopelvic balance and a spinopelvic mobility
  • classifying 415 the spinopelvic condition of the patient based on the input
  • the hip joint kinematic information may be used to assess proposed parameters for a surgical plan for the patient including one or more implants (e.g., make, model, and/or size) and/or one or more implant placements (e.g., position and/or orientation).
  • implants e.g., make, model, and/or size
  • implant placements e.g., position and/or orientation.
  • FIG.5 an exemplary computer model of the human anatomy is depicted in accordance with an embodiment.
  • the computer model of the human anatomy may be a musculoskeletal model representing an average or generic human body.
  • the computer model may roughly represent a portion or an entirety of the human anatomy as a series of discrete, interconnected segments.
  • the computer model may comprise a plurality of segments connected by a plurality of joints.
  • the segments and/or joints may be simplified representations of the human anatomy and, as such, may approximate various structures.
  • a single segment e.g., lower leg and/or lower arm
  • one or more bones of the human anatomy are excluded entirely from the computer model.
  • the plurality of joints may be major joints of the human anatomy (e.g., hip, knee, etc.).
  • Each joint may connect two or more adjacent segments and may specify the manner and range of movement of the adjacent segments with respect to one another.
  • the joint may specify the manner and range of movement consistent with a corresponding natural, healthy joint of the human anatomy.
  • the joint may specify the manner and range of movement consistent with a corresponding joint exhibiting one or more conditions, including but not limited to disease, damage, and/or injury.
  • ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 [0123]
  • the human anatomy may be represented as 19 discrete segments connected by 18 joints.
  • the 19 discrete segments may include feet, lower legs, upper legs, lower torso (e.g., the pelvis and the sacral base (S1 vertebra)), central torso (e.g., lumbar portion of the spine), upper torso (e.g., thoracic portion of the spine), neck, head, scapulae, upper arms, lower arms, and/or hands.
  • lower legs e.g., the pelvis and the sacral base (S1 vertebra)
  • central torso e.g., lumbar portion of the spine
  • upper torso e.g., thoracic portion of the spine
  • neck head
  • scapulae e.g., upper arms, lower arms, and/or hands.
  • the 18 joints may include ankles, knees, hips, lumbar or spinopelvic (e.g., between lower torso and central torso, representing spinopelvic articulation of one or more anatomical joints between the S1 vertebra and the L1 vertebra), thoracic (e.g., between central torso and upper torso, representing articulation of one or more anatomical joints between the L1 vertebra and the T1 vertebra), lower neck (e.g., between upper torso and neck, representing articulation of one or more anatomical joints between the T1 vertebra and the C1 vertebra), upper neck (e.g., between neck and head, imitating articulation between the C1 vertebra and the skull), scapulae (e.g., between upper torso and scapulae), shoulders (e.g., between scapulae and upper arms), elbows, and/or wrists.
  • spinopelvic e.g., between lower torso and
  • a joint of the computer model may represent a single anatomical joint.
  • a joint of the computer model may represent a plurality of anatomical joints as a single articulating joint.
  • the lumbar joint may be generally located at a position corresponding to a joint between the S1 vertebra and the L5 vertebra, but the spinopelvic joint may represent the sum of all lumbar motion of joints between the S1 vertebra and the L1 vertebra.
  • the thoracic joint may be generally located at a position corresponding to a joint between the L1 vertebra and the T12 vertebra, but the thoracic joint may represent the sum of all motion of ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 joints between the L1 vertebra and the T1 vertebra.
  • the lower neck joint may be generally located at a position corresponding to a joint between the T1 vertebra and the C7 vertebra, but the lower neck joint may represent the sum of all motion of joints between the T1 vertebra and the C1 vertebra.
  • Additional anatomical joints may be combined in a single represented joint of the computer model as would be apparent to a person having an ordinary level of skill in the art.
  • some joints and/or segments described herein may include a greater degree of detail and/or may be divided into a plurality of joints and/or segments to provide greater resolution and accuracy to specific regions of the human anatomy based on a particular purpose.
  • the computer model is used for hip simulation
  • the hip joints, lumbar or spinopelvic joint, knee joints, and/or additional joints may be modified as described.
  • the spine may be divided into a greater number of segments and joints to represent the vertebrae of the spine more precisely.
  • the computer model may further comprise ligaments and other soft tissue structures to further improve the ability of the model to predict risk of impingement and dislocation.
  • the hip capsule may be included as a combination of 1D, 2D, and/or 3D elements to represent its contribution to resistance to dislocation.
  • tensioning of the hip capsule may inform the surgeon regarding medialization and lateralization of the cup and/or additional implant parameters that may affect hip ligament laxity.
  • the properties of the soft tissue structures around the simulated joint may be altered to simulate changes in state due to injury, malfunction, and/or surgery.
  • stiffness and laxity properties of the hip capsule may be altered in a particular region (e.g., anterior region) to simulate a surgical cut through the tissue and/or subsequent surgical repair.
  • the surgical cut and/or repair may simulate ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 a planned surgical approach (e.g., posterior approach) for the hip replacement procedure.
  • expected post-operative conditions of the soft tissue may be accounted for to provide greater accuracy to simulated hip conditions of the computer model.
  • the computer model may account for additional or alternative changes in soft tissue properties as would be apparent to a person having an ordinary level of skill in the art.
  • the computer model may further comprise muscles to correctly capture their force-generating capacity and predict contact forces at the implant during the simulated activities of daily living.
  • the muscles may be included as unidimensional elements that produce force to move the segments.
  • the muscles may be included as 3D elements that additionally capture relative translation between soft tissue structures and distributed pressure on implant components.
  • muscle elements may be altered to consider the surgical approach and/or simulate muscle weakness, lack of integrity, and other conditions in a similar manner as described previously for the hip capsule.
  • the input related to the spinopelvic condition of the patient may take a variety of forms.
  • receiving 410 input related to the spinopelvic condition of the patient includes obtaining one or more lateral 2D images (e.g., x-rays), such as those depicted in FIG.3A, of the spinopelvic joint of the patient.
  • the input may include a lateral 2D image of the patient in a standing position and/or a lateral 2D image of the patient in a sitting position.
  • the spinopelvic balance and/or spinopelvic mobility of the patient may be classified 415.
  • sacral slope also referred to as sacral tilt
  • lumbar lordosis may be used to classify 415 the spinopelvic condition of the patient.
  • Sacral slope (SS) or sacral tilt (ST), which is defined as the angle between the endplate of the S1 vertebra and the horizontal plane, or lumbar lordosis (LL), which is ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 defined as the curve of the lower spine, may be determined from the lateral 2D images and used to classify 815 the spinopelvic balance and/or spinopelvic mobility of the patient.
  • a user may manually provide a classification 415 for the spinopelvic balance and/or spinopelvic mobility of the patient.
  • sacral slope may be determined in each 2D image by landmarking the 2D images.
  • landmarking includes identifying a location of a superior/posterior S1 endplate 601 and/or a location of an inferior/anterior S1 endplate 602. In some embodiments, landmarking further includes identifying a location of one or more of a hip center 603, a posterior acetabulum 604, and an anterior acetabulum 605.
  • anatomical landmarks may be identified during landmarking as would be apparent to one having an ordinary level of skill in the art.
  • the landmarks are identified based on user input.
  • a computing device such as a processor of the system as further described herein, may automatically identify one or more landmarks based on historical image data and machine learning techniques.
  • the sacral tilt in each 2D image may be determined based on the identified landmarks.
  • an endplate orientation line 606 may be formed between the superior/posterior S1 endplate 601 and the inferior/anterior S1 endplate 602 as shown in FIG.6 to define an orientation of the S1 endplate.
  • FIG.7A depicts a measurement of sacral slope in both the standing position and the sitting position on lateral x-ray images in accordance with an embodiment.
  • spinopelvic balance may be classified as “stuck standing,” “stuck sitting,” kyphotic, or normal.
  • spinopelvic balance may be included in the user input as would be apparent to a person having an ordinary level of skill in the art.
  • spinopelvic mobility may be classified as fused, stiff, hypermobile, or normal.
  • additional medically recognized conditions related to spinopelvic mobility may be included in the user input as would be apparent to a person having an ordinary level of skill in the art.
  • Each of the described classifications of spinopelvic balance may be defined by the sacral slope in the standing position and/or the sitting position.
  • the “stuck standing” classification is defined by a sacral slope of greater than 30° in both the standing position and the sitting position.
  • the hypermobile classification is defined by a change in sacral slope of greater than 30°.
  • the normal classification is defined by any change in sacral slope that does not fall in the remaining spinopelvic mobility classifications (e.g., greater than 10°, but less than or equal to 30°).
  • the defined ranges for each classification may be varied and the methods described herein may be carried out in substantially the same manner with minor modifications as would be apparent to a person having an ordinary level of skill in the art. Accordingly, a sacral slope of the patient in a standing position and a sacral slope of the patient in a sitting position may be used to classify 415 the spinopelvic mobility of the patient based on a change in the sacral slope.
  • An angle between the first vector 608 and the second vector 609 may be measured to calculate the PI.
  • the PI is calculated as 73°.
  • a pelvic femoral angle (PFA) may be calculated as an angle formed by the first vector 608 and a third vector 610 that parallels the femoral diaphysis.
  • the PFA is calculated as 20°.
  • an anti-inclination angle (AI) may be calculated as an angle formed by an acetabular orientation line 611 (i.e., formed between the posterior acetabulum 604 and the anterior acetabulum 605) and the horizontal 607.
  • the AI is calculated as 52°.
  • a sacral acetabular angle may be calculated as an angle formed by an acetabular orientation line 611 and an extension of the endplate orientation line 606.
  • the SAA is calculated as 96°. Additional or alternative angles may be calculated from the 2D ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 images as would be apparent to a person having an ordinary level of skill in the art. In some embodiments, the angles are calculated based on user input.
  • a computing device such as a processor of the system as further described herein, may automatically calculate one or more angles based on the identified landmarks and/or machine learning techniques.
  • the various angles may be used to classify the mobility of the patient and identify limitations thereto as would be apparent to a person having an ordinary level of skill in the art.
  • Such mobility information may be incorporated into the computer model as described herein.
  • FIG.7B depicts a measurement of lumbar lordosis in both the standing position and the flexed-seated position on lateral x-ray images in accordance with an embodiment.
  • the lumbar lordosis of the patient in a standing position and/or flex-seated position may be used to classify 415 the spinopelvic balance of the patient.
  • the difference between the standing LL and flex-seated LL values ( LLf) may be calculated.
  • the LLf may be used as a classifier. For example, a LLf greater than 20° may be classified as normal and a LLf less than 20° may be classified as stiff.
  • FIG.7C depicts a measurement of lumbar lordosis in both the standing position and the relaxed-seated position on lateral x-ray images in accordance with an embodiment.
  • the lumbar lordosis of the patient in a standing position and/or relaxed-seated position may be used to classify 415 the spinopelvic balance of the patient.
  • the difference between the standing LL and relaxed-seated LL values ( LLr) may be calculated.
  • the LL r may be used as a classifier. For example, a LL r less than 10° may be classified as stiff, a LLr between 10° and 30° may be classified as normal, and a LLr greater than 30° may be classified as hypermobile. Patients with stiff and/or hypermobile spines may be associated with higher rates of impingement and/or dislocation. ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • the system may allow a user to select between different classifiers for spinopelvic mobility.
  • the classifier options may include one or more of the classifiers illustrated in FIGS.7A-7C.
  • different classifiers may require different imagery (e.g., relaxed vs. flexed seated) to be collected.
  • the system may prompt the collection of specific imagery in response to the selection of a classifier.
  • the user can supply previously captured imagery and the system may limit classifier options based on the available imagery.
  • additional patient-specific measurements beyond the described spinopelvic measurements may be used as inputs to the computer model to condition the computer model as described further herein, thereby customizing the simulations to a specific patient.
  • input data may include measurements, dimensions, geometries, and/or landmark locations for the patient anatomy.
  • the input data may be received and/or determined based on imaging data including but not limited to, computed tomography (CT), magnetic resonance (MR), and ultrasound.
  • CT computed tomography
  • MR magnetic resonance
  • ultrasound ultrasound
  • imaging data may be used to reconstruct bone and/or soft tissue geometries, which can be used to customize the computer model.
  • femur and pelvis geometries may be reconstructed from a CT scan of the hip and inform the computer model on patient-specific input and output variables, including, but not limited to, femur anteversion, bone-on-bone impingement, and soft-tissue impingement. Accordingly, mobility in the computer model may more accurately replicate the movement of the specific patient and account for limitations thereto in order to accurately simulate range of motion.
  • conditioning 420 the computer model based on the spinopelvic condition may comprise modifying the computer model to represent the spinopelvic condition of the patient (i.e., the pathological behavior associated with the classification of the spinopelvic condition of the patient).
  • conditioning 420 the ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 computer model may comprise limiting the motion of the spinopelvic joint of the computer model consistent with the spinopelvic balance and the spinopelvic mobility of the patient.
  • the motion of the spinopelvic joint may be limited to a range based on the lateral 2D images.
  • the motion of the spinopelvic joint may be limited to the range between the sacral slopes of the standing position and the sitting position based on the lateral 2D images.
  • the motion of the spinopelvic joint may be limited to a range based on the sacral slope values.
  • the motion of the spinopelvic joint may be limited to a range based on standard or average values for the spinopelvic balance and/or spinopelvic mobility. For example, the motion of the spinopelvic joint may be limited to a range that is typical for an individual with the indicated spinopelvic condition.
  • the manners of conditioning 420 the computer model as described herein may, in some instances, result in underestimating spinopelvic mobility and thus limiting motion of the spinopelvic joint to a greater degree than presented in the patient.
  • input sacral slope values and/or sacral slope values determined from lateral 2D images may not represent the maximum boundaries of motion of the spinopelvic joint.
  • the assessment of the motion of the spinopelvic joint as discussed herein refers to motion in the sagittal plane and may not ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 account for mobility in the transverse plane and/or frontal plane.
  • the computer model and the resultant joint kinematic information produced therewith may not be sensitive to mobility in the transverse plane and/or frontal plane.
  • mobility of the spinopelvic joint of the patient in the transverse plane and/or frontal plane may be fixed, left unconstrained, or limited in accordance with standard or average values for spinopelvic mobility in the respective planes.
  • additional information associated with the mobility in the transverse plane and/or frontal plane may be received and used to condition the computer model accordingly.
  • the computer model may simulate 425 activities of daily living including but not limited to sitting down, standing up, laying down, rising up from a laying position, walking on a flat surface, walking on an inclined and/or declined surface, walking up a flight of stairs, walking down a flight of stairs, crouching, bending over, and/or kneeling.
  • Further activities of daily living may include spine motion in the sagittal plane. Examples may include twist and lateral bending of the spine such as reaching out behind, pivoting, a golf swing, and a reach to the side from a seated position.
  • the simulation may account for the limitations of the spinopelvic condition.
  • a specific pose or motion associated with an activity of daily living may be performed by compensating with a greater range of motion at the hip joint than in a normal patient.
  • the computer model may limit motion of the spinopelvic joint consistent with ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 the spinopelvic condition and simulate the activities of daily living by enacting a greater degree of motion at the hip joint.
  • the movement of the hip joint through each activity may be assessed, i.e., a relative orientation of the pelvis segment and the upper leg segment may be determined.
  • the computer model may be used to determine a range of motion associated with each activity of daily living under the limitations of the spinopelvic condition.
  • the activities of daily living selected for assessment may comprise activities that occur substantially in the sagittal plane with respect to the spinopelvic joint as described herein. However, the activities of daily living may nonetheless comprise substantial motion of the hip joint in additional planes.
  • the at least one simulation may be performed 425 based on motion capture marker data.
  • motion capture data may be collected from one or more subjects as part of an experimental setup in a motion capture laboratory.
  • the motion capture data may be used to develop the biomechanics of the computer model based on the principles of inverse kinematics, thereby enabling the use of the computer model to simulate patient-specific biomechanics based on an indicated spinopelvic condition.
  • FIG.8 an illustrative motion capture system is depicted in accordance with an embodiment.
  • Physical markers may be fixed on the skin of one or more subjects in correspondence to known anatomical landmarks.
  • the locations of the physical markers may be recorded by cameras or other sensors of a motion capture system.
  • the physical markers are reflective markers, and the cameras are configured to detect the light from the reflective markers.
  • Virtual markers corresponding to each of the ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 physical markers may be positioned within the computer model in correspondence to the same anatomical landmarks.
  • the one or more subjects may perform a variety of activities associated with daily living, e.g., sitting down, standing up, laying down, rising up from a laying position, walking on a flat surface, walking on an inclined and/or declined surface, walking up a flight of stairs, walking down a flight of stairs, crouching, bending over, kneeling, etc.
  • the motion capture system may collect location information for each of the physical markers throughout the activities, and a mathematical algorithm (i.e., inverse kinematics algorithm) may be used to move the segments and joints of the computer model in a manner consistent with the movement of the one or more subjects by minimizing the differences in the positions of the physical markers and the corresponding virtual markers.
  • methodologies alternative to motion capture may be used to collect patient motion data and drive the computer model simulations.
  • technologies including, but not limited to, video-fluoroscopy, stereo-radiography, goniometers, skin stretch sensors, inertial measurement units, accelerometers, and gyroscopes.
  • Patient motion collected with these methodologies may be used to drive the whole computer model or a portion of it.
  • the computer model is scaled to the dimensions of each subject from the motion capture data collection. The distance between the physical markers detected by the motion capture system may be used to estimate the dimensions of segments of the computer model.
  • the distance between the marker placed at the knee and the marker placed at the ankle may be used to calculate the length of the subject's lower leg and inform the scaling of the model.
  • the pelvis (lower torso) of the model may be scaled using the markers attached to it, which may also scale the hip joint center location.
  • ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202
  • the mathematical algorithm may implement “unconstrained inverse kinematics,” in which each segment of the computer model follows the movement of the virtual markers attached thereto (informed by the movement of the corresponding physical markers as detected by the motion capture system), and each segment moves independently from other segments.
  • the mathematical algorithm may implement “constrained inverse kinematics,” in which relative motion of segments may be constrained by the joints and thus limited to specific types of motion indicated by the joints.
  • a hip joint and/or a knee joint may limit relative motion by permitting rotation and restricting translation between the segments. Additional ways of carrying out the development of the biomechanics of the computer model are described in Lu, T. W. and O'Connor, J. J., “Bone Position Estimation from Skin Marker Coordinates Using Global Optimisation with Joint Constraints,” Journal of Biomechanics, 32(2), pp 129-134 (1999), which is incorporated by reference herein in its entirety.
  • the musculoskeletal model and tracked motion capture data may simulate “normal spine” activities of daily living.
  • the lumbar spine is discretized into segments (e.g., five segments, such as one per vertebra) connected by spherical joints.
  • the spherical rotations may be constrained in the simulation to be equal across all joints (e.g., lateral bending between L1 and L2 is constrained to be equal to lateral bending between L2 and L3, L3 and L4, and so on). In this way, the lumbar spine motion may be homogeneous across vertebral joints.
  • a subsequent simulation may be run in which most joints of the musculoskeletal model are constrained to the motion obtained in the first simulation (i.e., the “normal spine” simulation) with the exception of some joints (e.g., the ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 hips), which are left unconstrained, and the lumbar spine joints, which are constrained to be within a threshold range (e.g., ⁇ 20°) in each degree of freedom (e.g., the overall lumbar twist calculated between S1 and L1 cannot go outside the threshold range).
  • a threshold range e.g., ⁇ 20°
  • hip motions for non-normal spines may be derived by constraining the spinopelvic joint flexion within bounds and/or translating the extra flexion into the hips.
  • analyzing 430 impingement in the at least one simulation includes transforming the simulation into an implant coordinate system and sweeping the simulated implant through a series of motions to detect when impingement (e.g., between the stem and cup or liner) occurs.
  • FIG.9A illustrates a modeled implant 900 coordinate systems in accordance with an embodiment. In certain embodiments, the coordinate system may be defined by an orientation of the acetabular cup 904.
  • the opening of the acetabular cup 904 may define a plane (e.g., including an x axis and a y axis).
  • the origin may be defined as the center of the circle defined by the acetabular cup’s 904 intersection with the plane.
  • the axes of the plane may be further defined based on the orientation of the stem 906 when the ball 902 is inserted in the acetabular cup 904.
  • ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 [0162]
  • FIG.9B illustrates an example simulated sweep 914 in which the stem 906 rotates about an axis until impingement between the stem 906 and cup 904 or liner 908 occurs.
  • the outputted joint contact information may be used to inform implant placement as further described herein. For example, since total hip replacement edge loading (i.e., determined by contact locations near the edge of the acetabular cup component) may lead to implant failure. Accordingly, joint contact information may be pertinent to cup and stem placement to reduce the risk of edge loading. [0166] In some embodiments, the joint kinematic information may be outputted 435 in a computer-readable format to a local device or a remote device.
  • the joint kinematic information may be displayed on a display device such as a display of a personal computer, a mobile device, a tablet, the display 125 of the CASS 100 of FIG.1, and the like. Accordingly, a user may be able to view the joint kinematic information to evaluate a surgical plan, select an implant model and/or size, select and implant position and/or orientation, and the like.
  • the joint kinematic information may include one or ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 more calculated post-operative ranges of motion depicted as values and/or as graphics for comparison with the ranges of motion required for the activities of daily living.
  • the joint kinematic information may inform selection of one or more parameters (e.g., implant model, size, position, and/or orientation).
  • the parameters may be selected via the input device (e.g., a touchscreen of a mobile device, tablet, or other device displaying the joint kinematic information) and recorded.
  • the outputted joint kinematic information may be used to assess parameters of a surgical plan, such as a position and orientation of an implant (e.g., an acetabular cup).
  • the joint kinematic information may be outputted 435 to a surgical system (e.g., CASS 100 of FIG.1).
  • the surgical system may use proposed implant information (e.g., a make, model, and size of a proposed implant) and anatomical information of the patient to assess one or more proposed placements of the implant.
  • the system may assess one or more implant placements, where each implant placement includes an implant position and an implant orientation (i.e., relative anterior or posterior orientation), to determine a post-operative range of motion of the hip joint associated with the implant placement in the manner disclosed herein and as understood by a person having an ordinary level of skill in the art.
  • the post-operative range of motion associated with each implant placement may be compared to the outputted joint kinematic information to determine whether the required range of motion of the patient is permitted by the implant placement and/or how much of the required range of motion of the patient is permitted by the implant placement.
  • the joint kinematic information may be used to optimize and/or select an implant placement of the implant based on the required range of motion.
  • a risk of impingement and/or capsule laxity for one or more activities of daily living may be quantified based on a comparison of the required ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 range of motion with a post-operative range of motion associated with a proposed implant placement.
  • joint forces calculated for each range of motion position as described herein may also be outputted (e.g., displayed as a pressure map graphic with the range of motion or a separate graphic) and used to assess each implant placement.
  • unduly high joint forces may be detrimental to joint stability. Accordingly, joint forces beyond a predetermined threshold value may be negatively weighed in the assessment of each implant placement.
  • the location of the joint forces may be factored into the assessment. For example, unduly high joint forces near an edge or lip of the acetabular cup may pose a higher risk to joint stability. Accordingly, the magnitude and the location of joint forces may be used to determine a risk associated with the joint forces and accordingly weighed in the assessment of each implant placement.
  • a level of stability, a risk of impingement, a risk of dislocation, and/or other metrics associated with the stability of the joint may be outputted for each implant placement.
  • FIG.10 depicts an illustrative user interface 1000 for evaluating joint kinematic information in accordance with an embodiment.
  • the user interface may include a classification 415 of the spinopelvic condition of a patient.
  • the user interface may include selections and/or visualizations of parameters 1004 of the implant.
  • Example parameters include implant type, liner options, ball size, neck length and stem type.
  • the user interface can include an option to compare one or more additional sets of implant parameters 1004.
  • the evaluation, as described herein, for the one or more additional sets of implant parameters 1004 may be concurrently displayed or selectively ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 individually displayed.
  • a recommendation for one or more of the parameters 1004 may be provided by the surgical system (e.g., CASS 100 of FIG.1) based on the joint kinematic information.
  • the user interface 1000 includes placement values 1008 of the implant.
  • the placement values include a cup inclination, a cup anteversion, and a stem anteversion.
  • the user interface can include an option to compare one or more additional sets of placement values 1008.
  • the range of motion parameters may be displayed in a range of motion profile 1014.
  • the range of motion profile 1014 may be calculated over a plurality of simulations that find the maximum rotation of the stem before impingement in the plurality of different directions. Optimally, the plurality of simulations is sufficiently high (e.g., 18) such that the area within the range of motion profile 1014 approximately indicates the angles that can be reached by the stem without impingement with the cup or liner.
  • the activity of daily living motions 1016 may be displayed on top of the range of motion profile 1014 as lines that include the hip angles achieved throughout each activity of daily life motion. If the activity of daily living motion 1016 is entirely contained by the range of motion profile 1014, the activity may be completed without impingement.
  • the user interface 1000 can depict an activity wheel 1012 that displays a metric relevant to impingement for different activities of daily life.
  • the activity wheel 1012 may display the minimum distance 1020 to impingement for all, or a subset of, activities of daily living.
  • Each activity of daily living line 1018 may be represented by an arc. If the arc touches the circle representative of the minimum distance 1020, an indication of impingement may be made.
  • the status of the icons 1104 may update automatically as adjustments are made to the implant parameters 1004 and placement values 1008.
  • the icons 1104 are organized in groups that indicate whether the activity of daily living is more prone to impingement on the anterior or posterior side.
  • the three-dimensional model 1102 of the anatomy and/or a model of the implant 1108 e.g., the liner
  • the three-dimensional model 1102 of the anatomy and/or a model of the implant 1108 may be configured to depict impingement areas 1106/1110.
  • a summary of areas 1106/1110 impinging during the included activities of daily living is displayed on the three-dimensional model with highlighted areas (e.g., through colorization or outlining).
  • interacting with an impingement area 1106/1110 can present the user with the activity of daily living in which the impingement occurs (e.g., highlighting the icon(s) 1104 and/or overlaying an identifier of the activity of daily living).
  • an alternative impingement diagram 1010 and activity wheel 1012 may be generated that illustrate bone-on-bone impingement.
  • the range of motion profile may be a three-dimensional diagram (i.e., instead of a planar diagram).
  • Distance to impingement may be similarly calculated and displayed in the activity wheel 1012.
  • distance to impingement in bone-on-bone impingement can be directly calculated as a three-dimensional distance between potentially impinging objects within the three-dimensional model.
  • the implant model 1108 can present an indicator 1112 of the jump distance (i.e., the distance the head needs to travel to dislocate) when the stem impinges in a location.
  • the indicator 1112 may include a color-coded border to the implant model.
  • a jump distance indicator 1112 may be useful when lipped liners are used and the lip orientation is planned to have a largest jump distance corresponding with impingement. By considering jump distance, the system and/or user may maximize joint stability when impingement cannot be avoided.
  • a system may comprise at least one processor and a computer-readable storage medium comprising instructions configured to, when executed, cause the at least one processor to obtain a computer model of the human anatomy, receive input related to a spinopelvic condition of the patient, classify the spinopelvic condition of the patient based on the input, condition the computer model based on the spinopelvic condition, perform at least one simulation of one or more activities of daily living with the computer model, and output hip joint kinematic information based on the at least one simulation as described herein.
  • the system may further comprise an input device configured to receive the input related to the spinopelvic condition of the patient as user input and transmit the user ACTIVE ⁇ 1605978092.2 Attorney Docket No.
  • PT-6083-WO-PCT/D031202 input to the at least one processor.
  • the input device may be implemented in any manner as would be apparent to a person having an ordinary level of skill in the art.
  • the devices, systems, and methods as described herein are not intended to be limited in terms of the particular embodiments described, which are intended only as illustrations of various features. Many modifications and variations to the devices, systems, and methods can be made without departing from their spirit and scope, as will be apparent to those skilled in the art. [0187] While the devices, systems, and methods are generally described herein as focusing on the hip joints, it should be understood that the methods may be limited to one specific hip joint of interest, e.g., an operative hip joint for which a surgical procedure is being planned.
  • the spinopelvic characterization (e.g., sacral slope angles and/or spinopelvic classification) may be generated or determined without the use of imaging.
  • an adequately sensitive motion capture system may be configured to determine sacral slope angles at one or more poses of the patient.
  • the motion capture system may be a camera-based motion capture system as described.
  • the motion capture system may additionally or alternatively use inertial or electromagnetic sensors to capture motion with adequate sensitivity to determine sacral slopes. Accordingly, the resulting characterization may be provided as input as described herein to condition the computer model. [0190] While user input is generally described herein, it should be understood that the process may be further automated by excluding user input.
  • the data processing system 1300 may employ a hub architecture including a north bridge and memory controller hub (NB/MCH) 1301 and south bridge and input/output (I/O) controller hub (SB/ICH) 1302.
  • a processing unit 1303, a main memory 1304, and a graphics processor 1305 may be connected to the NB/MCH 1301.
  • the graphics processor 1305 may be connected to the NB/MCH 1301 through, for example, an accelerated graphics port (AGP).
  • AGP accelerated graphics port
  • a network adapter 1306 connects to the SB/ICH 1302.
  • An audio adapter 1307, a keyboard and mouse adapter 1308, a modem 1309, a read only memory (ROM) 1310, a hard disk drive (HDD) 1311, an optical drive (e.g., CD or DVD) 1312, a universal serial bus (USB) ports and other communication ports 1313, and PCI/PCIe devices 1314 may connect to the SB/ICH 1302 through a bus system 1316.
  • the PCI/PCIe devices 1314 may include Ethernet adapters, add-in cards, and/or PC cards for notebook computers.
  • the ROM 1310 may be, for example, a flash basic input/output system (BIOS).
  • the HDD 1311 and the optical drive 1312 may use an integrated drive electronics (IDE) or serial advanced technology attachment (SATA) interface.
  • IDE integrated drive electronics
  • SATA serial advanced technology attachment
  • a super I/O (SIO) device 1315 may be connected to the SB/ICH 1302.
  • An operating system may run on the processing unit 1303. The operating system may coordinate and provide control of various components within the data processing system 1300.
  • the operating system may be a commercially available operating system.
  • An object-oriented programming system such as the Java TM programming system, may run in conjunction with the operating system and provide calls to the operating system ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202 from the object-oriented programs or applications executing on the data processing system 1300.
  • the data processing system 1300 may be an IBM® eServer TM System ® running the Advanced Interactive Executive operating system or the Linux operating system.
  • the data processing system 1300 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.
  • ACTIVE ⁇ 1605978092.2 Attorney Docket No. PT-6083-WO-PCT/D031202
  • data processing system 1300 can be any known or later developed data processing system without architectural limitation.
  • 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. [0203] 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).
  • a range includes each individual member.
  • a group having 1-3 cells refers to groups having 1, 2, or 3 cells.
  • a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth.
  • 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.
  • the term “about” as used herein ACTIVE ⁇ 1605978092.2 Attorney Docket No.

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Abstract

Des systèmes et des méthodes d'analyse de conflit fémoro-acétabulaire sont présentement divulgués. Une méthode consiste à : recevoir un modèle tridimensionnel d'une anatomie humaine comprenant une articulation spino-pelvienne ; recevoir une entrée associée à une pathologie spino-pelvienne d'un patient ; déterminer une pente sacrée et/ou d'une lordose lombaire du patient sur la base de l'entrée ; classer la pathologie spino-pelvienne du patient sur la base de la pente sacrée et/ou de la lordose lombaire dans une pluralité de positions ; modifier le modèle tridimensionnel sur la base de la pathologie spino-pelvienne et d'un placement d'une prothèse ; réaliser au moins une simulation d'une ou de plusieurs activités avec le modèle tridimensionnel modifié ; et afficher une analyse de conflit fémoro-acétabulaire sur un dispositif d'affichage sur la base de l'au moins une simulation.
PCT/US2025/011032 2024-01-10 2025-01-10 Système et méthode pour déterminer un risque de conflit fémoro-acétabulaire chez des patients avec une prothèse de hanche à l'aide d'une modélisation basée sur une image Pending WO2025151691A1 (fr)

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